Siddoway, C. J.

¶ 1 — Comments to § 23 of the Restatement (Third) of Torts, which deals with strict liability imposed on the owners of abnormally dangerous animals, observe that the common law has been satisfied overall with the generalization that livestock are not excessively dangerous, but *106“[i]n the future, courts might wish to give consideration to particular genders ... of a species that involve danger levels uncommon for the species itself.” Restatement (Third) of Torts: Liability for Physical and Emotional Harm § 23 cmt. e (Am. Law Inst. 2010) (emphasis added). In this case, Jay Rhodes asks us to hold the owner of a ram (a male sheep) strictly liable for harm caused by the ram on account of the ram’s gender-based dangerousness, rather than any abnormal dangerousness of which the owner was aware.

¶2 Mr. Rhodes is a particularly sympathetic plaintiff and appellant, both in the circumstances he presents and the forthrightness of his argument on appeal. But we conclude that existing Washington common law strikes the appropriate balance in imposing limited strict liability on the owners of domestic animals and otherwise imposing a duty of care commensurate with the character of their animals. We affirm the summary judgment dismissal of Mr. Rhodes’s complaint.

FACTS AND PROCEDURAL BACKGROUND

¶3 Jay Rhodes and Rodney MacHugh are longtime friends and neighbors. Both men live in Richland and have farmed for decades. Mr. Rhodes has raised cows, horses, and occasionally pigs and goats, but he described the summer of 2012 as “my first excursion with sheep. And an unfortunate one.” Clerk’s Papers (CP) at 21. Mr. MacHugh has bred sheep for over 30 years. Because Mr. MacHugh’s land is prone to flooding, Mr. Rhodes has allowed Mr. MacHugh to keep some of his livestock on Mr. Rhodes’s property.

¶4 In the summer of 2012, Mr. MacHugh and Mr. Rhodes went to a livestock yard in Lewiston, Idaho, where Mr. MacHugh purchased a ram to replace his existing ram, which he described as “in really old shape.” CP at 26. The replacement ram was eight or nine months old1 and *107weighed in the neighborhood of 150 pounds. It showed no vicious tendencies. The men took it directly to Mr. Rhodes’s property where, for the following month, it caused no problems. In the weeks before Mr. MacHugh put the ram in with ewes, Mr. Rhodes described it as “real friendly. He’d come up to me several times when I was changing water, and I’d pet him.” CP at 22.

¶5 On August 20, 2012, Mr. Rhodes went into his yard to turn on his sprinklers. By that time, Mr. MacHugh had put several ewes in the pasture with the ram. Mr. Rhodes walked past them and toward the five-foot sprinklers in the pasture. Just as he touched the valve at the top of the sprinklers, the ram butted him from behind, knocking him to the ground. According to Mr. Rhodes, the ram continued to “jump up in the air and then he’d hit me with his head,” knocking him out “a couple of times,” for as much as 30 minutes. CP at 23. Fortunately, a neighbor who stopped by to bring Mr. Rhodes some cantaloupes saw what was going on. Although Mr. Rhodes told her not to come into the pasture, she began throwing her cantaloupes at the ram, which was sufficiently distracted that Mr. Rhodes was able to crawl to the gate. She helped him out and slammed the gate on the charging ram. Mr. Rhodes, then 82 years old, suffered a concussion, five broken ribs, and a broken sternum and shoulder. He was hospitalized for 16 days.

¶6 Mr. Rhodes filed this action in an effort to recover for his injuries. He did not contend that the ram was abnormally dangerous, and he refused to accuse his friend of negligence, testifying, “I don’t think Mr. MacHugh thought there was anything wrong” with the ram. CP at 23. For his part, Mr. MacHugh admitted that he had owned as many as three “mean” rams over the years, but that “on my place, if they’re the least bit mean, they go real quick.” CP at 27. He testified that he had selected this ram because it was the “friendliest” of three that the seller had raised on a bottle after their mother died. CP at 26.

¶7 Because Mr. Rhodes relied exclusively on a theory of strict liability that he asked the court to extend to the *108owners of all rams, not just those known to be abnormally dangerous, the parties presented the legal issue to the trial court on summary judgment. Mr. MacHugh’s motion for summary judgment dismissing the claim was granted. Mr. Rhodes appeals.

ANALYSIS

¶8 The sole issue on appeal is whether summary judgment in favor of Mr. MacHugh was proper because he is not strictly liable for harm caused by a ram he did not know to be abnormally dangerous. No material facts are in dispute, and we, like the trial court, are presented with a pure question of law that we review de novo. Triplett v. Dep’t of Soc. & Health Servs., 166 Wn. App. 423, 427, 268 P.3d 1027 (2012).

¶9 For more than a century, the rule in Washington regarding liability for harm caused by a domestic animal2 has been:

“The owner or keeper of a domestic animal not naturally inclined to commit mischief, while bound to exercise ordinary care to prevent injury being done by it to another, is not liable for such injury if the animal be rightfully in the place when the mischief is done, unless it is affirmatively shown, not only that the animal was vicious, but that the owner or keeper had knowledge of the fact. When such scienter exists, the owner or keeper is accountable for all the injury such animal may do, without proof of any negligence or fault in the keeping, and regardless of his endeavors to so keep the animal as to prevent the mischief.”

Lynch v. Kineth, 36 Wash. 368, 370-71, 78 P. 923 (1904) (emphasis omitted) (quoting 2 Cyc. Animals 368-69 (1901)). More recently, see Johnston v. Ohls, 76 Wn.2d 398, 400, 457 *109P.2d 194 (1969); and Sligar v. Odell, 156 Wn. App. 720, 732, 233 P.3d 914 (2010); and see also 16 David K. DeWolf & Keller W. Allen, Washington Practice: Tort Law and Practice § 3:6, at 133 (4th ed. 2013), noting that “[s]trict liability for injuries caused by individual animals known to be abnormally dangerous is still the general rule,” but “when the animal is not an abnormally dangerous specimen of its class, negligence in controlling the animal must be proven.”

¶10 Washington cases are consistent with the Restatement (Second) of Torts (Am. Law Inst. 1977). In Arnold v. Laird, 94 Wn.2d 867, 871, 621 P.2d 138 (1980), our Supreme Court noted that the Restatement (Second) “recognizes two separate causes of action” against the owner of a domestic animal that causes injury. Under § 509, strict liability applies where the animal “has known dangerous propensities abnormal to its class.” Arnold, 94 Wn.2d at 871. Section 518, on the other hand, “provides that if there are no known abnormally dangerous propensities, the owner is liable only if he is negligent in failing to prevent the harm. The amount of care required is commensurate with the character of the animal.” Id. (emphasis omitted) (citing Restatement (Second) § 518 cmt. f).

¶ 11 Mr. Rhodes concedes that rams have not historically been regarded as being inherently dangerous animals. Br. of Appellant at 1-2; Restatement (Second) § 509 cmt. e (“[T]he law has not regarded bulls, stallions and rams as being abnormally dangerous animals to be kept under the strict liability stated in this Section.”). Nevertheless, relying on a comment to § 23 of the most recent Restatement, he asks that we recognize that “[t] he dangerous propensities of rams are well-known and strict liability should attach, and this whether the animal is ‘domestic’ or otherwise.” Br. of Appellant at 3.

*110¶12 The language of § 23 of the Restatement (Third) is similar to that of Restatement (Second) § 509,3 yet the comments to § 23 propose a possible gender- or breed-based modification of the general rule treating domestic animals as not excessively dangerous. Comment e states, in part:

Overall, the common law has been satisfied with the generalization that livestock and dogs are not excessively dangerous and has applied this generalization to all livestock and dogs. In the future, courts might wish to give consideration to particular genders or breeds of a species that involve danger levels uncommon for the species itself If so, it might be appropriate to impose strict liability, without individualized, scienter, on the owner of such an animal.

Restatement (Third) § 23 cmt. e (emphasis added). Mr. Rhodes asks us to act on this acknowledgment and common knowledge that while ewes may be timid, rams are known to be dangerous.

¶13 Prior versions of the Restatement have not overlooked the different temperament of male domestic animals, pointing out that “[b]ulls are more dangerous than cows and steers; stallions are more dangerous than mares and geldings; rams are more dangerous than ewes and lambs.” Restatement (Second) § 509 cmt. e. But historically the framework of liability for negligence has been viewed as adequate to address gender differences, and refusing to broaden strict liability has also been justified by policy reasons.

¶14 The Restatement (Second) recognizes the relatively dangerous propensities of male domestic animals such as bulls, stallions, and rams but characterizes them as normal to their class. As the comments to § 509 observe, “[T]hese animals have been kept for stud purposes from time imme*111morial so that the particular danger involved in their dangerous tendencies has become a normal incident of civilized life.” Restatement (Second) § 509 cmt. e; see also id. § 509 cmt. d (noting that such animals “do not introduce any unusual danger, since the somewhat dangerous characteristics of these animals are a customary incident of farming”). In other words, a ram has not been considered “abnormally” dangerous for purposes of applying strict liability under § 509 because its dangerous propensities are “normal” for its species.

¶15 It is also for policy reasons that owners of male domestic animals have not been held to a standard of strict liability, because often it is the very characteristics that cause the males to be dangerous that make them useful to society. The comments to § 518 of the Restatement (Second) observe that “ [t] he high temper normal to stud animals is so inseparable from their usefulness for breeding purposes that they are not kept at the risk of the liability stated in § 509.” Restatement (Second) § 518 cmt. f. The comments explaining the rationale for § 509’s rule of strict liability similarly observe that

the virility which makes [bulls, stallions, and rams] dangerous is necessary for their usefulness in performing their function in the socially essential breeding of livestock, [and] justifies the risk involved in their keeping. Therefore, the law has not regarded bulls, stallions and rams as being abnormally dangerous animals to be kept under the strict liability stated in this Section.

Id. § 509 cmt. e; see also id. § 509 cmt. d (“[T]he slightly added risk due to their dangerous character is counterbalanced by the desirability of raising livestock.”).

¶16 The law is not oblivious to the greater risk posed by male livestock used for breeding in the context of liability for negligence, and greater precautions are typically required in light of their characteristics. Restatement (Second) § 509 cmt. e. “The amount of care required is commensurate with the character of the animal.” Arnold, 94 Wn.2d at 871. *112As the comments to § 518 explain, “the keeper of a bull or stallion is required to take greater precautions to confine it to the land on which it is kept and to keep it under effective control when it is taken from the land than would be required of the keeper of a cow or gelding.” Restatement (Second) § 518 cmt. g.

¶17 “Rules of law . . . should not be changed for light or transient causes; but, when time and events prove the need for a change, changed they must be.” State ex rel. Wash. State Fin. Comm. v. Martin, 62 Wn.2d 645, 666, 384 P.2d 833 (1963). Here, the utility of domestic animals remains undiminished. Those who raise them and face the greatest exposure to relatively more dangerous genders or breeds will be familiar with their characteristics. Third parties continue to have recourse for an owner’s negligence, and owners are required to take greater precautions to confine and control animals in light of their characteristics. Mr. Rhodes’s unfortunate excursion with Mr. MacHugh’s ram does not persuade us that the limited scope of strict liability that Washington has historically imposed on the owners of domestic animals should be enlarged.4

¶18 Affirmed.

Korsmo and Fearing, JJ., concur.

Review denied at 185 Wn.2d 1019 (2016).

Chief Judge Fuld.

The principal question posed on this appeal is whether a person who has sustained property damage caused by blasting on nearby property can maintain an action for damages without a showing that the blaster was negligent. Since 1893, when this court decided the case of Booth v. Rome, W. & O. T. R. R. Co. (140 N. Y. 267), it has been the law of this State that proof of negligence was required unless the blast was accompanied by an actual physical invasion of the damaged property— for example, by rocks or other material being cast upon the premises. We are now asked to reconsider that rule.

The plaintiff Spano is the owner of a garage in Brooklyn which was wrecked by a blast occurring on November 27, 1962. *14There was then in that garage, for repairs, an automobile owned by the plaintiff Davis which he also claims was damaged by the blasting. Each of the plaintiffs brought suit against the two defendants who, as joint venturers, were engaged in constructing a tunnel in the vicinity pursuant to a contract with the City of New York.1 The two eases were tried together, without a jury, in the Civil Court of the City of New York, New York County, and judgments were rendered in favor of the plaintiffs. The judgments were reversed by the Appellate Term and the Appellate Division affirmed that order, granting leave to appeal to this court.

It is undisputed that, on the day in question (November 27, 1962), the defendants had set off a total of 194 sticks of dynamite at a construction site which was only 125. feet away from the damaged premises. Although both plaintiffs alleged negligence in their complaints, no attempt was made to show that the defendants had failed to exercise reasonable care or to take necessary precautions when they were blasting. Instead, they chose "to rely, upon the trial, solely on the principle of absolute liability either on a tort theory or on .the basis of their being third-party beneficiaries of the defendants’ contract with the city. At the close of the plaintiff Spano’s case, when def endants ’ attorney moved to' dismiss the action on the ground, .among others, that no negligence, had been proved, the trial judge expressed the view that the defendants could be held liable even ■though they were not shown to have been careless. The case then proceeded, with evidence being introduced solely on the question of damages and proximate cause. Following the trial, the court awarded damages of some $4,400 to Spano and of $329 to Davis.

On appeal, a divided Appellate Term reversed that judgment, declaring that it deemed itself concluded by the established rule in this State requiring proof of negligence. Justice Markowitz, *15who dissented, urged that the Booth case should no longer be considered controlling precedent.

The Appellate Division affirmed; it called attention to a decision in the Third Department (Thomas v. Hendrickson Bros., 30 A D 2d 730, 731), in which the court observed that “ [i]f Booth is to be overruled, ‘ the announcement thereof should come from the authoritative .source and not in the form of interpretation or prediction by an intermediate appellate court ’ ”.

In our view, the time has come for this court to make that “ announcement ” and declare that one who engages in blasting must .assume responsibility, and be liable without fault, for any injury he causes to neighboring property.

The concept of absolute liability in blasting cases is hardly a novel one. The overwhelming majority of American jurisdictions have adopted such a rule. (See Prosser, Torts [2d ed.], § 59, p. 336; 3 Restatement, Torts, §§ 519, 520, comment e; Ann., 20 ALR 2d 1372. )2 Indeed, this court itself, several years ago, noted that a change in our law would "conform to the more widely (indeed almost universally) approved doctrine that a blaster is absolutely liable for any damages he causes, with or without trespass”. (Schlansky v. Augustus V. Riegel, Inc., 9 N Y 2d 493,496.)

We need not rely solely, however, upon out-of-state decisions in order to attain our result. Not only has the rationale of the Booth case (140 N. Y. 267, supra) been overwhelmingly rejected elsewhere but it appears to be fundamentally inconsistent with earlier cases in our own court which had held, long before Booth was decided, that a party was absolutely liable for damages to neighboring property caused by explosions. (See, e.g., Hay v. Cohoes Co., 2 N. Y. 159; Heeg v. Licht, 80 N. Y. 579.) In the Hay case (2 N. Y. 159, supra), for example, the defendant was engaged in blasting an excavation for a canal and the force of the blasts caused large quantities of earth and stones to be thrown against the plaintiff’s house, knocking down his stoop *16and part of Ms cMmney. The court held the defendant absolutely liable for the damage caused, stating (2 N. Y., at pp. 160-161):

‘ ‘ It is an elementary principle in reference to private rights, that every individual is entitled to the undisturbed possession and lawful enjoyment -of his own property. • The mode -of enjoyment is necessarily limited by the rights -of others—otherwise it might be made destructive of their rights altogether. Hence the maxim sic útere tuo, Sc. The defendants had the right to dig the canal. The plaintiff the right to the undisturbed possession -of his property! If these rights conflict, the former must yield to the latter, as the more important of the two, since, upon grounds of public policy, it is better that one man should -surrender a particular use of his land, than that another should be deprived of the beneficial use -of his property -altogether, which might be the consequence if the privilege'of the former should be wholly unrestricted. ' The case before us illustrates this principle. For if the defendants in -excavating their canal, in itself a lawful use -of their land, could, in the manner mentioned by the witnesses, -demolish the stoop of the plaintiff with impunity, they might, for the same purpose, -on the exercise of reasonable care, demolish , his' house, and thus deprive him of all use of his property.” -

Although the court in Booth drew -a distinction between -a situation— such as w-as presented in the Bay case—Where there was “ a physical invasion ” of, -or trespass -on, the plaintiff’s property and one in which the damage.was caused by “ setting the air in motion, or in some other unexplained way ” (140 N. Y., at pp. 279, 280), it is clear that the court, in the earlier cases, was not concerned with the particular manner by which the damage was caused but by the -simple fact that any explosion in a built-up area was likely to cause damage. Thus, in Heeg v. Licht (80 N. Y. 579, supra), the court held that there should be absolute liability where the damage was caused by the accidental explosion of stored gunpowder, even in the absence of a physical trespass (p. 581):

“ The defendant had erected a building and -stored materials therein, which from their character were *17. liable .to .and actually did explode, causing injury to the plaintiff. The fact that the explosion took place tends to establish that the magazine was danger ous and liable to cause damage to the property of persons residing in the vicinity. * * * ' The fact that the magazine was liable to such a contingency, which could not be guarded against or averted by the greatest degree of care and vigilance, evinces its dangerous character, * * * In such a case, the rule which exonerates a party engaged in a lawful business, when free from negligence, has no application. ’ ’

Such reasoning should, we venture, have led to the conclusion that the intentional setting off of explosives — that is, blasting— in an area in which it was likely to cause harm to neighboring property similarly results in absolute liability. However, the court in the Booth case rejected such an extension of the rule for the reason that “ [t]o exclude the defendant from blasting to adapt its lot to the contemplated uses, at the instance of the plaintiff, would not be a compromise between conflicting rights, but an extinguishment of the right of the one for the benefit of the other ” (140 N. Y., at p. 281). The court expanded on this • by stating, 1 ‘ This sacrifice, we think, the law does not exact. Public policy is promoted by the building up of towns and cities and the improvement of property. Any unnecessary restraint on freedom of .action of a property owner hinders this.”

This rationale cannot withstand analysis. The plaintiff in Booth was not seeking, as the court implied, to “ exclude the defendant from blasting ” and thus prevent desirable improvements to the latter’s property. Rather, he was merely seeking compensation for the damage which was inflicted upon his own property as a result of that blasting. The question, in other words, was not whether it was lawful or proper to engage in blasting but who should bear the cost of any resulting damage — the person who engaged in .the dangerous activity or the innocent neighbor injured thereby. Viewed in such a light, it clearly appears that Booth was wrongly decided and should be forthrightly overruled.

In more recent oases, our court has already gone far toward mitigating the harsh effect of the rule laid down in the Booth case. Thus, we have held that negligence can properly be *18inferred from the mere fact that a blast has caused extensive damage, even where the plaintiff is unable to ¡show ‘ ‘ the method of blasting or -the strength -of the charges -or the character of the .soil .or rock.” (Schlansky v. Augustus V. Riegel, Inc., 9 N Y 2d 493, 497, supra; see, also, Brown v. Rockefeller Center, 289 N. Y. 729.) But, even under .this liberal interpretation of Booth, it would still remain possible for a defendant who engages in blasting operations—which he realizes are likely to cause injury — to' avoid liability by showing that he ■ exercised reasonable care. Since blasting involves a substantial risk of harm no matter the degree of care exercised, we perceive no reason for ever permitting .a person who engages in such an activity to impose this risk upon nearby persons or property without assuming responsibility "therefor.

Indeed, the defendants devote but brief .argument in defense of the Booth rule. The principle thrust of their -argument is directed not to the requisite standard of care to be used but, rather, to the sufficiency .of the plaintiffs’ pleadings and the proof adduced on the issue of causation.3

As to the sufficiency of the pleadings, we need but point out that both Spano’s and Davis’s complaints alleged that the defendants engaged in blasting operations which resulted in damage -to their respective property. Thus, they contained adequate “notice of the transactions * * * intended to be proved and the material elements -of [the] cause .of action ” (CPLR 3013). The fact that, in Davis ’is case, these allegations were subsumed in a cause -of action for .negligence is immaterial, since the inclusion of unnecessary additional allegations does not affect" the -sufficiency of a complaint. (See, e.g., Rager v. McCloskey, 305 N. Y. 75, 80; Abbey v. Wheeler, 170 N.Y. 122, 127.)

There .remains, then, .only the matter of proof -on the issue -of causation. Although the evidence adduced by the plaintiffs on this question was entirely circumstantial, it m-ay not be said that it was -insufficient as a matter of law. The plaintiffs ’ prin*19cipal witness was a contractor who had leased a portion of the premises from Spano. It was hi.s testimony that there was no damage on or to the premises prior to November 27; that he had heard an explosion at about noon on that day while he was working some three blocks away and that, when he returned a few hours later, the building 1 ‘ was cracked in the wall * * * the window broke, and the cement floor .all pop up.” In addition, an insurance adjuster, an expert with wide experience in handling explosion claims, who inspected the damage to Davis’s car, testified that the damage was evidently “ caused by a concussion of one form or another.” The defendants-’ expert attributed the damage to another cause — poor maintenance and building deterioration—but,' admittedly, the defendants were engaged in blasting operations in the area at the time and, as the Appellate Term expressly found, the -inference that this was the cause of the damage could properly be drawn. Even though the proof was not insufficient as a matter of law, however, the Appellate Division affirmed on the sole ground that no negligence had been proven against the defendants and thus had no occasion to consider the question whether, in fact, the blasting caused the damage. That being so, we must remit the case to the Appellate Division so that it may pass upon the weight .of the evidence (CPLR 5501, subd. [c]; 5613; see Spett v. President Monroe Bldg. & Mfg. Corp., 19 N Y 2d 203).

The .order appealed from'should be reversed, with costs, and the matter remitted to the Appellate Division for further proceedings in accordance with this .opinion.

Judges Burke, Scileppi, Bergan, Breitel and Jasen concur.

Order reversed, etc.

ON CERTIORARI TO THE UTAH COURT OF APPEALS

DURHAM, Justice:

This case is before the court on a petition for a writ of certiorari to the Utah Court of Appeals. Plaintiffs Jeff Christensen and Kyle James Fausett claim that the court of appeals erred when it concluded that defendant Burns International Security Services (“Burns”) was not hable under the doctrine of respondeat superior for the actions of its employee, Gloria Swenson. The court of appeals determined that Swenson was acting outside the scope of her employment at the time of her automobile accident with Christensen and Fausett and therefore affirmed the trial court’s grant of summary judgment. Christensen v. Burns Int’l Sec. Servs., 844 P.2d 992, 995 (Utah Ct.App.1992). We reverse.

Burns provides security services for the Geneva Steel Plant (“Geneva”) in Orem, Utah. Burns employed Swenson as a security guard in June 1988. On the day of the accident, July 26, 1988, Swenson was assigned to guard duty at Gate 4, the northeast entrance to the Geneva property. Security guards at Gate 4 worked eight-hour continuous shifts, with no scheduled breaks. However, employees were permitted to take ten-tó fifteen-minute unscheduled lunch and restroom breaks.

When taking their lunch breaks, Gate 4 guards generally ate a bag lunch but occasionally ordered take-out food from the sole restaurant within close physical proximity to Gate 4, the Frontier Cafe. The Frontier Cafe was located directly across the street from the Geneva plant, approximately 150 to 250 yards from Gate 4. The cafe’s menu was posted near the telephone at Gate 4. Aside from vending machines located within a nearby Geneva office budding, the Frontier Cafe provided the sole source of food accessible to Gate 4 guards within their ten- to fifteen-minute breaks. Indeed, the Frontier Cafe was the only restaurant in the immediate area. Whether they brought their lunches or ordered from the cafe, Gate 4 guards were expected to eat at their posts.

Shortly after 11:00 a.m. on the day of the accident, Swenson noticed a lull in the traffic at Gate 4 and decided to get a cup of soup from the Frontier Cafe. She placed a telephone order for the soup from Gate 4 and then drove her automobile to the cafe. She intended to pick up the soup and return to Gate 4 to eat at her post. She expected the round trip to take approximately ten to fifteen minutes, as permitted by Burns’ unscheduled break policy. On her return trip, however, she collided with plaintiffs’ motorcycle at a public intersection just outside Geneva’s *127property. Both Christensen and Fausett were injured.

Christensen and Fausett filed a negligence action against Swenson and Burns. After answering the complaint, Burns moved for summary judgment, claiming that it was not hable under the doctrine of respondeat superior because Swenson was not acting within the scope of her employment at the time of the accident. The trial court granted Bums’ motion, and Christensen and Fausett appealed. The court of appeals affirmed the trial court’s decision, concluding that reasonable minds could not disagree that Swenson was acting outside the scope of her employment at the time of the accident. Christensen, 844 P.2d at 995. We granted plaintiffs’ petition for certiorari.

Summary judgment is appropriate when the record indicates that there is no genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law. Utah R.Civ.P. 56(c); Clover v. Snowbird Ski Resort, 808 P.2d 1037, 1039 (Utah 1991). We review a trial court’s order granting summary judgment for correctness, according no deference to the trial court’s legal conclusions. Clover, 808 P.2d at 1039-40; Blue Cross & Blue Shield v. State, 779 P.2d 634, 636 (Utah 1989). In addition, we view ah relevant facts and all inferences arising from those facts in the light most favorable to the party opposing the motion. Clover, 808 P.2d at 1039. Should we conclude that a genuine issue of material fact exists, we must reverse the grant of summary judgment and remand for trial on that issue. Atlas Corp. v. Clovis Nat’l Bank, 737 P.2d 225, 229 (Utah 1989).

Under the doctrine of respondeat superior, employers are vicariously Hable for torts committed by employees while acting within the scope of their employment. Clover, 808 P.2d at 1040. Whether an employee is acting within the scope of her employment is ordinarily a question of fact. Id. The question must be submitted to the jury “ ‘whenever reasonable minds may differ as to whether the [employee] was at a certain time involved wholly or partly in the performance of [the employer’s] business or within the scope of employment.’” Id. (quoting Carter v. Bessey, 97 Utah 427, 432, 93 P.2d 490, 493 (1939)). However, when the employee’s activity is so clearly within or outside the scope of employment that reasonable minds cannot differ, the court may decide the issue as a matter of law. Id.; Birkner v. Salt Lake County, 771 P.2d 1053, 1057 (Utah 1989).

In Birkner, we stated that acts faUing within the scope of employment are “ ‘those acts which are so closely connected with what the servant is employed to do, and so fairly and reasonably incidental to it, that they may be regarded as methods, even though quite improper ones, of carrying out the objectives of employment.’ ” 771 P.2d at 1056 (quoting W. Page Keeton et ah, Prosser and Keeton on the Law of Torts § 70, at 502 (5th ed. 1984)). We articulated three criteria helpful in determining whether an employee is acting within or outside the scope of her employment. First, the employee’s conduct must be of the general kind the employee is hired to perform, that is, “the employee must be about the employer’s business and the duties assigned by the employer, as opposed to being whoHy involved in a personal endeavor.” Id. at 1056-57. Second, the employee’s conduct must occur substantially within the hours and ordinary spatial boundaries of the employment. Id. at 1057. Finally, “the employee’s conduct must be motivated, at least in part, by the purpose of serving the employer’s interest.” Id.

The court of appeals held that Swenson was not substantially within the ordinary spatial boundaries of her employment because the accident did not occur on Geneva property.1 Christensen, 844 P.2d at 995. *128Christensen and Fausett argue that the court of appeals erred in its application of the second criterion identified in Birkner. Burns responds that the court of appeals properly construed the second Birkner criterion in holding that Swenson was acting outside the scope of her employment at the time of the accident.

Because the court of appeals concluded that Swenson failed to satisfy the second Birkner criterion, it did not address the first and third criteria. See Christensen, 844 P.2d at 995. However, our review of the record indicates that reasonable minds could differ on all three criteria. Thus, to avoid a second summary judgment on remand, we address all three of the Birkner criteria.

The first Birkner criterion requires that the employee’s conduct be of the general kind the employee is hired to perform, that is, “the employee must be about the employer’s business and the duties assigned by the employer, as opposed to being wholly involved in a personal endeavor.” Birkner, 771 P.2d at 1056-57. Reasonable minds could differ as to whether Swenson was about Burns’ business when she was involved in the traffic accident between Gate 4 and the Frontier Cafe.

We base this conclusion on two disputed issues of material fact. First, Swenson claims that Burns employed her as a security guard to “see and be seen” on and around the Geneva plant. Thus, traveling the short distance to the Frontier Cafe in uniform arguably heightened the secure atmosphere that Bums sought to project. Burns, on the other hand, claims that Swenson was not hired to perform that function. Burns’ position is supported by the deposition of another security guard who stated that he considered lunch trips to the Frontier Cafe to be entirely personal in nature.

A second material issue of fact remains as to whether Burns tacitly sanctioned Gate 4 guards’ practice of obtaining lunch from the Frontier Cafe. Bums expected its Gate 4 guards to work eight-hour continuous shifts and to remain at their posts as much as possible. However, because Burns also recognized that the guards must at times eat meals and use the restroom, the company permitted them to take ten- to fifteen-minute paid breaks. The record indicates that Burns was aware that its employees occasionally traveled to the Frontier Cafe during these unscheduled breaks but had never disciplined them for doing so. Indeed, Swenson asserts that a menu from the Frontier Cafe was posted in plain view at Gate 4. Thus, reasonable minds could differ as to whether Burns tacitly sanctioned, or at least contemplated, that its guards would satisfy their need for nourishment by obtaining meals from the Frontier Cafe.

The second Birkner criterion states that the employee’s conduct must occur substantially within the hours and ordinary spatial boundaries of the employment. Birkner, 771 P.2d at 1057. It is undisputed that Swen-son’s action occurred within the hours of her employment. She was at her post and in uniform when she decided to take advantage of a lull in plant traffic to eat lunch.

With respect to spatial boundaries, we find that reasonable minds might differ as to whether Swenson was substantially within the ordinary spatial boundaries of her employment when traveling to and from the Frontier Cafe. Again, the court of appeals concluded that Swenson did not pass this criterion because the accident did not occur on Geneva property. Christensen, 844 P.2d at 995. While it is true that Swenson was not on Geneva property when the accident occurred, she was attempting to obtain lunch from a restaurant within the geographic area accessible during her ten- to fifteen-minute break. Given the other facts of this case, reasonable minds could differ as to whether Swenson’s trip to the Frontier Cafe fell sub-*129stantiaUy within the ordinary spatial boundaries of her employment.2

Furthermore, Burns could not point to specific orders barring guards from leaving the facility in their own vehicles to go to the Frontier Cafe on break, although two managers opined that such behavior was prohibited. This dispute alone presents a genuine issue of material fact. If guards were expressly forbidden to drive to the Frontier Cafe to pick up lunch during their break, a jury could find that Swenson was substantially outside the ordinary spatial boundaries of her employment; if they were not so forbidden, a jury might find her to have been acting substantially within the ordinary spatial boundaries of her employment.3

Under the third criterion of the Birkner test, “the employee’s conduct must be motivated, at least in part, by the purpose of serving the employer’s interest.” Birkner, 771 P.2d at 1057. Applying this criterion to the instant case poses the question of whether Swenson’s trip to the Frontier Cafe was motivated, at least in part, by the purpose of serving Burns’ interest. Reasonable minds might also differ on this question.

First, two Burns managers admitted in their depositions that employee breaks benefit both the employee and the employer. Employees must occasionally eat meals and use the restroom, and employers receive the corresponding benefit of productive, satisfied employees. Reasonable minds could differ as to whether Swenson’s particular break fell into this mutual-benefit category.

Second, given the continuous-shift nature of the job and the comparatively brief breaks permitted, Burns’ break policy obviously placed a premium on speed and efficiency. Swenson claimed that traveling to the Frontier Cafe enabled her to obtain lunch within the allotted period and thus maximize the time spent at her post. In this respect, reasonable minds might conclude that Swen-son’s conduct was motivated, at least in part, by the purpose of serving Burns’ interest. Evidence indicating that Swenson tried to save time on her lunch break by phoning her order ahead, driving instead of walking, and attempting to return immediately to her post is also relevant in this regard.

In sum, we hold that reasonable minds could differ as to whether Swenson was acting within or outside the scope of her employment when she collided with plaintiffs’ motorcycle. Thus, summary judgment is inappropriate. We reverse and remand for further proceedings.

HOWE, Justice,

concurring:

I concur. I write to address the concerns of the court of appeals when, in affirming the summary judgment in favor of Burns, it wrote:

Holding otherwise would unduly expand the scope of employment. Every off-site location regularly patronized by an employee for personal purposes could potentially be considered within the ordinary spatial boundaries of the employment. Such a holding would also blur the rule that conduct occurring during an employee’s off-premises lunch hour is outside the scope of employment. See, e.g., 1 Arthur Larson, The Law of Workmen’s Compensation § 15.51 (1992).

*130Christensen v. Burns Int’l Sec. Servs., 844 P.2d 992, 995 (Utah Ct.App.1992).

Larson in his treatise recognizes exceptions to the general rule relied on by the court of appeals. One such exception is where the employee is paid during the time taken out for lunch or coffee and to suit the employer’s convenience, the employee rushes out to “get a quick bite to eat, and [hurries] back because of the pressure of work.... Here the very making of a lightning excursion for lunch is an effort expended in the employer’s interest to conserve his time.” 1 Arthur Larson, The Law of Workmen’s Compensation, § 15.52 (1993). Larson cites many cases where the exception was relied on. Only one need be mentioned. In Shoemaker v. Snow Crop Marketers Division of Clinton Foods, Inc., 74 Idaho 151, 258 P.2d 760 (1958), an employee was awarded compensation when he was injured while retrieving his packed lunch from a building adjoining his employer’s premises. He was on paid time and under orders of his employer to hurry back.

Although the case presently before the court is not a workers’ compensation case, I believe that this well-recognized exception may be applicable here, as the majority opinion correctly opines.

GEER, Judge.

This appeal results from a medical malpractice action arising out of gall bladder surgery performed on plaintiff Mary Louise Diggs at the Forsyth Medical Center. Plaintiffs complaint alleges that defendants Forsyth Memorial Hospital, Inc., Novant Health, Inc., and Novant Health Triad Region, L.L.C. (collectively the “hospital defendants”) are vicariously liable for the negligence of (1) the hospital nursing staff and (2) the team assigned to administer anesthesiology to plaintiff during her gall bladder surgery. Plaintiff has appealed from the trial court’s order granting summary judgment in favor of the hospital defendants.

Based upon our review of the record, we hold that plaintiff has failed to establish a basis for holding Novant Health, Inc. (“NHI”) or Novant Health Triad Region, L.L.C. (“NHTR”) liable and, therefore, affirm the entry of summary judgment in favor of those two defendants. With respect to Forsyth Memorial Hospital, Inc. (“FMH”), however, we reverse.

In arguing that it is entitled to judgment as to plaintiff’s claims based on the negligence of the hospital’s nursing staff, FMH has only challenged the competency of the testimony of plaintiff’s nursing expert. Since we hold that the testimony was admissible under N.C.R. Evid. 702 and State v. Tyler, 346 N.C. 187, 204, 485 S.E.2d 599, 608, cert. denied, 522 U.S. 1001, 139 L. Ed. 2d 411, 118 S. Ct. 571 (1997), the trial court erred in granting summary judgment on plaintiff’s claims based on the negligence of the nursing staff. With respect to the anesthesiology team, FMH has argued that it could not be held vicariously *293 liable because the individuals responsible for the anesthesia were independent contractors. Although we agree with FMH that plaintiff has failed to. present sufficient evidence of actual agency, the record reveals that genuine issues of material fact exist regarding the apparent agency of the anesthesiology team. Accordingly, we hold that the trial court also erred in granting summary judgment to FMH as to the claims based on the negligence of the anesthesiology team.

Factual and Procedural History

In September 1999, plaintiff, who was in her early eighties, was diagnosed by her gastroenterologist, Dr. Gary Poleynard, with common duct stones and complications due to gall stone disease. Dr. Poleynard recommended surgery and referred plaintiff to defendant Dr. Ismael Goco, a board-certified general surgeon. After examining plaintiff at his office, Dr. Goco concurred with Dr. Poleynard’s diagnosis and his recommendation of surgery.

Plaintiff chose to have Dr. Goco perform the gall bladder surgery. Dr. Goco had hospital privileges at two hospitals in Winston-Salem: defendant Forsyth Medical Center (“FMC”) and Medical Park Hospital, Inc. On 12 October 1999, plaintiff was admitted to FMC. FMC is operated by defendant FMH. NHTR owns FMH and is in turn owned by NHL

Plaintiffs gall bladder surgery required general anesthesia. Piedmont Anesthesia & Pain Consultants, P.A. (“Piedmont”) had a contract with FMH that granted Piedmont the exclusive right to provide anesthesia services at FMC. Piedmont employees Dr. Joseph McConville and nurse Sheila Crumb were responsible for administering anesthesia to plaintiff through an induction and intubation process. Ms. Crumb performed the intubation, which involved inserting a tube into plaintiffs trachea, under the supervision of Dr. McConville. Ms. Crumb made three attempts before successfully completing the intubation. At some point during the attempts, Ms. Crumb perforated plaintiffs esophagus, a fact that was not discovered until many hours after the gall bladder surgery was over. Plaintiff contends that as a result of that perforation, she has suffered severe and permanent injuries.

On 11 October 2002, plaintiff filed suit against not only the hospital defendants, but also Ms. Crumb, Dr. McConville, and Piedmont (collectively “the anesthesiology defendants”). The complaint alleged that the anesthesiology defendants were individually liable for their *294 negligence in administering the anesthesia and that the hospital defendants were vicariously liable for the anesthesiology defendants’ negligence, as well as the negligence of the hospital floor nurses who, following plaintiffs surgery, failed to immediately notice the perforation. 1

On 5 March 2004, plaintiff moved to compel the hospital defendants to respond to certain interrogatories and requests for production of documents. On 15 April 2004, the trial court' entered an order allowing this motion in part and denying this motion in part. Plaintiff has appealed this order to the extent it refused to order production of certain documents.

On 22 March 2004, the hospital defendants moved for summary judgment. On 19 April 2004, the trial court granted that motion. Since plaintiff voluntarily dismissed her claims against the anesthesiology defendants on 16 April 2004, plaintiffs appeal of this summary judgment order is properly before this Court as an appeal from a final judgment.

Summary Judgment Order

This Court will uphold a trial court’s grant of summary judgment “if considering the pleadings, depositions, answers to interrogatories, and admissions on file, together with affidavits, there is no genuine issue of material fact and a party is entitled to judgment as a matter of law.” Moore v. Coachmen Indus., Inc., 129 N.C. App. 389, 393-94, 499 S.E.2d 772, 775 (1998). The moving parties — in this case, the hospital defendants — bear the initial burden of showing the lack of any triable issue of fact and the propriety of summary judgment. Id. at 394, 499 S.E.2d at 775.

Once the moving party has met its initial burden, in order to survive summary judgment, the nonmoving party — here, plaintiff — must produce “ ‘a forecast of evidence demonstrating that the [nonmoving party] will be able to make out at least a prima facie case at trial.’ ” Id. at 394, 499 S.E.2d at 775 (quoting Collingwood v. Gen. Elec. Real Estate Equities, Inc., 324 N.C. 63, 66, 376 S.E.2d 425, 427 (1989)). On appeal, we view the evidence in the light most favorable to the non-moving party and decide whether summary judgment was appropriate under a de novo standard of review. Falk Integrated Techs., Inc. v. Stack, 132 N.C. App. 807, 809, 513 S.E.2d 572, 574 (1999).

*295 I. Plaintiffs Claims Based on Negligence of the Nursing Staff

Plaintiff contends that the hospital nurses breached their duty of care by failing to notify plaintiffs anesthesiologist promptly when they observed plaintiffs troubled breathing and sharp throat pain following her surgery. According to plaintiff, had the nurses done so, the perforation of her esophagus would have been identified earlier and lessened the seriousness of the injuries resulting from that perforation. In support of this claim, plaintiff relies upon the expert testimony of a nurse, Rosalyn Marie Harris-Offutt.

Defendants, however, argue that they are entitled to summary judgment because (1) Ms. Harris-Offutt was not qualified to testify as an expert witness under Rule 702(b)(2) of the Rules of Evidence, 2 and (2) Ms. Harris-Offutt, as a nurse, is not qualified to testify regarding medical causation. In opposing a motion for summary judgment in a medical malpractice case, a plaintiff must demonstrate that her expert witness is competent to testify and, in the absence of such a showing, summary judgment is properly granted. See Weatherford v. Glassman, 129 N.C. App. 618, 623, 500 S.E.2d 466, 469 (1998) (holding that deposition testimony offered in opposition to a motion for summary judgment in a medical malpractice case must reveal that the witness is competent to testify as to the matters at issue). The question. before this Court is, therefore, whether the record reveals that Ms. Harris-Offutt is competent to testify.

A. Rule 702(W2) of the Rules of Evidence

Rule 702(b) provides that medical malpractice experts are not qualified to testify unless they are licensed health care providers who meet certain criteria, including the following:

(2) During the year immediately preceding the date of the occurrence that is the basis for the action, the expert witness must have devoted a majority of his or her professional time to either or both of the following:

a. The active clinical practice of the same health profession in which the party against whom or on whose behalf the testimony is offered, and if that party is a specialist, the active clinical practice of the same specialty or a similar *296 specialty which includes within its specialty the performance of the procedure that is the subject of the complaint and have prior experience treating similar patients ....

Defendants contend that Ms. Harris-Offutt is unqualified under Rule 702(b) because she had not been active in the clinical practice of nursing in the year preceding plaintiff’s injury.

In support of their contention, defendants point to the deposition testimony of Janet Day Berrier, a representative of Thomasville Medical Center where Ms. Harris-Offutt was at one time employed. Ms. Berrier testified that the last date that Ms. Harris-Offutt worked for Thomasville Medical Center as a certified registered nurse anesthetist was 31 December 1986. Plaintiff, on the other hand, filed an affidavit from Ms. Harris-Offutt, stating: “During the year immediately preceding October 12, 1999; I devoted a majority of my professional time to the active clinical practice of nursing as a registered nurse[.]”

Although defendants point to Ms. Harris-Offutt’s deposition as showing that she spends her time as a legal consultant rather than as a nurse, Ms. Harris-Offutt also stated in her deposition that she spends part of her time in the clinical practice of nursing and part of her time engaging in legal consulting. Thus, the deposition offered by defendants does not necessarily contradict the affidavit offered by plaintiff.

Defendants further argue that Ms. Harris-Offutt’s clinical work is not relevant since she worked as a registered nurse and not as a floor nurse. Ms. Harris-Offutt’s affidavit states, however:

There is no specialty in nursing known as “floor nursing.” Floor nurses in hospitals are usually registered nurses. Registered nurses are not limited to the hospital setting, but work in many different settings including nursing homes, the private offices of physicians and the private offices of registered nurses[.]

Defendants offered no expert testimony to the contrary.

Defendants’ remaining arguments regarding the differences between Ms. Harris-Offutt’s work experiences and the work experience of the hospital nursing staff go to the weight, but not the admissibility, of Ms. Harris-Offutt’s evidence. Howerton v. Arai Helmet, Ltd., 358 N.C. 440, 461, 597 S.E.2d 674, 688 (2004) (holding that once an expert has passed Rule 702’s threshold of admissibility, “lingering *297 questions or controversy concerning the quality of the expert’s conclusions go to the weight of the testimony rather than its admissibility”). Thus, for purposes of summary judgment, plaintiff has forecast sufficient evidence that Ms. Harris-Offutt is qualified to testify under Rule 702(b)(2).

B. Nurse Expert’s Testimony Regarding Medical Causation

Plaintiff and defendants also disagree as to whether Ms. Harris-Offutt is qualified to give an opinion about medical causation because she is a nurse and not a licensed physician. Defendants’ position has been rejected by our Supreme Court.

In State v. Tyler, 346 N.C. 187, 204, 485 S.E.2d 599, 608 (emphasis added) (internal citations omitted) (quoting State v. Mitchell, 283 N.C. 462, 467, 196 S.E.2d 736, 739 (1973)), cert. denied, 522 U.S. 1001, 139 L. Ed. 2d 411, 118 S. Ct. 571 (1997), the Supreme Court held:

“The essential question in determining the admissibility of opinion evidence is whether the witness, through study or experience, has acquired such skill that he was better qualified than the jury to form an opinion on the subject matter to which his testimony applies.” The evidence in the present case clearly indicates that [Nurse] Rosenfeld, through both study and experience, was better qualified than the jury to form an opinion on the cause of Fleetwood’s death and on the effect of the sedative medication Versed. Rosenfeld’s position as a nurse was merely a factor to be considered by the jury in evaluating the weight and credibility of her testimony.

See also State v. White, 340 N.C. 264, 294, 457 S.E.2d 841, 858. (“Nurses are qualified to render expert opinions as to the cause of a physical injury even though they are not licensed to diagnose illnesses or prescribe treatment, and there is no basis for any preference of licensed physicians for such medical testimony.”), cert. denied, 516 U.S. 994, 133 L. Ed. 2d 436, 116 S. Ct. 530 (1995). These decisions are controlling. Ms. Harris-Offutt’s testimony as to medical causation cannot be excluded simply because she is not a physician.

In sum, we hold that plaintiff has made the necessary forecast that Ms. Harris-Offutt is qualified to render expert testimony under Rule 702(b)(2) and that prior case law establishes that she may testify regarding medical causation. Since defendants have relied upon no other argument to justify summary judgment in connection with neg *298 ligence by the hospital staff nurses, we further hold that the trial court erred in granting summary judgment as to those claims with respect to FMH, which employed the nurses.

C. Liability of NHI and NHTR

Defendants NHI and NHTR, however, argue that the trial court properly dismissed them as defendants because they did not employ the hospital nursing staff. They submitted evidence that NHI is “the sole member” of NHTR, while NHTR is “the sole member” of FMH, which operates FMC. Further, according to defendants’ evidence, “[n]either [NHTR] nor [NHI] operate the hospital presently known as Forsyth Medical Center.” Specifically, “all of the employees of Forsyth Medical Center . . . are employed by Forsyth Memorial Hospital, Inc.” Plaintiff has presented no contrary evidence.

Instead, plaintiff cites Cahill v. HCA Mgmt. Co., 812 F.2d 170 (4th Cir. 1987), in support of her contention that “[b]oth the owners and operators of a hospital can be held liable for the negligence of its employees, servants and agents.” In Cahill, the district court had entered a directed verdict in favor of a hospital management company when the negligent individual was employed by the hospital and not the management company. The Fourth Cirduit reversed the directed verdict because the plaintiff presented evidence that the hospital loaned the employee to the management company and the management company had in fact supervised and controlled the individual. Id. at 171. Plaintiff in this case has offered no comparable evidence. Accordingly, the trial court properly entered summary judgment in favor of NHTR and NHI with respect to the claims based on the acts of the hospital nursing staff.

II. Plaintiff’s Claims Based on Negligence of the Anesthesiology Defendants

Plaintiff has also asserted claims against the hospital defendants based on the negligence of the anesthesiology defendants, including Dr. McConville, Ms. Crumb, and Piedmont. The hospital defendants contend that the trial court properly granted summary judgment because the anesthesiology defendants were independent contractors and not employees of the hospital. Plaintiff, on the other hand, argues that she has offered sufficient evidence of actual agency, apparent agency, and a non-delegable duty to warrant denial of the motion for summary judgment.

*299 A. Liability Based on Actual Agency

As this Court has held, “[u]nder the doctrine of respondeat superior, a hospital is liable for the negligence of a physician or surgeon acting as its agent. There will generally be no vicarious liability on an employer for the negligent acts of an independent contractor.” Hylton v. Koontz, 138 N.C. App. 629, 635, 532 S.E.2d 252, 257 (2000) (internal citations omitted), disc. review denied, 353 N.C. 373, 546 S.E.2d 603 (2001). This Court has established that “,[t]he vital test in determining whether an agency relationship exists is to be found in the fact that the employer has or has not retained the right of control or superintendence over the contractor or employee as to details.” Id. at 636, 532 S.E.2d at 257 (internal quotation marks omitted). Specifically, “ ‘the principal must have the right to control both the means and the details of the process by which the agent is to accomplish his task in order for an agency relationship to exist.’ ” Wyatt v. Walt Disney World Co., 151 N.C. App. 158, 166, 565 S.E.2d 705, 710 (2002) (emphasis added) (quoting Williamson v. Petrosakh Joint Stock Co. of the Closed Type, 952 F. Supp. 495, 498 (S.D. Tex. 1997)). See also Hoffman v. Moore Reg’l Hosp., Inc., 114 N.C. App. 248, 251, 441 S.E.2d 567, 569 (holding that the principal must have “control and supervision over the details of the [agent’s] work”), disc. review denied, 336 N.C. 605, 447 S.E.2d 391 (1994).

In arguing that an agency relationship existed, plaintiff relies exclusively on two contracts entered into between Piedmont and FMH: the Anesthesia Agreement and the Anesthesia Services Agreement. 3 The Anesthesia Services Agreement specifically provided, however, that “FMH shall neither have nor exercise any control or direction over the methods by which [Piedmont] or any Physician shall perform it or his work and functions; the sole interest and responsibility of FMH and the Hospital are to assure that the services covered by this Agreement shall be performed and rendered in a competent, efficient and satisfactory manner.” Further, under the agreements, (1) the physicians associated with Piedmont are not prohibited from practicing outside of the Hospital; (2) Piedmont and the hospital bill patients separately for their respective services; (3) Piedmont is responsible for meeting its own hiring needs; and (4) Piedmont is responsible for managing its own scheduling. Our review *300 of the agreements and depositions in the record does not reveal that the hospital defendants had any “right to control the manner or method” of the anesthesiology work performed by Piedmont and its personnel. Hylton, 138 N.C. App. at 636, 532 S.E.2d at 257 (internal quotation marks omitted).

The contractual terms relied upon by plaintiff in opposing summary judgment do not address the actual provision of anesthesia services to patients. Instead, plaintiff primarily points to FMH’s right (1) to require that doctors employed by Piedmont become members of FMH’s Medical-Dental Staff and that they comply with the rules and regulations governing that Staff, (2) to approve and credential all Piedmont nurse anesthetists, and (3) to require Piedmont to remove from FMH’s anesthesia service any physician for specified grounds. These provisions, however, relate only to a hospital’s duty to ensure that all medical personnel permitted to provide services to FMH patients are qualified to do so. See Blanton v. Moses H. Cone Mem’l Hosp., Inc., 319 N.C. 372, 376, 354 S.E.2d 455, 458 (1987) (“We hold that a reasonable man of ordinary prudence in the position of the hospital owes a duty of care to its patients to ascertain that a doctor is qualified to perform an operation before granting him the privilege to do so.”). They do not establish the degree of control necessary for agency.

The remaining provisions cited by plaintiff constitute general policies detailing how the two businesses — FMH and Piedmont— would cooperate and coordinate their work. As such, they cannot support a finding of agency. See Hoffman, 114 N.C. App. at 251, 441 S.E.2d at 569 (holding that “general policy rules ... are not indicative of that kind of control and supervision over the details of a physician’s work that a plaintiff must show in order to prove that there was an employer-employee relationship”).

We hold that the provisions in the agreements between Piedmont and FMH are materially indistinguishable from those in Hylton and Hoffman that this Court held, in the absence of any further evidence, warranted summary judgment. See Hylton, 138 N.C. App. at 636-37, 532 S.E.2d at 257-58 (upholding grant of summary judgment when the anesthesiology agreement provided that the hospital would have no control over the method and means by which the anesthesiologists performed their work, the physicians were not precluded from practicing outside the hospital, the physicians received no compensation from the hospital, the parties billed the patient separately, and the *301 hospital did not schedule the physicians); Hoffman, 114 N.C. App. at 250-51, 441 S.E.2d at 569 (upholding grant of summary judgment when the physician was a member of a private group, the physician’s schedule was determined by the group rather than the hospital, and the patient was billed for the physician’s services by the group and not the hospital). Plaintiff has, therefore, failed to present sufficient evidence to establish a prima facie case of actual agency.

B. Liability Based on Apparent Agency

It is well-established that even in the absence of an agency relationship, “ ‘[w]here a person, by words or conduct, represents or permits it to be represented that another is his agent, he will be estopped to deny the agency as against third persons, who have dealt, on the faith of such representation, with the person so held out as agent, even if no agency exists in fact.’ ” Univ. of N.C. v. Shoemate, 113 N.C. App. 205, 215, 437 S.E.2d 892, 898 (quoting Barrow v. Barrow, 220 N.C. 70, 72, 16 S.E.2d 460, 461 (1941)), disc. review denied, 336 N.C. 615, 447 S.E.2d 413 (1994). This doctrine of apparent agency was first considered by our Supreme Court as a basis for hospital liability for malpractice in Smith v. Duke Univ., 219 N.C. 628, 14 S.E.2d 643 (1941), overruled on other grounds by Rabon v. Rowan Mem’l Hosp., Inc., 269 N.C. 1, 152 S.E.2d 485 (1967).

The Court initially established the principle — addressed above— that evidence that a physician has privileges at a hospital is not sufficient, standing alone, to make the physician an agent of the hospital: “Ordinarily, the hospital undertakes only to furnish room, food, facilities for operation, and attendance, and is not liable for damages resulting from the negligence of a physician in the absence of evidence of agency, or other facts upon which the principle of respon-deat superior can be applied.” Id. at 634, 14 S.E.2d at 647. After concluding that the plaintiff had failed to demonstrate that the doctor — the patient’s treating physician — was an agent of the hospital, the Supreme Court turned to the question of apparent agency:

There was no evidence that [the doctor] in treating [the patient] assumed to act for Duke University otherwise than in his individual capacity as a practicing physician, or that [the doctor] was held out by the defendant as having been employed by it to treat pay patients, or that the hospital undertook to furnish physicians and surgeons for the treatment of the maladies of patients, and hence no liability can attach to defendant on the *302 theory that [the doctor] was acting within the scope of an apparent authority or employment.

Id. at 635, 14 S.E.2d at 648 (emphasis added).

Our Supreme Court has since recognized that, in the years following Smith, the nature of hospitals has substantially changed. After observing that the Smith assumptions regarding hospitals were “no longer appropriate in this era,” Harris v. Miller, 335 N.C. 379, 389, 438 S.E.2d 731, 736-37 (1994), the Court explained:

First of all, hospitals are now in the business of treatment. As stated in Rabon v. [Rowan Memorial] Hospital:

“The conception that the hospital does not undertake to treat the patient, does not undertake to act through its doctors and nurses, but undertakes instead simply to procure them to act upon their own responsibility, no longer reflects the fact. Present day hospitals, as their manner of operation plainly demonstrates, do far more than furnish facilities for treatment. They regularly employ on a salary basis a large staff of physicians, nurses and internes [sic]', as well as administrative and manual workers, and they charge patients for medical care and treatment, collecting for such services, if necessary, by legal action. Certainly, the person who avails himself of ‘hospital facilities’ expects that the hospital will attempt to cure him, not that its nurses or other employees will act on their own responsibility.”

Id., 438 S.E.2d at 737 (quoting Rabon, 269 N.C. at 11, 152 S.E.2d at 492).

In applying the doctrine of apparent agency, courts throughout the country have struggled with this change in the nature of hospitals from institutions providing only facilities to institutions actually providing medical services, such as emergency room care or, as in this case, anesthesia. In Sword v. NKC Hosps., Inc., 714 N.E.2d 142 (Ind. 1999), the Indiana Supreme Court conducted a helpful and detailed analysis of the applicability of apparent agency with respect to a hospital’s liability for negligence in the provision of services, such as anesthesia, by independent contractors.

In surveying other jurisdictions, the Indiana Supreme Court noted that courts have employed apparent agency to hold hospitals liable for the negligence of independent contractors in both emergency room and anesthesia contexts. Id. at 150. The court explained:

*303 While the language employed by these courts sometimes varies, generally they have employed tests which focus primarily on two basic factors. The first factor focuses on the hospital’s manifestations and is sometimes described as an inquiry whether the hospital acted in a manner which would lead a reasonable person to conclude that the individual who was alleged to be negligent was an employee or agent of the hospital. Courts considering this factor often ask whether the hospital held itself out to the public as a provider of hospital care, for example, by mounting extensive advertising campaigns. In this regard, the hospital need not make express representations to the patient that the treating physician is an employee of the hospital; rather a representation also may be general and implied. The second factor focuses on the patient’s reliance. It is sometimes characterized as an inquiry as to whether the plaintiff acted in reliance upon the conduct of the hospital or its agent, consistent with ordinary care and prudence.

Id. at 151 (internal quotation marks and citations omitted). With respect to the reliance factor, the court pointed out that some jurisdictions ask whether the plaintiff reasonably believed that the hospital was providing the pertinent medical care, while other jurisdictions presume reliance. Id. Over all, the court concluded that “[c]entral to both of these factors — that is, the hospital’s manifestations and the patient’s reliance — is the question of whether the hospital provided notice to the patient that the treating physician was an independent contractor and not an employee of the hospital.” Id.

Following its survey of the development of the law in other jurisdictions, the Indiana Supreme Court adopted the formulation of apparent agency set forth in the Restatement (Second) of Torts § 429 (1965). Sword, 714 N.E.2d at 152. That section of the Restatement provides:

One who employs an independent contractor to perform services for another which are accepted in the reasonable belief that the services are being rendered by the employer or by his servants, is subject to liability for physical harm caused by the negligence of the contractor in supplying such services, to the same extent as though the employer were supplying them himself or by his servants.

Restatement (Second) of Torts § 429. The Indiana Supreme Court construed § 429 to require that the “trier of fact . . . focus on the *304 reasonableness of the patient’s belief that the hospital or its'employees were rendering health care.” Sword, 714 N.E.2d at 152.

According to Sword,

This ultimate determination is made by considering the totality of the circumstances, including the actions or inactions of the hospital, as well as any special knowledge the patient may have about the hospital’s arrangements with its physicians. We conclude that a hospital will be deemed to have held itself out as the provider of care unless it gives notice to the patient that it is not the provider of care and that the care is provided by a physician who is an independent contractor and not subject to the control and supervision of the hospital. A hospital generally will be able to avoid liability by providing meaningful written notice to the patient, acknowledged at the time of admission.

Id. The court noted, however, that written notice might not suffice if the patient did not have an adequate opportunity to make an informed choice, such as in the case of a medical emergency. Id.

After conducting a similar survey of the development of the law nationwide, the South Carolina Supreme Court also chose to adopt the approach set out in the Restatement (Second) of Torts § 429. Simmons v. Tuomey Reg’l Med. Ctr., 341 S.C. 32, 50-51, 533 S.E.2d 312, 322 (2000). The court held:

Under section 429, the plaintiff must show that (1) the hospital held itself out to the public by offering to provide services; (2) the plaintiff looked to the hospital, rather than the individual physician, for care; and (3) a person in similar circumstances reasonably would have believed that the physician who treated him or her was a hospital employee. When the plaintiff does so, the hospital will be held vicariously liable for any negligent or wrongful acts committed by the treating physician.

Id. at 51, 533 S.E.2d at 322. The court limited application of this test “to those situations in which a patient seeks services at the hospital as an institution, and is treated by a physician who reasonably appears to be a hospital employee.” Id. at 52, 533 S.E.2d at 323. It stressed that its holding did “not extend to situations in which the patient is treated in an emergency room by the patient’s own physician after arranging to meet the physician there. Nor does our holding encompass situations in which a patient is admitted to a hospital by a private, independent physician whose only connection to a par- *305 ticulax hospital is that he or she has staff privileges to admit patients to the hospital. Such patients could not reasonably believe his or her physician is a hospital employee.” Id.

Comparable tests have been adopted in numerous other jurisdictions, particularly with respect to the rendering of anesthesia or emergency services. See, e.g., Gilbert v. Sycamore Mun. Hosp., 156 Ill. 2d 511, 525, 622 N.E.2d 788, 796 (1993) (concluding (1) that the element of “holding out” is “satisfied if the hospital holds itself out as a provider of emergency room care without informing the patient that the care is provided by independent contractors,” and (2) “[t]he element of justifiable reliance on the part of the plaintiff is satisfied if the plaintiff relies upon the hospital to provide complete emergency room care, rather than upon a specific physician”); Gatlin v. Methodist Med. Ctr., Inc., 772 So. 2d 1023, 1027 (Miss. 2000) (with respect to a hospital’s liability for the acts of an independent contractor anesthesiologist, holding that the controlling “analysis seeks to determine whether the patient was seeking treatment from the hospital, without regard for the identity of the particular, physicians .working at the hospital, or whether the patient instead sought the services of a particular physician who merely happened to be on staff at a particular hospital”); White v. Methodist Hosp. South, 844 S.W.2d 642, 647-48 (Term. Ct. App. 1992) (allowing, with respect to the provision of anesthesia services, an inference of reliance when a hospital offers a service and the patient has no choice as to who will perform that service); Pamperin v. Trinity Mem’l Hosp., 144 Wis. 2d 188, 210, 423 N.W.2d 848, 857 (1988) (“[W]e conclude that, if [plaintiff] proves that [the hospital] held itself out as á provider of emergency room care without informing [plaintiff] that the care was provided by independent contractors, [plaintiff] has satisfied the first requirement for proving liability under the doctrine of apparent authority.... In determining that a plaintiff acted in reliance upon the conduct of the hospital or its agent, . . . [c]ourts have uniformly recognized that, except when the patient enters a hospital intending to receive care from a specific physician while in the hospital, it is the reputation of the hospital itself upon which a patient relies.”).

We believe the analysis of these jurisdictions is persuasive and consistent with the prior holdings of our appellate courts. In Smith, our Supreme Court suggested that apparent agency would be applicable to hold the hospital liable for the acts of an independent' contractor if the hospital held itself out as providing services and care. 219 N.C. at 635, 14 S.E.2d at 648. In Shoemate, this Court *306 established that this “holding out” may be accomplished through either verbal representations or conduct. 113 N.C. App. at 215, 437 S.E.2d at 898.

This Court has also addressed the element of reliance in circumstances similar to those addressed by the Restatement (Second) of Torts § 429: when the patient has relied upon a medical provider to render medical services, but that provider has caused those services to be provided by an independent contractor. In Noell v. Kosanin, 119 N.C. App. 191, 196-97, 457 S.E.2d 742, 746 (1995), the plaintiff chose a surgeon to perform her plastic surgery based on his reputation. That surgeon used a particular anesthesiologist, who was an independent contractor, to administer- anesthesia to all of his patients requiring general anesthesia. Id. at 196, 457 S.E.2d at 746. Consistent with this practice, the plaintiff received a pamphlet stating that the anesthesiologist worked jointly with the surgeon. This Court held that “[tjhese facts are sufficient to create a jury question as to whether plaintiff reasonably assumed [the surgeon] was in charge of her entire surgical procedure, including anesthesia care and recovery.” Id. at 197, 457 S.E.2d at 746. This holding parallels the principle in the Restatement (Second) of Torts § 429, which asks whether a patient accepts services from an independent contractor “in the reasonable belief that the services are being rendered by the employer or by his servants.”

This Court pursued a similar analysis in Sweatt v. Wong, 145 N.C. App. 33, 549 S.E.2d 222 (2001), in which the plaintiff engaged a particular surgeon to remove her gallbladder. While the patient was still in the hospital recovering, that surgeon went on vacation, leaving the plaintiff in the care of another doctor, who was an independent contractor. In holding that the trial court had properly denied a motion for judgment notwithstanding the verdict because issues of fact existed as to apparent agency, this Court stressed that the patient was not given a choice as to which physician would continue her care in the surgeon’s absence, but rather the surgeon had simply announced that the second doctor had assisted him in the surgery and would take good care of the patient. Id. at 42, 549 S.E.2d at 227. This Court held that these facts were sufficient for a finding that the patient justifiably relied upon representations of agency. Id. This analysis, like that of § 429 and Noell, does not require any showing of a change of position by the patient, but rather focuses on whether the patient was relying upon the surgeon to provide services and reasonably believed that the second doctor was an agent of the surgeon.

*307 Defendants point to Hoffman as establishing a different test. As this Court explained in Sweatt, however, “[i]n [Hoffman], the plaintiff patient sought to recover damages for alleged medical negligence from a hospital under the theory of respondeat superior for the negligence of the treating physician who was found to be an independent contractor.” Id. (emphasis added). Although the plaintiff in Hoffman, who was admitted to a hospital at the request of her private physician for a particular procedure, did not choose the doctor who would perform that procedure, the consent form specifically listed five possible doctors and the patient was looking to one of those doctors to provide her care. 114 N.C. App. at 249-50, 441 S.E.2d at 569. The case fell squarely within the traditional Smith analysis regarding treating physicians. There was no indication in the opinion that the hospital was holding itself out as providing the services involved as opposed to simply providing facilities for the performance of the procedure by private practitioners. Under those circumstances, this Court required evidence “that Mrs. Hoffman would have sought treatment elsewhere or done anything differently had she known for a fact that [the doctor] was not an employee of the hospital.” Id. at 252, 441 S.E.2d at 570.

When, however, a hospital does hold itself out as providing services, we believe the approach of the Restatement (Second) of Torts § 429 is consistent with our prior decisions considering apparent agency. We are also persuaded by the weight of authority from other jurisdictions. Under this approach, a plaintiff must prove that (1) the hospital has held itself out as providing medical services, (2) the plaintiff looked to the hospital rather than the individual medical provider to perform those services, and (3) the patient accepted those services in the reasonable belief that the services were being rendered by the hospital or by its employees. A hospital may avoid liability by providing meaningful notice to a patient that care is being provided by an independent contractor. See, e.g., Cantrell v. Northeast Ga. Med. Ctr., 235 Ga. App. 365, 368, 508 S.E.2d 716, 719-20 (1998) (concluding that trial court did not err in granting a directed verdict to hospital when “conspicuous signage was posted and forms signed by the patient or representative revealed the independent contractor status of the doctor”), cert. denied, No. 599C0393, 1999 Ga. LEXIS 888 (Ga. Oct. 22, 1999).

Plaintiff has submitted sufficient evidence to meet this test. The hospital had a Department of Anesthesiology with a Chief of Anesthesiology and a Medical Director, a fact that a jury could rea *308 sonably find indicated to the public that FMC was providing anesthesia services to its patients. 4 Further, defendants chose to provide those services by contracting with Piedmont to provide anesthesia services to the hospital on an exclusive basis. Piedmont doctors served as the hospital’s Chief of Anesthesiology and anesthesia Medical Director. As Dr. McConville put it, his group “provide [d] the anesthesia services for the operating room at Forsyth and so there is — so our group covers the surgical caseload.” Plaintiff and other surgical patients had no choice as to who would provide anesthesia services for their operations.

Plaintiffs affidavit states that she was unaware that Dr. McConville and Ms. Crumb were not employees of the hospital. She explained “I did not select Sheila Crumb nor Dr. Joseph McConville to provide medical care to me; that in choosing to have my operation at Forsyth Medical Center, I relied on the fact that medical care would be provided by employees of Forsyth Medical Center, excluding my surgeon, Dr. Goco.” She further stated: “[0]ne of the reasons that I had my operation performed at Forsyth Medical Center was because it was part of Novant Health, a large healthcare organization . . . .”

In addition, plaintiff pointed to the form on FMC letterhead that she signed entitled “Consent to Operation and/or Other Procedures.” The form specified: “I therefore authorize my physician, his or her associates or assistants to perform such surgical procedures as they, in the exercise of their professional judgment, deem necessary and advisable.” (Emphasis added.) By contrast, with respect to anesthesia services, the form stated: “I authorize the administration of such anesthetics as may be necessary or advisable by the anesthetist/anesthesiologist responsible for this service and I request the administration of such anesthetics.” (Emphasis added.) Finally, the form stated: “I have had sufficient opportunity to discuss my condition and treatment with my physician and his or her associates and all of my questions have been answered to my satisfaction.” (Emphasis added.)

This consent form stands in contrast to that provided to the patient in Hoffman. A jury could decide based on this form that plaintiff was, through this form, requesting anesthesia services from FMC and that — given the distinction made between plaintiffs personal *309 physician and the unnamed anesthesiologist — plaintiff was accepting those services in the reasonable belief that the services would be provided by the hospital and its employees. See Jennison v. Providence St. Vincent Med. Ctr., 174 Or. App. 219, 234, 25 P.3d 358, 367 (2001) (“Nowhere did the consent form indicate that the radiologists were independent contractors. Thus, it is reasonable to assume that when a patient in [plaintiff’s] situation signs a consent form like the one she signed and later has an x-ray taken, the patient would believe that it would be a hospital employee who would ultimately interpret that x-ray.”).

Given the current record, we hold that the trial court erred in granting summary judgment with respect to plaintiff’s claims based on apparent agency with respect to defendant FMH. With respect to defendants NHTR and NHI, plaintiff argues only that “Novant held itself out to the public as owning and/or operating Forsyth Medical Center and Plaintiff relied upon this.” Her affidavit stated “that the hospital held itself out to me and the public as being part of Novant.” Plaintiff, however, cites no authority in support of her contention that NHTR and NHI may be held liable based on apparent agency for the acts of Dr. McConville and Ms. Crumb. N.C.R. App. P. 28(b)(6) (“Assignments of error ... in support of which no reason or argument is stated or authority cited, will be taken as abandoned.”). The record contains no evidence that NHTR and NHI, as opposed to the hospital, held themselves out as providing anesthesia services or that they, as opposed to the hospital, contracted to supply the services. Accordingly, the trial court properly granted summary judgment as to NHTR and NHI.

Plaintiff has also argued (1) that the hospital defendants owed plaintiff a non-delegable duty and (2) that the hospital defendants are liable, even apart from agency principles, for the failure to obtain informed consent from plaintiff regarding anesthesia services. Plaintiff has cited no authority suggesting that these theories provide a basis for holding NHI or NHTR liable. With respect to FMH, because of our resolution of this appeal, we need not address these alternative arguments.

Discovery of Privileged Documents

On appeal, plaintiff also argues that the trial judge erred in denying her motion to compel production of (1) certain documents contended by defendants to be protected by attorney-client privilege and the work product doctrine and (2) “[a]ll Statistical Reports for *310 Forsyth Medical Center for infection control for 1996-2000.” It is well established, even with respect to claims of work product and attorney-client privilege, that “orders regarding discovery matters are within the discretion of the trial court and will not be upset on appeal absent a showing of abuse of discretion.” Evans v. United Servs. Auto. Assoc., 142 N.C. App. 18, 27, 541 S.E.2d 782, 788, cert. denied, 353 N.C. 371, 547 S.E.2d 810 (2001).

A. Attorney-Client Privilege and Work Product

Plaintiffs document request number 19 sought: “Any documents not in Plaintiff’s hospital chart at Forsyth Medical Center which discuss the perforation of Plaintiffs esophagus and/or any problems regarding Plaintiffs intubation during her October 12, 1999 hospitalization.” After contending that the responsive documents were protected from production by the attorney-client privilege and the work product doctrine as set forth in Rule 26(b)(3) of the Rules of Civil Procedure, defendants submitted the documents to the trial judge for in camera review. After reviewing the documents, the trial court denied plaintiffs motion to compel with respect to request number 19.

On appeal, defendants filed with this Court a sealed copy of the documents reviewed by the trial court and included in their brief a general description of those documents. The record indicates that these documents were defendants’ “Risk Management file.” We have carefully examined the documents and the information provided by defendants regarding the nature of those documents.

Rule 26(b)(3) provides that documents prepared “in anticipation of litigation” are afforded a qualified immunity from discovery. The party asserting the work product privilege — in this case, defendants — bears the burden of showing that the documents were prepared “in anticipation of litigation.” Evans, 142 N.C. App. at 29, 541 S.E.2d at 789. This Court has explained that “[t]he phrase ‘in anticipation of litigation’ is an elastic concept” and “North Carolina’s definition of [the phrase] is unique in its phraseology.” Cook v. Wake County Hosp. Sys., Inc., 125 N.C. App. 618, 623, 482 S.E.2d 546, 550, disc. review allowed, 346 N.C. 277, 487 S.E.2d 543, appeal withdrawn, 347 N.C. 397, 494 S.E.2d 404 (1997). According to our Supreme Court, documents prepared “in anticipation of litigation” include “not only materials prepared after the other party has secured an attorney, but those prepared under circumstances in which a reasonable person might anticipate a possibility of litigation.” Willis v. Duke Power Co., 291 N.C. 19, 35, 229 S.E.2d 191, 201 (1976).

*311 Nevertheless, “[m]aterials prepared in the ordinary course of business are not protected” under Rule 26(b)(3). Id. This Court, applying Willis, considered whether an accident report prepared by a hospital regarding a doctor’s slip and fall constituted work product. After noting that risk management documents do not automatically constitute work product, the Court reviewed the hospital’s “risk management policy.” Cook, 125 N.C. App. at 624-25, 482 S.E.2d at 551. That policy set out mandatory reporting procedures for incidents and accidents as an administrative tool for identifying areas of risk and reporting occurrences not consistent with desired safe operation of the hospital or care of patients. Id. at 625, 482 S.E.2d at 551. The Court pointed out that the accident reports were not discretionary, but were required of all employees. Id. Once a report was made, the administration and Risk Management would make the final decision to report potential claims of liability. Id. A monthly summary of reports was prepared for administrative and medical staff review. Id.

Based on these policy provisions, the Court concluded that “defendant’s accident reporting policy exists to serve a number of nonlitigation, business purposes” and imposes a “continuing duty on hospital employees to report any extraordinary occurrences within the hospital to risk management” regardless whether the hospital chose to consult its attorney in anticipation of litigation. Id. The Court concluded:

Here, absent any other salient facts, it cannot be fairly said that the employee prepared the accident report because of the prospect of litigation. In short, the accident report would have been compiled, pursuant to the hospital’s policy, regardless of whether Cook intimated a desire to sue the hospital or whether litigation was ever anticipated by the hospital.

... We conclude that defendant’s position is contrary to the discovery rules established by the Willis and [Simon v. G.D. Searle & Co., 816 F.2d 397, 401 (8th Cir.), cert. denied, 484 U.S. 917, 98 L. Ed. 2d 225, 108 S. Ct. 268 (1987)] Courts, and therefore, the trial court erred in denying plaintiffs’ motions to compel production of the accident report.

Id. at 625-26, 482 S.E.2d at 551-52.

In this case, plaintiff has submitted FMH’s policy “for the reporting of all unexpected events.” This policy appears materially indistinguishable from that in Cook and, therefore, under Cook, documents *312 generated pursuant to that policy would not be entitled to protection under Rule 26(b)(3). We are, however, unable to determine from the current record whether the documents at issue were generated pursuant to that policy. While none of the documents are entitled “Quality Assessment Report,” as specified in the policy, certain documents appear to correspond to the reports and summaries required by the hospital’s policy, including documents numbered 61-68 and 70-81.

We must therefore remand to the trial court for further review as to these documents. See Willis, 291 N.C. at 36, 229 S.E.2d at 201 (remanding because “[t]he record is insufficient for us to determine the extent to which” defendant’s claims files “may be subject to the trial preparation immunity”). On remand, defendants bear the burden of demonstrating that the specified documents were not prepared pursuant to the hospital policy or were not otherwise documents “prepared in the ordinary course of business.” Id. at 35, 229 S.E.2d at 201.

We are similarly unable to determine on this record whether documents 92-107 and 154 are entitled to protection under the work product doctrine or the attorney-client privilege. Because the record contains no indication who prepared the documents or for what purpose, we must remand for further review. On remand, defendants should submit affidavits specifying the author of each document, the date each document was prepared, the purpose for which the document was prepared, and the recipients — if any — of each document.

Document 168 is not addressed by defendants in their brief. This document is a letter by Dr. McConville apparently to his insurance agency dated 18 October 1999 relating to plaintiff. We do not know on what basis defendants contend this document is protected from disclosure or if the trial judge considered whether this document was subject to production apart from any risk management documents otherwise protected. Plaintiff has not had any opportunity to argue why she is entitled to have this document produced. Plaintiff may even have already received this document in other discovery. Without expressing any opinion on the issue, we leave for consideration on remand whether this document should be produced.

With respect to the remaining documents, we believe that the trial court did not abuse its discretion in determining that documents numbered 84-91, 108-53, 155-60, 164, 169-70, and 179-203 were protected either by the attorney-client privilege or the work prod *313 uct doctrine. Defendants have represented that copies of documents 161-63 and 165-67 have already been produced to plaintiff; these are simply copies attached to documents protected from disclosure. As to the documents specified in this paragraph, we affirm the trial court’s order.

B. Statistical Reports

Defendant objected to plaintiffs request for “[a]ll Statistical Reports for Forsyth Medical Center for infection control for 1996-2000” on the grounds of relevance. Defendant points out that “[t]here is no dispute in this case that the ‘infection’ which the appellant had was an internal one which came from a leaking esophagus, not from infection of her incision or other source in the hospital environment.” While plaintiff argues, without any citation to the record, that the reports deal with all infections at FMC (and not just infections from external sources) and that the documents “would be clearly admissible under Rule 404(b) of the North Carolina Rules of Evidence to prove a pattern, practice, plan and modus operandi,” plaintiff does not explain to what issue in this case a pattern, practice, plan, or modus operandi would be relevant. In the absence of such a showing, we cannot conclude that the trial court’s ruling denying this request was manifestly unreasonable.

Conclusion

For the foregoing reasons, we reverse the trial court’s grant of summary judgment in favor of FMH and remand this action for further proceedings. We affirm the entry of summary judgment as to NHI and NHTR. We reverse the trial court’s discovery order with respect to document numbers 61-68, 70-81, 92-107, 154, and 168 and remand for further review regarding whether they are entitled to protection under Rule 26(b)(3) or the attorney-client privilege. We affirm the remaining portion of the trial court’s discovery order.

Affirmed in part, reversed in part, and remanded.

Funke, J.

*117 Stephanie A. Sparks, as personal representative of the estate of Gary W. Isom and as temporary guardian of Justin W. Isom; Melanie Crosby, as personal representative of the estate of Tiffany R. Isom; and Nancy Ragains, as personal representative of the estate of Susan G. Isom (appellants), appeal the district court's order granting the motion for summary judgment of M&D Trucking, L.L.C. (M&D). M&D cross-appeals. For the reasons set forth herein, we affirm.

I. BACKGROUND

1. FACTS

Around 5 a.m. on August 28, 2014, Kenneth Bryan Johnson was driving a truck and trailer and failed to stop at a stop sign, **981 striking a vehicle carrying members of the Isom family: Gary, Susan, their son Justin, and Gary's adult daughter Tiffany. Gary, Susan, and Tiffany died as a result of the collision, and Justin was seriously injured. Johnson had been driving longer than permitted under applicable law, and Johnson had consumed alcohol less than 4 hours before going on service. Johnson had a criminal history relating to the operation of motor vehicles, including driving on a suspended license, driving without a license, and driving under the influence of alcohol.

Johnson contracted with Turbo Turtle Logistics LLC (Turbo Turtle) and was driving a truck and trailer with Turbo Turtle signage on the date of the accident. According to deposition testimony from Turbo Turtle president Robert Brackett, Turbo Turtle is a logistics and brokerage company; logistics meaning the physical transportation of products, and brokerage meaning the arranging of transportation of freight by others. At the time of the accident, Turbo Turtle was a motor carrier. At all relevant times, Brackett testified that he was the only employee of Turbo Turtle and that the drivers were independent contractors. Brackett explained Johnson had been one of Turbo Turtle's independent contractor drivers approximately 30 days prior to the accident and that he leased a truck and trailer from Turbo Turtle during that time. Johnson was not allowed to use Turbo Turtle's equipment for any work that was not dispatched through Turbo Turtle or M&D, the company which was hired to transport the load Johnson carried during the accident.

Turbo Turtle had had a business relationship with M&D since Turbo Turtle's creation in 2012. Brackett testified that Turbo Turtle got involved with M&D because Turbo Turtle was trying to add trucks and did not have time to look for work. Brackett opined that, likely, M&D worked with Turbo Turtle to add to its *118 capacity in using Turbo Turtle's drivers, trucks, and trailers. From its inception until the end of its relationship with M&D, Brackett explained that about 98 percent of Turbo Turtle's work came from M&D. **982 M&D operates as a brokerage and trucking company. M&D did not have an ownership interest in Turbo Turtle. At the time of the accident, Michael Plambeck was the manager and Dan Rudnick assisted. According to Plambeck, through its trucking division, M&D employed four to five drivers who drove trucks and trailers owned by M&D. Through its brokerage division, M&D got orders from customers and then sent the load information out to M&D drivers or other carriers. According to Rudnick, M&D's customers did not know which loads would be assigned to M&D drivers and which would be assigned to other carriers. The customers would be billed the same amount regardless of which type of driver was used. While not separate companies, M&D had separate licensing for its brokerage and trucking services and separate insurance plans.

M&D and Turbo Turtle signed a contract detailing the relationship between the companies titled "Contract for Dispatch Services at Reduced Rate With Mutual Non-Competition Upon Early Termination by Either Party." The contract provided that M&D would be the exclusive dispatch servicer for Turbo Turtle with an exception for summer and fall harvesttime in South Dakota. As to Turbo Turtle's drivers, the contract stated, "[Turbo Turtle] will assure that at least 42 weeks of the yearly hauling in total for all of the [independent contractors] under contract with [Turbo Turtle] results from M&D dispatch services"; "[Turbo Turtle] will maintain at least one [independent contractor] under dispatch by M&D at all times"; and "this contract does not require the dedication by [Turbo Turtle] of a particular [independent contractor] to dispatch by M&D." It additionally applied a 2-year, noncompetition agreement should the parties prematurely break the contract. By operation of this contract, Brackett claimed M&D was leasing his four Turbo Turtle trucks. Plambeck, in turn, asserted that any drivers arranged through Turbo Turtle were Turbo Turtle employees or contractors and, as such, M&D never conducted background checks, criminal history background checks, review of a driver's driving record or traffic violations, or **983 review of the performance of Turbo Turtle's drivers. Instead, Plambeck testified, M&D requested and received from Turbo Turtle various legal forms necessary for work between a broker and carrier, including a "DOT motor carrier number" saying Turbo Turtle is legally allowed to haul freight, insurance verification, and W-9 forms for tax purposes. Brackett alleged the contract between M&D and Turbo Turtle was in effect at the time of the accident. Plambeck claimed that M&D terminated the contract on August 28, 2014, once they became aware that Turbo Turtle hauled a load for a different company, while Brackett opined that the contract was terminated in connection with the accident.

Brackett, Plambeck, and Rudnick explained the general procedure between M&D and Turbo Turtle for assigning and transporting hired loads. Plambeck described that a customer would communicate the details of a load to M&D; M&D would document the information on a "load sheet" with the load number, pickup location, destination, telephone numbers, and load quantity; M&D would communicate to Turbo Turtle or a specific driver the load information; and the driver would receive a paper at the pickup and destination and that paper would be sent to M&D for billing purposes. Brackett explained M&D would communicate the load information to Turbo Turtle by sending the individual *119 drivers text messages and Turbo Turtle a copy of those messages. According to Brackett, Turbo Turtle would have no knowledge of who the actual customers were. For payment on loads carried by Turbo Turtle drivers, M&D would charge the customer the same amount as it would have if it used its own driver, M&D would keep a percentage of the total and pay the rest to Turbo Turtle, and Turbo Turtle would keep a percentage of the amount provided by M&D and pay the rest to the driver.

Specifically, on the facts surrounding the accident at issue, M&D had a telephone conversation with Northern Ag Service, Inc., now known as NORAG LLC (Northern Ag), about picking up fracking sand from Genoa, Nebraska, to transport to **984 Blackwell, Oklahoma. Northern Ag is a freight broker, meaning vendors call Northern Ag about moving various loads and Northern Ag then matches the vendor with a carrier or, sometimes, with another broker who contacts another carrier. M&D did not tell Northern Ag which of the ordered loads would be handled by M&D and which would be handled by outside drivers.

Plambeck testified that Northern Ag was fully aware that M&D was a brokerage and trucking company and that it used its own company drivers as well as drivers from other companies to haul loads for Northern Ag. However, there was no written contract in place detailing the relationship between M&D and Northern Ag, and a manager for Northern Ag testified during a deposition that M&D never informed Northern Ag that it was working with outside drivers. He explained that he believed Northern Ag thought it was dealing only with M&D, not knowing Turbo Turtle was handling some of its loads, and that Northern Ag hired M&D to be the carrier. In various records of pickup and destination locations created by Northern Ag for its use, Northern Ag repeatedly listed M&D as the carrier. In the origin ticket/origin bill of lading created by Northern Ag for the load carried during the accident, M&D was listed as the carrier on the pickup.

On August 27 and 28, 2014, M&D, Turbo Turtle, and Johnson had various cell phone communications. Plambeck testified that around 11 p.m., someone from M&D text messaged either Turbo Turtle or Johnson about carrying one of the Northern Ag loads. Rudnick explained that he had contact with either Turbo Turtle or Johnson that night, because a load number did not work and Rudnick had to provide a new number. Plambeck testified Johnson was not required to call M&D once he picked up the load. From information obtained from Johnson's cell phone, the following communications occurred:

• At 9:01 a.m. on August 27, 2014, M&D text messaged Johnson and canceled a load that he was carrying for M&D due to rain.

**985 • Approximately 30 minutes later, M&D text messaged Johnson and dispatched him and his truck to transport a load of sand from Genoa, Nebraska, to Waterford City, North Dakota.

• At 10:47 a.m., Johnson made a short telephone call to M&D.

• At 10:53 a.m., Johnson text messaged Turbo Turtle and informed it that M&D had dispatched him on a load from Genoa to Waterford City.

• At 11:43 p.m., Johnson received a text message from Turbo Turtle stating, "Genoa, NE Sand to Blackwell, OK."

• At 12:09 a.m. on August 28, 2014, Johnson received a telephone call from M&D lasting approximately 1 minute 41 seconds.

*120 • At 12:41 a.m., Johnson received a telephone call from M&D lasting approximately 8 minutes 41 seconds.

• From 12:54 a.m. to 12:58 a.m., Johnson and Turbo Turtle exchanged six text messages, including discussions about truckstops available en route to Blackwell.

The accident between the Isom family and Johnson occurred around 5 a.m. on August 28, 2014. A police report from the accident listed Turbo Turtle as the motor carrier.

2. APPELLANTS' CLAIMS

Appellants brought the instant action against Turbo Turtle, Johnson, and M&D. Pursuant to a stipulation and joint motion, the court dismissed the claims against Turbo Turtle and Johnson. On the claims against M&D, the stipulation and motion to dismiss provided: "This Dismissal does not involve any other defendant or potential tortfeasor. The Plaintiffs reserve all claims against M&D ... and the claims against it remain pending and are not dismissed." The order dismissing the claims against Turbo Turtle and Johnson confirmed: "This Dismissal does not extend to M&D .... The Plaintiffs' claims against M&D [remain] pending ...."

As to M&D, appellants alleged that (1) Johnson was an agent of M&D, and M&D was liable for his negligence through the doctrine of respondeat superior; (2) M&D was negligent in hiring, training, or supervising Johnson given Johnson's unfitness **986 to operate motor vehicles on public roads and a criminal history regarding the operation of motor vehicles; and (3) M&D was negligent per se in that M&D was the operator and/or statutory lessee of the truck and trailer driven by Johnson under the federal Motor Carrier Safety Improvement Act of 1999 (FMCSA) and Federal Motor Carrier Safety Regulations (FMCSR) and, thus, liable for Johnson's and its own negligence.

3. SUMMARY JUDGMENT

M&D filed a motion for summary judgment claiming there was no genuine issue of material fact and that M&D was entitled to summary judgment as a matter of law. In support of the motion, M&D asserted Johnson was not an employee of M&D, Johnson was an independent contractor of Turbo Turtle who was in turn an independent contractor of M&D, and M&D did not have sufficient control over Johnson to be vicariously liable.

Following a hearing on the motion, the district court granted M&D summary judgment as to all three claims. On the claim of respondeat superior, the court first determined appellants' claim is not barred by the prior settlement with Turbo Turtle and Johnson through operation of Neb. Rev. Stat. § 25-21 ,185.11(1) (Reissue 2016) ("[a] release, covenant not to sue, or similar agreement entered into by a claimant and a person liable shall discharge that person from all liability to the claimant but shall not discharge any other persons liable upon the same claim unless it so provides"). The court then determined that Johnson was not an employee of M&D and that M&D did not exert sufficient control over Johnson to establish appellants' claim of respondeat superior. On the claim of negligent hiring, training, or supervising, the court determined M&D complied with its reasonable duty of care as a broker in that the record did not support a finding that M&D knew or should have known Turbo Turtle had an inadequate safety record or that Turbo Turtle hired an unsafe driver in Johnson. Finally, the court noted that negligence per se is not recognized as a separate cause of action in Nebraska for a violation of FMCSA and FMCSR.

**987 *121 II. ASSIGNMENTS OF ERROR

Appellants assign, restated, that the district court erred in granting summary judgment, because there was a genuine issue of material fact of (1) whether M&D was Johnson's common-law or statutory employer and (2) whether M&D negligently hired, trained, or supervised Johnson.

On cross-appeal, M&D assigns, restated, that the district court erred in finding that appellants' decision to settle with Turbo Turtle and Johnson does not operate as a release of M&D in the event that Turbo Turtle or Johnson are deemed agents of M&D.

III. STANDARD OF REVIEW

An appellate court will affirm a lower court's grant of summary judgment if the pleadings and admitted evidence show that there is no genuine issue as to any material facts or as to the ultimate inferences that may be drawn from those facts and that the moving party is entitled to judgment as a matter of law. 1 In reviewing a summary judgment, an appellate court views the evidence in the light most favorable to the party against whom the judgment was granted and gives that party the benefit of all reasonable inferences deducible from the evidence. 2 Statutory interpretation presents a question of law, for which an appellate court has an obligation to reach an independent conclusion irrespective of the decision made by the court below. 3

IV. ANALYSIS

1. EMPLOYEE VERSUS INDEPENDENT CONTRACTOR

Appellants first assign the district court erred in its determination that Johnson was an independent contractor and not M&D's employee. Appellants claim there is substantial **988 evidence that M&D controlled Johnson's work, as well as other relevant factors to create a question of fact as to whether M&D was Johnson's common-law employer.

On a motion for summary judgment, the question is not how a factual issue is to be decided, but whether any real issue of material fact exists. 4 Ordinarily, a party's status as an employee or an independent contractor is a question of fact. 5 However, where the facts are not in dispute and where the inference is clear that there is, or is not, a master and servant relationship, the matter is a question of law. 6 By stating "where the inference is clear," this court means that there can be no dispute as to pertinent facts pertaining to the contract and the relationship of the parties involved and only one reasonable inference can be drawn therefrom. 7

In this matter, the material facts are not in dispute. Rather, the parties argue about the inferences to be drawn from those facts concerning the legal relationships of the parties. We determine these inferences are clear and can be determined as a matter of law.

*122 A determination of whether Johnson was M&D's employee or an independent contractor is determined from all the facts in the case and depends on the facts underlying the relationship of the parties irrespective of the words or terminology used by the parties. 8 No single test exists for determining whether one performs services for another as an employee or as an independent contractor, and the following 10 factors must be considered: (1) the extent of control which, by the agreement, the potential employer may exercise over the details of the work; (2) whether the one potentially employed is engaged in a distinct occupation or business; (3) the type of **989 occupation, with reference to whether, in the locality, the work is usually done under the direction of the potential employer or by a specialist without supervision; (4) the skill required in the particular occupation; (5) whether the potential employer or the one potentially employed supplies the instrumentalities, tools, and the place of work for the person doing the work; (6) the length of time for which the one potentially employed is engaged; (7) the method of payment, whether by the time or by the job; (8) whether the work is part of the regular business of the potential employer; (9) whether the parties believe they are creating an agency relationship; and (10) whether the potential employer is or is not in business. 9

(a) Extent of Control

The extent of control is the chief factor distinguishing an employment relationship from that of an independent contractor. 10 In examining the extent of the potential employer's control over the worker in this context, it is important to distinguish control over the means and methods of the assignment from control over the end product of the work to be performed. 11 An independent contractor is one who, in the course of an independent occupation or employment, undertakes work subject to the will or control of the person for whom the work is done only as to the result of the work and not as to the means or methods used. 12 Even the party contracting with an independent contractor may, without changing the status, exercise such control as is necessary to assure performance of the contract in accordance with its terms. 13

Appellants contend several facts support a finding that M&D exerted sufficient control over Johnson for a determination that **990 the relationship went beyond that of an independent contractor to an employer-employee. Specifically, appellants point to the text messages and cell phone calls between M&D, Turbo Turtle, and Johnson representatives on August 27 and 28, 2014; the contract between M&D and Turbo Turtle which provided M&D would be the exclusive dispatch servicer for Turbo Turtle; and the agreement between Turbo Turtle and Johnson that Johnson could not drive the leased equipment for loads outside those for M&D and Turbo Turtle.

However, these factual allegations do not lead to a determination that M&D and Johnson's relationship went beyond that of an independent contractor. The text messages cited by appellants show that M&D

*123 canceled a load due to rain at 9:01 a.m. on August 27, 2014; that M&D provided Johnson load information for a different load to North Dakota 30 minutes later; and that Turbo Turtle provided load information to Johnson about the Northern Ag load at 11:43 p.m. By providing only the pickup and destination locations, these messages go to the result of the work and not the means or methods used. 14 Additionally, the fact that M&D text messaged Johnson the North Dakota load information directly rather than Turbo Turtle is not at odds with an independent contractor relationship. M&D and Turbo Turtle had a history of M&D's making direct communications with Turbo Turtle's drivers; Turbo Turtle was informed of the North Dakota load by Johnson; and M&D communicated with Turbo Turtle directly about the Northern Ag load, which Turbo Turtle then communicated to Johnson. Through the text messages, the record demonstrates only that M&D was controlling Johnson as to the end product of the work to be performed and did so pursuant to its agreement with Turbo Turtle.

The cell phone calls also do not provide sufficient support that M&D controlled Johnson's actions as to the means and methods to be used. Appellants argue the timing of these calls **991 implies M&D was directing Johnson on the routes to take or the means in which to haul the load, because they occurred after he had the load information, but there is no evidence in the record as to the subject or content of the cell phone calls. Instead, the only information available about the content of the calls is from M&D representatives who testified that, while they do not remember the content of these specific calls, they contacted Johnson only concerning load information. Additionally, it is not a clear inference from the timing of these calls that they were instructing Johnson on the routes to take or the means to haul the load. These cell phone calls occurred relatively soon after Turbo Turtle text messaged Johnson the Northern Ag load information which could imply the conversations were merely communications expanding on the load information. The conversations could also have been concerning the status of other loads or a variety of other topics. Without further evidence on the subject of the calls, there is no clear implication that, as appellants suggest, the calls were M&D's instructing Johnson on the means or methods in which to drive the load.

As to the contract between M&D and Turbo Turtle and the agreement between Turbo Turtle and Johnson, appellants argue these agreements lead to the conclusion that Johnson was permitted to drive only M&D's loads, which was evidence that M&D exercised control over Johnson under an employer-employee relationship. However, the record does not lead to such conclusion. Johnson never contracted with M&D; instead, Turbo Turtle contracted with M&D and Turbo Turtle contracted with Johnson. According to the contract between M&D and Turbo Turtle, M&D was to provide exclusive dispatch services to Turbo Turtle with an exception for periods in which Turbo Turtle was carrying loads related to harvesttime. While the contract required at least one of Turbo Turtle's drivers be available for dispatch by M&D, the contract stated that it did not "require the dedication by [Turbo Turtle] of a particular [independent contractor] to dispatch by M&D." Johnson's **992 agreement with Turbo Turtle, in turn, provided that Johnson could not drive Turbo Turtle's equipment for any load other than those issued by Turbo Turtle or M&D but did not prevent Johnson from *124 using other equipment to carry outside loads. There is also nothing in the record that the agreement prohibited Johnson from carrying loads for Turbo Turtle that were unrelated to M&D, and Turbo Turtle was permitted under the M&D contract to assign non-M&D loads during harvesttime. Therefore, appellants' contention that Johnson could carry only M&D loads is refuted by the record.

In consideration of all of the above and in review of the record, there is insufficient evidence to create a genuine issue of material fact that M&D exerted the extent of control necessary over Johnson for a determination that the relationship went beyond that of an independent contractor to an employer-employee.

(b) Other Factors

Appellants contend additional factors weigh toward a determination that Johnson and M&D had an employer-employee relationship: whether the one potentially employed is engaged in a distinct occupation or business, the length of time for which the one potentially employed is engaged, whether the work is part of the regular business of the potential employer, and whether the potential employer is or is not in business. 15 To support this contention, appellants note M&D, Turbo Turtle, and Johnson were engaged in the same business of transporting goods; M&D was hired to transport the load in question by Northern Ag, which believed M&D would be the sole carrier of the loads; and M&D's own drivers were transporting other loads in the same order for Northern Ag. Appellants claim these factors, when added to the cell phone calls and text messages between M&D and Johnson and the exclusive language of the Turbo Turtle agreements with M&D and Johnson, create an issue of fact as to whether Johnson was an employee of M&D.

**993 However, along with the analysis in the previous section, these additional factors do not determine Johnson was M&D's employee. The fact that M&D had a trucking division as well as a brokerage division is not determinative of an employer-employee relationship. Johnson was in a distinct business from M&D in that M&D operated a brokerage division within its company utilizing outside drivers; Johnson was not exclusively bound to M&D's shipments and could take other work from Turbo Turtle, including during harvesttime; and Johnson did not use M&D's equipment and leased the equipment from Turbo Turtle instead. Johnson contracted with Turbo Turtle and not M&D and had driven for Turbo Turtle for only approximately 30 days prior to the accident, a relatively short amount of time. Additionally, while M&D did drive some of the Northern Ag loads utilizing its own drivers, it was also common for M&D to dispatch outside companies and drivers for the Northern Ag loads.

Considering all of the above, the record is insufficient to create a genuine issue of material fact that the relationship went beyond that of an independent contractor to an employer-employee.

2. LIABILITY AS INDEPENDENT CONTRACTOR

Appellants next argue M&D would be liable for Johnson's negligence, even if Johnson were an independent contractor.

Generally, one who employs an independent contractor is not liable for physical harm caused to another by the acts or omissions of the contractor or its servants. 16 Our case law has recognized four exceptions to the general *125 rule. 17 Specifically, a party contracting with an independent contractor can be liable for physical harm caused to another if (1) the contracting party retains control over the contractor's work, (2) the contracting party is in possession and control of premises, **994 (3) a statute or rule imposes a specific duty on the contracting party, or (4) the contractor's work involves special risks or dangers. 18 We often refer to the latter three exceptions as involving nondelegable duties. 19 A nondelegable duty means that a contracting party to an independent contractor, by assigning work consequent to a duty, is not relieved from liability arising from the delegated duties negligently performed. 20

(a) Retention of Control

While M&D did not retain sufficient control over Johnson's work to subject M&D to liability for Johnson's negligence as an agent or employee, appellants allege that M&D retained some control over the relevant work and that M&D is therefore liable for a failure to exercise reasonable care in the use of that control. 21

To fall within this exception to the general rule of nonliability, the contracting party's involvement in overseeing the work must be substantial. 22 Furthermore, that control must directly relate to the work that caused the injury. 23 In other words, the key element of control must exist with respect to the very thing from which the injury arose. 24 To impose liability, the contracting party must have (1) supervised the work that caused the injury, (2) actual or constructive knowledge of the danger that ultimately caused the injury, and (3) the opportunity to prevent the injury. 25

Appellants argue M&D acted in a supervisory role when it assigned Johnson the load from Northern Ag, had actual **995 and/or constructive knowledge that Johnson was unavailable for driving under the hours-of-service requirements of FMCSA and FMCSR, 26 and had the opportunity to use a different driver who was not in violation of those requirements but failed to do so. Specifically, appellants point to the communication between M&D and Johnson on August 27, 2014, where M&D text messaged to cancel a load Johnson was carrying at 9:01 a.m., text messaged to dispatch him on a load from Nebraska to North Dakota 30 minutes later, and communicated with Turbo Turtle to dispatch Johnson on the load carried during the accident at 11:43 p.m.

The record does not support appellants' contention that M&D had sufficient supervision of Johnson's work. Having the right to control and supervise the work in this context implies having the ability to oversee and direct the manner in which the work that caused the injury is carried out. 27 As we have already concluded, *126 M&D did not have control of the method or means in which Johnson performed his work. Furthermore, concerning the Northern Ag load specifically, the text messages indicate that Johnson was provided, at that time, with only the pickup, destination, and content details of the load. The messages did not direct Johnson on the timing of the load, the route, and what stops to make. Without more, nothing in the record indicates that Johnson was required to drive beyond the hours-of-service restriction and that M&D had control and supervision of Johnson to direct him to make such a violation.

(b) Control of Premises

Appellants argue M&D is liable as the party in possession and control of premises where physical harm is caused.

**996 Appellants allege M&D had a lease agreement with Turbo Turtle and, as a result, was in control of Johnson and the truck and trailer.

Under 49 C.F.R. § 376.2 (e) (2016), a "lease" is defined as "[A] contract or arrangement in which the owner grants the use of equipment, with or without [a] driver, for a specified period to an authorized carrier for use in the regulated transportation of property, in exchange for compensation." In addition, 49 C.F.R. §§ 376.12 and 376.22 (2017) require that a lease contain the following provisions: provide the lessee exclusive possession, control, and use of the equipment for the duration of the lease and the lessee shall assume complete responsibility for the operation of the equipment for the duration of the lease; clearly specify the legal obligation of the lessee to maintain insurance coverage for the protection of the public; and provide that control and responsibility for the operation of the equipment shall be that of the lessee from the time possession is taken until possession is returned. Further, 49 C.F.R. §§ 376.11 and 376.22 (2017) provide specific requirements for the operation of a lease, including that receipts are to be provided from the lessee to the lessor when possession is taken, the equipment must be identified as being operated by the lessee, and the equipment must carry a copy of the lease.

This contract was not a lease agreement whereby M&D was leasing Turbo Turtle's drivers, trucks, and trailers when it communicated a job. Here, Turbo Turtle and Johnson maintained control over the use of the truck and trailer. Turbo Turtle was responsible for the equipment's upkeep, insurance, and signage, as well as the hiring of the drivers, and Johnson and Turbo Turtle were free to coordinate the means and manner in which they accomplished the loads M&D provided to them. Moreover, there was no evidence in the record that either Turbo Turtle or Johnson received receipts when M&D allegedly took possession of the equipment, that the equipment displayed any identifying information that it was **997 being operated by M&D, or that Johnson carried a copy of the contract.

Appellants cite to Plambeck's deposition for the proposition that the contract was a lease. During that deposition, Plambeck made two comments regarding a lease agreement and indicated that prior to the contract, M&D had two other agreements with Turbo Turtle. The first contract he described as a "lease agreement that M&D ... used as a standard lease agreement for any companies that [M&D] brokered loads to." The second contract he described as a "trailer lease" which allowed Turbo Turtle to pull one of M&D's trailers.

The record before us is void of the first contract of which Plambeck testified. As a result, we cannot determine the terms or conditions of that agreement and whether it would qualify as a lease under FMCSA

*127 and FMCSR. Upon a question as to whether the trailer lease was still in effect in 2014, Plambeck stated that "I would call [the contract] a lease agreement too, so which one do you mean?" Plambeck then testified that Turbo Turtle's right to lease a trailer from M&D continued on an as-needed basis. The contract itself authorized Turbo Turtle to lease one of M&D's trailers. However, later in his deposition, Plambeck testified that none of the equipment involved in the accident was being leased from M&D. Noting the failure of the contract to comply with FMCSA and FMCSR requirements for a lease, Plambeck's statement, without more, does not imply that M&D treated the contract as a lease agreement for Turbo Turtle's drivers and equipment, nor does it make the contract such a lease agreement.

(c) Statute or Rule

(i) Statutory Employer-Employee Under FMCSA and FMCSR

Appellants argue FMCSA and FMCSR impose liability on M&D, because Johnson was a driver being controlled exclusively by M&D at the time of the accident and, as such, Johnson was M&D's statutory employee.

**998 In support of their argument, appellants cite to several definitions within the FMCSR. Specifically, 49 C.F.R. § 376.2 (d)(2) which defines "owner" as someone "who, without title, has the right to exclusive use of equipment," and 49 C.F.R. § 390.5 (2017) which defines an "employer" as someone "who owns or leases a commercial motor vehicle in connection with [a business affecting interstate commerce]" and "employee" as someone "employed by an employer" and can include "an independent contractor while in the course of operating a commercial motor vehicle." Appellants claim M&D had the right to exclusive use of Johnson and his equipment, M&D had this right to exclusive use in connection with its interstate trucking business, and, thus, Johnson was an M&D employee under FMCSR, even if considered an independent contractor.

However, appellants are incorrect in their claim that M&D was the owner of the equipment. As analyzed above, Johnson and his equipment were not exclusively controlled by M&D at the time of the accident, Johnson's equipment was owned by Turbo Turtle who was responsible for its maintenance and insurance, and the contract between M&D and Turbo Turtle was not a lease agreement for that equipment. Because M&D was not the owner of Johnson's equipment and did not lease Johnson's equipment, M&D does not meet the definition of employer and Johnson does not meet the definition of employee under FMCSA and FMCSR.

(ii) Motor Carrier Under FMCSA and FMCSR

Appellants argue that FMCSA and FMCSR impose liability on M&D, because M&D was the motor carrier of the Northern Ag load. M&D, in turn, argues it was acting as a broker of the load in question and, thus, did not have liability under FMCSA and FMCSR.

FMCSA and FMCSR generally require that a commercial motor carrier operate only if registered and that such **999 registration requires proof of financial responsibility in order to ensure collectability of a judgment against the motor carrier. 28 This act and these regulations protect the public and provide financial responsibility for motor carrier accidents by creating a legal right and a duty to *128 control vehicles operated for the regulated motor carrier's benefit. 29

The FMCSR, at 49 C.F.R. § 390.5 , codified as Neb. Rev. Stat. § 75-362 (31) (Cum. Supp. 2014), defines "motor carrier" as

a for-hire motor carrier or a private motor carrier. The term includes a motor carrier's agents, officers and representatives as well as employees responsible for hiring, supervising, training, assigning, or dispatching of drivers and employees concerned with the installation, inspection, and maintenance of motor vehicle equipment and/ or accessories. ... [T]his definition includes the terms employer and exempt motor carrier .

For purposes of federal interstate transportation law, a "broker" means:

a person, other than a motor carrier or an employee or agent of a motor carrier, that as a principal or agent sells, offers for sale, negotiates for, or holds itself out by solicitation, advertisement, or otherwise as selling, providing, or arranging for, transportation by motor carrier for compensation. 30

The FMCSR, at 49 C.F.R. § 371.2 (a) (2017), distinguishes motor carriers from brokers by stating:

Motor carriers, or persons who are employees or bona fide agents of carriers, are not brokers within the meaning **1000 of this section when they arrange or offer to arrange the transportation of shipments which they are authorized to transport and which they have accepted and legally bound themselves to transport.

As such, when distinguishing between a motor carrier and a broker, the determinative question is whether the disputed party accepted legal responsibility to transport the shipment. 31

In arguing M&D was acting as a motor carrier on Johnson's Northern Ag load, appellants allege M&D was a licensed motor carrier, M&D was Northern Ag's exclusive point of contact, Northern Ag identified M&D as the motor carrier on internal documents, M&D solicited the loads from Northern Ag for its own account, M&D directly dispatched Johnson, and M&D had control over Johnson and his truck and trailer.

Whether M&D was also a licensed motor carrier is indeterminative to the question whether M&D was the motor carrier for purposes of liability for Johnson's negligence. Instead, this question requires inquiry into M&D's actions with regard to the particular load at issue. 32 A transportation company may have authority to act as a shipper, broker, or carrier, and a court must focus on the specific transaction at issue-not on whether the transportation company acts as a motor carrier in other transactions. 33 At the time of the accident, M&D had both a trucking and a brokerage division to its company *129 with separate licenses and insurance plans, while Turbo Turtle was a licensed motor carrier with its own license and insurance. M&D gave the load in question to Turbo Turtle and its **1001 driver. There is no evidence M&D instructed Johnson beyond providing pickup and destination information. Johnson drove Turbo Turtle's truck and trailer, and Turbo Turtle's signage and motor carrier number were displayed on the equipment. After the accident, the police report listed Turbo Turtle as the motor carrier.

The fact that M&D held itself as Northern Ag's exclusive source of contact is insufficient to convert M&D into a motor carrier under FMCSA and FMCSR. 34 There is no requirement under FMCSA and FMCSR that a broker cannot be the exclusive source of contact for a transportation customer. The record further demonstrates this is a normal practice of the trucking industry. For example, Northern Ag was a freight brokerage company that arranged loads for transport with customers to whom M&D and other of Northern Ag's brokers and carriers had no direct contact.

Appellants contend that M&D solicited the loads from Northern Ag for its own account and that, as a result, M&D was a motor carrier for the load at issue. In support of their contention, appellants rely on Schramm v. Foster 35 for the holding that an entity may be treated as a motor carrier, as opposed to a broker, if it engages in solicitation for its own account. However, there was no evidence that M&D was contractually obligated to transport the Northern Ag loads exclusively and there was no evidence that M&D conveyed to Northern Ag that it would be transporting the load itself. In fact, a Northern Ag manager testified that on behalf of Northern Ag, he solicited brokers as well as carriers to fill shipping orders. In addition, Plambeck testified that Northern Ag was aware that M&D was a brokerage company and that M&D was using M&D drivers and also using brokered carriers for Northern Ag loads. Plambeck also testified that M&D

**1002 never told Northern Ag that it would haul all of the offered loads through M&D's trucking division. As a result, there is no evidence that M&D solicited the Northern Ag loads as a motor carrier for its own account.

M&D did not directly dispatch Johnson on the load in question. Instead, Northern Ag contacted M&D with the load information, M&D communicated that information to Turbo Turtle, and Turbo Turtle communicated that information to Johnson. Johnson's cell phone records indicate Turbo Turtle was the one who contacted Johnson about the Northern Ag load, while M&D had directly dispatched Johnson on a previous North Dakota load. Johnson communicated with Turbo Turtle about routes and stops but there was no evidence in the record establishing that Johnson communicated with M&D about the means and method of the load. However, even if M&D had directly dispatched Johnson on the Northern Ag load, such an action would not determine M&D was a motor carrier. The text messages in which M&D instructed Johnson on the North Dakota load and the text messages in which Turbo Turtle instructed Johnson on the Northern Ag load provided only pickup and destination information. The provision of such information is consistent with the role of a third-party logistics company with the responsibility of coordinating shipment of *130 the freight relative to the customer's needs. 36

While relevant to the question of whether M&D legally bound themselves to transport the Northern Ag loads, Northern Ag listing M&D on the bill of lading and other pickup/dropoff records is not dispositive evidence M&D was acting as the motor carrier. The identification of a transportation company as the "carrier" on the bill of lading does not prove that the transportation company was in fact the carrier in this transaction. In Schramm , the court found that a bill of lading prepared by a third party, which identified the defendant as the **1003 "carrier" of the load was insufficient to establish the defendant's carrier status, because the defendant played no role in its preparation. 37

In the instant matter, the record indicates that typically two different documents were generated for each load shipped: one by the customer when the load was picked up and one by Northern Ag when the load was dropped off. Nothing in the record indicates that M&D had any involvement in preparing either document. For the load involved in the accident, only the pickup document was generated, because the load was not dropped off. The pickup document listed M&D as the carrier and was created by the customer. However, as discussed above, when the load was picked up, the truck and trailer displayed Turbo Turtle's signage and carrier number. M&D's signage and carrier number were not displayed on the truck and trailer, and there is no evidence in the record indicating that Johnson was carrying any sort of lease agreement for M&D to use Turbo Turtle's truck. As such, Turbo Turtle's involvement with the shipment would have been readily apparent to the customer at the pickup location. Similarly, the Northern Ag manager's testimony that Northern Ag had no knowledge M&D was assigning loads to Turbo Turtle does not account for this readily apparent information from the dropoff locations. When considering these factors in the context of the entire record, Northern Ag's internal records and its manager's testimony listing M&D as the motor carrier are insufficient on their own to lead a reasonable trier of fact to determine M&D was the carrier.

Appellants' contention that M&D had control over Johnson and his equipment fails to support a finding that M&D was a motor carrier for the load in question. The record on appeal does not indicate that M&D had exclusive control over Johnson and his equipment. As analyzed above, the contract between M&D and Turbo Turtle did not create or operate as a lease **1004 agreement, Turbo Turtle was not required to make specific drivers available to M&D, Johnson did not directly contract with M&D, Johnson's agreement with Turbo Turtle was that he could drive only Turbo Turtle's equipment for loads issued by Turbo Turtle or M&D but there was no such restriction if Johnson used other equipment, there was an exception in the M&D and Turbo Turtle contract where Turbo Turtle could drive outside loads for harvesttime, and Turbo Turtle owned and was responsible for maintenance and insurance on the equipment.

Based upon our review of the record, all of the above factors indicate that there is insufficient evidence to present a genuine issue of material fact that M&D was the motor carrier of the load at issue.

3. NEGLIGENT HIRING, TRAINING, OR SUPERVISION

Appellants argue that the district court erred in dismissing their claim that M&D

*131 negligently hired, trained, or supervised Johnson. Under this assignment, appellants contend that the district court's reasoning was tainted by its incorrect determination that M&D was a broker and not a motor carrier.

We have previously held that an employer is subject to liability for physical harm to third persons caused by the employer's failure to exercise reasonable care in selecting an employee, even if such employee is an independent contractor. 38 However, as we determined above, the record fails to provide sufficient evidence to present a genuine issue of material fact that Johnson was M&D's employee or that M&D negligently hired, trained, or supervised Johnson.

FMCSA and FMCSR require motor carriers to obtain and maintain records on each of the drivers they employ, such as driving and medical records. 39 However, as we determined **1005 above, the record also fails to provide sufficient evidence to present a genuine issue of material fact that M&D was the motor carrier of the load at issue and instead demonstrates M&D was acting as a broker.

Thus, the district court did not err in dismissing appellants' claim that M&D negligently hired, trained, or supervised Johnson.

4. CROSS-APPEAL

Because we determine the district court did not err in granting M&D's motion for summary judgment and dismissing appellants' claims, we need not address M&D's cross-appeal that the district court erred in failing to find appellants' claim of respondeat superior was barred by the settlement between appellants, Turbo Turtle, and Johnson.

V. CONCLUSION

For the reasons stated above, there are no genuine issues of material fact. M&D is entitled to a judgment as a matter of law, because Johnson's relationship with M&D was that of an independent contractor; M&D did not have liability under that independent contractor relationship for Johnson's negligence; and M&D was a broker of the load at issue and not a motor carrier responsible for Johnson's hiring, training, or supervision. Thus, the district court did not err in granting M&D's motion for summary judgment and dismissing appellants' claims.

AFFIRMED .

Cardozo, J.

The defendant is a manufacturer of automobiles. It sold an automobile to a retail dealer. The retail dealer resold to the plaintiff. While the plaintiff was in the car, it suddenly collapsed. He was *385thrown out and injured. One of the wheels was made of defective wood, and its spokes crumbled into fragments. The wheel was not made by the defendant; it was bought from another manufacturer. There is evidence, however, that its defects could have been discovered by reasonable inspection, and that inspection was omitted. There is no claim that the defendant knew of the defect and willfully concealed it. The case, in other words, is not brought within the rule of Kuelling v. Lean Mfg. Co. (183 N. Y. 78). The charge is one, not of fraud, but of negligence. The question to be determined is whether the defendant owed a duty of care and vigilance to any one but the immediate purchaser.

The foundations of this branch of the law, at least in this state, were laid in Thomas v. Winchester (6 N. Y. 397). A poison was falsely labeled. The sale was made to a druggist, who in turn sold to a customer. The customer recovered damages from the seller who affixed the label. “The defendant’s negligence,” it was said, “put human life in imminent danger.” A poison falsely labeled is likely to injure any one who gets it. Because the danger is to be foreseen, there is a duty to avoid the injury. Cases were cited by way of illustration in which manufacturers were not subject to any duty irrespective of contract. The distinction was said to be that their conduct, though negligent, was not likely to result in injury to any one except the purchaser. We are not required to say whether the chance of injury was always as remote as the distinction assumes. Some of the illustrations might be rejected to-day. The principle of the distinction is for present purposes the important thing.

Thomas v. Winchester became quickly a landmark of the law. In the application of its principle there may at times have been uncertainty or even error. There has never in this state been doubt or disavowal of the principle itself. The chief cases are well known, yet to recall *386some of them will he helpful. Loop v. Litchfield (42 N. Y. 351) is the earliest. It was the case of a defect in a small balance wheel used on a circular saw. The manufacturer pointed out the defect to the buyer, who wished a cheap article and was ready to assume the risk. The risk can hardly have been an imminent one, for the wheel lasted five years before it broke. In the meanwhile the buyer had made a lease of the machinery. It was held that thti manufacturer was not answerable to the lessee. Loop v. Litchfield was followed in Losee v. Clute (51 N. Y. 494), the case of the explosion of a steam boiler. That decision has been criticised (Thompson on Negligence, 233; Shearman & Redfield on Negligence [6th ed.], § 117); but it must be confined to its special facts. It was put upon the ground that the risk of injury was too remote. The buyer in that case had not only accepted the boiler, hut had tested it. The manufacturer knew that his own test was not the final one. The finality of the test has a bearing on the measure of diligence owing to persons other than the purchaser (Beven, Negligence [3d ed.], pp. 50, 51, 54; Wharton, Negligence [2d ed.], § 134).

These early cases suggest a narrow construction of the rule. Later cases, however, evince a more liberal spirit. First in importance is Devlin v. Smith (89 N. Y. 470). The defendant, a contractor, built a scaffold for a painter. The painter’s servants were injured. The contractor was held liable: He knew that the scaffold, if improperly constructed, was a most dangerous trap. He knew that it was to he used by the workmen. He was building it for that very purpose. Building it for their use, he owed them a duty, irrespective of his contract with their master, to build it with care.

From Devlin v. Smith we pass over intermediate cases and turn to the latest case in this court in which Thomas v. Winchester was followed. That case is Statler v. Ray Mfg. Co. (195 N. Y. 478, 480). The defendant *387manufactured a large coffee urn. It was installed in a restaurant. When heated, the urn exploded and injured the plaintiff. W e held that the manufacturer was liable. We said that the urn “was of such a character inherently that, when applied to the purposes for which it was designed, it was liable to become a source of great danger to many people if not carefully and properly constructed.” It may be that Devlin v. Smith and Statler v. Ray Mfg. Co. have extended the rule of Thomas v. Winchester. If so, this court is committed to the extension. The defendant argues that things imminently dangerous to life are poisons, explosives, deadly weapons — things whose normal function it is to injure or destroy. But whatever the rule in Thomas v. Winchester may once have been, it has no longer that restricted meaning. A scaffold (Devlin v. Smith, supra) is not inherently a destructive instrument. It becomes destructive only if imperfectly constructed. A large coffee urn (Statler v. Ray Mfg. Co., supra) may have within itself, if negligently made, the potency of danger, yet no one thinks of it as an implement whose normal function is destruction. What is true of the coffee urn is equally true of bottles of aerated water (Torgeson v. Schultz, 192 N. Y. 156). We have mentioned only cases in this court. But the rule has received a like extension in our courts of intermediate appeal. In Burke v. Ireland (26 App. Div. 487), in an opinion by Cullen, J., it was applied to a builder who constructed a defective building; in Kahner v. Otis Elevator Co. (96 App. Div. 169) to the manufacturer of an elevator; in Davies v. Pelham Hod Elevating Co. (65 Hun, 573; affirmed in this court without opinion, 146 N. Y. 363) to a contractor who furnished a defective rope with knowledge of the purpose for which the rope was to be used. We are not required at this time either to approve or to disapprove the application of the rule that was made in these cases. It is enough that they help to characterize the trend of judicial thought.

*388 Devlin v. Smith was decided in 1882. A year later a very similar case came before the Court of Appeal in England (Heaven v. Pender, L. B. [11 Q. B. D.] 503). We find in the opinion of Brett, M. B., afterwards Lord Esher (p. 510), the same conception of a duty, irrespective of contract, imposed upon the manufacturer by the law itself: “Whenever one person supplies goods, or machinery, or the like, for the purpose of their being used by another person under such circumstances that every one of ordinary sense would, if he thought, recognize at once that unless he used ordinary care and skill with regard to the condition of the thing supplied or the mode of supplying it, there will be danger of injury to the person or property of him for whose use the thing is supplied, and who is to use it, a duty arises to use ordinary care and skill as to the condition or manner of supplying such thing.” He then points out that for a neglect of such ordinary care or skill whereby injury happens, the appropriate remedy is an action for negligence. The right to enforce this liability is not to be confined to the immediate buyer. The right, he says, extends to the persons or class of persons for whose use the thing is supplied. It is enough that the goods “would in all probability be used at once * * * before a reasonable opportunity for discovering any defect which might exist,” and that the thing supplied is of such a nature “that a neglect of ordinary care or skill as to its condition or the manner of supplying it would probably cause danger to the person or property of the person for whose use it was supplied, and who was about to use it.” On the other hand, he would exclude a case “in which the goods are supplied under circumstances in which it would be a chance by whom they would be used or whether they would be used or not; or whether they would be used before there would probably be means of observing any defect,” or where the goods are of such a nature that “a want of care or skill as to their condition or the manner 'of supplying them would not probably *389produce danger of injury to person or property.” What was said by Lord Esher in that case did not command the full assent of his associates. His opinion has been criticised “as requiring every man to take affirmative precautions to protect his neighbors as well as to refrain from injuring them” (Bohlen, Affirmative Obligations in the Law of Torts, 44 Am. Law Reg. [N. S.] 341). It may not be an accurate exposition of the law of England. Perhaps it may need some qualification even in our own state. Like most attempts at comprehensive definition, it may involve errors of inclusion and of exclusion. But its tests and standards, at least in their underlying principles, with whatever qualification may be called for as they are applied to varying conditions, are the tests and standards of our law.

We hold, then, that the principle of Thomas v. Winchester is not limited to poisons, explosives, and things of like nature, to things which in their normal operation are implements of destruction. If the nature of a thing is such that it is reasonably certain to place life and limb in peril when negligently made, it is then a thing of danger. Its nature gives warning of the consequences to be expected. If to the element of danger there is added knowledge that the thing will housed by persons other than the purchaser, and used without new tests, then, irrespective of contract, the manufacturer of this thing of danger is under a duty to make it carefully. That is as far as we are required to go for the decision of this case. There must be knowledge of a danger, not merely possible, but probable. It is possible to use almost anything in a way that will make it dangerous if defective. That is not enough to charge the manufacturer with a duty independent of his contract. Whether a given thing is dangerous may be sometimes a question for the court and sometimes a question for the jury. There must also be knowledge that in the usual course of events the danger will he shared by others than the buyer. Such knowledge may often be *390inferred from the nature of the transaction. But it is possible that even knowledge of the danger and of the use will not always be enough. The proximity or remoteness of the relation is a factor to be considered. We are dealing now with the liability of the manufacturer of the finished product, who puts it on the market to be used without inspection by his customers. If he is negligent, where danger is to be foreseen, a liability will follow. We are not required at this time to say that it is legitimate to go back of the manufacturer of the finished product and hold the manufacturers of the component parts. To make their negligence a cause of imminent danger, an independent cause must often intervene; the manufacturer of the finished product must also fail in his duty of inspection. It may be that in those circumstances the negligence of the earlier members of the series is too remote to constitute, as to the ultimate user, an actionable wrong (Beven on Negligence [3d ed.], 50, 51, 51; Wharton on Negligence [2d ed.], § 134; Leeds v. N. Y. Tel. Co., 178 N. Y. 118; Sweet v. Perkins, 196 N. Y. 482; Hayes v. Hyde Park, 153 Mass. 511, 516). We leave that question open. We shall have to deal with it when it arises. The difficulty which it suggests is not present in this case. There is here no break in the chain of cause and effect. In such circumstances, the presence of a known danger, attendant upon a known use, makes vigilance a duty. We have put aside the notion that the duty to safeguard life and limb, when the consequences of negligence may be foreseen, grows out of contract and nothing else. We have put the source of the obligation where it ought to be. We have put its source in the law.

From this survey of the decisions, there thus emerges a definition of the duty of a manufacturer which enables us to measure this defendant’s liability. Beyond all question, the nature of an automobile gives warning of probable danger if its construction is defective. This *391automobile was designed to go fifty miles an hour. Unless its wheels were sound and strong, injury was almost certain. It was as much a thing of danger as a defective engine for a railroad. The defendant knew the danger. It knew also that the car would be used by persons other than the buyer. This was apparent from its size; there were seats for three persons. It was apparent also from the fact that the buyer was a dealer in cars, who bought to resell. The maker of this car supplied it for the use of purchasers from the dealer just as plainly as the contractor in Devlin v. Smith supplied the scaffold for use by the servants of the owner. The dealer was indeed the one person of whom it might be said with some approach to certainty that by him the car would not be used. Yet the defendant would have us say that he was the one person whom it was under a legal duty to protect. The law does not lead us to so inconsequent a conclusion. Precedents drawn from the days of travel by stage coach do not fit the conditions of travel to-day. The principle that the danger must be imminent does not change, but the things subject to the principle do change. They are whatever the needs of life in a developing civilization require them to be.

In reaching this conclusion, we do not ignore the decisions to the contrary in other jurisdictions. It was held in Cadillac M. C. Co. v. Johnson (221 Fed. Rep. 801) that an automobile is not within the rule of Thomas v. Winchester. There was, however, a vigorous dissent. Opposed to that decision is one of the Court of Appeals of Kentucky (Olds Motor Works v. Shaffer, 145 Ky. 616). The earlier cases are summarized by Judge Sanborn in Huset v. J. I. Case Threshing Machine Co. (120 Fed. Rep. 865). Some of them, at first sight inconsistent with our conclusion, may be reconciled upon the ground that the negligence was too remote, and that another cause had intervened. But even when they cannot be reconciled, the difference is rather in the applica*392tion of the principle than in the principle itself. Judge Sanborn says, for example, that the contractor who builds a bridge, or the manufacturer who builds a car, cannot ordinarily foresee injury to other persons than the owner as the probable result (120 Fed. Rep. 865, at p. 867). We take a different view. We think that injury to others is to be foreseen not merely as a possible, but as an almost inevitable result. (See the trenchant criticism in Bohlen, supra, at p. 351). Indeed, Judge Sanborn concedes that his view is not to be reconciled with our decision in Devlin v. Smith (supra). The doctrine of that decision has now become the settled law of this state, and we have no desire to depart from it.

In England the limits of the rule are still unsettled. Winterbottom v. Wright (10 M. & W. 109) is often cited. The defendant undertook to provide a mail coach to carry the mail bags. The coach broke down from latent defects in its construction. The defendant, however, was not the manufacturer. The court held that he was not liable for injuries to a passenger. The case was decided on a demurrer to the declaration. Lord Esher points out in Heaven v. Pender (supra, at p. 513) that the form of the declaration was subject to criticism. It did not fairly suggest the existence of a duty aside from the special contract which was the plaintiff’s main reliance. (See the criticism of Winterbottom v. Wright, in Bohlen, supra, at pp. 281, 283). At all events, in Heaven v. Pender (supra) the defendant, a dock owner, who put up a staging outside a ship, was held liable to the servants of the shipowner. In Elliott v. Hall (15 Q. B. D. 315) the defendant sent out a defective truck laden with goods which he had sold. The buyer’s servants unloaded it, and were injured because of the defects. It was held that the defendant was under a duty “not to he guilty of negligence with regard to the state and condition of the truck.” There seems to have been a *393return to the doctrine of Winterbottom v. Wright in Earl v. Lubbock (L. B. [1905] 1 K. B. 253). In that case, however, as in the earlier one, the defendant was not the manufacturer. He had merely made a contract to keep the van in repair. A later case (White v. Steadman, L. R. [1913], 3 K. B. 340, 348) emphasizes that element. A livery stable keeper who sent out a vicious horse was held liable not merely to his customer but also to another occupant of the carriage, and Thomas v. Winchester was cited and followed (White v. Steadman, supra, at pp. 348, 349). It was again cited and followed in Dominion Natural Gas Co. v. Collins (L. R. [1909] A. C. 640, 646). From these cases a consistent principle is with difficulty extracted. The English courts, however, agree with ours in holding that one who invites another to make use of an appliance is bound to the exercise of reasonable care (Caledonian Ry. Co. v. Mulholland, L. R. [1898] A. C. 216, 227; Indermaurv. Dames, L. R. [1 C. P.] 274). That at bottom is the underlying principle of Devlin v. Smith. The contractor who builds the scaffold invites the owner’s workmen to use it. The manufacturer who sells the automobile to the retail dealer invites the dealer’s customers to use it. The invitation is addressed in the one case to determinate persons and in the other to an indeterminate class, but in each case it is equally plain, and in each its consequences must be the same.

There is nothing anomalous in a rule which imposes upon A, who has contracted with B, a duty to C and D and others according as he knows or does not know that the subject-matter of the contract is intended for their use. We may find an analogy in the law which measures the liability of landlords. If A leases to B a tumbledown house he is not liable, in the absence of fraud, to B’s guests who enter it and are injured. This is because B is then under the duty to repair it, the lessor has the right to suppose that he will fulfill that duty, and, if he *394omits to do so, his guests must look to him (Bohlen, supra, at p. 276). But if A leases a building to be used by the lessee at once as a place of public entertainment, the rule is different. There injury to persons other than the lessee is to be foreseen, and foresight of the consequences involves the creation of a duty (Junhermann v. Tilyou R. Co., 213 N. Y. 404, and cases there cited).

In this view of the defendant’s liability there is nothing inconsistent with the theory of liability on which the case was tried. It is true that the court told the jury that “an automobile is not an inherently dangerous vehicle.” The meaning, however, is made plain by the context. The meaning is that danger is not to be expected when the vehicle is well constructed. The court left it to the jury to say whether the defendant ought to have foreseen that the car, if negligently constructed, would become “imminently dangerous.” Subtle distinctions are drawn by the defendant between things inherently dangerous and things imminently dangerous, but the case does not turn upon these verbal niceties. If danger was to be expected as reasonably certain, there was a duty of vigilance, and this whether you call the danger inherent or imminent. In varying forms that thought was put before the jury. We do not say that “the court would not have been justified in ruling as a matter of law that the car was a dangerous thing. If there was any error, it was none of which the defendant can complain.

We think the defendant was not absolved from a duty of inspection because it bought the wheels from a reputable manufacturer. It was not merely a dealer in automobiles. It was a manufacturer of automobiles. It was responsible for the finished product. It was not at liberty to put the finished product on the market without subjecting the component parts to ordinary and simple tests (Richmond & Danville R. R. Co. v. Elliott, 149 U. S. 266, 272). Under the charge of the trial judge nothing more was *395required of it. The obligation to inspect must vary with the nature of the thing to be inspected. The more probable the danger, the greater the need of caution. There is little analogy between this case and Carlson v. Phoenix Bridge Co. (132 N. Y. 273), where the defendant bought a tool for a servant’s use. The making of tools was not the business in which the master was engaged. Reliance on the skill of the manufacturer was proper and almost inevitable. But that is not the defendant’s situation. Both by its relation to the work and by the nature of its business, it is charged with a stricter duty.

Other rulings complained of have been considered, but no error has been found in them.

The judgment should be affirmed with costs.

Willard Bartlett, Ch. J. (dissenting).

The plaintiff was injured in consequence of the collapse of a wheel of an automobile manufactured by the defendant corporation which sold it to a firm of automobile dealers in Schenectady, who in turn sold the car to the plaintiff. The wheel was purchased by the Buick Motor Company, ready made, from the Imperial Wheel Company of Flint, Michigan, a reputable manufacturer of automobile wheels which had furnished the defendant with eighty thousand wheels, none of which had proved to be made of defective wood prior to the accident in the present case. The defendant relied upon the wheel manufacturer to make all necessary tests as to the strength of the material therein and made no such tests itself. The present suit is an action for negligence brought by the subvendee of the motor car against the manufacturer as the original vendor. The evidence warranted a finding by the jury that the wheel which collapsed was defective when it left the hands of the defendant. The automobile was being prudently operated at the time of the accident and was moving at a speed of only eight miles an hour. There was *396no allegation or proof of any actual knowledge of the defect on the part of the defendant or any suggestion that any element of fraud or deceit or misrepresentation entered into the sale.

The theory upon which the case was submitted to the jury by the learned judge who presided at the trial was that, although an automobile is not an inherently dangerous vehicle, it may become such if equipped with a weak wheel; and "that if the motor car in question, when it was put upon the market was in itself inherently dangerous by reason of its being equipped with a weak wheel, the 'defendant was chargeable with a knowledge of the defect so far as it might be discovered by a reasom able inspection and the application of reasonable tests. This liability, it was further held, was not limited to the original vendee, but extended to a subvendee like the plaintiff, who was not a party to the original contract of sale.

I think that these rulings, which have been approved by the Appellate Division, extend the liability of the vendor of a manufactured article further than any case which has yet received the sanction of this court. It has heretofore been held in this state that the liability of the vendor of a manufactured article for negligence arising out of the existence of defects therein does not extend to strangers injured in consequence of such defects but is confined to the immediate vendee. The exceptions to this general rule which have thus far been recognized in New York are cases in which the article sold was of such a character that danger to life or limb was involved in the ordinary use thereof; in other words, where the article sold was inherently dangerous. As has already been pointed out, the learned trial judge instructed the jury that an automobile is not an inherently dangerous vehicle.

The late Chief Justice Cooley of Michigan, one of the most learned and accurate of American law writers, *397states the general rule thus: “The general rule is that a contractor, manufacturer, vendor or furnisher of an article is not liable to third parties who have no contractual relations with him for negligence in the construction, manufacture or sale of such article.” (2 Cooley on Torts [3d ed.], I486.)

The leading English authority in support of this rule, to which all the later cases on the same subject refer, is Winterbottom v. Wright (10 Meeson & Welsby, 109), which was an action by the driver of a stage coach against a contractor who had agreed with the postmaster-general to provide and keep the vehicle in repair for the purpose of conveying the royal mail over a prescribed route. The coach broke down and upset, injuring the driver, who sought to recover against the contractor on account of its defective construction. The Court of Exchequer denied him any right of recovery on the ground that there was no privity of contract between the parties, the agreement having been made with the postmaster-general alone. i£If the plaintiff can sue,” said Lord Abinger, the Chief Baron, “every passenger or even any person passing along the road, who was injured by the upsetting of the coach, might bring a similar action. Unless we confine the operation of such contracts as this to the parties who enter into them, the most absurd and outrageous consequences, to which I can see no limit, would ensue.”

The doctrine of that decision was recognized as the law of this state by the leading New York case of Thomas v. Winchester (6 N. Y. 397, 408), which, however, involved an exception to the general rule. There the defendant, who was a dealer in medicines, sold to a druggist a quantity of belladonna, which is a deadly poison, negligently labeled as extract of dandelion. The druggist in good faith used the poison in filling a prescription calling for the harmless dandelion extract and the plaintiff for whom the prescription was put up was poisoned by the *398belladonna. This court held that the original vendor was liable for the injuries suffered by the patient. Chief Judge Ruggles, who delivered the opinion of the court, distinguished between an act of negligence imminently dangerous to the lives of others and one that is not so, saying: “If A. build a wagon and sell it to B., who sells it to C. and C. hires it to D., who in consequence of the gross negligence of A. in building the wagon is overturned and injured, D. cannot recover damages against A., the builder. A.’s obligation to build the wagon faithfully, arises solely out of his contract with B. The public have nothing to do with it. * * * So, for the same reason, if a horse be defectively shod by a smith, and a person hiring the horse from the owner is thrown and injured in consequence of the smith’s negligence in shoeing; the smith is not liable for the injury. ”

In Torgeson v. Schultz (192 N. Y. 156, 159) the defendant was the vendor of bottles of aerated water which were charged under high pressure and likely to explode unless used with precaution when exposed to sudden changes of temperature. The plaintiff, who was a servant of the purchaser, was injured by the explosion of one of these bottles. There was evidence tending to show that it had not been properly tested in order to insure users against such accidents. We held that the defendant corporation was liable notwithstanding the absence of any contract relation between it and the plaintiff “under the doctrine of Thomas v. Winchester (supra), and similar cases based upon the duty of the vendor of an article dangerous in its nature, or likely to become so in the course of the ordinary usage to be contemplated by the vendor, either to exercise due care to warn users of the danger or to take reasonable care to present the article sold from proving dangerous when subjected only to customary usage.” The character of the exception to the general rule limiting liability for negligence to the original parties to the contract of sale, was still more clearly stated by Judge *399Hiscock, writing for the court in Statler v. Ray Manufacturing Co. (195 N. Y. 478, 482), where he said that “in the case of an article of an inherently dangerous nature, a manufacturer may become liable for a negligent construction which, when added to the inherent character of the appliance, makes it imminently dangerous, and causes or contributes to a resulting injury not necessarily incident to the use of such an article if properly constructed, but naturally following from a defective construction.” In that case the injuries were inflicted by the explosion of a battery of steam-driven coffee urns, constituting an appliance liable to become dangerous in the course of ordinary usage.

The case of Devlin v. Smith (89 N. Y. 470) is cited as an authority in conflict with the view that the liability of the manufacturer and vendor extends to third parties only when the article manufactured and sold is inherently dangerous. In that case the builder of a scaffold ninety feet high which was erected for the purpose of enabling painters to stand upon it, was held to be liable to the administratrix of a painter who fell therefrom and was killed, being at the time in the employ of the person for whom the scaffold was built. It is said that the scaffold if properly constructed was not inherently dangerous; and hence that this decision affirms the existence of liability in the case of an article not dangerous in itself but made so only in consequence of negligent construction. Whatever logical force there may be in this view it seems to me clear from the language of Judge Rapallo, who wrote the opinion of the court, that the scaffold was deemed to be an inherently dangerous structure; and that the case was decided as it was because the court entertained that view. Otherwise he would hardly have said, as he did, that the circumstances seemed to bring the case fairly within the principle of Thomas v. Winchester.

I do not see how we can uphold the judgment in the *400present case without overruling what has been so often said by this court and other courts of like authority in reference to the absence of any liability for negligence on the part of the original vendor of an ordinary carriage to any one except his immediate vendee. The absence of such liability was the very point actually decided in the English case of Winterbottom v. Wright (supra), and the illustration quoted from the opinion of Chief Judge Ruggles in Thomas v. Winchester (supra) assumes that the law on the subject was so plain that the statement would be accepted almost as a matter of course. In the case at bar the defective wheel on an automobile moving only eight iniles an hour was not any more dangerous to the occupants of the car than a similarly defective wheel would be to the occupants of a carriage drawn by a horse at the same speed; and yet unless the courts have been all wrong on this question up to the present time there would be no liability to strangers to the original sale in the case of the horse-drawn carriage.

The rule upon which, in my judgment, the determination of this case depends, and the recognized exceptions thereto, were discussed by Circuit Judge Sanborn of the United States Circuit Court of Appeals in the Eighth Circuit, in Huset v. J. I. Case Threshing Machine Co. (120 Fed. Rep. 865) in an opinion which reviews all the leading American and English decisions on the subject up to the time when it was rendered (1903). I have already discussed the leading New York cases, but as to the rest I feel that I can add nothing to the learning of that opinion or the cogency of its reasoning. I have examined the cases to which Judge Sanborn refers, but if I were to discuss them at length I should be forced merely to paraphrase his language, as a study of the authorities he cites has led me to the same conclusion; and the repetition of what has already been so well said would contribute nothing to the advantage of the bench, the bar or the individual litigants whose case is before us.

*401A few cases decided since his opinion was written, however, may he noticed. In Earl v. Lubbock (L. R. 1905 [1 K. B. Div.] 253) the Court of Appeal in 1904 considered and approved the propositions of law laid down by the Court of Exchequer in Winterbottom v. Wright (supra), declaring that the decision in that case, since the year 1842, had stood the test of repeated discussion. The master of the rolls approved the principles laid down by Lord Abinger as based upon sound reasoning; and all the members of the court agreed that his decision was a controlling authority which must he followed. That the Federal courts still adhere to the general rule, as I have stated it, appears by the decision of the Circuit Court of Appeals in the Second Circuit, in March, 1915, in the case of Cadillac Motor Car Co. v. Johnson (221 Fed. Rep. 801). That case, like this, was an action by a subvendee against a manufacturer of automobiles for negligence in failing to discover that one of its wheels was defective, the court holding that such an action could not be maintained. It is true there was a dissenting opinion in that case, but it was based chiefly upon the proposition that rules applicable to stage coaches are archaic when applied to automobiles and that if the law did not afford a remedy to strangers to the contract the law should he changed. It this be true, the change should he effected by the legislature and not by the courts. A perusal of the opinion in that case and in the Huset case will disclose how uniformly the courts throughout this country have adhered to the rule and how consistently they have refused to broaden the scope of the exceptions. I think we should adhere to it in the case at bar and, therefore, I vote for a reversal of this judgment.

Hiscock, Chase and Cuddeback, JJ., concur with Cardozo, J., and Hogan, J., concurs in result; Willard Bartlett, Ch. J., reads dissenting opinion; Pound, J., not voting.

Judgment affirmed.

*456GIBSON, C. J.

Plaintiff, a waitress in a restaurant, was injured when a bottle of Coca Cola broke in her hand. She alleged that defendant company, which had bottled and delivered the alleged defective bottle to her employer, was negligent in selling “bottles containing said beverage which on account of excessive pressure of gas or by reason of some defect in the bottle was dangerous . . . and likely to explode.” This appeal is from a judgment upon a jury verdict in favor of plaintiff.

Defendant’s driver delivered several cases of Coca Cola to the restaurant, placing them on the floor, one on top of the other, under and behind the counter, where they remained at least thirty-six hours. Immediately before the accident, plaintiff picked up the top case and set it upon a near-by ice cream cabinet in front of and about three feet from the refrigerator. She then proceeded to take the bottles from the case with her right hand, one at a time, and put them into the refrigerator. Plaintiff testified that after she had placed three bottles in the refrigerator and had moved the fourth bottle about eighteen inches from the ease “it exploded in my hand.” The bottle broke into two jagged pieces and inflicted a deep five-inch cut, severing blood vessels, nerves and muscles of the thumb and palm of the hand. Plaintiff further testified that when the bottle exploded, “It made a sound similar to an electric light bulb that would have dropped. It made a loud pop.” Plaintiff’s employer testified, “I was about twenty feet from where it actually happened and I heard the explosion.” A fellow employee, on the opposite side of the counter, testified that plaintiff “had the bottle, I should judge, waist high, and I know that it didn’t bang either the case or the door or another bottle . . . when it popped. It sounded just like a fruit jar would blow up. . . .” The witness further testified that the contents of the bottle “flew all over herself and myself and the walls and one thing and another.”

The top portion of the bottle, with the cap, remained in plaintiff’s hand, and the lower portion fell to the floor but did not break. The broken bottle was not produced at the trial, the pieces having been thrown away by an employee of the restaurant shortly after the accident. Plaintiff, however, described the broken pieces, and a diagram of the bottle was made showing the location of the “fracture line” where the bottle broke in two.

*457One of defendant’s drivers, called as a witness by plaintiff, testified that he had seen other bottles of Coca Cola in the past explode and had found broken bottles in the warehouse when he took the cases out, but that he did not know what made them blow up.

Plaintiff then rested her case, having announced to the court that being unable to show any specific acts of negligence she relied completely on the doctrine of res ipsa loquitur.

Defendant contends that the doctrine of res ipsa loquitur does not apply in this case, and that the evidence is insufficient to support the judgment.

Many jurisdictions have applied the doctrine in cases involving exploding bottles of carbonated beverages. (See Payne v. Rome Coca-Cola Bottling Co., 10 Ga.App. 762 [73 S.E. 1087] ; Stolle v. Anheuser-Busch, 307 Mo. 520 [271 S.W. 497, 39 A.L.R. 1001] ; Bradley v. Conway Springs Bottling Co., 154 Kan. 282 [118 P.2d 601] ; Ortego v. Nehi Bottling Works, 199 La. 599 [6 So.2d 677] ; MacPherson v. Canada Dry Ginger Ale, Inc., 129 N.J.L. 365 [29 A.2d 868]; Moeres v. Coca-Cola Bottling Co., 290 Mich. 567 [287 N.W. 922] ; Benkendorfer v. Garrett (Tex. Civ. App.), 143 S.W.2d 1020.) Other courts for varying reasons have refused to apply the doctrine in such cases. (See Gerber v. Faber, 54 Cal.App.2d 674 [129 P.2d 485] ; Loebig’s Guardian v. Coca-Cola Bottling Co., 259 Ky. 124 [81 S.W.2d 910]; Stewart v. Crystal Coca-Cola Bottling Co., 50 Ariz. 60 [68 P.2d 952]; Glaser v. Seitz, 35 Misc. 341 [71 N.Y.S. 942]; Luciano v. Morgan, 267 App. Div. 785 [45 N.Y.S.2d 502]; cf. Berkens v. Denver Coca-Cola Bottling Co., 109 Colo. 140 [122 P.2d 884]; Ruffin v. Coca Cola Bottling Co., 311 Mass. 514 [42 N.E.2d 259]; Slack v. Premier-Pabst Corporation, 40 Del. 97 [5 A.2d 516] ; Wheeler v. Laurel Bottling Works, 111 Miss. 442 [71 So. 743, L.R.A. 1916E 1074] ; Seven-Up Bottling Co. v. Gretes, _Va._[27 S.E.2d 925]; Dail v. Taylor, 151 N.C. 284 [66 S.E. 135, 28 L.R.A.N.S. 949].) It would serve no useful purpose to discuss the reasoning of the foregoing cases in detail, since the problem is whether under the facts shown in the instant case the conditions warranting application of the doctrine have been satisfied.

Res ipsa loquitur does not apply unless (1) defendant had exclusive control of the thing causing the injury and (2) the accident is of such a nature that it ordinarily *458would not occur in the absence of negligence by the defendant. (Honea v. City Dairy, Inc., 22 Cal.2d 614, 616-617 [140 P.2d 369], and authorities there cited; cf. Hinds v. Wheadon, 19 Cal.2d 458, 461 [121 P.2d 724]; Prosser on Torts [1941], 293-301.)

Many authorities state that the happening of the accident does not speak for itself where it took place some time after defendant had relinquished control of the instrumentality causing the injury. Under the more logical view, however, the doctrine may be applied upon the theory that defendant had control at the time of the alleged negligent act, although not at the time of the accident, provided plaintiff first proves that the condition of the instrumentality had not been changed after it left the defendant’s possession. (See cases collected in Honea v. City Dairy, Inc., 22 Cal.2d 614, 617-618 [140 P.2d 369].) As said in Dunn v. Hoffman Beverage Co., 126 N.J.L. 556 [20 A.2d 352, 354], “defendant is not charged with the duty of showing affirmatively that something happened to the bottle after it left its control or management; ... to get to the jury the plaintiff must show that there was due care during that period.” Plaintiff must also prove that she handled the bottle carefully. The reason for this prerequisite is set forth in Prosser on Torts, supra, at page 300, where the author states: “Allied to the condition of exclusive control in the defendant is that of absence of any action on the part of the plaintiff contributing to the accident. Its purpose, of course, is to eliminate the possibility that it was the plaintiff who was responsible. If the boiler of a locomotive explodes while the plaintiff engineer is operating it, the inference of his own negligence is at least as great as that of the defendant, and res ipsa loquitur will not apply until he has accounted for his own conduct.” (See, also, Olson v. Whitthorne (& Swan, 203 Cal. 206, 208-209 [263 P. 518, 58 A.L.R. 129].) It is not necessary, of course, that plaintiff eliminate every remote possibility of injury to the bottle after defendant lost control, and the requirement is satisfied if there is evidence permitting a reasonable inference that it was not accessible to extraneous harmful forces and that it was carefully handled by plaintiff or any third person who may have moved or touched it. (Cf. Prosser, supra, p. 300.) If such evidence is presented, the question becomes one for the trier of fact (see, e. g., *459 MacPherson v. Canada Dry Ginger Ale, Inc., 129 N.J.L. 365 [29 A.2d 868, 869]), and, accordingly, the issue should be submitted to the jury under proper instructions.

In the present case no instructions were requested or given on this phase of the case, although general instructions upon res ipsa loquitur were given. Defendant, however, has made no claim of error with reference thereto on this appeal. Upon an examination of the record, the evidence appears sufficient to support a reasonable inference that the bottle here involved was not damaged by any extraneous force after delivery to the restaurant by defendant. It follows, therefore, that the bottle was in some manner defective at the time defendant relinquished control, because sound and properly prepared bottles of carbonated liquids do not ordinarily explode when carefully handled.

The next question, then, is whether plaintiff may rely upon the doctrine of res ipsa loquitur to supply an inference that defendant’s negligence was responsible for the defective condition of the bottle at the time it was delivered to the restaurant. Under the general rules pertaining to the doctrine, as set forth above, it must appear that bottles of carbonated liquid are not ordinarily defective without negligence by the bottling company. In 1 Shearman and Redfield on Negligence (rev. ed. 1941), page 153, it is stated that: “The doctrine . . . requires evidence which shows at least the probability that a particular accident could not have occurred without legal wrong by the defendant.”

An explosion such as took place here might have been caused by an excessive internal pressure in a sound bottle, by a defect in the glass of a bottle containing a safe pressure, or by a combination of these two possible causes. The question is whether under the evidence there was a probability that defendant was negligent in any of these respects. If so, the doctrine of res ipsa loquitur applies.

The bottle was admittedly charged with gas under pressure, and the charging of the bottle was within the exclusive control of defendant. As it is a matter of common knowledge that an overcharge would not ordinarily result without negligence, it follows under the doctrine of res ipsa loquitur that if the bottle was in fact excessively charged an inference of defendant’s negligence would arise. If *460the explosion resulted from a defective bottle containing a safe pressure, the defendant would be liable if it negligently-failed to discover such flaw. If the defect were visible, an inference of negligence would arise from the failure of defendant to discover it. Where defects are discoverable, it may be assumed that they will not ordinarily escape detection if a reasonable inspection is made, and if such a defect is overlooked an inference arises that a proper inspection was not made. A difficult problem is presented where the defect is unknown and consequently might have been one not discoverable by a reasonable, practicable inspection. In the Honea case we refused to take judicial notice of the technical practices and information available to the bottling industry for finding defects which cannot be seen. In the present case, however, we are supplied with evidence of the standard methods used for testing bottles.

A chemical engineer for the Owens-Illinois Glass Company and its Pacific Coast subsidiary, maker of Coca Cola bottles, explained how glass is manufactured and the methods used in testing and inspecting bottles. He testified that his company is the largest manufacturer of glass containers in the United States, and that it uses the standard methods for testing bottles recommended by the glass containers association. A pressure test is made by taking a sample from each mold every three hours—approximately one out of every 600 bottles—and subjecting the sample to an internal pressure of 450 pounds per square inch, which is sustained for one minute. (The normal pressure in Coca Cola bottles is less than 50 pounds per square inch.) The sample bottles are also subjected to the standard thermal shock test. The witness stated that these tests are “pretty near” infallible.

It thus appears that there is available to the industry a commonly-used method of testing bottles for defects not apparent to the eye, which is almost infallible. Since Coca Cola bottles are subjected to these tests by the manufacturer, it is not likely that they contain defects when delivered to the bottler which are not discoverable by visual inspection. Both new and used bottles are filled and distributed by defendant. The used bottles are not again subjected to the tests referred to above, and it may be inferred that defects not discoverable by visual inspection do not develop in bottles after they are manufactured. Obviously, if such defects do *461occur in used bottles there is a duty upon the bottler to make appropriate tests before they are refilled, and if such tests are not commercially practicable the bottles should not be re-used. This would seem to be particularly true where a charged liquid is placed in the bottle. It follows that a defect which would make the bottle unsound could be discovered by reasonable and practicable tests.

Although it is not clear in this case whether the explosion was caused by an excessive charge or a defect in the glass, there is a sufficient showing that neither cause would ordinarily have been present if due care had been used. Further, defendant had exclusive control over both the charging and inspection of the bottles. Accordingly, all the requirements necessary to entitle plaintiff to rely on the doctrine of res ipsa loquitur to supply an inference of negligence are present.

It is true that defendant presented evidence tending to show that it exercised considerable precaution by carefully regulating and cheeking the pressure in the bottles and by making visual inspections for defects in the glass at several stages during the bottling process. It is well settled, however, that when a defendant produces evidence to rebut the inference of negligence which arises upon application of the doctrine of res ipsa loquitur, it is ordinarily a question of fact for the jury to determine whether the inference has been dispelled. (Druzanich v. Criley, 19 Cal.2d 439, 444 [122 P.2d 53]; Michener v. Hutton, 203 Cal. 604, 610 [265 P. 238, 59 A.L.R. 480].)

The judgment is affirmed.

Shenk, J., Curtis, J., Carter, J., and Sehauer, J., concurred.

TRAYNOR, J.

I concur in the judgment, but I believe the manufacturer’s negligence should no longer be singled out as the basis of a plaintiff’s right to recover in cases like the present one. In my opinion it should now be recognized that a manufacturer incurs an absolute liability when an article that he has placed on the market, knowing that it is to be used, without inspection, proves to have a defect that causes injury to human beings. McPherson v. Buick Motor Co., 217 382 [111 N.E. 1050], Ann.Cas. 1916C 440, L.R.A. 1916F, established the principle, recognized by this court, that irrespective of privity of contract, the manufacturer *462is responsible for an injury caused by such an article to any person who comes in lawful contact with it. (Sheward v. Virtue, 20 Cal.2d 410 [126 P.2d 345]; Kalash v. Los Angeles Ladder Co., 1 Cal.2d 229 [34 P.2d 481].) In these cases the source of the manufacturer’s liability was his negligence in the manufacturing process or in the inspection of component parts supplied by others. Even if there is no negligence, however, public policy demands that responsibility be fixed wherever it will most effectively reduce the hazards to life and health inherent in defective products that reach the market. It is evident that the manufacturer can anticipate some hazards not. Those who suffer injury from defective products are unprepared to meet its consequences. The cost of an injury and the loss of time or health may be an overwhelming misfortune to the person injured, and a needless one, for the risk of injury can be insured by the manufacturer and distributed among the public as a cost of doing business. It is to the public interest to discourage the marketing of products having defects that are a menace to the public. If such products nevertheless find their way into the market it is to the public interest to place the responsibility for whatever injury they may cause upon the manufacturer, who, even if he is not negligent in the manufacture of the product, is responsible for its reaching the market. However intermittently such injuries may occur and however haphazardly they may strike, the risk of their occurrence is a constant risk and a general one. Against such a risk there should be general and constant protection and the manufacturer is best situated to afford such protection.

The injury from a defective product does not become a matter of indifference because the defect arises from causes other than the negligence of the manufacturer, such as negligence of a submanufacturer of a component part whose defects could not be revealed by inspection (see Sheward v. Virtue, 20 Cal.2d 410 [126 P.2d 345]; O’Rourke v. Bay & Night Water Heater Co., Ltd., 31 Cal.App.2d 364 [88 P.2d 191]; Smith v. Peerless Glass Co., 259 N.Y. 292 [181 N.E. 576]), or unknown causes that even by the device of res ipsa loquitur cannot be classified as negligence of the manufacturer. The inference of negligence may be dispelled by an affirmative showing of proper care. If the evidence against the fact in*463ferred is “clear, positive, uncontradicted, and of such a nature that it cannot rationally be disbelieved, the court must instruct the jury that the nonexistence of the fact has bee established as a matter of law.” (Blank v. Coffin, 20 Cal.2 457, 461 [126 P.2d 868].) An injured person, however, is not ordinarily in a position to refute such evidence or identify the cause of the defect, for he can hardly be familiar with the manufacturing process as the manufacturer himself is. In leaving it to the jury to decide whether the inference has been dispelled, regardless of the evidence against it, the negligence rule approaches the rule of strict liability. It is needlessly circuitous to make negligence the basis of recovery and impose what is in reality liability without negligence. If public policy demands that a manufacturer of goods be responsible for their quality regardless of negligence there is no reason not to fix that responsibility openly.

In the case of foodstuffs, the public policy of the state is formulated in a criminal statute. Section 26510 of the Health and Safety Code prohibits the manufacturing, preparing, compounding, packing, selling, offering for sale, or keeping for sale, or advertising within the state, of any adulterated food. Section 26470 declares that food is adulterated when “it has been produced, prepared, packed, or held under insanitary conditions whereby it may have been rendered diseased, unwholesome or injurious to health.” The statute imposes criminal liability not only if the food is adulterated, but if its container, which may be a bottle (§ 26451), has any deleterious substance (§26470 (6)), or renders the product injurious to health. (§26470 (4)). The criminal liability under the statute attaches without proof of fault, so thaf the manufacturer is under the duty of ascertaining whether an article manufactured by him is safe. (People v. Schwartz, 28 Cal.App.2d Supp. 775 [70 P.2d 1017].) Statutes of this kind result in a strict liability of the manufacturer in tort to the member of the public injured. (See eases cited in Prosser, Torts, p. 693, note 69.)

The statute may well be applicable to a bottle whose defects cause it to explode. In any event it is significant that the statute imposes criminal liability without fault, reflecting the public policy of protecting the public from dangerous products placed on the market, irrespective of negligence in their manufacture. While the Legislature imposes criminal lia*464bility only with regard to food products and their containers, there are many other sources of danger. It is to the public interest to prevent injury to the public from any defective goods by the imposition of civil liability generally.

The retailer, even though not equipped to test a product, is under an absolute liability to his customer, for the implied warranties of fitness for proposed use and merchantable quality include a warranty of safety of the product. (Goetten Owl Drug Co., 6 Cal.2d 683 [59 P.2d 142] ; Mix v. Ingersoll Candy Co., 6 Cal.2d 674 [59 P.2d 144] ; Gindraux v. Maurice Mercantile Co., 4 Cal.2d 206 [47 P.2d 708]; Jensen v. Berris, Cal.App.2d 537 [88 P.2d 220]; Ryan v. Progressive Grocery Stores, 255 N.Y. 388 [175 N.E. 105; 74 A.L.R. 339] ; Race v. Krum, 222 N.Y. 410 [118 N.E. 853, L.R.A. 1918F 1172].) This warranty is not necessarily a contractual one (Chamberlain Co. v. Allis-Chalmers etc. Co., 51 Cal.App.2d 520, 524 [125 P.2d 113]; see 1 Williston on Sales, 2d ed., §§ 197-201), for public policy requires that the buyer be insured at the seller’s expense against injury. (Race v. Krum, supra; Ryan v. Progressive Grocery Stores, supra; Chapman v. Roggenkamp, 182 Ill.App. 117, 121; Ward v. Great Atlantic & Pacific Tea Co., 231 Mass. 90, 94 [120 N.E. 225, 5 A.L.R. 242]; see Prosser, The Implied Warranty of Merchantable Quality, 27 Minn.L.Rev. 117, 124; Brown, The Liability of Retail Dealers For Defective Food Products, 23 Minn.L.Rev. 585.) The courts recognize, however, that the retailer cannot bear the burden of this warranty, and allow him to recoup any losses by means of the warranty of safety attending the wholesaler’s or manufacturer’s sale to him. (Ward v. Great Atlantic & Pacific Tea Co., supra; see Waite, Retail Responsibility and Judicial Law Making, 34 Mich.L.Rev. 494, 509.) Such a procedure, however, is needlessly circuitous and engenders wasteful litigation. Much would be gained if the injured person could base his action directly on the manufacturer’s warranty.

The liability of the manufacturer to an immediate buyer injured by a defective product follows without proof of negligence from the implied warranty of safety attending the sale. Ordinarily, however, the immediate buyer is a dealer who does not intend to use the product himself, and if the warranty of safety is to serve the purpose of protecting health and safety it must give rights to others than the dealer. In the words *465of Judge Cardozo in the McPherson ease: “The dealer was indeed the one person of whom it might be said with some approach to certainty that by him the car would not be used.” Yet, the defendant would have us say that he was the one person whom it was under a legal duty to protect. The law does not lead us to so inconsequent a solution.” While the defendant’s negligence in the McPherson case made it unnecesssary for the court to base liability on warranty, Judge Cardozo’s reasoning recognized the injured person as the real party in interest and effectively disposed of the theory that the liability of the manufacturer incurred by his warranty should apply only to the immediate purchaser. It thus paves the way for a standard of liability that would make the manufacturer guarantee the safety of his product even when there is no negligence.

This court and many others have extended protection according to such a standard to consumers of food products, taking the view that the right of a consumer injured by unwholesome food does not depend “upon the intricacies law of sales” and that the warranty of the manufacturer to the consumer in absence of privity of contract rests on public policy. (Klein v. Duchess Sandwich Co., Ltd., 14 Cal.2d 282 [93 P.2d 799]; Ketterer v. Armour & Co., 200 F. 321, 322, 323 [160 C.C.A. 111, L.R.A. 1918D 798]; Decker & Sons v. Capps, 139 Tex. 609 [164 S.W.2d 828, 142 A.L.R. 1479]; see Perkins, Unwholesome Food As A Source of Liability, 5 Iowa L.Bull. 6, 86.) Dangers to life and health inhere in other consumers’ goods that are defective and there is no reason to differentiate them from the dangers of defective food products. (See Bohlen, Studies in Torts, Basis of Affirmative Obligations, American Cases Upon The Liability of Manufacturers and Vendors of Personal Property, 109, 135; Llewellyn, On Warranty of Quality and Society, 36 Col.L.Rev. 699, 704, note 14; Prosser, Torts, p. 692.)

In the food products cases the courts have resorted to various fictions to rationalize the extension of the manufacturer’s warranty to the consumer: that a warranty runs with the chattel; that the cause of action of the dealer is assigned to the consumer; that the consumer is a third party beneficiary of the manufacturer’s contract with the dealer. They have also held the manufacturer liable on a mere fiction of negli*466gence: “Practically he must know it [the product] is fit, or bear the consequences if it proves destructive.” (Parks v. C. C. Yost Pie Co., 93 Kan. 334 [144 P. 202, L.R.A. 1915C 179]; see Jeanblane, Manufacturer’s Liability to Persons Other Than Their Immediate Vendees, 24 Va.L.Rev. 134.) Such fictions are not necessary to fix the manufacturer’s liability under a warranty if the warranty is severed from the contract of sale between the dealer and the consumer and based on the law of torts (Decker & Sons v. Capps, supra; Prosser, Torts, p. 689) as a strict liability. (See Green v. General Petroleum Corp., 205 Cal. 328 [270 P. 952, 60 A.L.R. 475]; McGrath v. Basich Bros. Const. Co., 7 Cal.App.2d 573, 46 P.2d 981]; Prosser, Nuisance Without Fault, 20 Tex.L. Rev., 399, 403; Feezer, Capacity To Bear The Loss As A Factor In The Decision Of Certain Types of Tort Cases, 78 U. of Pa.L.Rev. 805, 79 U. of Pa.L.Rev. 742; Carpenter, The Doctrine of Green v. General Petroleum Corp., 5 So.Cal.L.Rev. 263, 271; Pound, The End of Law As Developed In Legal Rules And Doctrines, 27 Harv.L.Rev. 195, 233.) Warranties are not necessarily rights arising under a contract. An action on a warranty “was, in its origin, a pure action of tort,” and only late in the historical development of warranties was an action in assumpsit allowed. (Ames, The History of Assumpsit, 2 Harv.L.Rev. 1, 8; 4 Williston on Contracts (1936) § 970.) “And it is still generally possible where a distinction of procedure is observed between actions of tort and of contract to frame the declaration for breach of warranty in tort.” (Williston, loc. cit.; see Prosser, Warranty On Merchantable Quality, 27 Minn.L.Rev. 117, 118.) On the basis of the tort character of an action on a warranty, recovery has been allowed for wrongful death as it could not be in an action for breach of contract. (Greco v. S. S. Kresge Co., 277 N.Y. 26 [12 N.E.2d 577, 115 A.L.R. 1020]; see Schlick v. New York Dugan Bros., 175 Mise. 182 [22 N.Y.S.2d 238]; Prosser, op. cit., p. 119.) As the court said in Greco v. S. S. Kresge Co., supra, “Though the action may be brought solely for the breach of the implied warranty, the breach is a wrongful act, a default, and, in its essential nature, a tort.” Even a seller’s express warranty can arise from a noncontractual affirmation inducing a person to purchase the goods. (Chamberlain Co. v. Allis-Chalmers etc. Co., 51 Cal.App.2d 520 [125 P.2d 113].) “As an actual agreement to contract is not essential, the obli*467gation of a seller in such a case is one imposed by law as distinguished from one voluntarily assumed. It may be called an obligation either on a quasi-contract or quasi-tort, because remedies appropriate to contract and also to tort are applicable.” (1 Williston on Sales, 2d ed. §197; see Ballantine, Classification of Obligations, 15 Ill.L.Rev. 310, 325.)

As handicrafts have been replaced by mass production with its great markets and transportation facilities, the close relationship between the producer and consumer of a product has been altered. Manufacturing processes, frequently valuable secrets, are ordinarily either inaccessible to or beyond the ken of the general public. The consumer no longer has means or skill enough to investigate for himself the soundness of a product, even when it is not contained in a sealed package, and his erstwhile vigilance has been lulled by the steady efforts of manufacturers to build up confidence by advertising and marketing devices such as trade-marks. (See Thomas v. Winchester, 6 N.Y. 397 [57 Am.Dec. 455]; Baxter v. Ford Motor Co., 168 Wash; 456 [12 P.2d 409, 15 P.2d 1118, 88 A.L.R. 521]; Crist v. Art Metal Works, 230 App.Div. 114 [243 N.Y.S. 496], affirmed 255 N.Y. 624 [175 N.E. 341]; see also Handler, False and Misleading Advertising, 39 Yale L.J. 22; Rogers, Good Will, Trade-Marks and Unfair Trading (1914) ch. VI, A Study of The Consumer, p. 65 et seq.; Williston, Liability For Honest Misrepresentations As Deceit, Negligence Or Warranty, 42 Harv.L.Rev. 733; 18 Cornell L.Q. 445.) Consumers, no longer approach products warily but accept them on faith, relying on the reputation of the manufacturer or the trade mark. (See Max Factor & Co. v. Kunsman, 5 Cal.2d 446, 463 [55 P.2d 177]; Old Dearborn etc. Co. v. Seagram-Distillers Corp., 299 U.S, 183 [57 S.Ct. 139, 81 L.Ed. 109, 106 A.L.R. 1476]; Schechter, The Rational Basis of Trade Mark Protection, 40 Harv.L.Rev. 813, 818.) Manufacturers have sought to justify that faith by increasingly high standards of inspection and a readiness to make good on defective products by way of replacements and refunds. (See Bogert and Pink, Business Practices Regarding Warranties In The Sale Of Goods, 25 Ill.L.Rev. 400.) The manufacturer’s obligation to the consumer must keep pace with the changing relationship between them; it cannot be escaped because the marketing of a product has become so complicated as to require one or more *468intermediaries. Certainly there is greater reason to impose liability on the manufacturer than on the retailer who is but a conduit of a product that he is not himself able to test. (See Soule, Consumer Protection, 4 Encyclopedia of The Social Sciences, 282; Feezer, Manufacturer’s Liability For Injuries Caused By His Products: Defective Automobiles, 37 Mich.L. Rev. 1; Llewellyn, Cases And Materials on Sales, 340 et seq.)

The manufacturer’s liability should, of course, be defined in terms of the safety of the product in normal and proper use, and should not extend to injuries that cannot be traced to the product as it reached the market.

Appellant’s petition for a rehearing was denied August 3, 1944. Edmonds, J., voted for a rehearing.

Cardozo, Ch. J.

The action is for breach of warranty.

Plaintiff through his wife, who acted as his agent, bought a loaf of bread at the defendant’s grocery. The loaf had concealed in it a pin, which hurt the plaintiff’s mouth. There has been a judgment for the damage.

“Where the buyer, expressly or by implication, makes known to the seller the particular purpose for which the goods are required, and it appears that the buyer relies on the seller’s skill or judgment (whether he be the grower or manufacturer or not), there is an implied warranty that the goods shall be reasonably fit for such purpose” (Pers. Prop. Law; Cons. Laws, ch. 41, § 96, subd. 1).

The plaintiff did not rely on the seller’s skill or judgment. His wife stated to the salesman that she wished to have a loaf of “Ward’s bread.” The salesman gave her what she asked for, wrapped in a sealed package as it had come from the Ward Baking Company, the baker. She made her own choice, and used her own judgment.

The leading case in this State as to the meaning of the statute quoted is Rinaldi v. Mohican Co. (225 N. Y. 70). The sale was one of pork, which turned out to be diseased. We held that reliance on the seller’s skill and judgment might be gathered from the purchase *391as a reasonable inference. We left the question open whether a like inference would be drawn upon a sale in the original package as bought by the vendor from others.

Since Rinaldi v. Mohican Co., the scope of the implied warranty upon a sale of food in sealed containers has been discussed in other courts. There are decisions to the effect that even in such circumstances an implied warranty ensues if the seller’s judgment has been trusted for the selection of the brand or make (Ward v. Great Atlantic & Pacific Tea Co., 231 Mass. 90; Ireland v. Liggett Co., 243 Mass. 243; Lieberman v. Sheffield Farms, (App. Term) 117 Misc. Rep. 531; Williston, Sales, vol. 1, §§ 242, 242-a). We assume for present purposes that so the rule should be declared. Invariably, however, the limitation has been added that there can be no inference of reliance where the buyer selects the brand and gets what he selects. The customer will be taken to confide in “the skill and experience of the seller in determining the kind of canned goods which he will purchase, unless he demands goods of a definite brand or trade name” (Ward v. Great Atlantic & Pacific Tea Co., supra). The statute is then explicit. “In the case of a sale of a specified article under its patent or other trade name, there is no implied warranty as to its fitness for any particular purpose” (Pers. Prop. Law, § 96, subd. 4). There is no room for a holding that choice shall be imputed to the seller when the transaction shows upon its face that the judgment of the seller was superseded, and choice determined by the buyer.

The award of damages, if it is to be upheld, must rest upon some other basis than the imputation of reliance.

“Where the goods are bought by description from a seller who deals in goods of that description (whether he be the grower or manufacturer or not),there is an implied warranty that the goods shall be of merchantable quality” (Pers. Prop. Law, § 96, subd. 2).

*392The facts excluding a warranty under subdivision 1, we are to inquire whether there is a warranty under subdivision 2.

Under the common-law rule long in force in this State, the warranty of merchantable quality was limited to sales by a manufacturer or grower (Hargous v. Stone, 5 N. Y. 73; Hoe v. Sanborn, 21 N. Y. 552; Bartlett v. Hoppock, 34 N. Y. 118; Carleton v. Lombard, Ayres Co., 149 N. Y. 137; Bierman v. City Mills Co., 151 N. Y. 482; Howard Iron Works v. Buffalo Elevating Co., 113 App. Div. 562; 188 N. Y. 619; Williston, Sales, vol. 1, §§ 232, 233). All this has been changed since the coming of the Sales Law (Williston, supra). Dealer as well as manufacturer or grower affirms as to anything he sells, if purchased by description, that it is of merchantable quality. The burden may be heavy. It is one of the hazards of the business.

Most of the sales of defective food stuffs have been dealt with by the courts as if subdivision 1 of the section defining warranties gave the exclusive rule to be applied. In some instances the goods were not purchased by description. In others, the courts may have been unmindful of the fact that the warranty of merchantable quality is no longer confined to manufacturers or growers. Innovations of this order are slow to make their way. Gradually, however, as the statute has become better known, the bearing of subdivision 2 upon sales of food in sealed containers has been perceived by court and counsel. The nature of the transaction must determine in each instance the rule to be applied. There are times when a warranty of fitness has no relation to a warranty of merchantable quality. This is so, for example, when machinery competently wrought is still inadequate for the use to which the buyer has given notice that it is likely to be applied. There are times on the other hand when the warranties co-exist, in which event a recovery may be founded upon either. “Fitness for a particular *393purpose may be merely the equivalent of merchantability” (Williston, Sales, vol. 1, § 235, and cases there cited).

A dual warranty is thus possible for food stuffs as for anything else. Both in this court and in others the possibility is recognized. Aron & Co. v. Sills (240 N. Y. 588) was an action for breach of warranty by retailer against wholesaler upon a sale of condensed milk. At the Appellate Division, the warranty was treated as governed by subdivision 1. When the case came to us, we put that subdivision aside, holding that there was no necessity of deciding whether there was sufficient evidence of reliance, and placed our affirmance of the judgment upon subdivision 2. “Whether under the circumstances of this particular case any inference is possible that the buyer relied upon the seller’s skill or judgment we need not decide. For even were the trial court in error as to the existence of an implied warranty that the goods in question were fit for human consumption, bought as they were by description from one who dealt in them, there was a warranty that they were of merchantable quality. If condensed milk is unfit for consumption, clearly it does not comply with this warranty” (240 N. Y. 588).

A like rule has been declared in Massachusetts and in the Federal courts, at all events in controversies between the dealer and the maker (Inter-state Grocer Co. v. Bentley Co., 214 Mass. 227 [sale of sardines]; Parker v. Shaghalian & Co., 244 Mass. 19 [sale of candy]; McNeil & Higgins Co. v. Czarnikow-Rienda Co., 274 Fed. Rep. 397 [sale of sugar]).

“Where the buyer specifies what he wants, he can, of course, not rely upon any superior knowledge of the seller that it will serve its purposes. If he did, he must give the seller some latitude of selection. But he may still insist that it must be of a quality which will pass in the market under that description, and he may rightly *394rely upon the seller to secure him such a quality” (L. Hand, J., in McNeil & Higgins Co. v. Czarnikow-Rienda Co., supra).

The result has not been different in cases where the consumer rather than another dealer has been the victim of the wrong.

Thus, in Wren v. Holt ([1903] 1 K. B. 610) the plaintiff was made ill through the presence of arsenic in beer, which he had bought from the defendant, who was not the manufacturer. In buying the beer, he asked for the product of a particular firm of brewers. A recovery was upheld for breach of an implied warranty of merchantable quality as upon a purchase by description, and this though there had been no reliance on the skill and judgment of the seller. Again, in Morelli v. Fitch ([1928] 2 K. B. 636) there was a recovery for breach of a like warranty upon a sale of a bottle of ginger ale by the keeper of a public house. The customer had asked for ale of a particular make, trusting to his own judgment rather than to the experience of the seller. Even so, the warranty of merchantable quality was held to be a sufficient basis for the recovery of damages.

Loaves baked with pins in them are not of merchantable quality. The dealer is thus charged with liability though the buyer selects the brand, just as he would be hable for concealed defects upon a sale of wool or silk. Assume that the sale had been made by a manufacturer or a grower, and that there had been a request for a special brand. There would then be no warranty of fitness for any “particular” purpose. Would any one dispute, however, that a defect of this order, destroying value altogether, would be covered by the warranty of merchantable quality? The question carries its own answer. The rule is different, to be sure, upon a sale of specific goods, not purchased by description (Hight v. Bacon, 126 Mass. 10). It may even be different, though the purchase is by description, if the goods are subject *395to inspection and the defects are of such a nature that inspection will reveal them (Williston, Sales, § 234; Pers. Prop. Law, § 96, subd. 3). Here the sale was by description, the defect was wholly latent, and inspection was impossible. In such circumstances, the law casts the burden on the seller, who may vouch in the manufacturer, if the latter was to blame. The loss in its final incidence will be borne where it is placed by the initial wrong.

The argument is made that the only damage to be recovered for the breach of the warranty of merchantable quality is the price of the bread, the difference between the value of a good loaf and a bad one. The rule is not so stubborn. Undoubtedly, the difference in value supplies the ordinary measure (Pers. Prop. Law, § 150, subds. 6 and 7; § 151). The measure is more liberal where special circumstances are present with proof of special damage (§ 150, subd. 7; § 151). Here the dealer had notice from the nature of the transaction that the bread was to be eaten. Knowledge that it was to be eaten was knowledge that the damage would be greater than the price (Williston, Sales, vol. 2, § § 614, 614-a; Swain v. Schieffelin, 134 N. Y. 471; Dushane v. Benedict, 120 U. S. 630; Gearing v. Berkson, 223 Mass. 257; French v. Vining, 102 Mass. 132; Birdsinger v. McCormick Harvesting Machine Co., 183 N. Y. 487, 492; American Law Institute, Restatement of Law of Contracts, § 321). For damages thus foreseen, the buyer has his remedy, whether the warranty is one of fitness or of merchantable quality (Williston, supra; Wren v. Holt, supra; Morelli v. Fitch, supra; Swain v. Schieffelin, supra).

There is no variance between proof and pleading sufficient to destroy the judgment.

The facts proved without objection make out a breach of warranty under subdivision 2. In such circumstances the plaintiff ought not to lose the benefit of his judgment because he fancied that he had brought himself within subdivision 1. “The seller may not complain if the jury *396is told that a warranty exists more limited in its scope than in truth is the fact” (Aron & Co. v. Sills, supra; cf. Abounader v. Strohmeyer & Arpe Co., 243 N. Y. 458). The facts being conceded, the court applies the law.

The conclusion thus reached makes it unnecessary to consider whether there has been a breach of the Agriculture and Markets Law sustaining a recovery (Agriculture & Markets Law; Cons. Laws, ch. 69, §§ 198, 199; Pine Grove Poultry Farm v. Newtown B.-P. Mfg. Co., 248 N. Y. 293; Abounader v. Strohmeyer & Arpe Co., supra). The judgment should be affirmed with costs.

Pound, Crane, Lehman, O’Brien and Hubbs, JJ., concur; Kellogg, J., not sitting.

Judgment affirmed.

*556Opinion

BAXTER, J.

—Plaintiff’s ankles were badly injured when her General Motors (GM) car collided with another vehicle. She sued GM, asserting that defects in her automobile allowed its left front wheel to break free, collapse rearward, and smash the floorboard into her feet. GM denied any defect and claimed that the force of the collision itself was the sole cause of the injuries. Expert witnesses debated the issues at length. Plaintiff prevailed at trial, and the Court of Appeal affirmed the judgment.

We granted review to resolve three questions. First, may a product’s design be found defective on grounds that the product’s performance fell below the safety expectations of the ordinary consumer (see Barker v. Lull Engineering Co. (1978) 20 Cal.3d 413, 426-432 [143 Cal.Rptr. 225, 573 P.2d 443, 96 A.L.R.3d 1]) if the question of how safely the product should have performed cannot be answered by the common experience of its users? Second, in an action for enhanced collision injuries caused by an uncrashworthy vehicle, where a correct general instruction on legal cause is given, is it error to refuse a defense instruction that any defect cannot be a legal cause of injury if the accident would have produced the same injury even without the defect? Third, if the refusal is error, is it reversible per se? (See, e.g., Self v. General Motors Corp. (1974) 42 Cal.App.3d 1, 10-11 [116 Cal.Rptr. 575].)

We reach the following conclusions: The trial court erred by giving an “ordinary consumer expectations” instruction in this complex case. Moreover, the court should have granted GM’s request for a special instruction explaining its correct theory of legal cause. However, neither error warrants reversal unless it caused actual prejudice, and both errors were harmless on this record. We will therefore affirm the Court of Appeal’s judgment.

Facts

On the early afternoon of January 16,1984, plaintiff was driving her 1982 Camaro in the southbound center lane of Bolsa Chica Road, an arterial street in Westminster. There was a slight drizzle, the roadway was damp, and apparently plaintiff was not wearing her seat belt. A 1972 Datsun, approaching northbound, suddenly skidded into the path of plaintiff’s car. The Datsun’s left rear quarter struck plaintiff’s Camaro in an area near the left *557front wheel. Estimates of the vehicles’ combined closing speeds on impact vary from 30 to 70 miles per hour.1

The collision bent the Camaro’s frame adjacent to the wheel and tore loose the bracket that attached the wheel assembly (specifically, the lower control arm) to the frame. As a result, the wheel collapsed rearward and inward. The wheel hit the underside of the “toe pan”—the slanted floorboard area beneath the pedals—causing the toe pan to crumple, or “deform,” upward into the passenger compartment.

Plaintiff received a fractured rib and relatively minor scalp and knee injuries. Her most severe injuries were fractures of both ankles, and the more serious of these was the compound compression fracture of her left ankle. This injury never healed properly. In order to relieve plaintiff’s pain, an orthopedic surgeon fused the joint. As a permanent result, plaintiff cannot flex her left ankle. She walks with considerable difficulty, and her condition is expected to deteriorate.

After the accident, the Camaro was acquired by a salvage dealer, Noah Hipolito. Soon thereafter, plaintiff’s son, Jeffrey Bishop, and her original attorney, Richard Hawkins, each inspected and photographed the car and its damaged floorboard area. The failed bracket assembly was retrieved. However, Hipolito later discarded the damaged toe pan, repaired the Camaro, and resold it. Thus, except for the bracket assembly, no part of the vehicle was retained as evidence.

Plaintiff sued GM for her ankle injuries, asserting a theory of strict tort liability for a defective product. She claimed the severe trauma to her ankles was not a natural consequence of the accident, but occurred when the collapse of the Camaro’s wheel caused the toe pan to crush violently upward against her feet. Plaintiff attributed the wheel collapse to a manufacturing defect, the substandard quality of the weld attaching the lower control arm bracket to the frame. She also claimed that the placement of the bracket, and the configuration of the frame, were defective designs because they did not limit the wheel’s rearward travel in the event the bracket should fail.

The available physical and circumstantial evidence left room for debate about the exact angle and force of the impact and the extent to which the toe pan had actually deformed. The issues of defect and causation were addressed through numerous experts produced by both sides in such areas as *558biomechanics, metallurgy, orthopedics, design engineering, and crash-test simulation.

Plaintiff submitted the results of crash tests, and also asserted the similarity of another real-world collision involving a 1987 Camaro driven by Dana Carr. According to plaintiff’s experts, these examples indicated that Camaro accidents of similar direction and force do not generally produce wheel bracket assembly failure, extensive toe pan deformation, or severe ankle injuries such as those plaintiff had experienced. These experts opined that without the deformation of the toe pan in plaintiff’s car, her accident could, not have produced enough force to fracture her ankles.

A metallurgist testifying on plaintiff’s behalf examined the failed bracket from her car. He concluded that its weld was particularly weak because of excess “porosity” caused by improper welding techniques. Plaintiff’s experts also emphasized the alternative frame and bracket design used by the Ford Mustang of comparable model years. They asserted that the Mustang’s design, unlike the Camaro’s, provided protection against unlimited rearward travel of the wheel should a bracket assembly give way.

GM’s metallurgist disputed the claims of excessive weakness or porosity in the bracket weld. Expert witnesses for GM also countered the assertions of defective design. GM asserted that the Camaro’s bracket was overdesigned to withstand forces in excess of all expected uses. According to expert testimony adduced by GM, the Mustang’s alternative frame and bracket configuration did not fit the Camaro’s overall design goals and was not distinctly safer for all collision stresses to which the vehicle might be subjected. Indeed, one witness noted, at least one more recent Ford product had adopted the Camaro’s design.

A second major thrust of GM’s defense was that the force of the collision, rather than any product defect, was the sole cause of plaintiff’s ankle injuries. Using the results of accident reconstruction, computer simulations, and actual crash tests, GM sought to prove that the probable collision force concentrated on the left front wheel of plaintiff’s Camaro exceeded the “yield strength” of any feasible weld or design.

By similar means, GM also sought to show that plaintiff’s ankle injuries were not caused by the upward movement of the toe pan, but by the inertial forward and downward motion of plaintiff’s unrestrained body and legs against the toe pan at the instant of impact. From plaintiff’s other injuries, and from photographs showing the general pattern of damage to the Camaro’s interior, GM’s experts inferred that plaintiff was not wearing her seat belt and had locked or braced her legs in reaction to the imminent collision.

*559Hence, they concluded, her rigid ankles had absorbed the Ml force of her inertial forward movement, which was sufficient to cause the fractures. Based on their test results, GM’s witnesses opined that plaintiff’s ankles had probably moved forward, struck the toe pan, and broken before significant deformation of the toe pan occurred.

The court instructed the jury that a manufacturer is liable for “enhanced” injuries caused by a manufacturing or design defect in its product while the product is being used in a foreseeable way. Over GM’s objection, the court gave the standard design defect instruction without modification. (See BAJI No. 9.00.5 (7th ed. 1986).) This instruction advised that a product is defective in design “if it fails to perform as safely as an ordinary consumer would expect when used in an intended or reasonably foreseeable manner or if there is a risk of danger inherent in the design which outweighs the benefit of the design.” (Italics added.)

The jury was also told that in order to establish liability for a design defect under the “ordinary consumer expectations” standard, plaintiff must show (1) the manufacturer’s product failed to perform as safely as an ordinary consumer would expect, (2) the defect existed when the product left the manufacturer’s possession, (3) the defect was a “legal cause” of plaintiff’s “enhanced injury,” and (4) the product was used in a reasonably foreseeable manner.

With respect to all theories of liability, the instructions indicated that “[a] legal cause of injury is a cause which is a substantial factor in bringing about the injury.” (See BAJI No. 3.76 (7th ed. 1986).) However, the trial court refused the following instruction proffered by GM: “If you find that the subject Camaro . . . was improperly designed, but you also find that [plaintiff] would have received enhanced injuries even if the design had been proper, then you must find that the design was not a substantial factor in bringing about her injuries and therefore was not a contributing cause thereto.”

In a series of special findings, the jury determined that the Camaro contained a defect (of unspecified nature) which was a “legal cause” of plaintiff’s “enhanced injury.” The jury further concluded that although plaintiff was guilty of comparative fault, her conduct was not a legal cause of her enhanced injuries. Plaintiff received an award of $1.65 million.

GM appealed. Among other things, it argued that the trial court erred by instructing on ordinary consumer expectations in a complex design-defect case, and by failing to give GM’s special instruction on causation.

*560Following one line of authority, the Court of Appeal concluded that a jury may rely on expert assistance to determine what level of safe performance an ordinary consumer would expect under particular circumstances. Hence, the Court of Appeal ruled, there was no error in use of the ordinary consumer expectations standard for design defect in this case.

The Court of Appeal agreed with GM that its specific instruction on causation should not have been refused. However, the court rejected precedent suggesting that an error of this kind is reversible per se. Here, the Court of Appeal ruled, the error was harmless. After dismissing GM’s remaining appellate claims, the Court of Appeal affirmed the judgment. We granted review.

Discussion

1. Test for design defect.

A manufacturer, distributor, or retailer is liable in tort if a defect in the manufacture or design of its product causes injury while the product is being used in a reasonably foreseeable way. (Cronin v. J.B.E. Olson Corp. (1972) 8 Cal.3d 121, 126-130 [104 Cal.Rptr. 433, 501 P.2d 1153] (Cronin); Greenman v. Yuba Power Products, Inc. (1963) 59 Cal.2d 57, 62 [27 Cal.Rptr. 697, 377 P.2d 897, 13 A.L.R.3d 1049] (Greenman).) Because traffic accidents are foreseeable, vehicle manufacturers must consider collision safety when they design and build their products. Thus, whatever the cause of an accident, a vehicle’s producer is liable for specific collision injuries that would not have occurred but for a manufacturing or design defect in the vehicle. (Cronin, supra, at p. 126.)

In Cronin, supra, a bread van driver was hurt when the hasp retaining the bread trays broke during a collision, causing the trays to shift forward and propel him through the windshield. He sued the van’s producer, alleging that the hasp had failed because of the defective metal used in its manufacture. The court instructed that the driver could recover if he proved a defect, unknown to him, which caused injury while the van was being used as intended or designed. The manufacturer appealed the subsequent damage award. It urged the court should have instructed that liability could not be imposed unless the defect rendered the product “unreasonably dangerous.”

We rejected this contention, holding that the “unreasonably dangerous” test derived from the Restatement (see Rest.2d Torts, § 402A) is inapplicable in California. As we observed, the Restatement defines “unreasonably dangerous” as “dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its characteristics.” (Id., com. i, p. 352, *561italics added.) The original purpose of this formula, we explained, was to make clear that common products such as sugar, butter, and liquor are not defective simply because they pose inherent health risks well known to the general public. However, Cronin indicated, the formula had been applied so as to force injured persons to prove both an actual defect and “unreasonable” danger. (8 Cal.3d at pp. 132-133.)

This “double burden,” Cronin reasoned, ran contrary to the purpose of Greenman, supra, to relieve persons injured by defective products from proof of elements that ring of negligence. Instead, Cronin concluded, an injured plaintiff should recover so long as he proves that the product was defective, and that the defect caused injury in reasonably foreseeable use. (Cronin, supra, 8 Cal.3d at pp. 133-134.)

In Barker v. Lull Engineering Co., supra, 20 Cal.3d 413 (Barker), the operator of a high-lift loader sued its manufacturer for injuries he received when the loader toppled during a lift on sloping ground. The operator alleged various design defects which made the loader unsafe to use on a slope. In a pre-Cronin trial, the court instructed that the operator could recover only if a defect in the loader’s design made the machine “ ‘unreasonably dangerous for its intended use.’ ” (Id., at p. 417.) The operator appealed the defense verdict, citing the “unreasonably dangerous” instruction as prejudicial error.

The manufacturer responded that even if the “unreasonably dangerous” test was inappropriate for manufacturing defects, such as the substandard fastener material in Cronin, it should be retained for design defects. This rule would not produce the undue double burden that concerned us in Cronin, the manufacturer insisted, because unreasonable danger is part of the definition of design defect, not an additional element of strict product liability. Without this limitation, the manufacturer contended, juries would lack guidance when determining if a defect had sprung not from a mistake in supply or assembly, but from a flaw in the product’s specifications.

The Barker court disagreed. It reasoned as follows: Our concerns in Cronin extended beyond double-burden problems. There we also sought to avoid the danger that a jury would deny recovery, as the Restatement had intended, “so long as the product did not fall below the ordinary consumer’s expectations as to [its] safety. . . .” (Barker, supra, 20 Cal.3d at p. 425, fn. omitted.) This danger was particularly acute in design defect cases, where a manufacturer might argue that because the item which caused injury was identical to others of the same product line, it must necessarily have satisfied ordinary consumer expectations. (Id., at p. 426.)

*562Despite these difficulties, Barker explained, it is possible to define a design defect, and the expectations of the ordinary consumer are relevant to that issue. At a minimum, said Barker, a product is defective in design if it does fail to perform as safely as an ordinary consumer would expect. This principle, Barker asserted, acknowledges the relationship between strict tort liability for a defective product and the common law doctrine of warranty, which holds that a product’s presence on the market includes an implied representation “ ‘that it [will] safely do the jobs for which it was built.’ ” (20 Cal.3d at p. 430, quoting Greenman, supra, 59 Cal.2d at p. 64.) “Under this [minimum] standard," Barker observed, “an injured plaintiff will frequently be able to demonstrate the defectiveness of the product by resort to circumstantial evidence, even when the accident itself precludes identification of the specific defect at fault. [Citations.]” (20 Cal.3d at p. 430, italics added.)

However, Barker asserted, the Restatement had erred in proposing that a violation of ordinary consumer expectations was necessary for recovery on this ground. “As Professor Wade has pointed out, ... the expectations of the ordinary consumer cannot be viewed as the exclusive yardstick for evaluating design defectiveness because ‘[i]n many situations ... the consumer would not know what to expect, because he would have no idea how safe the product could be made.’ ” (20 Cal.3d at p. 430, quoting Wade, On the Nature of Strict Tort Liability for Products (1973) 44 Miss. L.J. 825, 829, italics added.)

Thus, Barker concluded, “a product may be found defective in design, even if it satisfies ordinary consumer expectations, if through hindsight the jury determines that the product’s design embodies ‘excessive preventable danger,’ or, in other words, if the jury finds that the risk of danger inherent in the challenged design outweighs the benefits of such design. [Citations.]” (20 Cal.3d at p. 430, fn. omitted.) Barker held that under this latter standard, “a jury may consider, among other relevant factors, the gravity of the danger posed by the challenged design, the likelihood that such danger would occur, the mechanical feasibility of a safer alternative design, the financial cost of an improved design, and the adverse consequences to the product and to the consumer that would result from an alternative design. [Citations.]” (Id., at p. 431.)

Barker also made clear that when the ultimate issue of design defect calls for a careful assessment of feasibility, practicality, risk, and benefit, the case should not be resolved simply on the basis of ordinary consumer expectations. As Barker observed, “past design defect decisions demonstrate that, as a practical matter, in many instances it is simply impossible to eliminate the *563balancing or weighing of competing considerations in determining whether a product is defectively designed or not. . . .” (20 Cal.3d at p. 433.)

An example, Barker noted, was the “crashworthiness” issue presented in Self v. General Motors Corp., supra, 42 Cal.App.3d 1. The debate there was whether the explosion of a vehicle’s fuel tank in an accident was due to a defect in design. This, in turn, entailed concerns about whether placement of the tank in a position less vulnerable to rear end collisions, even if technically feasible, “would have created a greater risk of injury in other, more common situations.” (Barker, supra, 20 Cal.3d at p. 433.) Because this complex weighing of risks, benefits, and practical alternatives is “implicit” in so many design-defect determinations, Barker concluded, “an instruction which appears to preclude such a weighing process under all circumstances may mislead the jury.” (Id., at p. 434.)

Campbell v. General Motors Corp. (1982) 32 Cal.3d 112 [184 Cal.Rptr. 891, 649 P.2d 224] (Campbell) provided additional strong hints about the proper use of the ordinary consumer expectations prong of Barker. Plaintiff Campbell, a bus passenger, was thrown from her seat and injured during a sharp turn. She sued GM, the manufacturer of the bus, alleging that the vehicle was defectively designed because there was no “grab bar” within easy reach of her seat. Campbell presented no expert testimony, but she submitted photographs of the interior of the bus, showing where safety bars and handles were located in relation to the seat she had occupied. At the conclusion of her case in chief, GM moved for nonsuit, arguing that her evidence of design defect and proximate cause was not sufficient. The trial court granted the motion, but we reversed.

We emphasized that in order to establish a design defect under Barker's ordinary consumer expectations test, it was enough for Campbell to show “the objective conditions of the product” so that the jurors could employ “[their] own sense of whether the product meets ordinary expectations as to its safety under the circumstances presented by the evidence. [Fn. omitted.] Since public transportation is a matter of common experience, no expert testimony was required to enable the jury to reach a decision on this part of the Barker inquiry." (Campbell, supra, 32 Cal.3d at p. 126.)

“Indeed, it is difficult to conceive what testimony an ‘expert’ could provide. The thrust of the first Barker test is that the product must meet the safety expectations of the general public as represented by the ordinary consumer, not the industry or a government agency. ‘[0]ne can hardly imagine what credentials a witness must possess before he can be certified as an expert on the issue of ordinary consumer expectations.’ ” (Campbell, *564 supra, 32 Cal.3d at pp. 126-127, quoting Schwartz, Foreword: Understanding Products Liability (1979) 67 Cal.L.Rev. 435, 480, italics added.)

Had we ended our discussion at this point, it would have been clear that a product violates ordinary consumer expectations only when the circumstances arouse such reasonable expectations based on common experience of the product’s users. However, dictum in the next paragraph of Campbell injected ambiguity. We said, “The quantum of proof necessary to establish a prima facie case . . . under the first [i.e., ordinary consumer expectations] prong of Barker cannot be reduced to an easy formula. However, if the product is one within the common experience of ordinary consumers” (italics added), it will generally be enough for the injured plaintiff to show the circumstances of the accident and “the objective features of the product which are relevant to an evaluation of its safety. . . .” (32 Cal.3d at p. 127.) One might infer from this passage that the ordinary consumer expectations prong of Barker is not limited to product performance “within the common experience” of the product’s ordinary consumers.

Several subsequent Court of Appeal cases considered the point. In Bates v. John Deere Co. (1983) 148 Cal.App.3d 40 [195 Cal.Rptr. 637], plaintiff caught his leg in a commercial cotton picker while clearing debris from the moving machinery. He claimed the machine should have included an emergency shutoff switch within reach of the remote position from which its sole operator periodically had to undertake this debris-clearing task. Defense experts suggested that such a feature might induce a false sense of security and make the machine even more dangerous.

The trial court properly found a design defect under the risk-benefit test, but defendant challenged the court’s additional use of the ordinary consumer expectations test. Although it saw no need to decide the issue, the Court of Appeal agreed that “[w]e, too, find it difficult to apply the . . . [consumer expectations] test to these facts, in part because it is difficult to conceive that an ordinary consumer would know what to expect concerning the safety design of a commercial cotton picker. [Citing Barker.]” (148 Cal.App.3d at p. 52.)

In Lunghi v. Clark Equipment Co. (1984) 153 Cal.App.3d 485 [200 Cal.Rptr. 387], the Court of Appeal upheld the trial court’s refusal to instruct on reasonable consumer expectations because unassisted lay jurors “would not know what to expect” about the safety design of a Bobcat model 440 loader, and no experts had testified on the issue. However, the Court of Appeal remarked that on retrial, “appellants are free to present evidence in the form of expert opinions on the reasonable expectations of consumers of the product involved here. . . .” (Id., at p. 496.)

*565In Akers v. Kelly Co. (1985) 173 Cal.App.3d 633 [219 Cal.Rptr. 513] (Akers), there was an accident involving a “dockboard,” a spring-loaded plate which attaches to a loading dock and adjusts to form a bridge between the dock and truck beds of different elevations. Several hours after the prongs of a forklift struck the dockboard, it suddenly flew apart, injuring a nearby worker. Experts debated at length whether the dockboard’s components should have been designed to withstand forklift impacts, and whether a failure in design was a cause of the accident. Over defendant’s objection, the trial court instructed only on the consumer expectations test for design defect.

The Court of Appeal affirmed. It declined to read Campbell as limiting the consumer expectations test to products or accidents of common experience. (Akers, supra, 173 Cal.App.3d at p. 650.) That test, said Akers, “is entirely appropriate in a case such as this one. There are certain kinds of accidents— even where fairly complex machinery is involved—which are so bizarre that the average juror, upon hearing the particulars, might reasonably think: ‘Whatever the user may have expected from that contraption, it certainly wasn’t that.’ Here, a dockboard flew apart and injured [plaintiff]. A reasonable juror with no previous experience of dockboards could conclude that the dockboard in question failed to meet ‘consumer expectations’ as to its safety. . . .” (Id., at p. 651.) This was so, the Court of Appeal concluded, even though expert testimony might be necessary to establish that the manufacturer was responsible for the flaw which caused the product to fail. (Ibid.)

To similar effect is West v. Johnson & Johnson Products, Inc. (1985) 174 Cal.App.3d 831 [220 Cal.Rptr. 437, 59 A.L.R.4th 1] (West). The plaintiff in West became seriously ill in February 1980, during her menstrual period. At this time, there were increasing indications that tampon use sometimes causes toxic shock syndrome (TSS). After reading medical reports, plaintiff’s physicians belatedly concluded that she had suffered TSS caused by tampons which defendant had designed and produced. At trial, experts debated the nature of plaintiff’s illness, and they also disputed whether the tampon design and materials used by defendant encouraged TSS. The trial court instructed only on the consumer expectations prong of Barker.

On appeal, defendant argued that the risk-benefit test alone was proper. However, West agreed with Akers that Campbell does not preclude the consumer expectations test in complex cases involving expert testimony. In a time before general awareness and warnings about TSS, the court reasoned, plaintiff “had every right to expect” that use of this seemingly innocuous product “would not lead to a serious (or perhaps fatal) illness. . . .” Hence, the consumer expectations instruction was appropriate. (West, supra, 174 Cal.App.3d at p. 867.)

*566Finally, in Rosburg v. Minnesota Mining & Mfg. Co. (1986) 181 Cal..App.3d 726 [226 Cal.Rptr. 299], plaintiff claimed she was entitled to judgment under the consumer expectations test because her own testimony that she believed her breast implants would last a lifetime without leaking was the only lay evidence of what consumers expected. However, the Court of Appeal ruled that breast implant performance is beyond common experience, and that expert testimony on what the consumer should expect was therefore relevant and admissible. Here, the court observed, both plaintiff’s surgeon and another defense expert had insisted that failures were expectable and patients were not advised otherwise. Hence, there was substantial evidence to support the finding below that no defect was proven under the consumer expectations test. (Id., at pp. 7S2-733.)2

In Barker, we offered two alternative ways to prove a design defect, each appropriate to its own circumstances. The purposes, behaviors, and dangers of certain products are commonly understood by those who ordinarily use them. By the same token, the ordinary users or consumers of a product may have reasonable, widely accepted minimum expectations about the circumstances under which it should perform safely. Consumers govern their own conduct by these expectations, and products on the market should conform to them.

In some cases, therefore, “ordinary knowledge . . . as to . . . [the product’s] characteristics” (Rest.2d Torts, supra, § 402A, com. L, p. 352) may permit an inference that the product did not perform as safely as it should. If the facts permit such a conclusion, and if the failure resulted from the product’s design, a finding of defect is warranted without any further proof. The manufacturer may not defend a claim that a product’s design failed to perform as safely as its ordinary consumers would expect by presenting expert evidence of the design’s relative risks and benefits.3

However, as we noted in Barker, a complex product, even when it is being used as intended, may often cause injury in a way that does not engage its *567ordinary consumers’ reasonable minimum assumptions about safe performance. For example, the ordinary consumer of an automobile simply has “no idea” how it should perform in all foreseeable situations, or how safe it should be made against all foreseeable hazards. (Barker, supra, 20 Cal.3d at p. 430.)

An injured person is not foreclosed from proving a defect in the product’s design simply because he cannot show that the reasonable minimum safety expectations of its ordinary consumers were violated. Under Barker’s alternative test, a product is still defective if its design embodies “excessive preventable danger” (20 Cal.3d at p. 430), that is, unless “the benefits of the . . . design outweigh the risk of danger inherent in such design” (id., at p. 432). But this determination involves technical issues of feasibility, cost, practicality, risk, and benefit (id., at p. 431) which are “impossible” to avoid (id., at p. 433). In such cases, the jury must consider the manufacturer’s evidence of competing design considerations (id., at pp. 433-434), and the issue of design defect cannot fairly be resolved by standardless reference to the “expectations” of an “ordinary consumer.”

As we have seen, the consumer expectations test is reserved for cases in which the everyday experience of the product’s users permits a conclusion that the product’s design violated minimum safety assumptions, and is thus defective regardless of expert opinion about the merits of the design. It follows that where the minimum safety of a product is within the common knowledge of lay jurors, expert witnesses may not be used to demonstrate what an ordinary consumer would or should expect. Use of expert testimony for that purpose would invade the jury’s function (see Evid. Code, § 801, subd. (a)), and would invite circumvention of the rule that the risks and benefits of a challenged design must be carefully balanced whenever the issue of design defect goes beyond the common experience of the product’s users.4

*568By the same token, the jury may not be left free to find a violation of ordinary consumer expectations whenever it chooses. Unless the facts actually permit an inference that the product’s performance did not meet the minimum safety expectations of its ordinary users, the jury must engage in the balancing of risks and benefits required by the second prong of Barker.

Accordingly, as Barker indicated, instructions are misleading and incorrect if they allow a jury to avoid this risk-benefit analysis in a case where it is required. (20 Cal.3d at p. 434.). Instructions based on the ordinary consumer expectations prong of Barker are not appropriate where, as a matter of law, the evidence would not support a jury verdict on that theory. Whenever that is so, the jury must be instructed solely on the alternative risk-benefit theory of design defect announced in Barker. 5

GM suggests that the consumer expectations test is improper whenever “crashworthiness,” a complex product, or technical questions of causation are at issue. Because the variety of potential product injuries is infinite, the line cannot be drawn as clearly as GM proposes. But the fundamental distinction is not impossible to define. The crucial question in each individual case is whether the circumstances of the product’s failure permit an *569inference that the product’s design performed below the legitimate, commonly accepted minimum safety assumptions of its ordinary consumers.6

GM argues at length that the consumer expectations test is an “unworkable, amorphic, fleeting standard” which should be entirely abolished as a basis for design defect. In GM’s view, the test is deficient and unfair in several respects. First, it defies definition. Second, it focuses not on the objective condition of products, but on the subjective, unstable, and often unreasonable opinions of consumers. Third, it ignores the reality that ordinary consumers know little about how safe the complex products they use can or should be made. Fourth, it invites the jury to isolate the particular consumer, component, accident, and injury before it instead of considering whether the whole product fairly accommodates the competing expectations of all consumers in all situations (see Daly v. General Motors Corp., supra, 20 Cal.3d 725, 746-747). Fifth, it eliminates the careful balancing of risks and benefits which is essential to any design issue.

In its amicus curiae brief, the Product Liability Advisory Council, Inc. (Council) makes similar arguments. The Council proposes that all design defect claims be resolved under a single risk-benefit analysis geared to “reasonable safety.”

We fully understand the dangers of improper use of the consumer expectations test. However, we cannot accept GM’s insinuation that ordinary consumers lack any legitimate expectations about the minimum safety of the products they use. In particular circumstances, a product’s design may perform so unsafely that the defect is apparent to the common reason, experience, and understanding of its ordinary consumers. In such cases, a lay jury is competent to make that determination.

Nor are we persuaded by the Council’s proposal. In essence, it would reinvest product liability claims with the requirement of “unreasonable danger” that we rejected in Cronin and Barker.

When use of the consumer expectations test is limited as Barker intended, the principal concerns raised by GM and the Council are met. Within these limits, the test remains a workable means of determining the existence of *570design defect. We therefore find no compelling reason to overrule the consumer expectations prong of Barker at this late date, and we decline to do so.7

Applying our conclusions to the facts of this case, however, we agree that the instant jury should not have been instructed on ordinary consumer expectations. Plaintiff’s theory of design defect was one of technical and mechanical detail. It sought to examine the precise behavior of several obscure components of her car under the complex circumstances of a particular accident. The collision’s exact speed, angle, and point of impact were disputed. It seems settled, however, that plaintiff’s Camaro received a substantial oblique blow near the left front wheel, and that the adjacent frame members and bracket assembly absorbed considerable inertial force.

An ordinary consumer of automobiles cannot reasonably expect that a car’s frame, suspension, or interior will be designed to remain intact in any and all accidents. Nor would ordinary experience and understanding inform such a consumer how safely an automobile’s design should perform under the esoteric circumstances of the collision at issue here. Indeed, both parties assumed that quite complicated design considerations were at issue, and that expert testimony was necessary to illuminate these matters. Therefore, injection of ordinary consumer expectations into the design defect equation was improper.

We are equally persuaded, however, that the error was harmless, because it is not reasonably probable defendant would have obtained a more favorable result in its absence. (E.g., Pool v. City of Oakland (1986) 42 Cal.3d 1051, 1069 [232 Cal.Rptr. 528, 728 P.2d 1163]; see Cal. Const., art. VI, § 13; Code Civ. Proc., § 475.) In assessing prejudice from an erroneous instruction, we consider, insofar as relevant, “(1) the degree of conflict in the evidence on critical issues [citations]; (2) whether respondent’s argument to the jury may have contributed to the instruction’s misleading effect [citation]; (3) whether the jury requested a rereading of the erroneous instruction [citation] or of related evidence [citation]; (4) the *571closeness of the jury’s verdict [citation]; and (5) the effect of other instructions in remedying the error [citations].” (Pool, supra, 42 Cal.3d at pp. 1069-1070, quoting LeMons v. Regents of University of California (1978) 21 Cal.3d 869, 876 [148 Cal.Rptr. 355, 582 P.2d 946].)

Here there were no instructions which specifically remedied the erroneous placement of the consumer expectations alternative before the jury. Moreover, plaintiff’s counsel briefly reminded the jury that the instructions allowed it to find a design defect under either the consumer expectations or risk-benefit tests. However, the consumer expectations theory was never emphasized at any point. As previously noted, the case was tried on the assumption that the alleged design defect was a matter of technical debate. Virtually all the evidence and argument on design defect focused on expert evaluation of the strengths, shortcomings, risks, and benefits of the challenged design, as compared with a competitor’s approach.

Neither plaintiff’s counsel nor any expert witness on her behalf told the jury that the Camaro’s design violated the safety expectations of the ordinary consumer. Nor did they suggest the jury should find such a violation regardless of its assessment of such competing design considerations as risk, benefit, feasibility, and cost. The jury never made any requests which hinted it was inclined to apply the consumer expectations test without regard to a weighing of risks and benefits.

Under these circumstances, we find it highly unlikely that a reasonable jury took that path. We see no reasonable probability that the jury disregarded the voluminous evidence on the risks and benefits of the Camaro’s design, and instead rested its verdict on its independent assessment of what an ordinary consumer would expect. Accordingly, we conclude, the error in presenting that theory to the jury provides no basis for disturbing the trial judgment.8

*5722. Causation instructions.

GM next claims the trial court committed prejudicial error by refusing to instruct that any design defect was not a “substantial” or “contributing” cause of plaintiff’s “enhanced” injuries if those same injuries would have occurred even with a nondefective design. This proffered instruction conformed to GM’s trial theories that given the angle and force of the collision, the wheel would have collapsed regardless of any defect, and, in any event, that the wheel’s collapse played no part in the ankle injuries plaintiff received.

A party is entitled upon request to correct, nonargumentative instructions on every theory of the case advanced by him which is supported by substantial evidence. The trial court may not force the litigant to rely on abstract generalities, but must instruct in specific terms that relate the party’s theory to the particular case. (E.g., Hasson v. Ford Motor Co. (1977) 19 Cal.3d 530, 543 [138 Cal.Rptr. 705, 564 P.2d 857, 99 A.L.R.3d 158]; Borenkrautw. Whitten (1961) 56 Cal.2d 538, 545-546 [15 Cal.Rptr. 635, 364 P.2d 467]; Phillips v. G. L. Truman Excavation Co. (1961) 55 Cal.2d 801, 806 [13 Cal.Rptr. 401, 362 P.2d 33]; Selfw. General Motors Corp., supra, 42 Cal.App.3d 1, 10 (Self).)

GM’s proposed instruction was correct in form and substance. A manufacturer is liable only when a defect in its product was a legal cause of injury. (Cronin, supra, 8 Cal.3d at pp. 133-134.) A tort is a legal cause of injury only when it is a substantial factor in producing the injury. (Mitchell v. Gonzales (1991) 54 Cal.3d 1041, 1048-1054 [1 Cal.Rptr.2d 913, 819 P.2d 872].) If the external force of a vehicle accident was so severe that it would have caused identical injuries notwithstanding an abstract “defect” in the vehicle’s collision safety, the defect cannot be considered a substantial factor in bringing them about. (E.g., Doupnik v. General Motors Corp. (1990) 225 Cal.App.3d 849, 862-864 [275 Cal.Rptr. 715]; Endicott v. Nissan Motor *573 Corp. (1977) 73 Cal.App.3d 917, 926 [141 Cal.Rptr. 95, 9 A.L.R.4th 481]; Self, supra, 42 Cal.App.3d at p. 10.)9

The general causation instruction given by the trial court correctly advised that plaintiff could not recover for a design defect unless it was a “substantial factor” in producing plaintiff’s “enhanced” injuries. However, this instruction dealt only by “negative implication” (Self supra, 42 Cal.App.3d at p. 10) with GM’s theory that any such defect was not a “substantial factor” in this case because this particular accident would have broken plaintiff’s ankles in any event. As we have seen, GM presented substantial evidence to that effect. GM was therefore entitled to its special instruction, and the trial court’s refusal to give it was error.10

GM argues vigorously that the error is reversible per se. GM claims a California rule that the erroneous denial of instructions explaining a “central theory” of a party’s case is prejudicial as a matter of law.

Substantial authority supports GM’s view. However, GM’s contention is out of step with the usual rules governing instructional error. More significantly, it overlooks the proper application of California’s constitutional requirement that a judgment not be reversed unless error caused actual prejudice in light of the whole record. Hence, we conclude, the error at issue *574must be subjected to an examination whether actual prejudice occurred under the particular circumstances.

A judgment may not be reversed on appeal, even for error involving “misdirection of the jury,” unless “after an examination of the entire cause, including the evidence,” it appears the error caused a “miscarriage of justice.” (Cal. Const., art. VI, § 13.) When the error is one of state law only, it generally does not warrant reversal unless there is a reasonable probability that in the absence of the error, a result more favorable to the appealing party would have been reached. (People v. Watson (1956) 46 Cal.2d 818, 835 [299 P.2d 243].)

Thus, when the jury receives an improper instruction in a civil case, prejudice will generally be found only “ ‘[w]here it seems probable that the jury’s verdict may have been based on the erroneous instruction . . . .’” (LeMons v. Regents of University of California, supra, 21 Cal.3d 869, 875, quoting Robinson v. Cable (1961) 55 Cal.2d 425, 428 [11 Cal.Rptr. 377, 359 P.2d 929].) That assessment, in turn, requires evaluation of several factors, including the evidence, counsel’s arguments, the effect of other instructions, and any indication by the jury itself that it was misled. (Pool v. City of Oakland, supra, 42 Cal.3d 1051, 1069-1070.)

However, a substantial body of California decisions recites that the erroneous denial of correct specific instructions covering a civil litigant’s supportable “theory of the case” is “inherently” prejudicial. Decades old, this principle has been stated, or at least implicitly applied, in a wide variety of situations, ranging from the complete preclusion of a claim or defense (e.g., Hasson v. Ford Motor Co., supra, 19 Cal.3d 530, 548 [contributory negligence]; Phillips v. G. L. Truman Excavation Co., supra, 55 Cal.2d 801, 806 [same]; Bernal v. Richard Wolf Medical Instruments Corp. (1990) 221 Cal.App.3d 1326, 1337-1338 [272 Cal.Rptr. 41] [warranty theories in product liability action]; Paverud v. Niagara Machine & Tool Works (1987) 189 Cal.App.3d 858, 862-864 [234 Cal.Rptr. 585] [superseding cause]; White v. Uniroyal, Inc. (1984) 155 Cal.App.3d 1, 29-33 [202 Cal.Rptr. 141] [peculiar risk doctrine]) to mere lack of specificity in relating correct general principles to the particular facts (e.g., Borenkraut v. Whitten, supra, 56 Cal.2d 538, 544-546 [specific duty of care when priming automobile carburetor]; Williams v. Carl Karcher Enterprises, Inc. (1986) 182 Cal.App.3d 479, 489-490 [227 Cal.Rptr. 465] [affirmative duty to eliminate known dangerous condition in restaurant]; Ng. v. Hudson (1977) 75 Cal.App.3d 250, 261-262 [142 Cal.Rptr. 69] [“proximate cause” as including aggravation of dormant preexisting condition]; Self, supra, 42 Cal.App.3d 1, 10 [defect not “substantial factor” if same injury would have occurred regardless of defect]; see also, *575e.g., Lopez v. Ormonde (1968) 258 Cal.App.2d 176, 180 [65 Cal.Rptr. 513] [refusal of imminent peril instructions; prejudice assumed]; Edelman v. Zeigler (1965) 233 Cal.App.2d 871, 883-884 [44 Cal.Rptr. 114] [refusal of res ipsa loquitur instructions; prejudice assumed]).

The rationale generally given is that an error of this nature prevents jury consideration of the omitted “theory” and thus denies, to that extent, the right to a jury trial. We once declared that “[s]uch an error cannot be cured by the beneficent provisions of article VI, section [13 of the California Constitution]” (Phillips v. G. L. Truman Excavation Co., supra, 55 Cal.2d at p. 808), and this reasoning has been followed with little elaboration in more recent cases. (E.g., White v. Uniroyal, Inc., supra, 155 Cal.App.3d at p. 33; Ng v. Hudson, supra, 75 Cal.App.3d at pp. 261-262; Fish v. Los Angeles Dodgers Baseball Club (1976) 56 Cal.App.3d 620, 641 [128 Cal.Rptr. 807, 91 A.L.R.3d 1].)

The “inherent prejudice” line of authority is not unbroken. A number of decisions, when addressing erroneous denials of specific “theory” instructions, have assessed the actual effect of the error on the judgment. (Agarwal v. Johnson (1979) 25 Cal.3d 932, 951-952 [160 Cal.Rptr. 141, 603 P.2d 58] [court instructed generally on respondeat superior liability, but failed to instruct sua sponte on limits of vicarious liability for punitive damages; any error deemed harmless under Cal. Const., art. VI, § 13]; Hildebrand v. Los Angeles Junction Ry. Co. (1960) 53 Cal.2d 826, 831, 832 [3 Cal.Rptr. 313, 350 P.2d 65] [court instructed generally that “party who asserts the affirmative of an issue” has burden of proof, but refused plaintiff’s specific instruction that defendant has burden of proving contributory negligence; error deemed harmless after “review [of] entire record” under art. VI, former § WA (now § 13)]; Walbrook Ins. Co. v. Liberty Mutual Ins. Co. (1992) 5 Cal.App.4th 1445, 1461-1462 [7 Cal.Rptr.2d 513] [refusal in insurance bad faith action to instruct that amount of underlying personal injury verdict furnishes inference of value of claim; error deemed harmless under “all the circumstances” where other instructions invited jury to consider “strength and weaknesses” of third party’s claim]; Sesler v. Ghumman (1990) 219 Cal.App.3d 218, 226 [268 Cal.Rptr. 70] [refusal to instruct in detail on duty of care when turning left against multiple lanes of traffic; LeMons factors applied to assess prejudice; misleading argument of plaintiff’s counsel emphasized]; Montez v. Ford Motor Co. (1980) 101 Cal.App.3d 315, 322 [161 Cal.Rptr. 578] [refusal to give plaintiff’s proffered instruction defining manufacturing defect deemed harmless under art. VI, § 13]; Wechlo v. Winyard (1973) 33 Cal.App.3d 990, 996 [109 Cal.Rptr. 462] [refusal of last clear chance instruction deemed prejudicial because of evidence that jury focused closely on issues of negligence and contributory negligence]; *576see Continental Airlines, Inc. v. McDonnell Douglas Corp. (1989) 216 Cal.App.3d 388, 404-408 [264 Cal.Rptr. 779] [error to omit elements of fraud by nondisclosure, but judgment may be upheld where missing elements necessarily found in connection with other theories].)

In deciding what standard of reversibility should apply to the erroneous omission of instructions explaining the theory of a claim or defense, we take guidance from a recent decision of this court, People v. Cahill (1993) 5 Cal.4th 478 [20 Cal.Rptr.2d 582, 853 P.2d 1037] (Cahill). There we abrogated California’s traditional rule that admission of an involuntary confession as evidence in a criminal case was reversible per se. In so doing, we examined at length the purpose and application of the California Constitution’s reversible error provision, article VI, section 13.

As we explained, the predecessor of article VI, section 13 (art. VI, § 4 1/2) was added to the California Constitution in 1911. Its purpose was to counteract prior assumptions that a reviewing court could not consider the trial evidence in deciding whether an error had caused prejudice. (Cahill, supra, 5 Cal.4th at pp. 489-490.) People v. O’Bryan (1913) 165 Cal. 55 [130 P. 1042] soon made clear that “[under] the new constitutional provision the appellate courts are empowered to examine ‘the entire cause, including the evidence’ and are required to affirm the judgment ... if error has not resulted ‘in a miscarriage of justice.’ [Citation.]” (Cahill, supra, 5 Cal.4th at p. 490, quoting O’Bryan, supra, at p. 64, italics in original.)

Confusion arose after O’Bryan because California courts developed a “variety of differently worded tests” to determine whether a miscarriage of justice had occurred. (Cahill, supra, 5 Cal.4th at p. 492.) People v. Watson, supra, 46 Cal.2d 818 resolved this confusion by articulating a “generally applicable” standard. For most errors, this test permits reversal “ ‘only when the [reviewing] court after an examination of the entire cause, including the evidence, is of the “opinion” that it is reasonably probable that a result more favorable to the appealing party would have been reached in the absence of the error.’ ” (Cahill, supra, 5 Cal.4th at p. 492, quoting Watson, supra, 46 Cal.2d at p. 836.) Of course, the Watson test has since been applied equally in civil and criminal cases.

Both O’Bryan and Watson recognized that certain limited forms of error would constitute a miscarriage of justice without regard to the state of the evidence. O’Bryan spoke particularly of criminal law errors which, under Anglo-American standards of justice, deny the accused a determination of guilt or innocence “ ‘by an orderly legal procedure in which the substantial rights belonging to defendants shall be respected.’ ” (Cahill, supra, 5 Cal.4th at p. 501, quoting O’Bryan, supra, 165 Cal. at p. 65, italics added by Cahill.)

*577In Cahill, supra, we sought to give meaning to the distinction articulated by O’Bryan. As we observed, “the kinds of errors that, regardless of the evidence, may result in a ‘miscarriage of justice’ because they operate to deny a criminal defendant the constitutionally required ‘orderly legal procedure’ (or, in other words, a fair trial)—for example, the denial of the defendant’s right to a jury trial or to an impartial trial judge [citation]—all involve fundamental ‘structural defects’ in the judicial proceedings . . . rather than the improper admission of a particular item of evidence.” (Cahill, supra, 5 Cal.4th at pp. 501-502.)

Cahill noted that by their nature, “ ‘structural defects in the constitution of the trial mechanism,’ ” such as those automatically reversible in criminal cases under federal constitutional law (see Arizona v. Fulminante (1991) 499 U.S. 279, 309-310 [113 L.Ed.2d 302, 330-332, 111 S.Ct. 1246]), are not susceptible to conventional harmless-error analysis. (Cahill, supra, 5 Cal.4th at p. 493.) Additional examples from California criminal law, as cited by Cahill, include improper denial of the right to separate counsel (see, e.g., People v. Douglas (1964) 61 Cal.2d 430, 436-439 [38 Cal.Rptr. 884, 392 P.2d 964]), conflict of interest on the part of counsel (see, e.g., People v. Mroczko (1983) 35 Cal.3d 86, 104-105 [197 Cal.Rptr. 52, 672 P.2d 835]), ineffectual waiver of right to jury trial (see, e.g., People v. Holmes (1960) 54 Cal.2d 442 [5 Cal.Rptr. 871, 353 P.2d 583]), and discrimination in jury selection (see, e.g., People v. Wheeler (1978) 22 Cal.3d 258, 283 [148 Cal.Rptr. 890, 583 P.2d 748]). (Cahill, supra, 5 Cal.4th at p. 493.)

By contrast, Cahill observed, admission of an involuntary confession is mere “trial error,” that is, “ ‘error which occurred during the presentation of the case to the jury. . . .’” This category of error, said Cahill, “ ‘may . . . be quantitatively assessed in the context of other evidence presented in order to determine whether its admission was [prejudicial or harmless].’ ” (5 Cal.4th at p. 502, quoting Arizona v. Fulminante, supra, 499 U.S. at pp. 307-308 [113 L.Ed.2d at pp. 329-330].) Indeed, Cahill noted, the “admission or rejection of evidence” is among those specific forms of error for which article VI, section 13, “by its terms, directs that. . . prejudicial [effect] . . . be determined ‘after an examination of the entire cause, including the evidence.’ ” (Cahill, supra, 5 Cal.4th at p. 502.)

Earlier California authorities justified an exception for involuntary confessions on grounds that a confession is such persuasive evidence of guilt. The cases reasoned that it would be extremely difficult to determine whether improper admission of this “evidentiary bombshell” was harmless in a particular case. (See, e.g., People v. Jacobson (1965) 63 Cal.2d 319, 330 [46 Cal.Rptr. 515, 405 P.2d 555]; People v. Schader (1965) 62 Cal.2d 716, 731 *578[44 Cal.Rptr. 193, 401 P.2d 665]; People v. Parham (1963) 60 Cal.2d 378, 385 [33 Cal.Rptr. 497, 384 P.2d 1001].)

Cahill explained, however, that “[i]n relying upon this rationale . . . , the California decisions . . . lost sight of the principal purpose and significance of . . . California’s constitutional provision explicitly addressing the matter of reversible error. The recognition that confessions, ‘as a class,’ ‘[a]lmost invariably’ will provide persuasive evidence of a defendant’s guilt [citation] . . . simply means that the improper admission of a confession is much more likely to affect the outcome of a trial than are other categories of evidence, and thus is much more likely to be prejudicial under the traditional harmless-error standard. But . . . that consequence does not, in our view, justify the judicial adoption of a state-law rule that automatically and monolithically treats all improperly admitted confessions as requiring reversal of the defendant’s conviction; the California constitutional reversible-error provision was adopted for the specific purpose of eliminating just such a prophylactic approach to reversible error. [Fn. omitted.]” (5 Cal.4th at p. 503, italics in original.)

Cahill next rejected contentions that a reversible-per-se rule should be retained in order to deter the extraction of involuntary confessions, a particularly “egregious” form of official misconduct, and to guard against the unreliability of such confessions. (5 Cal.4th at pp. 505-507.) Finally, for several reasons, Cahill declined to retain the rule as a matter of stare decisis.

In particular, Cahill noted that “retention of a reversible-per-se rule, solely on the basis of stare decisis, would fail to give proper recognition to the important public policies underlying the reversible error provision set forth in California’s Constitution—policies that remain of vital significance today. . . .” (5 Cal.4th at p. 508.) Among other things, Cahill explained that when a defendant has received a fair and accurate trial despite some error, “reversal of the judgment will result either in a superfluous retrial in which the outcome is a foregone conclusion or, even more unfortunately, in a new trial whose result is altered by the loss of essential witnesses or testimony through the passage of time. In either event, public confidence in the operation of the criminal justice system is diminished.” (Id., at p. 509.)

These principles, properly adapted, apply with equal or even greater force to the issue before us. Of course, we are here concerned with a civil, not a criminal trial. But the constitutional requirement of actual prejudice cannot apply any less stringently to a civil judgment than to a criminal conviction, in which the rights of an accused threatened with deprivation of liberty are at stake.

*579Indeed, as in Cahill, the express terms of article VI, section 13 of the California Constitution weigh against automatic reversal for the kind of error we consider here. The constitutional provision explicitly mentions “misdirection of the jury” as error which warrants reversal only if, “after an examination of the entire cause, including the evidence, the court [concludes] . . . that the error . . . resulted in a miscarriage of justice.” The word “misdirection” logically includes every kind of instructional error. It seems manifest that incorrect, ambiguous, conflicting, or wrongly omitted instructions may equally “misdirect” the jury’s deliberations. Nothing in the language or history of article VI, section 13 suggests that its requirement of actual prejudice, determined by reference to “the entire cause, including the evidence,” applies to some forms of “misdirection,” but not others.

Moreover, erroneous refusal of a proffered civil instruction clearly is not a fundamental denial of the orderly legal procedure due a criminal accused. Nor is it a “ ‘structural [defect] in the . . . trial mechanism’ ” that defies evaluation for harmlessness. Instead, like the improper admission of evidence at issue in Cahill, it is trial error, a mistake that occurred in presentation of the case to the jury. By its nature, error of this kind “ ‘may ... be quantitatively assessed in . . . context... in order to determine whether its [commission] was [prejudicial or harmless].’ ” (Cahill, supra, 5 Cal.4th at p. 502, quoting Arizona v. Fulminante, supra, 499 U.S. 279, 307-308 [113 L.Ed.2d 302, 329-330].)

We are not persuaded otherwise by earlier pronouncements that certain kinds of erroneous instructional omissions in civil cases are automatically reversible because they violate a litigant’s right to jury trial. In our view, if a civil litigant was permitted to introduce evidence, cross-examine witnesses, and present argument before a fairly selected jury that rendered its honest verdict on the trial record, there has been no “structural [defect] in the constitution of the trial mechanism” that might call for automatic reversal of a civil judgment without consideration of actual prejudice. Obviously, any substantial “error which occurred during the presentation of the case to the jury” distorts or impairs the jury function to some degree. That fact cannot turn every such civil trial error into a fundamental, structural denial of the right to a jury.

Nor can we accept the traditional rationale that certain forms of instructional omission in civil cases are “inherently” prejudicial. Cases that automatically applied that theory without reference to the actual record “lost sight of the principal purpose and significance of . . . California’s constitutional provision explicitly addressing the matter of reversible error. . . .” (Cahill, supra, 5 Cal.4th at p. 503.)

*580Erroneous civil instructional omissions, like the criminal evidentiary error at issue in Cahill, may be more or less likely to cause actual prejudice, depending on their nature and context. Particularly serious forms of error might “almost invariably” prove prejudicial in fact. But it does not follow that courts may “automatically and monolithically” treat a particular category of civil instructional error as reversible per se. Article VI, section 13 of the California Constitution requires examination of each individual case to determine whether prejudice actually occurred in light of the entire record. (See Cahill, supra, 5 Cal.4th at p. 503.)

Finally, we may not blindly endorse traditional rules of automatic reversal or “inherent” prejudice in order to preserve doctrinal stability. As in Cahill, our adherence to such principles would undermine the important and still-vital requirements and policies of article VI, section 13 of the California Constitution. No form of civil trial error justifies reversal and retrial, with its attendant expense and possible loss of witnesses, where in light of the entire record, there was no actual prejudice to the appealing party.

We therefore conclude that there is no rule of automatic reversal or “inherent” prejudice applicable to any category of civil instructional error, whether of commission or omission. A judgment may not be reversed for instructional error in a civil case “unless, after an examination of the entire cause, including the evidence, the court shall be of the opinion that the error complained of has resulted in a miscarriage of justice.” (Cal. Const., art. VI, §13.) Contrary implications in prior decisions such as Self, supra, 42 Cal.App.3d 1, are disapproved and overruled.

Instructional error in a civil case is prejudicial “where it seems probable” that the error “prejudicially affected the verdict.” (See Pool v. City of Oakland, supra, 42 Cal.3d 1051, 1069; LeMons v. Regents of University of California, supra, 21 Cal.3d 869, 875; People v. Watson, supra, 46 Cal.2d 818, 836.) Of course, that determination depends heavily on the particular nature of the error, including its natural and probable effect on a party’s ability to place his full case before the jury.

But the analysis cannot stop there. Actual prejudice must be assessed in the context of the individual trial record. For this purpose, the multifactor test set forth in such cases as LeMons and Pool, both supra, is as pertinent in cases of instructional omission as in cases where instructions were erroneously given. Thus, when deciding whether an error of instructional omission was prejudicial, the court must also evaluate (1) the state of *581the evidence, (2) the effect of other instructions, (3) the effect of counsel’s arguments, and (4) any indications by the jury itself that it was misled.11

Here, GM does not even suggest that the refusal of its causation instruction caused it actual, as opposed to “inherent,” prejudice. Nonetheless, we examine the error by the standards we have set forth above. Our evaluation convinces us that the error was harmless.

At the outset, we note that the omission of GM’s proposed language did not cause an entire absence of instructional support for GM’s causation defense. (Cf., e.g., Hasson v. Ford Motor Co., supra, 19 Cal.3d 530, 548 [contributory negligence instruction refused].) The trial court instructed that plaintiff could not recover for a design defect unless the defect was a “substantial” factor in producing her “enhanced” injuries. In general terms, the instructions thus encompassed GM’s causation theory, and they did not foreclose a defense verdict on that theory.

What GM failed to obtain was a further explanation of how general principles of causation related to GM’s specific claim that plaintiff’s ankle injuries were caused by the force of the accident, not by any design defect in the Camaro. In essence, the omitted language was thus similar in function and purpose to “pinpoint” instructions. It is well settled that the erroneous refusal of “pinpoint” instructions may be deemed harmless in appropriate cases. (See, e.g., People v. Wright (1988) 45 Cal.3d 1126, 1144-1152 [248 Cal.Rptr. 600, 755 P.2d 1049].)

The fact that no other instructions covered GM’s well-supported theory with the required specificity may weigh in favor of a finding that prejudice *582occurred in this case. However, other factors show there is no reasonable probability the jury was misled or the verdict affected.

It was obvious at trial that GM’s theory of causation was a major aspect of its case. Without objection, GM produced voluminous expert evidence in support of its hypothesis that even if plaintiff’s Camaro was defective, the force of the collision was the sole “substantial” cause of plaintiff’s ankle injuries.

Again without objection, GM’s counsel devoted significant argument to this theory, and counsel articulated it very clearly. At length, counsel urged the evidence showed that the toe pan’s deformation could not have broken plaintiff’s ankles and that the actual cause of injury was plaintiff’s own inertial impact against the floorboard. Moreover, counsel emphasized, “[i]f the crash is so severe that you think [plaintiff’s] ankles would have broken anyway,” then any defect was not a cause of plaintiff’s injuries.12

In turn, plaintiff also devoted substantial attention to the causation issue raised by GM. Plaintiff’s counsel presented contrary evidence, cross-examined defense experts, and argued that GM’s theory was not persuasive on the facts. However, neither plaintiff’s counsel nor the court ever suggested that it was legally irrelevant.

Thus, the evidence and argument uniformly supported the reasonable inference that the general causation instruction allowed GM to escape liability if plaintiff’s injuries would have occurred regardless of any defect. Hence, there seems little chance the jury was actually misled. The jury itself gave no indication it was confused on the point, or that its deliberations were affected accordingly. We therefore find no reasonable probability that the *583error in refusing GM’s special instruction on causation affected the jury’s verdict. Accordingly, we conclude, the error was harmless.

Conclusion

The trial court erred when it instructed on the consumer expectations test for design defect, and when it refused GM’s special instruction on causation. However, neither error caused actual prejudice. Accordingly, the judgment of the Court of Appeal, upholding the trial court judgment in favor of plaintiff, is affirmed.

Kennard, J., George, J., Werdegar, J., and Boren, J.,* concurred.

MOSK, Acting C. J., Concurring.

While I agree with the conclusion of the majority in this case, I cannot approve an opinion that purports to “take guidance” (maj. opn., ante, p. 576) from People v. Cahill (1993) 5 Cal.4th 478 [20 Cal.Rptr.2d 582, 853 P.2d 1037].

Cahill, an opinion that deemed coerced confessions to be harmless, was and remains a cruel aberration in the law. It casts doubt on our devotion to justice and perpetuates a medieval concept that convictions can be obtained by any means and at any cost to integrity.

Unnecessarily citing Cahill for “guidance” reflects unfavorably on the otherwise satisfactory analysis of this opinion.

ARABIAN, J., Concurring and Dissenting.

I concur in the majority’s holding that the trial court committed instructional error in two respects, incorrectly charging the jury on the “consumer expectations” component of design defect liability, and improperly refusing defendant General Motors’ requested instruction on legal causation. I cannot agree, however, with the conclusion that the latter error was harmless.

“It is hornbook law that each party to a lawsuit is entitled to have the jury instructed on all of his theories of the case that are supported by the pleadings and the evidence. It is incumbent upon the trial court to instruct on all vital issues involved.” (Phillips v. G. L. Truman Excavation Co. (1961) 55 Cal.2d 801, 806 [13 Cal.Rptr. 401, 362 P.2d 33].) Furthermore, a trial court may not compel a litigant to rely on “abstract generalities in presenting its legal theory of the case to the jury, but should instruct the jury on vital issues in terms that relate to the particular case before it.” (Self v. General Motors *584 Corp. (1974) 42 Cal.App.3d 1, 10 [116 Cal.Rptr. 575]; see also Hasson v. Ford Motor Co. (1977) 19 Cal.3d 530, 543 [138 Cal.Rptr. 705, 564 P.2d 857, 99 A.L.R.3d 158]; Borenkraut v. Whitten (1961) 56 Cal.2d 538, 545-546 [15 Cal.Rptr. 635, 364 P.2d 467]; Phillips v. G. L. Truman Excavation Co., supra, 55 Cal.2d at p. 806.)

The trial court here refused General Motors’ requested instruction on one of its two primary defense theories, to wit, that any design defect could not have been a “substantial” or “contributing” cause of plaintiff’s “enhanced” injuries if they would have occurred even with a nondefective design.1 The proposed instruction, as the majority concede, was correct in form and substance. If the force of the collision was so severe that plaintiff’s injuries would have occurred notwithstanding any abstract “defect” in the vehicle’s safety design, the defect cannot be considered a substantial factor or legal cause in bringing them about. (See Doupnik v. General Motors Corp. (1990) 225 Cal.App.3d 849, 862-864 [275 Cal.Rptr. 715]; Self v. General Motors Corp., supra, 42 Cal.App.3d at p. 10.)

As the majority further acknowledge, the proposed instruction encapsulated a “major thrust” of the defense theory at trial. General Motors presented substantial evidence that the force of the collision was the sole cause of plaintiff’s injuries, wholly apart from the existence of any defect. Its expert testified extensively in support of this theory, supporting his opinion with references to crash tests and voluminous documentation, and applying the data to the particular circumstances of the collision between plaintiff and the other driver. Thus, the proposed instruction set forth a correct statement of law and was amply supported by the evidence at trial. The trial court’s refusal to instruct the jury pursuant to its terms was plainly errroneous.

Was the error prejudicial? Viewed in the light of the relevant prejudicial-error standard and the pertinent analytical factors, I must conclude that it was. When the jury receives an improper instruction in a civil case, prejudice will be found “ ‘[w]here it seems probable that the jury’s verdict may have been based on the erroneous instruction . . . .’ ” (LeMons v. Regents of University of California (1978) 21 Cal.3d 869, 875 [148 Cal.Rptr. 355, 582 P.2d 946], quoting Robinson v. Cable (1961) 55 Cal.2d 425, 428 [11 Cal.Rptr. 377, 359 P.2d 929].) In assessing that probability, we look to several factors, including the degree of conflict in the evidence, counsel’s *585arguments, the effect of other instructions, and any indication from the jury that it was confused or misled. (Pool v. City of Oakland (1986) 42 Cal.3d 1051, 1069-1070 [232 Cal.Rptr. 528, 728 P.2d 1163].)

With respect to the potentially mitigating effect of other instructions, the standard definition of “legal cause” which the trial court read the jury plainly did not represent an adequate substitute for the requested pinpoint instruction. As the majority concede, the general instruction dealt only by “negative implication” (Self v. General Motors Corp., supra, 42 Cal.App.3d 1, 10) with General Motors’ theory that any defect could not have been a substantial factor because the injuries would have occurred in any event. “A trial court should not require a party to rely on abstract generalities in presenting its legal theory of the case to the jury, but should instruct the jury on vital issues in terms that relate to the particular case before it.” (Self v. General Motors Corp., supra, 42 Cal.App.3d at p. 10, italics added; see also Borenkraut v. Whitten, supra, 56 Cal.2d at p. 545.) That is precisely what failed to occur here. The abstract definition of “legal cause”—“difficult conceptual problem for jurors—and for trial judges and appellate judges, too, for that matter” (Self v. General Motors Corp., supra, 42 Cal.App.3d at p. 10)—provided the jury no meaningful guidance in terms related to the particular case before it. Received in a factual vacuum and untethered to the specific causation theory proffered by General Motors, the general causation instruction failed to provide the tailored nexus between facts and law to which General Motors was entitled, and which the jury manifestly required. Hence, I am compelled to conclude that this factor weighs strongly in favor of a finding of prejudice.

The record evidence lends additional weight to this conclusion. The majority note that General Motors produced “voluminous evidence” to demonstrate that the force of the accident was so severe that plaintiff’s injuries would have occurred regardless of any defect. We are apparently to infer, therefore, that the jury was adequately apprised—based on the evidence—of the law and logic underlying General Motors’ theory of defense. I would suggest that the more reasonable inference is precisely the opposite. Given the voluminous documentary and testimonial evidence adduced at trial, the jury was all the more in need of a clear and unambigous instruction to integrate and make sense of the conflicting evidence. Therefore, I must conclude that this factor as well supports a finding of prejudice.

The majority note that counsel for General Motors explained its causation theory to the jury during closing argument. Contrary to the conclusion of the majority, however, I do not find that this represented an adequate substitute for a proper legal instruction. Juries are generally instructed, as they were *586here, that “the court’s instructions . . . instruct you as to the applicable law,” and that “statements of counsel are not evidence” but merely the statements of advocates. Thus, although pertinent to the prejudice calculation, the arguments of counsel “are not to be judged as having the same force as an instruction from the court.” (Boyde v. California (1990) 494 U.S. 370, 384-385 [108 L.Ed.2d 316, 331-332, 110 S.Ct. 1190].)

Counsel’s argument was merely that—argument—unless and until a ratifying instruction from the trial court dignified it with the force of law. As the United States Supreme Court has well observed, “It is obvious that under any system of jury trials the influence of the trial judge on the jury is necessarily and properly of great weight, and that his lightest word or intimation is received with deference, and may prove controlling.” (Starr v. United States (1894) 153 U.S. 614, 626 [38 L.Ed. 841, 846, 14 S.Ct. 919], quoted with approval in Sanguinetti v. Moore Dry Dock Co. (1951) 36 Cal.2d 812, 819 [228 P.2d 55].) The omission of a critical charge may, of course, prove to be just as instrumental to the outcome. Thus, I am not prepared to say that the trial court’s refusal to instruct on a theory at the heart of the defense, in terms pertinent to the circumstances of the case, was rendered harmless as a result of counsel’s argument.

In view of these findings, it appears to me at the very least reasonably “probable” that the jury’s verdict may have been based on the erroneous refusal to instruct on a critical theory of the defense. (LeMons v. Regents of University of California, supra, 21 Cal.3d at p. 875.) Accordingly, I would reverse the judgment of the Court of Appeal.

KIRSHBAUM, Justice.

We granted certiorari to review the decision in Camacho v. Honda Motor Co., 701 P.2d 628 (Colo.App.1985), in which the Court of Appeals affirmed a trial court order dismissing claims filed by the petitioners, Jaime Camacho and Kathleen Camacho (the Camachos), against the respondents, Honda Motor Co., Ltd. and American Honda Motor Co., Inc. (Honda).1 The Court of Appeals held that the trial court properly granted a motion for summary judgment filed by Honda because the absence of leg protection devices could not as a matter of law render a motorcycle a defective and unreasonably dangerous product under the Restatement (Second) of Torts section 402A (1965). We reverse and remand with directions.

I

In March 1978, Jaime Camacho (Camacho) purchased a new 1978 Honda Hawk motorcycle, model CV400T2, from a Honda dealer.2 In May 1978, while driving the motorcycle through an intersection, Camacho collided with an automobile and sustained serious leg injuries. Camacho and his wife filed an action against Honda seeking damages for personal injuries, property losses, loss of consortium and exemplary *1242damages. The action was based on several theories, including strict liability.3 The Camachos alleged that the motorcycle was a defectively designed, unreasonably dangerous product under the Restatement (Second) of Torts section 402A because it was not equipped with “crash bars” — tubular steel bars attached to the motorcycle frame to protect the rider’s legs in the event of a collision. They asserted that if such crash bars had been installed on the motorcycle, Camacho’s leg injuries would have been mitigated.

Two mechanical engineers employed by the Camachos testified in depositions that, in light of their extensive research work on motorcycle crash bars, including testing conducted for the United States Department of Transportation, the state of the art in mechanical engineering and motorcycle design was such that effective injury-reducing, leg protection devices were feasible in March 1978 and that several manufacturers other than Honda had made such devices available as optional equipment;4 that, although room for further improvement of crash bars existed in March 1978, crash bars then available from manufacturers other than Honda provided some protection in low-speed collisions and, in particular, would have reduced or completely avoided the serious leg injuries suffered by Camacho; and that Honda itself had conducted some of the seminal research on crash bars in 1969, as the result of which Honda’s engineers had concluded that injury-reducing crash bars could be manufactured by strengthening the steel bars which had been tested and providing strong bolts to attach the bars to the motorcycle frame.

Honda moved for summary judgment, arguing that as a matter of law a motorcycle lacking crash bars cannot be deemed unreasonably dangerous. The trial court granted the motion, concluding that (1) because the danger of leg injury was obvious and foreseeable, Honda had no duty to totally alter the nature of its product by installing crash bars; and (2) Honda had no duty under the crashworthiness doctrine to add a safety feature to its product to reduce the severity of injuries resulting from accidents.

In agreeing with the trial court’s conclusions, the Court of Appeals held that the determination of whether a product is unreasonably dangerous because of a design defect is to be made on the basis of whether the extent of the danger “would have been fully anticipated by or within the contemplation of” the ordinary user or consumer. Camacho v. Honda Motor Co., 701 P.2d 628, 631 (Colo.App.1985). Because the criteria applied by the trial court and the Court of Appeals are inconsistent with our decisions in Ortho Pharmaceutical Corp. v. Heath, 722 P.2d 410 (Colo.1986), and Union Supply Co. v. Pust, 196 Colo. 162, 583 P.2d 276 (1978), we reverse and remand for further proceedings.

II

In Roberts v. May, 41 Colo.App. 82, 583 P.2d 305 (1978), the Court of Appeals recognized the applicability of the “crash-worthiness” doctrine in Colorado. Under this doctrine, a motor vehicle manufacturer *1243may be liable in negligence or strict liability for injuries sustained in a motor vehicle accident where a manufacturing or design defect, though not the cause of the accident, caused or enhanced the injuries. See generally 2 L. Frumer & M. Friedman, Products Liability § 3.03[4][f][v] (1987). The doctrine was first recognized in the landmark case of Larsen v. General Motors Corp., 391 F.2d 495 (8th Cir.1968), in which the court noted that a manufacturer’s duty encompassed designing and building a product reasonably fit and safe for its intended use, that automobiles are intended for use on the roadways and that injury-producing collisions are a frequent, foreseeable and statistically expectable result of such normal use. Incumbent upon the automobile manufacturer was a duty of reasonable care in the design and manufacture of its product, including a duty to use reasonable care to minimize the injurious effects of a foreseeable collision by employing commonsense safety features. Larsen v. General Motors Corp., 391 F.2d 495, 501-02. The crashworthiness doctrine has been adopted by the vast majority of courts in other jurisdictions which have considered the issue. E.g., Hermann v. General Motors Corp, 720 F.2d 414 (5th Cir.1983); Sours v. General Motors Corp., 717 F.2d 1511 (6th Cir.1983); Horn v. General Motors Corp., 17 Cal.3d 359, 131 Cal.Rptr. 78, 551 P.2d 398 (1976); Ford Motor Co. v. Evancho, 327 So.2d 201 (Fla.1976); Farmer v. International Harvester Co., 97 Idaho 742, 553 P.2d 1306 (1978); Smith v. Ariens Co., 375 Mass. 620, 377 N.E.2d 954 (1978); Hancock v. Paccar, Inc., 204 Neb. 468, 283 N.W.2d 25 (1979); McMullen v. Volkswagen of America, 274 Or. 83, 545 P.2d 117 (1976); see generally 1 R. Goodman, Automobile Design Liability § 1:4 (2d ed. 1983) (noting the nearly universal acceptance of the crashworthiness doctrine). We agree with the reasoning of those decisions, as did the Court of Appeals in its consideration of this case, and adopt the crashworthiness doctrine for this jurisdiction.

The crashworthiness doctrine has been applied to accidents involving motorcycles. E.g., Taylor v. American Honda Motor Co., 555 F.Supp. 59 (M.D.Fla.1983) (lack of leg protection devices); Stueve v. American Honda Motor Co., 457 F.Supp. 740 (D.Kan.1978) (inability of gas tank to withstand collision); Cota v. Harley Davidson, a Div. of AMF, Inc., 141 Ariz. 7, 684 P.2d 888 (Ariz.App.1984) (inability of gas tank to withstand collision); Nicolodi v. Harley-Davidson Motor Co., 370 So.2d 68 (Fla. Dist.Ct.App.1979) (lack of leg protection devices); O’Donnell v. City of Casyer, 696 P.2d 1278 (Wyo.1985) (inability of gas tank to withstand collision). Honda argues, however, that motorcycles are inherently dangerous motor vehicles that cannot be made perfectly crashworthy and, therefore, that motorcycle manufacturers should be free of liability for injuries not actually caused by a defect in the design or manufacture of the motorcycle. We find no principled basis to conclude that liability for failure to provide reasonable, cost-acceptable safety features to reduce the severity of injuries suffered in inevitable accidents should be imposed upon automobile manufacturers but not upon motorcycle manufacturers. The use of motorcycles for transportation over roadways is just as foreseeable as the use of automobiles for such purpose. The crashworthiness doctrine does not require a manufacturer to provide absolute safety, but merely to provide some measure of reasonable, cost-effective safety, in the foreseeable use of the product. E.g., Larsen v. General Motors Corp., 391 F.2d 495, 501-02; Nicolodi v. Harley-Davidson Motor Co., 370 So.2d 68, 70-71; see generally 1 R. Goodman, Automobile Design Liability § 1:4 (2d ed. 1983). Honda acknowledges that motorcycle accidents are just as foreseeable as automobile accidents and that motorcycle riders face a much greater risk of injury in the event of an accident than do occupants of automobiles. In view of the important goal of encouraging maximum development of reasonable, cost-efficient safety features in the manufacture of all products, the argument that motorcycle manufacturers should be exempt from liability under the crashworthiness doctrine because serious injury to users of that prod*1244uct is foreseeable must be rejected. Cota v. Harley Davidson, a Div. of AMF, Inc., 684 P.2d 888,894; Nicolodi v. Harley-Davidson Motor Co., 370 So.2d 68, 70-71.5

Ill

In determining the extent of liability of a product manufacturer for a defective product, this court has adopted the doctrine of strict products liability as set forth in the Restatement (Second) of Torts section 402A (1965). Smith v. Home Light & Power Co., 734 P.2d 1051 (Colo.1987); Blueflame Gas, Inc. v. Van Hoose, 679 P.2d 579 (Colo.1984); Anderson v. Heron Eng’g Co., 198 Colo. 391, 604 P.2d 674 (1979); Hiigel v. General Motors Corp., 190 Colo. 57, 544 P.2d 983 (1975). Section 402A provides:

Special Liability of Seller of Product for Physical Harm to User or Consumer

(1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if

(a) the seller is engaged in the business of selling such a product, and

(b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.

(2) The rule stated in Subsection (1) applies although

(a) the seller has exercised all possible care in the preparation and sale of his product, and

(b) the user or consumer has not bought the product from or entered into any contractual relation with the seller.

Honda asserts that as a matter of law a motorcycle designed without leg protection devices cannot be deemed “in a defective condition unreasonably dangerous to the user” because the risk of motorcycle accidents is foreseeable to every ordinary consumer and because it is obvious that motorcycles do not generally offer leg protection devices as a standard item. In support of this argument Honda relies on comment i to section 402A, which states in pertinent part:

i. Unreasonably dangerous. The rule stated in this Section applies only where the defective condition of the product makes it unreasonably dangerous to the user or consumer.

The article sold must be dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its characteristics.

The trial court and the Court of Appeals in essence applied this consumer contemplation test in dismissing the Camachos’ claims.

In Cronin v. J.B.E. Olson Corp., 8 Cal.3d 121, 104 Cal.Rptr. 433, 501 P.2d 1153 (1972), the California Supreme Court declined to require an injured person to establish that a product is unreasonably dangerous as a requisite to recovery for injuries in a strict liability design defect context. In Union Supply Co. v. Pust, 196 Colo. 162, 583 P.2d 276 (1978), this court rejected the Cronin rationale, recognizing that requiring a party who seeks recovery on the basis of an alleged defec*1245tive product to establish that the product is unreasonably dangerous appropriately places reasonable limits on the potential liability of manufacturers. However, we also held in Pust that the fact that the dangers of a product are open and obvious does not constitute a defense to a claim alleging that the product is unreasonably dangerous. We noted that adoption of such a principle would unfairly elevate the assumption of risk defense to a question of law.6 The obvious and foreseeable consumer contemplation test employed by the trial court and approved by the Court of Appeals is substantially similar to the open and obvious standard specifically rejected in Pust. It is not the appropriate standard in Colorado for measuring whether a particular product is in a defective condition unreasonably dangerous to the consumer or user.

A consumer is justified in expecting that a product placed in the stream of commerce is reasonably safe for its intended use, and when a product is not reasonably safe a products liability action may be maintained. See Bradford v. Bendix-Westinghouse Automotive Air Brake Co., 33 Colo.App. 99, 517 P.2d 406 (1973); accord, e.g., Atkins v. American Motors Corp., 335 So.2d 134 (Ala.1976); Putensen v. Clay Adams, Inc., 12 Cal.App.3d 1062, 91 Cal. Rptr. 319 (1970); Owens v. Allis-Chalmers Corp., 414 Mich. 413, 326 N.W.2d 372 (1982); Nesselrode v. Executive Beechcraft, Inc., 707 S.W.2d 371 (Mo.1986); O’Brien v. Muskin Corp., 94 N.J. 169, 463 A.2d 298 (1983); Voss v. Black & Decker Mfg. Co., 59 N.Y.2d 102, 463 N.Y.S.2d 398, 450 N.E.2d 204 (1983); Phillips v. Kimwood Mach. Co., 269 Or. 485, 525 P.2d 1033 (1974); Azzarello v. Black Bros. Co., 480 Pa. 547, 391 A.2d 1020 (1978); Galvan v. Prosser Packers, Inc., 83 Wash.2d 690, 521 P.2d 929 (1974); see also W. Prosser The Law of Torts § 96 at 641, 644-45 (4th ed. 1971) (Dean Prosser, Reporter for Restatement (Second) of Torts § 402A, noting that the basis of strict liability for design defects is that reasonable care must be used to design a product that is reasonably safe for its intended or foreseeable uses). Of course, whether a given product is reasonably safe and, therefore, not unreasonably dangerous, necessarily depends upon many circumstances. Any test, therefore, to determine whether a particular product is or is not actionable must consider several factors. While reference to “reasonable” or “unreasonable” standards introduces certain negligence concepts into an area designed to be free from those concepts, e.g., Barker v. Lull Eng’g Co., 20 Cal.3d 413, 143 Cal.Rptr. 225, 573 P.2d 443 (1978); Turner v. General Motors Corp., 584 S.W.2d 844 (Tex.1979); see generally J. Beasley, Products Liability and the Unreasonably Dangerous Requirement 21-*124635, 72-94 (1981); Birnbaum, Unmasking the Test for Design Defect: From Negligence [to Warranty] to Strict Liability to Negligence, 33 Vand.L.Rev. 593 (1980), that difficulty is much less troublesome than are the problems inherent in attempting to avoid dealing with the competing interests always involved in allocating the risk of loss in products liability actions, see generally W.P. Keeton, D. Dobbs, R. Keeton & D. Owen, Prosser and Keeton on the Law of Torts § 99 (5th ed. 1984); Wade, On Product “Design Defects” and Their Ac-tionability, 33 Vand.L.Rev. 551, 570-71 (1980). In this regard, comment c to section 402A contains the following pertinent observations:

c. On whatever theory, the justification for the strict liability has been said to be that the seller, by marketing his product for use and consumption, has undertaken and assumed a special responsibility toward any member of the consuming public who may be injured by it; that the public has the right to and does expect, in the case of products which it needs and for which it is forced to rely upon the seller, that reputable sellers will stand behind their goods; that public policy demands that the burden of accidental injuries caused by products intended for consumption be placed upon those who market them, and be treated as a cost of production against which liability insurance can be obtained; and that the consumer of such products is entitled to the maximum of protection at the hands of someone, and the proper persons to afford it are those who market the products.

These considerations strongly suggest that the consumer contemplation concept embodied in comment i, while illustrative of a particular problem, does not provide a satisfactory test for determining whether particular products are in a defective condition unreasonably dangerous to the user or consumer. In the final analysis, the principle of products liability contemplated by section 402A is premised upon the concept of enterprise liability for casting defective products into the stream of commerce. Jackson v. Harsco Corp., 673 P.2d 363 (Colo.1983). The primary focus must remain upon the nature of the product under all relevant circumstances rather than upon the conduct of either the consumer or the manufacturer. Smith v. Home Light & Power Co., 734 P.2d 1051; Jackson v. Harsco Cop., 673 P.2d 363; Bradford v. Bendix-Westinghouse Automotive Air Brake Co., 33 Colo.App. 99, 517 P.2d 406; Wade, On Product “Design Defects” and Their Actionability, 33 Vand.L. Rev. 551 (1980). Total reliance upon the hypothetical ordinary consumer’s contemplation of an obvious danger diverts the appropriate focus and may thereby result in a finding that a product is not defective even though the product may easily have been designed to be much safer at little added expense and no impairment of utility.7 W.P. Keeton, D. Dobbs, R. Keeton & D. Owen, Prosser and Keeton on The Law of Torts § 99 at 66 (5th ed. 1984). Uncritical rejection of design defect claims in all cases wherein the danger may be open and obvious thus contravenes sound public policy by encouraging design strategies which perpetuate the manufacture of dangerous products. Union Supply Co. v. Pust, 196 Colo. 162, 583 P.2d 276; accord, e.g., McGowne v. Challenge-Cook Bros., Inc., 672 F.2d 652 (8th Cir.1982) (applying Missouri Law); Davis v. Fox River Tractor Co., 518 F.2d 481 (10th Cir.1975) (applying Oklahoma law); Beloit Corp. v. Harrell, 339 So.2d 992 (Ala.1976); Byrns v. Riddell, Inc., 113 Ariz. 264, 550 P.2d 1065 (1976); Auburn Mach. Works Co. v. Jones, 366 So.2d 1167 (Fla.1979); Siruta v. Hesston Corp., 232 Kan. 654, 659 P.2d 799 (1983); Holm v. Sponco Mfg., Inc., 324 N.W.2d 207 (Minn.1982).

In Ortho Pharmaceutical Corp. v. Heath, 722 P.2d 410 (Colo.1986), we recently recognized that exclusive reliance upon con*1247sumer expectations is a particularly inappropriate means of determining whether a product is unreasonably dangerous under section 402A where both the unreasonableness of the danger in the design defect and the efficacy of alternative designs in achieving a reasonable degree of safety must be defined primarily by technical, scientific information.8 Moreover, manufacturers of such complex products as motor vehicles invariably have greater access than do ordinary consumers to the information necessary to reach informed decisions concerning the efficacy of potential safety measures. Harris, Enhanced Injury Theory: An Analytical Framework, 62 N.C.L.Rev. 643, 675 (1984). The principles that have evolved in the law of products liability have in part been developed to encourage manufacturers to use information gleaned from testing, inspection and data analysis to help avoid the “massive problem of product accidents.” Palmer v. A.H. Robins Co, Inc., 684 P.2d 187 (Colo.1984) (quoting Owen, Punitive Damages in Products Liability Litigation, 74 Mich.L.Rev. 1257, 1258 (1976)).

A product may be unreasonably dangerous due to a manufacturing defect, a design defect or a failure to warn. See generally Walkowiak, Reconsidering Plaintiff’s Fault in Product Liability Litigation: The Proposed Conscious Design Choice Exception, 33 Vand.L.Rev. 651, 654-56 (1980). The question in manufacturing defect cases is whether the product as produced conformed with the manufacturer’s specifications. Id. Resolution of whether a particular product is unreasonably dangerous is more difficult in design defect or failure to warn cases, where the product has been manufactured exactly as intended. In Ortho we noted that the following factors are of value in balancing the attendant risks and benefits of a product to determine whether a product design is unreasonably dangerous:

(1) The usefulness and desirability of the product — its utility to the user and to the public as a whole.

(2) The safety aspects of the product— the likelihood that it will cause injury and the probable seriousness of the injury.

(3) The availability of a substitute product which would meet the same need and not be as unsafe.

(4) The manufacturer’s ability to eliminate the unsafe character of the product without impairing its usefulness or making it too expensive to maintain its utility.

(5) The user’s ability to avoid danger by the exercise of care in the use of the product.

(6) The user’s anticipated awareness of the dangers inherent in the product and their avoidability because of general public knowledge of the obvious condition of the product, or of the existence of suitable warnings or instructions.

(7) The feasibility, on the part of the manufacturer, of spreading the loss by *1248setting the price of the product or carrying liability insurance.

Ortho Pharmaceutical Corp. v. Heath, 722 P.2d 410, 414 (relying on Wade, On the Nature of Strict Tort Liability for Products, 44 Miss.L.J. 825, 837-38 (1973)). The factors enumerated in Ortho are applicable to the determination of what constitutes a product that is in a defective unreasonably dangerous condition. By examining and weighing the various interests represented by these factors, a trial court is much more likely to be fair to the interests of both manufacturers and consumers in determining the status of particular products.

The question of the status of the motorcycle purchased by Camacho involves in part the interpretation of mechanical engineering data derived from research and testing — interpretation which necessarily includes the application of scientific and technical principles. In addition, the question posed under the crashworthiness doctrine is not whether the vehicle was obviously unsafe but rather whether the degree of inherent dangerousness could or should have been significantly reduced. The record contains some evidence to support the conclusion that Honda could have provided crash bars at an acceptable cost without impairing the motorcycle’s utility or substantially altering its nature and Honda’s failure to do so rendered the vehicle unreasonably dangerous under the applicable danger-utility test. It is far from certain, however, that the ultimate answer to this question can be determined on the basis of the limited facts thus far presented to the trial court.

IV

Camacho also asserts that the failure to provide adequate warnings rendered the Honda Hawk, motorcycle in a defective condition unreasonably dangerous. A manufacturer may be strictly liable to the user of a product when failure to provide adequate warnings renders the product defective and unreasonably dangerous. Palmer v. A.H. Robins Co, Inc., 684 P.2d 187 (Colo.1984); Anderson v. Heron Eng’g Co., 198 Colo. 391, 604 P.2d 674 (1979). The purpose of a warning is to ensure that an otherwise dangerous product is used in a reasonably safe manner. Union Supply Co. v. Pust, 196 Colo. 162, 583 P.2d 276 (1978); Hiigel v. General Motors Corp., 190 Colo. 57, 544 P.2d 983 (1975); Bailey v. Montgomery Ward & Co., 690 P.2d 1280 (Colo.App.1984); Restatement (Second) of Torts section 402A comment j (1965). Presuming, without deciding, that the Honda motorcycle was unreasonably dangerous or was rendered unreasonably dangerous by a failure to warn, it is unclear on precisely what basis Camacho asserts that a warning would have rendered the product reasonably safe.9 Arguably, a warning that injury-reducing crash bars were available as optional equipment or as add-on equipment would render an otherwise unreasonably dangerous motorcycle reasonably safe. See, e.g., Wagner v. International Harvester Co., 611 F.2d 224, 231 (8th Cir.1979) (where motor vehicle could not be used as intended without a known risk of accidents involving rollovers, manufacturer’s duty to supply safe product would have been fulfilled if rollover protection offered as option); cf. Height v. Kawasaki Heavy Indus., Ltd., 190 NJ.Super. 7, 461 A.2d 757 (where motorcycle rider burned by gasoline sprayed from relief valve following collision, refusal to instruct on failure to warn proper in absence of proof that warning would have made fuel system safer or that plaintiff could have done anything to prevent his burns other than avoid collision), cert, denied, 94 N.J. 615, 468 A.2d 244 (1983). We conclude that the efficacy of providing a warning is an appropriate issue for further inquiry by the trial court on remand.

V

Under C.R.C.P. 56(c), summary judgment is proper only when there is no *1249genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law. E.g., Continental Airlines, Inc. v. Keenan, 731 P.2d 708 (Colo.1987); Huydts v. Dixon, 199 Colo. 260, 606 P.2d 1303 (1980). The moving party has the burden of establishing the nonexistence of a genuine issue of material fact. Urban v. Beloit Corp., 711 P.2d 685 (Colo.1985); Ginter v. Palmer & Co., 196 Colo. 203, 585 P.2d 583 (1978).

The Camachos proffered evidence that the Honda Hawk motorcycle could have been equipped with crash bars which would mitigate injuries in low-speed, angled-impact collisions such as the one in which Camacho was involved. The Camachos’ expert witnesses’ interpretation of research and testing data indicated that the maneuverability of the motorcycle could be retained by making the crash bars no wider than the handlebars, that the stability of the motorcycle could be retained by mounting the crash bars relatively close to the center of gravity and that the addition of crash bars would not impair the utility of the motorcyclp as a fuel efficient, open-air vehicle nor impair the safety of the motorcycle in accidents which varied in kind from the accident involving Camacho. These conclusions are all strenuously disputed by Honda. However, precisely because the factual conclusions reached by expert witnesses are in dispute, summary judgment as to whether the design strategies of Honda were reasonable is improper.10 Roberts v. May, 41 Colo.App. 82,583 P.2d 305 (1978).

The judgment is reversed, and the case is remanded to the Court of Appeals with directions to remand the case to the trial court for further proceedings consistent with the views expressed in this opinion.

VOLLACK, J., dissents.

ERICKSON and ROVIRA, JJ., join in the dissent.

VOLLACK, Justice, dissenting:

Because I believe that the court of appeals correctly affirmed the trial court’s order, I respectfully dissent.

The issue before the court is what test should apply in determining whether a product has a design defect causing it to be in a defective condition that is unreasonably dangerous. After arriving at the appropriate test, we must decide whether the court of appeals correctly affirmed the trial court’s summary judgment order. The underlying factual issue is whether a manufacturer’s failure to equip a motorcycle with crash bars or other leg protection devices is a design defect that renders the motorcycle in a defective condition unreasonably dangerous.

I.

Although some jurisdictions have deleted the “unreasonably dangerous” language, Colorado has expressly retained it. Union Supply Co. v. Pust, 196 Colo. 162,171 n. 5, 583 P.2d 276, 282 n. 5 (1978); Pothoff v. Alms, 41 Colo.App. 51, 53, 583 P.2d 309, 311 (1978). A plaintiff must prove “that a product was both ‘defective’ and ‘unreasonably dangerous’ in order to sustain a cause of action in strict liability under section 402A.” Kysor Indus. Corp. v. Frazier, 642 P.2d 908, 911 (Colo.1982).

II.

We have not before decided what test should apply in determining whether a product is “unreasonably dangerous” in a design defect case. I believe the appropri*1250ate test is defined in Restatement (Second) of Torts § 402A comment i (1965). Comment i states: “The article sold must be dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its characteristics” [hereinafter the consumer contemplation test].

Some jurisdictions have adopted this test; others have adopted it in part or rejected it. See Nichols v. Union Underwear Co., 602 S.W.2d 429 (Ky.1980) (“Some seventeen jurisdictions adhere to this rule, eighteen have repudiated it, and sixteen, including Kentucky, have not addressed the issue.” Id. at 432).

Some states using this test are the following:

Illinois applies a “consumer expectation” test whereby a defective condition of a product will be considered “unreasonably dangerous” when it is “dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its characteristics.”

Riordan v. International Armament Corp., 132 Ill.App.3d 642, 650, 87 Ill.Dec. 765, 770, 477 N.E.2d 1293, 1298 (1985); Barnes v. Vega Indus., Inc., 234 Kan. 1012, 676 P.2d 761 (1984) (trial court did not err in giving jury instruction defining unreasonably dangerous in accord with the comment i consumer expectation test); Willamette Essential Oils v. Herrold & Jensen, 68 Or.App. 401, 683 P.2d 1374 (1984) (discussing Oregon’s Uniform Jury Instruction, which states: “ ‘A product may be shown to be defective by proof of one (or more) of the following: ... 1. A defect in manufacture; 2. A defective design; 3. Failure to perform safely under circumstances in which, from common knowledge, the average user reasonably could have expected the product to perform safely.’” Id. 683 P.2d at 1377); Seattle-First Nat’l Bank v. Tabert, 86 Wash.2d 145,154, 542 P.2d 774, 779 (1975) (defective product not reasonably safe in products liability “means that it must be unsafe to an extent beyond that which would be reasonably contemplated by the ordinary consumer.”).

Other jurisdictions have adopted a variation of the consumer expectation test. Dart v. Wiebe Mfg., Inc., 147 Ariz. 242, 709 P.2d 876 (1985) (where consumer expectation test is sufficient to resolve a case, that test is to be used; where that test “fails to provide a complete answer,” application of risk/benefit factors is appropriate. 147 Ariz. at 245-46, 709 P.2d at 879-80); Nichols v. Union Underwear Co., 602 S.W.2d 429 (Ky.1980) (consumer expectation or knowledge is just one factor to be considered by a jury in determining whether a product is unreasonably dangerous. Id. at 433); Knitz v. Minster Machine Co., 69 Ohio St.2d 460, 432 N.E.2d 814 (1982) (product is of defective design “if (1) it is more dangerous than an ordinary consumer would expect when used in an intended or reasonably foreseeable manner, or (2) if the benefits of the challenged design do not outweigh the risk inherent in such design.” Id. at 466, 432 N.E.2d at 818).

Other states have rejected the consumer expectation test. Prentis v. Yale Mfg. Co., 421 Mich. 670, 365 N.W.2d 176 (1984) (“[W]e adopt, forthrightly, a pure negligence, risk-utility test in products liability actions against manufacturers of products, where liability is predicated upon defective design.” Id. at 691, 365 N.W.2d at 186); Turner v. General Motors Corp., 584 S.W.2d 844 (Tex.1979) (risk-utility test will be applied “when the considerations of utility and risk are present in the state of the evidence.” Id. at 851).

III.

The Colorado Court of Appeals has held that in a strict liability case the focus is “on the product itself and the consumer’s expectations with regard to that product.” Bradford v. Bendix-Westinghouse Automotive Air Brake Co., 33 Colo.App. 99, 110, 517 P.2d 406, 413 (1974). In a products liability action against a brake pedal manufacturer, the court applied the language of section 402A comment i: “[A] product is ‘unreasonably dangerous’ if it is *1251dangerous ‘to an extent beyond that which would be contemplated by the ordinary consumer who purchases it....”’ Id.

In Curtis v. General Motors Corp., the Tenth Circuit Court of Appeals applied Colorado law in a case involving an automobile manufacturer’s alleged failure to provide adequate roll-over protection. 649 F.2d 808 (10th Cir.1981). The Tenth Circuit held that when a strict liability claim is predicated on a manufacturer’s failure to install an added safety device, “liability will not attach simply because a feasible alternative would have rendered the product safer.” 649 F.2d at 811, applied in Davis v. Caterpillar Tractor Co., 719 P.2d 324, 327 (Colo.App.1985).

The cases discussed demonstrate that states have taken a variety of approaches to resolve this question. Because of the nature of the product here, I believe the appropriate test is the consumer contemplation or consumer expectation test. The facts presented in this case differ from cases which involve the defective condition of products such as automobile brakes, prescription drugs, and gas tanks. With those types of products, the ordinary consumer is not capable of assessing the danger of the product. On the other hand, an ordinary consumer is necessarily aware that motorcycles can be dangerous. The plaintiff had the choice to purchase other motorcycles by other manufacturers which carried additional safety features, and instead elected to purchase this particular motorcycle and ride it without leg protection devices. The conclusion follows that the trial court’s ruling and the court of appeals’ decision were correct.

IV.

I believe the majority errs in applying the “crashworthiness” or “second collision” test to these facts. The “crashworthiness” test goes to injuries “usually caused by the so-called ‘second collision’ of the passenger with the interior part of the automobile, [which] are foreseeable.” Larsen v. General Motors Corp., 391 F.2d 495 (8th Cir. 1968), quoted in Roberts v. May, 41 Colo. App. 82, 85, 583 P.2d 305, 308 (1978). This case does not involve additional or enhanced injuries suffered by the plaintiff’s impact or “second collision” with the motorcycle itself.

I also believe the majority incorrectly relies on Ortho Pharmaceutical Corp. v. Heath, 722 P.2d 410 (Colo.1986). I believe the risk-benefit test cited by the majority and applied in Ortho is an appropriate test for products such as drugs, because their danger “is defined primarily by technical, scientific information,” and because some drugs are unavoidably unsafe in some respect. Id. at 414. A consumer of drugs cannot realistically be expected to foresee dangers in prescribed drugs which even scientists find to be complex and unpredictable. On the other hand, the purchaser of a motorcycle knows that the purchase and use of “an economical, open-air, maneuverable form of transportation,” maj. op. at 1247, n. 8, presents the risk of accidents and resulting injuries due to the open-air nature of the motorcycle.

Because I believe that the correct test under facts such as these is the consumer-contemplation test, I would affirm the court of appeals’ decision. Accordingly, I respectfully dissent.

I am authorized to state that Justice ERICKSON and Justice ROVIRA join in this dissent.

Affirmed by published opinion. Chief Judge WILKINSON wrote the opinion, in which Judge WIDENER and Judge KING joined.

OPINION

WILKINSON, Chief Judge:

Wilson M. Hood lost part of his thumb and lacerated his leg when he removed the blade guards from his new Ryobi miter saw and then used the unguarded saw for home carpentry. Hood sued Ryobi, alleging that the company failed adequately to warn of the saw’s dangers and that the saw was defective. Applying Maryland products liability law, the district court granted summary judgment to Ryobi on all claims.

The saw and owner’s manual bore at least seven clear, simple warnings not to operate the tool with the blade guards removed. The warnings were not required to spell out all the consequences of improper use. Nor was the saw defective — Hood altered and used the tool in violation of Ryobi’s clear warnings. Thus we affirm the judgment.

I.

Hood purchased a Ryobi TS-254 miter saw in Westminster, Maryland on February 25, 1995, for the purpose of performing home repairs. The saw was fully assembled at the time of purchase. It had a ten-inch diameter blade mounted on a rotating spindle controlled by a finger trigger on a handle near the top of the blade. To operate the saw, the consumer would use that handle to lower the blade through the material being cut.

Two blade guards shielded nearly the entire saw blade. A large metal guard, fixed to the frame of the saw, surrounded the upper half of the blade. A transparent plastic lower guard covered the rest of the blade and retracted into the upper guard as the saw came into contact with the work piece.

A number of warnings in the operator’s manual and affixed to the saw itself stated that the user should operate the saw only with the blade guards in place. For example, the owner’s manual declared that the user should “KEEP GUARDS IN PLACE” and warned: “ALWAYS USE THE SAW BLADE GUARD. Never operate the machine with the guard removed”; “NEVER operate this saw without all guards in place and in good operating condition”; and “WARNING: TO PREVENT POSSIBLE SERIOUS PERSONAL INJURY,NEVER PERFORM ANY CUTTING OPERATION WITH THE UPPER OR LOWER BLADE GUARD REMOVED.” The saw itself carried several decals stating “DANGER: DO NOT REMOVE ANY *610GUARD. USE OF SAW WITHOUT THIS GUARD WILL RESULT IN SERIOUS INJURY”; . “OPERATE ONLY WITH GUARDS IN PLACE”; and “WARNING ... DO NOT operate saw without the upper and lower guards in place.”

The day after his purchase, Hood began working with the saw in his driveway. While attempting to cut a piece of wood approximately four inches in height Hood found that the blade guards prevented the saw blade from passing completely through the piece. Disregarding the manufacturer’s warnings, Hood decided to remove the blade guards from the saw. Hood first detached the saw blade from its spindle. He then unscrewed the four screws that held the blade guard assembly to the frame of the saw. Finally, he replaced the blade onto the bare spindle and completed his cut.

Rather than replacing the blade guards, Hood continued to work with the saw blade exposed. He worked in this fashion for about twenty minutes longer when, in the middle of another cut, the spinning saw blade flew off the saw and back toward Hood. The blade partially amputated his left thumb and lacerated his right leg.

Hood admits that he read the owner’s manual and most of the warning labels on the saw before he began his work. He claims, however,.that he believed the blade guards were intended solely to prevent a user’s clothing or fingers from coming into contact with the saw. blade. He contends that he was unaware that removing the blade guards would permit the spinning blade to detach from the saw. But Ryobi, he claims, was aware of that possibility. In fact, another customer had sued Ryobi after suffering a similar accident in the mid-1980s.

On December 5, 1997, Hood sued several divisions of Ryobi in the United States District Court for the District of Maryland. Hood raised claims of failure to warn and defective design under several theories of liability. On cross-motions for summary judgment the district court entered judgment for the defendants on all claims, finding that in the face of adequate warnings Hood had altered the saw and caused his own injury. Hood v. Ryobi N. Am., Inc., 17 F.Supp.2d 448 (D.Md.1998). Hood appeals.

II.

A manufacturer may be liable for placing a product on the market that bears inadequate instructions and warnings or that is defective in design. Moran v. Faberge, Inc., 273 Md. 538, 332 A.2d 11, 15 (1975); Simpson v. Standard Container Co., 72 Md.App. 199, 527 A.2d 1337, 1339-40 (Ct.Spec.App.1987). Hood asserts that Ryobi failed adequatély to warn of the dangers of using the saw without the blade guards in place. Hood also contends that the design of the saw was defective. We disagree on both counts.1

A.

Hood first complains that the warnings he received were insufficiently specific. Hood admits that Ryobi provided'several clear and conspicuous warnings not to operate the saw without the blade guards. He contends, however, that the warnings affixed to the product and displayed in the operator’s manual were inadequate to alert him to the dangers of doing so. In addition to Ryobi’s directive “never” to operate a guardless saw, Hood would require the company to inform of the actual consequences of such conduct. Specifically, Hood contends that an adequate warning would have explained that removing the guards would lead to blade detachment.

We disagree. Maryland does not require an encyclopedic warning. Instead, “a warning need only be one that is rea*611sonable under the circumstances.” Levin v. Walter Kidde & Co., 251 Md. 560, 248 A.2d 151, 153 (1968). A clear and specific warning will normally be sufficient — “the manufacturer need not warn of every mishap or source of injury that the mind can imagine flowing from the product.” Liesener v. Weslo, Inc., 775 F.Supp. 857, 861 (D.Md.1991); see Levin, 248 A.2d at 154 (declining to require warning of the danger that a cracked syphon bottle might explode and holding “never use cracked bottle” to be adequate as a matter of law). In deciding whether a warning is adequate, Maryland law asks whether the benefits of a more detailed warning outweigh the costs of requiring the change. Moran, 332 A.2d at 15.

Hood assumes that the cost of a more detailed warning label is minimal in this case, and he claims that such a warning would have prevented his injury. But the price of more detailed warnings is greater than their additional printing fees alone. Some commentators have observed that the proliferation of label detail threatens to undermine the effectiveness of warnings altogether. See James A. Henderson, Jr. & Aaron D. Twerski, Doctrinal Collapse in Products Liability: The Empty Shell of Failure to Warn, 65 N.Y.U. L.Rev. 265, 296-97 (1990). As manufacturers append line after line onto product labels in the quest for the best possible warning, it is easy to lose sight of the label’s communicative value as a whole. Well-meaning attempts to warn of every possible accident lead over time to voluminous yet impenetrable labels — too prolix to read and too technical to understand.

By contrast, Ryobi’s warnings are clear and unequivocal. Three labels on the saw itself and at least four warnings in the owner’s manual direct the user not to operate the saw with the blade guards removed. Two declare that “serious injury” could result from doing so. This is not a case where the manufacturer has failed to include any warnings at all with its product. See Moran, 332 A.2d at 13-14. Ryobi provided warnings sufficient to apprise the ordinary consumer that it is unsafe to operate a guardless saw — warnings which, if followed, would have prevented the injury in this case.

It is apparent, moreover, that the vast majority of consumers do not detach this critical safety feature before using this type of saw. Indeed, although Ryobi claims to have sold thousands of these saws, Hood has identified only one fifteen-year-old incident similar to his. Hood has thus not shown that these clear, unmistakable, and prominent warnings are insufficient to accomplish their purpose. Nor can he prove that increased label clutter would bring any net societal benefit. We hold that the warnings Ryobi provided are adequate as a matter of law.

B.

Hood’s defective design claim is likewise unpersuasive. Hood’s injuries were the direct result of the alterations he made to the saw — alterations that directly contravened clear, unambiguous warnings. And such alterations defeat a claim of design defect.2

This rule has been expressed alternatively as one of duty and one of causation. First, a manufacturer is only required to design a product that is safe for its reasonably foreseeable uses. If that duty is met, the product is simply not defective. Banks v. Iron Hustler Corp., *612475 A.2d 1243, 1255 (Md.Ct.Spec.App.1984). Second, if a consumer alters a product in a way that creates a defect, the consumer’s conduct rather than the manufacturer’s is the proximate cause of any ensuing accident. See id. at 1253-55; Singleton v. Manitowoc Co., 727 F.Supp. 217, 222 (D.Md.1989), aff'd, 931 F.2d 887 (4th Cir.1991) (table). Under either rationale, a post-sale product alteration will defeat a design defect claim if that alteration leads directly to the plaintiffs injury.

Hood admits that he altered the table saw by removing the blade guards from the unit’s frame, and he acknowledges that the alteration led directly to his injuries. Hood asserts, however, that Ryobi should have foreseen that consumers might operate its saws with the guards removed. Hood notes that the operation of equipment without safety guards is a frequently cited OSHA violation. And, as noted, Ryobi itself has faced litigation on one other occasion for the same type of accident that befell Hood. In short, Hood contends that Ryobi should have designed its saw to operate equally well with the guards in place or removed.

We disagree. Maryland imposes no duty to predict that a consumer will violate clear, easily understandable safety warnings such as those Ryobi included with this product. For example, a manufacturer need not foresee that a consumer might store a gasoline can in his basement in contravention of clear warning labels. Simpson, 527 A.2d at 1341 (“ ‘Where warning is given, the seller may reasonably assume that it will be read and heeded; and a product bearing such a warning, which is safe for use if it is followed, is not in defective condition, nor is it unreasonably dangerous.’” (quoting Restatement (Second) of Torts § 402A cmt. j)). Nor must a manufacturer foresee that a worker will shove his arm into a conveyor machine to repair it without first shutting the machine down, again in violation of “explicit written warnings.” Kline v. ABCO Engineering Corp., 991 F.Supp. 747, 750-51 (D.Md.1997). When a consumer injures himself by using a product — or, as in this case, by altering it — in violation of clear, unmistakable, and easy-to-follow warnings, it is the consumer’s own conduct that causes the injury. Id.; see Higgins v. E.I. DuPont de Nemours & Co., 863 F.2d 1162, 1167-68 (4th Cir.1988). The manufacturer is not liable under a design defect theory.

We recognize that the American Law Institute has recently underscored the concern that comment j of the Second Restatement, read literally, would permit a manufacturer of a dangerously defective product to immunize itself from liability merely by slapping warning labels on that product. See Restatement (Third) of Torts: Prod. Liab. § 2 cmt. 1 & Reporter’s Note. We are all afflicted with lapses of attention; warnings aimed simply at avoiding consumer carelessness should not absolve a manufacturer of the duty to design reasonable safeguards for its products. See id. cmt. 1, illus. 14 (when warning could not eliminate the possibility of accidental contact with a dangerous shear point, decal declaring “keep hands and feet away” does not bar a design defect claim).

The Maryland courts have already made clear, however, that warnings will not inevitably defeat liability for a product’s defective design. See Klein v. Sears, Roebuck & Co., 92 Md.App. 477, 608 A.2d 1276, 1282-83 (Ct.Spec.App.1992) (such warnings as “never leave tool running unattended” and “do not place fingers or hands in the path of the saw blade” are too vague to defeat manufacturer’s liability for failing to include blade guards on its saws). Maryland has thus sought to encourage manufacturers to rid their products of traps for the unwary, while declining to hold them responsible for affirmative consumer misuse.

This case involves much more than a consumer’s inevitable inattention. Rather, Hood took affirmative steps to remove the safety, guards from his saw and — in contravention of warnings which were “clear, *613direct, simple, unequivocal!], unmistakable, definite, and easy to understand and obey” — then used the saw to cut several pieces of wood. Klein, 608 A.2d at 1282. Hood’s own conduct thus caused his injury and defeats any claim that the saw is defective in design.

III.

Warned never to operate his miter saw without the blade guards in place, Hood nonetheless chose to detach those guards and run the saw in a disassembled condition. We hold that Ryobi is not hable for Hood’s resulting injuries under any of the theories of recovery raised here. The judgment of the district court is therefore

AFFIRMED.

ORDER

CONWAY, District Judge.

I. INTRODUCTION

This is a product liability/personal injury case. Plaintiffs Arnaldo Medina and his wife, Luz Lopez, sue Defendants Louisville Ladder, Inc. and Home Depot U.S.A., Inc., for injuries Medina suffered when he fell from a wooden attic ladder and impacted his elbow. Louisville Ladder manufactured the ladder; Home Depot sold it to Medina. The Complaint asserts theories of strict product liability and negligence. Additionally, the pleading advances a loss of consortium claim on behalf of Luz Lopez.

The Defendants seek summary judgment. Additionally, they have filed a motion in limine requesting exclusion, on Daubert1 grounds, of the testimony of the *1326Plaintiffs’ liability expert, Donald Fournier. After carefully considering the parties’ submissions, and following a Daubert hearing, the Court concludes that both motions are due to be granted.

II. BACKGROUND

The product involved in the accident is an 11 -step, ceiling-mounted wooden attic ladder, designated as Model L224P. The ladder has a rated load capacity of 250 pounds. It consists of three separate sections that are attached with steel hinges, thereby allowing the product to fold up. Louisville Ladder manufactured the ladder in December 2004. Home Depot sold it to Medina in the Spring of 2005. The point of sale was Osceola County, Florida. The ladder carried a warning label in English and was supplied with an English-only instruction manual.

After he bought the ladder, Medina says he was going to try to install it himself, but he noticed that the installation instructions were in English. Medina has, at best, a very limited ability to read English. Medina hired a local handyman, Ismael Gonzales, to help him install the ladder. Apparently, Gonzales also cannot read English very well, or at all. In any event, neither man read the installation instructions. Medina and Gonzales improperly installed the ladder in that they failed to trim its legs as directed in the installation instructions. Consequently, the legs were not flush with the floor, and gaps existed at the ladder’s joints. Prior to the accident, Medina and his sons used the ladder 25-40 times without incident. On January 2, 2006, while Medina was on the ladder, the ladder collapsed and Medina fell to the floor, injuring his elbow. Upon inspection, it was discovered that the bottom folding section of the ladder had separated from the middle section, and the rivets securing the hinges connecting the bottom and middle sections had failed.

The gravamen of the Complaint is that the ladder was defective because it lacked warnings and instructions in Spanish, and that the Defendants were negligent in failing to include warnings and instructions in that language. At the Daubert hearing, Plaintiffs’ counsel conceded that the entire case stands or falls on the issue of whether the Defendants were legally obligated to furnish Spanish warnings and instructions.

III. DEFENDANTS’ MOTION IN LIMINE

Donald Fournier is a mechanical engineer.2 Plaintiffs offer the following summary of Mr. Fournier’s opinions regarding warnings and instructions:

(1) Louisville Ladder should have provided dual language instructions and warnings [for the] L224P ladder; (2) Louisville Ladder failed to provide Spanish language instructions despite the known fact that Orlando and Kissimmee have [a] large Hispanic population, many of whom do not read English; (3)[the] L224P is marketed and sold directly to [the] public, and it is foreseeable that consumers will not know to trim the legs of the ladder absent clear bilingual warnings and instructions; (4) hence, [there is a] greater duty [on] the ladder manufacturer(s) to indicate in an understandable way the importance of the critical assembly step.

Doc. 47 at 6 (alterations added). The Defendants seek exclusion of Fournier’s opinions on these subjects on the asserted basis that Fournier is not qualified as a warnings expert and his views regarding bilingual instructions are unreliable. This Court agrees on both points.

*1327In evaluating the admissibility of expert testimony, trial courts must consider whether

(1)the expert is qualified to testify competently regarding the matters he [or she] intends to address; (2) the methodology by which the expert reaches his [or her] conclusions is sufficiently reliable as determined by the sort of inquiry mandated in Daubert; and (3) the testimony assists the trier of fact, through the application of scientific, technical, or specialized expertise, to understand the evidence or to determine a fact in issue.

United States v. Abreu, 406 F.3d 1304, 1306 (11th Cir.2005) (alterations added) (quoting United States v. Frazier, 387 F.3d 1244, 1260 (11th Cir.2004)).

Regarding the second criterion, “[t]o assess the reliability of an expert opinion, the court considers a number of factors, including those listed by the Supreme Court in Daubert:

(1) whether the expert’s theory can be and has been tested;

(2) whether the theory has been subjected to peer review and publication;

(3) the known or potential rate of error of the particular scientific technique; and

(4) whether the technique is generally accepted in the scientific community.”

Abreu, 406 F.3d at 1306-07 (quoting Frazier, 387 F.3d at 1262). However, these listed factors “are only illustrative and may not all apply in every case.” Id. at 1307 (citing Frazier). In any event, “[t]he district court has wide latitude in deciding how to determine reliability.” Id.

Mr. Fournier is not qualified to render opinions regarding product warnings or bilingual instructions. As the Defendants note, Fournier “has no material background in warnings related to consumer products in general, or ladders in particular. The subject of warnings is not even mentioned in Mr. Fournier’s resume.” Doc. 37 at 15. Moreover, Fournier “has never written any articles on the subject of warnings, nor has he prepared an on-product warning or manual for any product which was sold commercially.” Id. Further, it does not appear he has ever been court-qualified as an expert regarding the specific subject of warning adequacy. Given these circumstances, the Court determines that Fournier cannot testify regarding the adequacy of the product warnings in this case. See Johnson v. Manitowoc Boom Trucks, Inc., 406 F.Supp.2d 852, 867 (M.D.Tenn.2005) (excluding expert’s testimony based on lack of qualifications regarding warnings), aff'd, 484 F.3d 426 (6th Cir.2007).

Similarly, the Plaintiffs have not demonstrated that Fournier has any experience regarding the necessity for Spanish-language instructions. At his deposition, Fournier could not recall ever evaluating the issue of bilingual instructions for a consumer product prior to being retained as an expert in the present case. Accordingly, Fournier’s testimony regarding bilingual warnings and instructions fails Daubert’s qualification prong.3

For largely the same reasons, Fournier’s opinions regarding bilingual warnings and instructions are unreliable. Fournier has not employed any reliable scientific- or experience-based methodology in arriving at his conclusions that Spanish-language instructions and warnings were necessary. Fournier’s conclusions were developed solely for this case, have not been peer-reviewed, and are not generally accepted. As defense counsel pointed *1328out at the Daubert hearing, the generalized, largely self-study approach Fournier took in reaching his conclusions is not the sort of thing that lends itself to a finding of reliability. For these reasons, too, Fournier’s opinions regarding bilingual instructions and warnings do not pass Daubert muster.4

Based on the foregoing, the Court concludes that Fournier’s expert testimony is inadmissible.

IV. DEFENDANTS’ SUMMARY JUDGMENT MOTION

A. Summary Judgment Standard

A motion for summary judgment should be granted when “the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law.” Fed.R.Civ.P. 56(c). “The party seeking summary judgment bears the initial burden of identifying for the district court those portions of the record ‘which it believes demonstrate the absence of a genuine issue of material fact.’ ” Cohen v. United Am. Bank of Cent. Fla., 83 F.3d 1347, 1349 (11th Cir.1996) (quoting Cox v. Adm’r U.S. Steel & Carnegie, 17 F.3d 1386, 1396, modified on other grounds, 30 F.3d 1347 (11th Cir.1994)). “There is no genuine issue for trial unless the non-moving party establishes, through the record presented to the court, that it is able to prove evidence sufficient for a jury to return a verdict in its favor.” Cohen, 83 F.3d at 1349. The Court considers the evidence and all inferences drawn therefrom in the light most favorable to the non-moving party. See Hairston v. Gainesville Sun Pub. Co., 9 F.3d 913, 918 (11th Cir.1993).

B. Analysis

As previously noted, Plaintiffs’ entire case rests on the premise that the Defendants had a legal obligation to provide Spanish-language warnings and instructions with the subject ladder. As support for that proposition, Plaintiffs rely on the case of Stanley Indus., Inc. v. W.M. Barr & Co., Inc., 784 F.Supp. 1570 (S.D.Fla.1992).5

Stanley arose from a fire at an industrial plant, allegedly caused by the spontaneous combustion of rags soaked in linseed oil. The two employees who used the linseed oil were brothers from Nicaragua. Their primary language was Spanish. The labeling on the linseed oil can was in English. “Both employees testified that they would have sought more information on how to use the product if the label contained warnings in Spanish concerning the flammability of the product.” 784 F.Supp. at 1573. Prior to the date of the fire, the defendants, acting cooperatively, regularly and actively advertised in Spanish in the Miami market. Additionally, the retailer (ironically, Home Depot) “employed a translator service to convert English instructions to Spanish for several of its product lines, including between forty and seventy products, which it marketed with bilingual instructions.” Id.

*1329The property owner sued Home Depot and the manufacturer of the linseed oil (Barr), asserting claims of negligent failure to warn, strict liability, and breach of warranty of fitness for a particular purpose. The inadequate warning theory was premised on the notion, among others, that

the language on the backside of the product label was in English only and contained no pictographs or symbols, and therefore was inadequate to fairly, appropriately and comprehensively warn Spanish-speaking, monolingual product users of the dangers likely to be encountered with the product’s use[,] especially the dangers associated with the risk of fire due to spontaneous combustion in linseed oil soaked rags.

Id. (alteration added). The defendants sought summary on causation grounds.

Judge Moreno of the Southern District determined as a threshold matter that issues regarding warning adequacy and proximate cause were “inextricably intertwined.” Id. at 1574. Turning to the adequacy issue, Judge Moreno began by noting: “The issue of adequacy of a warning that does not include multilingual warnings or universally accepted pictographs or symbols, in view of defendants’ active marketing of their products in the Hispanic media in the Miami market, is a question of first impression in this district.” Id. at 1575. After observing that under Florida law warning adequacy issues “are for the jury to resolve,” Judge Moreno discussed, and deemed analogous, two non-Florida warnings cases, Hubbard-Hall Chem. Co. v. Silverman, 340 F.2d 402 (1st Cir.1965), and Campos v. Firestone Tire & Rubber Co., 98 N.J. 198, 485 A.2d 305 (1984), superseded by statute as stated in Dewey v. R.J. Reynolds Tobacco Co., 121 N.J. 69, 577 A.2d 1239, 1253 (1990). Citing “the defendants’ joint advertising in Miami’s Hispanic media and the nature of the product,” and the fact that “a large portion of the unskilled or semi-skilled Miami workforce is comprised of foreign nationals whose native tongue is not English,” Judge Moreno then concluded that genuine issues of material fact existed regarding “the adequacy of the warning label, the duty to warn and proximate cause[.]” Stanley, 784 F.Supp. at 1575-76. On the specific subject of warning adequacy, Judge Moreno stated: “Given the advertising of defendants’ product in the Hispanic media and the pervasive presence of foreign-tongued individuals in the Miami workforce, it is for the jury to decide whether a warning, to be adequate, must contain language other than English or pictorial warning symbols.” Id. at 1576.

Respectfully, this Court disagrees with Stanley and declines to follow it. On the issue of whether bilingual instructions may be necessary in Florida, the decision represents isolated precedent. According to Westlaw, in the more than 15 years since Stanley was decided, not a single published Florida case (state or federal) has relied on the decision to conclude that bilingual warnings and instructions may be necessary under Florida law. According to the same database, no published Florida decisions (state or federal) have relied on Hubbard-Hall or Campos, the cases cited in Stanley, for that purpose, either.

More fundamentally, there is no indication that Florida law imposes a duty on manufacturers and sellers to provide bilingual warnings on consumer products, and this Court is unwilling to extend the concept of duty that far. Similarly, apart from Stanley, there is no indication that a product may be found unreasonably dangerous under Florida law merely because it lacks bilingual warnings and instructions. Again, this Court is unwilling to extend the bounds of strict product liability law and negligence that far. Further, the Court is unpersuaded that the circumstances Plaintiffs rely on to bring their *1330case within the ambit of Stanley- — that Home Depot advertises in Spanish in a state having a roughly 20% Hispanic population, that its store aisle-ways have English and Spanish signs, and that Louisville Ladder provides bilingual instructions to assemblers and purchasers in other countries — mandate a different conclusion.

In sum, Plaintiffs have not presented evidence from which a reasonable jury could conclude that the subject ladder was unreasonably dangerous, or that the Defendants were negligent. Additionally, by virtue of the exclusion of Mr. Fournier’s opinions, there is insufficient evidence to survive summary judgment on the issue of causation, i.e., whether the ladder failed due to improper installation.6

V. CONCLUSION

Based on the foregoing, it is ORDERED as follows:

1. Defendants’ Motion to Exclude the Testimony of Donald J. Fournier, Jr., P.E. (Doe. 37), filed on April 5, 2007, is GRANTED.

2. Defendants’ Dispositive Motion for Summary Judgment (Doc. 34), filed on March 30, 2007, is GRANTED.

3. Defendants’ Omnibus Motion In Li-mine (Doc. 31), filed on March 22, 2007, is MOOT.

4. The Clerk shall enter a final judgment providing that the Plaintiffs, Arnaldo Medina and Luz Lopez, shall take nothing on their claims against the Defendants, Louisville Ladder, Inc. and Home Depot U.S.A., Inc. The final judgment shall further provide that the Defendants shall recover their costs of action.

5. Any other pending motions are moot.

6. The Clerk shall close this case.

Justice GREEN

delivered the Opinion of the Court.

Under the learned intermediary doctrine, the manufacturer of a pharmaceutical product satisfies its duty to warn the end user of its product’s potential risks by providing an adequate warning to a “learned intermediary,” who then assumes the duty to pass on the necessary warnings to the end user. See, e.g., Gravis v. Parke-Davis & Co., 502 S.W.2d 868, 870 (Tex.Civ.App.-Corpus Christi 1973, writ ref'd n.r.e.). In this case, we consider the applicability of the learned intermediary doctrine to a patient’s claims against a prescription drug manufacturer, whose product allegedly caused a serious injury. We hold that the doctrine generally applies within the context of a physician-patient relationship and allows a prescription drug manufacturer to fulfill its duty to warn end users of its product’s potential risks by providing an adequate warning to the prescribing physician. We further hold that the court of appeals erred by *143creating an exception to the learned intermediary doctrine for direct-to-consumer (DTC) advertising. Although the patient alleged various common law causes of action, all of the patient’s claims turn on the prescription drug manufacturer’s failure to warn. Therefore, the learned intermediary doctrine applies to all of the patient’s claims, and the patient was required to show that an inadequate warning to the prescribing physicians caused the patient’s injuries. Because the patient presented no evidence that the allegedly inadequate warning was a producing cause of her physicians’ decisions to prescribe the prescription drug, her claims fail as a matter of law. Accordingly, we reverse the court of appeals’ judgment in part and render judgment that the plaintiffs take nothing.

I. Background

In March 2003, Patricia and Thomas Hamilton sued Centocor, Inc., a prescription drug manufacturer and subsidiary of Johnson & Johnson, claiming that Cento-cor provided “inadequate and inappropriate warnings and instruction for use” of its prescription drug Remicade, which made Remicade “defective and unreasonably dangerous,” and seeking damages for injuries that Patricia allegedly incurred from using the drug.1 In August 2006, the Hamiltons amended their claims and added Patricia’s prescribing and treating physicians as defendants. They claimed that Centocor was liable for, among other things, (1) “manufacturing, promoting, distributing and/or selling Remicade®,” which was “defective and unreasonably dangerous” because of “inadequate and inappropriate warnings and instructions for use”; (2) negligence; (3) gross negligence; (4) fraud; and (5) malice. The Hamiltons claimed that Remicade caused Patricia to suffer a serious drug-induced side effect called lupus-like syndrome. The Hamil-tons also alleged that Patricia’s medical providers failed to adequately warn Patricia of the risks associated with Remicade and failed to obtain her informed consent to the treatment.

In the course of her prescribed treatments, Patricia’s treating physician, Michael Bullen, M.D., showed her an informational video that he received from Centocor. The Hamiltons alleged that Centocor’s video over-emphasized the benefits of Remicade and intentionally omitted warnings about the potential side effect of lupus-like syndrome. They argued that the video bypassed the physician-patient relationship and required Centocor to warn Patricia directly of Remicade’s potential risks and side effects, thereby making Centocor liable for Patricia’s injuries. The jury found in favor of the Hamiltons, and the trial court entered judgment for approximately $4.6 million. The court of appeals reversed the award of 'future pain and mental anguish damages but affirmed the remainder of the trial court’s judgment, adopted a DTC advertising exception to the learned intermediary doctrine, and held that the record contained sufficient expert evidence to prove that Centocor’s actions caused Patricia’s injuries.

A. Patricia’s Medical History Prior to 2001

Patricia Hamilton has a complicated medical history. For more than two decades, she has suffered from Crohn’s disease, recurring joint pain, arthritis, and several other ailments. Crohn’s disease is a chronic, lifelong inflammatory condition that can affect any part of the digestive system. There is no cure for the disease; *144however, patients have several treatment options, which seek to control intestinal inflammation. Over the years, Patricia underwent various procedures to treat the disease and mitigate its effects. By 2001, Patricia had part of her small intestine, colon, and rectum removed, and she lived with a colostomy. During a resection surgery — a procedure to reconnect her bowels after removing damaged tissues — Patricia contracted hepatitis C from a blood transfusion. She was also diagnosed with sar-coidosis.2

B. Dr. Hauptman Treats Patricia’s Crohn’s Disease

In September 2001, Patricia experienced a “flare” in her Crohn’s disease and sought treatment from Ronald Hauptman, M.D., a gastroenterologist who was practicing in Corpus Christi. To confirm that Patricia’s symptoms were caused by her Crohn’s disease, Dr. Hauptman. tracked Patricia’s reported abdominal pains for several weeks and ordered a series of tests, including a CAT scan and an upper GI.3 By December 2001, Dr. Hauptman confirmed that Patricia was experiencing a moderate flare in her Crohn’s disease.

Dr. Hauptman testified that it was important to treat the Crohn’s flare quickly to mitigate the risk that Patricia would lose more of her bowels. Based on Patricia’s existing medical regimen and her reported allergic reactions to one type of anti-inflammatory medication used to treat Crohn’s disease, Dr. Hauptman testified that Patricia’s only two options to treat the Crohn’s flare were through steroids or Remicade infusions. According to Dr. Hauptman, he consulted with Patricia about the available treatments and explained the risks and benefits of each approach. Based in part on Patricia’s desire to avoid steroid treatments, which had previously caused severe adverse effects, Dr. Hauptman prescribed three treatments of Remicade, a relatively new drug that had been developed since Patricia’s surgery in 1997, administered at six-week intervals of 400 milligrams each.

C. Remicade

Remicade is a prescription drug, manufactured by Centocor, that is approved by the Food and Drug Administration (FDA) for the treatment of Crohn’s disease and rheumatoid arthritis.4 An immunomodulator medication, Remicade is designed to suppress the immune system’s inflammatory response to the affected bowel. Patients receive Remicade treatments through intravenous infusions — the medication is injected through an IV catheter in the patient’s arm.

1. The FDA Approval Process

Barbara Matthews, M.D., an FDA administrator from 1994 to 2000, testified as an expert on the FDA approval process. Dr. Matthews was the clinical reviewer of Centocor’s application for FDA approval of Remicade and testified about her knowledge of the drug and her review of the safety and clinical data supporting Cento-*145cor’s application. According to Dr. Matthews, once the FDA approves a drug for prescription use, the drug manufacturer drafts a package insert, which contains the clinical information, warnings, and other information known about the drug. The FDA then reviews the proposed package insert, makes revisions, and ultimately approves the insert for distribution with the drug. According to Dr. Matthews, the purpose of a package insert

is to describe both the safety and efficacy that were reported to [the] FDA and ... provide[ ] information to the physician regarding the types of events, the serious[ ] nature of some of the events, the incidents of the events and, yes, the physician uses [this information to assess the] risk to the patient when they prescribe the medication.

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The degree of risk to the individual patient really depends on the physician’s knowledge of the patient and then also the information that’s in the label but the label really doesn’t link directly that patient to the degree of risk.

Additionally, once a drug has received FDA approval, the manufacturer must submit periodic safety update reports to the FDA. These post-approval reports contain cumulative summaries of the drug’s safety information, including updated clinical studies and any other medical findings published about the drug. Depending on the number, nature, and severity of events reported for a given adverse reaction, the FDA may recommend that the manufacturer (1) continue to monitor the events, (2) change the warning label, or (3) conduct additional studies. Because the FDA requires continuing studies of the safety and efficacy of the prescription drug, it is common for the package insert to undergo revisions as new information becomes available.

2. The 2001 Remicade Package Insert

At the time of Patricia’s initial Remicade prescription in December 2001, Centocor provided Patricia’s doctors with a package insert that warned Remicade’s use could lead to certain adverse reactions. The package insert included the following warning information regarding lupus-like syndrome:

PRECAUTIONS:

Autoimmunity

Treatment with REMICADE may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with REMICADE, treatment should be discontinued (see ADVERSE REACTIONS, Autoantibodies/Lwpus-like Syndrome).

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ADVERSE REACTIONS:

A total of 771 patients were treated with REMICADE in clinical studies. In both rheumatoid arthritis and Crohn’s disease studies, approximately 6% of patients discontinued REMICADE because of adverse experiences. The most common reasons for discontinuation of treatment were dyspnea, urticaria and headache. Adverse events have been reported in a higher proportion of patients receiving the 10 mg/kg dose than the 3 mg/kg dose.

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Autoantibodies/Lupus-like Syndrome In the ATTRACT rheumatoid arthritis study through week 54, 49% of REMI-CADE-treated patients developed antinuclear antibodies (ANA) between screening and last evaluation, compared to 21% of placebo-treated patients. Anti-dsDNA antibodies developed in ap*146proximately 10% of REMICADE-treat-ed patients, compared to none of the placebo-treated patients. No association was seen between REMICADE dose/schedule and development of ANA or anti-dsDNA.

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In clinical studies, three patients developed clinical symptoms consistent with a lupus-like syndrome, two with rheumatoid arthritis and one with Crohn’s disease. All three patients improved following discontinuation of therapy and appropriate medical treatment. No cases of lupus-like reactions have been observed in up to three years of long-term follow-up (see PRECAUTIONS, Autoimmunity).

The package insert also included a table noting that serious adverse reactions — including systemic lupus erythematosus syndrome — occurred at frequencies of less than 2% “by body system in all patients treated with REMICADE.”

D. Lupus-Like Syndrome

According to Mary Olsen, M.D., an expert witness hired by Centocor but called by the Hamiltons, lupus-like syndrome, also called drug-induced lupus, has similar characteristics to the autoimmune disorder systemic lupus erythematosus (SLE), except that lupus-like syndrome is caused by a drug. All of the testifying experts generally agreed that symptoms of both lupus-like syndrome and SLE include joint pain and swelling, weight gain, fatigue, unusual weakness, leukopenia, lymphopenia, rash, oral ulcers, fever, and pericarditis. Patients with Crohn’s disease or rheumatoid arthritis, another autoimmune disorder, could also present similar symptoms to lupus-like syndrome, making it sometimes difficult to diagnose SLE or drug-induced lupus.

Physicians can conduct lab tests to check for the presence of anti-nuclear antibodies (ANA), double-stranded DNA antibodies (anti-dsDNA), and antihistone antibodies, which are specific indicators that may help a physician diagnose the presence of an autoimmune condition. Although no antibody is definitive of lupus-like syndrome, positive tests for ANA or anti-dsDNA may indicate the patient has lupus-like syndrome. Physicians also use electrophoresis and immunoelectrophoresis as other immunology blood tests to help diagnose lupus. According to Afilia Ertan, M.D., an expert witness for Centocor, the anti-dsDNA test is the most important indicator for diagnosing drug-induced lupus. Additionally, Dr. Olsen testified that antihistone antibodies are classically seen in patients with drug-induced lupus and “as a rule, an antihistone antibody often is a flag [that indicates] a drug-induced problem.” Because Remicade may produce ANA or anti-dsDNA in patients, however, Dr. Olsen explained that it is often difficult to diagnose lupus-like syndrome. A doctor must look to both the laboratory tests and the clinical presentation of symptoms. If a patient has drug-induced lupus rather than SLE, removing the patient from the drug should improve the patient’s lupus-like symptoms.

E. Dr. Bullen and the Remicade Infusions

Dr. Hauptman prescribed three infusions of Remicade over a six-week period from December 2001 to January 2002 and referred Patricia to Dr. Bullen for treatment. Dr. Bullen is an infectious disease specialist and, at that time, operated an infusion clinic in Corpus Christi where Patricia received the Remicade infusions. As the non-prescribing, treating physician, neither Dr. Bullen nor his staff discussed with Patricia the risks inherent in Remi-cade, but they informed her of the poten*147tial risks directly associated with the infusion process. At trial, Dr. Bullen did not recall confirming that Dr. Hauptman had informed Patricia of Remieade’s risks. Dr. Bullen stated that he was aware that Rem-icade could cause lupus-like syndrome, but admitted that he probably did not give Patricia any warnings or instructions concerning the risk of developing lupus-like syndrome.

Polly Swinney, a registered nurse at Bullen’s infusion clinic, took Patricia’s patient history, advised Patricia on the potential infusion-related side effects,5 and monitored Patricia during her Remicade treatments at the infusion center. Before Patricia received her first infusion, Dr. Bullen’s clinic performed a tuberculin skin test, per Dr. Hauptman’s orders, because of the serious risks related to treating tuberculosis-infected patients with Remi-cade.6 After confirming that Patricia did not have tuberculosis, Patricia received her first Remicade infusion at Dr. Bullen’s infusion clinic on December 19, 2001.

F. Centocor’s Informational Video

After Swinney connected Patricia’s IV and started the first Remicade infusion, she showed Patricia an informational video about Remicade and the treatment process, which Centocor had provided to Dr. Bullen. Centocor had submitted the video to the FDA, but the FDA neither approved nor disapproved it.

Dr. Bullen, Dr. Matthews, and Swin-ney generally agreed that the main purpose of the video was to educate patients and make them more comfortable with the infusion process. The video, titled “Patient Guide to Remicade® (infliximab) IV Administration,” was viewed by the jury during trial. It depicts the effects of Remicade on several people and includes statements from a doctor, identified as Alan Safdi, M.D., who explains the Remicade infusion process and warns about some of the drug’s side effects. The video shows several patients receiving Remicade infusions, provides answers to common questions about the treatment process, and shows the patients continuing their daily routines after the treatment while the bottom of the screen states: “RESULTS MAY VARY.” Although Dr. Safdi states that “there are very little side effects that people need to watch for” and adverse reactions are “extremely rare,” he also instructs patients to contact their medical providers if they have any discomfort and states that there have been some reports of serious, life-threatening side effects.

In addition to- Dr; Safdi’s verbal warnings, the video provides several written warnings and disclaimers at the end of the production. It instructs patients to contact their healthcare provider if they have any questions and provides a Remicade website address for further information. The video warns of various risks associated with the infusion process, advises that “[plhysicians should discuss with their patients all potential side effects that may occur during these infusions,” and cautions that the “video should not be used as a substitute for talking with your doctor.” For the treatment of fistulizing Crohn’s *148disease,7 the video warning states that “[t]he safety and efficacy of therapy continued beyond three doses have not been studied.” After listing a series of potential side effects, the warning instructs patients to “see the accompanying Full Prescribing Information.” It is undisputed that the video did not mention lupus-like syndrome as a potential side effect of Remicade.

Swinney testified that the infusion clinic received the videotapes from Centocor in cellophane-wrapped boxes that usually contained the video, informational brochures about Remicade, and package inserts that provided more extensive details about the drug. She claimed that after showing Patricia the video, she placed it back in the box with the written materials on top and gave it to Patricia. At trial, Patricia denied receiving any written information about Remicade, but stated that she never looked in the box that Swinney gave her or reviewed any additional written information about Remicade. During one of Patricia’s infusions, Swinney gave Patricia a second Centocor video to give to Patricia’s sister, who had rheumatoid arthritis. The second video contained the same visual content but was enclosed in different packaging material. The box containing the second video had a plastic sleeve on the inside cover that contained the Remicade package insert and an informational brochure.8

Patricia reported an excellent response to her Remicade treatments at Dr. Bul-len’s infusion clinic, and the treatments helped relieve the symptoms of her Crohn’s disease. After her first two Remi-cade infusions, Dr. Hauptman performed a colonoscopy on Patricia, which revealed that Patricia no longer had abnormalities in her small intestine. Following her third Remicade infusion, Dr. Hauptman believed that Patricia’s Crohn’s disease was in remission. Dr. Hauptman then planned to continue monitoring Patricia’s condition before determining whether Patricia needed a Remicade maintenance dose every eight weeks. Throughout her follow-up appointments with Dr. Hauptman, Patricia reported that she was having no problems with her bowels, leading Dr. Hauptman to conclude that the Remicade treatments were successful and that Patricia’s Crohn’s disease remained in remission. It is undisputed that, since taking Remicade, Patricia’s Crohn’s disease has been asymptomatic.

G. Dr. Pop-Moody Treats Patricia’s Arthritis

In the weeks following her initial treatments with Remicade, Patricia experienced severe arthritis-like pains in her joints. Patricia’s family physician referred her to a local rheumatologist, Adriana Pop-Moody, M.D. During her initial visit with Dr. Pop-Moody, Patricia explained her recent treatments with Remicade and told Dr. Pop-Moody that it had dramatically improved her Crohn’s condition and that her arthritis pains had markedly improved after her first three doses of Remicade. In April 2002, Dr. Pop-Moody prescribed treatments including additional Remicade infusions at regular intervals to treat Patricia’s joint pains. Between April 2002 and September 2003, Patricia received fourteen additional Remicade infusions at the Corpus Christi Medical Center.

*149Patricia continued to experience severe joint pain. Each treatment provided temporary relief, but the relief periods dwindled. In an attempt to improve Patricia’s condition, Dr. Pop-Moody decreased the time between infusions and increased the dosage of Remicade. Dr. Pop-Moody and Patricia remained convinced that Remi-cade was providing Patricia temporary relief from her joint pains. In her practice, Dr. Pop-Moody routinely diagnosed and treated patients with lupus. Even though Patricia tested positive for SLE in June 2002 — a condition similar to drug-induced lupus and a potential side effect of Remi-cade — because of Patricia’s complicated condition, Dr. Pop-Moody did not diagnose Patricia with drug-induced lupus at that time. In April 2008, Dr. Pop-Moody reviewed treatment options with Patricia and discussed that she might need to stop the Remicade infusions. Dr. Pop-Moody informed Patricia that she may have lupus-like syndrome, but Patricia’s medical records indicate that, despite this risk, Patricia desired to continue taking Remicade.

H. The Houston Doctors

Because of Patricia’s increasing joint pain and Dr. Pop-Moody’S inability to determine the cause of Patricia’s continuing ailments, Dr. Pop-Moody referred Patricia to rheumatologists at the University of Texas Health Science Center in Houston, where she saw Maureen D. Mayes, M.D., Noranna B. Warner, M.D., and Leslie Wilson, M.D. (collectively, the Houston Doctors). In response to Dr. Pop-Moody’S request, the Houston Doctors examined Patricia’s symptoms and Dr. Mayes and

Dr. Wilson made the following assessment in September 2003:

1. Symmetric polyarthritis involving the hands, elbows, shoulders, knees, and feet that could be consistent with lupus (potentially drug-induced by Remicade), although the literature is limited in supportive evidence of this entity. There have been several studies showing that the presence of double stranded DNA antibodies in patients who receive Remicade is not uncommon; however, there have been limited . cases of lupus-like syndrome seen with this medication. The patient, at this time, does appear to have a syndrome that could be classified as systemic lupus erythematosus. The clinical picture is less consistent with sarcoidosis or9 arthritis associated with sarcoidosis. The clinical presentation could be consistent with enteropathic arthritis. This could be arthritis associated with hepatitis C virus.

2. Leukopenia — possibly secondary to lupus-like syndrome or a side effect of Imuran.10

The Houston Doctors stopped Patricia’s Remicade treatments and, instead, prescribed steroids for her joint pains. At her October 2003 follow-up appointment, Patricia reported that she felt much better than she did at her previous visit. Dr. Warner sent Dr. Pop-Moody a status report, which documented Patricia’s improvement and stated in pertinent part:

*150The patient presented to our clinic for evaluation of possible lupus-like syndrome which may have been induced by Remicade therapy. Upon evaluation by her rheumatologist in Corpus Christi, the patient was found to have a positive ANA and positive double-stranded DNA antibodies. Other significant history included the episode of pericarditis in January of 2003 and the presence of leu-kopenia (absolute lymphopenia). Upon initial presentation to our clinic a few weeks ago, the patient’s physical exam showed significant tenderness on internal and external rotation of both of her shoulders. There was also some swelling of the fingers, particularly in the PIP joints bilaterally. There was decreased hand grip secondary to pain.

Today, the patient states that she is much improved since her previous visit....

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ASSESSMENT: Symmetric polyarthri-tis involving hands, shoulders, knees, feet, which is consistent with a lupus-like syndrome (potentially drug-induced by Remicade). The patient has improved on an increased dose of Imuran 150 mg daily, increased from 100 mg daily. The patient also had increased her predni-sone dose from 10 mg daily to 15 mg daily.

Within a few months of ceasing the Remi-cade infusions, Patricia’s lupus-like symptoms subsided. Patricia’s arthritic symptoms also improved dramatically after she ceased taking Remicade.

II. Procedural Background

A. Trial Court Proceedings

The case proceeded to a multi-week jury trial. At trial, Patricia and her doctors gave conflicting testimony about their conversations concerning the risks and potential adverse effects associated with Remi-cade. Specifically, Dr. Hauptman and Dr. Pop-Moody testified that they fully informed Patricia about the risks of developing lupus-like syndrome while Patricia averred that she received no such warning from either doctor when they initially prescribed Remicade treatments. Although Patricia admitted that she was informed by her physicians of certain risks associated with Remicade, including the rare risk of cancer, she testified that her doctors made no mention of the risk of developing lupus-like syndrome. She further stated that the risk of lupus-like syndrome was something that she would have wanted to know, that it “would have impacted [her] decision,” and that “[t]he question of lupus would have made [her] stop and ask more questions before [she] made a decision [to take Remicade].” Regardless of the conflicting testimony, it is undisputed that all of Patricia’s doctors were aware of the risk of lupus-like syndrome when they chose to prescribe and treat Patricia with Remi-cade. And according to all of the doctors who testified on the subject, lupus-like syndrome can be difficult to diagnose.

At the charge conference, the Hamiltons abandoned their original failure-to-warn claim and proposed separate jury questions on claims against Centocor for (1) fraud, (2) negligent misbranding, (3) negligent marketing, (4) negligent undertaking, (5) misrepresentation to Patricia’s prescribing physicians concerning the risk of lupus-like syndrome, and (6) misrepresentation to Patricia’s prescribing physicians concerning the risk of hepatitis C and liver damage. Centocor raised several objections to the Hamiltons’ proposed charge, including that it was error for the trial court to submit separately the claims for negligent misbranding, negligent marketing, negligent undertaking, misrepresentation regarding lupus-like syndrome, misrepresentation regarding hepatitis C and *151liver conditions, and fraud. Centocor argued that each of the Hamiltons’ claims were premised on a single failure-to-warn cause of action, the separate questions were duplicative, and the trial court should only submit one failure-to-warn claim to the jury. The trial court judge overruled each of Centocor’s objections and submitted all of the Hamiltons’ questions to the jury. Centocor also repeatedly raised the learned intermediary doctrine, contesting its duty to warn Patricia directly. It argued that the record lacked expert testimony to (1) support the Hamiltons’ claims that Centocor’s warnings to Patricia and her prescribing doctors were inadequate, and (2) prove that the allegedly inadequate product warning was the producing cause of Patricia’s injuries. Additionally, Cento-cor argued that there was no evidence Centocor breached the standard of care.

Before the trial court submitted the charge to the jury, the court granted a directed verdict in favor of Dr. Bullen and his infusion clinic, finding that Dr. Bullen and his staff had no duty to warn Patricia of the risks associated with Remicade because Dr. Bullen was not the prescribing physician.

The jury found Centocor liable for fraud, misrepresentation to Patricia’s doctors, negligent misbranding, negligent marketing to. Patricia’s doctors, and negligent undertaking. The jury awarded Patricia $1.2 million for past pain and mental anguish, $1 million for future pain and mental anguish, $1.1 million for past physical impairment, and $65,908 for past medical expenses. It also awarded Thomas $50,000 for loss of consortium and household services. The jury apportioned liability for the Hamiltons’ damages, finding Centocor 85% liable, Dr. Pop-Moody 10% liable, and Dr. Hauptman 5% liable. The jury determined that the. Hamiltons established fraud by clear and convincing evidence and awarded Patricia $15 million and Thomas $1 million in exemplary damages based on the fraud claim.

Before the trial court entered judgment on the jury’s verdict, Dr. Hauptman and Dr. Pop-Moody settled with the Hamil-tons, and the Hamiltons nonsuited those defendants.11 The trial court denied Cen-tocor’s motion for judgment notwithstanding the verdict. On February 13, 2007, the trial court apportioned responsibility, applied settlement credits, applied the exemplary damages caps, and entered judgment against Centocor, awarding a total of $4,687,461.70 to Patricia and $120,833.71 to Thomas in actual damages, punitive damages, and interest. The trial court entered judgment on the Hamiltons’ fraud claim only but stated that, in the alternative, the Hamiltons should recover actual damages under the various other theories presented to the jury.

B. Court of Appeals

Centocor timely appealed, arguing first that the learned intermediary doctrine precluded the Hamiltons’ recovery because, as a matter of law, Centocor’s warnings to Patricia’s prescribing physicians were adequate and Centocor had no duty to warn Patricia directly.12 310 S.W.3d 476, 499 (Tex.App.-Corpus Christi 2010). The *152court of appeals disagreed, however, and affirmed the trial court’s judgment on the Hamiltons’ fraud claim but reversed the damages award for future pain and mental anguish. Id. at 522.

The court of appeals first examined Cen-tocor’s duty under the learned intermediary doctrine, which generally limits á prescription drug manufacturer’s duty to warn of its product’s risks and potential side effects to prescribing physicians, who then serve as “learned intermediaries” and assume the duty to pass the warnings on to patients. See id. at 499-508. Relying on reasoning from the New Jersey Supreme Court’s opinion in Perez v. Wyeth Laboratories, 161 N.J. 1, 734 A.2d 1245, 1246^47 (1999), the court of appeals adopted “an exception to the learned intermediary doctrine when a drug manufacturer directly advertises to its consumers in a fraudulent manner.” 310 S.W.3d at 480-81. Guided by the Perez court’s decision, the court of appeals held “that when a pharmaceutical company directly markets to a patient, it must do so without fraudulently misrepresenting the risks associated with its product.” Id. at 508. The court therefore dismissed Centocor’s arguments based on the learned intermediary doctrine and, in a footnote, stated: “[W]e hold today that Centocor cannot rely on its adequate warnings to Patricia’s physicians when it directly misrepresented its product’s dangerous propensities to Patricia.” Id. at 508 & n. 18 (emphasis added).

The court of appeals next considered Centocor’s argument that the Hamiltons failed to present legally and factually sufficient evidence of causation and held that the Hamiltons met their burden of proof on causation.13 Id. at 508-12. The court then overruled Centocor’s claims that the trial court erred because (1) no expert testified that the Remicade warnings were inadequate, (2) the side effect of lupus-like syndrome did not make Remicade unreasonably dangerous, and (3) the Hamiltons presented no evidence that a different warning by Centocor would have prevented Patricia’s injuries. Id. at 512-16. The court of appeals overruled or dismissed as *153moot Centocor’s remaining issues, reversed the trial court’s damages award for future pain and mental anguish,14 and affirmed the trial court’s judgment on the Hamiltons’ fraud claim. See id. at 516-22.

C. Centocor’s Petition for Review

Centocor timely petitioned this Court for review, and raises four issues on appeal: (1) the court of appeals erred by creating an advertising exception to the learned intermediary doctrine, and the doctrine applies, thereby limiting Cento-cor’s duty to warn to Patricia’s prescribing physicians only and barring the Hamiltons’ claims; (2) the Hamiltons failed to present any expert testimony that the warning in Centocor’s informational video was inadequate, and the appellate court erred by considering Dr. Matthews’s testimony about the FDA approval process and the FDA regulations as sufficient evidence to show that the video’s allegedly inadequate warning made Remicade unreasonably dangerous; (3) the Hamiltons failed to show any evidence of causation because they presented no expert testimony of causation or epidemiological studies, but instead relied on the package insert and expert witnesses’ unsupported references to clinical trials; and (4) the appellate court erred in affirming the Hamiltons’ fraud claim because there was no evidence of any mens rea on the part of Centocor, which was isolated from the patient by the intermediary doctors, and that Patricia could not have relied on any alleged misrepresentation because she continued to take Remicade even after suing Centocor. In response to Centocor’s first issue, the Hamiltons raise a conditional cross-issue, alleging that if we hold that the learned intermediary doctrine applies, we should reinstate the Hamiltons’ claims against Dr. Bullen, the non-prescribing, treating physician, because Centocor deliberately used Dr. Bullen to provide direct marketing materials outside of the context of the prescribing physician’s doctor-patient relationship. We granted both petitions. 54 Tex.Sup.CtJ. 1578 (Aug. 26, 2011).15 We address the parties’ arguments in turn.

III. Learned Intermediary Doctrine

Generally, a manufacturer is required to provide an adequate warning to *154the end users of its product if it knows or should know of any potential harm that may result from the use of its product. See, e.g., Bristol-Myers Co. v. Gonzales, 561 S.W.2d 801, 804 (Tex.1978). In certain contexts, however, the manufacturer’s or supplier’s duty to warn end users of the dangerous propensities of its product is limited to providing an adequate warning to an intermediary, who then assumes the duty to pass the necessary warnings on to the end users. See, e.g., Aim v. Aluminum Co. of Am., 717 S.W.2d 588, 590-92 (Tex.1986); Richard C. Ausness, Learned Intermediaries and Sophisticated Users: Encouraging the Use of Intermediaries to Transmit Product Safety Information, 46 Syraouse L. Rev. 1185, 1195-96 (1996). It is firmly established in Texas that whether a duty exists is ordinarily a legal matter for the court to decide. See, e.g., Humble Sand & Gravel, Inc. v. Gomez, 146 S.W.3d 170, 181 (Tex.2004). Within the context of prescription drug manufacturers, the underlying premise for the learned intermediary doctrine is that prescription drugs are complex and vary in effect, depending on the unique circumstances of an individual user, and for this reason, patients can obtain them only through a prescribing physician. See Reyes v. Wyeth Labs., 498 F.2d 1264, 1276 (5th Cir.1974), cert. denied, 419 U.S. 1096, 95 S.Ct. 687, 42 L.Ed.2d 688 (1974).

Centocor argues that the learned intermediary doctrine applies and therefore it had no duty to warn Patricia directly of the risks and potential side effects associated with Remicade. It asserts that it provided warnings of specific side effects and risks associated with Remicade to Patricia’s doctors through the FDA-approved package insert, which Patricia did not challenge as inadequate. Centocor further argues that the appellate court erred by adopting a DTC advertising exception. Centocor claims that DTC advertising does not threaten the physician-patient relationship, but helps educate consumers about available medications — sometimes causing patients to seek treatment for ailments they otherwise would not have treated or sometimes even discovered. Additionally, Centocor points out that the FDA and other courts have recognized that over-warning can confuse the public and, ultimately, can harm treatment efforts by scaring patients from taking the necessary risks associated with some prescription drugs.

In response, the Hamiltons argue that Centocor cannot benefit from the learned intermediary doctrine because it provided an inadequate and misleading warning to the “learned intermediary” — Patricia’s prescribing and treating physicians. The Hamiltons contend that Centocor misrepresented the risks and side effects associated with Remicade to Patricia and her doctors by conveying instances of lupus-like syndrome observed only in clinical studies instead of all reported cases, thereby preventing Centocor from relying on the defense of the learned intermediary doctrine. Alternatively, if the learned intermediary doctrine applies, the Hamiltons urge us to adopt the DTC advertising exception and affirm the court of appeals’ judgment because when a drug manufacturer directly markets its product to patients, that manufacturer should have a duty, at minimum, to present non-misleading information about the drug and must be liable for its fraudulent or intentionally misleading marketing.

A. The Learned Intermediary Doctrine in Texas Jurisprudence

The learned intermediary doctrine has been part of Texas jurisprudence for many years. See, e.g., Gravis v. Parke-Davis & Co., 502 S.W.2d 863, 870 (Tex.Civ.App.-Corpus Christi 1973, writ ref'd n.r.e.). In *155Gravis, the court of appeals held that it was unreasonable for the law to impose a duty on prescription drug manufacturers to “specifically warn each and every patient that receives drugs prescribed by the physician or other authorized persons” and outlined the underlying rationale for the doctrine:

The entire system of drug distribution in America is set up so as to place the responsibility of distribution and use upon professional people. The laws and regulations prevent prescription type drugs from being purchased by individuals without the advice, guidance and consent of licensed physicians and pharmacists. These professionals are in the best position to evaluate the warnings put out by the drug industry. Our holding in no way relieves the drug company in their duty to warn or to provide a product free of defects.

Id. Since the Thirteenth Court of Appeals’ opinion in Gravis — the same court from which we consider the instant case — many Texas courts of appeals have applied the learned intermediary doctrine in prescription drug produets-liability cases. See, e.g., Wyeth-Ayerst Labs. Co. v. Medrano, 28 S.W.3d 87, 91 (Tex.App.-Texarkana 2000, no pet.) (“In prescription drug cases, the courts have found that it is reasonable for the manufacturer to rely on the health care provider to pass on its warnings. This is reasonable because the learned intermediary understands the propensities and dangers involved in the use of a given drug, and as the prescriber, he stands between this drug and the ultimate consumer.”).16

We first discussed the doctrine in Aim, v. Aluminum Co. of America, a case involving an aluminum bottle cap manufacturer’s *156duty to warn end users of hazards associated with its product. 717 S.W.2d at 590-92. Aim sued the manufacturer of soda bottle caps, claiming that an aluminum bottle cap popped off a soda bottle and struck him in the eye. Id. at 590. AJm claimed that Alcoa, the manufacturer of the machine that fastened the caps to the soda bottles, had a duty to warn him of the risk that a cap could pop off. Id. Although Alcoa manufactured the bottle-fastening machine, .the machine was owned and operated by an independent bottler. Id. at 589-90. Alcoa did not control the bottling process or sell the bottled soda, nor did it have any practical way of reaching consumers with any warning. Id. at 592. Because of Alcoa’s limited connection to the end user of the consumer product, we recognized the need for an intermediary:

[A] manufacturer or supplier may, in certain situations, depend on an intermediary to communicate a warning to the ultimate user of a product. However, the mere presence of an intermediary does not excuse the manufacturer from warning those whom it should reasonably expect to be endangered by the use of its product. The issue in every ease is whether the original manufacturer has a reasonable assurance that its warning will reach those endangered by the use of its product.

Id. at 591. We then analogized Aim’s position to that of a bulk supplier “who sells a product to another manufacturer or distributor who in turn packages and sells the product to the public.” Id. at 592. Because the bulk-supplier rationale applied to Alcoa’s duty to warn in that case, we explained:

Alcoa should be able to satisfy its duty to warn consumers by proving that its intermediary ’was adequately trained and warned, familiar with the propensities of the product, and capable of passing on a warning. But, if Alcoa failed to adequately warn and train [the intermediary] or if [the intermediary] was incapable of passing on the received warning, Alcoa would not have discharged its duty to the ultimate consumer.

Id. While Alcoa did not have a duty to warn Aim directly, it still had a duty to warn the bottler, and we concluded that the record contained some evidence to support the jury’s finding that Alcoa’s warning to the bottler was inadequate. Id. at 593-95.

Although Aim did not apply the learned intermediary doctrine within the context of a pharmaceutical manufacturer’s duty to warn consumers of dangers associated with prescription drugs, we noted that other courts had done so:

[W]hen a drug manufacturer properly warns a prescribing physician of the dangerous propensities of its product, the manufacturer is excused from warning each patient who receives the drug. The doctor stands as a learned intermediary between the manufacturer and the ultimate consumer. Generally, only the doctor could understand the propensities and dangers involved in the use of a given drug. In this situation, it is reasonable .for the manufacturer to rely on the intermediary to pass on its warnings. However, even in these circumstances, when the warning to the intermediary is inadequate or misleading, the manufacturer remains liable for injuries sustained by the ultimate user.

Id. at 591-92 (citations omitted).

More recently, we addressed the learned intermediary doctrine’s relevance in Humble Sand & Gravel, Inc. v. Gomez, 146 S.W.3d 170,- 185-96 (Tex.2004). In that case, we considered whether a supplier of flint used for an abrasive blasting agent had a duty to warn its customers’ employees of foreseeable dangers associated with *157the product, given the customer-employers’ knowledge of those dangers. Id. at 172-73. We discussed relevant provisions from the Second and Third Restatements of Torts and noted that, in situations that did not meet the generally accepted exceptions to a manufacturer’s duty to warn, the court must consider six balancing factors adopted from the Restatement to determine the scope of a supplier’s duty to warn the ultimate user of its product:

(1) the dangerous condition of the product; (2) the purpose for which the product is used; (3) the form of any warnings given; (4) the reliability of the third party as a conduit of necessary information about the product; (5) the magnitude of the risk involved; and (6) the burdens imposed on the supplier by requiring that he directly warn all users.

Id. at 190 (quoting Goodbar v. Whitehead Bros., 591 F.Supp. 552, 557 (WD.Va.1984), aff'd sub nom. Beale v. Hardy, 769 F.2d 213 (4th Cir.1985)); see also Restatement (Third) of Torts: Products Liability § 2 cmt. i (1998); Restatement (Second) of Torts § 388 cmt. n (1965). We noted that each of these factors “must be weighed against each other, the measure being reasonableness in the circumstances.” Humble Sand, 146 S.W.3d at 190. Because the record lacked “any evidence that, in general, warnings by flint suppliers could effectively reach their customers’ employees actually engaged in abrasive blasting,” we were unable to determine whether the suppliers had a duty to warn the customers’ employees directly and, accordingly, remanded the case for a new trial. Id. at 173.

As in Aim, we again recognized in Humble Sand that other courts have applied the learned intermediary doctrine within the prescription drug context and explained: “The rationale for this ‘learned intermediary’ rule is not that a direct warning from manufacturers to patients is infeasible, in the practical, physical sense of that word, but that it is better for the patient for the warning to come from his or her physician.” Id. at 190-91; see also Restatement (Third) of Torts: Products Liability § 6 cmt. b (“The rationale supporting this ‘learned intermediary’ rule is that only health-care professionals are in a position to understand the significance of the risks involved and to assess the relative advantages and disadvantages of a given form of prescription-based therapy. The duty then devolves on the health-care provider to supply to the patient such information as is deemed appropriate under the circumstances so that the patient can make an informed choice as to therapy.”).

Until now, we have not considered a case that squarely presents the applicability of the learned intermediary doctrine within the context of prescription drug products-liability cases. For reasons stated in Humble Sand, Aim, and Gravis, we hold that a prescription drug manufacturer fulfills its duty to warn end users of its product’s risks by providing adequate warnings to the intermediaries who prescribe the drug and, once fulfilled, it has no further duty to warn the end users directly. See Humble Sand, 146 S.W.3d at 190-91; Aim, 717 S.W.2d at 591-92; Gravis, 502 S.W.2d at 870. But as we have previously indicated, when the warning to the prescribing physician is inadequate or misleading, the prescription drug manufacturer remains liable for the injuries sustained by the patient. See Aim, 717 S.W.2d at 592.

Our decision to apply the learned intermediary doctrine in the context of prescription drugs, prescribed through a physician-patient relationship, not only comports with our prior references to the doctrine and many years of Texas case law, but it places us alongside the vast *158majority of other jurisdictions that have considered the issue.17 Our sister states have overwhelmingly adopted the learned intermediary doctrine in this context and, to date, only one state has rejected the doctrine altogether. See State ex rel. Johnson & Johnson Corp. v. Karl, 220 W.Va. 463, 647 S.E.2d 899, 913-14 (2007). The underlying rationale for the validity of the learned intermediary doctrine remains just as viable today as stated by Judge Wisdom in 1974:

*159Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. As a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his patient. His is the task of weighing the benefits of any medication against its potential dangers. The choice he makes is an informed one, an individualized medical judgment bottomed on a knowledge of both patient and palliative. Pharmaceutical companies then, who must warn ultimate purchasers of dangers inherent in patent drugs sold over the counter, in selling prescription drugs are required to warn only the prescribing physician, who acts as a “learned intermediary” between manufacturer and consumer.

Reyes, 498 F.2d at 1276. Accord Bean, 965 S.W.2d at 662 (adopting Reyes’ rationale for the doctrine). Cf. Diversicare Gen. Partner, Inc. v. Rubio, 185 S.W.3d 842, 850 (Tex.2005) (“The nature and intensity of care and treatment, including professional supervision, monitoring, assessment, quantities and types of medication, and other medical treatment are judgments made by professionals trained and experienced in treating and caring for patients and the patient populations in their health care facilities.”). Because patients can obtain prescription drugs only through their prescribing physician or another authorized intermediary and because the “learned intermediary” is best suited to weigh the patient’s individual needs in conjunction with the risks and benefits of the prescription drug, we are in agreement with the overwhelming majority of other courts that have considered the learned intermediary doctrine and hold that, within the physician-patient relationship, the learned intermediary doctrine applies and generally limits the drug manufacturer’s duty to warn to the prescribing physician.

B. Recognized Exceptions to the Learned Intermediary Doctrine

Having concluded that the learned intermediary doctrine generally applies in the prescription drug context, we next consider whether some exception to the doctrine is warranted here, so that, despite the doctrine, Centocor retained a duty to warn the patient directly. In the more than forty-five years since courts first adopted the learned intermediary doctrine in the prescription drug context, the healthcare industry has experienced substantial changes, especially surrounding the marketing of prescription drugs. See Vitanza, 778 A.2d at 846 (citing Sterling Drug, Inc. v. Cornish, 370 F.2d 82, 85 (8th Cir.1966), as the first case to adopt the doctrine). In light of these changes, some courts and commentators, including the Restatement, have recognized limited exceptions to the learned intermediary doctrine. See, e.g., Restatement (Third) of Torts: Products Liability § 6 (1998); see also, e.g., Timothy S. Hall, Reimagining the Learned Intermediary Rule for the New Pharmaceutical Marketplace, 35 Seton Hall L.Rev. 193, 205-16 (2004) (discussing the recognized exceptions to the doctrine).18

*160The most recent exception to merit significant national attention is the DTC advertising or “mass marketing” exception. Despite the significant academic literature on the topic, only a few courts have recognized a DTC advertising exception to the learned intermediary doctrine when a drug manufacturer directly markets to the consumer. In 1997, the Oklahoma Supreme Court recognized a marketing exception to the learned intermediary doctrine when the FDA mandated that the manufacturers, through their product labels, must communicate warnings directly to patients. Edwards v. Basel Pharm., 933 P.2d 298, 301 (Okla.1997). While this decision did not abrogate the learned intermediary doctrine on the basis of DTC advertising, soon thereafter, the New Jersey Supreme Court adopted a sweeping DTC advertising exception to the learned intermediary doctrine in Perez v. Wyeth Laboratories Inc., 161 N.J. 1, 734 A.2d 1245, 1246-47 (1999). Perez involved a prescription contraceptive called Norplant — a “hybrid” medical device that consists of a drug capsule that is surgically implanted in the patient’s arm. Id. at 1247. The plaintiffs alleged that Wyeth Laboratories had conducted a massive advertising campaign, “which it directed at women rather than at their doctors,” and sought damages because the DTC warnings failed to mention serious side effects including pain and permanent scarring attendant to the removal of the drug capsule. Id. at 1248. The New Jersey Supreme Court examined the theoretical underpinnings for the learned intermediary doctrine within the context of the dramatic changes associated with DTC advertising and determined that “[c]onsumer-directed advertising of pharmaceuticals *161thus belies each of the premises on which the learned intermediary doctrine rests.” Id. at 1256. As a result, the court held that the learned intermediary doctrine no longer provided complete protection to pharmaceutical manufacturers that provided adequate warnings to physicians on the risks and benefits of a drug when that company chose to market directly to consumers. Id. But see id. (noting that its decision differed from the Fifth Circuit’s holding in Norplant II, 165 F.3d at 379-80, and that, under Texas law, the learned intermediary doctrine applied in the context of the Norplant contraceptive). The Perez court did, however, recognize that a drug manufacturer’s compliance with “FDA advertising, labeling, and warning requirements” created a “rebuttable presumption that the [manufacturer’s] duty to consumers is met.”19 Id. at 1259.

In the more than twelve years since Perez, many courts have declined to follow the New Jersey Supreme Court’s sweeping departure from the learned intermediary doctrine. But cf. Murthy v. Abbott Labs., 847 F.Supp.2d 958 (S.D.Tex. 2012) (citing cases that rejected Perez, but relying on the appellate court’s holding in Cen-tocor to hold that Texas law recognizes a DTC advertising exception); see also Beale v. Biomet, Inc., 492 F.Supp.2d 1360, 1376 (S.D.Fla.2007) (“Since Perez was decided, no court — including any Florida court — has recognized the DTC exception to the learned intermediary doctrine, and several courts have expressly rejected the DTC exception.”). Cf. Karl, 647 S.E.2d at 913 (decided after Beale and adopting Perez’ s reasoning but, instead of adopting a DTC exception to the doctrine, rejecting the learned intermediary doctrine entirely). Even the Fifth Circuit has expressed that it is “skeptical that a Texas court would adopt [an overpromotion] exception” to the learned intermediary doctrine, which is closely akin to the DTC advertising exception. Ebel v. Eli Lilly & Co., 321 FedAppx. 350, 355 n. 2 (5th Cir.2009); see also Beale, 492 F.Supp.2d at 1377-78 (discussing the overpromotion exception).

To date, West Virginia is the only state whose highest court has followed the New Jersey Supreme Court’s holding in Perez. See Karl, 647 S.E.2d at 912-13.20 In State ex rel. Johnson & Johnson Corp. v. Karl, the West Virginia Supreme Court relied on the Perez court’s reasoning to reject the learned intermediary doctrine entirely: “Given the plethora of exceptions to the learned intermediary doctrine, we ascertain no benefit in adopting a doctrine that would require the simultaneous adoption of numerous exceptions in order to be justly utilized.” Id. at 910-11, 913. While Karl is the only instance where the highest court of another state has followed Perez, at least five other jurisdictions have expressly declined to adopt a DTC advertising exception to the learned intermediary doc*162trine.21

C. The DTC Advertising Exception Does Not Apply

At issue in this case is whether the court of appeals erred in adopting the DTC advertising exception to the learned intermediary doctrine. Not until the court of appeals’ holding below had any Texas court adopted a DTC advertising exception to the learned intermediary doctrine. See Centocor, 310 S.W.3d at 508.22 We agree that it is important to prohibit pharmaceutical manufacturers from disseminating grossly misleading advertising, and we note that Congress has enacted a comprehensive regulatory scheme, implemented by the FDA, which is meant to control the design, implementation, and marketing of prescription drugs, including both criminal and civil penalties for manufacturers that violate these regulations.23 See, e.g., 21 U.S.C. §§ 331, 333, 335b. We acknowledge that some situations may require exceptions to the learned intermediary doctrine, but without deciding whether Texas law should recognize a DTC advertising exception when a prescription drug manufacturer distributes intentionally misleading information directly to patients or prospective patients, we hold that, based on the facts of this case, no exception applies.24

Here, the alleged harm was not caused by Centocor’s direct advertising to Patricia. At trial, the Hamiltons admitted that the first time they heard of Remicade was when Patricia’s husband, Thomas, saw a textual banner displayed on the bottom ticker of -the CNN news channel, which stated that the FDA had approved Remi-cade for the treatment of Crohn’s disease. This innocuous news report is a far cry from the basis for the Perez court’s adoption of a DTC advertising exception where the pharmaceutical company “ma[de] direct claims to consumers for the efficacy of its product” through prescription drug advertisements. Cf. Perez, 734 A.2d at 1247. Instead of DTC advertising prompting her to request Remicade from her doctors, Pa*163tricia’s claims rest on the video that she viewed after her doctor had prescribed Remicade and after the infusion process had begun. Cf. Norplant I, 955 F.Supp. at 708 (“The court agrees with those courts that view such patient materials as an informational supplement to the physician-patient relationship. Moreover, because these materials are distributed by the [prescribing] physician, the court is of the opinion that the physician, as the learned intermediary, has a duty to review the materials before passing them on to the patient in order to ensure that any such materials that the physician chooses to pass on will accurately inform the patient about the drug.”); Banner v. Hoffmann-La Roche Inc., 383 NJ.Super. 364, 891 A.2d 1229, 1236 (N.J.App.Div.2006), cert. denied 190 N.J. 393, 921 A.2d 447 (2007) (refusing to extend the Perez DTC advertising exception because “the placement of informational brochures in a physician’s office cannot fairly be equated with a course of mass advertising or be deemed direct-to-consumer advertising so as to remove the predicates of the learned intermediary doctrine”).

Furthermore, the record indicates that this informational video is not the type of misleading DTC advertising that concerned the Perez court. According to Swinney, the nurse who remained present with Patricia during all of her Remicade treatments at Dr. Bullen’s clinic, the videos were available to help patients feel more relaxed about the infusion process, by explaining some of the benefits and side effects of the treatment process. After viewing the video, Dr. Matthews testified that she considered the video to be an educational tool to help inform patients about the infusion process. And Patricia admitted that the first time she saw any literature about Remicade was when she received her first Remicade infusion at Dr. Bullen’s clinic. Both Patricia and Swinney testified that Patricia was already receiving her first infusion when the video started. On this record, the rationale for adopting a DTC advertising exception to the learned intermediary doctrine is simply non-existent. See Norplant II, 165 F.3d at 379 (rejecting the plaintiffs’ argument for an “ ‘aggressive’ marketing” exception because of “the absence of any evidence on the record that any of the five plaintiffs actually saw, let alone relied, on any marketing materials issued to them by [the manufacturer]”); Ebel v. Eli Lilly & Co., 536 F.Supp.2d 767, 782 (S.D.Tex.2008), aff'd, 321 Fed.Appx. 350 (5th Cir.2009) (rejecting the DTC advertising exception because there was no evidence that the plaintiff relied on the marketing website). But see Medrano, 28 S.W.3d at 93 n. 5 (rejecting the DTC exception on the facts of that case while noting that the court could “foresee a situation where a manufacturer’s direct contact with the consumer could be received and relied on by that consumer outside the learned intermediary context”).25

Even so, we must believe that patients who seek prescription drugs based solely on DTC advertising will obtain them only when the prescribing physician has evaluated the potential risks and benefits for the particular patient. To safeguard the *164public from harmful products and misleading advertising, both the federal government and Texas law regulate the design, marketing, and distribution of prescription drugs. See, e.g., 21 U.S.C. §§ 301-99 (Federal Food, Drug, and Cosmetic Act); Tex. Health & Safety Code §§ 481.061, .071, .074; Tex. OCC.Code § 562.056(a). Drug manufacturers that fail to comply with FDA regulations can face criminal fines and imprisonment as well as civil penalties. See 21 U.S.C. §§ 331, 333, 335b; 21 C.F.R. § 202.1. Although pharmaceutical companies have increased DTC advertising since courts first adopted the learned intermediary doctrine,, the fundamental rationale for the doctrine remains the same: prescriptions drugs require a doctor’s prescription and, therefore, doctors are best suited to communicate the risks and benefits of prescription medications for particular patients through their face-to-face interactions with those patients.

Without deciding whether Texas law should recognize any of the other exceptions to the learned intermediary doctrine, we find no reason to adopt an- exception where the physician-patient relationship existed, the pharmaceutical company provided a warning to the patient’s prescribing doctors that included the side effect of which the patient complains, and the patient had already visited with her prescribing physician and decided to take the drug before she saw the informational video at issue. Accordingly, we hold that it was error for the court of appeals to create a DTC or fraudulent advertising exception to the learned intermediary doctrine based on the facts of this case.

IV. The Learned Intermediary Doctrine Within the Prescription Drug Context Is Not a Common-Law Affirmative Defense

The parties dispute whether the learned intermediary doctrine is an affirmative defense, which would shift to Centocor the burden to plead, prove, and request jury findings on the learned intermediary doctrine at trial. We agree with Centocor that, within the prescription drug context, the learned intermediary doctrine is more akin to a common-law rule rather than an affirmative defense.

The Hamiltons rely heavily on the appellate court’s holding in Coleman v. Cintas Sales Corp., 40 S.W.3d 544, 551-52 (Tex. App.-San Antonio 2001, pet. denied). Coleman involved a products-liability action brought by an employee against a uniform company when his uniform caught fire. Id. at 547. Cintas Sales Corporation did not argue the learned intermediary doctrine before the trial court but argued to the court of appeals that it had no duty to Coleman because Coleman’s employer served as a learned intermediary. Id. at 549. The court of appeals stated that the “ ‘learned intermediary’ [doctrine is a] defense[ ] that must be pled and proved by the manufacturer in the trial court,” and because Cintas failed to raise this issue to the trial court in its motion for summary judgment, the issue was not properly preserved for consideration on appeal. Id. at 551.

We find Coleman distinguishable from the instant case. Coleman did not involve a products-liability claim arising from a drug manufacturer’s failure to warn about the risks associated with its prescription drug. See id. at 547. As previously discussed in Part III, for more than forty-five years, courts have applied the learned intermediary doctrine within products-liability claims against prescription drugs manufacturers. See, e.g., Gravis, 502 S.W.2d at 870; Cornish, 370 F.2d at 85. We have repeatedly referenced the doctrine’s commonly recognized application in the pre*165scription drug context. See Aim, 717 S.W.2d at 591-92; Humble Sand, 146 S.W.3d at 185. As explained above, doctors have a legal duty to pass prescription drug warnings on to their patients. See, e.g., Tex. Civ. Prao. & Rem.Code § 74.104. And as the official comment to the Restatement (Second) of Torts notes, the learned intermediary doctrine applies particularly to the medical field and unavoidably unsafe products like prescription drugs, which, by law, cannot go from the manufacturer to the end user except through a prescribing physician. See Restatement (Second) of Torts § 402A cmt. k. In other products-liability contexts, such as the sophisticated user or bulk supplier scenarios, however, the doctrine could apply to any type of product, not just those that are unavoidably unsafe, and the applicability of the learned intermediary doctrine in those contexts turns on whether the manufacturer’s or supplier’s reliance on the intermediary to warn the end user is reasonable. See Aim, 717 S.W.2d at 592 (“In determining whether a bulk supplier’s duty to warn extends to ultimate users of a product, courts may consider whether the distributor is adequately trained, whether the distributor is familiar with the properties of the product and its safe use, and whether the distributor is capable of passing on its knowledge to consumers.”). Cf. Humble Sand, 146 S.W.3d at 195 (placing the burden on the product supplier to prove that the warning the plaintiff claims the supplier should have given would not have been effectual).

In contrast to the non-prescription drug situation in Coleman, we find more persuasive the Sixth Court of Appeals’ holding in Wyeth-Ayerst Laboratories Co. v. Medrano, 28 S.W.3d 87, 93-94 (Tex.App.-Texarkana 2000, no pet.), which directly addressed the issue in context of the plaintiff’s failure-to-warn and Deceptive Trade Practices Act (DTPA) claims against the prescription drug manufacturer. In Me-drano, the court held that the learned intermediary doctrine was not a common-law defense and that it, therefore, applied to all of the plaintiff’s causes of action, including the DTPA claim. Id. at 94. The court reasoned:

When the learned intermediary doctrine is asserted in a cause of action, it is used to show to whom a defendant, usually a prescription drug manufacturer, owes the duty to adequately warn. It is not used to show that the plaintiff has no valid case. Even when the learned intermediary doctrine applies, the manufacturer still has a duty to warn, and it can still be held liable directly to the plaintiff if the warning that it gave is inadequate.

Id. (citations omitted). The Medrano court’s interpretation of the learned intermediary doctrine within the prescription drug context also comports with the Fifth Circuit’s application of Texas law. See, e.g., Achermann v. Wyeth Pharm., 526 F.3d 203, 207-08 (5th Cir.2008) (“The learned-intermediary doctrine is not an affirmative defense. Under Texas law, it delineates to whom a defendant — usually a prescription drug manufacturer — owes the duty to warn, but it is not used to show that the plaintiff has no valid case.”); see also Norplant II, 165 F.3d at 378 (making an Erie guess that Texas law considers the learned intermediary doctrine to be a common-law doctrine rather than a common-law defense).

Here, it is undisputed that Patricia received Remicade through a physician-patient relationship. As discussed hereafter in Part VI, the underlying basis for the Hamiltons’ claims stems from Centocor’s alleged failure to warn Patricia of the risks and dangers associated with Remicade. Therefore, as in most failure-to-warn cases, the Hamiltons had to prove that *166Centoeor’s warning was inadequate. See, e.g., Technical Chem. Co. v. Jacobs, 480 S.W.2d 602, 605-06 (Tex.1972); Medrano, 28 S.W.3d at 94. While the learned intermediary doctrine shifts the manufacturer’s duty to warn the end user to the intermediary, it does not shift the plaintiffs basic burden of proof. See Medrano, 28 S.W.3d at 94. Doing so would create an anomalous situation where, once the defendant prescription-drug manufacturer invokes the learned intermediary doctrine, the plaintiff would be relieved of proving a key burden in any product warning case — that the product warning was inadequate. The burden on defendants in other industries to show reasonable reliance on an intermediary to effectively deliver a warning has no application in products-liability cases against a prescription drug manufacturer when the plaintiff received the drug through the existence of a physician-patient relationship.26

V. The Non-Prescribing Physician Had No Duty to Warn

We now address the Hamiltons’ conditional cross-issue. Because the learned intermediary doctrine applies and because we decline to adopt an exception to the doctrine in this context, the Hamiltons argue that we are implicitly expanding the doctrine and allowing drug manufacturers to bypass intermediary-prescribing physicians by sending informational videos and marketing materials to patients through non-prescribing, treating physicians and their clinics. By sending the Remicade patient video to Dr. Bullen, a non-prescribing physician, the Hamiltons claim that Centocor transferred its duty to warn to Dr. Bullen, who must warn Patricia of the risks associated with Remicade. In response, Dr. Bullen argues that the trial court correctly granted a directed verdict in his favor because, as a matter of law, he owed no duty to warn Patricia about medications that he did not prescribe. We agree with Dr. Bullen.27

Despite the intricate web of modern healthcare providers and treatments, the bedrock of our healthcare system is the physician-patient relationship, and the ultimate decision for any treatment rests with the prescribing physician and the patient. As a matter of both necessity and practicality, the duty to warn the patient of the potential risks and possible alternatives to any prescribed course of action rests with the prescribing physician. See Aim, 717 S.W.2d at 591.- The Hamiltons offer no case law in support of their duty-shifting position and we, too, have found none. While informational materials provided by healthcare providers, pharmaceutical and medical-device manufacturers, or the government are meant to educate patients and make them better informed *167about available treatment options 28a simple product brochure or short informational video cannot explain the complex intricacies of the human body or supplant the detailed, interconnected nature of the practice of medicine, which necessitates that an informed intermediary help determine the best course of treatment for a patient’s particular symptoms. To hold that each healthcare provider owes a separate and individual duty to warn each patient of all possible risks associated with a treatment prescribed by any doctor would not only undermine the prescribing doctor’s physician-patient relationship, but could thwart the efforts of prescription drug manufacturers to provide valuable educational information about available treatments. In most prescription drug contexts, the learned intermediary doctrine applies and the duty to warn the patient rests solely with the prescribing physician. Cf. Torrington Co. v. Stutz-man, 46 S.W.3d 829, 837-38 (Tex.2000) (discussing general principles of duty and situations in which a party could undertake certain actions to assume a duty to another).

Here, the decision to prescribe Remicade to treat Patricia’s condition was made well before she visited Dr. Bullen’s infusion center and well before she saw Centocor’s informational video. After reviewing Patricia’s complicated medical history, tracking her symptoms, and confirming the Crohn’s disease flare, Dr. Hauptman was faced with two available treatments — steroids or Remicade — and he and Patricia made the decision to try Remicade. While Dr. Bullen owed a duty to inform Patricia of the relevant risks associated with the treatment process, including the infusion method of delivery, and to obtain her informed consent to the treatment, which he properly performed, he owed no further duty to explain all of the potential risks associated with Remi-cade nor was he required to second-guess the professional judgment of Dr. Haupt-man. Cf. Morgan, 30 S.W.3d at 467 (holding that a pharmacist did not owe a legal duty to warn a patient of all the possible adverse effects of a prescription drug).

Having satisfied his responsibilities, Dr. Bullen owed no additional duty to warn Patricia merely because he provided informational materials to her that he received from Centocor. Here, Centocor provided the materials as a supplement to the physician-patient relationship, not meant to supplant that relationship. Moreover, none of the allegedly misleading information from Centocor could change the fact that Patricia could not receive Remicade except through a prescription. On the facts of this case, we decline to carve out an additional exception to the learned intermediary doctrine or create a “shared intermediary” duty to warn that would (1) encourage prescription drug manufacturers to withhold educational materials from patients, and (2) require other healthcare providers to second-guess the prescribing physician’s decision and undermine the physician-patient relationship. Accordingly, we affirm the trial court’s directed verdict in favor of Dr. Bullen, the infusion clinic, and its employees, and hold that, as a matter of law, Dr. Bullen owed no duty to warn Patricia of the potential side effect of lupus-like syndrome.29

*168VI. The Learned Intermediary Doctrine Applies to All of the Hamiltons’ Claims

Because the learned intermediary doctrine applies, we must determine whether the doctrine applies to all of the Hamil-tons’ claims. Centocor' argues that regardless of the pleadings and the questions submitted in the jury charge, all of the Hamiltons’ claims, including common-law fraud by omission, were premised on Cen-tocor’s alleged failure to warn about Remi-cade’s potential side effects. Therefore, Centocor contends that the learned intermediary doctrine applies to all of the Ham-iltons’ claims and, accordingly, that it had no duty to warn Patricia directly about Remicade’s potential side effects. In response, the Hamiltons contend that it was their prerogative as the plaintiffs to plead and try their case under any theory of liability they chose. They argue that consumers routinely sue for common-law fraud when manufacturers’ misrepresentations about their products cause harm, despite this Court’s adoption of the Restatement’s position on strict products liability, and Texas courts have not imposed any additional burden on consumers to prove failure-to-warn elements from strict products-liability causes of action for common-law claims.

Several federal courts applying Texas law have considered whether a patient can plead around the learned intermediary doctrine by bringing other common-law and non-products-liability claims against a prescription drug manufacturer. See, e.g., Norplant I, 955 F.Supp. at 709. In Norplant I, the plaintiffs brought claims against a prescription drug manufacturer for “strict products liability, negligence, breach of implied warranty of merchantability, misrepresentation, and consumer fraud based upon the Texas [DTPA] ” and alleged that the learned intermediary doctrine did not apply to “their claims for misrepresentation and violations of the DTPA arising out of a drug manufacturer’s voluntary communications to consumers through physician-distributed materials.” Id. at 709-10. Because the alleged misrepresentations and the allegedly false, misleading, and deceptive nature of the prescription drug manufacturer’s materials were based on the manufacturer’s failure to warn, the federal district court rejected the plaintiffs’ argument:

The gravamen of all of Plaintiffs’ causes of action, including misrepresentation and violation of the DTPA, is that [the prescription drug manufacturer] failed to adequately warn of or disclose the severity of Norplant’s side effects. Therefore, the learned intermediary doctrine applies to all of Plaintiffs’ causes of action. Additionally, whether the failure to warn is couched as an affirmative misrepresentation or a misrepresentation by concealment, the allegation collapses into a charge that the drug manufacturer failed to warn. If the doctrine could be avoided by casting what is essentially a failure to warn claim under a different cause of action such as violation of the DTPA or a claim for misrepresentation, then the doctrine would be rendered meaningless.

Id. at 709; see Ebel, 536 F.Supp.2d at 773 (applying Texas law) (“Where the crux of the suit is based on a failure to adequately warn, the learned intermediary doctrine may apply to strict liability, negligence, *169misrepresentation, and breach of warranty claims.”); see also Beale, 492 F.Supp.2d at 1372 (applying Florida law) (adopting Norplant F s reasoning and listing other jurisdictions that have applied the learned intermediary doctrine to all claims premised on the prescription drug manufacturer’s alleged failure to warn); Stafford v. Wyeth, 411 F.Supp.2d 1818, 1319-20 (W.D.Okla.2006) (recognizing that all of the plaintiffs claims — negligence, design defect, failure to warn, and misrepresentation — hinged on the prescription drug manufacturer’s alleged failure to warn). But see Hill v. Wyeth, Inc., No. 4:03CV1526 JCH, 2007 WL 674251, at *2 (E.D.Mo. Feb. 28, 2007) (not reported) (applying Missouri law) (distinguishing Norplant I and refusing to dismiss all but the plaintiffs failure-to-warn claim because the plaintiff “clearly intend[ed] to pursue claims unrelated to” its failure-to-warn claim by alleging causes of action including breach of express and implied warranties and design defects). Moreover, Texas appellate courts have applied the learned intermediary doctrine to a variety of causes of action predicated on the alleged inadequacy of a prescription drug manufacturer’s product warning. See, e.g., Rolen v. Burroughs Wellcome Co., 856 S.W.2d 607, 608 (Tex.App.-Waco 1993, writ denied) (involving a claim for breach of implied warranty of merchantability); Stewart v. Janssen Pharmaceutica, Inc., 780 S.W.2d 910, 910 (Tex.App.-El Paso 1989, writ denied) (involving negligence and strict liability claims).

We find the Norplant I court’s application of Texas law persuasive. Here, the Hamiltons initially pled a strict liability claim for failure to warn and retained that claim in their amended petition, but they decided not to carry it forward in their proposed jury charge. Furthermore, the Hamiltons’ fraud-by-omission claim is premised solely on its allegation that Cen-tocor knowingly omitted material facts about Remicade’s potential to cause lupus-like syndrome. In sum, the crux of the Hamiltons’ claims rests on Centocor’s alleged failure to provide an adequate warning of the potential risks and side effects associated with Remicade. We hold that when a patient alleges a fraud-by-omission claim against a prescription drug manufacturer for alleged omissions about a prescription drug’s potential side effects, (1) the patient cannot plead around the basic requirements of a failure-to-warn claim, and (2) the learned intermediary doctrine applies.30 Therefore, the learned intermediary doctrine applies to all of the Hamil-tons’ claims.

VII. The Hamiltons Presented No Evidence That the Allegedly Inadequate Warning Was the Producing Cause of Patricia’s Injuries

Although we conclude that the learned intermediary doctrine applies to all of the *170Hamiltons’ claims and find no reason to adopt any exception to the learned intermediary doctrine based on the facts of this case, as in other' products-liability cases premised on a product manufacturer’s failure to warn, if the warning to the intermediary was inadequate or misleading, then the manufacturer remains liable for injuries sustained by the end user. See, e.g., Aim, 717 S.W.2d at 592. The parties dispute whether Centocor’s warnings to Patricia’s prescribing physicians were adequate. Although the jury did not make a specific adequacy finding, all of the Hamil-tons’ claims require an implicit finding that Centocor’s warnings to Patricia and her medical providers were inadequate. Specifically, the jury found that Centocor misrepresented to Dr. Hauptman and Dr. Pop-Moody the probability that Patricia could suffer from drug-induced, lupus-like syndrome through its omission of material information in the product warning.

Generally, “[t]he adequacy of a warning is a question of fact to be determined by the jury.” Aim, 717 S.W.2d at 592; see Bituminous Cas. Corp. v. Black & Decker Mfg. Co., 518 S.W.2d 868, 873 (Tex.Civ.App.-Dallas 1974, writ refd n.r.e.). But when the prescribing physician is aware of the product’s risks and decides to use it anyway, any inadequacy of the product’s warning, as a matter of law, is not the producing cause of the patient’s injuries. See, e.g., Stewart, 780 S.W.2d at 912; Ethicon Endo-Surgery, Inc. v. Meyer, 249 S.W.3d 513, 516 (Tex.App.-Fort Worth 2007, no pet.); see also Ebel, 536 F.Supp.2d at 780 (“[W]here the physicians were unequivocal that new information about the risks would not have changed their decision to prescribe the medication, an inadequate warning was not the proximate cause of plaintiffs injury,” and “where a physician testifies that he was aware of the risks of which plaintiff complains, it is then the plaintiffs burden to prove that a different warning would have changed the physician’s decision to prescribe the medication.” (citations omitted)); Ackermann, 526 F.3d at 209 (“We need not determine, however, whether the warning for risk level of suicide was misleading, because, as [the prescription drug manufacturer] contends, this appeal is resolved on the second prong of the analysis, namely, whether any defect in the [manufacturer’s] warning was a substantial cause of [the plaintiffs injury].”). Cf. McNeil v. Wyeth, 462 F.3d 364, 373 (5th Cir.2006) (“Where the physician would have adequately informed a plaintiff of the risks of a disease, had the label been sufficient, but fails to do so on that account, and where the plaintiff would have rejected the drug if informed, the inadequate labeling could be a ‘producing’ cause of the injury, because it effectively sabotages the function of the intermediary.”).

Even assuming that the Hamil-tons presented sufficient evidence to show that Centocor’s warning to Patricia’s prescribing physicians was inadequate, the Hamiltons still had to prove that the inadequate warning was the producing cause of Patricia’s injuries.31 See, e.g., Jacobs, 480 S.W.2d at 605-06; Medrano, 28 S.W.3d at 94-95; Rolen, 856 S.W.2d at 609; Stewart, 780 S.W.2d at 911. It is undisputed that all of Patricia’s medical providers were aware that Patricia could potentially develop lupus-like syndrome as a side effect of *171Remicade. The Hamiltons presented no evidence that Patricia’s prescribing physicians or Patricia would have acted differently had Centocor provided a different warning that included post-approval information about lupus-like syndrome. Not only did the Hamiltons lack subjective evidence, but they presented no objective evidence that a different warning would have affected the decision of a reasonable doctor to prescribe Remicade for Patricia’s condition.

To support their argument that Cento-cor’s warning misrepresented the risks of contracting lupus-like syndrome, causing Patricia’s doctors to prescribe the drug, the Hamiltons focused on the three cases of lupus-like syndrome reported on Cento-cor’s 2001 package insert. The package insert stated: “In clinical studies, three patients developed clinical symptoms consistent with a lupus-like syndrome.... No cases of lupus-like reactions have been observed in up to three years of long-term follow-up.” In an attempt to show that this warning was misleading, the Hamil-tons introduced several documents indicating that Centocor was aware of more post-approval incidents of drug-induced lupus. Specifically, an internal Centocor e-mail referenced at least 174 reports of lupus-like syndrome associated with Remicade as of April 25, 2002.32 Dr. Matthews’s testimony and other trial exhibits indicated that the FDA was aware of these additional post-approval reports. According to Dr. Matthews — the only expert in the FDA approval process to testify about the Cen-tocor package inserts — although it initially seemed “not very clear” whether the statement, “[n]o cases of lupus-like reactions,” broadly encompassed all post-approval studies, on closer inspection, Dr. Matthews affirmatively stated that the warning “referred] to the long-term follow-up” of the specific patients in the pre-approval clinical studies. Dr. Matthews testified that, based on her review of all the post-approval reports for Remicade through 2003, the warning provided in the 2001 package insert was adequate. Moreover, despite its knowledge of the post-approval reports, the FDA did not require Centocor to change its package insert at that time.

Even assuming that Centocor’s knowledge of at least 174 post-approval reports of lupus-like syndrome and its failure to include that information in the package insert and the informational video made the warning to Patricia’s prescribing physicians inadequate or misleading, the undisputed evidence indicates that, even with those cases, the risk of experiencing drug-induced lupus was still “rare.” Experts from both sides testified that “rare” is commonly understood in the medical industry to mean less than 1% or 2% of all cases. The uncontroverted testimony of Dr. Matthews indicated that the 174 reported cases were out of nearly 500,000 patients who had received Remicade post-FDA approval — a mere 0.03% of all cases and well below the 1% definition of “rare.” Cf McNeil, 462 F.3d at 368 n. 4 (“We do not mean to suggest that de minimis differences in risk would send the adequacy question to the jury....”). Furthermore, Dr. Matthews testified that based on her review of all the post-approval data, at the time of trial, she believed the chance of developing lupus-like syndrome was still rare. Therefore, even if the patients in the 174 post-approval cases actually developed lupus-like syndrome because of Rem-*172icade and even if that information were included in the package insert, such de minimis differences in risk are legally insufficient to create a fact question for the jury. Patricia’s prescribing physicians would still have been faced with a decision of whether to prescribe a drug with a known rare side effect — a risk they were well aware of when they chose to prescribe Remicade.

Moreover, the Hamiltons failed to show that the warning’s alleged inadequacies regarding lupus-like syndrome would have changed Patricia’s prescribing physicians’ decision to prescribe Remicade in light of her complicated medical history and serious ailments. Dr. Hauptman testified that, based on his review of the academic literature, the Remicade package insert, and information he received from Centocor and through other experts at national meetings, he considered lupus-like syndrome to be a very rare side effect of the drug. Dr. Hauptman stated that he would want to know if Centocor was aware of more cases of patients contracting lupus-like syndrome and he believed reasonable patients would want to know if the risk had become “common or serious.” The fact that Dr. Hauptman would consider all clinical trials and post-approval evidence does not prove that he would not have prescribed Remicade — one of only two available treatments for Patricia’s Crohn’s disease — if additional reports would not have changed the relative risk of the side effect. Even if the additional reports mentioned in the Centocor e-mail constituted valid and reliable evidence of an elevated risk of developing lupus-like syndrome beyond that of a “rare” Remicade side effect, the fact that Dr. Hauptman would have considered such information, if included in the package insert, does not prove that the presence of such information would have changed his decision to prescribe Remi-cade to Patricia — a critical element of the Hamiltons’ claims.

Dr. Pop-Moody also testified that she was aware Remicade could cause lupus-like syndrome, but considered the cases very rare or “[l]ow on the differential.” When questioned about the three cases of lupus-like syndrome mentioned on the Remicade package insert, Dr. Pop-Moody testified that those were the only cases she was aware of at that time. Instead of proving that greater risk of lupus-like syndrome would have changed Dr. Pop-Moody’s decision to prescribe Remicade, the Hamiltons elicited no evidence to that effect. Like Dr. Hauptman, Dr. Pop-Moody admitted that she would have considered all available and pertinent information when making her decision to prescribe Remicade to Patricia. Yet again, the assertion that a doctor would consider all available information about a prescription drug’s risks and benefits before prescribing it does not prove that the alleged omission, which would not have changed the relative risk of contracting a potential side effect, was a producing cause of the patient’s injuries.

Not only did the Hamiltons fail to prove that Dr. Pop-Moody would have changed her prescription had Centocor provided information suggesting a higher risk of lupus-like syndrome, but the record indicates the opposite. Although post-approval studies after the Hamiltons filed suit in 2003 showed more reports of lupus-like syndrome and an increase in the number of patients in the pre-approval clinical studies that developed lupus-like syndrome, at the date of trial in 2006, Dr. Pop-Moody stated that she continued to prescribe “a lot of Remicade” and that she believed it to be an effective drug for many of her patients. Dr. Pop-Moody specifically warned Patricia that she might have SLE or lupus-like syndrome in April *1732003, but despite this warning, Patricia chose to continue receiving Remicade treatments and Dr. Pop-Moody continued prescribing them to her. Patricia’s actions indicate that, even if Centocor provided a different warning to her doctors, she would likely have continued Remicade treatments for her serious medical condition despite the risk of lupus-like syndrome. Patricia was also aware of other potentially serious, yet rare, side effects from Remicade, such as cancer, but chose to take the drug anyway.

Because Patricia’s prescribing physicians were aware of the potential risk of contracting lupus-like syndrome but chose to prescribe it in spite of those risks, and because the Hamiltons failed to present any evidence that including additional post-approval reports in the warning would have caused Patricia’s physicians to change their prescription, the Hamiltons failed to meet their burden of proof. See Stewart, 780 S.W.2d at 912; see also Ackermann, 526 F.3d at 208 (“If, however, ‘the physician was aware of the possible risks involved in the use of the product but decided to use it anyway, the adequacy of the warning is not a producing cause of the injury’ and the plaintiffs recovery must be denied.” (quoting Porterfield, v. Ethicon, Inc., 183 F.3d 464, 468 (5th Cir.1999))). Accordingly, because there is no causation evidence to support the Hamiltons’ claims, all of which are premised on Centocor’s alleged failure to warn, the Hamiltons’ claims must fail.33 We therefore need not address Centocor’s remaining issues.

VIII. Conclusion

All of the Hamiltons’ claims are premised on their theory that Centocor failed to adequately warn Patricia and her prescribing physicians of the risk that she could develop lupus-like syndrome from Remi-cade. Because the Hamiltons failed to meet their burden of proof on the causation element of their claims, as a matter of law, their claims fail. In sum, we hold that: (1) the learned intermediary doctrine generally applies within the context of the physician-patient relationship, and a prescription drug manufacturer fulfills its duty to warn its product’s end users by providing an adequate warning to the prescribing physician; (2) the court of appeals erred by adopting a DTC advertising exception to the doctrine; (3) the learned intermediary doctrine is not a common-law affirmative defense, but a common-law rule and its applicability was not waived by Centocor; (4) Dr. Bullen, as the non-prescribing, treating physician, owed no duty to warn Patricia of the risks associated with Remicade beyond the risks directly attributable to the infusion process; (5) because all of the Hamiltons’ claims are premised on Centoeor’s alleged failure to warn, the learned intermediary doctrine applies to all of their claims; and (6) the Hamiltons failed to introduce any evidence that the allegedly inadequate warning was the producing cause of Patricia’s purported injuries. Accordingly, we reverse the portions of the court of appeals’ judgment that are inconsistent with this opinion and render judgment that the Hamiltons take nothing.

LEVIN H. CAMPBELL, Circuit Judge.

Plaintiff appeals the district court’s dismissal, for failure to state a claim, of the complaint filed in this diversity action. See Fed.R.Civ.P. 12(b)(6). The complaint charged Miller Brewing Company and three manufacturers of glass products with negligence, gross negligence and breach of warranty in connection with the design and manufacture of a glass bottle used as a container for Miller Beer. 1 The complaint alleged that plaintiff, then eight years of age, was playing with friends near his home when he “found a non-returnable Miller High Life clear glass bottle” which had been “discarded by . persons unknown. . . .” During the course of play the “thin walled” bottle, in plaintiff’s words, “came in contact with a telephone pole.” Plaintiff, in his brief, has clarified this phrase, indicating that he was the party responsible for throwing the bottle against the pole. Following the impact of the glass container with the telephone pole the bottle shattered, and particles of glass entered plaintiff’s eye causing severe injury. Plaintiff’s basic premise is that Miller and the bottle manufacturers should have been aware of the dangers inherent in their “thin walled” “non-returnable” bottles and should have accordingly designed and marketed a product better able to safely withstand such foreseeable misuse as breakage in the course of improper handling by children.

The district court indicated that it accepted as true all the well-pleaded allegations, see O’Brien v. DiGrazia, 544 F.2d 543, 545 (1st Cir. 1976), cert. denied, 431 U.S. 914, 97 S.Ct. 2173, 53 L.Ed.2d 223 (1977), but nonetheless found the complaint deficient. The court concluded that “the defendant could [not] be negligent in any respect, nor, realistically, liable under any theory of warranty on the facts alleged. . . .” We affirm.

Plaintiff’s allegation of breach of warranty is based upon Mass. G.L. c. 106 § 2-314, which provides that a merchant impliedly warrants that his goods are, inter alia, “fit for the ordinary purposes for which such goods are used.” (Emphasis added.) The linchpin of the warranty claim (and, as will be seen, the negligence claim also) is thus the proper scope of the term ordinary purpose. While at first blush it might appear beyond dispute that throwing a glass container into a telephone pole is by no means an “ordinary” use of that product, some brief examination of recent authority relied on by plaintiff in support of the contrary view may be helpful in explaining just why the initial impression is, in fact, sound.

*190 In Back v. Wickes Corp.,-Mass.-, 378 N.E.2d 964 (1978), the Massachusetts Supreme Judicial Court explored the contours of section 2-314’s “ordinary purpose” concept and concluded that the “ ‘ordinary purposes’ contemplated by [that warranty] section include both those uses which the manufacturer intended and those which are reasonably foreseeable.” 378 N.E.2d at 969. “It is no more than a play on words,” the court concluded, “to charge that goods must be fit for ‘ordinary’ purposes, but not for ‘extraordinary’ or ‘different’ or ‘unusual’ purposes. Such [language] fails to inform . . as to whether the defendant has warranted the goods to be free from the propensity that caused the plaintiff’s injuries.” 378 N.E.2d at 968.

Seizing on these passages and the Supreme Judicial Court’s further admonition that a manufacturer must, in designing a product, “anticipate the environment in which [that] product will be used,” plaintiff urges that the present defendants might reasonably be found by a jury to have broken a fitness warranty by designing and manufacturing glass bottles unable to safely withstand the arguably foreseeable product abuse that occurred here.

The weakness with plaintiff’s contention, however, is that it divorces the language of the Back decision from that case’s underlying facts. Back involved the question of the liability of a manufacturer of motor homes for wrongful death and personal injuries resulting when one of its vehicles exploded and burst into flames following a collision with a cable fence at the side of the highway. Plaintiffs there maintained that the manufacturer’s positioning of the motor home’s gasoline tank was responsible for making an otherwise minor collision fatal. The court’s inquiry in Back, similar to that engaged in by other courts in the so-called second collision cases, see, e. g., Turcotte v. Ford Motor Co., 494 F.2d 173 (1st Cir. 1974); Larsen v. General Motors Corp., 391 F.2d 495 (8th Cir. 1968); Smith v. Ariens Co., 375 Mass. 620, 377 N.E.2d 954 (1978), focused on the question whether the defendant’s conscious design choices could be viewed as having rendered the motor home unreasonably dangerous to its users and therefore unfit for highway travel — its intended use. 378 N.E.2d at 970. In answering that question affirmatively and remanding the case for a new trial, we believe the Back court held only that a manufacturer’s warranty of product fitness for ordinary use includes a guarantee that such product will withstand, in a reasonably safe manner, foreseeable “misuse” incident to or arising out of the product’s intended use. See W. Prosser, The Law of Torts, § 96, p. 646 (1971). We think it would be stretching too far to believe that the Massachusetts courts are presently prepared to expand their definition of “ordinary purposes” to include the deliberate misuse of an otherwise reasonably safe container in a manner totally unrelated to any normal or intended use of that item. The Massachusetts Supreme Judicial Court previously has found no breach of a warranty of merchantability where a plaintiff was injured by glass breakage sustained in an attempt to pry the cover off a glass baby food jar with a beer-type can opener. 2 Vincent v. Nicholas E. Tsiknas Co., 337 Mass. 726, 151 N.E.2d 263 (1958). A fortiori, we can see no possible implied fitness warranty that an empty glass bottle discarded by unknown persons would more safely withstand being intentionally smashed against a solid stationary object. Under Massachusetts law the question of fitness for ordinary purposes is largely one centering around reasonable consumer expectations. Back, supra, 378 N.E.2d at 970; Vincent, supra, 151 N.E.2d at 265. “The propensity of glass to break under pressure is common knowledge,” Vincent, 151 N.E.2d at 265. No reasonable consumer would expect anything but that a glass beer bottle, apparently well suited for *191 its immediate intended use, would fail to safely withstand the type of purposeful abuse involved here. In fact, one would suspect that the present eight year old plaintiff knew well the expected result, if not the potential injury, of his conduct. What, if not the possibility of shattering the bottle, would lead him to throw it against the pole in the first place? Cf. Geary v. H. P. Hood & Sons, Inc., 336 Mass. 369, 145 N.E.2d 716, 717 (1957) (“It must be assumed . . . that children at play sometimes throw available objects for various reasons. But almost every object placed in schoolhouses and play yards for school purposes may conceivably inflict serious and regrettable injury when thrown.”)

The same considerations which lead us to conclude that the district court properly dismissed the plaintiff’s warranty claim indicate that the claims grounded in negligence are likewise fatally deficient. “By and large, the standard of safety of goods is the same under the warranty theory as. under the negligence theory. In both actions the plaintiff must show that the goods were unreasonably dangerous ... for the purpose to which they would.ordinarily be put. . . .”2 Harper and James, The Law of Torts, § 28.22, p. 1584 (1956); quoted in Schneider v. Chrysler Motors Corp., 401 F.2d 549 (8th Cir. 1968); see Smith v. Ariens Co., 375 Mass. 620, 377 N.E.2d 954, 957 (1978) (“Under our cases ... a manufacturer has [a] duty to design products so that they are reasonably fit for the purposes for which they are intended.”) 3

Plaintiff again, as he did in his warranty argument, attempts to expand the scope of the “intended” use concept by resort to the familiar, and sometimes misleading, rubric of “foreseeability.” But reliance on such generality is of limited assistance, for “In a sense, in retrospect almost nothing is unforeseeable.” Green v. Volkswagen of America, Inc, 485 F.2d 430, 438 (6th Cir. 1973) (quoting Mieher v. Brown, 54 Ill.2d 539, 301 N.E.2d 307 (Ill.1973), see also Prosser, supra, § 43, p. 267-68. One with the time and imagination and aided by hindsight no doubt can conjure up all sorts of arguably “foreseeable” misuses of a variety of otherwise reasonable safe products. We see no evidence that the Massachusetts courts have abandoned their previously expressed view that “a common or straightforward product, if safe for normal uses reasonably to be anticipated at the time of manufacture, is not defective [i. e., unfit for its intended use] simply because it is foreseeable that it may cause injury to someone using it improperly.” Tibbets v. Ford Motor Co., 4 Mass.App. 738, 358 N.E.2d 460, 462 (Appeals Ct. 1976). Indeed, the Supreme Judicial Court has recently cited with approval previous decisions of this and other circuit courts which have defined the scope of the concept of “intended use” as encompassing the “probable ancillary consequences of normal use,” and the consequences “incident to the normal and expected use” of a particular product. 4 Turcotte v. Ford Motor Co., 494 F.2d 173, 181 (1st *192 Cir. 1974), cited in Back v. Wickes, supra, 378 N.E.2d at 969; Larsen v. General Motors Corp., 391 F.2d 495, 502 (8th Cir. 1968), cited in Smith v. Ariens, supra, 377 N.E.2d at 957. Certainly the present product misuse falls far outside that definition.

Even under the most expansive theories of products liability, a “manufacturer is not an insurer and cannot be held to a standard of duty of guarding against all possible types of accidents and injuries” in any way causally related to the design and manufacture of its products. Schneider v. Chrysler Motors Corp., 401 F.2d 549, 557 (8th Cir. 1968). The world, as the Massachusetts Appeals Court has noted, is “full of rough edges.” Tibbets, supra, 358 N.E.2d at 462. Review of the relevant authority convinces us that the Massachusetts courts would not be prepared to hold a manufacturer liable for injuries sustained by an individual coming into contact with such “rough edges” created by his own intentional misuse of an otherwise “fit” product in a manner in no reasonable way related to the immediate intended uses for which the product was designed, manufactured and marketed. As the district court properly observed, the impact of endorsing a contrary conclusion would be overwhelming, with every discarded glass object holding the potential for generating a future lawsuit. 5

Affirmed.

*587McAULIFFE, Judge.

This products liability case presents two issues for review. The first involves instructions given on the subject of product misuse in a claim of strict liability in tort. The second involves the admissibility of reports offered as public records, or as material customarily relied upon by experts in the field in forming the basis of an opinion.

On February 25, 1980 Elizabeth Horton Ellsworth was severely burned when the flannelette nightgown she was wearing ignited as a result of its proximity to a front burner of her electric stove. By her original and amended declarations the plaintiff sued the seller of the nightgown, Sherne Lingerie, Inc. (Sherne) and the manufacturer of the textile from which the nightgown was made, Cone Mills Corporation (Cone Mills). The plaintiff advanced three principal theories of liability and sought punitive as well as compensatory damages. First, she alleged that Sherne and Cone Mills were negligent in failing to treat the nightgown so as to make it flame-resistant, and in failing to adequately warn consumers of the dangerous and flammable nature of the garment. Next, she alleged under the theory of strict liability in tort that both defendants had placed a defective and unreasonably dangerous garment into the stream of commerce, and that they had failed to give warnings of the risks or hazards associated with the garment. Finally, she sought recovery from Sherne on the ground that it had breached its implied warranty that the nightgown was fit for ordinary purposes.

At trial, the following facts were established. On the morning of February 25, 1980 plaintiff wore a lady’s nightgown into the kitchen to make coffee. She admitted that she was wearing the nightgown inside out and as a result the two pockets at the sides were flapping or protruding. The loosely fitting flannelette nightgown was made of a blend of 87%% cotton and Y¿Y¿°/o polyester. The fabric had been manufactured and sold by Cone Mills, and the night*588gown had been designed, manufactured and placed in the stream of commerce by Sherne.

In the kitchen, the plaintiff placed a tea kettle on the left front small burner of the electric range and turned the burner on “high.” The kettle only partially covered the burner and approximately Vie to lh inch of the burner’s perimeter was exposed. The plaintiff reached above the stove to obtain a coffee filter from one of the cupboards, and as she was reaching her gown came very close to or in contact with the exposed portion of the burner. The evidence permitted but did not compel a finding that the ignition source was the left pocket. As a result of the burns, the plaintiff suffered severe and permanent injuries.

Cone Mills sold the fabric for the nightgown to Sherne in 1977, and included in the shipping invoice the following warning:

This fabric is not intended for use in children’s sleepwear or robes in sizes 14 and under. Flammable. Does not meet standards for flammability in children’s sleepwear, FF5-74 and U.S. Department of Commerce Standard BOCFF3-71. Should not be worn near source of fire.

The language in the invoice was understood by Sherne to be a warning but Sherne made no attempt to convey the warning to consumers. Sherne offered testimony that no other American sleepwear manufacturer passed on any warning to the consumer.

Both defendants conceded it was foreseeable that the nightgown would be worn in a kitchen, and a defense expert conceded the likelihood it would be worn in close proximity to an electric range. Defense experts contended, however, that the fabric was safe for use in adult sleepwear, and that the fabric of the nightgown as well as the finished garment complied with the Federal standard for flammability of *589clothing textiles.1 Plaintiffs expert testified that the flammability characteristics of the nightgown caused it to be defective and unreasonably dangerous, and that the Federal flammability standard was inadequate for the protection of consumers in the light of information available at the time the nightgown was marketed.

At the close of the plaintiff’s case the trial judge granted the defendants’ motions for directed verdict on the punitive damage counts, and at the conclusion of the case the jury rendered a general verdict in favor of the defendants on the remaining counts. On appeal the Court of Special Appeals affirmed the lower court. Ellsworth v. Sherne Lingerie, Inc., 60 Md.App. 104, 481 A.2d 250 (1984). We granted plaintiff’s petition for certiorari to consider the following questions: (1) Whether the trial judge’s instructions on misuse of the product and the trial judge’s refusal to instruct that contributory negligence is not a defense to strict liability in tort constitute reversible error; and (2) whether annual reports to the President and the Congress required by the Flammable Fabrics Act and prepared by the Secretary of Health, Education and Welfare and the Consumer Product Safety Commission fall within the “public records” exception to the hearsay rule, or are otherwise admissible as reports regularly relied upon by experts in the field.

I

Misuse of Product

Appellant claims reversible error because the trial court gave an instruction on misuse of product as a possible defense to the strict liability claim. At trial, Judge Miller gave the following instruction to the jury:

With respect to strict liability, i[n] order for you to find in favor of the plaintiffs, you must find by a preponder*590anee of the evidence that the defendants manufactured a defective product which was unreasonably dangerous to the consumer and that the defect was the proximate cause of plaintiffs injuries. And that the defendant has not shown by a preponderance of the evidence that the plaintiff misused the product. So in the strict liability theory, it is for the plaintiff to show by a preponderance of the evidence that the defendants manufactured a defective product, which was unreasonably dangerous and that the defect was a proximate cause of the plaintiffs injuries.

On the other hand, it would be for the defendant, if they established—if the plaintiff established what I just mentioned, it would be the burden of the defendant to show that the defendant misused the product.

On a strict liability theory, you must find by a preponderance of the evidence that the defendant manufactured a defective product, which was unreasonably dangerous to the consumer and that the defect proximately caused the plaintiffs injuries. That is the burden of the plaintiff.

The burden is then upon the defendant to show that the plaintiff misused that product. So if the plaintiff meets her burden of [showing] the strict liability theory, you then- look as to whether the defendant might have shown a misuse of the product.

Appellant argues that the “evidence adduced at trial may be consistent with momentary inattention or carelessness on the part of Appellant, but is inconsistent with affirmative misconduct or use of the nightgown for an abnormal purpose.” Both defendants contend there was no error in the jury instruction on misuse. Sherne claims that “the trial court and the Court of Special Appeals found evidence in the record that the manner in which [plaintiff] used her nightgown may not have been a manner foreseeable by the manufacturer and therefore the misuse instruction to the *591jury was warranted.” Similarly, Cone Mills argues that misuse of the nightgown by the plaintiff became a jury issue based on evidence of the plaintiff’s use of the gown “in effect draping it over a hot burner for an appreciable period of time, [which] cannot seriously be considered a reasonably foreseeable manner of use.”

This Court, in Phipps v. General Motors Corp., 278 Md. 337, 363 A.2d 955 (1976) first applied the doctrine of strict liability in tort as expressed in the Restatement (Second) of Torts § 402 A.2 Under § 402 A, the seller will be liable if the product is in a “defective condition”, that is in a condition not contemplated by the ultimate consumer, and “unreasonably dangerous”, that is dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it, with ordinary knowledge common to the community as to its characteristics. Id. at 344, 363 A.2d 955. In Phipps, we noted:

Under § 402 A, various defenses are still available to the seller in an action based on strict liability in tort. These defenses are set forth and explained in the official comments following § 402 A. For example, the seller is not liable where injury results from abnormal handling or use of the product (Comment h), where mishandling or alteration after delivery of the product renders it unsafe (Comment g), or if warnings or instructions supplied with *592the product are disregarded by the consumer where, if used in accordance with these warnings, the product would be safe (Comment j). Id. at 346, 363 A.2d 955.3 Comment h to § 402 A provides a basis for the “misuse”

defense. It states:

A product is not in a defective condition when it is safe for normal handling and consumption. If the injury results from abnormal handling, as where a bottled beverage is knocked against a radiator to remove the cap; or from abnormal preparation for use, as where too much salt is added to food; or from abnormal consumption, as where a child eats too much candy and is made ill, the seller is not liable.

Most jurisdictions have adopted the Restatement view that misuse or abnormal use is a factor in a strict liability action.4

The courts, however, are split on the question of whether the issue of misuse properly arises as a part of a plaintiffs *593case, or is an affirmative defense. Some courts have referred to misuse as an affirmative defense or part of the defendant’s burden of proof. Davidson v. Stanadyne, Inc., 718 F.2d 1334 (5th Cir.1983) (applying the law of Texas); Beacham v. Lee-Norse, 714 F.2d 1010 (10th Cir.1983) (applying the law of Utah); Wood v. Stihl, Inc., 705 F.2d 1101 (9th Cir.1983) (applying the law of Washington); Noel v. S.S. Kresge Co., 669 F.2d 1150 (6th Cir.1982) (applying the law of Ohio); Harville v. Anchor-Wate Co., 663 F.2d 598 (5th Cir.1981) (applying the law of Texas); Hammond v. McDonough Power Equipment, Inc., 436 So.2d 842 (Ala.1983); Nelson v. Caterpillar Tractor Co., 694 P.2d 867 (Colo.Ct.App.1984); Uptain v. Huntington Lab, Inc., 685 P.2d 218 (Colo.Ct.App.1984); Matthews v. F.M.C. Corp., 190 Conn. 700, 462 A.2d 376 (1983); Gangi v. Sears, Roebuck & Co., 33 Conn.Sup. 81, 360 A.2d 907 (1976); Reeser v. Boats Unlimited, Inc., 432 So.2d 1346 (Fla.App.1983); McBride v. Ford Motor Co., 105 Idaho 753, 673 P.2d 55 (1983); Hancock v. Paccar, Inc., 204 Neb. 468, 283 N.W.2d 25 (1979); Márchese v. Warner Communications, Inc., 100 N.M. 313, 670 P.2d 113 (1983); Messler v. Simmons Gun Specialties, Inc., 687 P.2d 121 (Okl.1984); Kirkland v. General Motors Corp., 521 P.2d 1353 (Okl.1974); Allen v. Heil Co., 285 Or. 109, 589 P.2d 1120 (1979); Norman v. Fisher Marine Inc., 672 S.W.2d 414 (Tenn.App.1984); General Motors Corp. v. Hopkins, 548 S.W.2d 344 (Tex.1977); Mulherin v. Ingersoll-Rand Co., 628 P.2d 1301 (Utah 1981); Smith v. Sturm, Ruger & Co., Inc., 39 Wash.App. 740, 695 P.2d 600 (1985); Jackson v. Standard Oil Co. of California, 8 Wash.App. 83, 505 P.2d 139 (1972).

The recent trend in a number of courts has been to consider the question of misuse as a part of the plaintiff’s case, and as being directly related to the issues of defectiveness, or of proximate cause, or both. Schwartz v. American Honda Co., Inc., 710 F.2d 378 (7th Cir.1983) (applying the law of Illinois); McGowne v. Challenge-Cook Bros., Inc., 672 F.2d 652, 661 n. 2 (8th Cir.1982) (applying the law of Missouri); Amburgery v. Holan Division of Ohio Brass *594Co., 124 Ariz. 531, 606 P.2d 21, 22 (1980); Illinois State Trust Co. v. Walker Mfg. Co., 73 Ill.App.3d 585, 29 Ill.Dec. 513, 392 N.E.2d 70, 73 (1979); Henkel v. R. and S. Bottling Co., 323 N.W.2d 185, 191 (Iowa 1982); Hughes v. Magic Chef, Inc., 288 N.W.2d 542, 546 (Iowa 1980); Early-Gray, Inc. v. Walters, 294 So.2d 181, 186 (Miss.1974); Rogers v. Toro Mfg. Co., 522 S.W.2d 632, 637 (Mo.App.1975); Olson v. A.W. Chesterton Co., 256 N.W.2d 530, 535 (N.D.1977). Commentators have agreed. See L. Frumer & M. Friedman, Products Liability § 15.01 (1984); J. Dooley, Modern Tort Law § 32.79 (1983 & Cum.Supp.1984); Noel, Defective Products: Abnormal Use, Contributory Negligence, and Assumption of Risk, 25 Vand.L.Rev. 93, 96 (1972). ■

Other courts have referred to the “defense” of misuse without specifying whether it is an affirmative defense, or evidence that tends to negate the plaintiffs case. See for example Young v. Up-Right Scaffolds, Inc., 637 F.2d 810 (D.C.Cir.1980).

The problem of understanding the issue of misuse in strict liability cases is further compounded by the absence of agreement as to the meaning of the word. Misuse has been defined as: a use not reasonably foreseeable, Payne v. Soft Sheen Products, Inc., 486 A.2d 712, 725 (D.C.1985); Ford Motor Company v. Matthews, 291 So.2d 169, 174 (Miss.1974); a use of the product in a manner which defendant could not reasonably foresee, McGowne v. Challenge-Cook Bros., Inc., 672 F.2d 652, 661 (8th Cir.1982); Hughes v. Magic Chef, Inc., 288 N.W.2d 542, 545 (Iowa 1980); a use of a product where it is handled in a way which the manufacturer could not have reasonably foreseen or expected in the normal and intended use of the product and the plaintiff could foresee an injury as the result of the unintended use, Harville v. Anchor-Wate Co., 663 F.2d 598, 602-03 (1981) (applying the law of Texas); General Motors Corp. v. Hopkins, 548 S.W.2d 344, 348-52 (Tex.1977); a use or handling so unusual that the average consumer could not reasonably expect the product to be designed and manufactured to withstand it—a use which the seller, therefore, *595need not anticipate and provide for, Findlay v. Copeland Lumber Co., 265 Or. 300, 509 P.2d 28, 31 (1973); use of the product which constitutes wilful or reckless misconduct or an invitation of injury, Gangi v. Sears, Roebuck & Co., 33 Conn.Sup. 81, 360 A.2d 907, 909 (1976). The Fifth Circuit, in Jones v. Menard, 559 F.2d 1282, 1285 n. 4 (5th Cir.1977) (applying the law of Louisiana), defined misuse in the context of the three types of products cases. That court said,

[i]n inadequate warning cases misuse means that the seller had no duty to warn against unforeseeable uses of its products, while in design cases misuse means that the manufacturer had no duty to design a product so as to prevent injuries arising from unforeseeable uses of that product.... In defective manufacture cases, however, misuse means that the injury was not caused by some inherent defect in the product but by the consumer’s abnormal use of it....5

It has been suggested that misuse means any use not intended by the manufacturer, but this is too narrow and fails to take into account a variety of uses reasonably foreseeable although not subjectively intended. It has also been suggested that virtually anything is possible, and thus arguably foreseeable, so that foreseeability as a test is too broad.

We conclude, as have most courts which have considered the issue, that “reasonable foreseeability” is the *596appropriate test, and thus a seller is required to provide a product that is not unreasonably dangerous when used for a purpose and in a manner that is reasonably foreseeable.6 If a product is unreasonably dangerous for such use it is “defective” within the meaning of § 402 A of the Restatement, and if that defect is a cause of damage the seller will be responsible. On the other hand, if the product is not unreasonably dangerous when used for a purpose and in a manner that is reasonably foreseeable, it simply is not defective, and the seller will not be liable.7

Misuse of a product may also bar recovery where the misuse is the sole proximate cause of damage, or where it is the intervening or superseding cause.8 For example, a high speed electric drill may be defective because a manufacturing defect causes it to short circuit and produce a shock during normal usage. A plaintiff who attaches a brush to that drill and in attempting to clean his teeth suffers injury to his mouth from the high speed of the brush will lose because his misuse is the sole cause of his misfortune, and the defect in the drill is not in any way related to the harm.9

*597Misuse may also embrace the concept of mishandling. As Comment g of § 402 A states “the seller is not liable when he delivers the product in a safe condition, and subsequent mishandling ... make[s] it harmful by the time it is consumed.” The burden of proof is upon the plaintiff to show that the product was in a defective condition when it left the hands of the seller.

From what we have said it is apparent that questions of misuse of the product are involved in the determination of whether the product was defective, and whether a defect was the proximate cause of the injury. Because defectiveness and causation are elements which must be proved by the plaintiff, we conclude that misuse is not an affirmative defense. Misuse, therefore, is a “defense” only in the sense that proof of misuse negates one or more essential elements of a plaintiff’s case, and may thereby defeat recovery.

In contrast, “assumption of risk” is an affirmative defense, and where properly raised by the pleadings,10 may be an issue in a strict liability case. As the Court of Special Appeals stated in Sheehan v. Anthony Pools, 50 Md.App. 614, 626 n. 11, 440 A.2d 1085 (1982), aff'd, 295 Md. 285, 455 A.2d 434 (1983) (Part III adopted in full), “The three subjective elements that the defendant must show are: 1) the plaintiff actually knew and appreciated the particular risk or danger created by the defect; 2) the plaintiff voluntarily encountered the risk while realizing the danger; and 3) the plaintiff’s decision to encounter the known risk was unreasonable.”11 To conclude our general discussion of “defenses” we repeat our earlier holding that contributory negligence is not a defense in an action of strict liability in tort. Anthony Pools v. Sheehan, supra, 295 Md. at 299, 455 *598A.2d 434. Conduct which operates to defeat recovery may in fact be negligent, but confusion will be avoided if it is remembered that a plaintiff is barred only because such conduct constitutes misuse or assumption of risk, and not because it constitutes contributory negligence.12

Applying these principles to the facts of this case, we conclude the evidence was insufficient to generate an issue of misuse, and that the trial judge erred in allowing the jury to consider misuse of the product as a possible bar to recovery. Clearly, and concededly, Appellant was using the nightgown for a reasonably foreseeable purpose. We conclude that her manner of use of the nightgown, though possibly careless, was reasonably foreseeable as a matter of law. It certainly may be foreseen that wearing apparel, such as nightgowns and robes, will occasionally be worn inside out. It is also foreseeable that a loosely fitting gown will come into contact with sources of ignition in the environment where it may be expected to be worn, and particularly when worn in the kitchen and near a stove. Momentary inattention or carelessness on the part of the user, while it may constitute contributory negligence, does not add up to misuse of the product under these circumstances.

Plaintiff also alleges error because the trial court refused to instruct the jury that contributory negligence is not a defense to a strict liability action. A plaintiff in a *599products liability case may plead alternative causes of action, and if the plaintiff alleges negligence in addition to strict liability, a defendant may be entitled to instructions on contributory negligence, assumption of risk, and misuse. A jury could easily misapply a contributory negligence defense to a strict liability action13 and care must be taken to explain the law applicable to each cause of action.

In Sheehan v. Anthony Pools, supra, 50 Md.App. at 623, 440 A.2d 1085, the Court of Special Appeals noted that jury instructions were silent as to the manner in which an injured plaintiff had used a diving board. The court said that “there is substance to the [plaintiffs] claim that the jury was left without guidance on a point of critical importance, i.e., the type of conduct on the part of the consumer in the use of the product which could or could not afford a valid defense to the seller....” Id. The court concluded “an instruction should have been granted that [the plaintiff’s] inadvertent or careless use of the [product] would not bar his recovery.” Id. at 626, 440 A.2d 1085.

When theories of negligence and strict liability in tort are being presented to a jury, and the defense of contributory negligence is properly before the jury, a trial judge may well find it helpful to specifically instruct the jury that contributory negligence is not a defense to the strict liability action. In some cases, however, where the same conduct may conceivably constitute both contributory negligence and misuse of a product, a negative instruction may not be the best approach, and the trial judge may find that a careful explanation of each cause of action and any defenses applicable thereto is preferable. We therefore decline to adopt a per se rule relating to the granting of a negative instruction where both causes of action are *600present,14 preferring instead the flexible approach of Md. Rule 2-520(c):

The court may instruct the jury, orally or in writing or both, by granting requested instructions, by giving instructions of its own, or by combining any of these methods. The court need not grant a requested instruction if the matter is fairly covered by instructions actually given.

II

Evidentiary Rulings

We turn to a consideration of evidentiary questions that are likely to recur upon retrial. These questions involve five separate reports required by the Flammable Fabrics Act to be made to the President and the Congress by government officials.15 We shall treat separately three issues bearing on the admissibility of these reports or parts thereof: relevance, admissibility to demonstrate the basis of an expert’s opinion, and admissibility pursuant to a public records exception to the hearsay rule.

*601A

Relevance

Relevance has been defined in McCormick on Evidence § 185, at 541 (E. Cleary 3d ed. 1984) as follows:

There are two components to relevant evidence: materiality and probative value. Materiality looks to the relation between the propositions for which the evidence is offered and the issues in the case. If the evidence is offered to help prove a proposition which is not a matter in issue, the evidence is immaterial. What is “in issue,” that is, within the range of the litigated controversy, is determined mainly by the pleadings, read in the light of the rules of pleading and controlled by the substantive law.

The second aspect of relevance is probative value, the tendency of evidence to establish the proposition that it is offered to prove.

Under any theory advanced by appellant she was obliged to show that the nightgown was unreasonably dangerous to a prospective user when it was sold. Proof that the product was unreasonably dangerous is clearly required in an action based upon strict liability in tort, and it is no less important when the plaintiff is attempting to prove negligence in the design or sale of the product, or attempting to prove the negligent failure to include an adequate warning or instruction. Her burden was made more difficult by the fact that the material of this nightgown met and exceeded the requirements of the Federal standard for flammability of clothing textiles.16 Appellant sought to introduce evidence of the incidence and severity of burns caused by ignition of clothing that was subject to the Federal standard in order to overcome the inference that clothing which complied with that standard was not unreasonably dangerous.

*602Compliance with a statutory standard is evidence of due care, but compliance with the standard does not preclude a finding of negligence for failure to take additional precautions. See W. Prosser & W. Keeton, The Law of Torts § 36 (5th ed. 1984). Similarly, in a strict liability case proof that a product complied with a statutory standard does not preclude a finding of defectiveness. See J. Dooley, Modern Tort Law § 32.54 (1983 & 1984 Cum.Supp.). See also Gryc v. Dayton-Hudson Corp., 297 N.W.2d 727 (Minn.1980), cert. denied, 449 U.S. 921, 101 S.Ct. 320, 66 L.Ed.2d 149 (1980) (affirming an award for punitive damages despite evidence of compliance with the Flammable Fabrics Act).17

The reports are material to the issues and tend to establish the proposition that the nightgown as sold was unreasonably dangerous to prospective users, and therefore the reports should not have been excluded on grounds of relevance.

B

Basis of Expert’s Opinion

In addition to offering the reports as substantive evidence (see Part II C, infra) appellant also offered testimony concerning the contents of the reports to explain the basis of her expert’s opinion. Dr. Stephen Spivak, a professor in the Department of Textile and Consumer Economics at the University of Maryland, testified that the nightgown was defective and unreasonably dangerous due to its flammability characteristics, and that the 1953 Federal standard was inadequate for the protection of consumers. In attempting to explain the basis of his opinions, Dr. Spivak sought to utilize data taken from the reports. He testified concerning the statutory mandate for the preparation of the *603reports and that the data contained within the reports was recognized as reliable and was in fact relied upon by him and by other experts in the field. The trial judge ruled that testimony concerning the data contained in the reports was inadmissible as hearsay.

The proffered evidence was indeed hearsay, but was admissible for the limited purpose of explaining the basis for the expert’s opinion. In Attorney Grievance Comm’n v. Nothstein, 300 Md. 667, 679, 480 A.2d 807 (1984), Judge Smith carefully reviewed the history and development of this rule of evidence, and quoted as follows from D. Binder, Hearsay Handbook § 1.01, at 451 (2d ed. 1983):

The federal courts and a majority of state courts permit an expert witness to express an opinion that is based, in part, on hearsay of a kind that is customarily relied on by experts in that particular business, profession, or occupation. However, the hearsay itself is not admissible as substantive evidence. It is only admissible to explain the basis of the expert’s opinion. In other words, the trier of fact is allowed to give credence to an expert’s opinion that is based on the assumption that certain hearsay is true, but is not allowed to give credence to the hearsay itself. This rule has long been accepted in Maryland. Consol.

Mech. Contractors v. Ball, 263 Md. 328, 283 A.2d 154 (1971); Airlift, Ltd. v. Bd. of Co. Cornm’rs, 262 Md. 368, 278 A.2d 244 (1971); Baltimore & O.R.R. v. Hammond, 128 Md. 237, 97 A. 532 (1916); Baltimore City v. Hurlock, 113 Md. 674, 78 A. 558 (1910).

Appellant was entitled to elicit from her expert the reasons for his opinion, and having laid a proper foundation for the introduction of statistical information contained in the reports, the evidence should have been admitted.

C

Public Records Exception

Appellant also offered the reports as substantive evidence, suggesting their admissibility pursuant to a public *604records exception to the hearsay rule.18 The reports were properly authenticated, and the only objections interposed were on grounds of relevance and hearsay. In rejecting the reports, Judge Miller said:

I am not going to admit either one of them. I think to admit a document, first of all a hearsay document—it may be a document of the United States government, but you cannot try cases on the basis of documents containing hearsay information....

The reports are clearly hearsay in character, and contain not only primary hearsay, but secondary and tertiary hearsay as well. Appellant does not dispute this but contends that reports required by law to be prepared by a government official and submitted annually to the President and the Congress enjoy a presumption of reliability that is not rebutted by any evidence in this case, and that the reports should therefore have been admitted.

McCormick on Evidence § 315, at 888 (E. Cleary 3d ed. 1984) describes the common law exception for public records: “The common law evolved an exception to the hearsay rule for written records and reports of public officials under a duty to make them, made upon firsthand knowledge of the facts. These statements are admissible as evidence of the facts recited in them.”

The modern trend has been to admit public records when the information is gathered by a public officer under a statutory duty to investigate and record or certify facts ascertained by other than personal observation. 5 J. Wigmore, Evidence § 1635, at 531 (3d ed. 1940) states:

Now there may be cases in which the officer’s duty clearly does involve his ascertainment of facts occurring out of his presence and requiring his resort to sources of *605information other than his own senses of observation; for example, an assessor’s record of the value of real estate and its occupancy, or a registrar of voters’ record of electors’ residences. When such a duty clearly exists, the general doctrine above, that a witness should have personal knowledge, need not stand in the way, for (as already noted) it has its conceded limitations; and where the officer is vested with a duty to ascertain for himself by proper investigation, this duty should be sufficient to override the general principle. It is true that due caution should be observed before reaching the conclusion that the law has in fact in a given case intended to invest the officer with such an unusual duty. But when it clearly appears that a duty has been prescribed to investigate and to record or certify facts ascertained other than by personal observation, then it follows that, in accordance with the general principle of the present exception, the statement thus made becomes admissible.

In reaching the same result, McCormick on Evidence § 317, at 737-38 (E. Cleary 2d ed. 1972) reasoned:

To some extent, the conclusions of a professional investigator making inquiries required by his professional and public duty contain assurances of reliability analogous to those relied upon as assuring accuracy of his statements of fact from firsthand knowledge. A skilled investigator can be presumed to report as accurate or to rely upon a hearsay statement only after inquiry into its accuracy. Often such an inquiry, by one professionally equipped to make it well and on the scene at a time when events are fresh and inquiry is most likely to be fruitful, could be relied upon to assure the reliability of those hearsay statements upon which he relies. Much the same could be said of his conclusions. In both cases, it is clear that the report and its conclusions are recognized by all concerned to lay the foundation for future official action, which is likely to stimulate the same habitual accuracy in reporting facts known that underlies the exception for official records generally. (Footnotes omitted).

*606Fed.R.Evid. 803(8) provides that the following are not excluded by the hearsay rule, even though the declarant is available as a witness:

Public records and reports. Records, reports, statements, or data compilations, in any form, of public offices or agencies, setting forth (A) the activities of the office or agency, or (B)' matters observed pursuant to duty imposed by law as to which matters there was a duty to report, excluding, however, in criminal cases matters observed by police officers and other law enforcement personnel, or (C) in civil actions and proceedings and against the Government in criminal cases, factual findings resulting from an investigation made pursuant to authority granted by law, unless the sources of information or other circumstances indicate lack of trustworthiness.19

As stated in the advisory committee notes following the rule, “[¡Justification for the exception is the assumption that a public official will perform his duty properly and the unlikelihood that he will remember details independently of the record.”

The discussion of the Fourth Circuit Court of Appeals in Ellis v. International Playtex, Inc., 745 F.2d 292, 300 (4th *607Cir.1984), is helpful in understanding the reasons which underlie the rule:

“Admissibility in the first instance” is assumed because of the reliability of the public agencies usually conducting the investigation, and “their lack of any motive for conducting the studies other than to inform the public fairly and adequately.” Kehm v. Proctor & Gamble, 724 F.2d 613, at 618, 619 (8th Cir.1983). This is not to say that a report containing the findings of a public agency, made pursuant to an investigation authorized by law, is always admissible. To the contrary, if “sufficient negative factors are present” to indicate the report is not trustworthy, it should not be admitted. Fed.R.Evid. 803(8)(C), advisory committee note. The factors that may be used to determine admissibility include: (1) the timeliness of the investigation; (2) the special skill or experience of the official; and (3) possible motivation problems. Id. But the burden is on the party opposing admission to demonstrate that the report is not reliable. See Kehm, at 618; Baker v. Elcona Homes Corp., 588 F.2d 551, 558 (6th Cir.1978), cert. denied, 441 U.S. 933, 99 S.Ct. 2054, 60 L.Ed.2d 661 (1979).

Placing the burden on the opposing party makes considerable practical sense. Most government sponsored investigations employ well accepted methodological means of gathering and analyzing data. It is unfair to put the party seeking admission to the test of “re-inventing the wheel” each time a report is offered. Rather than requiring the moving party to spend considerable time and money to ensure that the experts who conducted the study are available at trial, it is far more equitable to place that burden on the party seeking to demonstrate why a time tested and carefully considered presumption is not appropriate.

The interpretations given Fed.R.Evid. 803(8)(C) by the federal courts have not been entirely harmonious. Initially, some courts expressed concern over the admission of reports where the government official did not appear to have *608firsthand knowledge of the facts. There is now general recognition, however, that the hearsay nature of the evidence is a factor to be considered in determining the presence or absence of trustworthiness, but the presence of any level of hearsay does not, by that fact itself, render the report untrustworthy. McCormick on Evidence § 316, at 890 (E. Cleary 3d ed. 1984) states:

Investigative reports ... as the name indicates embody the results of some kind of investigation and accordingly almost by definition are not the product of firsthand knowledge on the part of the declarant, which is characteristic of most hearsay exceptions. Also, investigations vary with respect to the timeliness and nature of the inquiry, the procedures followed, possible motivational factors, and the skill of the official or agency. It is not surprising that considerable differences of views developed among courts regarding the wisdom of admitting investigative reports as an exception to the rule against hearsay. The trend, however, has been to recognize that much useful evidence is to be found in investigative reports, with impetus from the many statutory enactments providing for admissibility. (Footnotes omitted).

The more difficult problem, and the one that has produced a significant disagreement among the courts, involves the admissibility of opinions, conclusions and determinations of the investigating officer or agency. The rule speaks to the admissibility of “factual findings” resulting from an investigation, but increasing numbers of federal appellate courts are allowing trial judges broad discretion to accept opinions and judgments found in “evaluative reports”. Reference to the legislative history is not helpful in resolving this conflict.

The meaning of the term “factual findings” is left unclear by the legislative history. The Advisory Committee’s Note, after referring to the federal statutes conferring admissibility upon various kinds of investigative reports, concluded “the willingness of Congress to recognize a substantial measure of admissibility for evaluative re*609ports is a helpful guide.” The Report of the House Committee on the Judiciary took an opposing stand: “The Committee intends that the phrase ‘factual findings’ be strictly construed and that evaluations or opinions contained in public reports shall not be admissible under this Rule.” House Comm, on Judiciary, Fed.Rules of Evidence, H.R.Rep. No. 650, 93d Cong., 1st Sess., p. 14 (1973). The Report of the Senate Committee on the Judiciary rejected this view: “The committee takes strong exception to this limited understanding of the application of the rule____ The committee concludes that the language of the rule together with the explanation provided by the Advisory Committee furnish sufficient guidance on the admissibility of evaluative reports.” Senate Comm, on Judiciary, Fed.Rules of Evidence, S.Rep. No. 1277, 93d Cong., 2d Sess., p. 18 (1974). McCormick on Evidence § 316, at 890-91 n. 7 (E. Cleary 3d ed. 1984).

The line between “fact” and “opinion” is often difficult to draw. An investigating body may hear diametrically opposed testimony on the question of whether one person or another struck the first blow, and proceed to decide the issue as a finding of “fact”. That determination necessarily has a judgmental quality, and differs, for example, from a finding of fact that a certain number of persons suffered burns from ignition of clothing fabric during a given period. Conclusions found in reports need not be judgmental. A conclusion that there has been a significant increase in fabric-related burn injuries is essentially factual if the datum shows a 60% increase. Thus, attaching labels of “fact” or “opinion” or “conclusion” will not necessarily resolve the issue, and careful attention must be given to the true nature of the statement and the totality of circumstances bearing on the ultimate issue of reliability. Third level *610hearsay may possess significant indicia of reliability in one case and be clearly unreliable in another.20

In Ellis and in Kehm reports of epidemiological studies conducted by the Center for Disease Control and reporting the incidence of menstruation and tampon use among those persons suffering toxic shock syndrome were found admissible, each court noting that complaints about the methodology of data collection were insufficient to overcome the presumption of reliability.

In Robbins v. Whelan, 653 F.2d 47 (1st Cir.), cert. denied, 454 U.S. 1123, 102 S.Ct. 972, 71 L.Ed.2d 110 (1981) a Department of Transportation National Highway Safety Bureau report providing information on maximum stopping distances for all automobiles manufactured in a certain year was held admissible, even though the data was supplied by individual automobile manufacturers. The court noted that data collection was required by regulations issued by the National Highway Safety Bureau, and although the required tests were not monitored by federal officials the circumstances under which the information was collected and reported were indicative of reliability.

The greater number of federal courts considering Rule 803(8)(C) have adopted the more liberal view of the Senate Committee on the Judiciary, and have admitted evaluative reports unless sufficient negative factors were present to demonstrate unreliability. See, e.g., Chandler v. Roudebush, 425 U.S. 840, 96 S.Ct. 1949, 48 L.Ed.2d 416 (1976) (prior administrative findings made with respect to employ*611ment discrimination claim admitted in federal-section trial de novo); Ellis v. International Playtex, Inc., supra (analysis of statistics relating to tampon use and incidence of toxic shock syndrome admitted); Wilson v. Beebe, 743 F.2d 342 (6th Cir.1984) (memorandum of police captain finding subordinate officer had acted contrary to department training in weapons use and handling admitted in negligence action against police officer); Litton Systems, Inc. v. American Tel. & Tel. Co., 700 F.2d 785 (2d Cir.1983) (Federal Communications Commission decision finding telephone company tariffs to be unreasonable, discriminatory, and unnecessarily restrictive admitted in anti-trust action); Falcon v. General Tel. Co. of Southwest, 626 F.2d 369 (5th Cir.1980), vacated on other grounds, 450 U.S. 1036, 101 S.Ct. 1752, 68 L.Ed.2d 234 (1981) (findings of Government Services Administration contained in letter to employer admitted in employment discrimination action); Garcia v. Gloor, 618 F.2d 264 (5th Cir.1980) (findings of Equal Employment Opportunities Commission and Texas Employment Commissioner’s Appeal Tribunal admitted in employment discrimination action); Lloyd v. American Export Lines, Inc., 580 F.2d 1179 (3d Cir.), cert. denied sub nom, Alvarez v. American Export Lines, Inc., 439 U.S. 969, 99 S.Ct. 461, 58 L.Ed.2d 428 (1978) (decision of Coast Guard hearing examiner that claims of assault and battery and of intoxication were not proven admitted in unseaworthiness claim); Baker v. Elcona Homes Corp., 588 F.2d 551 (6th Cir.1978), cert. denied, 441 U.S. 933, 99 S.Ct. 2054, 60 L.Ed.2d 661 (1979) (police accident report containing opinion of officer as to which vehicle entered intersection on red light admitted in civil action).

While most courts have determined that evaluative reports are to be admitted or excluded in the exercise of the sound discretion of the trial court, the Ninth Circuit has determined that administrative findings are admissible per se in employment discrimination claims whether brought under Title YII of the Civil Rights Act of 1964 (42 U.S.C. § 2000e et seq.) or under 42 U.S.C. § 1981. See Plummer *612v. Western Intern. Hotels Co., Inc., 656 F.2d 502 (9th Cir.1981).

We agree that the Public Records exception to the hearsay rule appropriately allows the reception of reliable facts, and will be recognized in this state in the form in which it appears at Fed.R.Evid. 803(8). We make clear, however, that the term “factual findings” will be strictly construed and that evaluations or opinions contained in public reports will not be received unless otherwise admissible under this State’s law of evidence.21

The Public Records exception as here adopted will permit the reception of reliable facts otherwise difficult to bring before the trier of fact, but avoid the influence of opinions that ordinarily ought to be received only after full opportunity for examination of the witness’ credentials and full opportunity for cross examination concerning the basis of any opinion expressed.

We also make clear that even though the burden rests upon the party opposing the introduction of a public record to demonstrate the existence of negative factors sufficient to overcome the presumption of reliability, this does not mean that additional evidence will be required in every case to meet that burden. Indicia of unreliability may be contained in the report itself, or may be disclosed by the evidence of the party offering the report.

Additionally, we point out that the inclusion within a factual report of inadmissible evaluations or opinions need not necessarily result in exclusion of the entire report, and the trial judge should consider redaction of the report in that event.

*613We do not rule on the admissibility of these reports because that determination should be made in the first instance by the trial judge if they are offered on retrial.

JUDGMENT OF THE COURT OF SPECIAL APPEALS REVERSED; CASE REMANDED TO THAT COURT WITH DIRECTIONS TO REVERSE THE JUDGMENT OF THE CIRCUIT COURT FOR MONTGOMERY COUNTY AND REMAND FOR A NEW TRIAL; COSTS TO BE PAID BY APPELLEES.

ELDRIDGE, Judge,

concurring:

I agree with the result reached by the majority, and I join in Part I of the opinion. I also agree with the majority’s adoption in Part II of the “Public Records” exception to the hearsay rule. Nevertheless, I would not “strictly construe” or limit the exception to “factual findings.” To deny the trial court any discretion in admitting evaluations or opinions contained in public records is both contrary to the weight of the case law and unsound.

One formulation of the public records exception is set forth in Fed.R.Evid. 803(8)(C), which provides that public documents containing “factual findings resulting from an investigation made pursuant to authority granted by law” are not to be excluded by the hearsay rule. (Emphasis added.) As we are adopting the public records exception as a common law development, and since we are not construing a rule or statute, we are not of course limited by the wording of the federal rule. Nonetheless, even the cases under the federal rule have not strictly construed or applied the phrase “factual findings.”

The majority cites several federal cases which have addressed the construction to be given the “factual findings” language of Rule 803(8)(C). The majority quotes Ellis v. International Playtex, Inc., 745 F.2d 292 (4th Cir.1984), regarding the rule’s underlying rationale. The court in Ellis further noted (745 F.2d at 301):

*614[303 Md. 581 (1985).]

“Although there has been some disagreement over whether ‘evaluative’ public records or reports were intended by Congress to be considered ‘factual findings’ for the purposes of Fed.R.Evid. 803(8)(C), it is well established that the phrase should be interpreted broadly.” (Emphasis added.)

One of the cases relied upon in Ellis was Kehm v. Proctor & Gamble Mfg. Co., 724 F.2d 613 (8th Cir.1983), in which it was stated (724 F.2d at 618):

“[Cjourts construing the term ‘factual findings’ in Rule 803(8)(C) have given it broad scope. See, e.g., United States v. American Telephone & Telegraph Company, 498 F.Supp. 353, 360 (D.D.C.1980) (citing cases). They have often admitted government reports setting forth agency opinions and conclusions on the ground that such reports, because they are public records based on investigations conducted pursuant to lawful authority, are presumptively reliable. That is, ‘there is no reason not to admit the findings simply because they tend towards the conclusory rather than the factual end, unless, as Rule 803(8)(C) further provides, the ‘sources of information or other circumstances indicate lack of trustworthiness.’ Id. See also Baker v. Elcona Homes Corp., [588 F.2d 551 (6th Cir.1978), cert. denied, 441 U.S. 933, 99 S.Ct. 2054, 60 L.Ed.2d 661 (1979)]; United States v. School District of Ferndale, Michigan, 577 F.2d 1339, 1354 (6th Cir.1978). We agree with the district court that once a report is conclusively shown to represent findings of a public agency made pursuant to an investigation authorized by law, the central inquiry becomes whether the report is trustworthy.”

The overwhelming majority of cases are in accord with this view. Litton Systems v. American Telephone & Telegraph Co., 700 F.2d 785 (2d Cir.1983), cert. denied, — U.S. -, 104 S.Ct. 984, 79 L.Ed.2d 220 (1984); Melville v. American Home Assur. Co., 584 F.2d 1306 (3d Cir.1978); Wetherill v. University of Chicago, 518 F.Supp. 1387 (N.D.Ill.1981); Zenith Radio Corp. v. Matsushita Electrical *615Industrial Co., Ltd., 505 F.Supp. 1125 (E.D.Pa.1980); see 4 Weinstein’s Evidence, ¶ 803(8)[03].

As I understand the majority, the Court is drawing a firm line between “fact” and “opinion,” and is requiring the trial judge to distinguish, in every instance in which a public record is offered for admission, between fact and opinion. The majority is not allowing the trial judge any latitude or discretion in admitting evaluations or conclusions if, as a matter of law, they are deemed to fall within the category of “opinions.” This is an unworkable rule.

The principal problem with this approach, as the majority seems to acknowledge, is that there is often no clear line between “fact” and “opinion.” This Court, regarding the gray area between the two, stated in Glaros v. State, 223 Md. 272, 277, 164 A.2d 461 (1960): “The assumption that there is a difference in kind between ‘fact’ and ‘opinion’ has been said to be an illusion. ‘There is no conceivable statement however specific, detailed, and “factual,” that is not in some measure the product of inference and reflection as well as observation and memory.’ ”

By not allowing the trial judge any discretion, the Court forces him to go painstakingly through any public record or report and attempt to exclude all material that may not be in the strictest sense “factual.” This could present a very difficult and time consuming task, and one in which there are no satisfactory guidelines. Moreover, the majority’s position will present a problem not only to the trial courts, but to the appellate courts as well. In every case where the public records exception is involved, an appeal may be predicated on the ground that certain “opinions” were erroneously admitted or that relevant “facts” were excluded.

In my view, the trial judges should be given some degree of discretion in admitting the contents of public records. If a public agency or official is deemed to supply sufficiently accurate and trustworthy reports for the factual findings to be admitted into evidence, it should logically follow that the agency’s or official’s conclusions would also be sufficiently *616reliable. To decide otherwise, by denying the trial court any discretion when admitting public records, is unreasonable.

Accordingly, I would follow the majority of cases in allowing the trial court a degree of discretion with regard to the admissibility of the contents of public records. Therefore, I cannot join all of Part II of the Court’s opinion.

Justice GONZALES

delivered the opinion for a unanimous Court.

The principal question in this case is when does the doctrine of comparative responsibility apply in a products-liability case. Relying on its reading of our decision in Keen v. Ashot Ashkelon, Ltd., 1 the court of appeals held that the decedent’s responsibility for the accident that resulted in his death should not be compared with the manufacturer’s responsibility because *587 the decedent’s actions merely amounted to the failure to discover or guard against a product defect. 2 We conclude that: (1) comparative responsibility applies in strict liability if a plaintiffs negligence is something other than the mere failure to discover or guard against a product defect, and (2) there was evidence here the decedent was negligent apart from the mere failure to discover or guard against a product defect. We also conclude that punitive damages may not be awarded in this case because the evidence is legally insufficient to support the finding of gross negligence. Therefore, we reverse the court of appeals’ judgment and render judgment for the plaintiffs’ actual damages, as reduced by the jury’s comparative responsibility finding.

I

Because there were no witnesses, relatively little is known first hand about the circumstances of the accident that is the basis of this litigation. Lee Sanchez, Jr. left his home to feed a pen of heifers in March 1993. The ranch foreman found his lifeless body the next morning and immediately called Sanchez’s father. Apparently, Sanchez’s 1990 Chevy pickup had rolled backward with the driver’s side door open pinning Sanchez to the open corral gate in the angle between the open door and the cab of the truck. Sanchez suffered a broken right arm and damaged right knee where the gate crushed him against the door pillar, the vertical metal column to which the door is hinged. He bled to death from a deep laceration in his right upper arm.

The Sanchez family, his estate, and his wife sued General Motors Corporation and the dealership that sold the pickup for negligence, products liability, and gross negligence based on a defect in the truck’s transmission and transmission-control linkage. The plaintiffs presented circumstantial evidence to support the following theory of how the accident happened. Sanchez drove his truck into the corral and stopped to close the gate. He mis-shifted into what he thought was Park, but what was actually an intermediate, “perched” position between Park and Reverse where the transmission was in “hydraulic neutral.” Expert witnesses explained that hydraulic neutral exists at the intermediate positions between the denominated gears, Park, Reverse, Neutral, Drive, and Low, where no gear is actually engaged. Under this scenario, as Sanchez walked toward the gate, the gear shift slipped from the perched position of hydraulic neutral into Reverse and the truck started to roll backwards. It caught Sanchez at or near the gate and slammed him up against it, trapping his right arm and knee. He was pinned between the gate and the door pillar by the pressure the truck exerted while idling in Reverse. Struggling to free himself, Sanchez severed an artery in his right arm and bled to death after 45 to 75 minutes.

In the trial court, G.M. offered alternative theories explaining the cause of the accident, all of which directed blame at Sanchez. It suggested that Sanchez left his truck in Reverse either accidentally or in a conscious attempt to prevent cattle from escaping the corral. Alternatively, G.M. suggested that Sanchez simply left the truck in Neutral and it rolled down the five degree slope toward the gate. Finally, G.M. argued that even if the accident was caused by a mis-shift as alleged by the plaintiffs, the mis-shift was a result of operator error, and not a defect in design.

The jury rejected G.M.’s theories and found that G.M. was negligent, the transmission was defectively designed, and G.M.’s warning was so inadequate as to constitute a marketing defect. The jury also found that Sanchez was fifty percent responsible for the accident, but the trial court disregarded this finding. The trial court rendered judgment for actual and punitive damages of $8.5 million for the plaintiffs. A panel of the court of appeals affirmed the trial court’s judgment with one justice dissenting. 3 Sitting en banc, a *588 majority of the court of appeals adopted the panel’s opinion and judgment. 4 Two justices joined the dissent, and one concurred in the judgment. 5

G.M. argues that there is no evidence to support liability for negligence or strict liability. Alternatively, G.M. challenges the trial court’s refusal to apply the comparative responsibility statute. 6 The plaintiffs respond that evidence supports both the negligence and strict liability findings, and that Sanchez’s negligence was nothing more than a failure to discover or guard against a product defect. Thus, they contend, comparative responsibility does not apply here as a defense to strict liability.

Here, G.M. does not dispute that Sanchez’s fatal injury was caused when he mis-shifted the truck’s transmission into hydraulic neutral, which then migrated into Reverse. The parties agree that all transmissions made today can mis-shift, that no design eliminates the possibility of a mis-shift, and that a mis-shifted car is dangerous. As G.M. puts it, a “[m]is-shift is just physics.” G.M. contends that it has no liability, even if its product is defective, because the plaintiffs failed to present evidence of a safer alternative design.

We consider first the evidence of strict liability. We will sustain G.M.’s no evidence point only if there is no more than a scintilla of evidence to prove the existence of a product defect. 7

II

A design defect renders a product unreasonably dangerous as designed, taking into consideration the utility of the product and the risk involved in its use. 8 A plaintiff must prove that there is a safer alternative design in order to recover under a design defect theory. 9 An alternative design must substantially reduce the risk of injury and be both economically and technologically feasible. 10 We first examine the evidence concerning the operation of the transmission in Sanchez’s truck and then determine whether the plaintiffs have proven a safer alternative design.

A

Most of the plaintiffs design evidence came in through the testimony of the plaintiffs’ expert, Simon Tamny, who testified about the operation of the 700R4 transmission in Sanchez’s truck. He opined that the G.M. transmission and transmission-control linkage presented a particular risk. All transmissions have an intermediate position between Reverse and Park. It is impossible, under federal standardization guidelines, to design a gear shift without an intermediate position between Reverse and Park. However, Tamny testified that G.M.’s transmission has the added danger that internal forces tend to move the gear selector toward Reverse rather than Park when the driver inadvertently leaves the lever in this intermediate position. Tamny explained how G.M. could alter the design to make the operation of the 700R4 safer.

When a driver moves the gearshift of Sanchez’s truck from one position to another, a system of rod linkage transmits the motion from the gearshift on the steering column to the manual lever of the transmission. The manual lever is a semicircular part which is also known as the “rooster comb” because of the series of tooth-like peaks and dips along the perim- *591 trial court. 15 Because the only evidence to prove causation was not competent, we sustained the legal sufficiency challenge. 16 To allow a Robinson challenge here, when G.M. did not object at all in the trial court to the reliability of the expert evidence, “would deny [the plaintiffs’] experts the opportunity to ‘pass muster’ in the first instance and usurp the trial court’s discretion as ‘gatekeeper.’ ” 17

G.M. argues that regardless of our resolution of the Robinson issues, the substance of Tamny’s testimony does not amount to evidence of a safer alternative design. G.M. contends that Tamny’s testimony was based on “speculation and conjecture,” citing Schaefer v. Texas Employers’ Insurance Association 18 and Burroughs Wellcome Co. v. Crye. 19 We disagree. In Schaefer, an expert testified that in his opinion, Schaefer’s disease resulted from his employment. The expert based his opinion on his assumptions that Schaefer had contracted the avian form of a certain disease, that the pathogen causing the disease was present in bird droppings at Schaefer’s workplace, and that Schaefer had contracted the disease from the bird droppings. 20 No evidence was introduced to show that Schaefer had the avian form of the disease. No evidence was introduced to show that bird droppings at Schaefer’s workplace were infected with the pathogen. Likewise, no evidence was introduced to show how Schaefer contracted the disease. Based on that record, we held that the expert’s opinion was founded upon mere possibility, speculation, and surmise. 21 In Burroughs Wellcome Co., Crye suffered an injury to her foot that she attributed to frostbite from using the defendant’s antiseptic spray. 22 Crye’s expert assumed that her foot turned white after she applied the spray. He attributed this symptom to frostbite in giving his opinion and stated that had the foot turned red, his diagnosis would be different. 23 At trial, the testimony indicated that Crye’s foot turned red after application of the antiseptic spray. We held that when the only facts in evidence contradict the assumption of the expert upon which his opinion is based, his opinion is “without probative value and cannot support a verdict or judgment.” 24

Unlike Schaefer or Burroughs Wellcome Co., here there is more to the evidence than an expert’s bald assertion that his design would be safer. Tamny described the current operation of the 700R4 transmission at length, and explained in some detail how his proposed design would make the transmission safer by eliminating the risk that the vehicle could move in a powered gear due to an inadvertent mis-shift. “It will take you from a 90% solution to a 99% solution,” he said. Tamny’s testimony about the engineering principles underlying his proposed design support his conclusion that his design features would be safer than those in the 700R4.

G.M. mis-characterizes Tamny’s testimony by considering whether each individual feature of Tamny’s design makes the design safer, instead of considering the design as a whole, and by considering the plaintiffs’ testimony in light of its statistical evidence instead of considering the plaintiffs’ evidence alone. G.M. argues that none of the other manufacturers’ designs incorporating different aspects of Tamny’s design have proven safer than G.M.’s and that Tamny offered no testing evidence or engineering principles to show his design was safer. Without this evidence, G.M. concludes, Tamny’s opinion is mere speculation.

*592 However, the plaintiffs did not have to build and test an automobile transmission to prove a safer alternative design. A design need only prove “capable of being developed.” 25 The Restatement (Third) of Torts: Products Liability takes the position that “qualified expert testimony on the issue suffices, even though the expert has produced no prototype, if it reasonably supports the conclusion that a reasonable alternative design could have been practically adopted at the time of sale.” 26 Furthermore, assuming we could consider evidence contrary to the verdict, 27 no manufacturer has incorporated Tammy’s design into an existing transmission. For that reason alone, G.M.’s statistical evidence comparing the safety of different existing designs could not conclusively establish the safety of Tamny’s design.

The evidence supporting Tamny’s conclusion that his design is safer raises a fact question that the jury resolved in favor of the plaintiffs. We conclude that the plaintiffs have presented more than a scintilla of evidence that Tamny’s alternative design substantially reduced the risk of injury.

Having determined that the plaintiffs met their burden of proving some evidence of design defect, we need not consider G.M.’s challenge to the findings of a marketing defect or negligence. We next consider whether to give effect to the jury’s comparative responsibility findings.

Ill

The jury found that Sanchez was fifty percent responsible for his accident. G.M. argues that this finding should be applied to reduce its liability for damages whether in negligence or strict liability. However, the plaintiffs argue that Sanchez’s actions amounted to no more than a failure to discover or guard against a product defect and, because of our decision in Keen v. Ashot Ashkelon, Ltd., 28 such negligence does not constitute a defense to strict liability. To review the plaintiffs’ claim, we must first consider the effect of the 1987 revisions to Chapter 33 of the Civil Practice and Remedies Code upon our decision in Keen.

Before 1987, cases were submitted under the statutory comparative negligence system of Chapter 33 of the Texas Civil Practice and Remedies Code. 29 Comparative negligence explicitly governed only claims for negligence. If strict liability was asserted against any defendant, comparative negligence did not apply. 30 Because Keen was filed before the effective date of the 1987 revisions to Chapter 33 and involved a claim based in strict liability, the statute did not apply. Thus, in Keen the common law of Duncan v. Cessna Aircraft CO. 31 governed the effect of a claimant’s negligence on a strict liability claim. 32 In Duncan, this Court adopted a comparative causation scheme in strict liability cases that allowed comparison of a plaintiffs conduct regardless of whether it should be characterized as assumption of the risk, misuse, or failure to mitigate or avoid damages. 33 It reaffirmed the rule in comment “n” to § 402A of the Restatement (Second) of Torts, that negligent failure to discover or guard against a product defect is not a defense. 34

*593 Relying on Duncan, the Keen majority held that a negligent failure to discover or guard against a product defect is not a defense against strict liability. 35 The Court characterized the plaintiffs conduct as a failure to discover or guard against a product defect, rather than an assumption of a known risk, thus implying that these were the only two choices. 36 The Court therefore refused to apply the jury’s comparative causation finding to reduce recoverable damages.

The scope of the Court’s holding in Keen is difficult to assess when read in fight of (1) the language in Duncan that seems to recognize the existence of a type of conduct that was more than a mere failure to discover or guard against a product defect and less than an assumption of the risk 37 and (2) the unanswered criticism of the majority opinion in the dissenting opinions by Chief Justice Phillips and Justice Gonzalez. 38 Both dissenting opinions fault the majority for considering only two types of plaintiff conduct: the failure to discover or guard against a product defect and assumption of the risk. 39 Both dissents argued that the plaintiff in Keen was negligent without regard to any defect, and such negligence should be considered when apportioning responsibility. 40 The Keen majority did not respond to this criticism, however. Thus, after Keen, it was unclear whether a plaintiffs negligence other than a failure to discover or guard against a product defect should be submitted as part of a comparative responsibility inquiry.

In 1987, the Legislature changed Chapter 38 from comparative negligence to comparative responsibility. Under comparative responsibility, a court reduces a claimant’s damages recovery by the “percentage of responsibility” attributed to him by the trier of fact. 41 The new statute expressly included suits based on strict tort liability. 42 It defined “Percentage of responsibility” as the percentage that a party “cause[d] or contribute^] to cause in any way, whether by negligent act or omission, ... [or] by other conduct or activity violative of the applicable legal standard” the harm for which damages are sought. 43 Thus, as the emphasized language indicates, the new statute applies to a claimant’s conduct that violated the duty to use ordinary care or some other applicable legal standard.

G.M. contends that the 1987 revisions of Chapter 33 effectively overrule Keen. It is not quite that simple. Implicit in this Court’s holding in Keen was that a consumer has no duty to discover or guard against a product defect. 44 The 1987 changes to Chapter 33, which apportion responsibility based on a breach of a legal duty or other applicable legal standard, do not impose a new duty on plaintiffs. The statute merely says that if a claimant breaches an existing duty, then comparative responsibility shall apply. Accordingly, if a plaintiffs failure to discover or guard against a product defect breaches no duty, the statute does not apply.

Thus, Keen’s viability after the 1987 revisions depends on whether a plaintiff in a strict liability case has a duty to take steps to discover and guard against product defects. The Duncan Court refused to recognize such a failure as a defense, relying in part on comment n to section 402A of the Restatement (Second): 45

*594 Contributory negligence of the plaintiff is not a defense when such negligence consists merely in a failure to discover the defect in the product, or to guard against the possibility of its existence. On the other hand the form of contributory negligence which consists in voluntarily and unreasonably proceeding to encounter a known danger, and commonly passes under the name of assumption of risk, is a defense under this Section as in other cases of strict liability. If the user or consumer discovers the defect and is aware of the danger, and nevertheless proceeds unreasonably to make use of the product and is injured by it, he is barred from recovery. 46

We note that comment “n” was not carried forward in the Restatement (Third). 47 The position of Restatement (Third), section 17(a), is that a plaintiffs conduct should be considered to reduce a damages recovery if it fails to conform to applicable standards of care, similar to the Texas 1987 statutory scheme. However, comment “d” to Restatement (Third) states:

[W]hen the defendant claims that the plaintiff failed to discover a defect, there must be evidence that the plaintiffs conduct in failing to discover a defect did, in fact, fail to meet a standard of reasonable care. In general, a plaintiff has no reason to expect that a new product contains a defect and would have little reason to be on guard to discover it. 48

We believe that a duty to discover defects, and to take precautions in constant anticipation that a product might have a defect, would defeat the purposes of strict liability. 49 Thus, we hold that a consumer has no duty to discover or guard against a product defect, but a consumer’s conduct other than the mere failure to discover or guard against a product defect is subject to comparative responsibility. Public policy favors reasonable conduct by consumers regardless of whether a product is defective. A consumer is not relieved of the responsibility to act reasonably nor may a consumer fail to take reasonable precautions regardless of a known or unknown product defect. We therefore disapprove of Keen to the extent it suggests that the failure to discover or guard against a product defect is a broad category that includes all conduct except the assumption of a known risk. Because we conclude that a consumer has no duty to discover or guard against a product defect, we next determine whether the decedent’s conduct in this case was merely the failure to discover or guard against a product defect or some other negligence unrelated to a product defect.

The truck’s owner’s manual describes safety measures designed to ensure that the truck would not move when parked: (1) set the parking brake; (2) place the truck completely in Park; (3) turn off the engine; (4) remove the key from the ignition; and (5) check that Park is fully engaged by pulling down on the gear shift. Sanchez’s father testified that his son probably read the entire owner’s manual. The plaintiffs own experts agreed at trial that Sanchez failed to perform any of the safety measures described in the owner’s manual and that performing any one of them would have prevented the accident. This evidence is sufficient to support the jury’s negligence finding.

Regardless of any danger of a mis-shift, a driver has a duty to take reasonable precautions to secure his vehicle before getting out of it. The danger that it could roll, or move if the engine is running, exists independently of the possi *595 bility of a mis-shift. For instance, the driver could inadvertently leave a vehicle in gear or a mechanical problem unrelated to a product defect could prevent Park from fully engaging. A moving vehicle without a driver is a hazard to public safety. The state licenses drivers who have demonstrated the minimum knowledge and skill necessary to safely operate a motor vehicle. 50 Many, perhaps most, consumer products may be operated without a license, including lawn and garden equipment, household appliances, and powered hand tools. It follows then that, because of this licensing requirement, as well as other special duties imposed on drivers, 51 more is expected of an operator of a motor vehicle than of users of most other consumer products. Thus, although we do not expect the average driver to have the engineering background to discover defects in their car’s, transmission, we do expect the reasonably prudent driver to take safety precautions to prevent a runaway car. 52 Sanchez had a responsibility to operate his truck in a safe manner. The fact that the precautions demanded of a driver generally would have prevented this accident does not make Sanchez’s negligence a mere failure to discover or guard against a mis-shift.

We recognize that there may be some tension between how we apply the law to the facts of this case and the Keen majority’s characterization of the plaintiffs conduct in that case. As discussed previously, the Keen analysis was flawed from the outset because it recognized only two categories of plaintiff conduct: mere failure to discover or guard against a defect and assumption of the risk. All conduct that was not assumption of the risk was categorized as failure to discover or guard against a defect and thus no defense. Today, we hold that a plaintiffs conduct other than the mere failure to discover or guard against a product defect is subject to comparative responsibility.

Sanchez’s actions amounted to conduct other than a mere failure to discover or guard against a product defect. We hold as a matter of law that such conduct must be scrutinized under the duty to use ordinary care or other applicable duty. We conclude that there was legally sufficient evidence to support the jury’s verdict that Sanchez breached the duty to use ordinary care and was fifty percent responsible for the accident.

IV

We next consider the punitive damages award. The plaintiffs are entitled to punitive damages if they established all elements of gross negligence. Broadly speaking, gross negligence is the breach of duty involving an extreme degree of risk, considering the probability and magnitude of the potential harm to others (an objective element) when the actor has actual awareness of the risk involved but nevertheless proceeds in conscious indifference to the rights, safety, or welfare of others (a subjective element). 53 Evidence of gross negligence is legally sufficient if, considered as a whole in the light most favorable to the prevailing party, it rises to a level that would enable reasonable and fair-minded people to differ in their conclusions. 54 Some evidence of simple negligence is not evidence of gross negligence; conversely, some evidence of care does not defeat a gross negligence finding. 55

*596 Only G.M.’s own gross negligence, either by the corporation’s own acts or omissions or by the agents’ or employees’ acts or omissions that are attributable to the corporation, will support punitive damages against it. 56 A court reviews all surrounding facts and circumstances to decide if a corporation itself is grossly negligent. 57 The inquiry “is determined by reasonable inferences the factfinder can draw from what the corporation did or failed to do and the facts existing at relevant times that contributed to a plaintiffs alleged damages.” 58

A

We first decide whether the evidence of the objective element, when considered as a whole, is legally sufficient. We have said that an “extreme degree of risk” is a likelihood of serious injury. 59 G.M.’s experts agreed that a mis-shifted automobile is very dangerous. The only dispute is whether the evidence is legally sufficient to show the likelihood of serious injury. We conclude the evidence is sufficient. The plaintiffs’ expert, Tamny, knew of “about 500” mis-shift cases. In experiments, the transmission migrated into Reverse each time Tamny intentionally mis-shifted. G.M.’s experts admitted they had just testified in a similar case in California. G.M.’s statistical evidence tended to show that the possibility of serious injury was remote, but reasonable minds could differ about the degree of risk. Thus the evidence supports the objective element.

B

The subjective element requires proof that the defendant knew about the danger, but its acts or omissions demonstrate that it did not care. 60 This element may be shown by direct or circumstantial evidence. 61 Much of the evidence the court of appeals discussed, including the bases for the expert opinions, was relevant to the issue of the degree of risk and G.M.’s knowledge of the danger, but did not show that G.M. was consciously indifferent. Considered as a whole, the evidence here rises to the level that reasonable minds could differ over whether G.M. was actually aware of the mis-shift danger, but that does not establish conscious indifference.

To show G.M.’s conscious indifference, the plaintiffs offered expert testimony from Juan Hererra, who characterized G.M.’s conduct as a “conscious decision,” and Tamny, who said that G.M. “knew that people were getting hurt and they made the decision not to do anything about the design ... or to warn properly.”

Hererra’s tautological statement sheds little light on the relevant issue, whether G.M. was consciously indifferent to a known serious risk. Moreover, Her-erra gave his opinion in response to a hypothetical question about a manufacturer who gives no warning. Here, G.M. gave a warning, which we will discuss presently. If an expert’s opinion is based on facts that are materially different from the facts in evidence, then the opinion is not evidence. 62 As for Tamny’s testimony, the fact that G.M. did not implement a new design is not evidence it was not working on the problem. G.M. presented evidence of engineering work over a period of years to modify and improve its transmissions. An example is the 1989 patent application describing a design to alleviate the mis-shift problem. The 1989 design could not be implemented because federal standardization guidelines require the Park, Reverse, Neutral, Drive, Low shift pattern.

*597 Moreover, there was no evidence that G.M. was aware of any other design with a better safety record than the 700R4 transmission. While Tamny testified as to his own alternative design, there is no evidence of G.M.’s prior knowledge of it. We do not believe that G.M. can be consciously indifferent solely for failing to adopt a safer design it did not know existed. One of the main factors supporting punitive damages in many product defect cases is the fact that the manufacturer is aware of specific design changes that would have made the product safer. 63 In Grimshaw for instance, Ford deliberately chose to implement a more dangerous design because it believed that it would save more money than it would have to pay out in damages. 64 There is no such evidence in this case. 65 No evidence supports the inference that G.M. made a conscious choice to implement a more dangerous design in preference to a known safer one that would have substantially reduced the risk.

As for the warning, the court of appeals concluded that G.M.’s warning was so vague that it would allow an inference that G.M. consciously decided to downplay the mis-shift danger. But an inference must not be based on mere surmise or speculation. 66 G.M. warned:

CAUTION: It can be dangerous to get out of your vehicle if ... your shift lever is not fully in “P” (Park).... Your vehicle can roll. If you have left the engine running, the vehicle can move suddenly. You or others could be injured. To be sure your vehicle won’t move, even when you’re parking on level ground, follow the steps below.

[[Image here]]

1. Hold the regular brake pedal down with your right foot and apply the parking brake all the way first....

2. To move the shift lever into “P” (Park), pull the lever toward you and move it up as far as it will go.

3. [applicable to four-wheel drive only]

[[Image here]]

4. If you don’t have to leave the engine running, (briefly)—

• Move the ignition key to “LOCK.”

• Remove the key and take it with you.

5. Before you leave the driver’s seat, check that your vehicle is in park by trying to pull the shift lever out of “P” (Park) — by pulling down on the shift lever without first pulling it toward you. If you can do this, it means the shift lever wasn’t fully locked into “P” (Park). Or, check that your vehicle is in park by pocketing the key. If you can remove the key, the vehicle is in “P” (Park).

While the warning here does not use the word “mis-shift,” it does warn that a vehicle not “fully in Park” could “move suddenly” and could be dangerous. It is not necessary to know the specific engineering facts about hydraulic neutral to appreciate that a vehicle can be shifted into something less than full Park. G.M. could have explicitly warned its customers that the vehicle can migrate into a powered gear if not fully in Park, but no other manufacturer has such a warning, and it was undisputed that following any one of the precautions contained in the warning would have *598 prevented the accident. The issue in gross negligence is not whether G.M. developed and used the best warning imaginable. We believe this warning, standing alone, does not provide a reasonable basis upon which to infer conscious indifference.

After reviewing the evidence in this case under the Moriel standard, we hold the evidence of conscious indifference is not legally sufficient to support the gross negligence finding.

V

In conclusion, we hold that (1) there is some evidence of a product defect; (2) comparative responsibility applies because there was evidence of negligence beyond the mere failure to discover or guard against a product defect; and (3) there is no evidence supporting the gross negligence finding. Accordingly, we reverse the court of appeals judgment and render judgment that the plaintiffs recover their actual damages reduced by the jury’s finding of fifty percent comparative responsibility.

Miller, Judge.

David R. Bowen and his wife sued Fred Cochran and Classy Cooker Manufacturer’s, Inc. for injuries he sustained when a gas cooking grill manufactured by Cochran exploded, causing severe bums to Bowen’s hands and forearms. The jury found in favor of Cochran.1 On appeal Bowen contends that the court erred in denying his motions for directed verdict on Cochran’s affirmative defenses of assumption of the risk and contributory negligence and erred in charging the jury on these defenses. We discern no error and affirm.

A directed verdict is proper where there is no conflict in the evidence as to any material issue and the evidence introduced with all reasonable inferences therefrom demands a particular verdict.2 “Except in plain, palpable and undisputed cases where reasonable minds cannot differ as to the conclusions to be reached, questions of contributory negligence and assumption of risk are for the jury.”3

*458The evidence showed that Bowen, who had previously bought two other cookers from Cochran, purchased a third cooker and was using it at his home. Bowen rolled up newspaper to light the burner on the cooker and then opened the gas valve. The cooker lit, and Bowen went into his home for approximately 30 minutes. When Bowen returned, the flame had extinguished, so he raised the lid and turned off the gas. After waiting for a few minutes for the gas smell to dissipate, Bowen made three attempts to relight the cooker by once again lighting the end of rolled up newspaper and placing it on the burner and then opening the gas valve. During the third attempt, Bowen bent over to look into the cooker when a burst of flame exploded, knocking him to the ground and burning his hands and forearms.

1. Bowen argues that the court erred in denying his motion for directed verdict on Cochran’s affirmative defense of assumption of the risk.

Cochran argues that he explained to Bowen how to properly light the cooker with a trigger lighter, but that Bowen instead chose to light the cooker with balls of newspaper and a match. He further argues that he also explained to Bowen how to properly ventilate the cooker if the flame went out and that Bowen was aware through his own experience that a gas cooker must be ventilated after the flame extinguishes before it can be relit.

To show assumption of the risk, “the defendant must present evidence that the plaintiff had actual knowledge of the danger, understood and appreciated the risk, and voluntarily exposed himself to that risk.”4 Cochran testified that the cookers are lit by opening the sliding door for ventilation, holding the trigger lighter to the burner to start a flame, and then turning on the gas valve. Although there were no written instructions on how to operate the cooker, Cochran provided. Bowen with a trigger lighter and explained to him how to light the cooker. Cochran himself observed Bowen improperly light the cooker by lighting the orifice at the end where the gas enters. He explained to Bowen that he was lighting it improperly and once again showed Bowen the proper lighting procedure.

There must be some evidence that Bowen knew that the cooker could explode if not properly lighted and ventilated, that he understood the risk if the cooker was improperly operated, and that he nevertheless decided to risk operating the cooker improperly. The evidence in fact showed that Bowen lit the cooker improperly on at least two occasions and in two different manners: once by using newspaper instead of the trigger lighter provided by Cochran, and a second time by lighting the end close to where the gas enters. Bowen also left the *459cooker unattended for 30 minutes with the gas turned on. From this evidence a jury could conclude that Bowen did in fact assume the risk of a flame bursting from the cooker. As there is some evidence to support the affirmative defense of assumption of the risk, the court did not err in denying Bowen’s motion for directed verdict on this ground.5

2. The jury could also have concluded that Bowen was contributorily negligent. “A plaintiff’s contributory negligence bars any recovery whatsoever if his failure to use ordinary care for his own safety is the sole proximate cause of his injuries, even though such negligence concurs with the negligence of the defendant.”6 The evidence that Bowen could have assumed the risk as explained in Division 1 is also evidence from which a jury could conclude that Bowen failed to use ordinary care in operating the cooker. Thus, the court did not err in denying Bowen’s motion for directed verdict on this ground.7

The dissent argues that the defense’s pleadings did not properly raise the affirmative defense of assumption of the risk, but this is irrelevant in light of the fact that this defense was raised by the evidence without objection, thereby amending the pleadings.8 Moreover, in his motion for directed verdict, Bowen argued that there was no evidence to support assumption of the risk, not that this defense was improperly pleaded. It was for the jury to weigh the evidence and decide whether the cooker’s potentially faulty design was to blame for Bowen’s injuries or that it was Bowen’s own actions in lighting the cooker with newspaper and a match (that creates a much larger flame than a trigger lighter), or his leaving the cooker unattended for 30 minutes, or improperly lighting the cooker as he had previously. Here, there is a conflict in the evidence as to a material issue, and the evidence does not demand a particular verdict. As there was some evidence to support assumption of the risk and contributory negligence, the court did not err in denying the motion for directed verdict.

3. Bowen argues that the court erred in instructing the jury on the affirmative defenses of assumption of the risk and contributory negligence. “When there is any evidence, however slight, upon a particular issue, it is not error for the court to charge the law in relation to that issue.”9 As there was evidence from which a jury could con-*460elude that Bowen assumed the risk of his injury and was contributorily negligent, the court did not err in giving such instructions.10

Judgment affirmed.

Eldridge, Judge,

dissenting.

I respectfully dissent, because neither the pleadings nor any evidence properly raises or supports the affirmative defense of assumption of the risk; therefore, it was error for the trial court to deny the motion for directed verdict and to charge on assumption of the risk over timely objection.

Cochran verbally instructed Bowen that to light the propane gas cooker the gas is turned on and the source of ignition is inserted through the opening of the sliding door to the burner, and that, when lighted, the needle valve is adjusted; if the cooker flame goes out, then the propane gas valve is shut off; the lid is opened and closed several times to force the collected gas out, because it is heavier than air; the gas is allowed to dissipate for five minutes; the gas valve is again opened; and the source of ignition is again touched to the burner until it lights. Bowen testified that he lit the cooker; that he left it burning; that he was gone about 30 minutes; and that on his return he found that the burner flame was out.

So I raised the lid [,] cut the gas off at the tank[,] and cut the needle valve off. ... I was waiting for a few minutes to be sure that you didn’t smell any more gas. And, of course, I left the lid up also. ... I first got me some paper, rolled it up real tight, lit the end of it, laid it back onto the burner [,] . . . opened the gas valve, and then opened the needle valve. I could hear the gas . . . then it did not light. . . . So I immediately turned the gas off again, turned the needle valve off again because,. . . trying to be very cautious as far as lighting this particular type of cooker. So I waited a few more minutes, got me another piece of paper, rolled it up, lit it, did the same process, leaning down laying the paper on the pipe, stick my arm way up in there, got it laying on the burner again, opened the gas valve at the tank and then opened the needle valve. Well, when I opened the needle valve, of course, you hear the gas spewing. It didn’t light. Well, I laid — eased down, started trying to look up in there to see where the flame was, and I could see the flame on the paper. Then all of a sudden this big ball of fire came at me, knocked me down.

*461Except for the use of a lighted paper laid on the burner so that his hand was not in the cooker with a trigger lighter flame, this was how Cochran instructed Bowen that lighting and relighting was to be done. In point of fact, to use a trigger lighter flame by putting a hand inside the cooker after the gas was turned on, instead of placing a burning paper on the burner and turning on the gas, was more dangerous. Thus, there was no evidence in the record to raise the issue of an assumption of the risk affirmative defense.

Obviously in this case, the gas buildup near the burner was ventilated sufficiently so that three attempts to relight the cooker with a flaming taper neither immediately lit the burner nor caused an instantaneous explosion upon the burning paper being placed in the opening, no less on the burner. If the cooker had not been ventilated, then the introduction of a trigger lighter flame or a flaming paper taper would have caused an explosion as soon as the flame reached the cooker opening. Thus, in fact the evidence was that Bowen placed the burning paper on the burner where it continued to burn without igniting the burner or the pooled gas immediately. However, the single door and the construction of the underside of the cooker with the drip pan allowed gas to pool to the top of the pan wall, because the heavier than air propane collects in a pool in the pan at the bottom of the cooker. The dead space in the burner caused a delayed ignition of the burner, which in turn ignited the accumulated gas pool in the pan, because the design was inadequate to ventilate adequately the cooker of the trapped gas in the pan, and the burner orifices allowed delayed ignition in the dead zone of the burner.

Cochran inspected the cooker after a worker was injured in a prior similar occurrence and told Bowen that everything was all right with the cooker as to design and function. Thus, any subjective knowledge of Bowen that the cooker was hazardous, because the cooker had a tendency to trap pooled gas when it had to be relit, was nullified by the assurances made by Cochran.

Neither the answer to the complaint nor the pretrial order raised the affirmative defense of assumption of the risk. The Civil Practice Act mandates that an affirmative defense be raised in the answer, in the pretrial order, or in a motion to provide timely notice of the issues to be tried. OCGA §§ 9-11-8 (c); 9-11-16; O’Quinn v. O’Quinn, 237 Ga. 653, 654 (229 SE2d 428) (1976) (affirmative defense raised by answer or motion for adjudication on the merits); Rimes Tractor & Equip, v. Agricredit Acceptance Corp., 216 Ga. App. 249, 250-251 (454 SE2d 564) (1995) (affirmative defense raised by pleadings or motion to a counterclaim); Brown v. Quarles, 154 Ga. App. 350, 351-352 (268 SE2d 403) (1980) (affirmative defense raised by motion); Bailey v. Polote, 152 Ga. App. 255, 257 (2) (262 SE2d 551) (1979) (same). The defendant did not amend his answer to raise the affirmative defense of assumption of the risk; therefore, the trial court erred in allowing *462any evidence purporting to prove such defense. Brown v. Little, 227 Ga. App. 484, 485 (1) (489 SE2d 596) (1997) (reversible error for trial court to allow evidence at trial over objection when issue not raised by pleadings, amendment, or pretrial order). Since the evidence failed to establish each and every element of the defense of assumption of the risk, then the evidence admitted at trial did not amend the pleadings to conform to the evidence; further, the plaintiff did not consent to such issue being tried because he moved for a directed verdict on such issue. OCGA § 9-11-15 (b); Borenstein v. Blumenfeld, 250 Ga. 606, 607-608 (1) (299 SE2d 727) (1983) (where evidence admissible for one issue raised in the pleadings, such evidence cannot be treated as a waived objection to allow it to amend the pleadings for an issue not pled); McDonough Constr. Co. v. McLendon Elec. Co., 242 Ga. 510, 514 (250 SE2d 424) (1978) (the admission at trial of unobjected-to evidence which raises an unpled defense acts as either an express or implied consent to try such issue and amends the pleadings to conform to the evidence admitted at trial); Brackett v. Cartwright, 231 Ga. App. 536, 537-538 (1) (499 SE2d 905) (1998). Thus, procedurally, the trial court erred as a matter of law in not granting the motion for directed verdict as to this issue not properly placed before the jury.

More importantly, the trial court erred in failing to grant the directed verdict as to the defense of assumption of the risk, because the defendant failed to affirmatively prove each essential element of such defense, which would allow the jury to decide the issue.

The affirmative defense of assumption of the risk bars a plaintiff from recovering on a negligence claim if it is established that he[,] without coercion of circumstances, chooses a course of action with full knowledge of its danger and while exercising a free choice as to whether to engage in the act or not. In Georgia, a defendant asserting an assumption of the risk defense must establish that the plaintiff (1) had actual knowledge of the danger; (2) understood and appreciated the risks associated with such danger; and (3) voluntarily exposed himself to those risks. Knowledge of the risk is the watchword of assumption of risk, and means both actual and subjective knowledge on the plaintiff’s part. The knowledge that a plaintiff who assumes a risk must subjectively possess is that of the specific, particular risk of harm associated with the activity or condition that proximately causes injury. The knowledge requirement does not refer to a plaintiff’s comprehension of general, non-specific risks that might be associated with such conditions or activities. ... In its simplest and primary sense, assumption of the risk means that the plaintiff, in advance, has given his consent to *463relieve the defendant of an obligation of conduct toward him, and to take his chances of injury from a known risk arising from what the defendant is to do or leave undone.

(Punctuation and footnotes omitted; emphasis in original.) Vaughn v. Pleasent, 266 Ga. 862, 864 (1) (471 SE2d 866) (1996). See also Muldovan v. McEachern, 271 Ga. 805, 807-808 (2) (523 SE2d 566) (1999); Beringause v. Fogleman Truck Lines, 200 Ga. App. 822, 824 (4) (409 SE2d 524) (1991). Even if any use of the cooker at all constituted generally a known danger because butane gas was used and the danger of gas collecting existed, then this still would fail to constitute an assumption of the risk, because the specific danger of gas collecting in the grease pit and the dead zone causing delayed ignition was neither actually and subjectively known nor understood and appreciated as a specific hazard. Beringause v. Fogleman Truck Lines, supra at 823-824.

A plaintiff who encounters a known general danger does not thereby consent to any future negligence of the defendant.

This is contributory negligence pure and simple; it is not assumption of risk. The plaintiff has exposed himself to the risk of future harm, but he has not consented to relieve the defendant of any future duty to act with reasonable care. This is a distinction which has baffled a great many law students, some judges, and unhappily a few very learned legal writers.

(Citation, punctuation and emphasis omitted.) Beringause v. Fogleman Truck Lines, supra at 823 (4).

Thus, the evidence failed to show both an actual and a specific subjective knowledge or understanding and appreciation of the specific risk that the gas would pool in the pan so that normal ventilation would not dissipate the heavy gas from the bottom pan of the cooker and that the gas -burner had delayed ignition from a dead zone causing the hazard of a possible flashback upon ultimate ignition of the burner. The trial court erred in treating a comprehension of a general, nonspecific, awareness and understanding of a risk of gas collecting as the actual and subjective knowledge mandated as an essential element of this defense. Jimenez v. Morgan Drive Away, 238 Ga. App. 638, 639-640 (1) (519 SE2d 722) (1999); Beringause v. Fogleman Truck Lines, supra at 823-825 (4). The trial court erred as a matter of law in denying the motion for directed verdict.

Further, the trial court erred as a matter of law in giving an incomplete charge on the defense of assumption of the risk, because it failed to charge on both actual and subjective knowledge of a specific risk and understanding and appreciation of such specific risk and that the knowledge required did not refer to a plaintiff’s compre*464hension of general, nonspecific, risks that might be associated with such condition or activities. Beringause v. Fogleman Truck Lines, supra at 824; see also Jimenez v. Morgan Drive Away, supra at 639-640. The better practice is for the trial court to give the above language quoted from Vaughn v. Pleasent verbatim as the charge on assumption of the risk.

Barnes, Judge,

dissenting.

I respectfully dissent, because the trial court should have directed a verdict on the assumption of risk defense, and because the trial court erred in charging the jury on assumption of risk.

“Knowledge of the risk is the watchword of assumption of risk.” (Citation and punctuation omitted.) Beringause v. Fogleman Truck Lines, 200 Ga. App. 822, 824 (4) (409 SE2d 524) (1991). We do not presume that a plaintiff has assumed the risk of activities or conditions he does not know about. “Moreover, he must not only know of the facts which create the danger, but he must comprehend and appreciate the nature of the danger he confronts. . . .” (Citation and punctuation omitted.) Id.

The defendant argues that the plaintiff assumed the risk of an explosion because he used a rolled-up newspaper to light the gas rather than the trigger lighter provided. Bowen testified that after he lit the gas cooker, it went out and he unsuccessfully tried twice to relight it before it exploded. He knew he should be “very cautious as far as lighting this particular type of cooker,” and testified that he aired out the grill before the first unsuccessful attempt to relight it and then immediately turned the gas off when it did not light. When the device did not light the second time, he tried to see where his flame was located, but an explosion knocked him down and burned him severely. He further testified that he did not know there was a wrong way to light the cooker.

The defendant testified that he knew of no problem with the cooker unless it was lit improperly and that he explained to buyers that if the flame went out, they should open the lid to ventilate it and then relight it. Plaintiff’s expert design engineer testified that the burner had “a great propensity” not to light quickly, because one end of the burner emitted insufficient gas to light the flame immediately. Only when enough gas had gathered inside the grill to touch the flame did the device ignite “dramatically.” Further, because the burner tube had only one opening instead of two, the release of any accumulated gas would be very slow. The gas, being heavier than air, would pool in the bottom of the burner tube, so that its only means of escape would be to spill out of the single opening after it had pooled. The defendant presented no testimony, expert or otherwise, to dispute or contradict the engineer’s explanation for the explosion that burned the plaintiff.

*465Decided November 15, 2001.

Mills & Moss, David C. Moss, for appellants.

Seacrest, Karesh, Tate & Bicknese, Karsten Bicknese, Daniel S. Wright, for appellees.

Although the defendant said he told the plaintiff to use the trigger lighter, no evidence indicated that he also told him that using an alternate lighting source might cause the gas cooker to explode. Further, no evidence at trial suggested that using a lighted, rolled piece of newspaper rather than the trigger lighter caused the explosion. If these facts constitute the assumption of risk, then anyone who lights a gas grill with a source other than that provided by the manufacturer has assumed the risk of explosion, a ridiculous result.

In order for the plaintiff in this case to have assumed the risk, there must be evidence that, knowing that the cooker did not light properly, that gas pooled in the burner tube when the flame went out, and that the gas did not dissipate due to the single-opening construction, he then made a conscious decision to attempt to relight the unit despite the danger of the pooled gas exploding. To the contrary, the defendant himself testified that he instructed purchasers to ventilate the unit by lifting the lid if the flame went out, which the plaintiff testified he did. No evidence existed in this case showing the plaintiff knew or should have known of the specific risk that caused the explosion, and the trial court erred in failing to grant a directed verdict and in charging the jury on the assumption of risk.

The evidence creates an issue for the jury regarding contributory negligence, but not regarding assumption of risk. “If, in the exercise of ordinary reasonable care for his own safety, [plaintiff] could and should have discovered the danger before he actually did and could and should have avoided the [injury], then he would have been contributorily negligent, but he would not have assumed the risk.” Beringause v. Fogleman Truck Lines, supra, 200 Ga. App. at 824 (4).

For these reasons, I respectfully dissent to the majority opinion.