H. K. Landram for Appellant.

C. Ray Robinson, Willard B. Treadwell, Dean S. Lesher, Loraine B. Rogers, Belli & Leahy and Melvin M. Belli for Respondent. 456*456

GIBSON, 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 case "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. 457*457

One 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]; Macres 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.

[1] 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 458*458 would 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.)

[2] 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].) [3] 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].) [4] 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*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. [5] 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.

[6] 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.

[7] 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. [8] If 460*460 the 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.

[9] 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 461*461 occur 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.

[10] It is true that defendant presented evidence tending to show that it exercised considerable precaution by carefully regulating and checking 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 Schauer, 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 N.Y. 382 [111 N.E. 1050, Ann.Cas. 1916C 440, L.R.A. 1916F 696], established the principle, recognized by this court, that irrespective of privity of contract, the manufacturer is responsible 462*462 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 and guard against the recurrence of others, as the public cannot. 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. Day & 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 inferred 463*463 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 been established as a matter of law." (Blank v. Coffin, 20 Cal.2d 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 that 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 cases 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 liability 464*464 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 v. 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, 31 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 465*465 of Judge Cardozo in the McPherson case: "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 unnecessary 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 of the 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 272, 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 negligence: 466*466 "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 Jeanblanc, 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 Misc. 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 obligation 467*467 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 Fink, 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 468*468 intermediaries. 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.

Page 697

Page 698

        [377 P.2d 898] [59 Cal.2d 59] Reed, Brockway & Ruffin and William F. Reed, San Diego, for plaintiff and appellant.

        Holt, Macomber, Graham & Baugh and William H. Macomber, San Diego, for defendant and appellant.

        Moss, Lyon & Dunn, Gerold C. Dunn and Henry F. Walker, Los Angeles, as amici curiae on behalf of defendant and appellant.

        No appearance for defendant and respondent.

        TRAYNOR, Justice.

        Plaintiff brought this action for damages against the retailer and the manufacturer of a Shopsmith, a combination power tool that could be used as a saw, drill, and wood lathe. He saw a Shopsmith demonstrated by the retailer and studied a brochure prepared by the manufacturer. He decided he wanted a Shopsmith for his home workshop, and his wife bought and gave him one for Christmas in 1955. In 1957 he bought the necessary attachments to use the Shopsmith as a lathe for turning a large piece of wood he wished to make into a chalice. After he had worked on the piece of wood several times without difficulty, it suddenly flew out of the machine and struck him on the forehead, inflicting serious injuries. About ten and a half months later, he gave the retailer and the manufacturer written notice of claimed breaches of warranties and filed a complaint against them alleging such breaches and negligence.

        After a trial before a jury, the court ruled that there was no evidence that the retailer was negligent or had breached any express warranty and that the manufacturer was not liable for the breach of any implied

Page 699

[377 P.2d 899] warranty. Accordingly, it submitted to the jury only the cause of action alleging breach of implied warranties against the retailer and the causes of action alleging negligence and breach of express warranties against the manufacturer. The jury returned a verdict for the retailer against plaintiff and for plaintiff against the manufacturer in the amount of $65,000. The trial court denied the manufacturer's motion for a new trial and [59 Cal.2d 60] entered judgment on the verdict. The manufacturer and plaintiff appeal. Plaintiff seeks a reversal of the part of the judgment in favor of the retailer, however, only in the event that the part of the judgment against the manufacturer is reversed.

        Plaintiff introduced substantial evidence that his injuries were caused by defective design and construction of the Shopsmith. His expert witnesses testified that inadequate set screws were used to hold parts of the machine together so that normal vibration caused the tailstock of the lathe to move away from the piece of wood being turned permitting it to fly out of the lathe. They also testified that there were other more positive ways of fastening the parts of the machine together, the use of which would have prevented the accident. The jury could therefore reasonably have concluded that the manufacturer negligently constructed the Shopsmith. The jury could also reasonably have concluded that statements in the manufacturer's brochure were untrue, that they constituted express warranties, ¹ and that plaintiff's injuries were caused by their breach.

        The manufacturer contends, however, that plaintiff did not give it notice of breach of warranty within a reasonable time and that therefore his cause of action for breach of warranty is barred by section 1769 of the Civil Code. Since it cannot be determined whether the verdict against it was based on the negligence or warranty cause of action or both, the manufacturer concludes that the error in presenting the warranty cause of action to the jury was prejudicial.

        Section 1769 of the Civil Code provides: 'In the absence of express or implied agreement of the parties, acceptance of the goods by the buyer shall not discharge the seller from liability in damages or other legal remedy for breach of any promise or warranty in the contract to sell or the sale. But, if, after acceptance of the goods, the buyer fails to give notice to the seller of the breach of any promise or warranty within a reasonable time after the buyer knows, or ought to know of such breach, the seller shall not be liable therefor.'

        Like other provisions of the uniform sales act (Civ.Code,[59 Cal.2d 61] §§ 1721-1800), section 1769 deals with the rights of the parties to a contract of sale or a sale. It does not provide that notice must be given of the breach of a warranty that arises independently of a contract of sale between the parties. Such warranties are not imposed by the sales act, but are the product of common-law decisions that have recognized them in a variety of situations. (See Gagne v. Bertran, 43 Cal.2d 481, 486-487, 275 P.2d 15, and authorities cited; Peterson v. Lamb Rubber Co., 54 Cal.2d 339, 348, 5 Cal.Rptr. 863, 353 P.2d 575; Klein v. Duchess Sandwich Co., Ltd., 14 Cal.2d 272, 276-283, 93 P.2d 799; Burr v. Sherwin Williams Co., 42 Cal.2d 682, 695-696, 268 P.2d 1041; Souza & McCue Constr. Co. v. Superior Court, 57 Cal.2d 508, 510-511, 20 Cal.Rptr. 634, 370 P.2d 338.) It is true that in many of these situations the court has invoked the sales act definitions of warranties (Civ.Code, §§ 1732, 1735) in defining the defendant's liability, but it has done so, not because the statutes so required, but because they provided appropriate standards for the

Page 700

[377 P.2d 900] court to adopt under the circumstances presented. (See Clinkscales v. Carver, 2 Cal.2d 72, 75, 136 P.2d 777; Dana v. Sutton Motor Sales, 56 Cal.2d 284, 287, 14 Cal.Rptr. 649, 636 P.2d 881.)

        The notice requirement of section 1769, however, is not an appropriate one for the court to adopt in actions by injured consumers against manufacturers with whom they have not dealt. (La Hue v. Coca-Cola Bottling, 50 Wash.2d 645, 314 P.2d 421, 422; Chapman v. Brown, D.C., 198 F.Supp. 78, 85, affd. Brown v. Chapman, 9 Cir., 304 F.2d 149.) 'As between the immediate parties to the sale (the notice requirement) is a sound commercial rule, designed to protect the seller against unduly delayed claims for damages. As applied to personal injuries, and notice to a remote seller, it becomes a booby-trap for the unwary. The injured consumer is seldom 'steeped in the business practice which justifies the rule,' (James, Product Liability, 34 Texas L.Rev. 44, 192, 197) and at least until he has had legal advice it will not occur to him to give notice to one with whom he has had no dealings.' (Prosser, Strict Liability to the Consumer, 69 Yale L.J. 1099, 1130, footnotes omitted.) It is true that in Jones v. Burgermeister Brewing Corp., 198 Cal.App.2d 198, 202-203, 18 Cal.Rptr. 311; Perry v. Thrifty Drug Co., 186 Cal.App.2d 410, 411 ,9 Cal.Rptr. 50; Arata v. Tonegato, 152 Cal.App.2d 837, 841, 314 P.2d 130, and Maecherlein v. [59 Cal.2d 62] Sealy Mattress Co., 155 Cal.App.2d 275, 278, 302 P.2d 331, the court assumed that notice of breach of warranty must be given in an action by a consumer against a manufacturer. Since in those cases, however, the court did not consider the question whether a distinction exists between a warranty based on a contract between the parties and one imposed on a manufacturer not in privity with the consumer, the decisions are not authority for rejecting the rule of the La Hue and Chapman cases, supra. (Peterson v. Lamb Rubber Co., 54 Cal.2d 339, 343, 5 Cal.Rptr. 863, 353 P.2d 575; People v. Banks, 53 Cal.2d 370, 389, 1 Cal.Rptr. 669, 348 P.2d 102.) We conclude, therefore, the even if plaintiff did not give timely notice of breach of warranty to the manufacturer, his cause of action based on the representations contained in the brochure was not barred.

        Moreover, to impose strict liability on the manufacturer under the circumstances of this case, it was not necessary for plaintiff to establish an express warranty as defined in section 1732 of the Civil Code. ² A manufacturer is strictly liable in tort when an article he places on the market, knowing that it is to be used without inspection for defects, proves to have a defect that causes injury to a human being. Recognized first in the case of unwholesome food products, such liability has now been extended to a variety of other products that create as great or greater hazards if defective. (Peterson v. Lamb Rubber Co., 54 Cal.2d 339, 347, 5 Cal.Rptr. 863, 353 P.2d 575 (grinding wheel); Vallis v. Canada Dry Ginger Ale, Inc., 190 Cal.App.2d 35, 42-44, 11 Cal.Rptr. 823 (bottle); Jones v. Burgermeister Brewing Corp., 198 Cal.App.2d 198, 204, 18 Cal.Rptr. 311 (bottle); Gottsdanker v. Cutter Laboratories, 182 Cal.App.2d App.2d 602, 607, 6 Cal.Rptr. 320, 79 A.L.R.2d 290 (vaccine); McQuaide v. Bridgport Brass Co., D.C., 190 F.Supp. 252, 254 (insect spray); Bowles v. Zimmer Manufacturing Co., 7 Cir., 277 F.2d 868, 875, 76 A.L.R.2d 120 (surgical pin); Thompson v. Reedman, D.C., 199 F.Supp. 120, 121 (automobile); Chapman v. Brown, D.C., 198 F.Supp. 78, 118, 119, affd. Brown v. Chapman, 9 Cir., 304 F.2d 149 (skirt); B. F. Goodrich Co. v. Hammond, 10 Cir., 269 F.2d 501, 504 (automobile tire); Markovich v. McKesson and Robbins, Inc., 106 Ohio App.

Page 701

[377 P.2d 901] 265, 149 N.E.2d 181, 186-188 [59 Cal.2d 63] (home permanent); Graham v. Bottenfield's Inc., 176 Kan. 68, 269 P.2d 413, 418 (hair dye); General Motors Corp. v. Dodson, 47 Tenn.App. 438, 338 S.W.2d 655, 661 (automobile); Henningsen v. Bloomfield Motors, Inc., 32 N.J. 358, 161 A.2d 69, 76-84, 75 A.L.R.2d 1 (automobile); Hinton v. Republic Aviation Corporation, D.C., 180 F.Supp. 31, 33 (airplane).)

        Although in these cases strict liability has usually been based on the theory of an express or implied warranty running from the manufacturer to the plaintiff, the abandonment of the requirement of a contract between them, the recognition that the liability is not assumed by agreement but imposed by law (see e. g., Graham v. Bottenfield's, Inc., 176 Kan. 68, 269 P.2d 413, 418; Rogers v. Toni Home Permanent Co., 167 Ohio St. 244, 147 N.E.2d 612, 614, 75 A.L.R.2d 103; Decker & Sons, Inc. v. Capps, 139 Tex. 609, 617, 164 S.W.2d 828, 142 A.L.R. 1479), and the refusal to permit the manufacturer to define the scope of its own responsibility for defective products (Henningsen v. Bloomfield Motors, Inc., 32 N.J. 358, 161 A.2d 69, 84-96; General Motors Corp. v. Dodson, 47 Tenn.App. 438, 338 S.W.2d 655, 658-661; State Farm Mut. Auto. Ins. Co. v. Anderson-Weber, Inc., 252 Iowa 1289, 110 N.W.2d 449, 455-456; Pabon v. Hackensack Auto Sales, Inc., 63 N.J.Super. 476, 164 A.2d 773, 778; Linn v. Radio Center Delicatessen, 169 Misc. 879, 9 N.Y.S.2d 110, 112) make clear that the liability is not one governed by the law of contract warranties but by the law of strict liability in tort. Accordingly, rules defining and governing warranties that were developed to meet the needs of commercial transactions cannot properly be invoked to govern the manufacturer's liability to those injured by their defective products unless those rules also serve the purposes for which such liability is imposed.

        We need not recanvass the reasons for imposing strict liability on the manufacturer. They have been fully articulated in the cases cited above. (See also 2 Harper and James, Torts, §§ 28.15-28,16, pp. 1569-1574; Prosser, Strict Liability to the Consumer, 69 Yale L.J. 1099; Escola v. Coca Cola Bottling Co., 24 Cal.2d 453, 461, 150 P.2d 436, concurring opinion.) The purpose of such liability is to insure that the costs of injuries resulting from defective products are borne by the manufacturers that put such products on the market rather than by the injured persons who are powerless to protect themselves. Sales warranties serve this purpose [59 Cal.2d 64] fitfully at best. (See Prosser, Strict Liability to the Consumer, 69 Yale L.J. 1099, 1124-1134.) In the present case, for example, plaintiff was able to plead and prove an express warranty only because he read and relied on the representations of the Shopsmith's ruggedness contained in the manufacturer's brochure. Implicit in the machine's presence on the market, however, was a representation that it would safely do the jobs for which it was built. Under these circumstances, it should not be controlling whether plaintiff selected the machine because of the statements in the brochure, or because of the machine's own appearance of excellence that belied the defect lurking beneath the surface, or because he merely assumed that it would safely do the jobs it was built to do. It should not be controlling whether the details of the sales from manufacturer to retailer and from retailer to plaintiff's wife were such that one or more of the implied warranties of the sales act arose. (Civ.Code, § 1735.) 'The remedies of injured consumers ought not to be made to depend upon the intricacies of the law of sales.' (Ketterer v. Armour & Co., D.C., 200 F. 322, 323; Klein v. Duchess Sandwich which Co., 14 Cal.2d 272, 282, 93 P.2d 799.) To establish the manufacturer's liability it was sufficient that plaintiff proved that he was injured while using the Shopsmith in a way it was intended to be used as a result of a defect in design and manufacture of which plaintiff was not aware that made the Shopsmith unsafe for its intended use.

        The manufacturer contends that the trial court erred in refusing to give three

Page 702

[377 P.2d 902] instructions requested by it. It appears from the record, however, that the substance of two of the requested instructions was adequately covered by the instructions given and that the third instruction was not supported by the evidence.

        The judgment is affirmed.

        GIBSON, C. J., and SCHAUER, McCOMB, PETERS, TOBRINER and PEEK, JJ., concur.

---------------

1 In this respect the trial court limited the jury to a consideration of two statements in the manufacturer's brochure. (1) 'WHEN SHOPSMITH IS IN HORRIZONTAL POSITION Rugged construction of frame provides rigid support from end to end. Heavy centerless-ground steel tubing insurers perfect alignment of components.' (2) 'SHOPSMITH maintains its accuracy because every component has positive locks that hold adjustments through rough or precision work.'

2 Any affirmation of fact or any promise by the seller relating to the goods is an express warranty if the natural tendency of such affirmation or promise is to induce the buyer to purchase the goods, and if the buyer purchases the goods relying thereon. No affirmation of the value of the goods, nor any statement purporting to be a statement of the seller's opinion only shall be construed as a warranty.'

Page 1033

        Paul L. Hendrix, Bruce E. Krell, San Francisco, Cal., for plaintiffs-appellants.

        Neil L. Shapiro, Brobeck, Phleger & Harrison, with Kenneth M. Kwartler, Cooper, White & Cooper, on brief, San Francisco, Cal., for defendant-appellee.

        Appeal from the United States District Court for the Northern District of California.

        Before SNEED, TANG and THOMPSON, Circuit Judges.

        SNEED, Circuit Judge:

        Plaintiffs are mushroom enthusiasts who became severely ill from picking and eating mushrooms after relying on information in The Encyclopedia of Mushrooms, a book published by the defendant. Plaintiffs sued the publisher and sought damages under various theories. The district court granted summary judgment for the defendant. We affirm.

Page 1034

I.

        The Encyclopedia of Mushrooms is a reference guide containing information on the habitat, collection, and cooking of mushrooms. It was written by two British authors and originally published by a British publishing company. Defendant Putnam, an American book publisher, purchased copies of the book from the British publisher and distributed the finished product in the United States. Putnam neither wrote nor edited the book.

        Plaintiffs purchased the book to help them collect and eat wild mushrooms. In 1988, plaintiffs went mushroom hunting and relied on the descriptions in the book in determining which mushrooms were safe to eat. After cooking and eating their harvest, plaintiffs became critically ill. Both have required liver transplants.

        Plaintiffs allege that the book contained erroneous and misleading information concerning the identification of the most deadly species of mushrooms. In their suit against the book publisher, plaintiffs allege liability based on products liability, breach of warranty, negligence, negligent misrepresentation, and false representations. Defendant moved for summary judgment asserting that plaintiffs' claims failed as a matter of law because 1) the information contained in a book is not a product for the purposes of strict liability under products liability law; and 2) defendant is not liable under any remaining theories because a publisher does not have a duty to investigate the accuracy of the text it publishes. The district court granted summary judgment for the defendant. Plaintiffs appeal. We affirm. ¹

II.

        A book containing Shakespeare's sonnets consists of two parts, the material and print therein, and the ideas and expression thereof. The first may be a product, but the second is not. The latter, were Shakespeare alive, would be governed by copyright laws; the laws of libel, to the extent consistent with the First Amendment; and the laws of misrepresentation, negligent misrepresentation, negligence, and mistake. These doctrines applicable to the second part are aimed at the delicate issues that arise with respect to intangibles such as ideas and expression. Products liability law is geared to the tangible world.

A. Products Liability

        The language of products liability law reflects its focus on tangible items. In describing the scope of products liability law, the Restatement (Second) of Torts lists examples of items that are covered. ² All of these are tangible items, such as tires, automobiles, and insecticides. ³ The American Law Institute clearly was concerned with including all physical items but gave no indication that the doctrine should be expanded beyond that area.

        The purposes served by products liability law also are focused on the tangible world and do not take into consideration the unique characteristics of ideas and expression. Under products liability law, strict

Page 1035

        Although there is always some appeal to the involuntary spreading of costs of injuries in any area, the costs in any comprehensive cost/benefit analysis would be quite different were strict liability concepts applied to words and ideas. We place a high priority on the unfettered exchange of ideas. We accept the risk that words and ideas have wings we cannot clip and which carry them we know not where. The threat of liability without fault (financial responsibility for our words and ideas in the absence of fault or a special undertaking or responsibility) could seriously inhibit those who wish to share thoughts and theories. As a New York court commented, with the specter of strict liability, "[w]ould any author wish to be exposed ... for writing on a topic which might result in physical injury? e.g. How to cut trees; How to keep bees?" Walter v. Bauer, 109 Misc.2d 189, 191, 439 N.Y.S.2d 821, 823 (Sup.Ct.1981) (student injured doing science project described in textbook; court held that the book was not a product for purposes of products liability law), aff'd in part & rev'd in part on other grounds, 88 A.D.2d 787, 451 N.Y.S.2d 533 (1982). One might add: "Would anyone undertake to guide by ideas expressed in words either a discrete group, a nation, or humanity in general?"

        Strict liability principles even when applied to products are not without their costs. Innovation may be inhibited. We tolerate these losses. They are much less disturbing than the prospect that we might be deprived of the latest ideas and theories.

        Plaintiffs suggest, however, that our fears would be groundless were strict liability rules applied only to books that give instruction on how to accomplish a physical activity and that are intended to be used as part of an activity that is inherently dangerous. We find such a limitation illusory. Ideas are often intimately linked with proposed action, and it would be difficult to draw such a bright line. While "How To" books are a special genre, we decline to attempt to draw a line that puts "How To Live A Good Life" books beyond the reach of strict liability while leaving "How To Exercise Properly" books within its reach.

        Plaintiffs' argument is stronger when they assert that The Encyclopedia of Mushrooms should be analogized to aeronautical charts. Several jurisdictions have held that charts which graphically depict geographic features or instrument approach information for airplanes are "products" for the purpose of products liability law. See Brocklesby v. United States, 767 F.2d 1288, 1294-95 (9th Cir.1985) (applying Restatement for the purpose of California law), cert. denied, 474 U.S. 1101, 106 S.Ct. 882, 88 L.Ed.2d 918 (1986); Saloomey v. Jeppesen & Co., 707 F.2d 671, 676-77 (2d Cir.1983) (applying Restatement for the purpose of Colorado Law); Aetna Casualty & Surety Co. v. Jeppesen & Co., 642 F.2d 339, 342-43 (9th Cir.1981) (applying Nevada law); Fluor Corp. v. Jeppesen & Co., 170 Cal.App.3d 468, 475, 216 Cal.Rptr. 68, 71 (1985) (applying California law). Plaintiffs suggest that The Encyclopedia of Mushrooms can be compared to aeronautical charts because both items contain representations of natural features and both are intended to be used while engaging

Page 1036

        Aeronautical charts are highly technical tools. They are graphic depictions of technical, mechanical data. The best analogy to an aeronautical chart is a compass. Both may be used to guide an individual who is engaged in an activity requiring certain knowledge of natural features. Computer software that fails to yield the result for which it was designed may be another. In contrast, The Encyclopedia of Mushrooms is like a book on how to use a compass or an aeronautical chart. The chart itself is like a physical "product" while the "How to Use" book is pure thought and expression. ⁴

        Given these considerations, we decline to expand products liability law to embrace the ideas and expression in a book. ⁵ We know of no court that has chosen the path to which the plaintiffs point. ⁶

B. The Remaining Theories

        As discussed above, plaintiffs must look to the doctrines of copyright, libel, misrepresentation, negligent misrepresentation, negligence, and mistake to form the basis of a claim against the defendant publisher. Unless it is assumed that the publisher is a guarantor of the accuracy of an author's statements of fact, plaintiffs have made no case under any of these theories other than possibly negligence. Guided by the First Amendment and the values embodied therein, we decline to extend liability under this theory to the ideas and expression contained in a book.

Page 1037

        In order for negligence to be actionable, there must be a legal duty to exercise due care. 6 B. Witkin, Summary of California Law, Torts Sec. 732 (9th ed. 1988). The plaintiffs urge this court that the publisher had a duty to investigate the accuracy of The Encyclopedia of Mushrooms' contents. We conclude that the defendants have no duty to investigate the accuracy of the contents of the books it publishes. A publisher may of course assume such a burden, ⁷ but there is nothing inherent in the role of publisher or the surrounding legal doctrines to suggest that such a duty should be imposed on publishers. Indeed the cases uniformly refuse to impose such a duty. ⁸ Were we tempted to create this duty, the gentle tug of the First Amendment and the values embodied therein would remind us of the social costs. ⁹

        Finally, plaintiffs ask us to find that a publisher should be required to give a warning 1) that the information in the book is not complete and that the consumer may not fully rely on it or 2) that this publisher has not investigated the text and cannot guarantee its accuracy. With respect to the first, a publisher would not know what warnings, if any, were required without engaging in a detailed analysis of the factual contents of the book. This would force the publisher to do exactly what we have said he has no duty to do--that is, independently investigate the accuracy of the text. We will not introduce a duty we

Page 1038

        For the reasons outlined above, the decision of the district court is AFFIRMED.

---------------

1 This court has jurisdiction through diversity. 28 U.S.C. Sec. 1332 (1988). California tort law applies. Sherman v. Mutual Benefit Life Ins. Co., 633 F.2d 782, 784 (9th Cir.1980).

2 The California courts look to the Restatement (Second) of Torts, Sec. 402A for guidance on products liability law. See Brooks v. Eugene Burger Management Corp., 215 Cal.App.3d 1611, 1624-25, 264 Cal.Rptr. 756, 763-64 (1989).

3 The relevant comment states:

The rule stated in this Section is not limited to the sale of food for human consumption, or other products for intimate bodily use, although it will obviously include them. It extends to any product sold in the condition, or substantially the same condition, in which it is expected to reach the ultimate user or consumer. Thus the rule stated applies to an automobile, a tire, an airplane, a grinding wheel, a water heater, a gas stove, a power tool, a riveting machine, a chair, and an insecticide. It applies also to products which, if they are defective, may be expected to and do cause only "physical harm" in the form of damage to the user's land or chattels, as in the case of animal food or a herbicide.

Restatement (Second) of Torts Sec. 402A comment d (1965).

4 In reversing a lower court opinion that aeronautical charts are not products, the Fluor court made the following comments:

[The trial court] explained that it believed strict liability principles are applicable only to items whose physical properties render them innately dangerous, e.g., mechanical devices, explosives, combustible or flammable materials, etc. This belief was erroneous.

... [A]lthough a sheet of paper might not be dangerous, per se, it would be difficult indeed to conceive of a salable commodity with more inherent lethal potential than an aid to aircraft navigation that, contrary to its own design standards, fails to list the highest land mass immediately surrounding a landing site.

Fluor Corp. v. Jeppesen & Co., 170 Cal.App.3d 468, 475-76, 216 Cal.Rptr. 68, 71-72 (1985). Plaintiffs argue that this language shows that California courts would not draw a line between physical products and intangible ideas.

The Fluor language, however, cannot be stretched that far. The court was simply discussing the fact that under products liability law, the injury does not have to be caused by impact from the physical properties of the item. In other words, the injury does not have to result because a compass explodes in your hand, but can result because the compass malfunctions and leads you over a cliff. Cf. Vandermark v. Ford Motor Co., 61 Cal.2d 256, 261, 37 Cal.Rptr. 896, 899, 391 P.2d 168, 171 (1964) (in bank) (negligence action allowed against manufacturer for injuries that resulted when automobile brakes malfunctioned causing accident). This is quite different from saying that liability can be imposed for such things as ideas which have no physical properties at all.

5 Plaintiffs also have brought a claim under Restatement (Second) Sec. 402B for false representation. This section provides strict liability for misrepresentations concerning the character or quality of "chattels" sold. To the extent that it is inappropriate to apply Sec. 402A because strict liability should not be applied to the transmission of ideas, the same logic would apply to Sec. 402B which also imposes strict liability.

6 See Jones v. J.B. Lippincott Co., 694 F.Supp. 1216, 1217-18 (D.Md.1988) (nursing student injured treating self with constipation remedy listed in nursing textbook; court held that Restatement Sec. 402A does not extend to dissemination of an idea of knowledge); Herceg v. Hustler Magazine, Inc., 565 F.Supp. 802, 803-04 (S.D.Tex.1983) (person died after imitating "autoerotic asphyxiation" described in magazine article; court held that contents of magazines are not within meaning of Restatement Sec. 402A); Walter v. Bauer, 109 Misc.2d 189, 190-91, 439 N.Y.S.2d 821, 822-23 (Sup.Ct.1981) (student injured doing science project described in textbook; court held that the book was not a defective product for purposes of products liability law because the intended use of a book is reading and the plaintiff was not injured by reading), aff'd in part & rev'd in part on other grounds, 88 A.D.2d 787, 451 N.Y.S.2d 533 (1982); Smith v. Linn, 386 Pa.Super. 392, 398, 563 A.2d 123, 126 (1989) (reader of Last Chance Diet book died from diet complications; court held that book is not a product under Restatement Sec. 402A), aff'd, 587 A.2d 309 (1991); cf. Cardozo v. True, 342 So.2d 1053, 1056-57 (Fla.Dist.Ct.App.) (transmission of words is not the same as selling items with physical properties so that where a bookseller merely passes on a book without inspection, the thoughts and ideas within the book do not constitute a "good" for the purposes of a breach of implied warranty claim under the UCC), cert. denied, 353 So.2d 674 (1977).

7 See Hanberry v. Hearst Corp., 276 Cal.App.2d 680, 683-84, 81 Cal.Rptr. 519, 521 (1969) (Good Housekeeping held liable for defective product because it had given the product its "Good Housekeeping's Consumer's Guaranty Seal"). In Hanberry, the defendant had made an independent examination of the product and issued an express, limited warranty. The defendant here has done nothing similar.

8 See First Equity Corp. v. Standard & Poor's Corp., 869 F.2d 175, 179-80 (2d Cir.1989) (investors who relied on inaccurate financial publications to their detriment may not recover their losses); Jones v. J.B. Lippincott Co., 694 F.Supp. 1216, 1216-17 (D.Md.1988) (publisher not liable to nursing student injured in treating self with remedy described in nursing textbook); Lewin v. McCreight, 655 F.Supp. 282, 283-84 (E.D.Mich.1987) (publisher not liable to plaintiffs injured in explosion while mixing a mordant according to a book on metalsmithing); Alm v. Van Nostrand Reinhold Co., 134 Ill.App.3d 716, 721, 89 Ill.Dec. 520, 524, 480 N.E.2d 1263, 1267 (1985) (publisher not liable to plaintiff injured following instructions in book on how to make tools); Roman v. City of New York, 110 Misc.2d 799, 802, 442 N.Y.S.2d 945, 948 (Sup.Ct.1981) (Planned Parenthood not liable for misstatement in contraceptive pamphlet); Gutter v. Dow Jones, Inc., 22 Ohio St.3d 286, 291, 490 N.E.2d 898, 902 (1986) (Wall Street Journal not liable for inaccurate description of certain corporate bonds); Smith v. Linn, 386 Pa.Super. 392, 396, 563 A.2d 123, 126 (1989) (publisher of diet book not liable for death caused by complications arising from the diet), aff'd, 587 A.2d 309 (1991); see also Herceg v. Hustler Magazine, Inc., 565 F.Supp. 802, 803 (S.D.Tex.1983) (finding magazine publisher not liable to family of youth who died emulating "autoerotic asphyxiation" as described in article but granting leave to amend incitement claim); cf. Libertelli v. Hoffman-La Roche, 7 Media L.Rptr. (BNA) 1734, 1736 (S.D.N.Y.1981) (publisher of Physician's Desk Reference not liable for failure to include drug warning because the work was like a published advertisement of products rather than a reference work); Yuhas v. Mudge, 129 N.J.Super. 207, 209-10, 322 A.2d 824, 825 (1974) (magazine publisher not liable for injury caused by advertised product); Beasock v. Dioguardi Enters., Inc., 130 Misc.2d 25, 30-31, 494 N.Y.S.2d 974, 979 (Sup.Ct.1985) (truck association not liable for injuries caused by products manufactured in adherence to industry standards adopted, approved and published by association).

The Weirum case, cited by the plaintiffs, is inapposite. Weirum v. RKO General, Inc., 15 Cal.3d 40, 123 Cal.Rptr. 468, 539 P.2d 36 (1975) (in bank). In Weirum, a radio station ran a promotional contest for teenagers encouraging them to pursue a travelling disc jockey. The station broadcast periodic updates on the disc jockey's location and encouraged teenagers to scramble to the next place. Two teens, who were speeding after the disc jockey, caused a fatal traffic accident. The radio station was held liable. In upholding the jury verdict, the Weirum court carefully limited its holding to the facts of the case, which the court described as "a competitive scramble in which the thrill of the chase to be the one and only victor was intensified by the live broadcasts which accompanied the pursuit." Id. at 48, 123 Cal.Rptr. at 473, 539 P.2d at 41; see also id. at 46 n. 4, 123 Cal.Rptr. at 471 n. 4, 539 P.2d at 39 n. 4 (noting that duty determinations must be made case by case). A publisher's role in bringing ideas and information to the public bears no resemblance to the Weirum scenario.

9 A stronger argument might be made by a plaintiff alleging libel or fraudulent, intentional, or malicious misrepresentation, but such is not contended in this case. Gutter v. Dow Jones, Inc., 490 N.E.2d at 902 n. 4.

[34 Cal.Rptr.2d 609] [8 Cal.4th 555] [882 P.2d 300] Grace, Skocypec, Cosgrove & Schirm, Barry R. Schirm, Jan L. Pocatera, Susan L. Olson, Lisa M. Kralik, McCutchen, Doyle, Brown & Enersen, David M. Heilbron, Leslie G. Landau and Robert A. Brundage, for defendant and appellant.

Harry M. Grossman as amicus curiae on behalf of defendant and appellant.

Charlotte E. Costan, Horton, Barbaro & Reilly, Frank P. Barbaro and Douglas A. Scott, for plaintiff and respondent.

[34 Cal.Rptr.2d 610] [882 P.2d 301] Ian Herzog, Douglas Devries, Leonard Sachs, Bruce Broillet, David Rosen, Thomas Stolpman, Gary Paul, Robert Steinberg, Roland Wrinkle, Harvey R. Levine, Leonard Esquina, Greene, Broillet, Taylor & Wheeler, Christine Spagnoli, Esner, Marylander, Zakheim & Higa, Stuart B. Esner and Grant Marylander as amici curiae on behalf of plaintiff and respondent.

[8 Cal.4th 556] BAXTER, Justice.

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) 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 [8 Cal.4th 557] front 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, [34 Cal.Rptr.2d 611] [882 P.2d 302] , 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 [8 Cal.4th 558] biomechanics, 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.

[8 Cal.4th 559] Hence, they concluded, her rigid ankles had absorbed the full 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.

[34 Cal.Rptr.2d 612] [882 P.2d 303] 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.

[8 Cal.4th 560] Following 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 [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, 8 Cal.3d at p. 126, 104 Cal.Rptr. 433, 501 P.2d 1153.)

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 [34 Cal.Rptr.2d 613] [882 P.2d 304] 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, [8 Cal.4th 561] italics 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, 104 Cal.Rptr. 433, 501 P.2d 1153.)

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, 104 Cal.Rptr. 433, 501 P.2d 1153.)

In Barker v. Lull Engineering Co., supra, 20 Cal.3d 413, 143 Cal.Rptr. 225, 573 P.2d 443 (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, 143 Cal.Rptr. 225, 573 P.2d 443.) 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, 143 Cal.Rptr. 225, 573 P.2d 443, 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, 143 Cal.Rptr. 225, 573 P.2d 443.)

[8 Cal.4th 562] Despite 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, 143 Cal.Rptr. 225, 573 P.2d [34 Cal.Rptr.2d 614] [882 P.2d 305] 443, quoting Greenman, supra, 59 Cal.2d at p. 64, 27 Cal.Rptr. 697, 377 P.2d 897.) "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, 143 Cal.Rptr. 225, 573 P.2d 443, 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, 143 Cal.Rptr. 225, 573 P.2d 443, 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, 143 Cal.Rptr. 225, 573 P.2d 443, 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, 143 Cal.Rptr. 225, 573 P.2d 443.)

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 [8 Cal.4th 563] balancing or weighing of competing considerations in determining whether a product is defectively designed or not...." (20 Cal.3d at p. 433, 143 Cal.Rptr. 225, 573 P.2d 443.)

An example, Barker noted, was the "crashworthiness" issue presented in Self v. General Motors Corp., supra, 42 Cal.App.3d 1, 116 Cal.Rptr. 575. 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, 143 Cal.Rptr. 225, 573 P.2d 443.) 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, 143 Cal.Rptr. 225, 573 P.2d 443.)

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 [882 P.2d 306] [34 Cal.Rptr.2d 615] "[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, 184 Cal.Rptr. 891, 649 P.2d 224.)

"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. '[O]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, [8 Cal.4th 564] supra, 32 Cal.3d at pp. 126-127, 184 Cal.Rptr. 891, 649 P.2d 224, 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, 184 Cal.Rptr. 891, 649 P.2d 224.) 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, 195 Cal.Rptr. 637.)

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, 200 Cal.Rptr. 387.)

[8 Cal.4th 565] In Akers v. Kelley 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 [34 Cal.Rptr.2d 616] [882 P.2d 307] 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, 219 Cal.Rptr. 513.) 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, 219 Cal.Rptr. 513.) 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 (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, 220 Cal.Rptr. 437.)

[8 Cal.4th 566] Finally, 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. 732-733, 226 Cal.Rptr. 299.)^[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 [34 Cal.Rptr.2d 617] [882 P.2d 308] 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. i., 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 [8 Cal.4th 567] ordinary 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, 143 Cal.Rptr. 225, 573 P.2d 443.)

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, 143 Cal.Rptr. 225, 573 P.2d 443), that is, unless "the benefits of the ... design outweigh the risk of danger inherent in such design" (id., at p. 432, 143 Cal.Rptr. 225, 573 P.2d 443). But this determination involves technical issues of feasibility, cost, practicality, risk, and benefit (id., at p. 431, 143 Cal.Rptr. 225, 573 P.2d 443) which are "impossible" to avoid (id., at p. 433, 143 Cal.Rptr. 225, 573 P.2d 443). In such cases, the jury must consider the manufacturer's evidence of competing design considerations (id., at pp. 433-434, 143 Cal.Rptr. 225, 573 P.2d 443), 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]

[34 Cal.Rptr.2d 618] [8 Cal.4th 568] [882 P.2d 309] By 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, 143 Cal.Rptr. 225, 573 P.2d 443.) 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 [8 Cal.4th 569] inference 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 [34 Cal.Rptr.2d 619] [882 P.2d 310] all consumers in all situations (see Daly v. General Motors Corp., supra, 20 Cal.3d 725, 746-747, 144 Cal.Rptr. 380, 575 P.2d 1162). 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 [8 Cal.4th 570] design 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 [8 Cal.4th 571] closeness [34 Cal.Rptr.2d 620] of [882 P.2d 311] the jury's verdict [citation]; and (5) the effect of other instructions in remedying the error [citations]." (Pool, supra, at pp. 1069-1070, 232 Cal.Rptr. 528, 728 P.2d 1163, 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]

[8 Cal.4th 572] 2. 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 [34 Cal.Rptr.2d 621] [882 P.2d 312] 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; 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. (1961) 55 Cal.2d 801, 806, 13 Cal.Rptr. 401, 362 P.2d 33; Self v. General Motors Corp., supra, 42 Cal.App.3d 1, 10, 116 Cal.Rptr. 575 [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, 104 Cal.Rptr. 433, 501 P.2d 1153.) 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 [8 Cal.4th 573] Corp. (1977) 73 Cal.App.3d 917, 926, 141 Cal.Rptr. 95; Self, supra, 42 Cal.App.3d at p. 10, 116 Cal.Rptr. 575.)^[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, 116 Cal.Rptr. 575) 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 [8 Cal.4th 574] must 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 [34 Cal.Rptr.2d 622] [882 P.2d 313] 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, 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.) 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, 232 Cal.Rptr. 528, 728 P.2d 1163.)

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, 138 Cal.Rptr. 705, 564 P.2d 857 [contributory negligence]; Phillips v. G.L. Truman Excavation Co., supra, 55 Cal.2d 801, 806, 13 Cal.Rptr. 401, 362 P.2d 33 [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, 15 Cal.Rptr. 635, 364 P.2d 467 [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 pre-existing condition]; Self, supra, 42 Cal.App.3d 1, 10, 116 Cal.Rptr. 575 [defect not "substantial factor" if same injury would have occurred regardless of defect]; see also, [8 Cal.4th 575] e.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, 13 Cal.Rptr. 401, 362 P.2d 33), 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, 202 Cal.Rptr. 141; Ng v. Hudson, supra, 75 Cal.App.3d at pp. 261-262, 142 Cal.Rptr. 69; Fish v. Los Angeles Dodgers Baseball Club (1976) 56 Cal.App.3d 620, 641, 128 Cal.Rptr. 807.)

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 art. VI, § 13]; Hildebrand v. Los Angeles Junction Ry. Co. (1960) 53 Cal.2d 826, [34 Cal.Rptr.2d 623] [882 P.2d 314] 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 § 4 1/2 (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]; see [8 Cal.4th 576] 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, 20 Cal.Rptr.2d 582, 853 P.2d 1037.) 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 omitted.]" (Cahill, supra, 5 Cal.4th at p. 490, 20 Cal.Rptr.2d 582, 853 P.2d 1037, quoting O'Bryan, supra, 165 Cal. at p. 64, 130 P. 1042, 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, 20 Cal.Rptr.2d 582, 853 P.2d 1037.) People v. Watson, supra, 46 Cal.2d 818, 299 P.2d 243 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, 20 Cal.Rptr.2d 582, 853 P.2d 1037, quoting Watson, supra, 46 Cal.2d at p. 836, 299 P.2d 243.) 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, 20 Cal.Rptr.2d 582, 853 P.2d 1037, quoting O'Bryan, supra, 165 [34 Cal.Rptr.2d 624] [882 P.2d 315] Cal. at p. 65, 130 P. 1042, italics added by Cahill.)

[8 Cal.4th 577] In 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, 20 Cal.Rptr.2d 582, 853 P.2d 1037.)

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, 111 S.Ct. 1246, 1264-1265, 113 L.Ed.2d 302), are not susceptible to conventional harmless-error analysis. (Cahill, supra, 5 Cal.4th at p. 493, 20 Cal.Rptr.2d 582, 853 P.2d 1037.) 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 by 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, 20 Cal.Rptr.2d 582, 853 P.2d 1037.)

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, 20 Cal.Rptr.2d 582, 853 P.2d 1037, quoting Fulminante, supra, 499 U.S. at pp. 307-308, 111 S.Ct. at 1264.) 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, 20 Cal.Rptr.2d 582, 853 P.2d 1037.)

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, [8 Cal.4th 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, 20 Cal.Rptr.2d 582, 853 P.2d 1037, italics in original.)

Cahill next rejected contentions that a reversible-per-se rule should be retained in order to deter the extraction of involuntary [34 Cal.Rptr.2d 625] [882 P.2d 316] confessions, a particularly "egregious" form of official misconduct, and to guard against the unreliability of such confessions. (5 Cal.4th at pp. 505-507, 20 Cal.Rptr.2d 582, 853 P.2d 1037.) 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, 20 Cal.Rptr.2d 582, 853 P.2d 1037.) 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, 20 Cal.Rptr.2d 582, 853 P.2d 1037.)

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.

[8 Cal.4th 579] Indeed, as in Cahill, the express terms of article VI, section 13 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, 20 Cal.Rptr.2d 582, 853 P.2d 1037, quoting Arizona v. Fulminante, supra, 499 U.S. 279, 307-308, 111 S.Ct. 1246, 1264.)

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, 20 Cal.Rptr.2d 582, 853 P.2d 1037.)

[34 Cal.Rptr.2d 626] [8 Cal.4th 580] [882 P.2d 317] Erroneous 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 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, 20 Cal.Rptr.2d 582, 853 P.2d 1037.)

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. 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, 116 Cal.Rptr. 575, 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, 232 Cal.Rptr. 528, 728 P.2d 1163; LeMons v. Regents of University of California, supra, 21 Cal.3d 869, 875, 148 Cal.Rptr. 355, 582 P.2d 946; People v. Watson, supra, 46 Cal.2d 818, 836, 299 P.2d 243.) 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 [8 Cal.4th 581] the 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]

[34 Cal.Rptr.2d 627] [882 P.2d 318] 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. (Compare, e.g., Hasson v. Ford Motor Co., supra, 19 Cal.3d 530, 548, 138 Cal.Rptr. 705, 564 P.2d 857 [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 [8 Cal.4th 582] occurred 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 [34 Cal.Rptr.2d 628] [882 P.2d 319] 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 [8 Cal.4th 583] error 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, GEORGE, WERDEGAR and BOREN,^[*] JJ., concur.

MOSK, Acting Chief Justice, 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. 623 of 34 Cal.Rptr.2d, p. 314 of 882 P.2d) 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, Justice, 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 [8 Cal.4th 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; 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, 13 Cal.Rptr. 401, 362 P.2d 33.)

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 [34 Cal.Rptr.2d 629] [882 P.2d 320] Motors Corp., supra, 42 Cal.App.3d at p. 10, 116 Cal.Rptr. 575.)

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 erroneous.

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, counsels' [8 Cal.4th 585] arguments, 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, 116 Cal.Rptr. 575) 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, 116 Cal.Rptr. 575, italics added; see also Borenkraut v. Whitten, supra, 56 Cal.2d at p. 545, 15 Cal.Rptr. 635, 364 P.2d 467.) That is precisely what failed to occur here. The abstract definition of "legal cause"--a "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, 116 Cal.Rptr. 575)--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 unambiguous instruction to integrate and make sense of the conflicting evidence. Therefore, I must conclude that this factor supports a finding of prejudice, as well.

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 [34 Cal.Rptr.2d 630] [882 P.2d 321] substitute for a proper legal instruction. Juries are generally instructed, as they were [8 Cal.4th 586] here, 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, 110 S.Ct. 1190, 1200, 108 L.Ed.2d 316.)

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, 14 S.Ct. 919, 923, 38 L.Ed. 841, quoted with approval in Sanguinetti v. Moore Dry Dock Co. (1951) 36 Cal.2d 812, 819, 228 P.2d 557.) 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, 148 Cal.Rptr. 355, 582 P.2d 946.) Accordingly, I would reverse the judgment of the Court of Appeal.

[1] In its statement of facts, the Court of Appeal adopted testimony by an accident witness that at the moment of impact, the Datsun had slowed from 50 miles per hour to between 15 and 25 miles per hour, and the Camaro was traveling about 30 miles per hour. GM did not challenge this factual assumption in its petition for rehearing.

[2] Under the particular circumstances, use of the consumer expectations test alone was approved in Grimshaw v. Ford Motor Co. (1981) 119 Cal.App.3d 757, 174 Cal.Rptr. 348. There, a 1972 Pinto was instantly engulfed in flames when another vehicle struck it from the rear at 28 to 37 miles per hour. There was evidence that Ford knew placement of the Pinto's fuel tank was unsafe. The theory of trial was consumer expectations. Two weeks before the case went to the jury, we decided Barker. Ford immediately requested a risk-benefit instruction, which the trial court refused. In a pre-Campbell appeal, the Court of Appeal affirmed. Noting both the timing and theory-of-trial problems, the court also observed that a risk-benefit instruction would actually have prejudiced Ford, because under Barker, it offered an additional means of recovery for design defect. (119 Cal.App.3d at pp. 802-803, 174 Cal.Rptr. 348.)

[3] For example, the ordinary consumers of modern automobiles may and do expect that such vehicles will be designed so as not to explode while idling at stoplights, experience sudden steering or brake failure as they leave the dealership, or roll over and catch fire in two-mile-per-hour collisions. If the plaintiff in a product liability action proved that a vehicle's design produced such a result, the jury could find forthwith that the car failed to perform as safely as its ordinary consumers would expect, and was therefore defective.

[4] Plaintiff insists that manufacturers should be forced to design their products to meet the "objective" safety demands of a "hypothetical" reasonable consumer who is fully informed about what he or she should expect. Hence, plaintiff reasons, the jury may receive expert advice on "reasonable" safety expectations for the product. However, this function is better served by the risk-benefit prong of Barker. There, juries receive expert advice, apply clear guidelines, and decide accordingly whether the product's design is an acceptable compromise of competing considerations.

On the other hand, appropriate use of the consumer expectations test is not necessarily foreclosed simply because the product at issue is only in specialized use, so that the general public may not be familiar with its safety characteristics. If the safe performance of the product fell below the reasonable, widely shared minimum expectations of those who do use it, perhaps the injured consumer should not be forced to rely solely on a technical comparison of risks and benefits. By the same token, if the expectations of the product's limited group of ordinary consumers are beyond the lay experience common to all jurors, expert testimony on the limited subject of what the product's actual consumers do expect may be proper. (See, e.g., Lunghi v. Clark Equipment Co., supra, 153 Cal.App.3d 485, 496, 200 Cal.Rptr. 387.)

[5] Plaintiff urges that any limitation on use of the consumer expectations test contravenes Greenman 's purpose to aid hapless consumers. But we have consistently held that manufacturers are not insurers of their products; they are liable in tort only when "defects" in their products cause injury. (E.g., Daly v. General Motors Corp. (1978) 20 Cal.3d 725, 733, 144 Cal.Rptr. 380, 575 P.2d 1162; Cronin, supra, 8 Cal.3d 121, 133.) Barker properly articulated that a product's design is "defective" only if it violates the "ordinary" consumer's safety expectations, or if the manufacturer cannot show the design's benefits outweigh its risks.

In its amicus curiae brief, the California Trial Lawyers Association (CTLA) contends that because actions of the Legislature indicate an intent to leave Barker undisturbed, we should not now limit the consumer expectations theory of design defect set forth in that decision. CTLA notes post-Barker statutes which restrict or preclude strict liability for certain products whose dangers are notorious and intentional or unavoidable. (Civ.Code, §§ 1714.4, subd. (a) ["risk" that firearms or ammunition may discharge cannot outweigh "benefits" of these products], 1714.45, subd. (a) [no strict liability for inherent, commonly known dangers of certain products intended for personal consumption].). Each of these statutes recites that it is declaratory of "existing law." (Id., §§ 1714.4, subd. (d), 1714.45, subd. (c) [including specific reference to Cronin, supra ].) But even if we accept CTLA's assertion of general legislative acquiescence in Barker, its hypothesis begs the question of Barker 's actual meaning. As we have explained, Barker itself strongly implies that the consumer expectations test does not apply when the degree of safety a product should exhibit under particular circumstances is a matter beyond the common experience and understanding of its ordinary users.

[6] Contrary to GM's suggestion, ordinary consumer expectations are not irrelevant simply because expert testimony is required to prove that the product failed as marketed, or that a condition of the product as marketed was a "substantial," and therefore "legal," cause of injury. We simply hold that the consumer expectations test is appropriate only when the jury, fully apprised of the circumstances of the accident or injury, may conclude that the product's design failed to perform as safely as its ordinary consumers would expect.

[7] GM observes that some other states have rejected the consumer expectation test. (E.g., Prentis v. Yale Mfg. Co. (1984) 421 Mich. 670, 365 N.W.2d 176, 185-186 [adopting pure negligence theory for product injury]; Turner v. General Motors Corp. (Tex.1979) 584 S.W.2d 844, 851.) But a substantial number of jurisdictions expressly recognize, consistent with Barker, that a product's design is defective if it either violates the minimum safety expectations of an ordinary consumer or contains dangers which outweigh its benefits. (E.g., Masaki v. General Motors Corp. (1989) 71 Haw. 1, 780 P.2d 566, 578-579; Dart v. Wiebe Mfg., Inc. (1985) 147 Ariz. 242, 709 P.2d 876, 878-880; Knitz v. Minster Machine Co. (1982) 69 Ohio St.2d 460, 432 N.E.2d 814, 818; see Palmer v. Avco Distributing Corp. (1980) 82 Ill.2d 211, 45 Ill.Dec. 377, 380, 412 N.E.2d 959, 962, 965.)

[8] In a separate argument, raised for the first time in GM's brief on the merits, both GM and the Council urge us to reconsider Barker 's holding--embodied in the standard instruction received by this jury--that under the risk-benefit test, the manufacturer has the burden of proving that the utility of the challenged design outweighs its dangers. (Barker, supra, 20 Cal.3d at pp. 431-432, 143 Cal.Rptr. 225, 573 P.2d 443.) We explained in Barker that placement of the risk-benefit burden on the manufacturer is appropriate because the considerations which influenced the design of its product are "peculiarly within ... [its] knowledge." (Id., at p. 431, 143 Cal.Rptr. 225, 573 P.2d 443.) Furthermore, we observed, the "fundamental policies" of Greenman dictate that a manufacturer who seeks to escape design defect liability on risk-benefit grounds "should bear the burden of persuading the trier of fact that its product should not be judged defective...." (Id. at pp. 431-432, 143 Cal.Rptr. 225, 573 P.2d 443.)

GM argues that Barker unfairly requires the manufacturer to "prove a negative"--i.e., the absence of a safer alternative design. The Council suggests our "peculiar knowledge" rationale is unrealistic under liberal modern discovery rules. We are not persuaded. Barker allows the evaluation of competing designs, but it does not require proof that the challenged design is the safest possible alternative. The manufacturer need only show that given the inherent complexities of design, the benefits of its chosen design outweigh the dangers. Moreover, modern discovery practice neither redresses the inherent technical imbalance between manufacturer and consumer nor dictates that the injured consumer should bear the primary burden of evaluating a design developed and chosen by the manufacturer. GM and the Council fail to convince us that Barker was incorrectly decided in this respect.

[9] This principle is distinct from the defense of "superseding cause," which absolves a tortfeasor, even though his conduct was a substantial contributing factor, when an independent event intervenes in the chain of causation, producing harm of a kind and degree so far beyond the risk the original tortfeasor should have foreseen that the law deems it unfair to hold him responsible. (See Doupnik v. General Motors Corp., supra, 225 Cal.App.3d 849, 863, 275 Cal.Rptr. 715; 6 Witkin, Summary of Cal.Law (9th ed. 1988) Torts, §§ 975-976, pp. 366-367; Rest.2d Torts, supra, § 440.) It is also distinct from the doctrine of "concurrent causes," which holds that when two or more tortious acts combine, each contributing significantly to a single ultimate harm, each act is deemed a substantial and legal cause of injury, making each concurrent tortfeasor fully liable. (See 6 Witkin, Summary of Cal.Law, supra, Torts, § 970, pp. 360-361; but cf. McGee v. Cessna Aircraft Co. (1983) 139 Cal.App.3d 179, 191, 188 Cal.Rptr. 542.)

[10] In Self, supra, an analogous case, the issue was whether the placement of a Chevrolet's fuel tank made the tank too vulnerable to the rupture and fire which occurred in a rear end collision. There the trial court wrongly refused GM's instruction that defective placement of the tank could not be a "substantial factor" in burn injuries suffered by the Chevrolet's passengers if the collision would have caused the same fire regardless of where the tank was located. Plaintiff argues that the instruction proffered by GM in this case was properly rejected because, unlike the Self instruction, it referred only to defects in the "subject vehicle" and did not focus on the specific defects at issue. We see no material distinction that justified rejection.

Plaintiff also urges that GM's proposed instruction might have misled the jury because, in contrast with Self, the instant lawsuit was only about "enhanced" injuries caused by a product defect. However, the proposed instruction made that clear. Again, plaintiff demonstrates no basis for refusing the instruction.

[11] Our adoption of this uniform test for civil instructional error disposes of GM's contention that we must find the erroneous consumer expectations instruction (ante, pp. 612-619 of 34 Cal.Rptr.2d, pp. 303-310 of 882 P.2d) prejudicial because it raises a mere possibility that the jury's verdict was based on an incorrect legal theory. (See, e.g., Cervantez v. J.C. Penney Co. (1979) 24 Cal.3d 579, 591, 156 Cal.Rptr. 198, 595 P.2d 975; Henderson v. Harnischfeger Corp. (1974) 12 Cal.3d 663, 671-674, 117 Cal.Rptr. 1, 527 P.2d 353; cf. People v. Green (1980) 27 Cal.3d 1, 69, 164 Cal.Rptr. 1, 609 P.2d 468.) The oft-repeated maxim that an appellate court may not "speculate" on the instructional basis of a general verdict cannot mean that a civil judgment must invariably be reversed unless the record explicitly shows that the jury did not rely on the erroneous theory. Such a rigid rule would be at odds with People v. Watson, supra, which sought to eliminate the notion that the "mere possibility" of prejudice from trial error warrants reversal under article VI, section 13. (46 Cal.2d 818, 836-837, 299 P.2d 243.) Indeed, our recent civil cases recognize that we must examine the evidence, the arguments, and other factors to determine whether it is reasonably probable that instructions allowing application of an erroneous theory actually misled the jury. (E.g., Pool v. City of Oakland, supra, 42 Cal.3d 1051, 1068-1073, 232 Cal.Rptr. 528, 728 P.2d 1163 [in false arrest action, issue of probable cause erroneously submitted to jury]; Seaman's Direct Buying Service, Inc. v. Standard Oil Co. (1984) 36 Cal.3d 752, 770-774, 206 Cal.Rptr. 354, 686 P.2d 1158 [instructions erroneously permitted tort liability for good-faith denial of contract].) For reasons already stated (ante, pp. 619-620 of 34 Cal.Rptr.2d, pp. 310-311 of 882 P.2d), we conclude that no such reasonable probability exists in this case.

[12] Counsel explained: "So now think about causation. First of all, toe pan deformation doesn't even cause the ankle injury because it is a compression fracture and you don't have compression under plaintiff's theory. So we have nothing to say the toe pan deformation even caused the ankle injury. Put that together with the timing that the ankle broke before the toe pan deformation.... [p] ... Those are two reasons ... so far why the toe pan deformation was not any cause of [plaintiff's] ankle injuries. [p] There's a third reason. If the crash is so severe that you think that [plaintiff's] ankles would have broken anyway, then whether or not there is a defect ...[,] that defect isn't the cause of [plaintiff's] injuries. For example, you've got an elephant that drops on a car and somebody receives a neck injury from it. And you are saying, well, there is a defect in the car and the defect is what caused the neck injury. But if you find that the collision was so severe that she would have received a neck injury no matter what ..., then you can't blame the defect. If you have got a severe collision and you are going to get injuries, thenyou can't, even if you find a defect, you can't blame the car. Remember, auto manufacturers can't build [a] 100-percent safe foolproof car.... [p] We are to build a reasonably safe car for reasonably foreseeable injuries. [p] So if you have some severe collision where you think she would have received these injuries anyway, then you can't hold the auto manufacturer responsible for the defect."

__________

[*] Hon. Roger W. Boren, Presiding Justice, Court of Appeal, Second District, Division Two, assigned by the Acting Chairperson of the Judicial Council.

[1] The requested instruction was as follows: "If you find that the subject Camaro vehicle was improperly designed, but you also find that Terri Soule would have received enhanced injuries even if the design had been proper, then you must find that the design was a not a substantial factor in bringing about her injuries and therefore was not a contributing cause thereto."

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Page 151

        Leon Segan, New York City (Fred J. Hirsh, New York City, on the brief), for Plaintiffs-Appellants.

        Daniel P. Jaffe, St. Louis, MO (Arthur L. Smith, Jeanine R. Bermel, Husch & Eppenberger, St. Louis, MO, Edward P. Dunphy, Armienti Brooks DeBellis & Dunphy, New York City, of counsel), for Defendant-Appellee.

        Before: MESKILL, CALABRESI and CABRANES, Circuit Judges.

        MESKILL, Circuit Judge:

        Plaintiffs include two surviving victims and the estate of one deceased victim of the December 7, 1993 assault on the 5:33 p.m. Long Island Railroad commuter train. ¹ The bullets used in the shootings were Winchester "Black Talon" hollowpoint bullets, designed to enhance the injuries of their victims. This action was brought in New York State Supreme Court against, inter alios, Olin Corporation, the manufacturer of the bullets. The complaint asserted causes of action in the negligent manufacture, advertising and marketing of a product that was unreasonably designed and ultrahazardous, the making of an unreasonably dangerous product and strict liability in tort. Defendants removed the case to the United States District Court for the Southern District of New York pursuant to 28 U.S.C. § 1441(a), on the grounds that the district court had original jurisdiction due to diversity of citizenship of the parties under 28 U.S.C. § 1332(a)(1). Olin then moved to dismiss the complaint in its entirety pursuant to Fed.R.Civ.P. 12(b)(6). The district court, Baer, J., granted the motion, finding that the complaint failed to state any claim under New York law upon which relief could be granted. McCarthy v. Sturm, Ruger and Co., 916 F.Supp. 366 (S.D.N.Y.1996). Plaintiffs appeal from the order dismissing their suit, or in the alternative ask us to certify the question of ammunition manufacturer liability to the New York Court of Appeals. Finding sufficient precedents in New York law to evaluate the merits of plaintiffs' claims, we decline to grant certification and affirm the judgment of the district court.

        On December 7, 1993, Colin Ferguson boarded the Long Island Railroad's 5:33 p.m. commuter train departing from New York City and opened fire on the passengers. Six people, including Dennis McCarthy, were killed and nineteen others, including Kevin McCarthy and Maryanne Phillips, were wounded in the vicious attack. Ferguson was armed with a 9mm semiautomatic handgun, which was loaded with Winchester "Black Talon" bullets (Black Talons). The injuries to Dennis and Kevin McCarthy and Maryanne Phillips were enhanced by the ripping and tearing action of the Black Talons because, unfortunately, the bullets performed as designed.

Page 152

        The Black Talon is a hollowpoint bullet designed to bend upon impact into six ninety-degree angle razor-sharp petals or "talons" that increase the wounding power of the bullet by stretching, cutting and tearing tissue and bone as it travels through the victim. The Black Talon bullet was designed and manufactured by Olin Corporation (Olin) through its Winchester division and went on the market in 1992. Although the bullet was originally developed for law enforcement agencies, it was marketed and available to the general public. In November 1993, following public outcry, Olin pulled the Black Talon from the public market and restricted its sales to law enforcement personnel. Colin Ferguson allegedly purchased the ammunition in 1993, before it was withdrawn from the market.

        Plaintiffs brought this action against Olin, Sturm, Ruger & Company Inc., the manufacturer of the handgun used by Ferguson, and Ram-Line Inc., the manufacturer of the fifteen round capacity magazine used with the handgun, in New York State Supreme Court to recover for the injuries of Kevin McCarthy and Maryanne Phillips and the death of Dennis McCarthy. The complaint was based on various theories of negligence and strict liability. Defendants removed the case to the United States District Court for the Southern District of New York, pursuant to 28 U.S.C. § 1441(a), on the grounds that the district court had original jurisdiction based on diversity of citizenship of the parties under 28 U.S.C. § 1332(a)(1). The action was subsequently discontinued with prejudice against Sturm, Ruger and Ram-Line.

        Olin moved to dismiss the complaint pursuant to Fed.R.Civ.P. 12(b)(6) for failure to state a claim upon which relief can be granted. The district court granted the motion. First addressing the issue of negligence, the court held that plaintiffs' negligence theories must fail because Olin owed no duty to plaintiffs to protect them from criminal misuse of the Black Talon ammunition. McCarthy, 916 F.Supp. at 368-70. With respect to the strict liability claims, the court held that plaintiffs failed to allege the existence of a design defect in the Black Talon because the ammunition must by its very nature be dangerous to be functional. Id. at 370-71. The risk of the Black Talon arises from the function of the product, not from a defect in the product. Id. at 371. The court noted that to state a claim in either negligence or strict liability, plaintiff must demonstrate that defendant's breach was the proximate cause of their injuries. Here, Ferguson's conduct was an extraordinary act which broke the chain of causation. Id. at 372. The district court also pointed to two recent decisions by the New York Supreme Court addressing almost identical claims and holding that they did not state a cause of action. Id. at 368. See Pekarski v. Donovan, Nos. 95-11161, 95-1175, 95-1187, slip op. (N.Y.Sup.Ct. Oneida County Sept. 27, 1995) (victims of shooting by ex-police officer brought suit against Olin Corp.); Forni v. Ferguson, No. 132994/94, slip. op. (N.Y.Sup.Ct. New York County Aug. 2, 1995), aff'd, 232 A.D.2d 176, 648 N.Y.S.2d 73 (1st Dep't 1996) (action by victim of Long Island Railroad shooting against Olin Corp.). ²

        Plaintiffs appeal the dismissal of their complaint, claiming that the issue of whether they will ultimately prevail is a matter to be determined on a factual basis and not merely on the pleadings. In the alternative, plaintiffs request that because the complaint is based on novel theories of liability under New York law, we certify the questions raised in this case to the New York Court of Appeals.

        We review de novo the district court's dismissal of the complaint under Fed.R.Civ.P. 12(b)(6) and draw all reasonable inferences in the plaintiffs' favor. Jackson Nat'l Life Ins. Co. v. Merrill Lynch & Co., 32 F.3d 697, 699-700 (2d Cir.1994). The complaint may be dismissed only if "it appears beyond doubt that the plaintiff[s] can prove no set of facts in support of [their] claim[s] which would entitle [them] to relief." Conley

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        A federal court sitting in a diversity case will apply the substantive law of the forum state on outcome determinative issues. See Erie R.R. Co. v. Tompkins, 304 U.S. 64, 58 S.Ct. 817, 82 L.Ed. 1188 (1938); Travelers Ins. Co. v. 633 Third Assocs., 14 F.3d 114, 119 (2d Cir.1994). We determine de novo what the law of New York is. Bank of New York v. Amoco Oil Co., 35 F.3d 643, 650 (2d Cir.1994) (citing Salve Regina College v. Russell, 499 U.S. 225, 111 S.Ct. 1217, 113 L.Ed.2d 190 (1991)). In making this determination, we afford the greatest weight to decisions of the New York Court of Appeals. Id. "Where the substantive law of the forum state is uncertain or ambiguous, the job of the federal courts is carefully to predict how the highest court of the forum state would resolve the uncertainty or ambiguity." Travelers Ins. Co., 14 F.3d at 119. "Where the high court has not spoken, the best indicators of how it would decide are often the decisions of lower [New York] courts." In re Brooklyn Navy Yard Asbestos Litigation, 971 F.2d 831, 850 (2d Cir.1992). We may also consider relevant cases from jurisdictions other than New York. Bank of New York, 35 F.3d at 650.

        Appellants argue that in New York, there is no definite rule of law as to liability for ammunition manufacturers, especially ammunition designed to cause enhanced injuries beyond ordinary bullets, and therefore the district court erred in dismissing their complaint. Appellants reason that because they raise "novel" theories of liability, discovery should be allowed so that the issues may be explored in "light of actual facts rather than pleading suppositions." As an alternative to their argument for remand, appellants ask us to certify the questions raised in this case to the New York Court of Appeals. We address appellants' arguments in reverse order, first discussing the standard applied to determine suitability for certification. Because we hold that certification is not warranted, we will then address the merits of the substantive issues raised in this appeal.

I. Certification to the New York Court of Appeals

        The procedure for certifying a question of law to the New York Court of Appeals is governed by Second Circuit Rule 0.27 and New York Court of Appeals Rule 500.17. See also N.Y. Const. art. VI, § 3(b)(9). "Certification is a discretionary device, both for the certifying court and for the court requested to answer the certified question[s]." Riordan v. Nationwide Mut. Fire Ins. Co., 977 F.2d 47, 51 (2d Cir.1992). See 2d Cir. R. 0.27 ("[T]his Court may certify to the highest court of a state an unsettled and significant question of state law that will control the outcome of a case pending before this Court."); N.Y. Ct.App. R. 500.17 (entitled "Discretionary Proceedings to Review Certified Questions From Federal Courts ..."). Certification provides us with

the benefit of an authoritative construction from the state's highest court before proceeding to the merits of the dispute ... [and] may further the interests of federal/state comity by providing the state court with the opportunity to rule on an issue of state law before being precluded from doing so by a contrary federal court judgment.

        Dorman v. Satti, 862 F.2d 432, 434-35 (2d Cir.1988); but see Fletcher v. Kidder, Peabody & Co., 184 A.D.2d 359, 361, 584 N.Y.S.2d 838, 840 (1st Dep't 1992) (New York state court not precluded from exercising its own judgment nor bound to follow decisions of federal Court of Appeals encompassing New York law), aff'd, 81 N.Y.2d 623, 601 N.Y.S.2d 686, 619 N.E.2d 998, cert. denied, 510 U.S. 993, 114 S.Ct. 554, 126 L.Ed.2d 455 (1993).

        Certification should not be used as " 'a device for shifting the burdens of this Court to those whose burdens are at least as great.' " Dorman, 862 F.2d at 435 (quoting Kidney v. Kolmar Laboratories, 808 F.2d 955, 957 (2d Cir.1987)). Ordinarily, certification is proper "only where there is a split of authority on the issue, where [a] statute's plain language does not indicate the answer, or when presented with a complex question of New York common law for which no New York authority can be found." Riordan, 977

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³

        Recently, the New York courts have had the opportunity to address issues almost identical to those raised in this case. See Pekarski v. Donovan, Nos. 95-11161, 95-1175, 95-1187, slip op. (N.Y.Sup.Ct. Oneida County Sept. 27, 1995); ⁴ Forni v. Ferguson, 232 A.D.2d 176, 648 N.Y.S.2d 73 (1st Dep't 1996). Basing their decisions on well-settled principles of New York tort law, the New York courts held that the plaintiffs could not state a cause of action upon which relief could be granted against Olin for the manufacture and marketing of the Black Talon bullet. " '[W]hile a federal court is not bound by lower state court decisions, they do have great weight in informing the court's prediction on how the highest court of the state would resolve the question.' " In re Brooklyn Navy Yard Asbestos Litigation, 971 F.2d at 850 (quoting In re Eastern and Southern Districts Asbestos Litigation, 772 F.Supp. 1380, 1390 (E. & S.D.N.Y.1991)). ⁵ Although the New York Court of Appeals has not addressed the issue of ammunition manufacturer liability, the Forni and Pekarski decisions, as well as existing precedents in New York law, provide us with sufficient guidance to analyze the district court's dismissal of this case. Therefore, we decline to certify any questions of law to New York's highest court. We will now address the merits of plaintiffs' appeal.

II. Strict Liability

        Appellants' first argument is that Olin should be held strictly liable for their injuries because the Black Talon ammunition was defectively designed and the design and manufacture of the bullets were inherently dangerous.

        A. Design Defect

        A manufacturer who places into the stream of commerce a defective product which causes injury may be held strictly liable. Amatulli v. Delhi Const. Corp., 77 N.Y.2d 525, 532, 569 N.Y.S.2d 337, 340, 571 N.E.2d 645, 648 (1991). In New York, there are three distinct claims for strict products liability: (1) a manufacturing defect, which results when a mistake in manufacturing renders a product that is ordinarily safe dangerous so that it causes harm, Victorson v. Bock Laundry Mach. Co., 37 N.Y.2d 395, 373 N.Y.S.2d 39, 335 N.E.2d 275 (1975); (2) a warning defect, which occurs when the inadequacy or failure to warn of a reasonably foreseeable risk accompanying a product causes harm, Torrogrossa v. Towmotor Co., 44 N.Y.2d 709, 405 N.Y.S.2d 448, 376 N.E.2d 920 (1978); and (3) a design defect, which results when the product as designed is unreasonably

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        To state a cause of action for a design defect, plaintiffs must allege that the bullet was unreasonably dangerous for its intended use. "[A] defectively designed product is one which, at the time it leaves the seller's hands, is in a condition not reasonably contemplated by the ultimate consumer." Robinson v. Reed-Prentice Division of Package Mach. Co., 49 N.Y.2d 471, 479, 426 N.Y.S.2d 717, 720, 403 N.E.2d 440, 443 (1980). See also Urena v. The Biro Manufacturing Co., 114 F.3d 359, 363 (2d Cir.1997) (applying the Robinson standard). "This rule, however, is tempered by the realization that some products, for example knives, must by their very nature be dangerous in order to be functional." Robinson, 49 N.Y.2d at 479, 426 N.Y.S.2d at 720, 403 N.E.2d at 443. The very purpose of the Black Talon bullet is to kill or cause severe wounding. Here, plaintiffs concede that the Black Talons performed precisely as intended by the manufacturer and Colin Ferguson.

Sadly it must be acknowledged that: [m]any products, however well-built or well-designed may cause injury or death. Guns may kill; knives may maim; liquor may cause alcoholism; but the mere fact of injury does not entitle the [person injured] to recover ... there must be something wrong with the product, and if nothing is wrong there will be no liability.

        DeRosa v. Remington Arms Co., 509 F.Supp. 762, 769 (E.D.N.Y.1981) (under New York law, shotgun as designed by defendant was not unreasonably dangerous for its foreseeable use) (quoting Murphy & Santagata, Analyzing Product Liability 4 (1979) and omitting footnotes) (alteration in original); Forni, 648 N.Y.S.2d at 74.

        Appellants have not alleged that the bullets were defective. "As a matter of law, a product's defect is related to its condition, not its intrinsic function." Forni, 648 N.Y.S.2d at 74 (citing Robinson, 49 N.Y.2d at 479, 426 N.Y.S.2d at 720, 403 N.E.2d at 443). The bullets were not in defective condition nor were they unreasonably dangerous for their intended use because the Black Talons were purposely designed to expand on impact and cause severe wounding.

        Appellants next argue that under the risk/utility test analysis applied by New York courts, appellee should be held strictly liable because the risk of harm posed by the Black Talons outweighs the ammunition's utility. The district court properly held that the risk/utility test is inapplicable "because the risks arise from the function of the product, not any defect in the product." McCarthy, 916 F.Supp. at 371. "There must be 'something wrong' with a product before the risk/utility analysis may be applied in determining whether the product is unreasonably dangerous or defective." Addison v. Williams, 546 So.2d 220, 224 (La.Ct.App.1989) (holding that Olin Corp. could not be held strictly liable for the manufacture of steel jacketed ammunition capable of causing enhanced injuries) (citing Note, Handguns and Products Liability, 97 Harv. L.Rev.1912, 1915 (1984)).

        The purpose of risk/utility analysis is to determine whether the risk of injury might have been reduced or avoided if the manufacturer had used a feasible alternative design. See Urena, 114 F.3d at 364-65 (burden of proving product is unreasonably dangerous requires showing that product could have been designed more safely). However, the risk of injury to be balanced with the utility is a risk not intended as the primary function of the product. Here, the primary function of the Black Talon bullets was to kill or cause serious injury. There is no reason to search for an alternative safer design where the product's sole utility is to kill and maim. Accordingly, we hold that appellants have failed to state a cause of action under New York strict products liability law.

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        B. Inherently Dangerous Product

        Appellants also argue that Olin should be held strictly liable because the Black Talon ammunition is "unreasonably dangerous per se." According to the appellants' theory, a product is unreasonably dangerous per se if a reasonable person would conclude that the danger of the product, whether foreseeable or not, outweighs its utility. ⁶ As the district court held, this is essentially a risk/utility analysis, which we have refused to apply. McCarthy, 916 F.Supp. at 371. Under New York's strict products liability jurisprudence, there is no cause of action for an unreasonably dangerous per se product. Thus, this claim was properly dismissed.

III. Negligence

        In their complaint, appellants asserted causes of action for the negligent marketing and manufacture of Black Talon bullets. On appeal, appellants do not appear to pursue their negligent manufacturing claim but rather focus their argument on Olin's negligent marketing of the ammunition. For the reasons discussed below, appellants cannot assert a cause of action under either theory of negligence.

        The crux of appellants' negligence theory is that Olin negligently marketed and placed the Black Talon ammunition for sale to the general public. Appellants argue that because of the severe wounding power of the bullets, Olin should have restricted sales to law enforcement agencies, for whom the bullet was originally designed. They also argue that Olin should have known that their advertising, which highlighted the ripping and tearing characteristics of the bullet, would attract "many types of sadistic, unstable and criminal personalities," such as Ferguson.

        To state a cause of action for negligence, the plaintiffs must show: (1) that Olin owed them a "duty, or obligation, recognized by law", (2) a breach of the duty, (3) a "reasonably close causal connection between [defendant's] conduct and the resulting injury" and (4) loss or damage resulting from the breach. W. Page Keeton et al., Prosser and Keeton on the Law of Torts § 30, at 164-65 (5th ed.1984) (hereinafter Prosser & Keeton). Becker v. Schwartz, 46 N.Y.2d 401, 410, 413 N.Y.S.2d 895, 899, 386 N.E.2d 807, 811 (1978). "In the absence of a duty, as a matter of law, no liability can ensue." Gonzalez v. Pius, 138 A.D.2d 453, 454, 525 N.Y.S.2d 868, 869 (2d Dep't 1988). "Thus it may be said that the defendant was negligent, but is not liable because he was under no duty to the plaintiff not to be." Prosser & Keeton, § 30 at 164.

        In tort cases, foreseeability is often confused with duty. Foreseeability "is applicable to determine the scope of duty--only after it has been determined that there is a duty." Pulka v. Edelman, 40 N.Y.2d 781, 785, 390 N.Y.S.2d 393, 396, 358 N.E.2d 1019, 1022 (1976). "The mere fact that a consequence might foreseeably result from an action or condition does not serve to establish a duty owing from a defendant to a plaintiff." Gonzalez, 138 A.D.2d at 454, 525 N.Y.S.2d at 869. The existence of a duty is a question of law to be decided by the court. New York courts are reluctant to impose a duty of care where there is little expectation that the defendant could prevent the actions of a third party. See Pulka, 40 N.Y.2d at 786, 390 N.Y.S.2d at 397, 358 N.E.2d at 1022 ("While a court might impose a legal duty where none existed before, such an imposition must be exercised with extreme care, for legal duty imposes legal liability." (citation omitted)). "[C]ommon law in the State of New York does not impose a duty to control the conduct of third persons to prevent them from causing injury to others. This is so ... even where as a practical matter defendant

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        New York courts do not impose a legal duty on manufacturers to control the distribution of potentially dangerous products such as ammunition. Accordingly, although it may have been foreseeable by Olin that criminal misuse of the Black Talon bullets could occur, Olin is not legally liable for such misuse. As the district court pointed out, appellants have not alleged that any special relationship existed between Olin and Ferguson. Here, Olin could not control the actions of Ferguson. "[I]t is unreasonable to impose [a] duty where the realities of every day experience show us that, regardless of the measures taken, there is little expectation that the one made responsible could prevent the ... conduct [of another]." Pulka, 40 N.Y.2d at 785, 390 N.Y.S.2d at 396, 358 N.E.2d at 1022; see also Forni, 648 N.Y.S.2d at 74 ("Plaintiffs did not, nor could they, show that defendants-manufacturers owed plaintiffs a duty of care.... New York does not impose a duty upon a manufacturer to refrain from the lawful distribution of a non-defective product.").

        It is "the responsibility of courts in fixing the orbit of duty, to limit the legal consequences of wrongs to a controllable degree and to protect against crushing exposure to liability." Strauss v. Belle Realty Co., 65 N.Y.2d 399, 402, 492 N.Y.S.2d 555, 557, 482 N.E.2d 34, 36 (1985) (internal quotation marks and citations omitted). To impose a duty on ammunition manufacturers to protect against criminal misuse of its product would likely force ammunition products--which legislatures have not proscribed, and which concededly are not defectively designed or manufactured and have some socially valuable uses--off the market due to the threat of limitless liability. Because Olin did not owe a legal duty to plaintiffs to protect against Colin Ferguson's horrible action, appellants' complaint does not state a cause of action for negligence and the claim was properly dismissed.

        Because we hold that the Black Talon bullets were not defectively designed, we must affirm the dismissal of appellants' strict liability claims. We also hold that Olin was under no legal duty to prevent criminal misuse of its product and therefore affirm the dismissal of the negligence claims. Although appellants are the victims of a horrible tragedy, under New York law, they have failed to state a cause of action upon which relief can be granted--in sum, New York law does not afford them a remedy. Accordingly, we affirm the judgment of the district court.

        CALABRESI, Circuit Judge, dissenting:

        This case is less about bullets than about federal/state relations. It raises important questions of when it is appropriate for this court to certify issues of New York law to the New York Court of Appeals. I believe that federal courts in general, and this circuit in particular, have tended to be far too reluctant to certify questions to the state courts. See, e.g., Martin Flumenbaum & Brad S. Karp, Certification of Unsettled Law Issues, N.Y.L.J., Jan. 29, 1992, at 3 (noting that the procedure for certification to the New York Court of Appeals "has been used only sparingly by the Second Circuit," which in 1992 had certified only five issues over the preceding six-year period). Specifically, federal courts have all too often refused to certify when they can rely on state lower court opinions to define state law. I view this reluctance as both wrong and unjust.

        Reluctance to certify is wrong because it leads to precisely the kind of forum shopping that Erie R.R. Co. v. Tompkins, 304 U.S. 64, 73-77, 58 S.Ct. 817, 819-22, 82 L.Ed. 1188 (1938), was intended to prevent. See Hanna v. Plumer, 380 U.S. 460, 468, 85 S.Ct. 1136, 1142, 14 L.Ed.2d 8 (1965) (noting that one of the aims of the Erie decision was "discouragement of forum-shopping"). This is especially so in situations where there is some law in the intermediate state courts, but no definitive holding by the state's highest tribunal. In such cases, and in the absence of certification, the party that is favored by the

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If the federal court treats the plaintiff more favorably than the state tribunal would, then the plaintiff always files in federal court; similarly any departure in the manufacturer's favor leads the defendant to remove any suit filed in state court. In either case, the state loses the ability to develop or restate the principles that it believes should govern the category of cases. Certification then ensures that the law we apply is genuinely state law.

        Id. ²

        When federal courts, in effect, prevent state courts from deciding unsettled issues of state law, they violate fundamental principles of federalism and comity. As the Supreme Court has noted, while certification may cause delay in any given case, "[i]t does, of course, in the long run save time, energy, and resources and helps build a cooperative judicial federalism." Lehman Bros. v. Schein, 416 U.S. 386, 391, 94 S.Ct. 1741, 1744, 40 L.Ed.2d 215 (1974); see also Arizonans For Official English v. Arizona, 520 U.S. 43, ----, 117 S.Ct. 1055, 1073, 137 L.Ed.2d 170 (1997). Federal courts that refuse to certify end up "mak[ing] important state policy, in contravention of basic federalism principles." Hakimoglu v. Trump Taj Mahal Assocs., 70 F.3d 291, 302 (3d Cir.1995) (Becker, J., dissenting); see also Richard Alan Chase, Note, A State Court's Refusal to Answer Certified Questions: Are Inferences Permitted?, 66 ST. JOHN'S L. REV. 407, 415 (1992) ("A federal court demonstrates respect for state sovereignty when it certifies a question to the state's highest court and defers to its judgment on unresolved issues of state law.").

        Reluctance to certify is unjust because, as has happened with some frequency, ³ the federal court, having refused to certify, may decide an issue of state law one way, only to

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        The case of DeWeerth v. Baldinger provides a striking example. In that case, the plaintiff, DeWeerth, had originally prevailed in the federal district court, which ruled that as a matter of New York law she had established ownership of a valuable impressionist painting that had been stolen from her forty years earlier. See DeWeerth v. Baldinger, 658 F.Supp. 688 (S.D.N.Y.1987). On appeal, this court reversed the district court's judgment, finding that New York limitations law requires a showing of reasonable diligence in locating stolen property, and that DeWeerth had failed to make such a showing. See DeWeerth v. Baldinger, 836 F.2d 103, 108-12 (2d Cir.1987). We elected not to certify this question of New York law to the New York Court of Appeals, endeavoring instead to resolve the issue on our own. See id. at 108 n. 5.

        Three years later, the New York Court of Appeals was presented with precisely the same issue, and held that the statute of limitations does not require a showing of reasonable diligence. See Solomon R. Guggenheim Found. v. Lubell, 77 N.Y.2d 311, 567 N.Y.S.2d 623, 626-27, 569 N.E.2d 426, 429-30 (1991). The Court of Appeals remarked, somewhat acidly:

Although the [Second Circuit in DeWeerth ] acknowledged that the question posed by the case was an open one, it declined to certify it to this Court, stating that it did not think that it "[would] recur with sufficient frequency to warrant use of the certification procedure." Actually, the issue has recurred several times in the three years since DeWeerth was decided, including the case now before us. We have reexamined the relevant New York case law and we conclude that the Second Circuit should not have imposed a duty of reasonable diligence on the owners of stolen art work for purposes of the Statute of Limitations.

        Id. (citations omitted).

        Following the New York Court of Appeals' decision in Guggenheim, DeWeerth attempted to reopen her case in order to have her dispute decided in accordance with the actual law of New York. See DeWeerth v. Baldinger, 804 F.Supp. 539 (S.D.N.Y.1992). Understandably, however, this court ruled that the subsequent clarification of state law did not justify disturbing a final judgment. See DeWeerth v. Baldinger, 38 F.3d 1266, 1272-73 (2d Cir.1994). Thus, despite the fact that "the DeWeerth panel's prediction was wrong," id. at 1273, and that DeWeerth was, in fact, entitled to the painting under New York law, she was left without a remedy. This happened not because of any decision by the highest court of New York, but rather because of the will of the federal courts. ⁴

        Before the advent of the certification procedure, this court had little choice but to "do [its] best to predict what the highest state

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⁶

        This last is why the statement quoted by the majority, ante, Op. at 153, that the certification "procedure must not be a device for shifting the burdens of this Court to those whose burdens are at least as great," Dorman v. Satti, 862 F.2d 432, 435 (2d Cir.1988) (citation and internal quotation marks omitted), while true enough, can rarely be determinative. In the first place, it is well known that state court judges have expressed both publicly and privately their desire for certification ⁷ and their irritation with the fact that federal courts often decide interesting and important questions rather than certifying them to the courts that should be deciding them. More importantly, a state court that feels overburdened, or that for any other reason does not wish to decide the certified question, is always free to refuse to answer it. See, e.g., N.Y. COMP.CODES R. & REGS. tit 22, § 500.17(d) (noting that the New York Court of Appeals "will examine the merits presented by the certified question ... to determine whether to accept the certification"); Ira P. Robbins, The Uniform Certification of Questions of Law Act: A Proposal for Reform, 18 J. LEGIS. 127, 137 (1992) ("[T]he ultimate power to accept or reject a certified question rests exclusively in the discretion of the answering court. Th[is] procedural safeguard[ ] more than protect[s] the answering court from a surfeit of certification cases because as a practical matter that court completely controls its docket and may reject certified-question cases if the number becomes overwhelming. The answering court need not even offer a reason for declining to answer ....") (footnotes omitted).

        Just as the Supreme Court of the United States can decide for itself whether it wishes to grant certiorari, so too can state courts make analogous decisions as to certification. If anything, it is the failure to certify when certification is plausible that burdens state courts, because such a failure puts pressure

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        This is not to say that certification should be used indiscriminately. As Judge Cabranes has explained, federal courts must be careful to certify only in appropriate cases. See L. Cohen & Co., Inc. v. Dun & Bradstreet, Inc., 629 F.Supp. 1419, 1422-24 (D.Conn.1986); see also Barnes v. Atlantic and Pac. Life Ins. Co., 514 F.2d 704, 705 n. 4 (5th Cir.1975) ("[W]e use much judgment, restraint and discretion in certifying. We do not abdicate."). But "appropriate" must mean virtually any case in which 1) a significant and dispositive issue of state law is in genuine doubt (despite the existence of non-binding lower court decisions, especially where those decisions--like the ones relied upon by the majority--were never appealed to the state's highest court), and 2) certification is specifically requested by the party that did not invoke federal court jurisdiction. By such a standard, I believe that certification is not used enough, and that cases like the one before us are especially suited to its use. ⁸

        In cases that are dramatic and involve "hot" issues, there is a tendency for the parties to describe themselves as raising new issues that are remarkable in their legal context. ⁹ But in fact, such cases are usually best looked at in the most traditional of ways. Courts must see how these cases fit into old categories before considering whether it is either necessary or proper to expand those old categories or to create new ones. And so it is with the case before us. For this reason, I begin with the most traditional of the causes of action that the plaintiffs have raised--negligence--and address it in its most "black letter" terms. Cf. Andrew Jay McClurg, The Tortious Marketing of Handguns: Strict Liability is Dead, Long Live Negligence, 19 SETON HALL LEGIS. J . 777, 778 (1995) ("[V]ictims of gun violence and their lawyers should refocus their sights on the more prosaic liability theory of common law negligence. In other words, it is time to go back to basics."). In doing this I do not, of course, seek to determine whether liability for negligence lies in a case like this one in New York. I examine the issue only to discern whether the question is sufficiently open to warrant certification.

A. Liability for negligence

        To hold a defendant liable in negligence in New York, a plaintiff must show: 1) a duty on the part of the defendant; 2) a breach of that duty by conduct involving an "unreasonable risk of harm," W. PAGE KEETON, DAN B. DOBBS, ROBERT E. KEETON & DAVID G. OWEN, PROSSER AND KEETON ON THE LAW OF TORTS, § 53 at 358 (5th ed.1984) [hereinafter PROSSER & KEETON]; 3) damages suffered by the plaintiff; and 4) causation, both in fact and proximate, between the breach and the plaintiff's harm. See, e.g., Febesh v. Elcejay Inn Corp., 157 A.D.2d 102, 555 N.Y.S.2d 46, 47 (1990); Stagl v. Delta Airlines, Inc., 52 F.3d 463, 467 (2d Cir.1995). So viewed, three of the four elements of a cause of action for negligence--damages, causation, and conduct involving an unreasonable risk of harm--are either readily present or sufficiently cognizable under New York law on the facts of this case that a federal court would err mightily to hold on its own to the contrary. The fourth, the existence of a duty, is a more difficult question. But it is one that, I submit, only the New York Court of Appeals (or the New York Legislature) can answer.

1. Conduct involving an unreasonable risk of harm

        The plaintiffs alleged in their complaint that the defendant created an unreasonable

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        Could a New York jury find that there was an undue risk of harm, if not in producing Black Talons, then in advertising them for use by (and selling them to) the general public? Put differently, could a jury find that the benefit gained by making Black Talons available to the public was outweighed by their potential harm. ¹¹ I believe that a reasonable jury could so find.

        The distinctive feature of the Black Talon bullet is that it "is designed to expand upon impact exposing razor-sharp edges at a 90-degree angle to the bullet. This expansion dramatically increases the wounding power of the bullets." McCarthy v. Sturm, Ruger and Co., 916 F.Supp. 366, 368 (S.D.N.Y.1996); see also Winchester Halts Sale of Disintegrating Bullet to Public, SALT LAKE TRIB., Nov. 23, 1993, at A4 [hereinafter Winchester Halts Sale ] ("The 9mm bullets disintegrate upon impact into tiny razor-like claws that tear up tissues and organs."); Wendell Jamieson, Winchester Disarms a Killer Bullet, NEWSDAY (New York), Nov. 23, 1993, at 5 (noting that "the devastating bullets ... bloom into claw-like prongs on impact and cause hideous, gaping wounds"). The defendant marketed the product to civilian consumers in a slick black box bearing the words "BLACK TALON" surrounded by the sharp, gleaming claws of a bird of prey. It is certainly possible that a fact-finder would conclude that any benefit that comes from marketing and selling bullets with this additional destructive feature to private citizens is outweighed by their potential for significant harm.

        There is nothing novel in finding negligence on these grounds. New York law recognizes that a defendant can be held liable for negligently marketing a product. See, e.g., Kaufman v. Eli Lilly and Co., 65 N.Y.2d 449, 492 N.Y.S.2d 584, 589, 482 N.E.2d 63, 68 (1985); Bikowicz v. Sterling Drug, Inc., 161 A.D.2d 982, 557 N.Y.S.2d 551, 552 (1990). And there is no reason why that principle should not allow recovery against a manufacturer who introduces a harmful product into general circulation, where the social utility of marketing that product to the public is outweighed by its risk of harm. See McClurg, supra; Joseph A. Page, Liability for Unreasonably and Unavoidably Unsafe Products: Does Negligence Doctrine Have a Role to Play?, 72 CHI.-KENT. L. REV . 87 (1996); ¹² see also Ezagui v. Dow Chem. Corp., 598 F.2d

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        The fact that the New York legislature has not chosen to forbid the distribution of Black Talons in no way alters the conclusion that the defendant may have been negligent in marketing them to the general public. ¹⁴ There are all sorts of situations in which the general distribution of an object is legal, but the decision to market and sell it to certain persons is nonetheless negligent because it poses an undue risk of harm. When fireworks were legal, it was still negligent to market and sell them to children. See Erwin v. Dunn, 201 S.W.2d 240, 242 (Tex.Civ.App.1947). Similarly, even in the absence of a statute, serving alcohol to intoxicated adults is negligent. And this is so despite the fact that serving alcohol to sober ones is not. See Morrissey v. Sheedy, 26 A.D.2d 683, 272 N.Y.S.2d 430, 431-32 (1966); Tyrrell v. Quigley, 186 Misc. 972, 60 N.Y.S.2d 821, 822 (N.Y.Sup.Ct.1946). Selling tanks to the armed forces is fine; selling them to the general public is, I would think, clearly negligent.

        I therefore conclude that there is little doubt that if the New York Court of Appeals

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2. Damages

        No one questions that the plaintiffs suffered harm of the most serious sort on the evening of December 7, 1993. Carolyn McCarthy lost her husband, who was shot in the head with a Black Talon bullet. Kevin McCarthy was shot in the head and hand, and now suffers paralysis. Maryanne Phillips was shot in her left arm, which was nearly destroyed by a Black Talon bullet. Whether these damages can be said to have resulted from the defendant's decision to market Black Talons is a question of causation, and is considered immediately below.

3. Causation

        Under New York law, a plaintiff alleging negligence must prove that the defendant's breach of duty was a cause of the plaintiff's injury. Generally, there must be cause in fact, a causal tendency (that is, a "causal link"), and proximate cause. See Guido Calabresi, Concerning Cause and the Law of Torts: An Essay for Harry Kalven, Jr., 43 U. CHI. L. REV . 69, 71-73 (1975) [hereinafter Calabresi, Concerning Cause ].

        The first of these, the requirement that the defendant's negligent act was a but for cause of the injury, see, e.g., Saulpaugh v. State, 132 A.D.2d 781, 517 N.Y.S.2d 328, 329 (1987), is readily met. To establish cause in fact, plaintiffs must generally prove that the specific damages they suffered resulted from the defendant's unduly risky conduct, and would not have occurred in the absence of the defendant's negligence. ¹⁵ In this case, cause in fact necessitates a showing that the damages complained of resulted from the uniquely destructive nature of the Black Talons. This is so because it is the marketing of bullets of this sort, with these uniquely destructive characteristics, that the plaintiffs allege to be unduly risky.

        The plaintiffs have clearly made such a showing here. Their allegations, if true, will support a finding that, but for the defendant's marketing of its product to persons like Colin Ferguson, the plaintiffs would not have suffered such extensive injuries. Indeed, the majority concedes that "[t]he injuries to Dennis and Kevin McCarthy and Maryanne Phillips were enhanced by the ripping and tearing action of the Black Talons." Ante, Op. at 151; cf. Bolm v. Triumph Corp., 33 N.Y.2d 151, 350 N.Y.S.2d 644, 647-48, 305 N.E.2d 769, 771-72 (1973) (holding that a manufacturer can be held liable in negligence "for defects in design which do not cause accidents but do enhance or aggravate injuries").

        Similarly there can be no doubt that a causal tendency was shown. ¹⁶ Knowing what we know now, we can surely say that the negligent marketing of bullets like the Black Talon increases the chances of such injuries occurring. Cf. Martin v. Herzog, 228 N.Y. 164, 126 N.E. 814, 816 (1920) ("[E]vidence of a collision occurring more than an hour after sundown between a car and an unseen buggy, proceeding without lights, is evidence from which a causal connection may be inferred between the collision and the lack of signals.").

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        The existence of proximate cause is more of a question, but under New York law it too could properly be found by a jury. Despite the fact that the question of proximate cause is normally one for the fact finder, see Derdiarian v. Felix Contracting Corp., 51 N.Y.2d 308, 434 N.Y.S.2d 166, 167, 414 N.E.2d 666, 668 (1980), the district court in the instant case concluded that, as a matter of law, the defendant's alleged negligence was not a proximate cause of the plaintiffs' injuries. See McCarthy, 916 F.Supp. at 372. This holding was erroneous.

        While it is true "that an intervening intentional or criminal act will generally sever the liability of the original tort-feasor," New York law is clear that "[t]hat doctrine has no application when the intentional or criminal intervention of a third party or parties is reasonably foreseeable." Kush v. City of Buffalo, 59 N.Y.2d 26, 462 N.Y.S.2d 831, 835, 449 N.E.2d 725, 729 (1983). Moreover, "[a]n intervening act may not serve as a superseding cause, and relieve an actor of responsibility, where the risk of the intervening act occurring is the very same risk which renders the actor negligent." Derdiarian, 434 N.Y.S.2d at 170, 414 N.E.2d at 671. It cannot be said that criminal acts like Colin Ferguson's were, as a matter of law, not foreseeable. And it is precisely the unreasonable risk of this type of criminal activity that forms the basis of the plaintiffs' negligence claim. Accordingly, whether the defendant's alleged breach was a proximate cause of the plaintiffs' injuries is a question for the jury in this case.

4. Duty

        Three of the four elements of negligence liability have, without question, been sufficiently alleged under New York law. The only aspect of this case--viewed as a negligence action--that is problematic is the existence of a duty. "In order to establish a prima facie case of negligence under New York law, a claimant must show that ... the defendant owed the plaintiff a cognizable duty of care...." Stagl, 52 F.3d at 467; see also Strauss v. Belle Realty Co., 65 N.Y.2d 399, 492 N.Y.S.2d 555, 557, 482 N.E.2d 34, 36 (1985). In this case, the plaintiffs must show that the defendant was under a duty to protect them from the harm caused by foreseeable criminal intervenors, and that such a duty entailed refraining from aggressively marketing its product to the general public.

        In many jurisdictions, the existence of a duty depends primarily on 1) the foreseeability of harm to the plaintiff that would flow from the defendant's negligent acts, ¹⁷ and 2) the absence of actions on the part of the plaintiff--like trespass or assumption of risk--that either destroy or lessen the defendant's liability. ¹⁸ In those jurisdictions, it is rarely worthwhile discussing duty separately from the existence of negligence, proximate cause, and special plaintiff attributes. In the absence of such plaintiff-based defenses, a general duty to refrain from causing foreseeable and unreasonable harm is assumed to exist.

        That is not, however, the law in New York. Under New York law, the question of the existence of a "[d]uty in negligence cases is [not] defined ... by foreseeability of injury." Strauss, 492 N.Y.S.2d at 557, 482 N.E.2d at 36; see also Pulka v. Edelman, 40 N.Y.2d 781, 390 N.Y.S.2d 393, 396, 358 N.E.2d 1019, 1022 (1976) ("Foreseeability should not be confused with duty.... [Foreseeability] is applicable to determine the scope of duty--only after it has been determined that there

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The question of the scope of an alleged tort-feasor's duty is, in the first instance, a legal issue for the court to resolve. In this analysis, not only logic and science, but policy play an important role. The common law of torts is, at its foundation, a means of apportioning risks and allocating the burden of loss. While moral and logical judgments are significant components of the analysis, we are also bound to consider the larger social consequences of our decisions and to tailor our notion of duty so that the legal consequences of wrongs are limited to a controllable degree.

        Waters v. New York City Housing Auth., 69 N.Y.2d 225, 513 N.Y.S.2d 356, 358, 505 N.E.2d 922, 923-24 (1987) (citations, brackets, and internal quotation marks omitted).

        Unlike foreseeability and causation, which are issues generally and more suitably entrusted to fact finder adjudication, the definition of the existence and scope of an alleged tortfeasor's duty is usually a legal, policy-laden declaration reserved for Judges to make prior to submitting anything to fact-finding or jury consideration. Common-law experience teaches that duty is not something derived or discerned from an algebraic formula. Rather, it coalesces from vectored forces including logic, science, weighty competing socioeconomic policies and sometimes contractual assumptions of responsibility. These sources contribute to pinpointing and apportioning of societal risks and to an allocation of burdens of loss and reparation on a fair, prudent basis.

        ....

        ... Courts traditionally and as part of the common-law process fix the duty point by balancing factors, including the reasonable expectations of parties and society generally, the proliferation of claims, the likelihood of unlimited or insurer-like liability, disproportionate risk and reparation allocation, and public policies affecting the expansion or limitation of new channels of liability.

        Palka v. Servicemaster Management Servs. Corp., 83 N.Y.2d 579, 611 N.Y.S.2d 817, 820-21, 634 N.E.2d 189, 192-93 (1994).

        This does not mean that the court is required--or even permitted--to weigh such policy considerations to determine the existence of a duty in each individual New York negligence case. Once the New York Court of Appeals has established that the relationship between plaintiffs and defendants in certain circumstances or categories of cases suffices to establish a duty of due care, all cases of like kind are covered by that finding, and there is no warrant to take a case from the jury for a separate judicial examination of duty.

        It follows that, before we can be confident that there is a jury question as to negligence in this case, we must find precedents that establish a duty between the parties in cases akin to this one. I am not prepared to make such a finding. Nor, however, am I prepared to say that the New York Court of Appeals would not find that such a precedent exists or create one in this case. I am not, in other words, satisfied that the New York Court of Appeals has made a policy determination, one way or the other, in circumstances akin to those here.

        The majority, instead, has no difficulty concluding that New York courts have determined that there is no duty here. It relies on the New York Court of Appeals' statement that

[i]n the ordinary circumstance, common law in the State of New York does not impose a duty to control the conduct of third persons to prevent them from causing injury to others; liability for the negligent acts of third persons generally arises when the defendant has authority to control the actions of such third persons. This is so, we have said, even where "as a practical matter" defendant could have exercised such control.

        Purdy v. Public Adm'r of Westchester, 72 N.Y.2d 1, 530 N.Y.S.2d 513, 516, 526 N.E.2d 4, 7 (1988) (citations omitted).

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        But the issue is nowhere near as simple as that. New York law is, in fact, quite clear that the defendant in many circumstances can be under a duty to the plaintiff that makes him liable for the harm caused by the intervening negligent acts of a third party. See, e.g., Modave v. Long Island Jewish Med. Ctr., 501 F.2d 1065, 1072 (2d Cir.1974) (Friendly, J.) (reciting "the unassailable proposition of New York law 'that a wrongdoer is liable for the ultimate result, though the mistake or even negligence of the physician who treated the injury may have increased the damage which would otherwise have followed from the original wrong' ") (quoting Milks v. McIver, 264 N.Y. 267, 190 N.E. 487, 488 (1934)).

        Moreover, in cases such as this one involving the introduction of goods into the stream of commerce, New York courts have had little difficulty in holding the original seller to have a duty not only to the purchaser and parties having a direct relationship with the purchaser, but also to third-party bystanders. Thus, in the celebrated case of Codling v. Paglia, 32 N.Y.2d 330, 345 N.Y.S.2d 461, 298 N.E.2d 622 (1973), the New York Court of Appeals found a duty to a bystander injured by the defendant's product (an automobile) even though the defendant seller had been found to be free from negligence by a jury and even though the negligence of the user/purchaser of the car was in part the cause of the bystander's injuries. See id., 345 N.Y.S.2d at 463, 298 N.E.2d at 624 (holding that, despite the negligent intervenor, "the manufacturer of a defective product may be held liable to an innocent bystander ... for damages sustained in consequence of the defect"). ¹⁹

        In fact, under appropriate conditions, a defendant can even be held liable for the intervening criminal acts of a third party. See, e.g., Stagl, 52 F.3d at 467; Nallan v. Helmsley-Spear, Inc., 50 N.Y.2d 507, 429 N.Y.S.2d 606, 612-13, 407 N.E.2d 451, 457-58

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        What then does the New York Court of Appeals mean when it says that it has

imposed a duty to control the conduct of others where there is a special relationship: a relationship between defendant and [an intervenor] whose actions expose plaintiff to harm such as would require the defendant to attempt to control the third person's conduct; or a relationship between the defendant and plaintiff requiring defendant to protect the plaintiff from the conduct of others[?]

        Purdy, 530 N.Y.S.2d at 516, 526 N.E.2d at 7.

        It cannot mean that a duty will be imposed only where there is privity between the defendant and the victim. See, e.g., Codling, 345 N.Y.S.2d at 461-65, 298 N.E.2d at 622-25 (finding that a defendant can be held liable to a third-party bystander). Nor can it mean that the defendant must actually be able to control the intervenor. See, e.g., Modave, 501 F.2d at 1072 (finding that a negligent doctor can be held liable for the harm caused by another negligent doctor at a different hospital). Rather, the cases in which New York courts have refused to find the requisite relationship are ones in which the defendant did not have much of an opportunity to prevent the harm, see Pulka, 390 N.Y.S.2d at 395-96, 358 N.E.2d at 1021, and in which imposing a duty would expose the defendant to liability "beyond sound public policy," Einhorn v. Seeley, 136 A.D.2d 122, 525 N.Y.S.2d 212, 216 (1988); see also Waters, 513 N.Y.S.2d at 358-59, 505 N.E.2d at 924. That is, they are the rather unusual cases where the allowance of liability would create "disproportionate risk and reparation allocation, and [would violate] public policies affecting the expansion or limitation of new channels of liability." Palka, 611 N.Y.S.2d at 821, 634 N.E.2d at 193. Thus, " 'duty' is not sacrosanct in itself, but is only an expression of the sum total of those considerations of policy which lead the law to say that the plaintiff is entitled to protection." PROSSER AND KEETON, supra, § 53 at 358.

        What of this case? On the one hand, it seems that the defendant could have substantially reduced the harm caused by these unusually destructive bullets by not marketing them to the general public. And the danger of exposing the defendant to liability beyond sound public policy might not be present here, especially if the New York courts were to conclude that marketing Black Talons to the general public causes more harm than benefit. ²⁰ On the other hand, this case may well involve "the expansion ... of new channels of liability," Palka, 611 N.Y.S.2d at 821, 634 N.E.2d at 193, since it involves a criminal intervenor in a case where no direct relationship exists between the injured plaintiff and the defendant. In this respect it is different from Modave (negligent intervenor and direct relationship between plaintiff and defendant), Codling (negligent intervenor and no direct relationship), and Nallan and Stevens (criminal intervenor and direct relationship).

        Under the circumstances, it is hard to know whether the New York Court of Appeals would find a duty. The fact that the foreseeable intervenor behaved in a criminal, rather than a negligent, manner does not change matters for the purposes of proximate cause. See Kush, 462 N.Y.S.2d at 835, 449 N.E.2d at 729 (noting that, although "an intervening intentional or criminal act will generally sever the liability of the original tort-feasor," New York law is clear that "[t]hat doctrine has no application when the intentional or criminal intervention of a third party or parties is reasonably foreseeable"). Does it do so for purposes of duty? That is a question to which the New York Court of

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²¹

        In this respect, the argument that, because it is legal to sell and advertise Black Talons, there can be no liability, is misplaced. As Judge Gabrielli has noted, "[t]he common-law duty of reasonable care to those within the ambit of foreseeable danger requires no buttressing by legislative enactment; nor does the absence of such legislation in the present instance exclude the possibility of liability." Pulka, 390 N.Y.S.2d at 398, 358 N.E.2d at 1023-24 (Gabrielli, J., dissenting). There is all of the difference in the world between making something illegal and making it tortious. Making an activity tortious forces the people who derive benefit from it to internalize the costs associated with it, thereby making sure that the activity will only be undertaken if it is desired by enough people to cover its costs. ²² It does not proscribe it

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²³

        It is precisely because the public policy decision of whether to impose a legal duty is one that the New York Court of Appeals has retained for itself that we should be especially inclined to certify the question to that Court, rather than to endeavor to resolve it ourselves. Certification is particularly warranted when "the resolution of [the issue] requires a careful weighing of competing state policies and potentially could affect a large number of people." Jackson v. Johns-Manville Sales Corp., 757 F.2d 614, 615 (5th Cir.1985). We are simply not entitled to make policy for the State of New York. Such is a task for the State's highest tribunal. ²⁴

B. Strict products liability

        The requirements for strict products liability in New York are not markedly dissimilar from those for negligent products liability. Once again: a) a duty is needed; b) that duty must be breached by the defendant's manufacture or sale of a defective product; c) the plaintiff must suffer an injury; and d) the defect must be the cause of the plaintiff's injury. ²⁵ The primary difference between the two causes of action is that a plaintiff may recover in strict products liability without showing that the defendant's conduct was wrongful, so long as its product was defective.

        As to duty, damages, and causation, the same arguments made with respect to negligence apply here as well. And for those

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        The additional problem with the claim of strict products liability is that the plaintiffs must establish the existence of a defect. The majority notes that the New York Court of Appeals has explained that "a defectively designed product is one which, at the time it leaves the seller's hands, is in a condition not reasonably contemplated by the ultimate consumer." Robinson v. Reed-Prentice Div. of Package Mach. Co., 49 N.Y.2d 471, 426 N.Y.S.2d 717, 720, 403 N.E.2d 440, 443 (1980). Since the Black Talons performed in precisely the manner contemplated by Colin Ferguson, the majority concludes that under New York's "consumer contemplation" test, the Black Talon is not a defective product.

        There is no doubt that, in order for strict products liability to apply, there must be a defect, i.e. "something wrong with the product, and if nothing is wrong there will be no liability." DeRosa v. Remington Arms Co., 509 F.Supp. 762, 769 (E.D.N.Y.1981) (citation and internal quotation marks omitted). But a large number of jurisdictions have held that there is something wrong with any product that is unreasonably dangerous, "even though it comports in all respects to its intended [and obvious] design." Azzarello v. Black Bros. Co., 480 Pa. 547, 391 A.2d 1020, 1025 (1978); see also Turner v. General Motors Corp., 584 S.W.2d 844, 850 (Tex.1979). In other words, these jurisdictions employ a risk/benefit calculus to establish a design defect. "Under this approach, a product is defective as designed if ... the magnitude of the danger outweighs the utility of the product," that is, if "the harmful consequences in fact from intended and reasonably foreseeable uses resulting from the way the product was designed and marketed up to the time of plaintiff's injury outweigh[ ] the benefits in terms of wants, desires, and human needs served by the product." PROSSER & KEETON, supra, § 99 at 699. ²⁶

        Historically, in determining whether a product is defectively designed, some courts have applied only the "risk/benefit test" while others have used only the "consumer contemplation test" alluded to by the majority. See id., § 99 at 698-700. But many courts have allowed a plaintiff to establish a defect, and hence liability, if the defendant's product fails either of these tests. See, e.g., Turner, 584 S.W.2d at 850; Barker v. Lull Eng'g Co., 20 Cal.3d 413, 143 Cal.Rptr. 225, 236, 573 P.2d 443, 454 (1978). ²⁷

        In Robinson, the case upon which the majority relies, the New York Court of Appeals appeared to require that the plaintiff meet both tests:

Where a product presents an unreasonable risk of harm, notwithstanding that it was meticulously made according to detailed plans and specifications, it is said to be defectively designed. This rule, however, is tempered by the realization that some products, for example knives, must by their very nature be dangerous in order to be functional. Thus, a defectively designed product is one which, at the time it leaves the seller's hands, is in a condition not reasonably contemplated by the ultimate consumer and is unreasonably dangerous for its intended use; that is one whose utility does not outweigh the danger inherent in its introduction into the stream of commerce.

        Robinson, 426 N.Y.S.2d at 720, 403 N.E.2d at 443.

        This dual requirement would be highly unusual. And more recently, the Court of Appeals, after quoting this passage from Robinson, went on to say that

[i]n order to establish a prima facie case in strict products liability for design defects,

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        Voss v. Black & Decker Mfg. Co., 59 N.Y.2d 102, 463 N.Y.S.2d 398, 402, 450 N.E.2d 204, 208 (1983). Significantly, this latter statement of what constitutes a prima facie case makes no mention at all of consumer expectations as a separate requirement additional to that imposed by the risk/benefit test.

        Moreover, in Denny v. Ford Motor Co., 87 N.Y.2d 248, 639 N.Y.S.2d 250, 254-58, 662 N.E.2d 730, 734-38 (1995), the Court of Appeals explained that, while the risk/benefit test is an essential element of a cause of action for design defect, the consumer contemplation test sounds more in commercial law than in torts, and is therefore an element of a claim of breach of an implied warranty. As a result, it is anything but clear whether, read in light of more recent developments in the jurisprudence of the New York Court of Appeals, Robinson in fact stands for the proposition that a plaintiff may not establish that a product was defectively designed for the purposes of attaching strict liability without proving that the product was in a condition not reasonably contemplated by the consumer. ²⁸

        Indeed, one recent commentator, after an extensive fifty-state survey, did not include New York on his list of the twenty-five "[s]tates which use consumer expectations as part of any test for strict liability design defects." John F. Vargo, The Emperor's New Clothes, 26 U. MEM. L. REV . 493, 951 index 2 (1996). Instead, he noted that, while "the Robinson court mixed the consumer expectation test with a risk-utility test," id. at 822, that court may not have intended that result, see id. at 823, and, after Voss and Denny, "New York law ... appears to relegate the consumer expectation test to the separate legal theory of warranty," id. at 837. ²⁹

        Significantly, the Restatement of Torts, upon which the Court of Appeals relied in Robinson, now takes the position that the existence of a design defect should be determined solely by the risk/benefit test. See RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY § 2(b) & cmts. c, f (Tentative Draft No. 2, 1995) [hereinafter, RESTATEMENT 3RD]. According to the most recent Restatement, the consumer contemplation test no longer applies. ³⁰ See id. at § 2 cmt. f (rejecting "conformance to consumer expectations as a defense" and declaring instead that "[t]he mere fact that a risk presented by a product design is open and obvious, or generally known, and that the product thus satisfies expectations, does not prevent a finding that the design is defective").

        Since it is more than possible that the New York Court of Appeals would apply the risk/benefit test to determine whether the Black Talon is a defective product, and since, as discussed above, it cannot be said as a matter of law (especially by a federal court) that the benefits of the Black Talon outweigh

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        Nonetheless, the fact that a product fails the risk/utility test may not be sufficient to give rise to strict liability. This is so because, as the majority notes, New York law has appeared to require that the plaintiff also show a reasonable alternative design before she will be permitted to recover in strict liability for a defectively designed product. See Voss, 463 N.Y.S.2d at 402, 450 N.E.2d at 208. But see Vargo, supra, at 832-37 (suggesting that, despite Voss, a showing of a reasonable alternative design is no longer required in New York after Denny ); Jerry J. Phillips, The Unreasonably Unsafe Product and Strict Liability, 72 CHI.-KENT L. REV. 129, 159 (1996) (explaining that the Court of Appeals in Denny "noted that the strict tort claim was tried on a risk-utility standard, apparently without reasonable alternative design being a necessary factor"). Moreover, it has been noted (in a controversial comment in the latest tentative draft of the third Restatement of Torts) ³¹ that this requirement

applies even though the plaintiff alleges that the category of product sold by the defendant is so dangerous that it should not have been marketed at all. Thus common and widely distributed products such as alcoholic beverages, tobacco, firearms, and above-ground swimming pools may be found to be defective only upon proof [that] ... reasonable alternative designs could have been adopted. Absent [such] proof ... courts do not impose liability based on a conclusion that an entire product category should not have been distributed in the first instance. That is, courts have not imposed liability for categories of products that are generally available and widely used and consumed, solely on the ground that they are considered socially undesirable by some segments of society.

        RESTATEMENT 3RD, supra, § 2 cmt. c.

        In the instant case, however, a possible alternative design does exist. It consists of the elimination of the extra-destructive "talons." The proposed Restatement contains a remarkably relevant discussion:

Several courts have suggested that the designs of some products are so manifestly unreasonable, in that they have low social utility and high degree of danger, that liability should attach even absent proof of a reasonable alternative design. In large part the problem is one of how the range of relevant alternative designs is described. For example, a toy gun that shoots hard rubber pellets with sufficient velocity to cause injury to children could be found to be defectively designed within the rule of § 2(b). Toy guns that do not produce injury would constitute reasonable alternatives to the dangerous toy. Thus, toy guns that project ping pong balls, soft gelatin pellets, or water might be found to be reasonable alternative designs to a toy gun that shoots hard pellets. However, if consideration is limited to toy guns that are capable of causing injury, then no reasonable alternative will, by hypothesis, be available. In that instance, the design feature that defines which alternatives are relevant--the capacity to injure--is precisely the feature on which the user places value and of which the plaintiff complains. If a court were to adopt this characterization of the product, it could conclude that liability should attach without proof of a reasonable alternative design. The court would condemn the product design as defective and not reasonably safe because the extremely high degree of danger posed by its use or consumption so substantially outweighs its negligible utility that no rational adult, fully aware of the relevant facts, would choose to use or consume the product.

        Id., § 2 cmt. d.

        It is worth noting that courts and commentators have been wrestling with the questions of what is a relevant safer alternative design, and whether entire categories of products can be deemed defective in the absence of an

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³²

        I therefore believe that the question of whether the defendant can be held strictly liable for the alleged defective design of the Black Talon, like the question of duty, is "a complex question of New York common law for which no [controlling] New York authority can be found." Riordan v. Nationwide Mut. Fire Ins. Co., 977 F.2d 47, 51 (2d Cir.1992). And that question, again like the question of duty, will turn in substantial part on considerations of public policy. See Azzarello, 391 A.2d at 1026 (noting that the question of whether "the utility of a product outweigh[s] the unavoidable danger it may pose" is "depend[ent] upon social policy"). Accordingly, I would certify both questions. ³³

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CONCLUSION

        I do not know whether the New York Court of Appeals would allow a cause of action for negligence or strict liability to proceed in this case. Nor do I know whether that Court should allow such liability. ³⁴ What I do know is that these questions are not for this Court to decide. And for that reason, I respectfully dissent.

---------------

1 Robert C. Phillips, the spouse of surviving victim Maryanne Phillips, and Carolyn McCarthy, in her individual capacity, the spouse of deceased victim Dennis McCarthy, are also named plaintiffs in the action.

2 The Appellate Division, First Department affirmed the decision on October 1, 1996, after the district court dismissed this action.

3 Although the dissenting opinion suggests that we should formulate a new standard to determine whether certification is appropriate, Dissenting Op. at Section I, we note that Riordan establishes the standard applicable in this Circuit for determining whether it is appropriate to certify a question to a state court, and that we have "no authority to depart from Second Circuit precedent unless it has been overruled in banc or by the Supreme Court." Leecan v. Lopes, 893 F.2d 1434, 1443 (2d Cir.1990).

4 In 1994, former Rome, New York police officer Joseph Merola killed two teenagers and wounded two others allegedly using Black Talon bullets during a shooting rampage. The victims of the shooting brought three separate actions against, inter alios, Olin in the New York Supreme Court, Oneida County. The cases were consolidated and are hereinafter collectively referred to as "Pekarski."

5 The dissenting opinion claims that our practice of according intermediate state court decisions substantial weight in our determination of how the state's highest court would likely rule will encourage forum-shopping. The dissenting opinion argues that this practice would encourage litigants who are favored by the intermediate court rulings to always file suit in federal court, to avoid the possibility, however slim, that the highest state court might overturn the intermediate court ruling. We note, however, that if we completely disregard state lower court rulings in determining how a state's highest court might rule, we would encourage forum-shopping by the litigants who are disfavored by the state lower court rulings. In any event, surely it makes sense to give the rulings of state lower courts, which are in a better position than federal courts to predict the workings of the state's highest court, substantial weight--especially where, as in the instant case, these state court rulings are consistent with the well-nigh unanimous opinion of courts across the country.

6 Appellants cite Halphen v. Johns-Manville Sales Corp., 484 So.2d 110 (La.1986) for support. In Halphen, the Louisiana Supreme Court held that strict liability could be imposed when a product was found to be unreasonably dangerous per se. "Halphen, however, did not endure as the law of Louisiana. In 1988, the Louisiana Legislature repealed Halphen 's category of unreasonably dangerous per se when it enacted the ... Products Liability Act." Young v. Logue, 660 So.2d 32, 53 (La.Ct.App.1995); see La.Rev.Stat. Ann. § 9:2800.51 et seq. (West 1988).

It is also noted that appellants argued in the district court that manufacturing the ammunition was an ultrahazardous activity. This claim is not pursued on appeal.

1 An analogous situation exists where there is authority from the state's highest court, but that authority is very old and has been ignored in recent years, during which time other jurisdictions have abandoned similar rulings. Cf. Harry Shulman, The Demise of Swift v. Tyson, 47 YALE L.J. 1336, 1350 (1938) (inquiring whether, under Erie, federal courts have "the power to disregard a state decision on the ground that it will doubtless be overruled by the state court at the first opportunity"); Arthur L. Corbin, The Common Law of the United States, 47 YALE L.J. 1351, 1352 (1938) (suggesting, critically, that under one reading of Erie, federal courts forced to apply state common law are "limited in a way in which the [state] judges themselves are not limited," insofar as they cannot look to intervening decisions of the courts of other states, or to any other sources that might lead them to disregard or limit prior cases).

2 See also Ira P. Robbins, The Uniform Certification of Questions of Law Act: A Proposal for Reform, 18 J. LEGIS. 127, 128 (1992) (noting that certification "resolves many of the problems associated with the Erie doctrine"); Appellate Certification of State Law Questions to State Courts, 9 No. 2 FED. LITIGATOR 56, 56 (1994) ("One of several considerations that can enter into a plaintiff's choice of forum when her citizenship is diverse from that of defendants is whether she would rather have a state court or a federal court decide matters of state law. Although federal courts are to decide such questions as state courts would, it is no secret that the tendencies of federal judges and state judges with respect to open questions in certain areas of the law are not always identical. To make the equation more complex, when a state supreme court has a procedure for certification of questions of law for determination by that court, a federal court may, but is not required to take advantage of it.").

3 See, e.g., Hakimoglu, 70 F.3d at 302-03 & n. 11 (Becker, J., dissenting) (collecting instances in which the Third Circuit has erroneously predicted the law of Pennsylvania). As Chief Judge Sloviter has explained, "[i]t is not that Third Circuit judges are particularly poor prognosticators. All of the circuits have similar problems in predicting state law accurately." Dolores K. Sloviter, A Federal Judge Views Diversity Jurisdiction Through the Lens of Federalism, 78 VA. L. REV . 1671, 1680 (1992); see also id. at 1680-81 & nn. 52-53 (cataloguing federal court errors in prediction); United Servs. Life Ins. Co. v. Delaney, 328 F.2d 483, 486-87 & nn. 5-9 (5th Cir.1964) (Brown, J., concurring) (discussing the "staggering" number of instances in which the courts of Texas, Alabama, and Florida have proved the Fifth Circuit's guesses to be erroneous).

4 This is quite different from cases in which the state's highest court declines to hear an appeal from an intermediate court and later, on hearing a similar case, decides it differently from the way the earlier case was decided. In all such cases, it is the highest court of the jurisdiction whose law applies that has decided, for its own reasons, to let the result in the first case stand. Likewise, when the state's highest court declines to accept certification from a federal court, it is the highest court of the jurisdiction whose law applies that, in effect, has decided to allow the federal court to guess as to the law of the state, and to permit that guess to be based on the usual sources of law employed by federal courts in diversity cases, including non-binding lower state court opinions, the law of other jurisdictions, etc. And a judgment--even a judgment to abstain--by the state's highest court is all that a litigant is entitled to receive. When instead a federal court fails to certify, the highest court of the state is denied the right to decide whether it wishes to resolve the issue. The loser loses because a court that has no ultimate say as to the applicable law has made itself into a court of last resort. For these reasons, I am unconvinced by Judge Selya's thoughtful arguments against certification. See Bruce M. Selya, Certified Madness: Ask a Silly Question. . ., 29 SUFFOLK U.L. REV. 677 (1995). I agree with him that certification is not a panacea (and that it creates some procedural problems), but that is a far different issue.

5 This is still the case today when federal courts are asked to ascertain the law of a state that has not provided for certification. See, e.g., Sargent v. Columbia Forest Prods., Inc., 75 F.3d 86, 89-90 (2d Cir.1996) (noting that Vermont has no certification statute, and for that reason, this court is required to guess--often incorrectly--as to the law of Vermont). But since this situation is due to the failure of the state to allow certification, it is fair to attribute the litigant's loss (even when it results from the federal court's bad guess as to state law) to a decision of the state, that is, of the jurisdiction which has the authority to determine the litigant's rights. See id. at 90 (explaining that the plaintiff was prejudiced by Vermont's failure to provide for certification because the defendant was able to remove the case to the federal courts, which were forced to make what turned out to be an erroneous guess as to state law).

6 See also Peterson v. U-Haul Co., 409 F.2d 1174, 1177 (8th Cir.) (admitting that prediction "is a hazardous and unsatisfactory method of deciding litigation"), modified on other grounds, 421 F.2d 837 (8th Cir.1969); Martinez v. Rodriquez, 410 F.2d 729, 730 (5th Cir.1969) ("No matter how many Federal Judges, trial, appellate, three-judge panel, or the full panoply of the court en banc, any decision would have been an Erie-guess. Now the guesswork has been eliminated, and we are quickly presented with a definitive explication of Florida law.").

7 See, e.g., Harrison v. Insurance Co. of North America, 294 Ala. 387, 318 So.2d 253, 254 (1975) (declaring that the certification "process can serve as a demonstration of cooperative judicial federalism which would justify those of us who think that the federal form of government has a contribution to make toward the preservation of justice in this country") (citation and internal quotation marks omitted); M. Bryan Schneider, "But Answer Came There None": The Michigan Supreme Court and the Certified Question of State Law, 41 WAYNE L. REV. 273, 302 (1995) (noting that in a recent survey "state court judges seemed remarkably receptive to certification from federal courts") (citing John B. Corr & Ira P. Robbins, Interjurisdictional Certification and Choice of Law, 41 VAND. L. REV . 411 (1988)). Indeed, more than one state high-court judge in this circuit has told me in informal conversation that they believe this court should certify more frequently.

8 The majority suggests that I am proposing a "new standard" for certification, in violation of Riordan v. Nationwide Mut. Fire Ins. Co., 977 F.2d 47 (2d Cir.1992). See ante, Op. at 158 n.3. Since, as discussed below, I think that this case presents "complex question[s] of New York common law for which no New York authority can be found," Riordan, 977 F.2d at 51, I do not believe that I am advocating a standard that is in any way inconsistent with our cases.

9 The plaintiffs in the instant case are guilty of this mistake. See McCarthy v. Sturm, Ruger and Co., 916 F.Supp. 366, 372 (S.D.N.Y.1996) ("Plaintiffs candidly argue that I should expand existing tort doctrines to cover this case....").

10 The plaintiffs' negligent manufacturing claim was based on the fact "that a manufacturer is obligated to exercise that degree of care in his plan or design so as to avoid any unreasonable risk of harm to anyone who is likely to be exposed to the danger when the product is used in the manner for which the product was intended, as well as an unintended yet reasonably foreseeable use." Micallef v. Miehle Co., 39 N.Y.2d 376, 384 N.Y.S.2d 115, 121, 348 N.E.2d 571, 577 (1976) (citations omitted).

11 This is nothing more than the traditional "Hand formula." See United States v. Carroll Towing Co., 159 F.2d 169, 173 (2d Cir.1947) (L.Hand, J.) (inquiring whether the burden of avoiding the harm is outweighed by the product of the probability of accident and the gravity of the resulting injury).

12 One commentator has described this type of negligent marketing claim in these terms:

The imposition of negligence-based tort liability on the manufacturers of unreasonably and unavoidably unsafe products would require proof that a reasonable person in defendant's position, with the knowledge that defendant possessed--or in the exercise of due care should have possessed--would not have marketed the product. Such a decision would be warranted if the foreseeable risks of harm from marketing the product would exceed the costs of avoiding that harm, which, in the product-liability context, is measured by the loss of utility that society incurs from the unavailability of the product.

Page, supra, at 97 (footnotes omitted). The decision not to limit the distribution of a dangerous product can constitute negligent marketing. See id. at 97 n. 40. Another commentator has articulated three potential negligent marketing claims: 1) a claim that the manufacturer acted unreasonably in marketing a product "that presents an unusually high risk of harm and negligible utility for legitimate purposes"; 2) a claim that the manufacturer implemented "a marketing strategy that deliberately, recklessly, or negligently target[ed] criminal consumers"; and 3) a claim that the manufacturer failed "to take reasonable steps in the marketing process to minimize the risk that its products [would] be purchased by persons likely to misuse them." McClurg, supra, at 799.

13 One lower federal court has attempted to cast doubt on this proposition, suggesting that a negligent marketing claim in a case like this one "really amount[s] to an alternate pleading of the [strict] product liability theory," and that the act of marketing a product cannot "give rise to liability absent a defect in the manufacture or design of the product itself." Hamilton v. Accu-Tek, 935 F.Supp. 1307, 1323 (E.D.N.Y.1996). To the extent that case suggests that there is no difference between a cause of action for negligent marketing of a product and one for strict liability for defective design, it is, in my opinion, manifestly incorrect.

Traditionally, products liability actions have been allowed to proceed on a number of grounds, including negligence and strict liability. See, e.g., Voss v. Black & Decker Mfg. Co., 59 N.Y.2d 102, 463 N.Y.S.2d 398, 401, 450 N.E.2d 204, 207 (1983) ("In New York, a plaintiff injured by an allegedly defective product may seek recovery against the manufacturer on the basis of any one or more of four theories of liability. Depending on the factual context in which the claim arises, the injured plaintiff ... may state a cause of action in contract, express or implied, on the ground of negligence, or ... on the theory of strict products liability.") (citation and internal quotation marks omitted); id. ("As the law of strict products liability has developed in New York, a plaintiff may assert that the product is defective because of a mistake in the manufacturing process or because of an improper design or because the manufacturer failed to provide adequate warnings regarding the use of the product.") (citations omitted).

It is true that, in cases such as this one, the question of defect in strict products liability may closely resemble the question of breach in negligence, as the existence of a defect, like the existence of negligence, may depend (at least in part) on whether the benefit of the product outweighs the risk of harm. See infra Part II.B; see also Denny v. Ford Motor Co., 87 N.Y.2d 248, 639 N.Y.S.2d 250, 255, 662 N.E.2d 730, 735 (1995) (noting that "the inquiry in design defect cases [is] close[ ] to that used in traditional negligence cases"). But a claim of negligent marketing differs from a claim of design defect in at least one important way:

Strict products liability for design defect ... differs from a cause of action for a negligently designed [or marketed] product in that the plaintiff is not required to prove that the manufacturer acted unreasonably in designing [or marketing] the product. The focus shifts from the conduct of the manufacturer to whether the product, as designed, was not reasonably safe. A manufacturer is held liable regardless of his lack of actual knowledge of the condition of the product because he is in the superior position to discover any design defects and alter the design before making the product available to the public.

Voss, 463 N.Y.S.2d at 401-02, 450 N.E.2d at 207-08. Conversely,

[t]o impose liability for negligence, it would not be necessary for the plaintiff to prove there was "something wrong" with the product. The plaintiff would need to show only that there was "something wrong" with the manufacturer's conduct. To find for the plaintiff under a negligent marketing theory, the court essentially would be saying: "Your product may be fine, but there was 'something wrong' with your selling it (or with the manner in which you sold it)."

McClurg, supra, at 801.

14 The general rule is, of course, that the legality of an act does not insulate it from possible tort liability. Illegality may be negligence per se, as it is in New York, see Van Gaasbeck v. Webatuck Cent. Sch. Dist. No. 1, 21 N.Y.2d 239, 287 N.Y.S.2d 77, 80, 234 N.E.2d 243, 245 (1967), but legality "does not preclude a finding of negligence," Feiner v. Calvin Klein, Ltd., 157 A.D.2d 501, 549 N.Y.S.2d 692, 693 (1990). Legality may, however, be relevant to the issue of duty. See infra Part II.A.4.

15 There are exceptions to this requirement, see, e.g., Modave v. Long Island Jewish Med. Ctr., 501 F.2d 1065, 1072-74 (2d Cir.1974); Summers v. Tice, 33 Cal.2d 80, 199 P.2d 1, 2-5 (1948) (in banc), but they need not detain us here.

16 "There is a causal link [that is, a causal tendency] between an act or activity and an injury when we conclude on the basis of the available evidence that the recurrence of that act or activity will increase the chances that the injury will also occur." Calabresi, Concerning Cause, supra, at 71. This concept is distinct from cause in fact. For instance, "but for the fact that the trolley driver had been speeding, the trolley car would not have been under a particular rotten tree when it fell and hit the car. Yet, unless speeding increases vibrations and vibrations increase the likelihood of trees falling, the admittedly but for cause would not be causally linked to the injury." Id. at 72.

17 See, e.g., Doucette v. Town of Bristol, 138 N.H. 205, 635 A.2d 1387, 1391 (1993) ("The existence of a duty under particular circumstances depends on what risks, if any, are reasonably foreseeable.") (citation and internal quotation marks omitted); Estates of Morgan v. Fairfield Family Counseling Ctr., 77 Ohio St.3d 284, 673 N.E.2d 1311, 1319 (1997) ("In Ohio, the existence of a duty depends on the foreseeability of the injury.") (citation, brackets, and internal quotation marks omitted).

18 See, e.g., Nutbrown v. Mount Cranmore, Inc., 140 N.H. 675, 671 A.2d 548, 551 (1996) (explaining that the doctrine of primary assumption of risk "is simply an alternative expression for the proposition that the defendant was not negligent, that is, there was no duty owed") (citation and internal quotation marks omitted); Gallagher v. Cleveland Browns Football Co., 74 Ohio St.3d 427, 659 N.E.2d 1232, 1236 (1996) (noting that "a defendant who asserts [a primary assumption of risk] defense asserts that no duty whatsoever is owed to the plaintiff").

19 The fact that the court in Codling found liability based on the nascent doctrine of strict products liability, rather than negligent products liability, is of no matter. In Codling, the trial court allowed the plaintiff's cause of action for negligence to proceed to the jury, which found no unreasonable conduct on the part of the defendant. See Codling, 345 N.Y.S.2d at 464-65, 298 N.E.2d at 625. The Court of Appeals made no suggestion in that case that the defendant was under no duty to the bystander plaintiff, such that, had the jury found negligence, the plaintiff would not have been permitted to recover. Indeed, the Court of Appeals quoted Codling 's statement that a product manufacturer should not be immune from liability to any persons injured by the product " 'where the manufacturer could reasonably contemplate injury to such persons by reason of the defect' " in a negligence case decided the very same year as Codling. Bolm, 350 N.Y.S.2d at 649-50, 305 N.E.2d at 773 (quoting Codling, 345 N.Y.S.2d at 467, 298 N.E.2d at 627).

It has been noted that "[t]he strict liability rule for products liability cases ... does not eliminate the requirement that, even where there is a defect in the product, there must be some duty owed to the plaintiff." Walton v. Chrysler Motor Corp., 229 So.2d 568, 573 (Miss.1970), overruled on other grounds by Toliver v. General Motors Corp., 482 So.2d 213 (Miss.1985); see also Allabach v. Santa Clara County Fair Ass'n , Inc., 46 Cal.App.4th 1007, 54 Cal.Rptr.2d 330, 333 n. 1 (1996). Many courts have indicated that the duty requirement is identical in strict liability and negligence claims. See, e.g., Wagatsuma v. Patch, 10 Haw.App. 547, 879 P.2d 572, 585 (1994); Briggs v. Hartford Ins. Co., 532 So.2d 1154, 1156 (La.1988). While the Third Circuit has rejected a district court's statement that "courts have consistently applied the identical duty requirement to strict liability and negligence claims," Griggs v. BIC Corp., 786 F.Supp. 1203, 1209 (M.D.Pa.), rev'd, 981 F.2d 1429, 1434-35 (3d Cir.1992), that case dealt with situations in which, while there was no duty in strict liability, there might still be a duty in negligence. I have uncovered no authority for the converse proposition: that a duty can exist in strict liability, but not in negligence. Such a position would be unlikely, to say the least.

Instead, in addition to Codling and Bolm, numerous cases suggest that, under New York law, the existence of a duty in strict liability establishes the existence of a duty in negligence as well. See, e.g., Colonno v. Executive I Assocs., 228 A.D.2d 859, 644 N.Y.S.2d 105, 107 (1996) (holding that, in a products liability action premised on negligence, "the principle emanating from strict products liability law now holds contractors to a general standard of reasonable care for the protection of third persons who may be foreseeably endangered by the contractor's negligence") (citations and internal quotation marks omitted). While the New York Court of Appeals has not spoken directly to this issue, there is absolutely no indication that New York law contemplates that there can be no duty in negligence despite the presence of a duty in strict liability. For a federal court to presume so in a diversity case without any statement to that effect from the New York Court of Appeals would be an extraordinary act.

20 Whether the imposition of liability in these circumstances would go beyond the dictates of sound public policy is, of course, a difficult policy issue, but it is certainly not out of the question that the Court of Appeals might make just that determination.

21 There is one situation in which that question has often come up in state courts. When a car owner negligently leaves the keys in the ignition of an unlocked car, and a thief steals the car and runs over a third-party pedestrian, does the car owner owe a duty to the pedestrian? In other words, could the defendant be held liable for the criminal acts of an intervenor absent any direct relationship with the plaintiff? Historically, a majority of jurisdictions answered this question in the negative, finding either no duty or no proximate cause. See Zinck v. Whelan, 120 N.J.Super. 432, 294 A.2d 727, 729-30 & n. 9 (App.Div.1972) (collecting cases). However, "[a] substantial and growing number of jurisdictions, though still a minority, have held, in the ordinary fact case of theft and accident within a reasonable time thereafter that there are at least jury questions as to duty, negligence and proximate cause." Id., 294 A.2d at 730 (collecting cases). A number of these jurisdictions have reached this conclusion in the absence of any statute forbidding the driver from leaving the keys in the ignition. See Roadway Express, Inc. v. Piekenbrock, 306 N.W.2d 784, 785-86 (Iowa 1981) (collecting cases).

In New York, the Court of Appeals initially indicated that it would allow liability in this situation. See Maloney v. Kaplan, 233 N.Y. 426, 135 N.E. 838, 839 (1922) (Pound, J.) ("The driver of a spirited horse, who leaves it unhitched in the street, may be liable for accidents immediately brought about by one who frightens the animal or touches it with the whip, so that it runs away; so the driver of an automobile who leaves it in the street without properly securing it may be liable for accidents immediately brought about by his negligence, although others may start the car."); see also Illidge v. Goodwin, 5 Carr. & Payne's Rep. 190 (C.P.1831) ("If a man chooses to leave a cart standing in the street, he must take the risk of any mischief that may be done."). Subsequently, however, the Court of Appeals refused to allow recovery, see Walter v. Bond, 292 N.Y. 574, 54 N.E.2d 691 (1944), aff'g 267 A.D. 779, 45 N.Y.S.2d 378 (1943), concluding that the car owner's negligence could not be a proximate cause of the plaintiff's injury, see Wilson v. Harrington, 295 N.Y. 667, 65 N.E.2d 101 (1946), aff'g 269 A.D. 891, 56 N.Y.S.2d 157 (1945); accord Lotito v. Kyriacus, 272 A.D. 635, 74 N.Y.S.2d 599, 600-01 (1947).

Not long after, the New York legislature enacted what is now N.Y. VEH. & TRAF. L. § 1210(a), which provides that "[n]o person driving or in charge of a motor vehicle shall permit it to stand unattended without first stopping the engine, locking the ignition, [and] removing the key from the vehicle." That "statute changed the prior case law and it is now clear that the intervention of an unauthorized person no longer operates to break the chain of causation." Guaspari v. Gorsky, 36 A.D.2d 225, 319 N.Y.S.2d 708, 711 (1971).

Because they found no proximate cause, the courts of New York never reached the question of duty. By enacting § 1210(a), the state legislature (reflecting the will of the people) imposed liability before the New York Court of Appeals had occasion to reconsider its decision and perhaps join the "substantial and growing number of jurisdictions" that have found not only proximate cause, but also a duty, in cases of this sort. As such, we have no indication of what the Court of Appeals would say about duty in this situation in the absence of a statute. It is worth noting, however, that the Court of Appeals' earliest and only pronouncement on the subject, Maloney v. Kaplan, held, at least by implication, that a duty did exist.

22 Cf. Note, Absolute Liability for Ammunition Manufacturers, 108 HARV. L. REV . 1679, 1691 (1995) ("The primary advantage of [imposing tort liability on ammunition manufacturers] is that it will force consumers of ammunition to internalize costs that have heretofore been borne by third parties and society in general. Such internalization will provide manufacturers and consumers with the proper incentives to choose care and activity levels that more closely equate costs and benefits.") (footnote omitted); id. at 1690 (noting that, unlike banning ammunition, imposing liability "does not reflect any moral or ethical condemnation of ammunition manufacturers").

23 Indeed, the fact that the Black Talon has not been banned should not be taken to suggest that a majority of New Yorkers necessarily favors its continued availability. To the contrary, the public outcry against Black Talons was so great even before Colin Ferguson's crime that their manufacturer chose to withdraw them from public distribution in the face of mounting political pressure. See Jamieson, supra, at 5. Bills had been introduced in Congress both to ban the bullets, see id., and, alternatively, to tax them out of existence. See Winchester Bows to Pressure, Halts Talon Bullet Sales, BALT. SUN , Nov. 23, 1993, at 5A. Police groups, including New York City's Police Commissioner, had advocated banning the bullets. See Jamieson, supra, at 5. Even emergency room physicians had condemned the bullets because of the danger of contracting blood-borne diseases when the razor-sharp talons pierce both their surgical gloves and their skin. See Winchester Halts Sale, supra, at A4; All Things Considered: Winchester Will no Longer Make the Black Talon Bullet (National Public Radio broadcast, Nov. 23, 1993).

In fact, one of the plaintiffs in this action, Carolyn McCarthy, was elected to Congress largely on a platform of opposition to assault weapons and extra-destructive ammunition. See NBC Nightly News (NBC television broadcast, Nov. 6, 1996) ("Carolyn McCarthy has been elected to Congress. The widow of one of the victims of the 1993 massacre on New York's Long Island Railroad turned politician after her local congressman voted against a ban on assault weapons. Last night she defeated him.").

24 Naturally, that task may also be undertaken by the state's legislature. See supra note 21 (noting that the New York legislature imposed liability, where the Court of Appeals had not, for the injuries caused to a third person when a car owner leaves the keys in an unlocked car and an intervening thief steals the car and strikes the third person).

25 These are not the elements of a cause of action in strict products liability. Those elements are much more specific, and depend on the theory of liability being asserted. See, e.g., Fane v. Zimmer, Inc., 927 F.2d 124, 128 (2d Cir.1991) (explaining, for example, that in design defect cases the typical plaintiff must show "that (1) the product is 'defective' because it is not reasonably safe as marketed; (2) the product was used for a normal purpose; (3) the defect was a substantial factor in causing the plaintiff's injuries; (4) the plaintiff by the exercise of reasonable care would not have both discovered the defect and apprehended its danger; (5) the plaintiff would not have otherwise avoided the injury by the exercise of ordinary care") (citation and internal quotation marks omitted). Rather, these are the basic requirements for any cause of action in tort for products liability, regardless of the particular theory of recovery.

26 The difference between this risk/utility test and the Learned Hand test for negligence is that the latter requires that a reasonable person knew or ought to have known of the undue danger at the time that she or he acted, while the former imposes strict liability and is not limited by what the actor knew or should have known. See Voss, 463 N.Y.S.2d at 401-02, 450 N.E.2d at 207-08.

27 For a detailed analysis of the various tests adopted by state courts in determining the existence of a design defect, see John F. Vargo, The Emperor's New Clothes, 26 U. MEM. L. REV . 493, 538-47 (1996).

28 The plaintiffs also claimed below that the defendant's decision to manufacture Black Talons as designed was negligent. It should be noted that, regardless of the applicability of the consumer expectations test in strict liability, New York law does not allow a manufacturer to rely on the obvious nature of the defect (that is, on reasonable consumer expectations) to defend against a claim of negligent design and manufacture. See Micallef v. Miehle Co., 39 N.Y.2d 376, 384 N.Y.S.2d 115, 348 N.E.2d 571 (1976).

29 This commentator suggests that the Court of Appeals'

prior statement concerning consumer expectations could be explained in at least two different ways. The court may be adopting a modified Barker [v. Lull Eng'g Co., supra ] rule in design cases--the design defect may be established by application of the consumer expectations test, but if this test proves inappropriate, the plaintiff may establish design defect through [a variation of the risk/benefit calculus]. An alternative interpretation is that the consumer expectation test is used for manufacturing defects, and the risk-utility test is used for design cases.

Id. at 832.

30 I have elsewhere argued in favor to the consumer expectations test, and have expressed doubts about the appropriateness of the risk/benefit test. See Guido Calabresi & Jeffrey O. Cooper, New Directions in Tort Law, 30 VAL. U.L. REV . 859, 864-65 (1996). But my personal preferences are, of course, irrelevant to the task before us.

31 For a description of the controversy surrounding this section of the Restatement, see Vargo, supra, at 519-36; Carl T. Bogus, The Third Revolution in Products Liability, 72 CHI.-KENT L. REV. 3, 15-16 (1996).

32 Whatever the merits of the contention that entire categories of products can be found defective even in the absence of evidence of an alternative design, it is important to emphasize that this is not a case in which the plaintiffs seek to impose liability on the manufacturers of all handguns or ammunition, and in which by definition there could be no reasonable alternative design short of failing to manufacture that type of product at all. Rather, this is a case in which the plaintiffs seek to impose liability for the decision to create extra-destructive ammunition that shreds human flesh upon impact and to market that product to the general public. There exists an alternative design--no talons--and an alternative marketing strategy--sale only to police officers, see Bogus, supra, at 15 n. 83 ("Some products may be unreasonably dangerous when sold to the public-at-large but not when sold to a particular class of purchasers. For example, x-ray equipment may be reasonably dangerous when sold to licensed facilities, and handguns may be reasonably dangerous when sold to law enforcement officers, even if such products are unreasonably dangerous when sold to the public-at-large.")--either of which stop well short of imposing liability on the entire ammunition product category.

33 A third potential cause of action may also exist on these facts--ultrahazardous activity liability. Like negligence and strict liability, ultrahazardous activity liability requires the existence of a duty relationship which is breached by the defendant's ultrahazardous activity, thereby causing demonstrable injury to the plaintiff. The district court refused to consider whether there was a breach in this case (in other words, whether the defendant's activities were ultrahazardous) because it found that there was no duty relationship. It agreed with the defendant that "the doctrine of ultrahazardous activity does not apply to products; rather, it is limited to activities involving the use of land." McCarthy, 916 F.Supp. at 371 (emphasis added) (citing Forni v. Ferguson, No. 132994/94 (N.Y. Sup.Ct. New York County Aug. 2, 1995), aff'd, 648 N.Y.S.2d 73 (N.Y.App.Div.1996)).

It seems to me particularly ironic to say that New York courts would limit the applicability of ultrahazardous activity liability solely to cases involving land, given that, in the seminal case of ultrahazardous activity liability in the United States--Sullivan v. Dunham, 161 N.Y. 290, 55 N.E. 923, 924 (1900)--the Court of Appeals declared that "the safety of the person is more sacred than the safety of property," and held that prior cases that had allowed liability only for trespass upon land, and not trespass upon persons, did not prevent the imposition of liability on a defendant whose ultrahazardous activity had injured a passerby.

In fact, New York law has at times allowed ultrahazardous liability for activities not involving the defendant's use of land. See, e.g., Margosian v. U.S. Airlines, Inc., 127 F.Supp. 464, 467 (E.D.N.Y.1955) (finding that an airplane pilot whose plane crashed on the plaintiff's property was liable under New York law despite the lack of negligence because aviation was, at the time, an ultrahazardous activity) (citing Rochester Gas & Elec. Corp. v. Dunlop, 148 Misc. 849, 266 N.Y.S. 469 (Monroe County Ct.1933), and RESTATEMENT (FIRST) TORTS § 520 cmt. b (1939) (classifying aviation as an ultrahazardous activity)). Subsequently, New York courts have refused to allow ultrahazardous activity liability for the use of airplanes, concluding "in light of the technical progress achieved in the design, construction, operation and maintenance of aircraft generally, that flying should no longer be deemed to be an ultrahazardous activity." Wood v. United Air Lines, 32 Misc.2d 955, 223 N.Y.S.2d 692, 697 (N.Y.Sup.Ct.1961), aff'd, 16 A.D.2d 659, 226 N.Y.S.2d 1022 (1962); accord Crist v. Civil Air Patrol, 53 Misc.2d 289, 278 N.Y.S.2d 430, 433-34 (N.Y.Sup.Ct.1967). But these cases do not undermine the principle that ultrahazardous activity liability may be imposed on activities other than the use of land. See, e.g., Siegler v. Kuhlman, 81 Wash.2d 448, 502 P.2d 1181, 1184-87 (1972) (en banc) (transporting gasoline by truck constitutes an ultrahazardous activity). Indeed, one court has found that the manufacturing and marketing of assault weapons to the general public constitutes an ultrahazardous activity. See In re 101 California Street, No. 959316 (Cal.Super.Ct. 2d Dep't Apr. 10, 1995) (cited in Hamilton v. Accu-Tek, 935 F.Supp. 1307, 1324 (E.D.N.Y.1996)). But see Delahanty v. Hinckley, 564 A.2d 758, 760-61 (D.C.1989) (collecting cases refusing to allow ultrahazardous activity liability for the manufacture and sale of firearms). See generally McClurg, supra, at 788-91 (collecting cases and commentary).

Nonetheless, the plaintiffs chose not to pursue this argument on appeal, and I will go no further in discussing its possible viability or non-viability.

34 In this respect, I have, in my dissent, emphasized the arguments in favor of liability, not because I am necessarily convinced by them, but because that is what I must do to determine whether there is sufficient uncertainty to warrant certification.

428*428 Frank B. Morrison, Jr., Morrison Law Offices, Kalispell (argued), for plaintiffs and appellants.

Sherman V. Lohn (argued), Garlington, Lohn & Robinson, Kalispell, for Federated Foods.

Leonard Kaufman and James Ramlow (argued), Murray, Kaufman, Vidal, Gordon & Ogle, Kalispell, for Mark Sorenson, M.D.

GRAY, Justice.

Chad Emery appeals from an order of the Fourth Judicial District Court, Missoula County, granting summary judgment to Federated Foods, Inc., Kidd and Co., Inc., West Coast Grocery Co. and its successor-in-interest Super Valu Stores, Inc. (collectively hereafter Federated Foods). He also appeals an order changing venue to Flathead County on a negligence claim against Mark Sorenson, M.D. We reverse and remand.

We phrase the issues on appeal as follows:

1) Did the District Court err in changing venue to Flathead County on Emery's negligence claim against Dr. Sorenson?

2) Did the District Court err in refusing to consider the affidavits of Dr. Loube and Dr. Dingus?

3) Did the District Court err in granting summary judgment for Federated Foods on Emery's products liability claim?

4) Did the District Court err in declining to rule on the admissibility of a report compiled by the American Academy of Pediatrics?

In 1987, Laura Emery and her two children, Zach, age 7 and Chad, age 2 1/2, lived in Kalispell, Montana. On November 3, 1987, Laura finished her shift as a waitress and stopped at the Price Plus grocery store. At her children's request, she purchased a bag of generic large marshmallows, scanning the label before making her choice. When the family returned home, Laura put the marshmallows on the top shelf of her kitchen cupboard, out of the children's reach.

The next morning around 7:15 a.m., Ken Kerzman, a friend of Laura's, stopped by to shower and to complete paperwork at Laura's kitchen table. Although Laura had not risen from her bed on the living room couch, the children asked her if they could have some marshmallows before breakfast; she consented. Zach climbed onto the kitchen counter and retrieved the bag of marshmallows from the top shelf of the cupboard. Zach gave Chad some marshmallows and took some for himself. Chad began to choke on the marshmallows within several seconds, and pulled on Kerzman's pant leg. Kerzman executed the Heimlich Maneuver, forcing Chad to expel several pieces of marshmallow; Chad continued to choke. Kerzman held Chad upside down and alerted Laura; they drove Chad to the Kalispell hospital.

At the hospital, doctors suctioned a small liquified piece of marshmallow from Chad's airway. Chad sustained severe brain injuries as a result of the incident.

Laura Emery, on behalf of Chad Emery (Emery), filed the second amended complaint against Federated Foods on May 31, 1990. The complaint alleged that the 429*429 marshmallows were defective and dangerous to the consumer and that, in spite of the significant danger of aspiration by small children, the product contained no warning of such danger. Emery also asserted a breach of warranty claim against Federated Foods. The complaint further alleged that Dr. Mark Sorenson negligently treated Chad Emery at the Kalispell hospital. Claims against two Missoula doctors who treated Emery after he was transferred to Missoula subsequently were settled and dismissed.

Upon motion of Federated Foods, the District Court granted summary judgment for Federated Foods on the products liability and implied warranty claims. After these claims were dismissed, the District Court granted Dr. Sorenson's motion to change venue to Flathead County. The District Court certified the summary judgment order as final pursuant to Rule 54(b), M.R.Civ.P. Emery appeals the orders granting summary judgment and changing venue.

We note initially that, notwithstanding Emery's counsel's statement during oral argument that he also had appealed the dismissal of his breach of warranty claim, Emery did not argue or brief this question. As such, Emery cannot contest the District Court's grant of summary judgment against him on the breach of warranty claim. Nutter v. Permian Corp. (1986), 224 Mont. 72, 75, 727 P.2d 1338, 1340.

Did the District Court err in changing venue to Flathead County on Emery's negligence claim against Dr. Sorenson?

Emery filed his complaint in Missoula County. In Dr. Sorenson's first appearance in the action, he moved for a change of venue to Flathead County; the District Court denied the motion. After the dismissal of the other defendants, Dr. Sorenson renewed his motion to change venue. The District Court granted the motion, concluding that because Dr. Sorenson was the only remaining defendant, venue was proper in the county of his residence. Our review of such legal conclusions is plenary. See Steer, Inc. v. Dep't of Revenue (1990), 245 Mont. 470, 475, 803 P.2d 601, 603.

It is well-settled in Montana that venue will be determined by the status of the parties and pleadings at the time of the complaint or at the time the moving party appears in the action. Boucher v. Steffes (1972), 160 Mont. 482, 485, 503 P.2d 659, 660; Clark Fork Paving, Inc. v. Atlas Concrete & Paving (1978), 178 Mont. 8, 13, 582 P.2d 779, 782; Petersen v. Tucker (1987), 228 Mont. 393, 395, 742 P.2d 483, 484.

In Boucher, the plaintiff filed a complaint against defendant Steffes and the administratrix of defendant Byer's estate in Fallon County, where the administratrix resided. Defendant Steffes moved for a change of venue to Yellowstone County, the county of his residence, after the claim against the administratrix was dismissed. Boucher, 503 P.2d at 660. In Boucher, we held that when there are multiple defendants when the case is instituted, and the defendants who reside in the county where the action was filed are dismissed, the remaining defendant has no right to change venue to his or her county of residence. Boucher, 503 P.2d at 660. We concluded that the status of the parties and pleadings at the time the moving party appears in the action determines venue. Boucher, 503 P.2d at 660.

Applying these principles to the case before us, venue was clearly proper in Missoula County when Dr. Sorenson originally appeared in the action, as the complaint alleged claims against out-of-state corporations and two Missoula doctors. See §§ 25-2-117 and -118, MCA. We conclude, therefore, that the District Court erred in changing venue to Flathead County. To hold otherwise would require courts to reexamine the question of venue whenever the composition of the parties was altered; such a result would generate needless litigation and unduly burden the judiciary.

Finally, Dr. Sorenson asserts that because the District Court's order on Rule 430*430 54(b), M.R.Civ.P., does not mention the order changing venue, this Court lacks jurisdiction to determine whether venue was properly transferred. This argument is without merit. Rule 1(b)(2), M.R.App.P., provides for the direct appeal of an order changing or refusing to change venue when the basis for the motion is that the county designated in the complaint is not the proper county. As such, no Rule 54(b), M.R.Civ.P., certification is required.

Did the District Court err in refusing to consider the affidavits of Dr. Loube and Dr. Dingus?

In response to Federated Foods' motion for summary judgment, Emery submitted the affidavits of Dr. Julian M. Loube, a pediatrician, and Dr. Thomas A. Dingus, an industrial engineer. Although this Court was not provided with a transcript of the summary judgment hearing, apparently Federated Foods' only objection to the affidavits was that the subject matter of the lawsuit was not beyond the common understanding of a layperson and, therefore, expert testimony was not required.

In its order granting summary judgment for Federated Foods, the District Court stated:

[t]he Court is not convinced that either Dr. Loube or Dr. Dingus are experts on the allegedly latent design defect or hidden dangers of marshmallows. Furthermore, the affidavits do not offer any evidence upon which this Court can properly base a finding or inference that marshmallows possess any innocuous characteristics, either by design or composition, which would enhance the possibility of choking during consumption.

Emery contends that the District Court improperly refused to consider the affidavits of Dr. Loube and Dr. Dingus.

It is apparent from the District Court's opinion that the affidavits were before the District Court and it did consider their content. Moreover, in the District Court's May 24, 1993, order on remand from this Court, it stated that the affidavits were "relied on by the Court in reaching its decision ... and constituted [a part of] the record." Therefore, although the District Court concluded that the affidavits did not lend any support to Emery's argument, it did not reject the affidavits on the basis argued by Federated Foods or otherwise; nor did it exclude them from consideration. The court having considered the affidavits, we conclude only that the District Court did not err by refusing to consider them; we leave for later determination by that court the question of the admissibility of testimony by Dr. Loube and Dr. Dingus under the Montana Rules of Evidence. The propriety of the court's conclusion regarding the content of the affidavits is analyzed in the following issue.

Did the District Court err in granting summary judgment for Federated Foods on Emery's products liability claim?

In support of its motion for summary judgment, Federated Foods filed a brief and relied on the existing record. In opposition to summary judgment, Emery submitted four affidavits: Dr. Loube, Dr. Dingus, attorney Sharon Morrison, and Laura Emery. He also filed the sworn statement of Zach Emery, four exhibits and an accompanying brief.

In granting Federated Foods' motion for summary judgment, the District Court found that "the manner in which Chad consumed the marshmallows caused his damages," and concluded that no genuine issues of material fact existed. The District Court stated:

[I]t is the manufacturer's duty to warn inadequately informed users about the risk of danger involved with the use of a product ... The evidence in the record clearly supports a finding that the manner in which Chad consumed the marshmallows caused his damages. Under these circumstances, and for the reasons stated, the Court finds that the Defendants were not under any duty as a matter of law to warn the Plaintiffs that infants and toddlers can choke on large quantities of marshmallows eaten all at one time.

431*431 Relying on comment (j) of § 402A of the Restatement (Second) of Torts, the court concluded that a seller is not required to warn with respect to products which are only dangerous when consumed in excessive quantities if that danger is generally known and recognized.

Our standard in reviewing a grant of summary judgment is the same as that initially used by the district court. McCracken v. City of Chinook (1990), 242 Mont. 21, 24, 788 P.2d 892, 894. Summary judgment is appropriate when the pleadings, depositions, affidavits and other documents on file demonstrate that no genuine issue of material fact exists and that the moving party is entitled to judgment as a matter of law. Rule 56(c), M.R.Civ.P. The party seeking summary judgment has the burden of demonstrating a complete absence of any genuine factual issues. Mayer Bros. v. Daniel Richard Jewelers (1986), 223 Mont. 397, 399, 726 P.2d 815, 816. The burden then shifts to the non-moving party to show the existence of a genuine issue of material fact in order to withstand the summary judgment motion. Mayer Bros., 726 P.2d at 816.

We have stated on numerous occasions that the purpose of summary judgment is to encourage judicial economy through the elimination of any unnecessary trial. However, summary judgment is never to be a substitute for trial if there is an issue of material fact. Payne Realty v. First Sec. Bank (1992), 256 Mont. 19, 24, 844 P.2d 90, 93. All reasonable inferences that may be drawn from the offered proof must be resolved in favor of the party opposing summary judgment. If there is any doubt regarding the propriety of the summary judgment motion, it should be denied. Payne Realty, 844 P.2d at 93.

After careful review of the record in this case, we conclude that the District Court erroneously resolved disputed issues of material fact and, therefore, exceeded the scope of its role at the summary judgment stage of this case. Although Federated Foods argues that the affidavits submitted do not create genuine issues of material fact because the statements therein relate to non-essential, non-material facts, we conclude that the documents were sufficient to meet Emery's burden in opposing summary judgment. We will briefly review the applicable law in this area to illustrate the materiality and relevance of the proof offered by Emery.

A products liability claim for failure to warn requires proof of the following elements:

1) the product was in a defective condition, "unreasonably" dangerous to the user or consumer;

2) the defect caused the accident and injuries complained of; and

3) the defect is traceable to the defendant.

Riley v. Honda Motor Co. (1993), [259 Mont. 128], 856 P.2d 196, 198, 50 St.Rep. 714, 715; Brown v. North American Mfg. (1978), 176 Mont. 98, 105-6, 576 P.2d 711, 717. In reviewing the District Court's order in this case, we must consider the first two elements.

With respect to the first element, the failure to warn of an injury-causing risk associated with the use of a technically pure and fit product can render the product unreasonably dangerous. Riley, 856 P.2d at 198. The product is automatically defective if it is unreasonably dangerous and a warning is required but not given. Krueger v. General Motors Corp. (1989), 240 Mont. 266, 278, 783 P.2d 1340, 1348; Rost v. CF&I Steel Corp. (1980), 189 Mont. 485, 488, 616 P.2d 383, 385. A product may be defective if purchasers and likely users have been misinformed or inadequately informed about either the risks or the dangers involved in the use of the product or how to avoid or minimize the harmful consequences from such risk. Streich v. Hilton-Davis (1984), 214 Mont. 44, 54, 692 P.2d 440, 445-46.

Emery presented evidence to the District Court in support of his theory that the marshmallows involved in this case were defective and unreasonably dangerous because they lacked an effective warning. Dr. Loube's affidavit related to the potentially 432*432 hazardous properties of a marshmallow and included the following statements:

Food items are often particularly dangerous in that they change their characteristics and consistency when they are soaked with the liquid secretions that are present in the breathing tubes of the lungs. These secretions usually cause some swelling of the food so that it further obstructs the breathing passage.

.........

A marshmallow is a particularly hazardous confection as a risk of aspiration in children under the age of three. It is sweet and, therefore, has a great deal of appeal to small children. It appears soft and innocuous to parents and does not present the same apparent risk that might be perceived by a parent when considering a piece of hard candy or a jelly bean.

........

An aspirated piece of marshmallow can be very difficult to dislodge. Because it continues to expand after entering the airway it can efficiently obstruct a large breathing passage, perhaps even the trachea (the main breathing tube). An aspirated marshmallow fragment might not be reachable with a finger and could be difficult to dislodge with a Heimlich maneuver.

Further, Dr. Dingus stated that, absent an appropriate warning, it is foreseeable that a reasonable parent would not perceive that marshmallows present a danger to small children.

In spite of this evidence, the District Court stated that "the evidence does not support a finding that marshmallows pose any more of a threat of choking upon consumption than do the majority of other foods." The court also concluded that the affidavits did not offer any evidence upon which the court could base a finding or inference that marshmallows possess any innocuous characteristics, either by design or composition, which would enhance the possibility of choking during consumption.

We emphasize that summary judgment was not intended, nor can it be used, as a substitute for trial of issues of fact. Edgewater Townhouse Assoc. v. Holtman (1992), 256 Mont. 182, 185, 845 P.2d 1224, 1226. The question before the District Court was whether genuine issues of material fact existed regarding the potential danger of aspiration of marshmallows without an appropriate warning. We conclude that the District Court erroneously resolved issues of fact regarding the chemical properties of marshmallows and the foreseeability of the danger of aspiration in children.

Regarding the element of causation, we recently stated in Riley that while causation is ordinarily a question of fact in a failure to warn claim, it may be determined as a matter of law where reasonable minds can reach but one conclusion. Riley, 856 P.2d at 198. We also explained that this element can be satisfied by evidence indicating that a warning would have altered the plaintiff's use of the product or prompted the plaintiff to take precautions to avoid the injury. Riley, 856 P.2d at 198-99.

In Laura Emery's affidavit, she stated that "if I had been warned of the risk of small children choking on marshmallows, I would not have purchased them at all ... I usually read labels on food products prior to buying them. I always take note of warnings on labels about risks to children." At a minimum, pursuant to Riley, this evidence raises a genuine issue of material fact regarding causation.

Nonetheless, the District Court made a factual finding that "Chad's overindulgence caused his injuries" and concluded that "the evidence in the record clearly supports a finding that the manner in which Chad consumed the marshmallows caused his damages." We conclude that a genuine issue of material fact exists regarding the cause of Chad's damages. This question of causation — that is, whether the incident was caused by the manner and quantity of marshmallows eaten or by a product defective and unreasonably dangerous by virtue of the absence or inadequacy of a warning — remains to be decided by the fact-finder.

433*433 As a final matter, the District Court went on to state that:

[n]o evidence even suggests that Laura Emery was an inadequately informed user of marshmallows. Likewise, the record is devoid of substantial credible evidence which would support a finding that Ms. Emery was not cognizant of the potential harm presented by the consumption of marshmallows.

Laura Emery's affidavit stated that it did not occur to her that marshmallows presented a risk of choking in small children. Dr. Dingus' affidavit also stated that it is foreseeable that a reasonable parent, would not, without the presence of an appropriate warning, perceive that marshmallows present a danger to small children. Again, the affidavits presented belie the District Court's opinion and its conclusion that no disputed issues of material fact exist here.

In sum, we conclude that the affidavits submitted by Emery in opposition to Federated Foods' motion for summary judgment adequately discharged his burden of demonstrating genuine issues of material fact. We do not suggest that the disputed facts discussed herein are the only disputed facts that remain to be determined in this case; rather, those facts are indicative of the presence of disputed issues of fact and the error in granting summary judgment.

We hold that the District Court erred in granting summary judgment for Federated Foods on Emery's failure to warn claim.

Did the District Court err in declining to rule on the admissibility of a report compiled by the American Academy of Pediatrics?

At the summary judgment hearing, Emery's counsel attempted to introduce into evidence a report to the Food and Drug Administration by the American Academy of Pediatrics entitled "Foods and Choking in Children." Federated Foods' counsel objected to the report as hearsay. Emery contends that the study was offered pursuant to the hearsay exception for public records and reports under Rule 803(8), M.R.Evid., arguing that the report contains factual findings resulting from an investigation made pursuant to authority granted by law. Both sides briefed the question following the summary judgment hearing. The District Court did not rule on the admissibility of the report and does not mention it in its opinion and order on summary judgment.

We conclude that resolution of this issue is unnecessary and premature at this time. This Court was not provided with a transcript of the summary judgment hearing and the record before us does not reflect whether the District Court admitted or rejected the report. Furthermore, the thrust of the report's conclusions is duplicated in Dr. Loube's affidavit. Because we have determined that summary judgment was inappropriately granted based on the affidavits offered by Emery, the contents of the report are not necessary for our resolution of the summary judgment issue. In the event the report is offered into evidence at trial, the District Court will address the question of admissibility pursuant to the Montana Rules of Evidence.

Reversed and remanded for further proceedings consistent with this opinion.

HUNT, TRIEWEILER, NELSON and WEBER, JJ., concur.

TURNAGE, Chief Justice, dissenting:

I respectfully dissent.

Two-and-one-half-year-old Chad Emery choked on a marshmallow and sustained a permanent injury. Everyone is distressed at this unfortunate incident. However, the issue facing this Court is whether such incident is the basis for a products liability claim for failure of the respondents to warn Chad Emery's mother of the danger of allowing her son to eat a marshmallow.

The majority opinion, in citing this Court's prior case law in Brown v. North American Mfg. (1978), 176 Mont. 98, 105, 576 P.2d 711, 716, and Riley v. American Honda Motor Co., Inc. (1993), [259 Mont. 128], 856 P.2d 196, 198, 50 St.Rep. 714, 715, correctly states the established rule:

434*434 A products liability claim for failure to warn requires proof of the following elements:

"1) the product was in a defective condition, `unreasonably' dangerous to the user or consumer;

"2) the defect caused the accident and injuries complained of[.]" [Emphasis supplied.]

The majority opinion then further states:

The question before the District Court was whether genuine issues of material fact existed regarding the potential danger of aspiration of marshmallows without an appropriate warning. We conclude that the District Court erroneously resolved issues of fact regarding the chemical properties of marshmallows and the foreseeability of the danger of aspiration in children.

In the real world of life as it is, the marshmallows in this case were not a product in a defective condition and thereby unreasonably dangerous to the user or consumer. If marshmallows are unreasonably dangerous to eat without a warning, then so would be nearly every conceivable food item that a two-and-one-half-year-old child would try to eat; and I submit that children of that age will try to eat anything and everything.

The possibility of a small child choking on nearly all food items is, or should be, a matter of common knowledge to all adults.

The net result of the majority opinion may well be that warnings must be placed on nearly every food item available to the public if the provider is to avoid litigation for a claim of products liability — an interesting challenge for the providers of edible items.

I understand the majority concern about the limits on summary judgments and district judges granting summary judgments when genuine issues of fact exist.

In this case as a matter of law, however, the essential element of a products liability claim is missing — the marshmallow was not in a defective condition and unreasonably dangerous.

I would affirm.

HARRISON, J., concurs.

Page 445

        [631 A.2d 1250]

Page 449

        John I. Lisowski, Livingston, for defendant-respondent (Morgan, Melhuish, Monaghan, Arvidson, Abrutyn & Lisowski, attorneys; Clifford James, Shea & Gould, New York City, of counsel).

        Before Judges PETRELLA, D'ANNUNZIO and KEEFE.

        The opinion of the court was delivered by

Page 450

        KEEFE, J.A.D.

        Plaintiff William Graves suffered a spontaneous stomach rupture in the early morning hours of August 22, 1979, after ingesting[631 A.2d 1251] Arm & Hammer baking soda manufactured by Church & Dwight Company, Inc. (Church & Dwight) which he had taken to resolve indigestion. Misdiagnosed as having suffered a perforated ulcer, Graves only came to believe in 1983 that the baking soda caused his injury. On August 8, 1984, he and his wife filed a complaint against Church & Dwight. ¹ The eight-count complaint alleged misrepresentation and mislabeling; negligent failure to warn; strict liability in tort; breach of warranty; and fraud. ²

        The matter was tried over several weeks. Only the strict liability warning issue was submitted to the jury, the other claims having been dismissed. The jury was given four interrogatories to answer pertaining to liability. The questions were:

1. Did the plaintiff consume defendant's Arm & Hammer Baking Soda on the night in question?

2. Was the Arm & Hammer Baking Soda product defective by reason of its failure to warn about possible stomach rupture?

3. Was the failure to warn a proximate cause of plaintiff's consumption of Arm & Hammer Baking Soda on the night in question?

4. Was the consumption of Arm & Hammer Baking Soda a substantial contributing factor proximately causing plaintiff's stomach rupture?

        The jury unanimously found, in response to the first question, that defendant's product was involved in the incident. By a five-to-one majority it answered questions two in the affirmative and

Page 451

³

        The trial judge entered judgment in favor of defendant and denied plaintiffs' post-trial motion. Plaintiffs filed a notice of appeal, and defendant was permitted to file a nunc pro tunc cross-appeal from the denial of its summary judgment motion. However, defendant has not briefed the issue raised in its cross-appeal. Thus, the issue is deemed waived, and the cross-appeal is dismissed. Matter of Bloomingdale Conval. Ctr., 233 N.J.Super. 46, 48 n. 1, 558 A.2d 19 (App.Div.1989).

        The trial record discloses the following pertinent facts. As a child, William Graves had been given Arm & Hammer baking soda as an antacid by his grandmother. She would take a teaspoon and measure out "a certain amount" and put it in a glass of water. Plaintiff, however, had not used this home remedy from the time he stopped living with his grandmother in 1939 until August 22, 1979, the date of his injury.

        On August 21, 1979, Graves, then 52 years old, was senior assistant editor for National Geographic magazine. He and his wife Joyce, his bride of six months, were in Graves' house in Martha's Vineyard. His then 17 year-old son was also there. Graves ate dinner around 6:30 p.m.. He characterized the meal, ⁴ which was finished by 7:45 p.m., as "substantial but not huge."

        He felt fine when he retired to the bedroom shortly after dinner. He took an iced brandy with him, and read for no more [631 A.2d 1252] than an hour, before going to sleep between 9:00 and 9:30 p.m.

Page 452

        He awakened around or shortly after midnight with noticeable, although not severe, heartburn. Although he had been diagnosed with an ulcer at twenty-two, he had no real indigestion problems. He infrequently took Bisodol for bouts of indigestion; however, on this occasion, he had no Bisodol and thought of his grandmother's remedy.

        He went to the kitchen and took a box of baking soda out, "sifted some of the baking soda into the bottom of the glass," and filled the approximately eight-ounce glass with water to within an inch of its top. ⁵ This was the same technique he used when he took Bisodol. The baking soda was sufficient in amount to cover the bottom of the glass.

        At trial, Graves demonstrated the amount of baking soda he used on August 22 and the manner in which he mixed it with water. The amount was later stipulated to be 5.7 grams. The half-teaspoon dosage recommended by defendant measures 1.8 grams.

        Graves drank the solution down quickly. In four gulps he emptied two-thirds of the glass. Before he could return the glass to the counter, an enormous pain drove him to his hands and knees. His wife heard his screams and called for help. Graves told his wife that if he passed out, to tell emergency personnel that "all he did was take a little baking soda."

        Graves underwent surgery on August 22, 1979 and was misdiagnosed as suffering from a perforated ulcer. He had six subsequent surgeries for abscesses or hernia repair. His medical specials as of the time of trial totalled $55,085.84.

        Baking soda has been used as an antacid for more than 100 years. When the Food and Drug Administration ("FDA") was formed in the 1930s, baking soda, like aspirin, was accorded

Page 453

        Over the years, the recommended dosage varied from one-quarter teaspoon to two teaspoons. In 1979, the Arm and Hammer box recommended one-half teaspoon in a glass of water.

        In the 1960s and 1970s, the FDA conducted monograph studies on all GRAS products. Baking soda had its turn in 1974, when the FDA told manufacturers how to label their packaging, including a recommended dosage.

        The FDA employed five physicians to help with its baking soda monograph. Two of these, Dr. John Morrissey and Dr. Edward Moore, testified for the plaintiffs at trial. Both said that they relied on the manufacturer to tell them of the potential for, or known, adverse reactions; neither relied on the articles suggesting a causal relationship between baking soda and spontaneous stomach rupture that were included in a bibliography provided to them by FDA researchers.

        According to Morrissey and Moore, they would have been concerned with the possibility of stomach rupture from baking soda if they had known about these articles when they were consulting for the FDA. As it was, the FDA was concerned with the effect of long-term use on certain chronic conditions.

        Much of the testimony at trial focused on these articles and Church & Dwight's lack of knowledge of their existence. There is no doubt that some of them predate Graves' accident by more than fifty years. The defendant, however, disclaimed any pre-1979 knowledge of them.

        The basic premise of both sides was that Graves' stomach was overly distended by his meal, and that for some reason it was not emptying normally. Plaintiffs' theory essentially was that the baking soda combined with stomach acid to create a large volume of gas immediately that, in turn, caused the stomach rupture. Defendant [631 A.2d 1253] essentially sought to prove that Graves' stomach, whether emptying properly or not, was full enough that the

Page 454

        Plaintiffs' gastroenterologists Lawrence Feinman, Morrissey, and Moore found baking soda, as an antacid, could be unsafe in any dosage. However, defense expert, Dr. John Fordtran, opined that it was possible for the amount of baking soda taken by plaintiff to cause spontaneous stomach rupture under certain circumstances, which he hastened to add were not present in Graves' case, and defense expert, Francis Morel, an M.I.T. "aqueous chemist," felt the volume of the bicarbonate solution, but not the bicarbonate, caused the rupture of the overfilled stomach.

        In 1979, the Arm and Hammer label read in pertinent part:

Effective as an antacid to alleviate heartburn, sour stomach and/or acid indigestion.

DIRECTIONS: 1/2 tsp. in glass of water every 2 hours up to maximum dosage or as directed by physician.

. . . . .

WARNINGS: Do not take more than eight 1/2 tsp. for persons up to 60 years old or four 1/2 tsp. for persons 60 years or older in a 24 hour period, or use the maximum dosage of this product for more than 2 weeks, except under the advice and supervision of a physician. Do not use this product except under the advice and supervision of a physician. Do not use this product except under the advice and supervision of a physician if you are on a sodium restricted diet.

        Graves vacillated between saying that he had never read the label on the Arm and Hammer box, and saying that he must have read the label as a child in his grandmother's house. In any event, he did not read the label in the early hours of August 22, 1979.

        Plaintiffs' experts denounced the label, but were far from unanimous as to what warnings should have been given. Dr. Morton Leeds, a pharmacologist, opined that the label, "at a minimum," should indicate that the recommended dose "should not be exceeded." Dr. Feinman testified that the label contained no warning against taking too much baking soda when the stomach was overly

Page 455

        Dr. Moore suggested that only if "you replace the biceps [in the company's logo] with a skull and cross bones" was it possible that "maybe somebody would notice" the warning. Dr. Brian Strom, a clinical epidemiologist, opined that the 1979 label gave no notice of possible gastric rupture, and did not reveal the actual dangerousness of the product.

        Finally, plaintiffs offered a human factors expert, Dr. Robert Cunitz, to testify about the psychology of warnings. He similarly opined that there should have been a warning as to the possibility of stomach rupture, and that the 1979 label was ineffective. He came as close as any of plaintiffs' experts to talking about what kind of warning was necessary.

        Cunitz suggested that the warning be moved to the front of the package:

You can use the English language. You could use a pictograph of some picture of a stomach rupturing or something along those lines following somebody ingesting this product from a glass. I mean that would be pretty graphic[.] ... [A] circle and a slash through it would do or an x across it would do to let people know not to do that. Alternatively, you might have to spell out the hazard in words but you also need to include an instruction to avoid harm and you might show a cup or a glass with the product in it and a circle with a circle and a slash through it to indicate that one shouldn't take it this way and then back up with the written language.

        [631 A.2d 1254] After acknowledging that there were probably "twenty ways" to warn, Cunitz went on to suggest that in order to be effective to change a long established pattern of use, the Arm and Hammer name should be relegated to the top one-eighth or one-quarter of the front of the box the logo moved elsewhere, and that a warning take up the rest of the front panel.

        Defendant's expert on warnings, psychologist Dr. Donald Horst, offered an opinion that, given the long-accepted practice of using baking soda as an antacid and the general perception of it as safe, warning against a potential danger would be difficult. He did not hold out "much hope" of affecting what people will do with a

Page 456

        On appeal plaintiffs' present the following issues for resolution:

POINT I IT WAS PLAIN ERROR FOR THE COURT TO HAVE SUBMITTED JURY QUESTION 3, WHICH STATED, "WAS THE FAILURE TO WARN A PROXIMATE CAUSE OF PLAINTIFF'S CONSUMPTION OF ARM & HAMMER BAKING SODA ON THE NIGHT IN QUESTION?"

        A. THE TRIAL COURT ERRED IN APPLYING A "BUT FOR" RATHER THAN A "SUBSTANTIAL FACTOR" TEST IN THE VERBIAGE OF QUESTION 3 AND IN INSTRUCTING THE JURY ON PROXIMATE CAUSE.

        B. BECAUSE DEFENDANT'S PRODUCT BORE NO WARNING ON THE KNOWN RISK OF STOMACH RUPTURE, THE TRIAL COURT ERRED IN NOT INSTRUCTING THE JURY THAT PLAINTIFF WAS ENTITLED TO A REBUTTABLE PRESUMPTION THAT HE WOULD HAVE READ AND HEEDED A PROPER LABEL.

        C. THE TRIAL COURT ERRED IN NOT INSTRUCTING THE JURY THAT HAD DEFENDANT'S PRODUCT BORNE A WARNING, THIS DANGER COULD HAVE BEEN READ BY PLAINTIFF ON PRIOR OCCASIONS OR BEEN COMMUNICATED TO HIM BY THIRD PARTIES, SUCH AS HIS WIFE.

POINT II: THE TRIAL JUDGE COMMITTED REVERSIBLE ERROR IN INSTRUCTING THE JURY TO INTERCHANGEABLY APPLY BOTH SUBJECTIVE AND OBJECTIVE STANDARDS IN DETERMINING WHETHER THE LACK OF WARNING WAS THE PROXIMATE CAUSE OF PLAINTIFF'S INGESTING DEFENDANT'S PRODUCT ON THE NIGHT IN QUESTION AND IN HIS COMMENTS ON THE EVIDENCE.

POINT III:

        A. THE DISMISSAL OF PLAINTIFF'S CLAIM OF STRICT LIABILITY PREDICATED UPON DEFENDANT'S PRODUCT BEING UNREASONABLY DANGEROUS CONSTITUTED PLAIN ERROR.

        B. THE COURT ERRED IN DISMISSING PLAINTIFF'S CAUSE OF ACTION ALLEGING A MISREPRESENTATION AND A MISLABELING OF DEFENDANT'S PRODUCT.

POINT IV: WHERE DEFENDANT CONTENDED THAT NO WARNING WOULD HAVE PREVENTED PLAINTIFF'S INGESTION OF ITS PRODUCT, THE TRIAL JUDGE IMPROPERLY DENIED THE ADMISSION INTO EVIDENCE OF BOTH CONTEMPLATED AND ACTUAL POST-ACCIDENT LABEL CHANGES.

POINT V: THE JURY'S VERDICT ON QUESTION 3 WAS AGAINST THE WEIGHT OF THE EVIDENCE.

Page 457

POINT VI: A PARTIAL NEW TRIAL SHOULD BE GRANTED AS TO THOSE ISSUES WHICH HAVE NOT ALREADY BEEN DETERMINED BY THE JURY'S VERDICTS.

        Our review of the record in light of the issues presented satisfies us that there is no error in the Law Division proceedings warranting our intervention. Therefore, [631 A.2d 1255] we affirm the judgment under review for the reasons stated herein. ⁶

        In response to the second interrogatory submitted to the jury, the jury found that defendant's baking soda product was defective by reason of its failure to warn about possible stomach rupture.

        Plaintiffs' first argument on appeal is that "[i]t was error to submit to the jury the issue of proximate cause between the effect of a non-existing warning and plaintiff's ingestion of the product, where he possessed no conscious knowledge of the danger." The quoted statement from plaintiffs' brief implies that proximate cause, as found in the third jury question, is not an issue in a strict liability case where the plaintiff is unaware of the specific danger, and the manufacturer fails to warn of the danger in its product instructions. Another way of stating plaintiffs' argument is that, where a product is found to be defective for a lack of proper warning, there is a conclusive presumption that a consumer would have read and heeded a warning had it been given; thereby relieving Graves of his burden of proving proximate causation between the defect and his consumption of the product. No authority is cited to support plaintiffs' argument. Indeed, the law is clearly to the contrary. There are a number of cases from our Supreme Court, and this court, that require proof of proximate causation in failure to warn cases where the plaintiff was unaware of the danger. See, e.g. Michalko v. Cooke Color & Chem. Corp., 91 N.J. 386, 402, 451 A.2d 179 (1982); Freund v. Cellofilm Properties, Inc., 87 N.J. 229, 241, 432 A.2d 925 (1981); Molino v.

Page 458

        Rather, plaintiffs' question, properly phrased, should be whether there was a genuine factual dispute on the issue of proximate causation which required jury resolution. Evidence that the plaintiff had some knowledge of the danger is, for sure, one way in which such a fact issue may be created. See Campos v. Firestone Tire & Rubber Co., 98 N.J. 198, 209, 485 A.2d 305 (1984). That, of course, does not mean to say that the converse is true; i.e., it does not follow that there is no issue of fact simply because plaintiff had no knowledge of the danger. Fact issues pertaining to proximate causation may be created where there is evidence that

the user was blind, illiterate, intoxicated at the time of the use, irresponsible or lax in judgment or by some other circumstance tending to show that the improper use was or would have been made regardless of the warning.

[Coffman v. Keene Corp., supra, 257 N.J.Super. at 286, 608 A.2d 416 (App.Div.1992), quoting Technical Chem. Co. v. Jacobs, 480 S.W.2d 602, 606 (Tex.1972).]

        For the reasons stated infra at I.A. there were sufficient facts to submit the issue to the jury.

A.

        Plaintiffs alternatively challenge the propriety of submitting the third jury question, contending that, in a failure to warn case, a rebuttable presumption that Graves would have read any warning on the box, and heeded it, is created as a matter of law. They argue that the trial judge erred in failing to consider the presumption and direct a verdict in their favor, because there was no evidence in the record to rebut the presumption. On the other hand, plaintiffs argue that, even if there was sufficient rebuttal evidence, the judge should have instructed the jury that plaintiffs were to receive "the benefit of the doubt" that a warning would have been read and heeded; i.e. the judge should have informed the jury that such a presumption exists.

Page 459

        Although plaintiffs contended at trial that they were not obligated to prove proximate causation, the precise argument concerning[631 A.2d 1256] the existence of a "heeding presumption" was not raised until post-trial motions. However, because the heeding presumption is so intertwined with the concept of proximate causation, we deem it appropriate to decide the issue on the merits, rather than procedurally bar plaintiffs from raising it now.

        In Campos v. Firestone Tire & Rubber Co., supra., decided before this case was tried, there was a suggestion that a heeding presumption might find favor with the Supreme Court. However, it was not until Coffman v. Keene Corp., supra, was decided, that an appellate court of this state definitively found that the absence of a warning created a rebuttable presumption that a plaintiff would have read a proper warning had it been given. More specifically, Coffman stands for the proposition that the heeding presumption is sufficient to sustain plaintiff's burden of proof on proximate causation where the "defendant produces no evidence to overcome the presumption." 257 N.J.Super. at 290, 608 A.2d 416.

        We have no doubt that the Coffman court did not intend to limit its holding to asbestos cases, as defendant here suggests. The heeding presumption had its genesis in comment j of the Restatement of Torts 2d, 402A, See, Technical Chem. Co. v. W.T. Jacobs, 480 S.W.2d 602, 606 (Tex.1972). It has been applied to defective warning cases involving various products in the opinions of other states. See, e.g., the list of cases cited in Coffman, supra, 257 N.J.Super. at 287-88, 608 A.2d 416. Subsequent to Coffman, other parts of this court have stated that the heeding presumption has general application. Fabian v. Minster Machine Co., 258 N.J.Super. 261, 278, 609 A.2d 487 (App.Div.), certif. denied, 130 N.J. 598, 617 A.2d 1220 (1992) (involving a press/product liability case); Molino v. B.F. Goodrich Co., 261 N.J.Super. 85, 100-01, 617 A.2d 1235 (App.Div.1992) (involving tire/product liability case, specifically noting that the "presumption has been applied to products liability cases not involving asbestos.")

Page 460

        Thus, we agree with plaintiffs that a heeding presumption was relevant in the context of plaintiffs' liability theory. The effect of such a presumption is to require defendant to come forward with evidence sufficient to rebut the presumption, or risk a directed finding against it as to the presumed fact. In re Weeks, 29 N.J.Super. 533, 537-38, 103 A.2d 43 (App.Div.1954).

        While we have looked to the law of other states in deciding whether the heeding presumption should be adopted as a part of the substantive law of this State, see Campos and Coffman, supra, once the presumption has been adopted as a part of our substantive law, it is clear that the effect to be given to the presumption is dictated by the evidence law of New Jersey. Evid.R. 14 provides:

[I]f evidence to the contrary of a presumed fact is offered, the existence or non-existence of such fact shall be for the trier of fact, unless the evidence is such that the minds of reasonable men would not differ as to the existence or nonexistence of the presumed fact.

        Under the rule, an assumed fact must be taken to exist if evidence contrary to the assumed fact does not create a genuine issue of fact; i.e. if "reasonable men would not differ as to the existence or non-existence of the presumed fact." Id.; Harvey v. Craw, 110 N.J.Super. 68, 74, 264 A.2d 448 (App.Div.), certif. denied, 56 N.J. 479, 267 A.2d 61 (1970). Conversely, it is logical to conclude that rebuttal evidence sufficient to create a genuine issue of fact so that the "minds of reasonable men" could find that the presumed fact had not been established, is the quantum of evidence necessary to overcome the presumption, and is sufficient to make the existence or non-existence of the presumed fact a question for the jury. Biunno, Current N.J.Rules of Evidence, 1967 Commission Note and comment 1 on Evid.R. 14 (1993).

        The burden of coming forward with evidence to rebut the presumption is on the defendant, but the burden of proof never shifts from the plaintiff. Ford Motor Co. v. Township of Edison, 127 N.J. 290, 314-15, 604 A.2d 580 (1992). That is to say, [631 A.2d 1257] once the presumption is rebutted, the risk of non-persuasion remains with the party upon whom the burden of proof was originally placed, in

Page 461

        Furthermore, under New Jersey law, there is a general prohibition against calling presumptions to the attention of a jury. See Jurman v. Samuel Braen, Inc., 47 N.J. 586, 222 A.2d 78 (1966) and Kirschbaum v. Metropolitan Life Ins. Co., 133 N.J.L. 5, 42 A.2d 257 (E & A 1945). For these reasons, plaintiffs' reliance on Nissen Trampoline Co. v. Terre Haute First National Bank, 332 N.E.2d 820 (Ind.1975), rev'd on other grounds, 265 Ind. 457, 358 N.E.2d 974 (1976) (holding that the burden of proof on the heeding presumption shifts to the manufacturer), and their reliance on Butz v. Werner, 438 N.W.2d 509 (N.D.1989) (holding that a jury should be instructed on the heeding presumption), is misplaced, since the evidence law of the states where they were decided is contrary to that of New Jersey. ⁷

        Plaintiffs contend that there was no rebuttal evidence contrary to the presumed fact that Graves would have read a warning had it been given, and, for that reason, proximate cause was not an issue in the case. Defendant, on the other hand, calls our attention to several areas of evidence which it claims rebutted the heeding presumption. Although we do not endorse all of defendant's arguments on this point, there are several areas of evidence which sufficiently support the conclusion that a jury question was presented.

        Graves characterized himself as a "compulsive" reader, especially paying attention to product labels because of a potentially fatal allergy to nuts. In that respect Graves testified, on direct examination, what he would have done if he had seen a warning on the baking soda box:

Q. My final question to you, Mr. Graves is this: Assume back in--on August 22, 1979, you picked up or load [sic] from your shelf in your cupboard that box of Arm & Hammer Baking Soda or a similar box.... And you had seen on it a big skull

Page 462

. . . . .

A. I wouldn't have taken it. I would have put up with the heartburn. I'm conditioned all my life to reading warnings and knowing that certain foods are enormously harmful to me and I think I simply wouldn't have taken it if I had seen an adequate warning or something to call my attention to it.

        By introducing evidence in his direct case concerning what he would have done had there been a warning on the product, Graves, perhaps, eschewed reliance on the heeding presumption, but, at the very least, put his credibility as a careful reader and heeder of health warnings in issue.

        For at least five years prior to his accident, Graves smoked two to three packs of cigarettes a day, and had a cigarette cough which would sometimes begin in the morning when he got up. He also attributed being winded when climbing stairs to his cigarette consumption. He was aware that cigarettes bore a warning label from the Surgeon General of the United States concerning health hazards. Nonetheless, when asked whether he would have smoked cigarettes on the morning of the accident had a skull and cross bones been on the package of cigarettes, Graves admitted that he "hadn't thought of that."

        The evidence concerning Graves smoking, notwithstanding warnings on cigarette packages, was admitted without objection. Such evidence, in our view, provided the jury with a basis to make an analogy between Graves smoking in the face of the health warnings on cigarettes, and his projected behavior if a warning had been on the baking soda.

        [631 A.2d 1258] Additionally, Graves gave inconsistent testimony as to when he last read the baking soda label. Indeed, a jury could reasonably conclude that he had never done so. In any event, while the inconsistency is not determinative, standing alone, the history he gave on reading the label is. The latest date on which Graves could have read the label, was 1939, the year he stopped living with his grandmother. He never remembers reading the label for

Page 463

Q. Did you stand there and read the label that night to find out how much the manufacturer of this product Arm & Hammer Baking Soda told you to put in the glass?

A. No. I didn't.

Q. Why not?

A. I've taken it off and on for over half a century and it always worked, and I've simply felt I think that a reasonable amount would--would work again, would do the job. ⁸

        Graves' attitude toward the product, coupled with his physical distress after awakening from a sound sleep, could also have been viewed by the jury as producing an instinctive reaction, resulting in Graves reaching for the baking soda, and pouring it into the glass, rather than measuring it as his grandmother had done. Evidence that plaintiff gave inconsistent testimony concerning whether the label provided had ever been read, and/or, evidence that plaintiff's conduct was so instinctive that no warning would have helped, creates sufficient facts to rebut the heeding presumption. Technical Chem. Co. v. Jacobs, supra, 480 S.W.2d at 606; Campos v. Firestone Tire & Rubber Co., supra, 98 N.J. at 210, 485 A.2d 305.

B.

        Plaintiffs, again focusing on the third jury interrogatory, argue that the trial judge erred in applying a "but for" rather than a "substantial factor" test in his instructions concerning proximate causation relative to that question. Specifically, plaintiffs' contend that the interrogatories should have stated: "Was the failure to warn a substantial factor in plaintiff's consumption of

Page 464

        Interestingly, plaintiffs' argument that the substantial factor test should have been utilized is a concession that a fact-finder could conclude under the evidence in this case that causes other than the lack of warning contributed to plaintiff's consumption of the baking soda on the night in question. Although plaintiffs do not specifically say so in their brief, the argument appears to concede that Graves' overly distended stomach, and the resulting discomfort, were at least contributing causes of his accident, and that is why the "substantial factor" test is appropriate. The very concept of proximate cause "includes the notion of concurrent cause when more than one act contributes to the accidental harm." [631 A.2d 1259] Brown v. United States Stove Co., 98 N.J. 155, 171, 484 A.2d 1234 (1984). Certainly, a jury could have found on this record that Graves's distress resulting from his dysfunctional stomach caused him to ingest the baking soda, and that the absence of an adequate warning of possible stomach rupture was just one, albeit, a substantial factor, in contributing to that conduct. Thus, we agree with plaintiffs that the substantial factor test was the appropriate test of proximate causation in the context of the third jury interrogatory.

        On appeal, a jury charge must be reviewed in its entirety. State v. Wilbely, 63 N.J. 420, 422, 307 A.2d 608 (1973). In the

Page 465

        Plaintiffs cite one excerpt from the charge that they now contend shows the imposition of a "but for" test:

Now, what do we mean [by proximate cause] in the context of a lack of warning case? ... [I]s it probable that such a warning would have been effective in deterring the plaintiff from the conduct, in this case, the consumption of the product in question which he claims caused his injury.

        Plaintiffs do not specifically articulate their quarrel with the portion of the charge they quote. We assume it has to do with the use of the word "probable," which arguably invokes the standard definition of proximate cause as "a cause which naturally and probably led to and might have been expected to produce the injury complained of." Model Jury Charge (Civil), Proximate Cause, § 7.11 (1973). Assuming that to be the case, plaintiffs, nevertheless, offer no support for the argument that the mere use of the word "probable" could have interfered with the jury's function. We are not of the view that the quoted section of the charge reasonably conveyed to the jury an instruction that it could answer the question in the affirmative only if it found that Graves would not have consumed the baking soda "but for" the lack of warning. As noted earlier, we must look to the charge as a whole in determining whether the jury was mislead. Immediately after the now objected to portion of the charge, the trial judge told the jury that: "[b]y proximate cause we do not mean that be the only cause." Later in his instructions on the same issue he said:

Again whenever I say proximate cause understand there may be more than one proximate cause to any particular accident[.] [S]o long [as] its a contributing factor[,] to [that] extent it may indeed be a proximate cause.

        Finally, on this point, it is reasonable to infer that plaintiffs' failure to specifically object to the charge on the specific grounds now advanced can be taken to mean that counsel did not consider the claimed error to be significant in the context of the trial. State v. Macon, 57 N.J. 325, 333, 273 A.2d 1 (1971).

Page 466

C.

        Plaintiffs also contend that the trial judge committed reversible error in instructing the jury to interchangeably apply both subjective and objective standards in determining whether the lack of warning was a proximate cause of plaintiff's ingesting defendant's product on the night in question.

        There are different standards for different elements in such cases, as the Supreme Court stated in Campos v. Firestone Tire & Rubber Co., supra. There is an objective duty of a manufacturer to produce a defect-free product. Campos, supra, 98 N.J. at 209, 485 A.2d 305; cf. Johansen v. Makita USA, Inc., 128 N.J. 86, 102, 607 A.2d 637 (1992), (duty to manufacture a safe product exists irrespective of plaintiff's conduct). The objective duty of the manufacturer in a warning setting is best exemplified by the Legislature's recent codification of prior law:

An adequate product warning or instruction is one that a reasonably prudent person in the same or similar circumstances would have provided with respect [631 A.2d 1260] to the danger and that communicates adequate information on the dangers and safe use of the product, taking into account the characteristics of, and the ordinary knowledge common to, the persons by whom the product is intended to be used[.]

[ N.J.S.A. 2A:58C-4.]

        It is the subjective knowledge of the plaintiff, however, that is relevant in determining whether a breach of the manufacturer's duty is a proximate cause of the injury in question. Campos supra, 98 N.J. at 209, 485 A.2d 305.

        In our view, the trial judge maintained that distinction in his instructions. He directed the jury first to apply a reasonable person standard to determine whether defendant's warning was adequate, and then to determine if an adequate warning would have deterred Graves specifically. Both in his original instructions to the jury on interrogatory number three, and in his supplemental instructions on that interrogatory in response to the jury's question, the trial judge necessarily had to discuss the objective standard and the subjective standard together because

Page 467

        Nor do we find error in the trial judge's comment to the jury that the human factors experts could not testify as to what went on in Graves' mind. The judge's statement that the best such testimony could do is inform them what the "public at large," or those in "controlled groups," do, was an accurate comment on the testimony offered. The trial judge did not prohibit the jury from drawing an inference from the general proposition to Graves' subjective thought process. A judge may comment on the evidence when it will assist the jury in its findings. Dafler v. Raymark Industries, Inc., 259 N.J.Super. 17, 37, 611 A.2d 136 (App.Div.), certif. granted, 130 N.J. 601, 617 A.2d 1223 (1992).

D.

        At trial, plaintiffs objected to the trial judge's use of the phrase "the night in question" with respect to the third jury interrogatory. They argued then, as they now do on appeal, that the use of that phrase foreclosed the jury from considering the effect, if any, that an adequate warning might have had on Graves' conduct had it been placed on the product years earlier, postulating that the warning could then have been communicated to Graves through third parties.

        There was evidence before the jury, fortified by counsels' arguments, that defendant could have and should have warned of the risk of stomach rupture many years before 1979. Dr. Cunitz, plaintiffs' human factors expert, testified that the existence of warnings over a long term have an impact on consumer expectations relative to a product's qualities. He said:

Well, what happens is common sense changes. That's really what it is. Had there been a warning for a good number of years on this product, then people's common knowledge and, therefore, their common sense about the product begins to change and ultimately does change.

Page 468

        Indeed, a jury may have reasonably inferred from this testimony, and other related testimony offered at the trial, that a warning, placed on the baking soda before 1979, may have had some impact on Graves' knowledge concerning the product's efficacy. If the jury instructions were such that the trial judge foreclosed the jury's consideration of that issue, we might agree with plaintiffs' argument that the issue of proximate causation was too narrowly focused. But our review of the instructions do not reveal any such limitation on the jury's understanding of its function in addressing that question.

        Moreover, the words themselves do not constitute error standing alone. Clearly, plaintiffs had the burden of proving that the defect in the product's instructions and warnings, whenever that defect is considered to have existed, was a proximate cause of Graves' consumption of the product on August 22, 1979. Certainly there [631 A.2d 1261] would have been nothing wrong with the question had the trial judge placed the date of consumption in the interrogatory. Substituting the date with the phrase "on the night in question" is a distinction without a difference. The important thing is that the judge's instructions did not limit the jury's consideration of all the evidence relevant to the subjective aspect of Graves' conduct and knowledge in determining the issue of proximate causation.

        Plaintiffs contend that the trial judge erred in dismissing their "unreasonably dangerous product" claim which they contend was set forth in Count IV of their complaint. We have reviewed that count of the complaint and fail to find any clear reference to such a claim. However, we shall address the issue on its merits.

        Plaintiffs argue that they postulated defendant's liability on separate theories of a failure to warn, and on "having placed an unreasonably dangerous product in the market place." Their reliance upon the "unreasonably dangerous" phrase is apparently based on the words of Restatement of Torts, Second, § 402A. However, that rubric has long been in disfavor in this State.

Page 469

        There are but "three theories under which a manufacturer or seller may be held strictly for harm caused by a product--defective manufacture, defective design, and defective warnings[.]" Dewey v. R.J. Reynolds Tobacco Co., 121 N.J. 69, 94-95, 577 A.2d 1239 (1990). This was so, before and after the New Jersey Product Liability Act, N.J.S.A. 2A:58C-1 et seq. If plaintiffs are arguing a theory, albeit mislabeled, different from their failure to warn theory, we can only assume that what they are really contending is that defendant's baking soda product is one whose risks outweigh its utility, a concept used in a design defect liability case. See O'Brien v. Muskin Corp., 94 N.J. 169, 463 A.2d 298 (1983). However, if plaintiffs are claiming that defendant is liable under a design defect theory, their argument is factually unsupported by the evidence.

        Undoubtedly, there was expert evidence offered by plaintiffs from which one could infer that the ingestion of any amount of baking soda carried some risk, and that it simply should not have been marketed as an antacid. However, baking soda has other safe uses. No suggestion was made by any of plaintiffs' witnesses that baking soda was a dangerous product for all purposes. No one suggested taking the product off the market. Quite simply, the resolution of the issue plaintiffs' experts posed in this narrow view of the evidence cannot be resolved in the context of the risk/utility analysis applicable to a pure design defect case, because the crux of the safety problem lies in the warning rather than the physical properties of the product itself. See, Freund, supra, 87 N.J. at 242, 432 A.2d 925. ("[W]here the design defect

Page 470

        Plaintiffs contend that the trial judge erred in dismissing their causes of action based upon Restatement of Torts, Second, § 388 (Chattel Known to be Dangerous for Intended Use), Restatement of Torts, Second § 402B (Misrepresentation by Seller of Chattels to Consumer) and N.J.S.A. 24:5-1, -10, -18a, and -18f (misbranding of a drug product). The trial judge held that these causes of action were essentially based on negligence principles and subsumed[631 A.2d 1262] by strict liability. In dismissing them, the judge relied upon this court's decision in Tirrell v. Navistar Intern., Inc., 248 N.J.Super. 390, 591 A.2d 643 (App.Div.1991), certif. denied, 126 N.J. 390, 599 A.2d 166 (1991) which held that, even before the adoption of the Product Liability Act, our common law had progressed to the point where personal injury claims resulting from product injuries were to be pled and proved on strict liability principles, rather than on breach of implied warranty or negligence concepts. Id. at 399, 591 A.2d 643.

        Defendant contends on appeal, that the causes of action in question were the subject of amendments to interrogatories, rather than amendments to pleadings, after the New Jersey Product Liability Act became effective, and, therefore, are barred by the Act. Defendant also contends that, with respect to the New Jersey statutory cause of action, no private right of action is created by the statute because of its penal nature, or, alternatively, the statute does not apply to products which cause injuries outside of the State of New Jersey.

        We will assume, for the purpose of discussion, that the New Jersey Product Liability Act did not preclude these causes of action, that the causes of action are not based on negligence, that

Page 471

        However, it is not sufficient simply for plaintiffs to prove that some legal error exists in the trial record. Plaintiffs are obliged to show that the legal error was "of such a nature as to have been clearly capable of producing an unjust result[.]" R. 2:10-2. Plaintiffs utterly fail to address in their brief how a strict liability claim based upon a failure to warn differs from the three dismissed causes of action, and how those differences may have impacted on the jury's determination in this case.

        It appears to us that the three theories proposed by plaintiff are simply alternative ways in which a jury might determine that the product was defective, i.e. unsafe, because of inadequate warnings. Because that is precisely what the jury found in response to the second jury interrogatory, we are at a loss to understand how plaintiffs were harmed by the consolidation of those theories into the strict liability/warning theory on which the jury was instructed. Under any theory of liability, even those excluded by the trial judge, the jury was required to determine proximate causation. Plaintiffs fail to explain how a finding in their favor on any of the excluded causes of action might have impacted on the proximate causation issue in a more favorable way. Thus, we find no reversible error in the trial court's exclusion of the subject causes of action.

        Plaintiffs contend that the trial judge improperly precluded evidence of both contemplated and actual post-accident label changes. They contend that the actual changes should have been permitted into evidence because they do not qualify as remedial changes, but, rather, reflect on the credibility of defendant in that it took the position that the baking soda could not generate enough gas to cause a rupture but subsequently changed the label to warn against such injury. With respect to the proposed but not

Page 472

        The evidence, if admitted, was clearly relevant on the question of product defect, and the fourth jury interrogatory which was not answered. Because the jury resolved the product defect issue in plaintiff's favor, the exclusion of that evidence produced no harm to plaintiff. Thus, even if the trial judge was wrong in excluding the evidence, a question we specifically do not decide, such error would not be reversible. R. 2:10-2.

        Plaintiffs contend that if the third jury interrogatory was properly submitted for [631 A.2d 1263] the jury's consideration, its verdict in response to the question is against the weight of the evidence. However, plaintiffs' argument focuses on the question of product defect, a question that was resolved in plaintiffs' favor when the jury answered the second interrogatory. The question addressed in number three was whether, even if the proper warning had been placed on the product, such warning would have been a substantial factor in preventing Graves' consumption of it, and the resulting harm. Plaintiffs fail to analyze the evidence on that issue toward a conclusion that reasonable minds could not differ on the subject as required by R. 2:10-1. As indicated earlier in this opinion, we conclude that a genuine fact issue was presented on the proximate cause issue. The jury's resolution of that issue against plaintiffs has a factual basis in the record.

        The judgment under review is affirmed.

---------------

1 References herein to "Graves" or "plaintiff" is to William Graves. References to "plaintiffs" is to William and Joyce A. Graves.

2 Church & Dwight's motion to dismiss the complaint as time-barred or, in the alternative, for a Lopez v. Swyer hearing was denied by order of April 22, 1985. In response to defendant's motion for leave to appeal, a panel of this court summarily reversed the denial of a Lopez hearing.

After the hearing on remand, the complaint was dismissed as time-barred. This court reversed that dismissal. 225 N.J.Super. 49, 541 A.2d 725 (App.Div.1988). A divided Supreme Court split evenly on its review of the decision, and the Appellate Division ruling stood. 115 N.J. 256, 558 A.2d 463 (1989).

3 Question four apparently was based on defendant's theory that the mere ingestion of any liquid would have caused Graves to suffer the spontaneous rupture.

4 For dinner plaintiff had two martinis with some Fritos, followed by chili (probably one eighteen ounce bowl but possibly part of a second), cornbread, salad with dressing, and a glass of wine.

5 At trial an attempt was made to show that Graves took Davis baking powder, rather than Arm & Hammer baking soda. This dispute accounts for the first special interrogatory on product identification. The issue is not, however, being disputed on appeal.

6 We do not address the issues necessarily in the same order as they were raised by plaintiff.

7 We note that Evid.R. 301, now effective in this State, is consistent with our rulings concerning the effect of a rebuttable presumption in New Jersey.

8 The amount plaintiff actually consumed was approximately three times the recommended dose.

JUSTICE ALITO, delivered the opinion of the Court.

We must decide whether federal law pre-empts the New Hampshire design-defect claim under which respondent Karen Bartlett recovered damages from petitioner Mutual Pharmaceutical, the manufacturer of sulindac, a generic nonsteroidal anti-inflammatory drug (NSAID). New Hampshire law imposes a duty on manufacturers to ensure that the drugs they market are not unreasonably unsafe, and a drug's safety is evaluated by reference to both its chemical properties and the adequacy of its warnings. Because Mutual was unable to change sulindac's composition as a matter of both federal law and basic chemistry, New Hampshire's design-defect cause of action effectively required Mutual to change sulindac's labeling to provide stronger warnings. But, as this Court recognized just two Terms ago in PLIVA, Inc. v. Mensing, 564 U. S. ___ (2011), federal law prohibits generic drug manufacturers from independently changing their drugs' labels. Accordingly, state law imposed a duty on Mutual not to comply with federal law. Under the Supremacy Clause, state laws that require a private party to violate federal law are pre-empted and, thus, are "without effect." Maryland v. Louisiana, 451 U. S. 725, 746 (1981).

The Court of Appeals' solution—that Mutual should simply have pulled sulindac from the market in order to comply with both state and federal law—is no solution. Rather, adopting the Court of Appeals' stop-selling rationale would render impossibility pre-emption a dead letter and work a revolution in this Court's pre-emption case law.

Accordingly, we hold that state-law design-defect claims that turn on the adequacy of a drug's warnings are preempted by federal law under PLIVA. We thus reverse the decision of the Court of Appeals below.

I

Under the Federal Food, Drug, and Cosmetic Act (FDCA), ch. 675, 52 Stat. 1040, as amended, 21 U. S. C. §301 et seq., drug manufacturers must gain approval from the United States Food and Drug Administration (FDA) before marketing any drug in interstate commerce. §355(a). In the case of a new brand-name drug, FDA approval can be secured only by submitting a new-drug application (NDA). An NDA is a compilation of materials that must include "full reports of [all clinical] investigations," §355(b)(1)(A), relevant nonclinical studies, and "any other data or information relevant to an evaluation of the safety and effectiveness of the drug product obtained or otherwise received by the applicant from any source," 21 CFR §§314.50(d)(2) and (5)(iv) (2012). The NDA must also include "the labeling proposed to be used for such drug," 21 U. S. C. §355(b)(1)(F); 21 CFR §314.50(c)(2)(i), and "a discussion of why the [drug's] benefits exceed the risks under the conditions stated in the labeling," 21 CFR §314.50(d)(5)(viii); §314.50(c)(2)(ix). The FDA may approve an NDA only if it determines that the drug in question is "safe for use" under "the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof." 21 U. S. C. §355(d). In order for the FDA to consider a drug safe, the drug's "probable therapeutic benefits must outweigh its risk of harm." FDA v. Brown & Williamson Tobacco Corp., 529 U. S. 120, 140 (2000).

The process of submitting an NDA is both onerous and lengthy. See Report to Congressional Requesters, Government Accountability Office, Nov. 2006, New Drug Development, 26 Biotechnology L. Rep. 82, 94 (2007) (A typical NDA spans thousands of pages and is based on clinical trials conducted over several years). In order to provide a swifter route for approval of generic drugs, Congress passed the Drug Price Competition and Patent Term Restoration Act of 1984, 98 Stat. 1585, popularly known as the "Hatch-Waxman Act." Under Hatch-Waxman, a generic drug may be approved without the same level of clinical testing required for approval of a new brandname drug, provided the generic drug is identical to the already-approved brand-name drug in several key respects.

First, the proposed generic drug must be chemically equivalent to the approved brand-name drug: it must have the same "active ingredient" or "active ingredients," "route of administration," "dosage form," and "strength" as its brand-name counterpart. 21 U. S. C. §§355(j)(2)(A)(ii) and (iii). Second, a proposed generic must be "bioequivalent" to an approved brand-name drug. §355(j)(2)(A)(iv). That is, it must have the same "rate and extent of absorption" as the brand-name drug. §355(j)(8)(B). Third, the generic drug manufacturer must show that "the labeling proposed for the new drug is the same as the labeling approved for the [approved brand-name] drug." §355(j)(2)(A)(v).

Once a drug—whether generic or brand-name—is approved, the manufacturer is prohibited from making any major changes to the "qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application." 21 CFR §314.70(b)(2)(i). Generic manufacturers are also prohibited from making any unilateral changes to a drug's label. See §§314.94(a)(8)(iii), 314.150(b)(10) (approval for a generic drug may be withdrawn if the generic drug's label "is no longer consistent with that for [the brandname] drug").

II

In 1978, the FDA approved a nonsteroidal antiinflammatory pain reliever called "sulindac" under the brand name Clinoril. When Clinoril's patent expired, the FDA approved several generic sulindacs, including one manufactured by Mutual Pharmaceutical. 678 F. 3d 30, 34 (CA1 2012) (case below); App. to Pet. for Cert. 144a-145a. In a very small number of patients, NSAIDs— including both sulindac and popular NSAIDs such as ibuprofen, naproxen, and Cox2-inhibitors—have the serious side effect of causing two hypersensitivity skin reactions characterized by necrosis of the skin and of the mucous membranes: toxic epidermal necrolysis, and its less severe cousin, Stevens-Johnson Syndrome. 678 F. 3d, at 34, 43-44; Dorland's Illustrated Medical Dictionary 1872 (31st ed. 2007); Physicians' Desk Reference 146-147, 597 (6th ed. 2013); Friedman, Orlet, Still, & Law, Toxic Epidermal Necrolysis Due to Administration of Celecobix (Celebrex), 95 Southern Medical J. 1213, 1213-1214 (2002).

In December 2004, respondent Karen L. Bartlett was prescribed Clinoril for shoulder pain. Her pharmacist dispensed a generic form of sulindac, which was manufactured by petitioner Mutual Pharmaceutical. Respondent soon developed an acute case of toxic epidermal necrolysis. The results were horrific. Sixty to sixty-five percent of the surface of respondent's body deteriorated, was burned off, or turned into an open wound. She spent months in a medically induced coma, underwent 12 eye surgeries, and was tube-fed for a year. She is now severely disfigured, has a number of physical disabilities, and is nearly blind.

At the time respondent was prescribed sulindac, the drug's label did not specifically refer to Stevens-Johnson Syndrome or toxic epidermal necrolysis, but did warn that the drug could cause "severe skin reactions" and "[f]atalities." App. 553; 731 F. Supp. 2d 135, 142 (NH 2010) (internal quotation marks omitted). However, Stevens-Johnson Syndrome and toxic epidermal necrolysis were listed as potential adverse reactions on the drug's package insert. 678 F. 3d, at 36, n. 1. In 2005—once respondent was already suffering from toxic epidermal necrolysis—the FDA completed a "comprehensive review of the risks and benefits, [including the risk of toxic epidermal necrolysis], of all approved NSAID products." Decision Letter, FDA Docket No. 2005P-0072/CP1, p. 2 (June 22, 2006), online at http://www.fda.gov/ohrms/dockets/ dockets/05p0072/05p-0072-pav0001-vol1.pdf (as visited June 18, 2013, and available in Clerk of Court's case file). As a result of that review, the FDA recommended changes to the labeling of all NSAIDs, including sulindac, to more explicitly warn against toxic epidermal necrolysis. App. 353-354, 364, 557-561, 580, and n. 8.

Respondent sued Mutual in New Hampshire state court, and Mutual removed the case to federal court. Respondent initially asserted both failure-to-warn and design-defect claims, but the District Court dismissed her failure-towarn claim based on her doctor's "admi[ssion] that he had not read the box label or insert." 678 F. 3d, at 34. After a 2-week trial on respondent's design-defect claim, a jury found Mutual liable and awarded respondent over $21 million in damages.

The Court of Appeals affirmed. 678 F. 3d 30. As relevant, it found that neither the FDCA nor the FDA's regulations pre-empted respondent's design-defect claims. It distinguished PLIVA, Inc. v. Mensing, 564 U. S. ___ —in which the Court held that failure-to-warn claims against generic manufacturers are pre-empted by the FDCA's prohibition on changes to generic drug labels—by arguing that generic manufacturers facing design-defect claims could simply "choose not to make the drug at all" and thus comply with both federal and state law. 678 F. 3d, at 37. We granted certiorari. 568 U. S. ___ (2012).

III

The Supremacy Clause provides that the laws and treaties of the United States "shall be the supreme Law of the Land . . . any Thing in the Constitution or Laws of any State to the Contrary notwithstanding." U. S. Const., Art. VI, cl. 2. Accordingly, it has long been settled that state laws that conflict with federal law are "without effect." Maryland v. Louisiana, 451 U. S., at 746; McCulloch v. Maryland, 4 Wheat. 316, 427 (1819). See also Gade v. National Solid Wastes Management Assn., 505 U. S. 88, 108 (1992) ("[U]nder the Supremacy Clause, from which our pre-emption doctrine is derived, any state law, however clearly within a State's acknowledged power, which interferes with or is contrary to federal law, must yield" (internal quotation marks omitted)).

Even in the absence of an express pre-emption provision, the Court has found state law to be impliedly preempted where it is "impossible for a private party to comply with both state and federal requirements." English v. General Elec. Co., 496 U. S. 72, 79 (1990). See also Florida Lime & Avocado Growers, Inc. v. Paul, 373 U. S. 132, 142-143 (1963) ("A holding of federal exclusion of state law is inescapable and requires no inquiry into congressional design where compliance with both federal and state regulations is a physical impossibility for one engaged in interstate commerce").

In the instant case, it was impossible for Mutual to comply with both its state-law duty to strengthen the warnings on sulindac's label and its federal-law duty not to alter sulindac's label. Accordingly, the state law is pre-empted.

A

We begin by identifying petitioner's duties under state law. As an initial matter, respondent is wrong in asserting that the purpose of New Hampshire's designdefect cause of action "is compensatory, not regulatory." Brief for Respondent 19. Rather, New Hampshire's designdefect cause of action imposes affirmative duties on manufacturers.

Respondent is correct that New Hampshire has adopted the doctrine of strict liability in tort as set forth in Section 402A of the Restatement (Second) of Torts. See 2 Restatement (Second) of Torts §402A (1963 and 1964) (hereinafter Restatement 2d). See Buttrick v. Arthur Lessard & Sons, Inc., 110 N. H. 36, 37-39, 260 A. 2d 111, 112-113 (1969). Under the Restatement—and consequently, under New Hampshire tort law—"[o]ne 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" even though he "has exercised all possible care in the preparation and sale of the product." Restatement 2d §402A, at 347-348.

But respondent's argument conflates what we will call a "strict-liability" regime (in which liability does not depend on negligence, but still signals the breach of a duty) with what we will call an "absolute-liability" regime (in which liability does not reflect the breach of any duties at all, but merely serves to spread risk). New Hampshire has adopted the former, not the latter. Indeed, the New Hampshire Supreme Court has consistently held that the manufacturer of a product has a "duty to design his product reasonably safely for the uses which he can foresee." Thibault v. Sears, Roebuck & Co., 118 N. H. 802, 809, 395 A. 2d 843, 847 (1978). See also Reid v. Spadone Mach. Co., 119 N. H. 457, 465, 404 A. 2d 1094, 1099 (1979) ("In New Hampshire, the manufacturer is under a general duty to design his product reasonably safely for the uses which he can foresee" (internal quotation marks omitted)); Chellman v. Saab-Scania AB, 138 N. H. 73, 78, 637 A. 2d 148, 150 (1993) ("The duty to warn is part of the general duty to design, manufacture and sell products that are reasonably safe for their foreseeable uses"); cf. Simoneau v. South Bend Lathe, Inc., 130 N. H. 466, 469, 543 A. 2d 407, 409 (1988) ("We limit the application of strict tort liability in this jurisdiction by continuing to emphasize that liability without negligence is not liability without fault"); Price v. BIC Corp., 142 N. H. 386, 390, 702 A. 2d 330, 333 (1997) (cautioning "that the term `unreasonably dangerous' should not be interpreted so broadly as to impose absolute liability on manufacturers or make them insurers of their products"). Accordingly, respondent is incorrect in arguing that New Hampshire's strict-liability system "imposes no substantive duties on manufacturers." Brief for Respondent 19.^[1]

B

That New Hampshire tort law imposes a duty on manufacturers is clear. Determining the content of that duty requires somewhat more analysis. As discussed below in greater detail, New Hampshire requires manufacturers to ensure that the products they design, manufacture, and sell are not "unreasonably dangerous." The New Hampshire Supreme Court has recognized that this duty can be satisfied either by changing a drug's design or by changing its labeling. Since Mutual did not have the option of changing sulindac's design, New Hampshire law ultimately required it to change sulindac's labeling.

Respondent argues that, even if New Hampshire law does impose a duty on drug manufacturers, that duty does not encompass either the "duty to change sulindac's design" or the duty "to change sulindac's labeling." Brief for Respondent 30 (capitalization and emphasis deleted). That argument cannot be correct. New Hampshire imposes design-defect liability only where "the design of the product created a defective condition unreasonably dangerous to the user." Vautour v. Body Masters Sports Industries, Inc., 147 N. H. 150, 153, 784 A. 2d 1178, 1181 (2001); Chellman, supra, at 77, 637 A. 2d, at 150. To determine whether a product is "unreasonably dangerous," the New Hampshire Supreme Court employs a "riskutility approach" under which "a product is defective as designed if the magnitude of the danger outweighs the utility of the product." Vautour, supra, at 154, 784 A. 2d, at 1182 (internal quotation marks omitted). That riskutility approach requires a "multifaceted balancing process involving evaluation of many conflicting factors." Ibid. (internal quotation marks omitted); see also Thibault, supra, at 809, 395 A. 2d, at 847 (same).

While the set of factors to be considered is ultimately an open one, the New Hampshire Supreme Court has repeatedly identified three factors as germane to the risk-utility inquiry: "the usefulness and desirability of the product to the public as a whole, whether the risk of danger could have been reduced without significantly affecting either the product's effectiveness or manufacturing cost, and the presence and efficacy of a warning to avoid an unreasonable risk of harm from hidden dangers or from foreseeable uses." Vautour, supra, at 154, 784 A. 2d, at 1182; see also Price, supra, at 389, 702 A. 2d, at 333 (same); Chellman, supra, at 77-78, 637 A. 2d, at 150 (same).

In the drug context, either increasing the "usefulness" of a product or reducing its "risk of danger" would require redesigning the drug: A drug's usefulness and its risk of danger are both direct results of its chemical design and, most saliently, its active ingredients. See 21 CFR §201.66(b)(2) (2012) ("Active ingredient means any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure of any function of the body of humans" (italics deleted)).

In the present case, however, redesign was not possible for two reasons. First, the FDCA requires a generic drug to have the same active ingredients, route of administration, dosage form, strength, and labeling as the brand-name drug on which it is based. 21 U. S. C. §§355(j)(2)(A)(ii)-(v) and (8)(B); 21 CFR §320.1(c). Consequently, the Court of Appeals was correct to recognize that "Mutual cannot legally make sulindac in another composition." 678 F. 3d, at 37. Indeed, were Mutual to change the composition of its sulindac, the altered chemical would be a new drug that would require its own NDA to be marketed in interstate commerce. See 21 CFR §310.3(h) (giving examples of when the FDA considers a drug to be new, including cases involving "newness for drug use of any substance which composes such drug, in whole or in part"). Second, because of sulindac's simple composition, the drug is chemically incapable of being redesigned. See 678 F. 3d, at 37 ("Mutual cannot legally make sulindac in another composition (nor it is apparent how it could alter a one-molecule drug anyway)").

Given the impossibility of redesigning sulindac, the only way for Mutual to ameliorate the drug's "risk-utility" profile—and thus to escape liability—was to strengthen "the presence and efficacy of [sulindac's] warning" in such a way that the warning "avoid[ed] an unreasonable risk of harm from hidden dangers or from foreseeable uses." Vautour, supra, at 154, 784 A. 2d, at 1182. See also Chellman, 138 N. H., at 78, 637 A. 2d, at 150 ("The duty to warn is part of the general duty to design, manufacture and sell products that are reasonably safe for their foreseeable uses. If the design of a product makes a warning necessary to avoid an unreasonable risk of harm from a foreseeable use, the lack of warning or an ineffective warning causes the product to be defective and unreasonably dangerous" (citation omitted)). Thus, New Hampshire's design-defect cause of action imposed a duty on Mutual to strengthen sulindac's warnings.

For these reasons, it is unsurprising that allegations that sulindac's label was inadequate featured prominently at trial. Respondent introduced into evidence both the label for Mutual's sulindac at the time of her injuries and the label as revised in 2005 (after respondent had suffered her injuries). App. 553-556. Her counsel's opening statement informed the jury that "the evidence will show you that Sulindac was unreasonably dangerous and had an inadequate warning, as well. . . . You will hear much more evidence about why this label was inadequate in relation to this case." Tr. 110-112 (Aug. 17, 2010). And, the District Court repeatedly instructed the jury that it should evaluate sulindac's labeling in determining whether Mutual's sulindac was unreasonably dangerous. See App. 514 (jury instruction that the jury should find "a defect in design" only if it found that "Sulindac was unreasonably dangerous and that a warning was not present and effective to avoid that unreasonable danger"); ibid. (jury instruction that no design defect exists if "a warning was present and effective to avoid that unreasonable danger"). Finally, the District Court clarified in its order and opinion denying Mutual's motion for judgment as a matter of law that the adequacy of sulindac's labeling had been part of what the jury was instructed to consider. 760 F. Supp. 2d 220, 231 (2011) ("if the jury found that sulindac's risks outweighed its benefits, then it could consider whether the warning—regardless of its adequacy—reduced those risks . . . to such an extent that it eliminated the unreasonable danger").^[2]

Thus, in accordance with New Hampshire law, the jury was presented with evidence relevant to, and was instructed to consider, whether Mutual had fulfilled its duty to label sulindac adequately so as to render the drug not "unreasonably dangerous." In holding Mutual liable, the jury determined that Mutual had breached that duty.

C

The duty imposed by federal law is far more readily apparent. As PLIVA made clear, federal law prevents generic drug manufacturers from changing their labels. See 564 U. S., at ___ (slip op., at 10) ("Federal drug regulations, as interpreted by the FDA, prevented the Manufacturers from independently changing their generic drugs' safety labels"). See also 21 U. S. C. §355(j)(2)(A)(v) ("[T]he labeling proposed for the new drug is the same as the labeling approved for the [approved brand-name] drug"); 21 CFR §§314.94(a)(8)(iii), 314.150(b)(10) (approval for a generic drug may be withdrawn if the generic drug's label "is no longer consistent with that for [the brand-name] drug"). Thus, federal law prohibited Mutual from taking the remedial action required to avoid liability under New Hampshire law.

D

When federal law forbids an action that state law requires, the state law is "without effect." Maryland, 451 U. S., at 746. Because it is impossible for Mutual and other similarly situated manufacturers to comply with both state and federal law,^[3] New Hampshire's warning-based design-defect cause of action is pre-empted with respect to FDA-approved drugs sold in interstate commerce.^[4]

IV

The Court of Appeals reasoned that Mutual could escape the impossibility of complying with both its federal- and state-law duties by "choos[ing] not to make [sulindac] at all." 678 F. 3d, at 37. We reject this "stop-selling" rationale as incompatible with our pre-emption jurisprudence. Our pre-emption cases presume that an actor seeking to satisfy both his federal- and state-law obligations is not required to cease acting altogether in order to avoid liability. Indeed, if the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be "all but meaningless." 564 U. S., at ___ (slip op., at 14).

The incoherence of the stop-selling theory becomes plain when viewed through the lens of our previous cases. In every instance in which the Court has found impossibility pre-emption, the "direct conflict" between federal- and state-law duties could easily have been avoided if the regulated actor had simply ceased acting.

PLIVA is an obvious example: As discussed above, the PLIVA Court held that state failure-to-warn claims were pre-empted by the FDCA because it was impossible for drug manufacturers like PLIVA to comply with both the state-law duty to label their products in a way that rendered them reasonably safe and the federal-law duty not to change their drugs' labels. Id., at ___ (slip op., at 11). It would, of course, have been possible for drug manufacturers like PLIVA to pull their products from the market altogether. In so doing, they would have avoided liability under both state and federal law: such manufacturers would neither have labeled their products in a way that rendered them unsafe nor impermissibly changed any federally approved label.

In concluding that "it was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same," id., at ___ (slip op., at 12), the Court was undeterred by the prospect that PLIVA could have complied with both state and federal requirements by simply leaving the market. The Court of Appeals decision below had found that Mensing's state-law failure-to-warn claims escaped pre-emption based on the very same stop-selling rationale the First Circuit relied on in this case. See Mensing v. Wyeth, Inc., 588 F. 3d 603, 611 (CA8 2009) ("[G]eneric defendants were not compelled to market metoclopramide. If they realized their label was insufficient. . . they could have simply stopped selling the product"). Moreover, Mensing advanced the stop-selling rationale in its petition for rehearing, which this Court denied. PLIVA, supra; Pet. for Reh'g in No. 09-993 etc., p. 2. Nonetheless, this Court squarely determined that it had been "impossible" for PLIVA to comply with both its state and federal duties. 564 U. S., at ___ (slip op., at 12).^[5]

Adopting the First Circuit's stop-selling rationale would mean that not only PLIVA, but also the vast majority—if not all—of the cases in which the Court has found impossibility pre-emption, were wrongly decided. Just as the prospect that a regulated actor could avoid liability under both state and federal law by simply leaving the market did not undermine the impossibility analysis in PLIVA, so it is irrelevant to our analysis here.

V

The dreadful injuries from which products liabilities cases arise often engender passionate responses. Today is no exception, as JUSTICE SOTOMAYOR's dissent (hereinafter the dissent) illustrates. But sympathy for respondent does not relieve us of the responsibility of following the law.

The dissent accuses us of incorrectly assuming "that federal law gives pharmaceutical companies a right to sell a federally approved drug free from common-law liability," post, at 1, but we make no such assumption. Rather, as discussed at length above, see supra, at 8-13, we hold that state-law design-defect claims like New Hampshire's that place a duty on manufacturers to render a drug safer by either altering its composition or altering its labeling are in conflict with federal laws that prohibit manufacturers from unilaterally altering drug composition or labeling. The dissent is quite correct that federal law establishes no safe-harbor for drug companies—but it does prevent them from taking certain remedial measures. Where state law imposes a duty to take such remedial measures, it "actual[ly] conflict[s] with federal law" by making it "`impossible for a private party to comply with both state and federal requirements.'" Freightliner Corp. v. Myrick, 514 U. S. 280, 287 (1995) (quoting English, 496 U. S., at 78-79). The dissent seems to acknowledge that point when it concedes that, "if federal law requires a particular product label to include a complete list of ingredients while state law specifically forbids that labeling practice, there is little question that state law `must yield.'" Post, at 6-7 (quoting Felder v. Casey, 487 U. S. 131, 138 (1988)). What the dissent does not see is that that is this case: Federal law requires a very specific label for sulindac, and state law forbids the use of that label.

The dissent responds that New Hampshire law "merely create[s] an incentive" to alter sulindac's label or composition, post, at 7, but does not impose any actual "legal obligation," post, at 13. The contours of that argument are difficult to discern. Perhaps the dissent is drawing a distinction between common-law "exposure to liability," post, at 12, and a statutory "legal mandate," ibid. But the distinction between common law and statutory law is irrelevant to the argument at hand: In violating a common-law duty, as surely as by violating a statutory duty, a party contravenes the law. While it is true that, in a certain sense, common-law duties give a manufacturer the choice "between exiting the market or continuing to sell while knowing it may have to pay compensation to consumers injured by its product," post, at 16, statutory "mandate[s]" do precisely the same thing: They require a manufacturer to choose between leaving the market and accepting the consequences of its actions (in the form of a fine or other sanction). See generally Calabresi & Melamed, Property Rules, Liability Rules, and Inalienability: One View of the Cathedral, 85 Harv. L. Rev. 1089 (1972) (discussing liability rules). And, in any event, PLIVA— which the dissent agrees involved a state-law "requirement that conflicted with federal law," post, at 13—dealt with common-law failure-to-warn claims, see PLIVA, supra, at ___ (slip op., at 4). Because PLIVA controls the instant case, the dissent is reduced to fighting a rearguard action against its reasoning despite ostensibly swearing fealty to its holding.

To suggest that Bates v. Dow Agrosciences LLC, 544 U. S. 431 (2005), is to the contrary is simply misleading. The dissent is correct that Bates held a Texas state-law design-defect claim not to be pre-empted. But, it did so because the design-defect claim in question was not a "requirement `for labeling or packaging'" and thus fell outside the class of claims covered by the express preemption provision at issue in that case. Id., at 443-444 (emphasis in original). Indeed, contrary to the impression one might draw from the dissent, post, at 12-13, the Bates Court actually blessed the lower court's determination that the State's design-defect claim imposed a preemptable "requirement": "The Court of Appeals did, however, correctly hold that the term `requirements' in §136v(b) reaches beyond positive enactments, such as statutes and regulations, to embrace common-law duties." Bates, supra, at 443. The dissent offers no compelling reason why the "common-law duty" in this case should not similarly be viewed as a "requirement." We agree, of course, that "determining precisely what, if any, specific requirement a state common-law claim imposes is important." Post, at 12, n. 5. As Bates makes clear, "[t]he proper inquiry calls for an examination of the elements of the common-law duty at issue; it does not call for speculation as to whether a jury verdict will prompt the manufacturer to take any particular action." 544 U. S., at 445 (citation omitted). Here, as we have tried to make clear, the duty to ensure that one's products are not "unreasonably dangerous" imposed by New Hampshire's design-defect cause of action, Vautour, 147 N. H., at 153, 784 A. 2d, at 1181, involves a duty to make one of several changes. In cases where it is impossible—in fact or by law—to alter a product's design (and thus to increase the product's "usefulness" or decrease its "risk of danger"), the duty to render a product "reasonably safe" boils down to a duty to ensure "the presence and efficacy of a warning to avoid an unreasonable risk of harm from hidden dangers or from foreseeable uses." Id., at 154, 784 A. 2d, at 1182. The duty to redesign sulindac's label was thus a part of the common-law duty at issue—not merely an action Mutual might have been prompted to take by the adverse jury verdict here.

Finally, the dissent laments that we have ignored "Congress' explicit efforts to preserve state common-law liability." Post, at 26. We have not. Suffice to say, the Court would welcome Congress'"explicit" resolution of the difficult pre-emption questions that arise in the prescription drug context. That issue has repeatedly vexed the Court—and produced widely divergent views—in recent years. See, e.g., Wyeth v. Levine, 555 U. S. 555 (2009); PLIVA, 564 U. S. ___. As the dissent concedes, however, the FDCA's treatment of prescription drugs includes neither an express pre-emption clause (as in the vaccine context, 42 U. S. C. §300aa-22(b)(1)), nor an express nonpre-emption clause (as in the over-the-counter drug context, 21 U. S. C. §§379r(e), 379s(d)). In the absence of that sort of "explicit" expression of congressional intent, we are left to divine Congress' will from the duties the statute imposes. That federal law forbids Mutual to take actions required of it by state tort law evinces an intent to pre-empt.

* * *

This case arises out of tragic circumstances. A combination of factors combined to produce the rare and devastating injuries that respondent suffered: the FDA's decision to approve the sale of sulindac and the warnings that accompanied the drug at the time it was prescribed, the decision by respondent's physician to prescribe sulindac despite its known risks, and Congress' decision to regulate the manufacture and sale of generic drugs in a way that reduces their cost to patients but leaves generic drug manufacturers incapable of modifying either the drugs' compositions or their warnings. Respondent's situation is tragic and evokes deep sympathy, but a straightforward application of pre-emption law requires that the judgment below be reversed.

It is so ordered.

JUSTICE BREYER, with whom JUSTICE KAGAN joins, dissenting.

It is not literally impossible here for a company like petitioner to comply with conflicting state and federal law. A company can comply with both either by not doing business in the relevant State or by paying the state penalty, say damages, for failing to comply with, as here, a state-law tort standard. See post, at 16-18 (SOTOMAYOR, J., dissenting). But conflicting state law that requires a company to withdraw from the State or pay a sizable damages remedy in order to avoid the conflict between state and federal law may nonetheless "`stan[d] as an obstacle to the accomplishment' of" the federal law's objective, in which case the relevant state law is pre-empted. Post, at 17 (quoting Crosby v. National Foreign Trade Council, 530 U. S. 363, 373 (2000)).

Normally, for the reasons I set forth in Medtronic, Inc. v. Lohr, 518 U. S. 470, 503 (1996) (opinion concurring in part and concurring in judgment), in deciding whether there is such a conflict I would pay particular attention to the views of the relevant agency, here the Food and Drug Administration (FDA). Where the statute contains no clear pre-emption command, courts may infer that the administrative agency has a degree of leeway to determine the extent to which governing statutes, rules, regulations, or other administrative actions have pre-emptive effect. See id., at 505-506 (citing Smiley v. Citibank (South Dakota), N. A., 517 U. S. 735, 739-741 (1996); Hillsborough County v. Automated Medical Laboratories, Inc., 471 U. S. 707, 721 (1985); Lawrence County v. Lead-Deadwood School Dist. No. 40-1, 469 U. S. 256, 261-262 (1985); Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc., 467 U. S. 837, 842-845 (1984)). See also Wyeth v. Levine, 555 U. S. 555, 576-577 (2009). Cf. Skidmore v. Swift & Co., 323 U. S. 134, 140 (1944). The FDA is responsible for administering the relevant federal statutes. And the question of pre-emption may call for considerable drug-related expertise. Indeed, one might infer that, the more medically valuable the drug, the less likely Congress intended to permit a State to drive it from the marketplace.

At the same time, the agency can develop an informed position on the pre-emption question by providing interested parties with an opportunity to present their views. It can translate its understandings into particular preemptive intentions accompanying its various rules and regulations. And "[i]t can communicate those intentions . . . through statements in `regulations, preambles, interpretive statements, and responses to comments.'" Medtronic, supra, at 506 (opinion of BREYER, J.). (quoting Hillsborough, supra, at 718).

Here, however, I cannot give special weight to the FDA's views. For one thing, as far as the briefing reveals, the FDA, in developing its views, has held no hearings on the matter or solicited the opinions, arguments, and views of the public in other ways. For another thing, the FDA has set forth its positions only in briefs filed in litigation, not in regulations, interpretations, or similar agency work product. See Bowen v. Georgetown Univ. Hospital, 488 U. S. 204, 212-213 (1988) ("[A]gency litigating positions that are wholly unsupported by regulations, rulings, or administrative practice" are entitled to less than ordinary weight). Cf. Christensen v. Harris County, 529 U. S. 576, 587 (2000).

Finally, the FDA has set forth conflicting views on this general matter in different briefs filed at different times. Compare Wyeth, supra, at 577, 579, 580, n. 13 (noting that the FDA had previously found no pre-emption, that the United States now argued for pre-emption, and that this new position was not entitled to deference), with PLIVA, Inc. v. Mensing, 564 U. S. ___, ___, n. 3, ___ (2011) (slip op., at 6-7, n. 3, 8-11) (declining to defer to the United States' argument against pre-emption and, instead, finding pre-emption), and with Brief for United States as Amicus Curiae 12-13 (now arguing, again, for preemption). See National Cable & Telecommunications Assn. v. Brand X Internet Services, 545 U. S. 967, 981 (2005) (agency views that vary over time are accorded less weight); Motor Vehicle Mfrs. Assn. of United States, Inc. v. State Farm Mut. Automobile Ins. Co., 463 U. S. 29, 41-42 (1983) (same); Verizon Communications Inc. v. FCC, 535 U. S. 467, 502, n. 20 (2002) (same).

Without giving the agency's views special weight, I would conclude that it is not impossible for petitioner to comply with both state and federal regulatory schemes and that the federal regulatory scheme does not pre-empt state common law (read as potentially requiring petitioner to pay damages or leave the market). As two former FDA Commissioners tell us, the FDA has long believed that state tort litigation can "supplemen[t] the agency's regulatory and enforcement activities." Brief for Donald Kennedy et al. as Amici Curiae 5. See also Wyeth, supra, at 578 ("In keeping with Congress' decision not to pre-empt common-law tort suits, it appears that the FDA traditionally regarded state law as a complementary form of drug regulation").

Moreover, unlike the federal statute at issue in Medtronic, the statute before us contains no general preemption clause. See 518 U. S., at 481-482. Cf. Wyeth, supra, at 574 (presence of pre-emption clause could show that "Congress thought state-law suits posed an obstacle to its objectives"). Furthermore, I have found no convincing reason to believe that removing this particular drug from New Hampshire's market, or requiring damage payments for it there, would be so harmful that it would seriously undercut the purposes of the federal statutory scheme. Cf. post, at 21-22.

Finally, similarly situated defendants in other cases remain free to argue for "obstacle pre-emption" in respect to damage payments or market withdrawal, and demonstrate the impossibility-of-compliance type of conflict that, in their particular cases, might create true incompatibility between state and federal regulatory schemes.

For these reasons, I respectfully dissent.

JUSTICE SOTOMAYOR, with whom JUSTICE GINSBURG joins, dissenting.

In PLIVA, Inc. v. Mensing, 564 U. S. ___ (2011), this Court expanded the scope of impossibility pre-emption to immunize generic drug manufacturers from state-law failure-to-warn claims. Today, the Court unnecessarily and unwisely extends its holding in Mensing to pre-empt New Hampshire's law governing design-defects with respect to generic drugs.

The Court takes this step by concluding that petitioner Mutual Pharmaceutical was held liable for a failure-towarn claim in disguise, even though the District Court clearly rejected such a claim and instead allowed liability on a distinct theory. See infra, at 13-15. Of greater consequence, the Court appears to justify its revision of respondent Karen Bartlett's state-law claim through an implicit and undefended assumption that federal law gives pharmaceutical companies a right to sell a federally approved drug free from common-law liability. Remarkably, the Court derives this proposition from a federal law that, in order to protect consumers, prohibits manufacturers from distributing new drugs in commerce without federal regulatory approval, and specifically disavows any intent to displace state law absent a direct and positive conflict.

Karen Bartlett was grievously injured by a drug that a jury found was unreasonably dangerous. The jury relied upon evidence that the drug posed a higher than normal risk of causing the serious skin reaction that produced her horrific injuries; carried other risks; and possessed no apparent offsetting benefits compared to similar pain relievers, like aspirin. See 760 F. Supp. 2d 220, 233-241, 243-244 (NH 2011). The Court laments her "tragic" situation, ante, at 20, but responsibility for the fact that Karen Bartlett has been deprived of a remedy for her injuries rests with this Court. If our established pre-emption principles were properly applied in this case, and if New Hampshire law were correctly construed, then federal law would pose no barrier to Karen Bartlett's recovery. I respectfully dissent.

I

I begin with "two cornerstones of our pre-emption jurisprudence," Wyeth v. Levine, 555 U. S. 555, 565 (2009), that should control this case but are conspicuously absent from the majority opinion. First, "`the purpose of Congress is the ultimate touchstone' in every pre-emption case." Ibid. (quoting Medtronic, Inc. v. Lohr, 518 U. S. 470, 485 (1996)). Second, we start from the "assumption that the historic police powers of the States [are] not to be superseded by [a] Federal Act unless that was the clear and manifest purpose of Congress." Rice v. Santa Fe Elevator Corp., 331 U. S. 218, 230 (1947). "That assumption," we have explained, "applies with particular force when," as is the case here, "Congress has legislated in a field traditionally occupied by the States." Altria Group, Inc. v. Good, 555 U. S. 70, 77 (2008).^[6]

The Court applied both of these principles to the Federal Food, Drug, and Cosmetic Act (FDCA), ch. 675, 52 Stat. 1040, as amended, 21 U. S. C. §301 et seq., in Levine, where we held that a state failure-to-warn claim against a brand-name drug manufacturer was not pre-empted by federal law. 555 U. S., at 581. Tracing the history of federal drug regulation from the 1906 Federal Food and Drugs Act, 34 Stat. 768, up to the FDCA and its major amendments, the Court explained that federal drug law and state common-law liability have long been understood to operate in tandem to promote consumer safety. See Levine, 555 U. S., at 566-568, 574. That basic principle, which the majority opinion elides, is essential to understanding this case.

The FDCA prohibits the "introduction into interstate commerce [of] any new drug" without prior approval from the United States Food and Drug Administration (FDA). 21 U. S. C. §355(a). Brand-name and generic drug manufacturers are required to make different showings to receive agency approval in this premarketing review process. See ante, at 2-3. But in either case, the FDA's permission to market a drug has never been regarded as a final stamp of approval of the drug's safety. Under the FDCA, manufacturers, who have greater "access to information about their drugs" than the FDA, Levine, 555 U. S., at 578-579, retain the ultimate responsibility for the safety of the products they sell. In addition to their ongoing obligations to monitor a drug's risks and to report adverse drug responses to the FDA, see 21 CFR §§314.80, 314.81, 314.98 (2012), manufacturers may not sell a drug that is "deemed to be misbranded" because it is "dangerous to health" when used in the dosage or manner called for in the drug's label. 21 U. S. C. §352(j); see §331(a); Brief for United States as Amicus Curiae 30-31 (hereinafter U. S. Brief) (indicating that the misbranding prohibition may apply to a drug that was previously approved for sale when significant new scientific evidence demonstrates that the drug is unsafe).

Beyond federal requirements, state common law plays an important "complementary" role to federal drug regulation. Levine, 555 U. S., at 578. Federal law in this area was initially intended to "supplemen[t] the protection for consumers already provided by state regulation and common-law liability." Id., at 566. And as Congress "enlarged the FDA's powers," it "took care to preserve state law." Id., at 567. In the 1962 amendments to the FDCA, which established the FDA's premarketing review in its modern form, Congress adopted a saving clause providing that the amendments should not be construed to invalidate any provision of state law absent "a direct and positive conflict." §202, 76 Stat. 793. And in the years since, with "state common-law suits `continu[ing] unabated despite . . . FDA regulation,'" Levine, 555 U. S., at 567 (quoting Riegel v. Medtronic, Inc., 552 U. S. 312, 340 (2008) (GINSBURG, J., dissenting)), Congress has not enacted a pre-emption provision for prescription drugs (whether brand-name or generic) even as it enacted such provisions with respect to other products regulated by the FDA.^[7]

Congress' preservation of a role for state law generally, and common-law remedies specifically, reflects a realistic understanding of the limitations of ex ante federal regulatory review in this context. On its own, even rigorous preapproval clinical testing of drugs is "generally . . . incapable of detecting adverse effects that occur infrequently, have long latency periods, or affect subpopulations not included or adequately represented in the studies." Kessler & Vladeck, A Critical Examination of the FDA's Efforts to Preempt Failure-to-Warn Claims, 96 Geo. L. J. 461, 471 (2008); see National Academies, Institute of Medicine, The Future of Drug Safety: Promoting and Protecting the Health of the Public 37-38 (2007) (hereinafter Future of Drug Safety) (discussing limitations "inherent" to a system of premarket clinical trials). Moreover, the FDA, which is tasked with monitoring thousands of drugs on the market and considering new drug applications, faces significant resource constraints that limit its ability to protect the public from dangerous drugs. See Levine, 555 U. S., at 578-579, and n. 11; Brief for Former FDA Commissioner Donald Kennedy et al. as Amici Curiae 6-7, 12-20. Tort suits can help fill the gaps in federal regulation by "serv[ing] as a catalyst" to identify previously unknown drug dangers. Bates v. Dow Agrosciences LLC, 544 U. S. 431, 451 (2005).

Perhaps most significant, state common law provides injured consumers like Karen Bartlett with an opportunity to seek redress that is not available under federal law. "[U]nlike most administrative and legislative regulations," common-law claims "necessarily perform an important remedial role in compensating accident victims." Sprietsma v. Mercury Marine, 537 U. S. 51, 64 (2002). While the Court has not always been consistent on this issue, it has repeatedly cautioned against reading federal statutes to "remove all means of judicial recourse for those injured" when Congress did not provide a federal remedy. Silkwood v. Kerr-McGee Corp., 464 U. S. 238, 251 (1984); see e.g., Bates, 544 U. S., at 449; Lohr, 518 U. S., at 487 (plurality opinion). And in fact, the legislative history of the FDCA suggests that Congress chose not to create a federal cause of action for damages precisely because it believed that state tort law would allow injured consumers to obtain compensation. See Levine, 555 U. S., at 574-575, and n. 7.

II

In light of this background, Mutual should face an uphill climb to show that federal law pre-empts a New Hampshire strict-liability claim against a generic drug manufacturer for defective design. The majority nevertheless accepts Mutual's argument that "compliance with both federal and state [law was] a physical impossibility." Florida Lime & Avocado Growers, Inc. v. Paul, 373 U. S. 132, 142-143 (1963); see ante, at 7. But if state and federal law are properly understood, it is clear that New Hampshire's design-defect claim did not impose a legal obligation that Mutual had to violate federal law to satisfy.

A

Impossibility pre-emption "is a demanding defense," Levine, 555 U. S., at 573, that requires the defendant to show an "irreconcilable conflict" between federal and state legal obligations, Silkwood, 464 U. S., at 256. The logic underlying true impossibility pre-emption is that when state and federal law impose irreconcilable affirmative requirements, no detailed "inquiry into congressional design" is necessary because the inference that Congress would have intended federal law to displace the conflicting state requirement "is inescapable." Florida Lime, 373 U. S., at 142-143. So, for example, if federal law requires a particular product label to include a complete list of ingredients while state law specifically forbids that labeling practice, there is little question that state law "must yield." Felder v. Casey, 487 U. S. 131, 138 (1988).

The key inquiry for impossibility pre-emption, then, is to identify whether state and federal law impose directly conflicting affirmative legal obligations such that state law "require[s] the doing of an act which is unlawful under" federal law. California Fed. Sav. & Loan Assn. v. Guerra, 479 U. S. 272, 292 (1987). Impossibility does not exist where the laws of one sovereign permit an activity that the laws of the other sovereign restricts or even prohibits. See Barnett Bank of Marion Cty., N. A. v. Nelson, 517 U. S. 25, 31 (1996); Michigan Canners & Freezers Assn., Inc. v. Agricultural Marketing and Bargaining Bd., 467 U. S. 461, 478, n. 21 (1984). So, to modify the previous example, if federal law permitted (but did not require) a labeling practice that state law prohibited, there would be no irreconcilable conflict; a manufacturer could comply with the more stringent regulation. And by the same logic, impossibility does not exist where one sovereign's laws merely create an incentive to take an action that the other sovereign has not authorized because it is possible to comply with both laws.

Of course, there are other types of pre-emption. Courts may find that state laws that incentivize what federal law discourages or forbid what federal law authorizes are preempted for reasons apart from impossibility: The state laws may fall within the scope of an express pre-emption provision, pose an obstacle to federal purposes and objectives, or intrude upon a field that Congress intended for federal law to occupy exclusively. See Crosby v. National Foreign Trade Council, 530 U. S. 363, 372-373 (2000). But absent a direct conflict between two mutually incompatible legal requirements, there is no impossibility and courts may not automatically assume that Congress intended for state law to give way. Instead, a more careful inquiry into congressional intent is called for, and that inquiry should be informed by the presumption against pre-emption.

In keeping with the strict standard for impossibility, cases that actually find pre-emption on that basis are rare. See Abrams, Plenary Power Preemption, 99 Va. L. Rev. 601, 608 (2013). Mensing is an outlier, as the Court found impossibility because a generic drug manufacturer could not strengthen its product label to come into line with a state-law duty to warn without the exercise of judgment by the FDA. See 564 U. S., at ___-___ (slip op., at 13-14). But nothing in Mensing, nor any other precedent, dictates finding impossibility pre-emption here.

B

To assess whether it is physically impossible for Mutual to comply with both federal and state law, it is necessary to identify with precision the relevant legal obligations imposed under New Hampshire's design-defect cause of action.

The majority insists that Mutual was required by New Hampshire's design-defect law to strengthen its warning label. In taking this position, the majority effectively recharacterizes Bartlett's design-defect claim as a de facto failure-to-warn claim. The majority then relies on that recharacterization to hold that the jury found Mutual liable for failing to fulfill its duty to label sulindac adequately, which Mensing forbids because a generic drug manufacturer cannot independently alter its safety label. Ante, at 13; see Mensing, 564 U. S., at ___ (slip op., at 10). But the majority's assertion that Mutual was held liable in this case for violating a legal obligation to change its label is inconsistent with both New Hampshire state law and the record.

For its part, Mutual, in addition to making the argument now embraced by the majority, contends that New Hampshire's design-defect law effectively required it to change the chemical composition of sulindac. Mutual claims that it was physically impossible to comply with that duty consistent with federal law because drug manufacturers may not change the chemical composition of their products so as to create new drugs without submitting a new drug application for FDA approval. See 21 CFR §§310.3(h), 314.70(b)(2)(i). But just as New Hampshire's design-defect law did not impose a legal obligation for Mutual to change its label, it also did not mandate that Mutual change the drug's design.

1

a

Following blackletter products liability law under §402A of the Restatement (Second) of Torts (1963-1964) (hereinafter Second Restatement), New Hampshire recognizes strict liability for three different types of product defects: manufacturing defects, design defects, and warning defects. See Cheshire Medical Center v. W. R. Grace & Co., 49 F. 3d 26, 29 (CA1 1995). Because the District Court granted Mutual summary judgment on Bartlett's failureto-warn claim, only New Hampshire's design-defect cause of action remains at issue in this case.

A product has a defective design under New Hampshire law if it "poses unreasonable dangers to consumers." Thibault v. Sears, Roebuck & Co., 118 N. H. 802, 807, 395 A. 2d 843, 846 (1978). To determine whether a product is unreasonably dangerous, a jury is asked to make a riskbenefit assessment by considering a nonexhaustive list of factors. See ante, at 9-10. In addition, New Hampshire has specifically rejected the doctrine, advocated by the Restatement (Third) of Torts: Products Liability §2(b) (1997) (hereinafter Third Restatement), that a plaintiff must present evidence of a reasonable alternative design to show that a product's design is defective. Instead, "while proof of an alternative design is relevant in a design defect case," it is "neither a controlling factor nor an essential element." Vautour v. Body Masters Sports Industries, Inc., 147 N. H. 150, 156, 784 A. 2d 1178, 1183 (2001).

While some jurisdictions have declined to apply designdefect liability to prescription drugs, New Hampshire, in common with many other jurisdictions, does subject prescriptions drugs to this distinct form of strict products liability. See 678 F. 3d 30, 35 (CA1 2012) (citing Brochu v. Ortho Pharmaceutical Corp., 642 F. 2d 652, 655 (CA1 1981)); see also Third Restatement §6, Comment f (collecting cases from other jurisdictions). Drug manufacturers in New Hampshire have an affirmative defense under comment k to §402A of the Second Restatement, which exempts "[u]navoidably unsafe products" from strict liability if the product is properly manufactured and labeled. As explained by the lower courts in this case, see 678 F. 3d, at 36; 731 F. Supp. 2d 135, 150-151 (NH 2010), New Hampshire takes a case-by-case approach to comment k under which a defendant seeking to invoke the defense must first show that the product is highly useful and that the danger imposed by the product could not have been avoided through a feasible alternative design. See Brochu, 642 F. 2d, at 657. Comment k did not factor into the jury's assessment of liability in this case because Mutual abandoned a comment k defense before trial. Ante, at 12, n. 2.^[8]

b

The design-defect claim that was applied to Mutual subjects the manufacturer of an unreasonably dangerous product to liability, but it does not require that manufacturer to take any specific action that is forbidden by federal law. Specifically, and contrary to the majority, see ante, at 11, New Hampshire's design-defect law did not require Mutual to change its warning label. A drug's warning label is just one factor in a nonexclusive list for evaluating whether a drug is unreasonably dangerous, see Vautour, 147 N. H., at 156, 784 A. 2d, at 1183, and an adequate label is therefore neither a necessary nor a sufficient condition for avoiding design-defect liability. Likewise, New Hampshire law imposed no duty on Mutual to change sulindac's chemical composition. The New Hampshire Supreme Court has held that proof of an alternative feasible design is not an element of a design-defect claim, see Kelleher v. Marvin Lumber & Cedar Co., 152 N. H. 813, 831, 891 A. 2d 477, 492 (2006), and as the majority recognizes, ante, at 11, sulindac was not realistically capable of being redesigned anyway because it is a single-molecule drug.^[9]

To be sure, New Hampshire's design-defect claim creates an incentive for drug manufacturers to make changes to its product, including to the drug's label, to try to avoid liability. And respondent overstates her case somewhat when she suggests that New Hampshire's strict-liability law is purely compensatory. See Brief for Respondent 19. As is typically true of strict-liability regimes, New Hampshire's law, which mandates compensation only for "defective" products, serves both compensatory and regulatory purposes. See Heath v. Sears, Roebuck & Co., 123 N. H. 512, 521-522, 464 A. 2d 288, 293 (1983). But exposure to liability, and the "incidental regulatory effects" that flow from that exposure, Goodyear Atomic Corp. v. Miller, 486 U. S. 174, 185-186 (1988), is not equivalent to a legal mandate for a regulated party to take (or refrain from taking) a specific action. This difference is a significant one: A mandate leaves no choice for a party that wishes to comply with the law, whereas an incentive may only influence a choice.

Our cases reflect this distinction. In Bates, for example, we rejected an argument that design-defect claims brought against a pesticide manufacturer were pre-empted because they would likely "induce" the manufacturer to change its product label and thus run afoul of an express pre-emption provision forbidding state labeling "requirements" that were different or in addition to federal requirements. 544 U. S., at 444-446. A requirement, we explained, "is a rule of law that must be obeyed." Id., at 445. "[A]n event, such as a jury verdict, that merely motivates an optional decision," does not rise to that level. Ibid.^[10]

So too here. The fact that imposing strict liability for injuries caused by a defective drug design might make a drug manufacturer want to change its label or design (or both) does not mean the manufacturer was actually required by state law to take either action. And absent such a legal obligation, the majority's impossibility argument does not get off the ground, because there was no state requirement that it was physically impossible for Mutual to comply with while also following federal law. The case is therefore unlike Mensing, where it was "undisputed" that applicable state tort law "require[d] a drug manufacturer that is or should be aware of its product's danger" to strengthen its label—a requirement that conflicted with federal law preventing the manufacturer from doing so unilaterally, 564 U. S., at ___, ___ (slip op., at 4, 11-12). New Hampshire's design-defect law did not require Mutual to do anything other than to compensate consumers who were injured by an unreasonably dangerous drug.

2

Moreover, the trial record in this case confirms that, contrary to the majority's insistence, Mutual was not held liable for "breach[ing] [its] duty" "to label sulindac adequately." Ante, at 13.

When Bartlett filed suit against Mutual, she raised distinct claims based on design defect and failure to warn. App. 102-108; see 659 F. Supp. 2d 279, 282 (NH 2009). Pursuing both claims was consistent with New Hampshire law's recognition that "design defect and failure to warn claims are separate." LeBlanc v. American Honda Motor Co., 141 N. H. 579, 586, 688 A. 2d 556, 562 (1997). After the District Court granted summary judgment to Mutual on the failure-to-warn claim, the court repeatedly explained that an alleged failure to warn by Mutual could not and did not provide the basis for Bartlett's recovery. See 760 F. Supp. 2d, at 248-249.^[11]

The majority notes that the District Court admitted evidence regarding sulindac's label. Ante, at 11-12. But the court did so because the label remained relevant for the more limited purpose of assessing, in combination with other factors, whether sulindac's design was defective because the product was unreasonably dangerous. See 678 F. 3d, at 41. The District Court's instructions to the jury adhered to this limited purpose. The court first told the jury to determine whether sulindac was unreasonably dangerous by weighing its danger against its utility. App. 513. The court further instructed the jury that if it determined that sulindac was unreasonably dangerous without reference to the warning label, it could then consider the presence and efficacy of the label to evaluate whether the product was unreasonably dangerous "even with its warning." Id., 513-514. In other words, to hold Mutual liable, the jury was required to find that sulindac "was unreasonably dangerous despite its warning, not because of it." Id., at 341. The District Court also explained to the jury that because Bartlett's claim addressed only whether sulindac's design was defective, Mutual's conduct, "which included any failure to change its warning, was `not relevant to this case.'" 760 F. Supp. 2d, at 248.

The distinction drawn by the District Court between permissible and impermissible uses of evidence regarding sulindac's label is faithful to New Hampshire law. That law recognizes that the effectiveness of a warning label is just one relevant factor in determining whether a product's design is unreasonably dangerous, and that designdefect and failure-to-warn claims are "separate." LeBlanc, 141 N. H., at 586, 688 A. 2d, at 562.^[12] In short, as the District Court made clear, Mutual was not held liable for "failing to change" its warning. 760 F. Supp., at 248-249.

C

Given the distinction that New Hampshire draws between failure-to-warn claims and design-defect claims, as well as the clear and repeated statements by the trial judge that Mutual's liability was not predicated on breaching a duty to label sulindac adequately, on what basis does the majority reach a contrary conclusion? Though the majority insists otherwise, ante, at 17, it appears to rely principally on an implicit assumption about rights conferred by federal premarket approval under the FDCA. After correctly observing that changing sulindac's chemical composition would create a new drug that would have to go through its own approval process, the majority reasons that Mutual must have been under a state-law duty to change its label because it had no other option to avoid liability while continuing to sell its product. Ante, at 10-11. But that conclusion is based on a false premise.

A manufacturer of a drug that is unreasonably dangerous under New Hampshire law has multiple options: It can change the drug's design or label in an effort to alter its risk-benefit profile, remove the drug from the market, or pay compensation as a cost of doing business. If federal law or the drug's chemical properties take the redesign option off the table, then that does not mean the manufacturer suddenly has a legal obligation under state law to improve the drug's label. Indeed, such a view of state law makes very little sense here because even if Mutual had strengthened its label to fully account for sulindac's risks, the company might still have faced liability for having a defective design. See Thibault, 118 N. H., at 808, 395 A. 2d, at 847 (explaining that strict liability "may attach even though . . . there was an adequate warning"). When a manufacturer cannot change the label or when doing so would not make the drug safe, the manufacturer may still choose between exiting the market or continuing to sell while knowing it may have to pay compensation to consumers injured by its product.^[13]

From a manufacturer's perspective, that may be an unwelcome choice. But it is a choice that a sovereign State may impose to protect its citizens from dangerous drugs or at least ensure that seriously injured consumers receive compensation. That is, a State may impose such a choice unless the FDCA gives manufacturers an absolute right to sell their products free from common-law liability, or state law otherwise "stands as an obstacle to the accomplishment" of federal objectives. Crosby, 530 U. S., at 373 (internal quotation marks omitted). Because the majority does not rely on obstacle pre-emption, it must believe that a manufacturer that received FDA premarket approval has a right not only to keep its drug on the market unless and until the FDA revokes approval, but also to be free from state-law liability that makes doing so more expensive. That proposition is fundamentally inconsistent with the FDCA's text, structure, saving clause, and history. See supra, at 3-6; Levine, 555 U. S., at 583 (THOMAS, J., concurring in judgment).

It is simply incorrect to say that federal law presupposes that drug manufacturers have a right to continue to sell a drug free from liability once it has been approved. Nothing in the language of the FDCA, which is framed as a prohibition on distribution without FDA approval, see 21 U. S. C. §355(a), suggests such a right. Federal law itself bars the sale of previously approved drugs if new information comes to light demonstrating that the drug is "dangerous to health" and thus "misbranded." See §§331(a), 352(j); see supra, at 3-4.^[14] Even outside that scenario, manufacturers regularly take drugs off the market when evidence emerges about a drug's risks, particularly when safer drugs that provide the same therapeutic benefits are available.^[15] According to the FDA, while it has formal authority to withdraw approval for a drug based on new adverse information, see §355(e), it is far more common for a manufacturer to stop selling its product voluntarily after the FDA advises the manufacturer that the drug is unsafe and that its risk-benefit profile cannot be adequately addressed through labeling changes or other measures. See U. S. Brief 5.

New Hampshire's design-defect cause of action thus does no more than provide an impetus for an action that is permitted and sometimes encouraged or even required by federal law.

D

The majority derides any suggestion that Mutual's ability to "stop selling" sulindac is relevant to the validity of its impossibility pre-emption defense. Ante, at 2, 14-16. But the majority's argument is built on the mistaken premise that Mutual is legally obligated by New Hampshire's design-defect law to modify its label in a way that federal law forbids. It is not. See supra, at 11-13. For that reason, rejecting impossibility pre-emption here would not render the doctrine "a dead letter" or "`all but meaningless.'" Ante, at 2, 15 (quoting Mensing, 564 U. S., at ___ (slip op., at 14)). On the other hand, it is the majority that "work[s] a revolution in this Court's [impossibility] pre-emption case law," ante, at 2, by inferring a state-law requirement from the steps a manufacturer might wish to take to avoid or mitigate its exposure to liability.

Not all products can be made safe for sale with an improved warning or a tweak in design. New Hampshire, through its design-defect law, has made a judgment that some drugs that were initially approved for distribution turn out to be inherently and unreasonably dangerous and should therefore not be sold unless the manufacturer is willing to compensate injured consumers. Congressional intent to pre-empt such a cause of action cannot be gleaned from the existence of federal specifications that apply to the product if it is sold. Instead, whether New Hampshire's design-defect cause-of-action is pre-empted depends on assessing whether it poses an obstacle to a federal policy to approve sulindac for use. Yet the majority skips that analysis and instead finds impossibility where it does not exist by relying on a question-begging assumption that Congress intended for Mutual to have a way to continue selling sulindac without incurring common-law liability. See ante, at 9-11.

The distinction between impossibility and obstacle preemption is an important one. While obstacle pre-emption can be abused when courts apply an overly broad conception of the relevant federal purpose to find pre-emption, see Levine, 555 U. S., at 601-602 (THOMAS, J., concurring in judgment), it is a useful framework for a case like this one because it would at least lead the Court to ask the right questions.

For example, properly evaluating the asserted conflict here through the lens of obstacle pre-emption would allow the Court to consider evidence about whether Congress intended the FDA to make an optimal safety determination and set a maximum safety standard (in which case state tort law would undermine the purpose) rather than a minimal safety threshold (in which case state tort law could supplement it). See, e.g., Williamson v. Mazda Motor of America, Inc., 562 U. S. ___, ___ (2011) (slip op., at 11). By contrast, the majority's overbroad impossibility framework takes no account of how federal drug safety review actually works. Though the majority gestures to the rigorous nature of the FDA's review of new drug applications, ante, at 2-3, nothing in the majority's reasoning turns on how the FDA's premarketing review operates or on the agency's capacity to engage in postmarketing review.

In taking the approach it does, the majority replaces careful assessment of regulatory structure with an ipse dixit that pharmaceutical companies must have a way to "escape liability," ante, at 11, while continuing to sell a drug that received FDA approval. As a result, the majority effectively makes a highly contested policy judgment about the relationship between FDA review and state tort law—treating the FDA as the sole guardian of drug safety—without defending its judgment and without considering whether that is the policy judgment that Congress made.^[16]

III

While the majority never addresses obstacle preemption, Mutual did argue in the alternative that Bartlett's design-defect cause of action is pre-empted because it conflicts with the purposes and objectives of the FDCA, as supplemented by the Hatch-Waxman Act, 98 Stat. 1585. Though it presents a closer question than the impossibility argument on which the majority relies, I would reject Mutual's obstacle pre-emption defense as well.

Mutual's most substantial contention is that New Hampshire's design-defect claim frustrates the policy underlying the FDCA's broader scheme of vesting authority in the FDA as an expert agency to determine which drug designs should enter and remain in interstate commerce. The FDA, through an amicus brief filed by the United States, generally supports this argument. The FDA states that the question whether a design-defect claim^[17] is pre-empted is "difficult and close," and it recognizes that "[s]everal factors do weigh in favor of finding no preemption," including the absence of textual support in the FDCA for the idea that an approved drug must be made available in any particular State. See U. S. Brief 12, 21-22. But the FDA ultimately contends that designdefect claims are pre-empted unless they parallel the FDCA's misbranding prohibition because the agency believes that permitting juries to balance the health risks and benefits of an FDA-approved drug would undermine the FDA's drug-safety determinations and could reduce access to drugs that the FDA has determined are safe and effective.

Our cases have "given `some weight' to an agency's views about the impact of tort law on federal objectives when `the subject matter is technica[l] and the relevant history and background are complex and extensive.'" Levine, 555 U. S., at 576 (quoting Geier v. American Honda Motor Co., 529 U. S. 861, 883 (2000)). But courts do not "defe[r] to an agency's conclusion that state law is preempted," 555 U. S., at 576, and the tension that the FDA identifies in an effort to justify complete pre-emption of design-defect claims for prescription drugs does not satisfy the "high threshold [that] must be met if a state law is to be pre-empted for conflicting with the purposes of a federal Act," Chamber of Commerce of United States of America, v. Whiting, 563 U. S. ___, ___ (2011) (slip op., at 22) (internal quotation marks omitted); see Silkwood, 464 U. S., at 256. Given the FDCA's core purpose of protecting consumers, our recognition in Levine that state tort law generally complements the statute's safety goals, the practical limits on the FDA's ability to monitor and promptly address concerns about drug safety once a drug is in the market, see supra, at 5, 20-21, n. 11, and the absence of any federal remedy for injured consumers, I would reject this broad obstacle pre-emption argument as well.^[18]

IV

The most troubling aspect of the majority's decision to once again expand the scope of this Court's traditionally narrow impossibility pre-emption doctrine is what it implies about the relationship between federal premarket review and state common-law remedies more generally. Central to the majority's holding is an assumption that manufacturers must have a way to avoid state-law liability while keeping particular products in commerce. See ante, at 9-11, 14-15. This assumption, it seems, will always create an automatic conflict between a federal premarket review requirement and state-law design-defect liability because premarket review, by definition, prevents manufacturers from unilaterally changing their products' designs.^[19] That is true, for example, of the designs (i.e., the chemical composition) of brand-name drugs under the FDCA no less than it is for generic drugs. See ante, at 3-4.

If the creation of such an automatic conflict is the ultimate end-point of the majority's continued expansion of impossibility pre-emption, then the result is frankly astonishing. Congress adopted the FDCA's premarketing approval requirement in 1938 and then strengthened it in 1962 in response to serious public-health episodes involving unsafe drugs. See Future of Drug Safety 152. Yet by the majority's lights, the very act of creating that requirement in order to "safeguard the consumer," United States v. Sullivan, 332 U. S. 689, 696 (1948), also created by operation of law a shield for drug manufacturers to avoid paying common-law damages under state laws that are also designed to protect consumers. That is so notwithstanding Congress' effort to disclaim any intent to pre-empt all state law. See supra, at 4. The majority's reasoning thus "has the `perverse effect' of granting broad immunity `to an entire industry that, in the judgment of Congress, needed more stringent regulation.'" Riegel, 552 U. S., at 338 (GINSBURG, J., dissenting) (quoting Lohr, 518 U. S., at 487 (plurality opinion)).

This expanded notion of impossibility pre-emption threatens to disturb a considerable amount of state law. The FDCA's premarket approval process for prescription drugs has provided a model for the regulation of many other products.^[20] In some statutes, Congress has paired premarket regulatory review with express pre-emption provisions that limit the application of state common-law remedies, including, in some instances, claims for defective product design. See, e.g., Riegel, 552 U. S., at 323-325; see supra, at 4, and n. 2. In other instances, such as with prescription drugs, it has not. Under the majority's approach, it appears that design-defect claims are categorically displaced either way, and Congress' efforts to set the boundaries of pre-emption more precisely were largely academic. This could have serious consequences for product safety. State design-defect laws play an important role not only in discovering risks, but also in providing incentives for manufacturers to remove dangerous products from the market promptly. See Levine, 555 U. S., at 578-579; Bates, 544 U. S., at 451; see also Conk, Is There a Design Defect in the Restatement (Third) of Torts: Products Liability? 109 Yale L. J. 1087, 1130 (2000) ("The tort system can encourage FDA regulatory vigor and competence"). If manufacturers of products that require preapproval are given de facto immunity from design-defect liability, then the public will have to rely exclusively on imperfect federal agencies with limited resources and sometimes limited legal authority to recall approved products. And consumers injured by those products will have no recourse.

The manner in which Congress has addressed preemption with respect to vaccines is particularly instructive. "[V]accines have been subject to the same federal premarket approval process as prescription drugs," and prior to Congress' intervention, "compensation for vaccinerelated injuries ha[d] been left largely to the States." Bruesewitz v. Wyeth LLC, 562 U. S. ___, ___ (2011) (slip op., at 1). In 1986, in response to a rise in tort suits that produced instability in the vaccine market, Congress enacted the National Childhood Vaccine Injury Act (Vaccine Act), 42 U. S. C. §300aa-22(b)(1). The Act established a no-fault compensation program funded through an excise tax on vaccines to compensate individuals injured or killed by vaccine side effects. "The quid pro quo for this" system, the Court stated in Bruesewitz, "was the provision of significant tort-liability protections for vaccine manufacturers." 562 U. S., at ___ (slip op., at 4).

While Members of this Court disagreed on the scope of the tort protections the Vaccine Act was intended to offer, the Act's history demonstrates that Congress is perfectly capable of responding when it believes state tort law may compromise significant federal objectives under a scheme of premarket regulatory review for products it wants to make available. And it illustrates that "an important reason to require that preemption decisions be made by Congress," rather than by courts on the basis of an expanded implied pre-emption doctrine, is Congress' ability to tie its pre-emption decisions "to some alternative means for securing compensation." Metzger, Federalism and Federal Agency Reform, 111 Colum. L. Rev. 1, 33 (2011). By instead reaching out to find pre-emption in a context where Congress never intended it, the majority leaves consumers like Karen Bartlett to bear enormous losses on their own.

* * *

The Court recognizes that "[t]his case arises out of tragic circumstances." Ante, at 20. And I do not doubt that Members of the majority personally feel sympathy for Karen Bartlett. But the Court's solemn affirmation that it merely discharges its duty to "follo[w] the law," ante, at 17, and gives effect to Congress' policy judgment, rather than its own, is hard to accept. By once again expanding the scope of impossibility pre-emption, the Court turns Congress' intent on its head and arrives at a holding that is irreconcilable with our precedents. As a result, the Court has left a seriously injured consumer without any remedy despite Congress' explicit efforts to preserve state common-law liability.

I respectfully dissent.

[1] We can thus save for another day the question whether a true absolute-liability state-law system could give rise to impossibility pre-emption. As we have noted, most common-law causes of action for negligence and strict liability do not exist merely to spread risk, but rather impose affirmative duties. See Riegel v. Medtronic, Inc., 552 U. S. 312, 323-324 (2008) ("In [Medtronic, Inc. v. Lohr, 518 U. S. 470 (1996)], five Justices concluded that common-law causes of action for negligence and strict liability do impose `requirement[s]' and would be pre-empted by federal requirements specific to a medical device. . . . We adhere to that view"); id., at 324 ("Absent other indication, reference to a State's `requirements' includes its common-law duties. As the plurality opinion said in Cipollone [v. Liggett Group, 505 U. S. 504, 522 (1992)], common-law liability is `premised on the existence of a legal duty,' and a tort judgment therefore establishes that the defendant has violated a state-law obligation").

[2] That Mutual's liability turned on the adequacy of sulindac's warnings is not unusual. Rather, New Hampshire—like a large majority of States—has adopted comment k to §402A of the Restatement (Second) of Torts, which recognizes that it is "especially common in the field of drugs" for products to be "incapable of being made safe for their intended and ordinary use." Restatement 2d, at 353; Bellotte v. Zayre Corp., 116 N. H. 52, 54-55, 352 A. 2d 723, 725 (1976). Under comment k, "[s]uch a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous." Restatement 2d, at 353-354. This Court has previously noted that, as of 1986, "a large number of courts" took comment k to mean that manufacturers "did not face strict liability for side effects of properly manufactured prescription drugs that were accompanied by adequate warnings." Bruesewitz v. Wyeth,562 U. S. ___, ___, n. 41 (2011) (slip op., at 10, n. 41).

Mutual withdrew its comment k defense "for purposes of the trial of this matter." Defendant's Notice of Withdrawal of Defenses, in Case No. 08-cv-358-JL (D NH), p. 1. However, as noted above, both respondent and the trial court injected the broader question of the adequacy of sulindac's label into the trial proceedings.

[3] JUSTICE BREYER argues that it is not "literally impossible" for Mutual to comply with both state and federal law because it could escape liability "either by not doing business in the relevant State or by paying the state penalty, say damages, for failing to comply with, as here, a state-law tort standard." Post, at 1 (dissenting opinion). But, as discussed below, infra, at 15-16—leaving aside the rare case in which state or federal law actually requires a product to be pulled from the market—our pre-emption cases presume that a manufacturer's ability to stop selling does not turn impossibility into possibility. See, e.g., Florida Lime & Avocado Growers, Inc. v. Paul, 373 U. S. 132, 143 (1963) (There would be "impossibility of dual compliance" where "federal orders forbade the picking and marketing of any avocado testing more than 7% oil, while the California test excluded from the State any avocado measuring less than 8% oil content"). And, of course, PLIVA, Inc. v. Mensing, 564 U. S. ___ (2011), forecloses any argument that impossibility is defeated by the prospect that a manufacturer could "pa[y] the state penalty" for violating a state-law duty; that prospect would have defeated impossibility in PLIVA as well. See id., at ___ (slip op., at 12) ("[I]t was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same"). To hold otherwise would render impossibility pre-emption "all but meaningless." Id., at ___ (slip op., at 14).

[4] We do not address state design-defect claims that parallel the federal misbranding statute. The misbranding statute requires a manufacturer to pull even an FDA-approved drug from the market when it is "dangerous to health" even if "used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof." 21 U. S. C. §352(j); cf. Bates v. Dow Agrosciences LLC, 544 U. S. 431, 447 (2005) (state-law pesticide labeling requirement not pre-empted under express pre-emption provision, provided it was "equivalent to, and fully consistent with, [federal] misbranding provisions"). The parties and the Government appear to agree that a drug is misbranded under federal law only when liability is based on new and scientifically significant information that was not before the FDA. Because the jury was not asked to find whether new evidence concerning sulindac that had not been made available to the FDA rendered sulindac so dangerous as to be misbranded under the federal misbranding statute, the misbranding provision is not applicable here. Cf. 760 F. Supp. 2d 220, 233 (NH 2011) (most of respondent's experts' testimony was "drawn directly from the medical literature or published FDA analyses").

[5] Respondent attempts to distinguish this case from PLIVA, arguing that "[w]here, as in PLIVA, state law imposes an affirmative duty on a manufacturer to improve the product's label, suspending sales does not comply with the state-law duty; it merely offers an indirect means of avoiding liability for noncompliance with that duty." Brief for Respondent 39. But that difference is purely semantic: the state-law duty in PLIVA to amend metoclopramide's label could just as easily have been phrased as a duty not to sell the drug without adequate warnings. At least where a State imposes liability based on a balancing of a product's harms and benefits in light of its labeling—rather than directly prohibiting the product's sale—the mere fact that a manufacturer may avoid liability by leaving the market does not defeat a claim of impossibility.

[6] The majority's failure to adhere to the presumption against preemption is well illustrated by the fact that the majority calls on Congress to provide greater clarity with regard to the "difficult pre-emption questions that arise in the prescription drug context." Ante, at 19-20. Certainly, clear direction from Congress on pre-emption questions is useful. But the whole point of the presumption against pre-emption is that congressional ambiguity should cut in favor of preserving state autonomy. See Rice v. Santa Fe Elevator Corp., 331 U. S. 218, 230 (1947).

[7] See 21 U. S. C. §360k(a) (medical devices); §379r (labeling requirements for nonprescription drugs); §379s (labeling and packaging requirements for cosmetics); 42 U. S. C. §300aa-22(b)(1) (vaccines). Instructively, Congress included a saving clause in the statutes addressing nonprescription drugs and cosmetics, which makes clear that the express pre-emption provisions in these statutes do not affect state product liability law. See 21 U. S. C. §§379r(e), 379s(d).

[8] Though the majority does not rely on comment k to find preemption, it misleadingly implies that New Hampshire, like "a large majority of States," has applied comment k categorically to prescription drugs to exempt manufacturers from "`strict liability for side effects of properly manufactured prescription drugs that [are] accompanied by adequate warnings.'" Ante, at 12, n. 2 (quoting Bruesewitz v. Wyeth LLC, 562 U. S. ___, ___, n. 41 (2011) (slip op., at 10, n. 41). That is incorrect. The majority also neglects to mention that while some courts have applied comment k categorically to prescription drug designs, "[m]ost courts have stated that there is no justification for giving all prescription drug manufacturers blanket immunity from strict liability under comment k." 2 American Law of Products Liability 3d §17.45, p. 108 (2010). Like New Hampshire courts, these courts apply comment k on a case-by-case basis. See 1 L. Frumer & M. Friedman, Products Liability §8.07[5], pp. 8-287 to 8-293 (2012).

[9] Because of this feature of New Hampshire law, it is unnecessary to consider whether the pre-emption analysis would differ in a jurisdiction that required proof of a feasible alternative design as an element of liability.

[10] The majority suggests my account of Bates is "simply misleading," ante, at 18, but it simply misses the point. I recognize that, under the Court's precedents, common-law duties may qualify as "requirements," at least as that term has been used in express pre-emption provisions in federal law. See Riegel v. Medtronic, Inc., 552 U. S. 312, 323-324 (2008). But determining precisely what, if any, specific requirement a state common-law claim imposes is important. In Bates, the lower court had accepted the same basic argument that the majority advances here: that the plaintiffs' design-defect claim that a pesticide was "unreasonably dangerous" was "merely a disguised claim for failure to warn" because success on the claim that the pesticide was dangerous to crops in soil above a certain pH level would "necessarily induce" a manufacturer to change its product's label to avoid liability. Dow Agrosciences LLC v. Bates, 332 F. 3d 323, 332-333 (CA5 2003). This Court explicitly rejected the notion that because design-defect liability might lead a manufacturer to make a label change, it meant that the State's design-defect claim imposed a requirement for labeling or packaging. See 544 U. S., at 445-446. The majority contends that this case is different because the duty to redesign sulindac's label was an element of New Hampshire's design-defect law. Ante, at 19. But it is not. See supra, at 11. Rather, altering a product label is merely one step a manufacturer might take to prevent its product from being considered unreasonably dangerous, and it is a step that New Hampshire law recognizes may be insufficient. See infra, at 16.

[11] For example, in a ruling on proposed jury instructions, the District Court made clear that "Bartlett cannot be allowed to circumvent this court's summary judgment ruling by using Sulindac's warning to establish that the drug is unreasonably dangerous (i.e., arguing that Sulindac is unreasonably dangerous because of its warning), where this court has already ruled that any inadequacy in the warning did not cause Bartlett's injuries." App. 343. Doing so, the court explained "would effectively turn this case back into a failure-to-warn case, rendering the summary judgment ruling meaningless." Ibid.

The District Court later told counsel that it had removed a failure-towarn instruction from the jury instructions because "[t]his is not a failure to warn case," and the court admonished counsel to "tread carefully" in arguing about the warning label because the label's adequacy was "not an issue before this jury." Id., at 496.

[12] To the extent the majority believes that the District Court in practice allowed the adequacy of the warning label to play a greater role at trial than it should have, see ante, at 11-12, that is irrelevant to the question before the Court. Statements by counsel, even if improper, do not change the state law cause of action that we evaluate for preemption purposes. And the Court of Appeals specifically concluded that the District Court's jury instructions were appropriate and that "[i]f Mutual wanted a further caution in the instructions" concerning its warning label, then Mutual "should have sought it." 678 F. 3d 30, 41-42 (CA1 2012).

[13] The majority's suggestion that a manufacturer's option of continuing to sell while paying compensation is akin to violating a statutory mandate and then suffering the consequence (such as paying a fine) is flawed. See ante, at 18. In that scenario, the manufacturer would have violated the law, and the fact that the law is enforced through monetary sanctions (rather than through an injunction or imprisonment) would not change that. Here, no matter how many times the majority insists otherwise, ibid., a manufacturer who sells a drug whose design is found unreasonably dangerous based on a balance of factors has not violated a state law requiring it to change its label. In both cases, the manufacturer may owe money. But only in the former will it have failed to follow the law. Cf. National Federation of Independent Business v. Sebelius, 567 U. S. ___, ___ (2012) (slip op., at 32) (recognizing that a condition that triggers a tax is not necessarily a "legal command" to take a certain action).

[14] The majority properly leaves open the question whether state design-defect claims that parallel the federal misbranding statute are preempted. See ante, at 14, n. 4. The majority fails to appreciate, however, that this statute undermines its impossibility argument (as compared to an argument based on obstacle pre-emption) because it shows that there is no federal right or obligation to continue to sell a drug like sulindac that was previously approved. In fact, the statute demonstrates that sometimes a drug manufacturer like Mutual may have a federal duty not to sell its drug.

[15] See Government Accountability Office, Drug Safety: Improvement Needed in FDA's Postmarket Decision-making and Oversight Process 10 (GAO-06-402, 2006) (noting that 10 drugs were voluntarily withdrawn for safety reasons between 2000 and 2006); Wysowski & Swartz, Adverse Drug Event Surveillance and Drug Withdrawals in the United States, 1969-2002, 165 Archives Internal Med. 1363 (2005) (noting that more than 75 drugs and drug products were withdrawn from the market for safety reasons between 1969 and 2002).

[16] Defending a policy judgment that treats the FDA as the exclusive guarantor of drug safety would be no easy task in light of evidence that resource constraints and gaps in legal authority, among other factors, limit the agency's ability to safeguard public health. See Kessler & Vladeck, A Critical Examination of the FDA's Efforts to Preempt Failure-to-Warn Claims, 96 Geo. L. J. 461, 483-495 (2008); see also Wyeth v. Levine, 555 U. S. 555, 578-579, and n. 11 (2009).

[17] The FDA purports to address what it calls a "pure" design-defect claim, and it references the Third Restatement §6 by way of illustration. The FDA's separate discussion of a "pure" design-defect claim is based on the premise that New Hampshire's design-defect claim turns on the adequacy of a drug's warning. See U. S. Brief 20. But that is incorrect. See supra, at 11.

[18] I note that we are not confronted with a case in which the FDA promulgated "lawful specific regulations describing" whether and under what circumstances state design-defect liability interferes with "the safe drug-related medical care" sought through the FDCA. Levine, 555 U. S., at 582 (BREYER, J., concurring). See also ante, at 2-3 (BREYER, J., dissenting).

[19] Or at least it creates an automatic conflict with the caveat that design-defect claims that parallel a federal duty for manufacturers to withdraw a product might not be pre-empted. See ante, at 13-14, n. 3.

[20] See, e.g., 7 U. S. C. §136a (pesticides); 21 U. S. C. §348 (food additives); §360b (animal drugs); §§360c(a)(1)(C), 360e (certain medical devices); §379e (color additives).