19 Class 19 19 Class 19

Causation in Fact

            Thus far, we have assumed that liability applies only to defendants who can be said in some way to have caused the injury. But the causation requirement is famously puzzling.  Why do we even have a causation requirement?  If our exclusive goal were compensation, for example, a causation requirement might be perverse.  Some defendants may be judgment proof and unable to pay much of anything. Moreover, causal reasoning is notoriously complicated.  When we label something a cause of something else, when we reason in terms of cause and effect, we are often making normative judgments about how a case should turn out.

               Consider, for example, Ronald Coase’s take on causation:

[Take, for example,] the case of a confectioner the noise and vibrations from whose machinery disturbed a doctor in his work. To avoid harming the doctor would inflict harm on the confectioner. The problem posed by this case was essentially whether it was worthwhile, as a result of restricting the methods of production which could be used by the confectioner, to secure more doctoring at the cost of a reduced supply of confectionery products. [….] If we are to discuss the problem in terms of causation, both parties cause the damage.

R. H. Coase, The Problem of Social Cost, 3 J. L. & Econ 1 (1960). As Coase sees it, it makes no sense to speak in the abstract about who causes what. Instead, causation gets at the fundamental policy goals underlying a problem and allocates responsibility accordingly.

            Other scholars push back against the idea that causation has no real meaning. H.L.A. Hart and Anthony Honoré, for example, urge that common sense and cultural conventions can make sense of the doctrine. H.L.A. Hart & Anthony Honoré, Causation in the Law 3 (1959).

            This debate aside, how do plaintiffs establish causation? What if causation in fact can be expressed only in terms of probabilities? Or if there are multiple possible causes or culprits?       

19.1 Causation in Fact: Baseline Standards 19.1 Causation in Fact: Baseline Standards

            How can a court go about establishing that A caused B, especially when the matter is uncertain? We will consider this question first by considering the basic rules courts use to measure causation in fact. 

19.1.1 Zuchowicz v. United States 19.1.1 Zuchowicz v. United States

140 F.3d 381
Steven ZUCHOWICZ, Plaintiff-Appellee Cross-Appellant,
v.
UNITED STATES of America, Defendant-Appellant Cross-Appellee.
Docket No. 97-6057.
Docket No. 97-6099.
United States Court of Appeals, Second Circuit.
Argued October 22, 1997.
Decided March 20, 1998.

[140 F.3d 383]

        Mary Jo Donahue, Trial Attorney, Torts Branch, Civil Division, U.S. Department of Justice, Washington, DC (Frank W. Hunger, Assistant Attorney General; Christopher F. Droney, United States Attorney; Carl J. Schuman, Assistant United States Attorney; Jeffrey Axelrad, Director, Torts Branch; Roger D. Einerson, Assistant Director, Torts Branch, on the brief), for Defendant-Appellant Cross-Appellee.

        Robert I. Reardon, Jr., The Reardon Law Firm, P.C., New London, CT (Angelo A. Ziotas, on the brief), for Plaintiff-Appellee Cross-Appellant.

        Before: NEWMAN, ALTIMARI, and CALABRESI, Circuit Judges,

        CALABRESI, Circuit Judge:

        The defendant, the United States of America, appeals from a judgment of the United States District Court for the District of Connecticut (Warren W. Eginton, Judge). This suit under the Federal Tort Claims Act, 28 U.S.C. §§ 1346(b), 2671-2680, was originally filed by Patricia Zuchowicz, who claimed to have developed primary pulmonary hypertension, a fatal lung condition, as a result of the defendant's negligence in prescribing an overdose of the drug Danocrine. Following Mrs. Zuchowicz's death in 1991, her husband, Steven, continued the case on behalf of his wife's estate, claiming that the defendant was responsible for her death. After a bench trial, the district court awarded the plaintiff $1,034,236.02 in damages.

        The case statement recited above goes to the heart of the law of torts. A plaintiff claims to have developed a fatal condition as a result of a defendant's negligence in prescribing an excessive amount of a drug—a tragic injury allegedly caused by defendant's wrong. There is no doubt in the case before us either as to the injury or as to the defendant's wrong; both are conceded. The only issue is causation.

        Did the action for which the defendant is responsible cause, in a legal sense, the harm which the plaintiff suffered? — a question easily put and often very hard to answer. There is, moreover, no older requirement in this area of law than the need to show such a link between the defendant's actions and the plaintiff's loss. It long precedes the obligation to show that the defendant was at fault.1 Along with the showing of injury,

[140 F.3d 384]

causation constituted an essential part of what the plaintiff had to demonstrate for the early common law action in trespass to lie.2

        Over the centuries the courts have struggled to give meaning to this requirement — in the simplest of situations, who hit whom,3 and in the most complex ones, which polluter's emissions, if any, hurt which plaintiff.4 It is the question that we must seek to answer today in the context of modern medicine and a very rare disease.

        I. Background

        A. Drug, Illness, and Death

        1. The Overdose

        The facts, as determined by the district court, are as follows. On February 18, 1989, Mrs. Zuchowicz filled a prescription for the drug Danocrine at the Naval Hospital pharmacy in Groton, Connecticut. The prescription erroneously instructed her to take 1600 milligrams of Danocrine per day, or twice the maximum recommended dosage. The defendant has stipulated that its doctors and/or pharmacists were negligent and violated the prevailing standard of medical care by prescribing this wrong dosage.

        Mrs. Zuchowicz took the 1600 milligrams of Danocrine each day for the next month. Thereafter, from March 24 until May 30, she took 800 milligrams per day. While taking Danocrine she experienced abnormal weight gain, bloating, edema, hot flashes, night sweats, a racing heart, chest pains, dizziness, headaches, acne, and fatigue. On May 30, she was examined by an obstetrician/gynecologist in private practice who told her to stop taking the Danocrine. During the summer, she continued to experience severe fatigue and chest tightness and pain, and began having shortness of breath. In October 1989, she was diagnosed with primary pulmonary hypertension ("PPH"), a rare and fatal disease in which increased pressure in an individual's pulmonary artery causes severe strain on the right side of the heart. At the time she was diagnosed with the disease, the median life expectancy for PPH sufferers was 2.5 years. Treatments included calcium channel blockers and heart and lung transplantation.

        Mrs. Zuchowicz was on the waiting list for a lung transplant when she became pregnant. Pregnant women are not eligible for transplants, and pregnancy exacerbates PPH. Mrs. Zuchowicz gave birth to a son on November 21, 1991. She died one month later, on December 31, 1991.

        2. Primary Pulmonary Hypertension

        Pulmonary hypertension is categorized as "primary" when it occurs in the absence of other heart or lung diseases. "Secondary" pulmonary hypertension is diagnosed when the hypertension results from another heart or lung disease, such as emphysema or blood clots. PPH is very rare. A National Institute of Health registry recorded only 197 cases of PPH from the mid-1980s until 1992. It occurs predominantly in young women. Exogenous agents known to be capable of causing PPH include birth control pills, some appetite suppressants, chemotherapy drugs, rapeseed oil, and L-Tryptophan.

        According to the district court's findings of fact, the disease involves the interplay of the inner layers of the pulmonary blood vessels known as the endothelium and the vascular smooth muscle. The endothelium releases substances called vasodilators and vasoconstrictors, which dilate and constrict the blood vessels. These substances can also cause growth of the vascular smooth muscle. Experts currently believe that an imbalance in

[140 F.3d 385]

vasodilators and vasoconstrictors plays a part in the development of pulmonary hypertension. If too many vasoconstrictors are released, the blood vessels contract, the endothelial cells die, and the vascular smooth muscle cells proliferate. These actions create increased pulmonary vascular resistance.

        3. Danocrine

        Danocrine has been extensively studied and prescribed since the late 1960s for endometriosis. According to the testimony of plaintiff's expert Dr. W. Paul D'Mowski, who personally performed much of the initial research on the drug, Danocrine is safe and effective when administered properly. Based on studies by Dr. D'Mowski and others, Danocrine was approved by the Food and Drug Administration ("FDA") for use in dosages not to exceed 800 mg/day. Mrs. Zuchowicz was accidentally given a prescription instructing her to take twice this amount—1600 mg/day. According to Dr. D'Mowski no formal studies of the effects of Danocrine at such high doses have been performed, and very, very few women have received doses this high in any setting.

        B. The Expert Testimony

        The rarity of PPH, combined with the fact that so few human beings have ever received such a high dose of Danocrine, obviously impacted on the manner in which the plaintiff could prove causation. The number of persons who received this type of overdose was simply too small for the plaintiff to be able to provide epidemiological, or even anecdotal, evidence linking PPH to Danocrine overdoses. The plaintiff (Mrs. Zuchowicz's husband and executor), therefore, based his case primarily on the testimony of two expert witnesses, Dr. Richard Matthay, a physician and expert in pulmonary diseases, and Dr. Randall Tackett, a professor of pharmacology who has published widely in the field of the effects of drugs on vascular tissues. In rendering a judgment for the plaintiff, the district court relied heavily on the evidence submitted by these two experts. The defendant challenges both the admissibility and the sufficiency of their testimony.

        1. Dr. Matthay

        Dr. Richard Matthay is a full professor of medicine at Yale and Associate Director and Training Director of Yale's Pulmonary and Critical Care Section. He is a nationally recognized expert in the field of pulmonary medicine, with extensive experience in the area of drug-induced pulmonary diseases. Dr. Matthay examined and treated Mrs. Zuchowicz. His examination included taking a detailed history of the progression of her disease, her medical history, and the timing of her Danocrine overdose and the onset of her symptoms.

        Dr. Matthay testified that he was confident to a reasonable medical certainty that the Danocrine caused Mrs. Zuchowicz's PPH. When pressed, he added that he believed the overdose of Danocrine to have been responsible for the disease. His conclusion was based on the temporal relationship between the overdose and the start of the disease and the differential etiology method of excluding other possible causes. While Dr. Matthay did not rule out all other possible causes of pulmonary hypertension, he did exclude all the causes of secondary pulmonary hypertension. On the basis of Mrs. Zuchowicz's history, he also ruled out all previously known drug-related causes of primary pulmonary hypertension.

        Dr. Matthay further testified that the progression and timing of Mrs. Zuchowicz's disease in relation to her overdose supported a finding of drug-induced PPH. Dr. Matthay emphasized that, prior to the overdose, Mrs. Zuchowicz was a healthy, active young woman with no history of cardiovascular problems, and that, shortly after the overdose, she began experiencing symptoms of PPH such as weight gain, swelling of hands and feet, fatigue, and shortness of breath. He described the similarities between the course of Mrs. Zuchowicz's illness and that of accepted cases of drug-induced PPH, and he went on to discuss cases involving classes of drugs that are known to cause other pulmonary diseases (mainly anti-cancer drugs). He noted that the onset of these diseases, which are recognized to be caused by the particular drugs, was very similar in timing

[140 F.3d 386]

and course to the development of Mrs. Zuchowicz's illness.

        2. Dr. Tackett

        Dr. Randall Tackett is a tenured, full professor of pharmacology and former department chair from the University of Georgia. He has published widely in the field of the effects of drugs on vascular tissues. Dr. Tackett testified that, to a reasonable degree of scientific certainty, he believed that the overdose of Danocrine, more likely than not, caused PPH in the plaintiff by producing: 1) a decrease in estrogen; 2) hyperinsulinemia, in which abnormally high levels of insulin circulate in the body; and 3) increases in free testosterone and progesterone. Dr. Tackett testified that these hormonal factors, taken together, likely caused a dysfunction of the endothelium leading to PPH. Dr. Tackett relied on a variety of published and unpublished studies that indicated that these hormones could cause endothelial dysfunction and an imbalance of vasoconstrictor effects.

        II. Discussion

        A. Was the Admission of the Plaintiff's Experts' Testimony Manifestly Erroneous?

        The defendant's first argument is that the district court erred in admitting the testimony of Dr. Tackett and Dr. Matthay. We review the district court's decision to admit or exclude expert testimony under a highly deferential abuse of discretion standard. See General Elec. Co. v. Joiner, ___ U.S. ___, ___, 118 S.Ct. 512, 517, 139 L.Ed.2d 508 (1997); McCullock v. H.B. Fuller Co., 61 F.3d 1038, 1042 (2d Cir.1995) ("The decision to admit expert testimony is left to the broad discretion of the trial judge and will be overturned only when manifestly erroneous.").

        The Federal Rules of Evidence permit opinion testimony by experts when the witness is "qualified as an expert by knowledge, skill, experience, training, or education," and "[i]f scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue." Fed.R.Evid. 702. And though in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 588-89, 113 S.Ct. 2786, 2794-95, 125 L.Ed.2d 469 (1993), the Supreme Court altered the traditional test for the admissibility of expert testimony, it did not change the standard of appellate review of these decisions, see Joiner, at ___, 118 S.Ct. at 517.5

        Under Daubert, trial judges are charged with ensuring that expert testimony "both rests on a reliable foundation and is relevant to the task at hand." 509 U.S. at 597, 113 S.Ct. at 2799. Thus, while Daubertand the Federal Rules of Evidence "allow district courts to admit a somewhat broader range of scientific testimony than would have been admissible under Frye, they leave in place the `gatekeeper' role of the trial judge in screening such evidence." Joiner, at ___, 118 S.Ct. at 517. Indeed Daubert strengthens this role, for it requires that judges make a "preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue." 509 U.S. at 592-93, 113 S.Ct. at 2796.

        The factors identified by the Supreme Court as relevant to this inquiry are: (1) whether the theory can be (and has been) tested according to the scientific method; (2) whether the theory or technique has been subjected to peer review and publication; (3) in the case of a particular scientific technique, the known or potential rate of error; and (4) whether the theory is generally accepted. See id. at 593-94, 113 S.Ct. at 2796-97. The Court emphasized, however, that these factors were not an exclusive or dispositive list of what should be considered, and

[140 F.3d 387]

that the trial court's inquiry should be a "flexible one." Id. at 594, 113 S.Ct. at 2797.

        The question in this case is whether, in light of these factors, the district court's decision to admit the testimony of Dr. Matthay and Dr. Tackett was an abuse of discretion. We addressed a similar question in McCullock v. H.B. Fuller Co., 61 F.3d 1038 (2d Cir.1995). In McCullock, we upheld the district court's decision to admit the testimony of an engineer and a medical doctor in a case involving a worker's exposure to glue fumes and her subsequent development of throat polyps. Applying the "manifestly erroneous" standard, we rejected the defendant's argument that the district court had not properly performed its gatekeeping function as required by Daubert. See id. at 1042-44. With respect to the doctor's testimony, we noted that the doctor

        based his opinion on a range of factors, including his care and treatment of [the plaintiff]; her medical history ...; pathological studies; ... his training and experience; use of a scientific analysis known as differential etiology (which requires listing possible causes, then eliminating all causes but one); and reference to various scientific and medical treatises.

        Id. at 1044. And we pointed out that the "[d]isputes as to the strength of his credentials, faults in his use of differential etiology as a methodology, or lack of textual authority for his opinion, go to the weight, not the admissibility of his testimony." Id.

        McCullock provides strong support for the instant plaintiff's position. In the case before us, as in McCullock, the district court carefully undertook and fulfilled its role in making the evaluation required by Daubert — a "preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue." 509 U.S. at 592-93, 113 S.Ct. at 2796. Where, as in this case, the district court decides to admit the testimony of well-credentialed experts relying on scientific methodology, we should and will be reluctant to upset that decision as an abuse of discretion.

        In the district court, the defendant made substantially the same arguments, regarding the validity of the methods used by Dr. Matthay and Dr. Tackett in reaching their conclusions, that it now raises on appeal. The district court rejected these arguments, stating that the plaintiff's experts "based their opinions on methods reasonably relied on by experts in their particular fields." We do not believe that the district court's decision in this regard was erroneous, let alone manifestly so.

        B. Were the District Court's Factual Findings with Respect to Causation Clearly Erroneous?

        We review the district court's factual findings for clear error. See, e.g., Mathie v. Fries, 121 F.3d 808, 811 (2d Cir.1997); see also Fed.R.Civ.P. 52(a). The defendant argues that, even assuming that the testimony of the plaintiff's experts was admissible, the district court's finding that the Danocrine overdose more likely than not caused Mrs. Zuchowicz's illness was clearly erroneous. The defendant contends that, since Danocrine has never been previously linked to PPH, the district court's conclusion that the drug caused Mrs. Zuchowicz's illness was impermissible. For the reasons stated below, we reject the defendant's arguments.

        1. Applicable Law

        The liability of the federal government under the Federal Tort Claims Act is determined according to the law of the state in which the injury occurred. See 28 U.S.C. § 1346(b); Taylor v. United States, 121 F.3d 86, 89 (2d Cir.1997). Connecticut law, therefore, provides the applicable standards in this case. A plaintiff alleging medical malpractice in Connecticut must first prove that the defendant negligently deviated from the customary standard of care. See, e.g., Edwards v. Tardif, 240 Conn. 610, 692 A.2d 1266, 1269 (1997). Since the defendant has stipulated that its agents were negligent in prescribing an overdose of the drug Danocrine, there is no question that this requirement is satisfied. In addition, "the plaintiff must establish a causal relationship between the physician's negligent actions or failure to act and the resulting injury by showing that the action or omission constituted a substantial factor in

[140 F.3d 388]

producing the injury." Id.; see also Mather v. Griffin Hosp., 207 Conn. 125, 540 A.2d 666, 669 (1988). This "substantial factor" causation requirement is the crux of the case before us.

        2. The Connecticut Law of Causation

        To meet the requirement that defendant's behavior was a substantial factor in bringing about the plaintiff's injury, the defendant must generally show: (a) that the defendant's negligent act or omission was a but for cause of the injury,6 (b) that the negligence was causally linked to the harm,7 and (c) that the defendant's negligent act or omission was proximate to the resulting injury.8

[140 F.3d 389]

This has long been the law in Connecticut, where Chief Justice Maltbie in Kinderavich v. Palmer, 127 Conn. 85, 15 A.2d 83 (1940), the leading Connecticut discussion of causation, expressly noted all three requirements decades before they were fully distinguished in the scholarly literature.9 See id., 15 A.2d at 86-87.

        In criticizing the use of an all-encompassing terminology of proximate cause, Maltbie separated out "those situations where the accident ... would have happened whether or not the act or omission in question had occurred." Id., 15 A.2d at 86 (discussing but for cause). He also distinguished those cases where the "particular conduct claimed to be negligent ... `had no real connection' with the injuries suffered." Id. (discussing causal link).10 And, finally, having differentiated these situations — and some others not currently germane — from those involving the requirement of proximate cause, the late Chief Justice went on to discuss at some length how proximity of causation was to be determined in Connecticut. See id., 15 A.2d at 87-89.

        In the case before us, as we shall see, neither the requirement of proximity nor that of causal link gives rise to any problems (though the presence of a strong causal link will prove to be highly significant). The case turns only on the difficulty of showing a but for cause. On whether, in other words, the plaintiff has sufficiently demonstrated: (a) that defendant's act in giving Mrs. Zuchowicz Danocrine was the source of her illness and death, and (b) that it was not just the Danocrine, but its negligent overdose that led to Mrs. Zuchowicz's demise.

        3. Connecticut Law and Experts

        In seeking to show both components of but for causation, plaintiff's reliance on experts must meet the substantive requirements of Connecticut law. Under that law, "[t]he expert opinion that seeks to establish the causal connection between the injury and the alleged negligence `must rest upon more than surmise or conjecture.'" Shelnitz v. Greenberg, 200 Conn. 58, 509 A.2d 1023, 1027 (1986) (citation omitted); see also Aspiazu v. Orgera, 205 Conn. 623, 535 A.2d 338, 342 (1987). The expert must deal not in mere possibilities, but in "reasonable medical probabilit[ies]." Aspiazu, 535 A.2d at 342. At the same time, it is well-established that causation "may be proved by circumstantial evidence," Shelnitz, 509 A.2d at 1027 (internal quotations and citation omitted), and that "[t]he causal relation between an injury and its later physical effects may be established by the direct opinion of a physician, by his deduction by the process of eliminating causes other than the traumatic agency, or by his opinion based upon a hypothetical question," id., 509 A.2d at 1028 (internal quotation marks and citation omitted).

        4. Was Danocrine a But For Cause of Mrs. Zuchowicz's Illness and Death?

        We hold that, on the basis of Dr. Matthay's testimony alone, the finder of fact

[140 F.3d 390]

could have concluded — under Connecticut law — that Mrs. Zuchowicz's PPH was, more likely than not, caused by Danocrine. While it was not possible to eliminate all other possible causes of pulmonary hypertension, the evidence presented showed that the experts had not only excluded all causes of secondary pulmonary hypertension, but had also ruled out all the previously known drug-related causes of PPH. In addition, Dr. Matthay testified, based on his expertise in pulmonary diseases, that the progression and timing of Mrs. Zuchowicz's illness in relationship to the timing of her overdose supported a finding of drug-induced PPH to a reasonable medical certainty. In this respect, we note that in the case before us, unlike many toxic torts situations, there was not a long latency period between the onset of symptoms and the patient's exposure to the drug that was alleged to have caused the illness. Rather, as Dr. Matthay testified, the plaintiff began exhibiting symptoms typical of drug-induced PPH shortly after she started taking the Danocrine. Under the circumstances, we cannot say that the fact finder was clearly erroneous in determining that, more probably than not, the Danocrine caused Mrs. Zuchowicz's illness.

        5. Was the Overdose a But For Cause of Mrs. Zuchowicz's Illness and Death?

        To say that Danocrine caused Mrs. Zuchowicz's injuries is only half the story, however. In order for the causation requirement to be met, a trier of fact must be able to determine, by a preponderance of the evidence, that the defendant's negligence was responsible for the injury. In this case, defendant's negligence consisted in prescribing an overdose of Danocrine to Mrs. Zuchowicz. For liability to exist, therefore, it is necessary that the fact finder be able to conclude, more probably than not, that the overdose was the cause of Mrs. Zuchowicz's illness and ultimate death. The mere fact that the exposure to Danocrine was likely responsible for the disease does not suffice.

        The problem of linking defendant's negligence to the harm that occurred is one that many courts have addressed in the past. A car is speeding and an accident occurs. That the car was involved and was a cause of the crash is readily shown. The accident, moreover, is of the sort that rules prohibiting speeding are designed to prevent. But is this enough to support a finding of fact, in the individual case, that speeding was, in fact, more probably than not, the cause of the accident? The same question can be asked when a car that was driving in violation of a minimum speed requirement on a super-highway is rear-ended. Again, it is clear that the car and its driver were causes of the accident. And the accident is of the sort that minimum speeding rules are designed to prevent. But can a fact finder conclude, without more, that the driver's negligence in driving too slowly led to the crash? To put it more precisely—the defendant's negligence was strongly causally linked to the accident, and the defendant was undoubtedly a but for cause of the harm, but does this suffice to allow a fact finder to say that the defendant's negligence was a but for cause?

        At one time, courts were reluctant to say in such circumstances that the wrong could be deemed to be the cause. They emphasized the logical fallacy of post hoc, ergo propter hoc, and demanded some direct evidence connecting the defendant's wrongdoing to the harm. See, e.g., Wolf v. Kaufmann, 227 A.D. 281, 282, 237 N.Y.S. 550, 551 (1929) (denying recovery for death of plaintiff's decedent, who was found unconscious at foot of stairway which, in violation of a statute, was unlighted, because the plaintiff had offered no proof of "any causal connection between the accident and the absence of light").

        All that has changed, however. And, as is so frequently the case in tort law, Chief Judge Cardozo in New York and Chief Justice Traynor in California led the way. In various opinions, they stated that: if (a) a negligent act was deemed wrongful because that act increased the chances that a particular type of accident would occur, and (b) a mishap of that very sort did happen, this was enough to support a finding by the trier of fact that the negligent behavior caused the harm. Where such a strong causal link exists, it is up to the negligent party to bring in evidence denying but for cause and suggesting

[140 F.3d 391]

that in the actual case the wrongful conduct had not been a substantial factor.

        Thus, in a case involving a nighttime collision between vehicles, one of which did not have the required lights, Judge Cardozo stated that lights were mandated precisely to reduce the risk of such accidents occurring and that this fact sufficed to show causation unless the negligent party demonstrated, for example, that in the particular instance the presence of very bright street lights or of a full moon rendered the lack of lights on the vehicle an unlikely cause. See Martin v. Herzog, 228 N.Y. 164, 126 N.E. 814, 816 (1920); see also Clark v. Gibbons, 66 Cal.2d 399, 58 Cal.Rptr. 125, 142, 426 P.2d 525, 542 (1967) (Traynor, C.J., concurring in part and dissenting in part on other grounds).

        The general acceptance of this view is both signaled and explained by Prosser, which states categorically:

        And whether the defendant's negligence consists of the violation of some statutory safety regulation, or the breach of a plain common law duty of care, the court can scarcely overlook the fact that the injury which has in fact occurred is precisely the sort of thing that proper care on the part of the defendant would be intended to prevent, and accordingly allow a certain liberality to the jury in drawing its conclusion.

        Prosser, supra note 6, § 41, at 270; see also Calabresi, supra note 6, at 71-73.

        It is clear that Connecticut accepts this approach. See, e.g., Knybel v. Cramer, 129 Conn. 439, 29 A.2d 576, 577-78 (1942) (after asking whether the defendant's negligence was the cause of an injury, the Connecticut Supreme Court of Errors stated "[w]here a statute is designed to protect persons against injury, one who has, as a result of its violation, suffered such an injury as the statute was intended to guard against has a good ground of recovery."); see also Small v. South Norwalk Savs. Bank, 205 Conn. 751, 535 A.2d 1292, 1296 (1988).

        The case before us is a good example of the above-mentioned principles in their classic form. The reason the FDA does not approve the prescription of new drugs at above the dosages as to which extensive tests have been performed is because all drugs involve risks of untoward side effects in those who take them. Moreover, it is often true that the higher the dosage the greater is the likelihood of such negative effects. At the approved dosages, the benefits of the particular drug have presumably been deemed worth the risks it entails. At greater than approved dosages, not only do the risks of tragic side effects (known and unknown) increase, but there is no basis on the testing that has been performed for supposing that the drug's benefits outweigh these increased risks. See generally 21 U.S.C. § 355(d) (indicating that the FDA should refuse to approve a new drug unless the clinical tests show that the drug is safe and effective for use under the conditions "prescribed, recommended, or suggested in the proposed labeling"). It follows that when a negative side effect is demonstrated to be the result of a drug, and the drug was wrongly prescribed in an unapproved and excessive dosage (i.e. a strong causal link has been shown), the plaintiff who is injured has generally shown enough to permit the finder of fact to conclude that the excessive dosage was a substantial factor in producing the harm.

        In fact, plaintiff's showing in the case before us, while relying on the above stated principles, is stronger. For plaintiff introduced some direct evidence of causation as well. On the basis of his long experience with drug-induced pulmonary diseases, one of plaintiffs experts, Dr. Matthay, testified that the timing of Mrs. Zuchowicz's illness led him to conclude that the overdose (and not merely Danocrine) was responsible for her catastrophic reaction.

        Under the circumstances, we hold that defendant's attack on the district court's finding of causation is meritless.

        C. Damages

        1. Defendant's Argument

        The defendant claims that the district court's award of damages for lost wages and earning capacity was not supported by the record. Prior to trial, the defendant suggested, and the plaintiff agreed

[140 F.3d 392]

to, a proposed finding of fact as to the amount of Mrs. Zuchowicz's earnings from her work as nurse's aide in 1987 and 1988 ($4301 and $5284, respectively). The defendant now objects to the district court's use of these numbers in calculating Mrs. Zuchowicz's lost earnings. The defendant seems to have overlooked the elementary principle of trial practice that once a fact has been agreed to by both parties and, as a result of such agreement has been submitted to the trial court as a proposed finding of fact, it need not be proved at trial. (And this remains so regardless of whether the parties have formally termed such a proposed finding a "stipulation"). The purpose of a pre-trial stipulation of this sort is precisely to narrow the scope of trial by eliminating issues that the parties do not dispute. It follows that the defendant's argument with respect to damages is completely without merit.

        2. Plaintiff's Request for Additur

        On cross-appeal, the plaintiff contends that the $900,000 in non-economic damages awarded by the district court was insufficient, claiming that this amount of money is so small in comparison to the harm suffered by Mrs. Zuchowicz that it must be overturned. We find that the district court's damage award was well within the range of appropriate awards, and reject the plaintiff's request.

        III. Conclusion

        We have examined all of the defendant's arguments and find them to be without merit. Accordingly, the judgment of the district court is affirmed.

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Notes:

1. In England the requirement of fault in cases of direct injury to plaintiffs by defendants is generally dated to Baron Bramwell's opinion in Holmes v. Mather, 10 Exch. 261 (1875), reprinted in Harry Shulman & Fleming James, Jr., Cases and Materials on the Law of Torts 43 (1942). In many of the states of the United States the requirement was imposed earlier. The opinion most frequently cited is that of Chief Justice Lemuel Shaw in Brown v. Kendall, 60 Mass. (6 Cush.) 292 (1850), reprinted in Harry Shulman, Fleming James, Jr., & Oscar S. Gray, Cases and Materials on the Law of Torts 34 (3d ed.1976).

2. The requirement of causation was a well-recognized and essential element of the plaintiff's case in chief in 17th century trespass actions such as Weaver v. Ward, Hobart 134, 80 Eng. Rep. 28 (K.B.1617), reprinted in Shulman, James & Gray, supra note 1, at 22, and Gibbons v. Pepper, 1 Ray. 38, 91 Eng. Rep. 922 (K.B.1695), reprinted in Shulman, James & Gray, supra note 1, at 24. The action in trespass, and especially trespass vi et armis (along with the later action of trespass on the case), is generally regarded as the ancestor of the modern personal injury suit.

3. See Dickenson v. Watson, T. Jones 205, 84 Eng. Rep. 1218 (K.B.1682), reprinted in Shulman, James & Gray, supra note 1, at 23

4. See Michie v. Great Lakes Steel Div., 495 F.2d 213 (6th Cir.1974).

5. In Daubert, the Supreme Court rejected the traditional Fryerule (which had required that a scientific theory be generally accepted by the scientific community to be admissible, see Frye v. United States, 293 F. 1013, 1014 (D.C.Cir.1923)), concluding that adherence to Frye's "rigid `general acceptance' requirement would be at odds with the `liberal thrust' of the Federal Rules [of Evidence]." Daubert, 509 U.S. at 588, 113 S.Ct. at 2794 (citations omitted).

6. In non-negligence cases, the same requirement applies as to those non-faulty acts or activities (e.g., product defects, extra-hazardous behavior) on whose existence the potential liability is grounded.

        In the last fifty years the strictness of the requirement that the plaintiff show that without defendant's act or omission the accident would not have occurred has been mitigated in several types of cases. For instance, where two defendants are both clearly at fault, where the plaintiff has little or no information as to which one's negligence was responsible for the injury, and especially where the defendants may have better access to such information, the modern trend is to place the burden on the defendants to disprove causation. See, e.g., Summers v. Tice, 33 Cal.2d 80, 199 P.2d 1, 4 (1948); see also, Modave v. Long Island Jewish Med. Ctr., 501 F.2d 1065, 1072-74 (2d Cir.1974) (Friendly, J.) (suggesting that, under New York law, a plaintiff may not need to prove which of two culpable defendants actually caused the plaintiff's injury even when the defendants were probably no more able to show what happened than was the plaintiff). Another important example of this easing trend has been the acceptance of statistical or market share evidence as a means of assigning at least part of a loss to various defendants whose conduct justified liability but who could not be identified, more probably than not, as having been but for causes of it. See, e.g., Sindell v. Abbott Labs., 26 Cal.3d 588, 163 Cal.Rptr. 132, 144-45, 607 P.2d 924, 936-37 (1980); Hymowitz v. Eli Lilly & Co., 73 N.Y.2d 487, 541 N.Y.S.2d 941, 947-48, 539 N.E.2d 1069, 1075 (1989). Many courts long ago abandoned the requirement of but for cause in situations where, since the negligence of any one of several defendants was sufficient to cause the harm, the negligence of none was its necessary cause. See, e.g., Corey v. Havener, 182 Mass. 250, 65 N.E. 69, 69 (1902). Indeed, some commentators attribute the acceptance of the "substantial factor" terminology, such as that used in Connecticut, to the problems a strict but for test would cause in this latter type of case. See, e.g., W. Page Keeton et al., Prosser and Keeton on the Law of Torts § 41, at 267-68 (5th ed.1984) [hereinafter Prosser]. While none of these easings in the requirement of proof of but for cause applies directly to the case before us, it is not unlikely that developments that are relevant to the instant case, see infra section II(B)(4), derived from a desire to achieve analogous goals through tort law. See generally Guido Calabresi, Concerning Cause and the Law of Torts: An Essay for Harry Kalven, Jr., 43 U. Chi. L.Rev. 69 (1975).

7. The effect of the requirement that a defendant's act or omission be causally linked to, or have a causal tendency toward, the harm that occurs is demonstrated most dramatically in cases in which (a) but for the defendant's actions the accident would clearly not have occurred, and (b) the defendant's actions are extremely close in time and space to the harm that came about, yet no one can reasonably believe that what the defendant did, though wrong, enhanced (at the time the defendant acted) the chances of the harm occurring or that it would increase the chances of a similar accident in the future if the defendant should repeat the same wrong. In such a situation, the requirement of causal link is not met and the defendant is not held liable.

        The leading case involving this requirement is Berry v. Sugar Notch Borough, 191 Pa. 345, 43 A. 240 (1899). In Berry, a tree fell on a trolley car whose excess speed had caused the tram to be at that specific place when the tree fell. The court held that the requirement of causation was not met. This result was correct since, although the accident would not have occurred but for the trolley's speeding, speeding does not increase the probability of trees falling on trolleys. Other similar cases (termed "darting out" cases) involve speeders who but for their velocity would not have been at the particular spot when children darted out from behind trees, etc., and were hit. In such cases — assuming that, had the speeders been at the same spot at the same time, they would have been unable to avoid the collision even if they were driving within the speed limit — no liability results. See 4 Fowler V. Harper, Fleming James, Jr., & Oscar S. Gray, The Law of Torts § 20.5, at 165 (2d ed. 1986).

        In a sense, the causal link requirement and the but for requirement are two different but related ways of asking whether a defendant's actions were a substantial factor in causing the injury. Causal link says that, even if defendant's wrong was a but for cause of the injury in a given case, no liability ensues unless defendant's wrong increases the chances of such harm occurring in general. But for says even if what the defendant did greatly increased the risk of certain injuries occurring, unless it was a sine qua non of the specific harm that actually came about, no liability will be assessed.

8. The requirements of proximity are many and varied, and are not simply linked to questions of closeness in time and space. Since, unlike but for cause and causal link, they play no role in the case before us, we will not discuss them further. See generally 4 Harper, James & Gray, supra note 7, §§ 20.4-20.6, at 130-85; Prosser, supra note 6, § 42, at 272-80.

9. The distinction between but for cause and proximate cause has long been recognized in the literature. See generally 4 Harper, James & Gray, supra note 7, § 20.1, at 85-89; Prosser, supra note 6, §§ 41-42, at 263-80. The significance of causal link as a separate requirement from proximate cause, though clearly recognized by Chief Justice Maltbie in Kinderavich, was probably first stated explicitly in the scholarly literature in America by the author of this opinion in the article Concerning Cause and the Law of Torts, supra note 6, at 71. It was, however, described as early as the 19th century by European scholars. See Izhak Englard, Victor Mataja's Liability for Damages from an Economic Viewpoint: A Centennial to an Ignored Economic Analysis of Tort, 10 Int'l Rev. L. & Econ. 173, 179 (1990).

10. In this regard, Chief Justice Maltbie cited cases in which the violation of a safety statute "played no part in producing the accident." Kinderavich, 15 A.2d at 86. Among these were Radwick v. Goldstein, 90 Conn. 701, 98 A. 583 (1916), a case where the violation of a statute, limiting speed in passing a railway car, put the defendant at a place and time such that he chanced to run into a bicyclist. In Radwick, Maltbie noted, the wrong was "held not to be of any consequence in determining liability," Kinderavich, 15 A.2d at 86, even though it undoubtedly was a but for cause of the particular collision.

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

19.1.2 Gemmink v. Jay Peak Inc. 19.1.2 Gemmink v. Jay Peak Inc.

Paul A. GEMMINK, Plaintiff-Appellant, v. JAY PEAK INC., Defendant-Appellee.

Docket No. 14-2725-cv.

United States Court of Appeals, Second Circuit.

Argued: Aug. 19, 2015.

Decided: Nov. 30, 2015.

*47Paul A. Gemmink, pro se.

Thomas P. Aieher, Cleary Shahi & Aieher, P.C., Rutland, VT, for Defendant-Ap-pellee.

Before: CALABRESI, STRAUB, POOLER, Circuit Judges.

CALABRESI, Circuit Judge:

I. BACKGROUND

On February 21, 2011, Paul Gemmink and his daughter, Christine, visited the *48Jay Peak ski resort in Jay, Vermont. The two skied down the Northwest Passage trail, with Christine preceding her father as she turned onto the Kokomo trail, which intersected the Northwest Passage trail. When Christine reached the base of the ski lift at the end of the trail, she noticed that her father had failed to follow her descent. Instead, a Jay Peak ski patroller would find Gemmink “combative and in obvious pain,” lying on his back by a tree on the left side of the Kokomo trail, near the Kokomo-Northwest Passage intersection. App’x at 31. Gemmink had been rendered unconscious and, though argumentative, could not recall or provide an account of the incident. Christine, however, had observed a ski jump situated near the trees on the right side of the intersection, leading her and her father to surmise that another patron “fl[ew] of[f] the jump” and collided with Gemmink. Id. at 30, 32. Gemmink suffered fractures to his left ribs and left transverse processes in the incident, injuries that, according to Gemmink, are usually attributable to a significant impact coming from right to left, and are therefore at least consistent with the theory that a skier jumped from the right of the intersection into Gemmink.

Proceeding pro se, Gemmink brought this action against Jay Peak to recover for injuries that he claims were sustained as a result of Jay Peak’s negligence. Specifically, Gemmink asserts that Jay Peak negligently permitted dangerous jumps on its ski trails and that, in consequence of such a constructed jump at the Kokomo-North-west Passage intersection, Gemmink suffered a collision with another skier resulting in harm to his left side. The District Court (Murtha, J.) granted Jay Peak’s motion 1 on for summary judgment, finding that Gemmink had failed to establish that Jay Peak’s alleged negligence was the cause of his injuries. Gemmink now appeals.

II. DISCUSSION

A.

This Court reviews a grant of summary judgment de novo. Amerex Group, Inc. v. Lexington Ins. Co., 678 F.3d 193, 199 (2d Cir.2012). Where, as here, the party opposing summary judgment bears the burden of proof at trial, summary judgment should be granted if the moving party can “point to an absence of evidence to support an essential element of the nonmoving party’s claim.” Goenaga v. March of Dimes Birth Defects Found., 51 F.3d 14, 18 (2d Cir. 1995). The court draws all inferences in favor of the nonmoving party, but the opposing party “must come forward with specific evidence demonstrating the existence of a genuine dispute of material fact.” Robinson v. Concentra Health Servs., Inc., 781 F.3d 42, 44 (2d Cir.2015).

Before the district court, it was assumed that the negligence of Jay Peak in the structure and maintenance of the jumps was sufficiently made out to survive summary judgment. Accordingly, for purposes of this opinion, we will assume ar-guendo that Gemmink has established such a potential basis for liability on the part of Jay Peak. The issue before us, then, is a not-infrequent one in torts cases: whether the plaintiff proffered sufficient evidence for a jury to find, more probably than not, that the ground for liability (here, the assumed negligence) was the cause of the plaintiffs injury.

As Professor Abraham has demonstrated in his recent article, a showing of cause-in-fact almost always involves circumstantial evidence. See Kenneth S. Abraham, Self-Proving Causation, 99 Va. L.Rev. 1811, 1815-16 (2013). Thus, in considering whether a plaintiff has proven causation, a trier of fact asks whether it is *49likely that the harm that occurred resulted from the negligence (or from another basis of liability) attributed to the defendant. In other words, is the reason that the defendant’s behavior is deemed risky, and the defendant deemed potentially hable, the harm that in fact occurred?

In such circumstances, as then-Chief Judge Cardozo set out in Martin v. Herzog, 228 N.Y. 164, 126 N.E. 814 (1920), a jury can assume that the injury occurred as the expected or ordinary result of the defendant’s conduct. Id. at 816. If for some reason it was not the ordinary result of the defendant’s conduct, that the “extraordinary” had occurred must be shown by the party wishing to counter causation. For example, if a defendant proprietor has failed to install lights on its stairways after dark, and a person coming down the stairs in the dark of night falls and injures himself, one can fairly assume that the failure to illuminate the stairs caused the injury. And it will be up to the defendant to show that something extraordinary happened, say, that an animal scampered up the stairs and tripped the injured person instead. In essence, the greater the risk that the defendant’s conduct will result in the harm the plaintiff suffered, the more likely that a jury will be allowed to find that such conduct was the cause of that harm.

In addition to considering the strength of the circumstantial evidence linking injury and harm, however, the cases dealing with questions of causation take into account two other factors. First, where one party has knowledge or access to information that renders that party better able than his adversary to explain what actually transpired, courts have tended to put the onus on that party to do so. This principle — that the party with superior knowledge bears the burden of coming forward with evidence — has always served as a basis of finding negligence under the doctrine of res ipsa loquitur. See, e.g., Griffen v. Manice, 166 N.Y. 188, 194-96, 59 N.E. 925 (1901). But it also serves as a basis for finding causation. See Williams v. Utica Coll. Of Syracuse Univ., 453 F.3d 112, 120-21 (2d Cir.2006); Williams v. KFC Nat. Mgmt. Co., 391 F.3d 411, 431-32 (2d Cir.2004) (Calabresi, J., concurring). Thus, the requirement that the plaintiff be able circumstantially to show a link between the expected risk of defendant’s conduct and what actually occurred tends to be greater when the plaintiff is better able to explain what happened, and is considerably less when, instead, it is the defendant who can better or more easily proffer evidence of what, in fact, occurred.

But cases of this sort also involve a third factor. Thus, in deciding whether sufficient proof of causation has been proffered to get to a jury, courts consider whether the law of the jurisdiction is indifferent as to error in one direction or the other. If an erroneous finding of causation is, in the law of the jurisdiction, more harmful than an erroneous finding of no causation, the requirements of circumstantial evidence and knowledge grow stronger. Conversely, where the law of the jurisdiction makes clear that an erroneous finding of no causation is more harmful, the requirements are diminished. Compare Williams v. Utica Coll. Of Syracuse Univ., 453 F.3d at 121 (finding summary judgment against plaintiff appropriate because, inter alia, New York courts placed only a minimal duty on the defendant to avert the type of harm incurred, which is “close to saying that if an error is to be made in this context, it is better made in favor of the defendant ”) (emphasis added), with Williams v. KFC Nat. Mgmt. Co., 391 F.3d at 432 (finding summary judgment against plaintiff inappropriate because, inter alia, of “the absence of any reason to *50prefer erring in favor of [the defendant] rather than the plaintiff’).

B.

With these three factors in mind, we turn to the case before us. The first factor favors the defendant. The causal link between Jay Peak’s assumed negligence in its maintenance of ski jumps and the injury incurred by the plaintiff is far too attenuated to sustain Gemmink’s claim. Our common experience does not tell us that this kind of lack of maintenance results in accidents of this sort with any frequency. And plaintiff has failed to proffer expert testimony suggesting a stronger link. See Human Rights Comm’n v. LaBrie, Inc., 164 Vt. 237, 668 A.2d 659, 667 (1995) (“Generally, expert ... testimony is required to support a finding of causation where the link is obscure and abstruse such that a layperson can have no well founded knowledge and can do no more than indulge in mere speculation.”) (internal quotation marks omitted).

The second is, at most, neutral. Neither Gemmink nor Jay Peak has greater knowledge or access to information concerning what actually happened on the Kokomo trail.

We turn, then, to the third factor: Is this an area where, in Vermont, liability of ski operators to skiers is close to strict, so that whether negligence was the cause of the alleged injury is a matter that, in uncertainty, should be decided in favor of the skier? Or is this an area where the risk of injury, even in the presence of negligence on the part of the ski operator, is assumed primarily by the skier, so that the requirement of causation is fairly placed on the skier (unless either (a) the evidentiary link between the evidence of negligence and causation of the kind of harm that occurred is particularly strong, or (b) the defendant is in a distinctly better position to tell us what happened)? Or, finally, is Vermont relatively indifferent to error in one direction or the other, offering no reason to favor either the plaintiff or defendant?

A review of Vermont law suggests that it follows the approach of symmetrical indifference. By statute, although assumption of risk has generally been subsumed in comparative negligence, 12 V.S.A. § 1036, it has been expressly retained as to sporting events, 12 V.S.A. § 1037. This would suggest that Vermont prefers to err on the side of finding no causation with respect to sport injuries like the one that here occurred. At the same time, however, the decision of whether the risk borne by the plaintiff in the sporting event was sufficiently “obvious and necessary” as to be assumed generally forms a jury question under Vermont law. See Estate of Frant v. Haystack Grp., Inc., 162 Vt. 11, 641 A.2d 765, 770-71 (1994) (rejecting the conclusion that “by enacting § 1037, the legislature intended to provide more protection from liability for ski areas” and stating that “ § 1037 is broad enough ... [that sjkiers should be deemed to assume only those skiing risks that the skiing industry is not reasonably required to prevent,” as determined by “a jury [applying] a contemporary sense of what constitutes an obvious or necessary risk”). Vermont’s approach stands in notable contrast both to Connecticut, where participants in sporting events rarely assume the risk of that participation, see, e.g., Jagger v. Mohawk Mtn. Ski Area, Inc., 269 Conn. 672, 849 A.2d 813, 827 (2004), and to New York, where assumption of risk is powerfully applied by courts to bar recovery by participants in sporting events, see, e.g., Martin v. New York, 64 A.D.3d 62, 878 N.Y.S.2d 823, 825-26 (3rd Dept.2009); N.Y. Gen. Obl. Law § 18-106. This contrast rein*51forces our conclusion that Vermont wants us to treat errors in this area pretty much symmetrically.

Consequently, we are left to infer causation, then, from only the placement of the ski jumps and the nature of Gemmink’s injuries. We cannot infer a causal link between Jay Peak’s assumed negligence in its maintenance of ski jumps and the injury incurred on the facts presented, and the plaintiff does not provide sufficient evidence to support a link between his injuries and alleged theory of causation. Under these circumstances, the district court was clearly correct in its holding that the evidence adduced by Gemmink was not sufficient to raise a question for the jury.

III. CONCLUSION

The judgment of the District Court is, therefore, AFFIRMED.

Judge POOLER joins only Parts I and 11(B) of the opinion.

19.2 Lost Chance Doctrine 19.2 Lost Chance Doctrine

            What should happen if a plaintiff was likely to suffer a bad outcome regardless of the defendant's involvement? Should it matter what kind of case is at issue--medical or otherwise? Lost chance doctrine, the subject of our next case, takes up this question.

19.2.1 Matsuyama v. Birnbaum, 890 N.E.2d 819 (Mass. 2008) 19.2.1 Matsuyama v. Birnbaum, 890 N.E.2d 819 (Mass. 2008)

MARSHALL, C.J.

          We are asked to determine whether Massachusetts law permits recovery for a "loss of chance" in a medical malpractice wrongful death action, where a jury found that the defendant physician's negligence deprived the plaintiff's decedent of a less than even chance of surviving cancer. We answer in the affirmative.[3] As we later explain more fully, the loss of chance doctrine views a person's prospects for surviving a serious medical condition as something of value, even if the possibility of recovery was less than even prior to the physician's tortious conduct. Where a physician's negligence reduces or eliminates the patient's prospects for achieving a more favorable medical outcome, the physician has harmed the patient and is liable for damages. Permitting recovery for loss of chance is particularly appropriate in the area of medical negligence. Our decision today is limited to such claims.

          The case before us was tried before a jury in the Superior Court. In response to special questions, the jury found the defendant physician negligent in misdiagnosing the condition of the decedent over a period of approximately three years. They found as well that the physician's negligence was a "substantial contributing 4*4 factor" to the decedent's death. They awarded $160,000 to the decedent's estate for the pain and suffering caused by the physician's negligence, and $328,125 to the decedent's widow and son for the decedent's loss of chance.[4] The defendants appealed, asserting, among other things, that loss of chance was not cognizable under the Massachusetts wrongful death statute, see G. L. c. 229, §§ 2 and 6,[5] or otherwise. We granted their application for direct appellate review.

          We conclude that recognizing loss of chance in the limited domain of medical negligence advances the fundamental goals and principles of our tort law. We also conclude that recognizing a cause of action from loss of chance of survival under the wrongful death statute comports with the common law of wrongful death as it has developed in the Commonwealth.[6] See Gaudette v. Webb, 362 Mass. 60, 71 (1972) (recognizing common-law origin of wrongful death actions in Commonwealth). The application of the doctrine to the evidence in this case supported the jury's findings as to loss of chance liability. Finally, although we determine that some portions of the jury instructions do not conform in all respects to the guidelines we set out below, they were broadly consistent with our decision today. Accordingly, we affirm.[7]

1. Background

          On the record before us, the jury could have found the following: the defendant, Dr. Neil S. Birnbaum, a 5*5 board-certified internist and president of the board of the codefendant, Dedham Medical Associates, Inc. (Medical Associates), became the primary care physician of the decedent, Kimiyoshi Matsuyama, in July, 1995, when the forty-two year old Matsuyama presented himself for a routine physical examination. Matsuyama's medical records at the time of his initial visit to Birnbaum disclosed complaints of gastric distress dating back to 1988. The records also indicated that in 1994 Matsuyama's previous physician had noted that Matsuyama might need an upper gastrointestinal series or small bowel follow-through to evaluate further his symptoms.[8] During the physical Matsuyama complained, as Birnbaum testified at trial, of "heartburn and difficulty breathing associated with eating and lifting." Birnbaum testified that he was aware at the time that Matsuyama, a person of Asian ancestry who had lived in Korea and Japan for the first twenty-four years of his life and had a history of smoking, was at a significantly higher risk for developing gastric cancer than was the general population of the United States.[9] Nevertheless, Birnbaum did not order any tests to determine the cause of Matsuyama's complaints. Based on his physical examination alone, Birnbaum diagnosed Matsuyama with gastrointestinal reflux disease and recommended over-the-counter medications to relieve Matsuyama's symptoms. Birnbaum followed a similar course of action in October, 1996, when Matsuyama returned for a sick visit, complaining that his heartburn was worse and that he had gastric pain after eating.

          In September, 1997, Matsuyama consulted Birnbaum about moles that had recently developed on his body. On visual inspection, Birnbaum made a diagnosis of "one benign seborrhea keratosis."[10] Birnbaum testified at trial that such moles are "common" 6*6 and "not something that I would [have] overly been that fearful of."

          Matsuyama next appeared for an office visit with Birnbaum on September 1, 1998, for a followup to a recent urgent care visit and for concerns about a mole over his left eye. Birnbaum was aware at the time that on August, 24, 1998, Matsuyama had presented himself at Medical Associates's urgent care facility complaining of severe stomach pain during the previous forty-eight hours, which the urgent care physician had diagnosed as gastritis. Birnbaum made a clinical diagnosis of nonulcer dyspepsia, again without the benefit of any evaluative gastrointestinal tests.[11] However, he did order a test on Matsuyama to determine the presence of Helicobacter pylori (H. pylori), a bacteria associated with gastric cancer, among other gastric maladies. When the test came back positive for H. pylori, Birnbaum directed his nurse to inform Matsuyama of the test results and to call in medications to treat Matsuyama's H. pylori. Neither the nurse nor Birnbaum told Matsuyama about the association of H. pylori with gastrointestinal diseases, of which Birnbaum was aware. By this time, Birnbaum testified, gastritis "probably was my leading diagnosis," but he did not order an endoscopy with biopsy or an upper gastrointestinal series, which he knew would definitively confirm or rule out his diagnosis.

          When Matsuyama next appeared in Birnbaum's office in November, 1998, for a routine checkup and followup, Birnbaum noted that the patient "was feeling better" and had no "significant symptoms" of gastric distress. Such was not the case on May 3, 1999, when Matsuyama went to Birnbaum complaining of epigastric pain, vomiting, sudden weight loss, and premature feelings of fullness after eating. Birnbaum ordered a gastrointestinal series and an abdominal ultrasound, which revealed a two-centimeter mass in Matsuyama's stomach. Subsequent medical 7*7 procedures confirmed the presence of infiltrative gastric adenoid carcinoma, signet ring cell type. Matsuyama then began treatment with specialists. He succumbed to gastric cancer the following October, leaving his wife and his minor son.

          In June, 2000, the plaintiff filed suit against Birnbaum and Medical Associates. Her complaint, as amended, alleged wrongful death, breach of contract, and negligence against both defendants.[12] Trial began in the Superior Court in July, 2004. The jury heard testimony from, among others,[13] the plaintiff's expert witness, Dr. Stuart Ira Finkel, a gastroenterologist. Finkel testified that, in his opinion, Birnbaum breached the applicable standard of care in evaluating and treating Matsuyama, resulting in Matsuyama's death. Specifically, Finkel opined that, in light of Matsuyama's complaints, symptoms, and risk factors, including the presence of H. pylori, his Japanese ancestry, his having lived in Japan or Korea for extended periods, his smoking history, and other well-known risk factors, an internist exercising the expected standard of care would have ordered an upper gastrointestinal series X-ray or an endoscopy, or referred Matsuyama to a specialist for endoscopy, beginning in 1995. The expert also testified that the appearance of Matsuyama's seborrheic keratosis in September, 1997, "could have and should have" triggered a suspicion of stomach cancer "right then and there." Finkel told the jury that if Birnbaum had ordered the appropriate testing on Matsuyama in 1995, the cancer "would have been diagnosed" and "treated in a timely fashion when it might still have been curable." As a result of Birnbaum's failure to make a timely diagnosis, Finkel opined, 8*8 the cancer metastasized to an advanced, inoperable phase, resulting in Matsuyama's premature death.[14]

          In the course of his testimony, Finkel offered an extensive discussion of the tumor-lymph nodes-metastasis (TNM) method for classifying gastric cancer into separate "stages," from stage 0 to stage 4, with each higher stage signaling a more advanced cancer and carrying a statistically diminished chance for survival, as measured by the standard gastric cancer metric of five years cancer free after treatment.[15],[16] Patients with stage 0, in which the cancer is confined to the stomach lining, have a better than 90% survival rate, Finkel averred; at stage 1, the survival rate drops to between 60% and 80%; at stage 2, between 30% and 50%; at stage 3, between 10% and 20%; and at stage 4, less than 4%.[17] Finkel opined that, as a result of Birnbaum's breach of the standard of care, Matsuyama lost the opportunity of having gastric 9*9 cancer "diagnosed and treated in a timely fashion when it might still have been curable."

          Dr. Mark Peppercorn, a gastroenterologist, testified as an expert for the defense. He testified that Birnbaum did not deviate from the accepted standard of care over the course of his treatment of Matsuyama; that Matsuyama's type of stomach cancer had "a different biology, a different characteristic from garden variety, if you want to use that poor term, cancer"; and that his type of cancer did not manifest symptoms until it was in an advanced stage. Peppercorn testified that staging of cancers is done by oncologists for treatment, not actuarial, purposes, with the following presumed five-year survival rates: at stage 1, from 60% to 90%; at stage 2, 25% to 40%; at stage 3, up to 10%; and at stage 4, "practically zero; less than [5%], probably."

          In addition to the medical expert testimony, the jury heard testimony from the plaintiff's forensic economist, Dr. Dana Hewins. Hewins testified that, using the standard statistical measures and methods in his field, Matsuyama, had he not died when he did, could have been expected to work an additional 17.7 years, during which time Matsuyama's net earnings from his income minus his personal consumption would have been $466,235.[18] Hewins also testified that Matsuyama could have been expected to live an additional 28.32 years (to age seventy-five), during which time the monetary value of his household services would have been $157,225. Thus, had Matsuyama attained his full work life and life expectancies, he would have contributed $623,460 to his household. Hewins did not offer any projections concerning what Matsuyama would have contributed in wages or services to his family had he died later than he did but earlier than his full work life and life expectancies.

          After a six-day trial, the case went to the jury.[19] In response 10*10 to special questions, the jury found Birnbaum negligent in Matsuyama's treatment, but found him not grossly negligent. They also found that Birnbaum's negligence was a "substantial contributing factor" to Matsuyama's death,[20] and awarded Matsuyama's estate $160,000 for pain and suffering caused by the negligence. Then, in response to a special jury question, see note 51, infra, the jury awarded damages for loss of chance, which they calculated as follows: they awarded $875,000 as "full" wrongful death damages,[21] and found that Matsuyama was suffering from stage 2 adenocarcinoma at the time of Birnbaum's initial negligence and had a 37.5% chance of survival at that time. They awarded the plaintiff "final" loss of chance damages of $328,125 ($875,000 multiplied by .375). Judgment entered against the defendants, jointly and severally, on the negligence-wrongful death count in the amount of $328,125, later amended to $281,310, see note 4, supra. A separate judgment entered against the defendants, jointly and severally, for damages in the amount of $160,000 on the counts for conscious pain and suffering.[22]

2. Loss of chance 

          Although we address the issue for the first time today, a substantial and growing majority of the States that have considered the question have indorsed the loss of chance doctrine, in one form or another, in medical malpractice actions.[23] We join that majority to ensure that the fundamental aims and 11*11 principles of our tort law remain fully applicable to the modern world of sophisticated medical diagnosis and treatment.

          The development of the loss of chance doctrine offers a window 12*12 into why it is needed. The doctrine originated in dissatisfaction with the prevailing "all or nothing" rule of tort recovery. See generally King, Jr., Causation, Valuation, and Chance in Personal Injury Torts Involving Preexisting Conditions and Future Consequences, 90 Yale L.J. 1353, 1365-1366 (1981) (King I). Under the all or nothing rule, a plaintiff may recover damages only by showing that the defendant's negligence more likely than not caused the ultimate outcome, in this case the patient's death; if the plaintiff meets this burden, the plaintiff then recovers 100% of her damages.[24] Thus, if a patient had a 51% chance of survival, and the negligent misdiagnosis or treatment caused that chance to drop to zero, the estate is awarded full wrongful death damages.[25] On the other hand, if a patient had a 49% chance of survival, and the negligent misdiagnosis or treatment caused that chance to drop to zero, the plaintiff receives nothing. So long as the patient's chance of survival before the physician's negligence was less than even, it is logically impossible for her to show that the physician's negligence was the but-for cause of her death, so she can recover nothing.[26] Thus, the all or nothing rule provides a "blanket release from liability for doctors and hospitals any time 13*13 there was less than a 50 percent chance of survival, regardless of how flagrant the negligence." Herskovits v. Group Health Coop. of Puget Sound, 99 Wash.2d 609, 614 (1983).

          As many courts and commentators have noted, the all or nothing rule is inadequate to advance the fundamental aims of tort law. See generally Restatement (Second) of Torts § 901 (1979) (delineating distinct rationales for tort liability); K.S. Abraham, Forms and Functions of Tort Law 14-20 (3d ed. 2007) (same). Fundamentally, the all or nothing approach does not serve the basic aim of "fairly allocating the costs and risks of human injuries," O'Brien v. Christensen, 422 Mass. 281, 288 (1996), quoting Vertentes v. Barletta Co., 392 Mass. 165, 171 (1984) (Abrams, J., concurring).[27] See King I, supra at 1377 (all or nothing rule places loss of chance losses "outside tort law," thereby "distort[ing] the loss-assigning role of tort law"). The all or nothing rule "fails to deter" medical negligence because it immunizes "whole areas of medical practice from liability." McMackin v. Johnson County Healthcare Ctr., 73 P.3d 1094, 1099 (Wyo. 2003), S.C., 88 P. 3d 491 (Wyo. 2004). It fails to provide the proper incentives to ensure that the care patients receive does not slip below the "standard of care and skill of the average member of the profession practising the specialty." Brune v. Belinkoff, 354 Mass. 102, 109 (1968). And the all or nothing rule fails to ensure that victims, who incur the real harm of losing their opportunity for a better outcome, are fairly compensated for their loss. See Delaney v. Cade, 255 Kan. 199, 209 (1994), quoting Keith, Loss of Chance: A Modern Proportional Approach to Damages in Texas, 44 Baylor L. Rev. 759, 760 (1992) ("the loss of chance doctrine serves to fairly compensate the plaintiff for the tortious deprivation of an opportunity to live longer or recover from a physical injury or condition inflicted by the defendant's wrongful act or omission").

As the Supreme Court of Wyoming recently stated:

"First, the loss of an improved chance of survival or improvement in condition, even if the original odds were 14*14 less than fifty percent, is an opportunity lost due to negligence. Much treatment of diseases is aimed at extending life for brief periods and improving its quality rather than curing the underlying disease. Much of the American health care dollar is spent on such treatments, aimed at improving the odds. In the words of the Delaware Supreme Court, `[i]t is unjust not to remedy such a loss.' Second, immunizing whole areas of medical practice from liability by requiring proof by more than fifty percent that the negligence caused the injury fails to deter negligence conduct. As Judge Posner wrote in DePass v. United States, `A tortfeasor should not get off scot free because instead of killing his victim outright he inflicts an injury that is likely though not certain to shorten the victim's life.'"

          McMackin v. Johnson County Healthcare Ctr., supra at 1099, quoting DePass v. United States, 721 F.2d 203, 208 (7th Cir. 1983) (Posner, J., dissenting). See Roberts v. Ohio Permanente Med. Group, Inc., 76 Ohio St. 3d 483, 488 (1996), rev'g Cooper v. Sisters of Charity of Cincinnati, Inc., 27 Ohio St.2d 242 (1971) ("Rarely does the law present so clear an opportunity to correct an unfair situation as does this case before us. The time has come to discard the traditionally harsh view we previously followed and to join the majority of states that have adopted the loss-of-chance theory").

          Courts adopting the loss of chance doctrine also have noted that, because a defendant's negligence effectively made it impossible to know whether the person would have achieved a more favorable outcome had he received the appropriate standard of care, it is particularly unjust to deny the person recovery for being unable "to demonstrate to an absolute certainty what would have happened in circumstances that the wrongdoer did not allow to come to pass." Hicks v. United States, 368 F.2d 626, 632 (4th Cir. 1966).

          Despite general agreement on the utility of the loss of chance doctrine, however, courts adopting it have not approached loss of chance in a uniform way.[28] See Annot., Medical Malpractice: "Loss of Chance" Causality, 54 A.L.R.4th 10 (1987 & Supp. 15*15 2008) (encyclopedic discussion of cases adopting distinct approaches). The unsettled boundaries of the doctrine have left it open to criticisms similar to those that the defendants have leveled here: that the loss of chance doctrine upends the long-standing preponderance of the evidence standard; alters the burden of proof in favor of the plaintiff; undermines the uniformity and predictability central to tort litigation; results in an expansion of liability; and is too complex to administer. See generally T.A. Weigand, Loss of Chance in Medical Malpractice: The Need for Caution, 87 Mass. L. Rev. 3 (2002); D.A. Fischer, Tort Recovery for Loss of a Chance, 36 Wake Forest L. Rev. 605 (2001). See also Smith v. Parrott, 833 A.2d 843, 847-849 (Vt. 2003)Fennell v. Southern Maryland Hosp. Ctr., Inc., 320 Md. 776, 789-784 (1990). While these objections deserve serious consideration, the doctrine of loss of chance, when properly formulated, survives these criticisms.

          Addressing the specific arguments advanced by the defendants is useful for delineating the proper shape of the doctrine. The defendants argue that the loss of chance doctrine "lowers the threshold of proof of causation" by diluting the preponderance of the evidence standard that "has been the bedrock of the Massachusetts civil justice system." Some courts have indeed approached the issue of how to recognize loss of chance by carving out an exception to the rule that the plaintiff must prove by a preponderance of the evidence that the defendant "caused" his injuries. See, e.g., Thompson v. Sun City Community Hosp., Inc., 141 Ariz. 597, 607-608 (1984) (adopting rule that "permits the case to go to the jury on the issue of causation with less definite evidence of probability than the ordinary tort case," and requiring jury to "find for the defendant unless they find a 16*16 probability that defendant's negligence was a cause of plaintiff's injury" [emphasis in original]). We reject this approach. "It is fundamental that the plaintiff bears the burden of establishing causation by a preponderance of the evidence." Johnson v. Summers, 411 Mass. 82, 91 (1991). Therefore, in a case involving loss of chance, as in any other negligence context, a plaintiff must establish by a preponderance of the evidence that the defendant caused his injury.

          However, "injury" need not mean a patient's death. Although there are few certainties in medicine or in life, progress in medical science now makes it possible, at least with regard to certain medical conditions, to estimate a patient's probability of survival to a reasonable degree of medical certainty. See Herskovits v. Group Health Coop. of Puget Sound, 99 Wash.2d 609, 616 (1983); King I, supra at 1386-1387. See also Glicklich v. Spievack, 16 Mass. App. Ct. 488, 494-495 (1983). That probability of survival is part of the patient's condition. When a physician's negligence diminishes or destroys a patient's chance of survival, the patient has suffered real injury. The patient has lost something of great value: a chance to survive, to be cured, or otherwise to achieve a more favorable medical outcome. See Herskovits v. Group Health Coop. of Puget Sound, supra at 618, quoting James v. United States, 483 F. Supp. 581, 587 (N.D. Cal. 1980) ("no one can say that the chance of prolonging one's life or decreasing suffering is valueless"). Thus we recognize loss of chance not as a theory of causation, but as a theory of injury. See Alexander v. Scheid, 726 N.E.2d 272, 279 (Ind. 2000) ("loss of chance is better understood as a description of the injury than as either a term for a separate cause of action or a surrogate for the causation element of a negligence claim"); Jorgenson v. Vener, 616 N.W.2d 366, 371 (S.D. 2000) ("The key to a successful application of this doctrine is recognizing and valuing the lost chance as the compensable injury ...").[29]

          Recognizing loss of chance as a theory of injury is consistent 17*17 with our law of causation, which requires that plaintiffs establish causation by a preponderance of the evidence. See Johnson v. Summers, supra at 91. See also Woronka v. Sewall, 320 Mass. 362, 365 (1946). In order to prove loss of chance, a plaintiff must prove by a preponderance of the evidence that the physician's negligence caused the plaintiff's likelihood of achieving a more favorable outcome to be diminished. That is, the plaintiff must prove by a preponderance of the evidence that the physician's negligence caused the plaintiff's injury, where the injury consists of the diminished likelihood of achieving a more favorable medical outcome. See Jorgenson v. Vener, supra ("Properly applied, the loss of chance doctrine does not alter or eliminate the requirement of proximate causation. Rather, a plaintiff must still prove by a preponderance of evidence, or more likely than not, that the defendant's actions reduced her chance of a better outcome"); King, Jr., "Reduction of Likelihood" Reformulation and Other Retrofitting of the Loss-of-a-Chance Doctrine, 28 U. Memphis L. Rev. 491, 492 (1998) (King II). The loss of chance doctrine, so delineated, makes no amendment or exception to the burdens of proof applicable in all negligence claims.[30]

          We reject the defendants' contention that a statistical likelihood of survival is a "mere possibility" and therefore "speculative." The magnitude of a probability is distinct from the degree of confidence with which it can be estimated. A statistical survival rate cannot conclusively determine whether a particular patient will survive a medical condition. But survival rates are not random guesses. They are estimates based on data obtained and analyzed scientifically and accepted by the relevant medical community as part of the repertoire of diagnosis and treatment, as applied to the specific facts of the plaintiff's case. See Glicklich v. Spievack, supra at 494 n.4 (recognizing established use of clinical staging systems for cancer in medical prognoses). Where credible evidence 18*18 establishes that the plaintiff's or decedent's probability of survival is 49%, that conclusion is no more speculative than a conclusion, based on similarly credible evidence, that the probability of survival is 51%.

          The defendants also point out that "[t]he cause, treatment, cure and survivability related to cancer is tremendously uncertain and complex," and argue that loss of chance is "rife with practical complexities and problems." Such difficulties are not confined to loss of chance claims. A wide range of medical malpractice cases, as well as numerous other tort actions, are complex and involve actuarial or other probabilistic estimates. Wrongful death claims, for example, often require, as part of the damages calculation, an estimate of how long the decedent might have lived absent the defendant's conduct. The calculation of damages in a claim for lost business opportunities may be similarly complex. See, e.g., Roblin Hope Indus., Inc. v. J.A. Sullivan Corp. (No. 2), 11 Mass. App. Ct. 76, 79 (1980).[31]

          The key is the reliability of the evidence available to the fact finder. In earlier periods, Massachusetts courts grappling with what we would now call loss of chance claims often lacked reliable expert evidence of what the patient's chances of survival or recovery would have been absent the alleged negligence. See, e.g., Wright v. Clement, 287 Mass. 175, 176 (1934) (affirming directed verdict for defendant despite evidence of negligent failure to diagnose scarlet fever and negligence in moving decedent from maternity ward because "there is nothing to show any probability that [the patient] would have recovered or lived longer or suffered less, if due care had been used"). More recently, as we noted above, at least for certain conditions, medical science has progressed to the point that physicians can gauge a patient's chances of survival to a reasonable degree of medical certainty, and indeed routinely use such statistics as a tool of medicine. See note 15, supra. Reliable modern techniques of gathering and 19*19 analyzing medical data have made it possible for fact finders to determine based on expert testimony — rather than speculate based on insufficient evidence — whether a negligent failure to diagnose a disease injured a patient by preventing the disease from being treated at an earlier stage, when prospects were more favorable. See Cusher v. Turner, 22 Mass. App. Ct. 491, 498 (1986) (upholding verdict against physician for negligent failure to diagnose ovarian cancer, on theory that "if such tests had been ordered ... the cancer would have been discovered and removed, preventing its spread throughout the plaintiff's body"); Glicklich v. Spievack, supra at 494-495 (reversing judgment not withstanding verdict for defendant where there was expert evidence that negligent failure to diagnose patient's breast cancer caused cancer to progress from "Stage I," in which her chances of surviving ten years with proper treatment would have been 94%, to "stage II," in which her chances of surviving ten years with proper treatment were "50% or less"). The availability of such expert evidence on probabilities of survival makes it appropriate to recognize loss of chance as a form of injury.[32] Cf. Wright v. Clement, supra. See also Aasheim v. Humberger, 215 Mont. 127, 133 (1985) (noting that loss of chance "recognizes the realities inherent in medical negligence litigation"). Through appropriate expert evidence, a plaintiff in a medical malpractice case may be able to sustain her burden of showing that, as a result of defendant's negligence, a decedent suffered a diminished likelihood of achieving a more favorable medical outcome.

          We are unmoved by the defendants' argument that "the ramifications of adoption of loss of chance are immense" across "all areas of tort." We emphasize that our decision today is limited to loss of chance in medical malpractice actions.[33] Such cases are particularly well suited to application of the loss of chance doctrine. 20*20 See Restatement (Third) of Torts: Liability for Physical Harm § 26 comment n (Proposed Final Draft No. 1, 2005) (Draft Restatement). First, as we noted above, reliable expert evidence establishing loss of chance is more likely to be available in a medical malpractice case than in some other domains of tort law. Id. Second, medical negligence that harms the patient's chances of a more favorable outcome contravenes the expectation at the heart of the doctor-patient relationship that "the physician will take every reasonable measure to obtain an optimal outcome for the patient." Id. See K.S. Abraham, Forms and Functions of Tort Law 117-118 (3d ed. 2007) (discussing argument that "health care providers undertake to maximize a patient's chances of survival, [and so] their failure to do so should be actionable. Ordinary actors who negligently risk causing harm have not undertaken such a duty"). Third, it is not uncommon for patients to have a less than even chance of survival or of achieving a better outcome when they present themselves for diagnosis, so the shortcomings of the all or nothing rule are particularly widespread. Finally, failure to recognize loss of chance in medical malpractice actions forces the party who is the least capable of preventing the harm to bear the consequences of the more capable party's negligence. See Draft Restatement, supra at 326 comment n.

          In sum, whatever difficulties may attend recognizing loss of chance as an item of damages in a medical malpractice action, these difficulties are far outweighed by the strong reasons to adopt the doctrine. We turn now to the defendants' argument that the wrongful death statute, G. L. c. 229, § 2, does not allow for loss of chance.

3. Wrongful death statute 

          The wrongful death statute imposes liability on anyone who "by his negligence causes the death of a person." G. L. c. 229, § 2. The defendants contend that the language of the statute — "causes the death" — precludes loss of chance claims and allows only claims that the defendant was a but-for cause of the decedent's death. This interpretation is not required by the wrongful death statute.

          21*21 The purpose of the wrongful death statute is "to compensate a decedent's survivors for the loss of the decedent's life." Thibert v. Milka, 419 Mass. 693, 695 (1995). The origin of wrongful death actions in Massachusetts can be traced to England, where such actions are said to have sprung from "the ancient custom of compensating for wrongfully inflicted death." S.M. Speiser & J.E. Rooks, Jr., Recovery for Wrongful Death § 1.1 (4th ed. 2005 & Supp. 2007). "In the very early days of the Anglo-Saxons, homicide in all forms was regarded as a civil offense, a private wrong. In order to prevent feuds among clannish groups and to encourage peace, what we now call `damages' for the killing of a person were payable to the deceased's relatives." Id. at § 1.3. When the earliest colonists arrived in what is now Massachusetts, they brought with them and embraced as their own common law the wrongful death cause of action. See id. at § 1.4, and cases cited ("the Massachusetts courts during the colonial period had consistently allowed compensation in death cases").[34]

          In the early Nineteenth Century, however, the common-law development of wrongful death actions was sidetracked by a single English decision, later repudiated by this court. In 1808, in Baker v. Bolton, 1 Campb. 493 (1808), a case involving a husband's suit against owners of a stagecoach that had overturned, killing his wife, Lord Ellenborough, an English judge, stated that "in a civil court, the death of a human being could not be complained of as an injury." See S.M. Speiser & J.E. Rooks, Jr., Recovery for Wrongful Death, supra at §§ 1.1, 1.2; Gaudette v. Webb, 362 Mass. 60, 68 (1972). For various reasons that do not concern us here, Lord Ellenborough's dictum quickly came to stand for the proposition, in both English and American courts, including this court, that no cause of action for wrongful death existed apart from statute. See, e.g., Carey v. Berkshire R.R., 1 Cush. 475, 478 (1848), citing Baker v. Bolton, supra (holding that "the death of a human being is not the ground of an action for damages").

          Even as it was being cited as authority, however, Lord Ellenborough's 22*22 rule came under harsh criticism from courts and scholars as both unfounded and barbaric. See Gaudette v. Webb, supra at 69-71. In Moragne v. States Marine Lines, Inc., 398 U.S. 375 (1970), the United States Supreme Court rejected Lord Ellenborough's dictum and held that a common-law action for wrongful death could be brought under United States maritime law. After a thorough and detailed historical discussion, the Supreme Court concluded that "the history of the common-law rule indicates that [Lord Ellenborough's rule] was based on a particular set of factors that [have] long since been thrown into discard even in England, and that had never existed in this country at all." Id. at 381.[35] Reasoning that where a duty exists at common law, "nothing in ordinary notions of justice suggests that a violation should be nonactionable simply because it was serious enough to cause death," id., the Court therefore rejected Lord Ellenborough's rule and held as a matter of common law that one may bring a wrongful death action under general maritime law. Although the Federal Death on the High Seas Act, 46 U.S.C. §§ 761, 762 (as then codified), did not expressly provide any remedy for the wrongful death at issue in the case,[36] the Court held that act was never meant to preempt the "evolving duty of seaworthiness" from which the courts would recognize a common-law action for wrongful death. See id. at 399-400.

          In Gaudette v. Webb, supra, this court, relying in part on the Moragne case, put Lord Ellenborough's mischief to rest in the Commonwealth. Rejecting the authority of Lord Ellenborough's dictum, we held that "the law in this Commonwealth has ... evolved to the point where it may now be held that the right to recovery for wrongful death is of common law origin, and we 23*23 so hold." Id. at 71. In holding that wrongful death claims existed at common law, this court concluded that claims under the wrongful death statute are common-law claims that continue to evolve, even as the wrongful death statutes impose certain procedural requirements on such claims. See Id. at 71-72.

"[O]ur wrongful death statutes will no longer be regarded as `creating the right' to recovery for wrongful death. They will be viewed rather as: (a) requiring that damages recoverable for wrongful death be based upon the degree of the defendant's culpability; (b) prescribing the range of damages recoverable against each defendant; (c) requiring that any action for wrongful death be brought by a personal representative on behalf of the designated categories of beneficiaries; and (d) requiring that the action be commenced within a specified period of time, as a limitation upon the remedy and not upon the right."

          Id. at 71. Thus, in Gaudette v. Webb, supra, we allowed a wrongful death claim to be brought under the wrongful death statute where the terms of the statute did not provide the plaintiff with any right to recover. Id. at 71-73.

          Like all common-law causes of action, our common law of wrongful death evolves to meet changes in the evolving life of the Commonwealth. See Sullivan v. Boston Gas Co., 414 Mass. 129, 134 (1993) ("Sound principles of common law evolve out of the interaction of the infinite variety of new patterns of human activity with principles crafted in response to already-experienced situations"); Gaudette v. Webb, supra. Although wrongful death did not traditionally encompass loss of chance of survival, we conclude that claims for loss of chance of survival are sufficiently akin to wrongful death claims as to be cognizable under the wrongful death statute, which governs the procedural requisites for such claims. See Gaudette v. Webb, supra at 71.[37] Now that medical science has developed credible methods of quantifying 24*24 the extent to which the malpractice damaged the patient's prospects for survival, and in light of the strong public policy favoring compensation for victims of medical malpractice and the deterrence of deviations from appropriate standards of care, loss of chance of survival rightly assumes a place in our common law of wrongful death, and we so hold.[38]

          The development of our law of wrongful death to encompass loss of chance of survival claims is entirely consistent with this court's holding in Gaudette v. Webb, 362 Mass. 60, 71 (1972),[39] 25*25 that the wrongful death statute will be viewed in part as "requiring that damages recoverable for wrongful death be based upon the degree of the defendant's culpability." Our method of calculating loss of chance damages furthers and refines this requirement. Moreover, it remedies the illogical and harsh results of a rule that would permit a person who had a prenegligence chance of survival of 51% to recover full damages while denying all recovery to the person whose prenegligence chance of survival was 49%.

          We turn now to the proper measure of damages in a loss of chance medical malpractice case.

4. Damages

          Our conclusion that loss of chance is a separate, compensable item of damages in an action for medical malpractice does not fully resolve the issues on appeal. We must consider, among other things, how the loss of the likelihood of a more favorable outcome is to be valued. The first question is what is being valued. In this case, the patient's prospects for achieving a more favorable outcome were measured in terms of the patient's likelihood of surviving for a number of years specified by the relevant medical standard: for gastric cancer, the five-year survival rate.[40] There is no single measure that will apply uniformly to all medical malpractice cases. See, e.g., Renzi v. Paredes, post 38, 42 (2008) (employing ten-year survival metric for breast cancer); Alexander v. Scheid, 726 N.E.2d 272, 279 (Ind. 2000) (measuring loss of chance damages in terms of "decreased life expectancy," measured in years); DeBurkarte v. Louvar, 393 N.W.2d 131, 135 (Iowa 1986) (employing ten-year survival metric for breast cancer). Precisely what yardstick to use to measure the reduction in the decedent's prospects for survival — life expectancy, five-year survival, ten-year survival, and so on — is a question on which the law must inevitably bow to some extent to the shape of the available medical evidence in each particular case. See McMackin v. Johnson County Healthcare Ctr., 73 P.3d 1094, 1100 (Wyo. 2003) (noting that "no clear-cut rule" can govern all measures of damages in loss of chance cases).

          26*26 A second, more challenging issue is how to calculate the monetary value for the lost chance. Courts adopting the loss of chance doctrine have arrived at different methods for calculating such damages. See generally Mead v. Adrian, 670 N.W.2d 174, 187-189 (Iowa 2003) (Cady, J., concurring specially). The most widely adopted of these methods of valuation is the "proportional damages" approach. See Cahoon v. Cummings, 734 N.E.2d 535, 541 (Ind. 2000), and cases cited (holding that proportional damages is "the better approach"). See also Delaney v. Cade, 255 Kan. 199, 217 (1994) (proportional damages approach constitutes proper view); McKellips v. Saint Francis Hosp., Inc., 741 P.2d 467, 475-477 (Okla. 1987) (same). Under the proportional damages approach, loss of chance damages are measured as "the percentage probability by which the defendant's tortious conduct diminished the likelihood of achieving some more favorable outcome." King I, supra at 1382. The formula aims to ensure that a defendant is liable in damages only for the monetary value of the portion of the decedent's prospects that the defendant's negligence destroyed. In applying the proportional damages method, the court must first measure the monetary value of the patient's full life expectancy and, if relevant, work life expectancy as it would in any wrongful death case. But the defendant must then be held liable only for the portion of that value that the defendant's negligence destroyed. See King II, supra at 542.

          Deriving the damages for which the physician is liable will require the fact finder to undertake the following calculations:[41]

27*27 (1) The fact finder must first calculate the total amount of damages allowable for the death under the wrongful death statute, G. L. c. 229, § 2, or, in the case of medical malpractice not resulting in death, the full amount of damages allowable for the injury. This is the amount to which the decedent would be entitled if the case were not a loss of chance case: the full amount of compensation for the decedent's death or injury.[42]
(2) The fact finder must next calculate the patient's chance of survival or cure immediately preceding ("but for") the medical malpractice.
(3) The fact finder must then calculate the chance of survival or cure that the patient had as a result of the medical malpractice.
(4) The fact finder must then subtract the amount derived in step 3 from the amount derived in step 2.
(5) The fact finder must then multiply the amount determined in step 1 by the percentage calculated in step 4 to derive the proportional damages award for loss of chance.

          To illustrate, suppose in a wrongful death case that a jury found, based on expert testimony and the facts of the case, that full wrongful death damages would be $600,000 (step 1), that the patient had a 45% chance of survival prior to the medical malpractice (step 2), and that the physician's tortious acts reduced 28*28 the chances of survival to 15% (step 3). The patient's chances of survival were reduced 30% (i.e., 45% minus 15%) due to the physician's malpractice (step 4), and the patient's loss of chance damages would be $600,000 multiplied by 30%, for a total of $180,000 (step 5). See, e.g., Mead v. Adrian, supra at 186-187 (Cady, J., concurring specially); McKellips v. Saint Francis Hosp., Inc., 741 P.2d 467, 476 (Okla. 1987).

          We are not unmindful of the criticism of the proportional damages approach.[43] However, we are in accord with those courts that have determined that the proportional damages method is the most appropriate way to quantify the value of the loss of chance for a more favorable outcome, because it is an easily applied calculation that fairly ensures that a defendant is not assessed damages for harm that he did not cause.[44] See, e.g., Pipe v. Hamilton, 274 Kan. 905, 910 (2002) ("The proportional damage approach ensures that a plaintiff recovers only the loss attributable to the loss of chance and not for an arbitrary amount awarded by the jury or for the total damages sustained"); Roberts v. Ohio Permanente Med. Group, Inc., 76 Ohio St. 3d 483, 489 (1996) (proportional damages approach "provides an equitable method of apportioning damages consistent with the degree of fault attributable to the health care provider. Thus, rather than compensating the plaintiff for all damages allowed in a malpractice or wrongful death action, the defendant is liable only for those damages attributable to his percentage of negligence").

          From our analysis thus far, it should be evident that the value of "the loss of opportunity to allow events to play out in order to see if the plaintiff's condition was in fact amenable to restoration," King II, supra at 533, is a matter beyond the average juror's ken; the evidence will necessarily come from experts. Expert testimony is required to ascertain what measure of a more 29*29 favorable outcome is medically appropriate (for example, five-year survival as in this case), to determine what statistical rates of survival apply in what circumstances, for example, a 37.5% chance of survival, and to apply these rates to the particular clinical circumstances of the patient.

          The defendants protest that such reliance on experts is likely to result in "imprecise" and "skewed" evidence on which to base a damages award. Our response is both general and specific. First, as a general matter, we disavow the defendants' claim that reliance on statistical evidence is "generally disfavored in the law." As we have noted, probabilistic evidence, in the form of actuarial tables, assumptions about present value and future interest rates, statistical measures of future harm, and the like, is the stock-in-trade of tort valuation. See DePass v. United States, 721 F.2d 203, 209-210 (7th Cir. 1983) (Posner, J., dissenting). For decades, judges, lawyers, jurors, and litigants have shown themselves competent to sift through such evidence in a variety of contexts, from mass toxic torts to single-car collisions. Second, in this particular case, all of the medical witnesses testified that the staging of cancer and the use of survival or recovery statistics derived therefrom are common practice with respect to gastric cancer. See note 15, supra. To the extent that expert testimony concerning the statistical likelihood of a more favorable outcome of Matsuyama's condition, or of any medical condition, may manifest a statistical bias or any other indicia of unreliability, that is a matter to be vetted in a pretrial motion to exclude the expert testimony, or at trial on cross-examination, or through the testimony of a defendant's own expert. See Cusher v. Turner, 22 Mass. App. Ct. 491, 498 & n.9 (1986), citing Glicklich v. Spievack, 16 Mass. App. Ct. 488, 494 n.4 (1983) (in medical malpractice case, "[p]recise evidence as to the `staging' of the cancer is not required ..."). See generally King II, supra at 546-547 (successful application of loss of chance doctrine depends on the quality of the appraisal of the decreased likelihood of a more favorable outcome caused by defendants' tortious conduct). Our decision today should not be construed to limit a defendant's right or ability vigorously to challenge the statistical evidence.

          We move now to a consideration of the merits.

5. Evidence of causation

          As a preliminary matter, we conclude 30*30 there is no merit to the defendants' argument that the evidence does not support a verdict against Birnbaum for loss of chance. As we stated above, the crux of liability for loss of chance is that Birnbaum's negligence caused a diminution in Matsuyama's likelihood of achieving a more favorable outcome for his medical condition. From the record summarized above, there was ample evidence from which the jury reasonably could conclude that Birnbaum committed a breach of the standard of care by failing to take the necessary steps earlier in his treatment of Matsuyama to determine through appropriate medical testing whether Matsuyama had gastric cancer. The jury were also well within their charge to conclude from the evidence that, but for Birnbaum's breach of care, Matsuyama's chances of survival would have been greater.[45] That the jury may have derived their conclusions by crediting the testimony of the plaintiff's expert over the testimony of the defense expert was in the normal course of their acting as a jury.[46]

          The defendants claim that the evidence was insufficient to show that, as the judge instructed the jury, "an act or omission of Birnbaum was a substantially contributing factor to the death of Mr. Matsuyama." The "substantial contributing factor" test is useful in cases in which damage has multiple causes, including but not limited to cases with multiple tortfeasors in which it may be impossible to say for certain that any individual defendant's conduct was a but-for cause of the harm, even though it can be shown that the defendants, in the aggregate, caused the harm.[47] 31*31 The substantial contributing factor test is less appropriate, however, as an instruction as to cause in a loss of chance case in which one defendant's malpractice alone is alleged to have caused the victim's diminished likelihood of a more favorable outcome.[48] The proper test in a loss of chance case concerning the conduct of a single defendant is whether that conduct was the but-for cause of the loss of chance.

          In the circumstances of this case, the judge's use of the "substantial contributing factor" test did not prejudice the defendant. Requiring the plaintiff to prove that the negligence was a substantial contributing factor in Matsuyama's death — rather than merely requiring the plaintiff to prove that the negligence reduced Matsuyama's chance of survival — arguably imposed a heightened burden of proof on the plaintiff. Indeed, it was Medical Associates, not the plaintiff, who proposed jury instructions incorporating the test that the "negligence was a substantial contributing cause of the alleged injury." The judge also clarified the "substantial contributing factor" instruction in a way that, while somewhat inartful, suggested that the jury should understand "substantial contributing factor" as indicating that the plaintiff was required to show that Birnbaum's negligence caused a loss of chance of survival. The judge instructed the jury that the word "substantial" "doesn't mean that Mr. Matsuyama's chance of survival was fifty percent or greater, only that there was a fair chance of survival or cure had Dr. Birnbaum not been negligent 32*32 and had he conformed to the applicable standard of care." The judge's formulation did not use the words "but-for cause," but his definition of "substantial" clearly focused the jury's attention on the idea that Birnbaum's negligence, if any, had to be a but-for cause of Matsuyama's losing a "fair chance of survival."[49]

          We turn now to the defendants' claims of error in the jury instructions.

6. Jury instructions 

a. Valuation

          The defendants challenge the jury instructions on valuation. Even were we to accept the loss of chance doctrine, the defendants say, and even if the evidence supports a finding against Birnbaum on that issue, the verdict against him must be reversed and the case retried because the judge gave improper instructions on valuation. While two instructions in particular were less than ideal, reversal is not required.[50]

          We do not agree that the judge's instructions and special jury verdict "forced the jury to find a loss of chance and precluded the defense from arguing that there was no loss of a substantial chance of survival based on the evidence." The defendants' focus here is on question 6 of the special jury questions, in particular the "Note" included in that question, and the judge's related instructions. That special jury question included survival rates for each stage of gastric cancer.[51],[52] We agree with the defendants that the determination of chance of survival was for the jury to decide, 33*33 based on the conflicting evidence before them, and should not have been included in the special question.[53] It will generally not be necessary for the judge to marshal such evidence for the jury.

          However, viewing the instructions as a whole, we conclude that the jury charge did not overstep the judge's broad discretion to fashion jury instructions. See Cahalane v. Proust, 333 Mass. 689, 692 (1956)General Dynamics Corp. v. Federal Pac. Elec. Co., 20 Mass. App. Ct. 677, 684 (1985). "Our decisions have consistently upheld the action of trial judges in putting before the jury possible conclusions warranted by the evidence in language that is `comprehensively strong, rather than hesitatingly barren, or 34*34 ineffective.'" Cahalane v. Proust, supra at 692-693, quoting Whitney v. Wellesley & Boston St. Ry., 197 Mass. 495, 502 (1908). Nothing in the judge's instructions or the special questions themselves would indicate to a reasonable juror that the judge was weighing in on the ultimate question of liability or "forcing" the jury to find a certain damages amount, as the defendants maintain. Throughout his jury charge, the judge took pains to emphasize that the jury's view of the evidence is the only view that mattered. Finally, the defendants argued throughout the trial, and forcefully in closing argument, that Matsuyama was in fact not harmed by Birnbaum's actions; there was no indication that any ruling or statement of the judge precluded the defendants from mounting a vigorous defense. The judge's instructions and jury verdict did not impermissibly weigh in on the question of liability.

          Further, for the reasons we have stated above, the judge did not commit reversible error in instructing on the viability of loss of chance as an item of damages, and he correctly chose to apply the proportional method to determine damages for Matsuyama's loss of chance. In conformity with the formula we have set out supra, he also required on the special jury questions that the jury determine full wrongful death damages and the percentage of Matsuyama's chances of survival but for Birnbaum's negligence. We recognize that the judge did not complete the proportional instruction we outlined above. As the defendants point out, the judge did not require the jury to determine Matsuyama's chance of survival as a result of Birnbaum's negligence, and to subtract that figure from Matsuyama's chance of survival prior to the negligence. In terms of the formula discussed supra, the judge correctly instructed the jury as to step 1 and step 2, but omitted steps 3 and 4. This compelled the jury to assume that Birnbaum's negligence (if any) reduced Matsuyama's chances of survival to zero: $875,000 multiplied by (.375 minus 0) equals $328,125, the damages awarded for loss of chance. In fact, the conflicting testimony at trial was that as a result of Birnbaum's negligence, Matsuyama had anywhere from 0 to a 5% chance of survival.[54] The judge should not have removed from the jury's consideration the question whether and to what extent Birnbaum's 35*35 negligence left Matsuyama with any chance of survival, both critical factors in valuing Matsuyama's lost chance. See Cahalane v. Proust, supra. See also G. L. c. 231, § 81.[55]

          However, a remand will not be necessary. The record before us shows that both prior to and after the jury instructions, the defendants objected to question 6, not on the ground of the judge's apportionment formula but on more general, and wholly different, grounds.[56],[57] This lack of a specific objection on point is fatal to their detailed objection on appeal. See Flood v. Southland Corp., 416 Mass. 62, 66 (1993) ("A general objection to a portion of a charge will not save appellate rights"). The defendants did argue in a supplemental trial brief that if this court were to recognize loss of chance, they should be entitled to an apportionment formula that takes account of the "difference" in 36*36 likelihood of survival, see note 57, supra. However, the defendants' proposed jury instructions contained no provision for calculating this difference. When the judge charged the jury in a way that lacked such a provision, none of the defendants' numerous objections either before or after the jury charge specifically touched on this issue. See note 56, supra. Nor have the defendants directed our attention to anything that would suggest that their general objections should be understood in context to refer specifically to this issue. Accordingly, we deem it waived. See Neagle v. Massachusetts Bay Transp. Auth., 45 Mass. App. Ct. 345, 348-349 (1998) (where counsel did not request special jury question on particular issue, and did not object to its omission from special jury questions, "this failure resulted in a waiver of the [party's] rights to have the issue ... submitted to the jury and to raise the issue on appeal").[58]

b. Gross negligence

          At the close of evidence, but prior to closing arguments, the judge allowed the plaintiff's oral motion to amend her complaint to add a claim against Birnbaum for gross negligence. See note 19, supra. The judge subsequently proceeded to charge the jury on gross negligence.[59] In response to a special question, the jury found Birnbaum not grossly negligent in his care and treatment of Matsuyama. Nevertheless, Birnbaum asserts on appeal that the judge, by impermissibly commenting 37*37 on the evidence of gross negligence in his charge to the jury, left jurors with the impression that, at the very least, Birnbaum should be found liable in negligence.[60] See G. L. c. 231, § 81 ("The courts shall not charge juries with respect to matters of fact, but they may state the testimony and the law"). We disagree.

          Where, as here, the judge had determined that the evidence warranted an instruction on gross negligence, the judge correctly gave such an instruction, which had been requested by the plaintiff. In light of the evidence from expert and other medical witnesses that Birnbaum missed or ignored Matsuyama's known risk factors for gastric cancer for a period of almost four years, as well as Birnbaum's own testimony that the capitation contract he voluntarily entered into caused him "difficulty" in providing patients like Matsuyama with "the best medical care," it was not error for the judge to include instructions on gross negligence.[61] See Altman v. Aronson, 231 Mass. 588, 591-592 (1919) ("The element of culpability which characterizes all negligence is in gross negligence magnified to a high degree as compared with that present in ordinary negligence. Gross negligence is a manifestly smaller amount of watchfulness and circumspection than the circumstances require of a person of ordinary prudence").

Judgment affirmed.

          [1] Of the estate of Kimiyoshi Matsuyama.

          [2] Dedham Medical Associates, Inc.

          [3] The loss of chance doctrine is also known as the "lost opportunity" doctrine. See Restatement (Third) of Torts: Liability for Physical Harm § 26 comment n (Proposed Final Draft No. 1, 2005) (Draft Restatement). See generally King, Jr., Causation, Valuation, and Chance in Personal Injury Torts Involving Preexisting Conditions and Future Consequences, 90 Yale L.J. 1353, 1365-1366 (1981) (King I).

          [4] The damages for loss of chance were apportioned between the decedent's widow and son. Those damages were reduced in a subsequent amended judgment to $281,310 to adjust for the receipt of Social Security survivor benefits.

          [5] General Laws c. 229, § 2, provides in relevant part: "A person who ... by his negligence causes the death of a person ... shall be liable in damages." General Laws c. 229, § 6, provides: "In any civil action brought under section two ... damages may be recovered for conscious suffering resulting from the same injury, but any sum so recovered shall be held and disposed of by the executors or administrators as assets of the estate of the deceased."

          [6] In a wrongful death action, loss of chance of survival is equivalent to loss of chance of a more favorable outcome (i.e., an outcome more favorable than death). See generally King, Jr., "Reduction of Likelihood" Reformulation and Other Retrofitting of the Loss-of-a-Chance Doctrine, 28 U. Memphis L. Rev. 491, 505 (1998) (King II) (characterizing loss of chance as "loss of chance of a more favorable outcome"). Because this appeal concerns a wrongful death action, we will sometimes refer simply to "survival" rather than to "a more favorable outcome."

          [7] We acknowledge amicus briefs filed by the Professional Liability Foundation in support of the defendants and by the Massachusetts Academy of Trial Attorneys in support of the plaintiff.

          [8] Although Birnbaum testified at trial that he had no specific recollection of having reviewed Matsuyama's prior medical records before or during the visit, he testified that he had access to those records and that it was his practice to review a patient's prior medical records when "the clinical situation" so required.

          [9] Birnbaum testified that a person who lived in Japan or Korea and ate the foods of those areas would have ten to twenty times the risk of developing gastric cancer than would a member of the general population of the United States.

          [10] Birnbaum identified "seborrhea keratosis" as a benign, waxy, darkly pigmented skin lesion. The jury heard conflicting testimony about whether Birnbaum's notes revealed the presence of one such lesion, as Birnbaum testified at trial, or more than one. The jury also heard testimony from Matsuyama's oncologist and the plaintiff's medical expert that the appearance of many seborrheic keratoses signals advanced stomach cancer. At the time of the examination, Birnbaum was unaware that seborrheic keratoses may signal gastric cancer.

          [11] Throughout the trial the jury heard evidence that gastritis and nonulcerative dyspepsia may be linked to gastric cancer.

          [12] The plaintiff alleged a separate count of "negligence-wrongful death" against Birnbaum and "negligence" against Dedham Medical Associates, Inc. (Medical Associates), and separate negligence counts against both defendants for failure to obtain informed consent and for conscious pain and suffering.

          [13] The plaintiff called Birnbaum to testify about his treatment of Matsuyama. Birnbaum also testified regarding the capitation contracts between Harvard Pilgrim Health Care, Matsuyama's medical insurance provider, and Medical Associates, which Birnbaum reviewed and approved as president of Medical Associates's board of directors. Among other things, the capitation contracts rewarded Medical Associates (and its physician shareholders, including Birnbaum) for keeping the costs of prescription drugs and medical tests such as biopsies below a certain annual figure. Birnbaum testified that the capitation contracts governed his reimbursements for Matsuyama, and that they effectively meant that doctors in his practice "ha[d] difficulty" providing capitated patients with "the best medical care for the patients."

          [14] The plaintiff also called two of the physicians who treated Matsuyama for gastric cancer. Dr. Benjamin Smith, who performed the endoscopic evaluation on Matsuyama in May, 1999, testified that the existence of cancer cannot be determined by physical examination alone, and that endoscopy with biopsies was the acknowledged "gold standard" for diagnosing gastric cancer. Dr. Charles Fuchs, Matsuyama's oncologist, testified, among other things, that Matsuyama had several known risk factors for gastric cancer, that endoscopy with a biopsy was the best way to determine the presence of such cancer, and that early stage detection of gastric cancer portends a better chance of survival.

          [15] These standards are well known. The National Cancer Institute's Dictionary of Cancer Terms defines "survival rate" as: "The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. The survival rate is often stated as a five-year survival rate, which is the percentage of people in a study or treatment group who are alive five years after diagnosis or treatment. Also called overall survival rate." Survival is a term whose particular definition will depend on the medical evidence in a given case.

          [16] Fuchs, the oncologist who treated Matsuyama and was called as a witness by the plaintiff, also testified that "the metric in cancer is at five years, what fraction, what percentage are alive .... [I]f they're alive in five years, we typically say that they're cured or that the cancer is unlikely to come back." Finkel, the plaintiff's expert witness, similarly referred to "survival rate" and "five-year survival" interchangeably. Dr. Mark Peppercorn, the defense expert witness, testified that the five-year survival rate is "the parameter most people use; it doesn't necessarily mean they're cured, but that's the parameter people use, five year survival." None of the experts or physicians who testified at trial offered an alternative metric for gauging the success of treating gastric cancer.

          [17] Both Birnbaum and his expert witness, Peppercorn, also testified that gastric cancer has "stages," with a high probability for survival at stage 1 and 5% probability or less at stage 4. Birnbaum agreed with the plaintiff's counsel that the five-year survival rate at stage 1 is 90% to 95%.

          [18] Hewins's figure for net loss of earnings assumed that Matsuyama would have used 30% of his gross earnings for personal consumption; his net loss of earnings figure did not consider taxes on Matsuyama's earnings. The evidence at trial showed that Matsuyama would not have been able to work to full capacity while he was being treated for cancer. Hewins testified that the work life statistics he employed to calculate income lost as a result of Matsuyama's death accounted for such contingencies as illness, disability, or retirement.

          [19] At the close of the plaintiff's evidence, her counsel moved to add a count for gross negligence, which the judge allowed as to Birnbaum over his counsel's objection. On Birnbaum's motion for a directed verdict, the judge dismissed only the claims for breach of contract and lack of informed consent. He later extended this ruling to the counts for breach of contract and lack of informed consent against Medical Associates on Medical Associates's oral motion.

          [20] The judge instructed the jury that "substantial" "doesn't mean that Mr. Matsuyama's chance of survival was [50%] or greater, only that there was a fair chance of survival or cure had Dr. Birnbaum not been negligent and had he conformed to the applicable standard of care."

          [21] This figure was an aggregate amount that included, in the words of the special question, losses for Matsuyama's "expected net income, services, protection, care, assistance, society, companionship, comfort, guidance, counsel and advice."

          [22] Prior to submitting the case to the jury, the judge withdrew from the jury the question whether Medical Associates was vicariously liable for Birnbaum's wrongful actions, and determined as a matter of law that vicarious liability applied.

          [23] The highest courts of at least twenty States and the District of Columbia have adopted the loss of chance doctrine. See Thompson v. Sun City Community Hosp., Inc., 141 Ariz. 597 (1984)Ferrell v. Rosenbaum, 691 A.2d 641 (D.C. 1997)Holton v. Memorial Hosp., 176 Ill.2d 95 (1997)Cahoon v. Cummings 734 N.E.2d 535 (Ind. 2000)DeBurkarte v. Louvar, 393 N.W.2d 131 (Iowa 1986)Delaney v. Cade, 255 Kan. 199 (1994)Hastings v. Baton Rouge Gen. Hosp., 498 So.2d 713, 720-722 (La. 1986)Wollen v. DePaul Health Ctr., 828 S.W.2d 681 (Mo. 1992)Aasheim v. Humberger, 215 Mont. 127 (1985)Perez v. Las Vegas Med. Ctr., 107 Nev. 1 (1991)Evers v. Dollinger, 95 N.J. 399 (1984)Alberts v. Schultz, 126 N.M. 807 (1999)Roberts v. Ohio Permanente Med. Group, Inc., 76 Ohio St. 3d 483 (1996)McKellips v. Saint Francis Hosp., Inc., 741 P.2d 467 (Okla. 1987)Hamil v. Bashline, 481 Pa. 256 (1978)Jorgenson v. Vener, 616 N.W.2d 366 (S.D. 2000)Brown v. Koulizakis, 229 Va. 524 (1985)Herskovits v. Group Health Coop. of Puget Sound, 99 Wash.2d 609 (1983)Thornton v. CAMC, 172 W. Va. 360 (1983)Ehlinger v. Sipes, 155 Wis.2d 1 (1990)McMackin v. Johnson County Healthcare Ctr., 73 P.3d 1094 (Wyo. 2003), S.C., 88 P.3d 491 (Wyo. 2004). One additional State's high court recognized loss of chance, Falcon v. Memorial Hosp., 436 Mich. 443 (1990), but the Legislature subsequently amended its medical malpractice statute to state that a "plaintiff cannot recover for loss of an opportunity to survive or an opportunity to achieve a better result unless the opportunity was greater than 50%." Mich. Comp. Laws Ann. § 600.2912a(2) (West), as amended by 1993 Mich. Pub. Acts 78, § 1, (effective April 1, 1994). See also Boone v. William W. Backus Hosp., 272 Conn. 551 (2005) (adopting loss of chance doctrine, but also apparently retaining requirement that decedent "had at least a 51 percent chance of survival" prior to negligence).

          Ten States' high courts have, in contrast, refused to adopt the loss of chance doctrine. See Gooding v. University Hosp. Bldg., Inc., 445 So.2d 1015 (Fla. 1984)Manning v. Twin Falls Clinic & Hosp., Inc., 830 P.2d 1185 (Idaho 1992)Fennell v. Southern Md. Hosp. Ctr., Inc., 320 Md. 776 (1990)Fabio v. Bellomo, 504 N.W.2d 758, 762 (Minn. 1993) ("We have never recognized loss of chance in the context of a medical malpractice action, and we decline to recognize it in this case"); Ladner v. Campbell, 515 So.2d 882 (Miss. 1987)Pillsbury-Flood v. Portsmouth Hosp., 128 N.H. 299 (1986)Kilpatrick v. Bryant, 868 S.W.2d 594, 602-603 (Tenn. 1993)Kramer v. Lewisville Memorial Hosp., 858 S.W.2d 397, 402-407 (Tex. 1993)Jones v. Owings, 318 S.C. 72 (1995)Smith v. Parrott, 175 Vt. 375 (2003). Two other States' high courts have held that loss of chance claims are incompatible with their States' wrongful death statutes, but have not decided whether loss of chance claims are otherwise actionable. See United States v. Cumberbatch, 647 A.2d 1098, 1102-1104 (Del. 1994)Joshi v. Providence Health Sys. of Or. Corp., 342 Or. 152 (2006).

          Other States' high courts have not addressed the issue or have explicitly left the question open. See, e.g., Holt v. Wagner, 344 Ark. 691 (2001) ("not closing the door to the future adoption of one of the versions of lost chance of survival" when issue is properly presented). The Draft Restatement, supra at § 26 comment n, discusses loss of chance but "takes no position on this matter, leaving it for future development and future Restatements."

          [24] Our appellate courts have not used the term "all or nothing" rule to refer to the tort principle that, in a medical malpractice action for wrongful death, once the defendant's negligence is shown to be more probably than not the cause of the person's death, the plaintiff is entitled to recover 100% of the value of all associated losses. However, the principle is enumerated in countless cases. See generally Harlow v. Chin, 405 Mass. 697, 714 (1989), and cases cited (in medical malpractice case, restating causal relationship rule, affirming damages award based on expert testimony of actuarial life expectancy). See also Murphy v. Conway, 360 Mass. 746, 750 (1972) (case in which plaintiff failed to produce expert evidence that defendant's negligent treatment of decedent's sore throat caused her death: "The evidence is insufficient to establish the probability that the decedent would have lived longer or suffered less even if the defendant had diagnosed and treated" illness properly).

          [25] That is, the full value of "the reasonably expected net income, services, protection, care, assistance, society, companionship, comfort, guidance, counsel, and advice of the decedent." G. L. c. 229, § 2.

          [26] This is because, when a plaintiff loses a less than even chance of survival, it was less likely than not that the negligence was a but-for cause of death. See Alholm v. Wareham, 371 Mass. 621, 626-627 (1976), quoting Bigwood v. Boston & N. St. Ry., 209 Mass. 345, 348 (1911) ("While the plaintiff is not bound to exclude every other possibility of cause for his injury except that of the negligence of the defendant, he is required to show by evidence a greater likelihood that it came from an act of negligence for which the defendant is responsible than from a cause for which the defendant is not liable").

          [27] In Bradford v. Baystate Med Ctr., 415 Mass. 202, 208 (1993), this court noted that "there is reason to question a rule of law that would totally exonerate a negligent physician from tort liability when the patient had a fair, but less than even, chance of survival if the physician had not been negligent," but expressly reserved the issue we decide today. Id.

          [28] Some courts have relied on § 323 of the Restatement (Second) of Torts (1965) in recognizing loss of chance. See, e.g., DeBurkarte v. Louvar, 393 N.W.2d 131, 135 (Iowa 1986)McKellips v. St. Francis Hosp., Inc., 741 P.2d 467, 474-475 (Okla. 1987)Hamil v. Bashline, 481 Pa. 256 (1978). We are in accord with the position taken by the Draft Restatement, supra at § 26, Reporters' Note to comment n, that this reliance is misplaced. Section 323 of the Restatement (Second) imposes a duty of reasonable care on the part of those who "undertake[], gratuitously or for consideration, to render services to another," and imposes liability on such persons for "harm resulting" when "failure to exercise such care increases the risk of such harm." Id. However, § 323 is silent on the question whether loss of chance itself is a form of harm. The placement of § 323 in Topic 7, "Duties of Affirmative Action," rather than in a topic concerning harm or causation, illustrates that § 323 is not an appropriate source for the doctrine of loss of chance. Id.

          [29] The Draft Restatement points out that "recognizing lost opportunity as harm is preferable to employing a diluted substantial-factor or other factual-causation test, thereby leaving recovery to the unconstrained inclination of any given jury and providing some fortunate plaintiffs with a full measure of damages for their physical harm while denying any recovery to others." Draft Restatement, supra at § 26 comment n.

          [30] The defendants claim that "any percent loss of chance below 50% ... would fundamentally shift the burden of proof from the plaintiff to the defendant" because "the only avenue of defense for the physician to escape liability is to establish with certainty that the negligence caused no harm." As we have implemented it, the loss of chance doctrine works no such shift in the burden of proof. The burden remains on the plaintiff to show that the physician's negligence more likely than not caused the plaintiff's injury. See Perez v. Las Vegas Med. Ctr., 107 Nev. 1, 6 (1991) ("By defining the injury as the loss of chance of survival, the traditional rule of preponderance is fully satisfied").

          [31] Determining causation under the "all or nothing" rule involves a similar use of statistical evidence. See Jorgenson v. Vener, 616 N.W.2d 366, 371 (S.D. 2000), quoting King I, supra at 1385 ("[A]lthough the doctrine [of loss of chance] relies on statistical evidence in order to assign a value to the lost chance, such use of mathematical calculations is already necessary under the traditional standards of causation and valuation. As Professor King points out, `How else ... do we even know whether we are talking about a better-than-even chance when applying the all-or-nothing rule?'").

          [32] Juries have, over time, heard increasingly sophisticated statistical epidemiological evidence in a variety of cases. The defendants argue that recognizing loss of chance undermines the "uniformity and predictability" of tort law. We do not agree. To the extent that evidence of the loss of chance is based on reliable expert testimony about accepted medical data, as it must be, permitting recovery for loss of chance damages does nothing to make our laws of medical malpractice less uniform or predictable than they are in the ordinary course.

          [33] We do not decide today whether a plaintiff may recover on a loss of chance theory when the ultimate harm (such as death) has not yet come to pass. Compare King II, supra at 544 (arguing against allowing recovery for future harms, and arguing instead for modifying statutes of limitations to accommodate claims regarding future harms after those harms materialize), with Alexander v. Scheid, 726 N.E.2d 272, 277-281 (Ind. 2000), and cases cited (allowing recovery on such theory).

          [34] The earliest wrongful death statute in what is now the Commonwealth is Province Laws 1693-1694, c. 6, § 6, which made municipalities liable for damages to a decedent's relatives when the person's death was caused by "a defect in a highway, causeway or bridge." See Gaudette v. Webb, 362 Mass. 60, 66 n.4 (1972) (summarizing history of wrongful death statutes in Massachusetts).

          [35] Lord Ellenborough's dictum likely derived from the felony-merger doctrine, according to which a felon was put to death and his property forfeited to the Crown, thereby removing from the reach of civil law both the defendant and any property from which to pay damages. See Moragne v. States Marine Lines, Inc., 398 U.S. 375, 382-383 (1970). Although in limited instances American law held that a civil trial could not proceed until after the criminal trial, "felony punishment [in the United States] did not include forfeiture of property." Id. at 384. Therefore, "[t]he historical justification marshaled for the rule in England never existed in this country." Id.

          [36] The Federal Death on the High Seas Act, 46 U.S.C. §§ 761, 762 (as then codified), allowed for recovery only for deaths on the high seas. The death in the Moragne case occurred in territorial waters. Id. at 376.

          [37] Other States have considered the question whether their own wrongful death statutes allow for recovery under a loss of chance theory. Many have found, for differing reasons, that they do. See, e.g., Cahoon v. Cummings, 734 N.E.2d 535, 539-540 (Ind. 2000)Perez v. Las Vegas Med. Ctr., 107 Nev. 1 (1991)McKellips v. Saint Francis Hosp., Inc., 741 P.2d 467 (Okla. 1987)Hamil v. Bashline, 481 Pa. 256 (1978)McMackin v. Johnson County Healthcare Ctr., 73 P.3d 1094 (Wyo. 2004). But see United States v. Cumberbatch, 647 A.2d 1098 (Del. 1994) (loss of chance not actionable under State wrongful death statute); Joshi v. Providence Health Sys. of Or. Corp., 342 Or. 152 (2006) (same).

          One State's high court has held that loss of chance claims are cognizable under that State's survival statute, which explicitly provides for the survival of "causes of action for death," Mo. Rev. Stat. § 537.020 (1986) ("Action for personal injury or death to survive regardless of death of either party"), but are not cognizable under the State's wrongful death statute on the grounds that statistical evidence does not "prove that decedent's death resulted from the failure to properly diagnose and treat." Wollen v. DePaul Health Ctr., 828 S.W.2d 681, 686 (Mo. 1992). The court's reasoning relies on the idea that the injury involved in a loss of chance of survival case is death, rather than the loss of chance itself. We do not so hold. In any event, in Massachusetts, a loss of chance claim brought under our survival statute, G. L. c. 228, § 1, rather than our wrongful death statute, would not appear to allow recovery for "the reasonably expected net income, services, protection, care, assistance, society, companionship, comfort, guidance, counsel, and advice of the decedent." G. L. c. 229, § 2. See Hallett v. Wrentham, 398 Mass. 550, 556 (1986) ("We conclude that the wrongful death act, G. L. c. 229, § 2, provides the exclusive action for the recovery of the damages it encompasses by the designated beneficiaries"). Such a result would hardly be consistent with principles of fairness and deterrence.

          [38] Because all human beings eventually die, an ordinary wrongful death claim is in effect a claim that the defendant's conduct brought on the death of the decedent sooner than it would otherwise have occurred; this is particularly so in the area of wrongful death claims based on alleged medical malpractice, because the relevant relationship between the decedent and the defendant physician or other health professional was formed as a result of, or concerned, a disease or illness on the part of the decedent. The damages calculation in an ordinary wrongful death case thus often involves estimating the life expectancy that a decedent would have enjoyed, absent the wrongful conduct of the defendant that caused the decedent's untimely death. See, e.g., Durdle v. Baron, 328 Mass. 460, 463 (1952)Lane v. Meserve, 20 Mass. App. Ct. 659, 666 (1985). In a loss of chance wrongful death case, the logic is similar: a plaintiff must show that her prospects for survival were diminished from what they would otherwise have been, and the magnitude of that diminution will determine damages. See part 4. infra.

          [39] Nothing in our decision today disturbs the other requirements of the wrongful death statute enumerated in Gaudette v. Webb, supra at 71, including requirements regarding who may bring the action; when it must be commenced; and the range of damages that may be recovered from each defendant.

          [40] The jury found that Matsuyama had stage 2 gastric cancer when he first consulted Birnbaum, and that he had a 37.5% "probability of cure."

          [41] These calculations will determine the loss of chance damages. We pause to clarify the issue of damages for pain and suffering, of which there are potentially two kinds. First, a jury could find, on appropriate evidence, that a physician's negligence caused pain and suffering quite apart from the loss of chance. Compensatory damages for this type of pain and suffering should be awarded in the same manner as in any malpractice case; they are not part of the proportional damages calculation.

          Second, a jury could find, on appropriate evidence, that the ultimate injury — in this case, dying of gastric cancer — involved pain and suffering. This second category of pain and suffering would more likely than not have occurred even absent the physician's negligent conduct. Thus, the physician may only be held liable for this pain and suffering to the extent that his negligent conduct diminished the decedent's likelihood of avoiding this outcome. Thus, this second category of pain and suffering is properly subject to the proportional damages calculation set out here.

          In this case, the jury awarded $160,000 in compensatory damages for "the pain and suffering of Kimiyoshi Matsuyama for which the negligence of Neil S. Birnbaum, M.D. was a substantially contributing factor." The judge instructed the jury that this figure was "for the conscious pain and suffering which was endured by Mr. Matsuyama during the period of his illness, if that period was caused by Dr. Birnbaum." While this instruction is not a model of clarity, we read it to refer to the first category of pain and suffering damages set out above: pain and suffering "caused by Dr. Birnbaum." There was sufficient evidence to support the jury's finding, and it was proper for the judge to exclude this pain and suffering from the proportional damages calculus.

          Neither party requested jury instructions about additional pain and suffering of the second type (the pain and suffering involved in dying of gastric cancer), which would, on appropriate evidence, have been part of the loss of chance proportional damage calculation set out here.

          [42] Our holding on damages is limited to loss of chance cases. See Renzi v. Paredes, post 38, 45-46 (2008).

          [43] See, e.g., Fischer, Tort Recovery for Loss of a Chance, 36 Wake Forest L. Rev. 605, 631-633 (2001) (claiming that proportional damages method fails to advance aims of deterrence because it routinely over or under compensates plaintiffs); Note, Identifying and Valuing the Injury in Lost Chance Cases, 96 Mich. L. Rev. 1335, 1347-1353 (1998) (same).

          [44] Birnbaum argued in his supplemental trial brief that, if the judge were to permit recovery for the loss of chance, the jury should be instructed on the "apportionate method" only (that is, the proportional damages approach) in order to avoid overcompensating the plaintiff.

          [45] Both Peppercorn and Fuchs testified that gastric cancer does not always proceed through the numbered stages in a sequential manner. Nevertheless, the jury were entitled to believe Finkel's explanation that Matsuyama's cancer was at an early stage in July, 1995, when he first saw Birnbaum, and thus more susceptible to treatment at that time, over Peppercorn's explanation that Matsuyama's gastric cancer was of an unusual type that essentially is asymptomatic until stage 4.

          [46] The defense, among other things, faults Finkel for not providing more certain testimony about when Matsuyama would have died absent Birnbaum's negligence. Because Birnbaum's own negligence was the reason that Matsuyama's fate (but for the negligence) is ultimately unknowable, this charge avails the defense nothing. See Hicks v. United States, 368 F.2d 626, 632 (4th Cir. 1966) (plaintiff in loss of chance case should not be required "to demonstrate to an absolute certainty what would have happened in circumstances that the wrongdoer did not allow to come to pass").

          [47] For example, in O'Connor v. Raymark Indus., 401 Mass. 586, 587 (1988), an asbestos case in which the plaintiff's tort claims against sixteen of the seventeen defendants had been settled, this court approved a special jury question asking whether the one remaining defendant's products "cause[d], or did it substantially contribute to cause, mesothelioma in [the decedent], and did it cause his death?" The judge in that case explained to the jury, "There can be and often are more than one cause present to produce an injury, and more than one person legally responsible for an injury or disease, so here, even if other manufacturers of asbestos-containing products were at fault, and their products contributed to [the decedent's] disease, [the defendant] is not thereby relieved from liability...." Id. at 589. The Draft Restatement, supra at 526 comment j, explains that the "substantial-factor" test "originated in the Restatement of Torts §§ 431-432 and was replicated in the Restatement Second of Torts §§ 431-432. Its primary function was to permit the factfinder to decide that factual cause existed when there were overdetermined causes — each of two separate causal chains sufficient to bring about the plaintiff's harm, thereby rendering neither a but-for cause."

          [48] Although there are two defendants in this case, only Birnbaum's conduct is at issue. Medical Associates's liability is vicarious. See note 22, supra.

          [49] Although not determinative on the issue of the correctness of the jury instructions, we note that in his closing argument, the plaintiff's counsel told the jury: "We do not hold Doctor Birnbaum responsible for Mr. Matsuyama getting cancer. We do hold Doctor Birnbaum responsible for allowing that cancer to progress in the face of multiple understood risk factors and thereby taking away all opportunity for meaningful detection, intervention, treatment, which would have resulted in Mr. Matsuyama having a higher degree of survival rate...."

          [50] It is obvious from the record that the judge made a most thoughtful effort to frame the jury instructions and the special questions in the manner best suited to the novel question of law before him, and he is to be commended for it.

          [51] Question 6 of the special jury questions was preceded by a question asking the jury to find whether Birnbaum's negligence was "a substantial contributing factor in causing the death of Kimiyoshi Matsuyama." The jury answered "Yes." They then continued to question 6, which stated in part:

          "What amount of damages will fully and fairly compensate [Matsuyama's widow] and [Matsuyama's son] for the loss to them of the expected net income, services, protection, care, assistance, society, companionship, comfort, guidance, counsel and advice of her husband and his father, Kimiyoshi Matsuyama, from the date of his death, October 21, 1999, through such period of time you find Kimiyoshi Matsuyama would have survived but for the negligence of Neil S. Birnbaum, M.D. which you find was a substantially contributing factor to the death of Kimiyoshi Matsuyama?

          "Please note: In arriving at this figure, if you find that the negligence of Neil S. Birnbaum which was a substantially contributing factor to the death of Kimiyoshi Matsuyama first occurred while Kimiyoshi Matsuyama was suffering from so-called `Stage I' adenocarcinoma, you must multiply your damage figure by a percentage figure by or between.6 (60%) and .9 (90%), in your sole discretion. If so-called `Stage 2' adenocarcinoma, by or between .25 (25%) and .5 (50%) in your sole discretion. If so-called `Stage 3' adenocarcinoma, by or between .1 (10%) and .2 (20%) in your sole discretion. If so-called `Stage 4' adenocarcinoma, by or between any positive, whole number, percentage between .01 (1%) and .05 (5%) in your sole discretion" (emphasis in original).

          [52] The judge explained to the jury:

          "[W]hat I've done is I've taken what I understood [the stage-specific probability of cure] to have been, and it's your recollection, but what I have understood to have been the low range of probability of cure suggested from the testimony of the medical experts and the high range with respect to each of the stages.

          "And so what you need to do is determine what stage and what was the probability of a cure at that stage based on the synthesis that I've given you in your verdict slip."

          [53] We refer here only to the issue of determining the patient's chances of survival before and after the alleged negligence. A judge is not precluded from instructing the jury about differentiating loss of chance damages from wrongful death damages, or any other matter.

          [54] Birnbaum's expert, Peppercorn, testified that at stage 4, a patient's chance of survival was "[p]ractically zero; less than [5%], probably."

          [55] If, properly instructed, the jury had found, most favorably for Birnbaum, that Matsuyama was left with a 5% chance of survival after Birnbaum's negligence, the difference in the jury's proportional award here would be $875,000 multiplied by 32.5% (37.5% minus 5%) for a total award of $284,375, rather than the $328,125 awarded by the jury.

          [56] In a bench conference before the jury charge, Birnbaum's counsel made only the following objection: "I also object to the language of Question No. 6" — the main loss of chance damages question — "which I would say improperly and inaccurately comments on the evidence." Medical Associates's counsel added, "I just want to be on the record as objecting to Question No. 6 of the verdict slip as well." The judge noted these objections. After the jury charge, the defendants made various other objections. Birnbaum's counsel objected to the instruction on "causation" that the jury "would have to find whether or not there was a fair chance of cure, not necessarily fifty percent. I object to that instruction as being contrary to the law, and I object to, further, anything except that the jury would be required to prove reasonable medical certainty that as a result of what Dr. Birnbaum did or did not do it resulted, caused Mr. Matsuyama's death." The judge, referring to "extensive lobby conferences on that" that had taken place, declined to change his instructions. Medical Associates's counsel also objected to the "fair chance" language and to the lack of a requirement that the jury find the lost chance to be "substantial," see note 58, infra.

          [57] In his supplemental trial brief, received on July 29, 2004, and docketed on August 12, 2004, Birnbaum argued, inter alia, that, if the judge were to permit the jury to determine damages on a loss of chance claim, the judge must instruct the jury on "apportionment method ... with the most logical being the difference in chance at the time of misdiagnosis versus the chance at the time of actual diagnosis." However, Birnbaum's proposed jury instructions did not include any version of this language, and this argument was not pressed in objection to the judge's jury instructions (although other, different arguments raised in this supplemental trial brief were).

          [58] The defendants also argue that the evidence did not support, and that the judge should have required the plaintiff to prove, the loss of a "substantial" chance of survival. We do not hold today that any such requirement must be imposed.

          [59] In relevant part, the judge stated: "So, that is essentially the rundown of the liability aspect of the case. If I say, if, you should in your discretion at the end of the day conclude that there was liability for negligence, there is evidence in this case, ladies and gentlemen, upon which you have the legal authority to find that Dr. Birnbaum's conduct was, as to loss, grossly negligent. So, I want to tell you basically what the definition of gross negligence is. Gross negligence is evidence which is substantially higher and appreciably higher magnitude than ordinary negligence. It is materially greater want of care under the circumstances with respect to the legal duty that is owed.... If it's a relatively small want of inattention which is nonetheless negligent, then so be it. It's a great departure from the obligation of attentiveness and it's gross inattention, then you have the authority in this case to find that Dr. Birnbaum on the facts of this case was negligent. I do not, obviously, suggest to you that you should or you shouldn't. I'm merely telling you that there are facts in which you could make that determination from this case, and that is entirely up to you."

          [60] Birnbaum does not fault the judge's instructions on the elements of a cause of action for gross negligence. See Altman v. Aronson, 231 Mass. 588, 593 (1919).

          [61] Our decision today should not be construed to suggest that a finding of gross negligence and an award of punitive damages cannot be secured in a loss of chance case. Where gross negligence is found in a loss of chance case, the fact finder will determine an amount of punitive damages exactly as in any other gross negligence case: according to the fact finder's determination of the egregiousness of the tortious conduct or in accordance with any statutorily prescribed amount. Punitive damages are not part of the proportional loss of chance damages calculus.

19.3 Multiple Defendants 19.3 Multiple Defendants

            Specific issues arise when multiple actors could have caused the plaintiff's injury. We will consider three cases that deal with this dilemma.

19.3.1 Summers v. Tice 19.3.1 Summers v. Tice

33 Cal.2d 80 (1948)

CHARLES A. SUMMERS, Respondent,
v.
HAROLD W. TICE et al., Appellants.

L. A. Nos. 20650, 20651.

Supreme Court of California.

Nov. 17, 1948.

Gale & Purciel, Joseph D. Taylor and Wm. A. Wittman for Appellants.

Werner O. Graf for Respondent.

CARTER, J.

Each of the two defendants appeals from a judgment against them in an action for personal injuries. Pursuant to stipulation the appeals have been consolidated.

Plaintiff's action was against both defendants for an injury to his right eye and face as the result of being struck by bird shot discharged from a shotgun. The case was tried by the court without a jury and the court found that on November 20, 1945, plaintiff and the two defendants were hunting quail on the open range. Each of the defendants was armed with a 12 gauge shotgun loaded with shells containing 7 1/2 size shot. Prior to going hunting plaintiff discussed the hunting procedure with defendants, indicating that they were to exercise care when shooting and to "keep in line." In the course of hunting plaintiff proceeded up a hill, thus placing the hunters at the points of a triangle. The view of defendants with reference to plaintiff was unobstructed and they knew his location. Defendant Tice flushed a quail which rose in flight to a 10-foot elevation and flew between plaintiff and defendants. Both defendants shot at the quail, shooting in plaintiff's direction. At that time defendants were 75 yards from plaintiff. One shot struck plaintiff in his eye and another in his upper lip. Finally it was found by the court that as [83] the direct result of the shooting by defendants the shots struck plaintiff as above mentioned and that defendants were negligent in so shooting and plaintiff was not contributorily negligent.

First, on the subject of negligence, defendant Simonson contends that the evidence is insufficient to sustain the finding on that score, but he does not point out wherein it is lacking. There is evidence that both defendants, at about the same time or one immediately after the other, shot at a quail and in so doing shot toward plaintiff who was uphill from them, and that they knew his location. That is sufficient from which the trial court could conclude that they acted with respect to plaintiff other than as persons of ordinary prudence. The issue was one of fact for the trial court. (See, Rudd v. Byrnes, 156 Cal. 636 [105 P. 957, 20 Ann.Cas. 124, 26 L.R.A.N.S. 134].)

Defendant Tice states in his opening brief, "we have decided not to argue the insufficiency of negligence on the part of defendant Tice." It is true he states in his answer to plaintiff's petition for a hearing in this court that he did not concede this point but he does not argue it. Nothing more need be said on the subject.

Defendant Simonson urges that plaintiff was guilty of contributory negligence and assumed the risk as a matter of law. He cites no authority for the proposition that by going on a hunting party the various hunters assume the risk of negligence on the part of their companions. Such a tenet is not reasonable. It is true that plaintiff suggested that they all "stay in line," presumably abreast, while hunting, and he went uphill at somewhat of a right angle to the hunting line, but he also cautioned that they use care, and defendants knew plaintiff's position. We hold, therefore, that the trial court was justified in finding that he did not assume the risk or act other than as a person of ordinary prudence under the circumstances. (See, Anthony v. Hobbie, 25 Cal.2d 814, 818 [155 P.2d 826]; Rudd v. Byrnes, supra.) None of the cases cited by Simonson are in point.

The problem presented in this case is whether the judgment against both defendants may stand. It is argued by defendants that they are not joint tort feasors, and thus jointly and severally liable, as they were not acting in concert, and that there is not sufficient evidence to show which defendant was guilty of the negligence which caused the injuries--the shooting by Tice or that by Simonson. Tice argues that there is [84] evidence to show that the shot which struck plaintiff came from Simonson's gun because of admissions allegedly made by him to third persons and no evidence that they came from his gun. Further in connection with the latter contention, the court failed to find on plaintiff's allegation in his complaint that he did not know which one was at fault--did not find which defendant was guilty of the negligence which caused the injuries to plaintiff.

Considering the last argument first, we believe it is clear that the court sufficiently found on the issue that defendants were jointly liable and that thus the negligence of both was the cause of the injury or to that legal effect. It found that both defendants were negligent and "That as a direct and proximate result of the shots fired by defendants, and each of them, a birdshot pellet was caused to and did lodge in plaintiff's right eye and that another birdshot pellet was caused to and did lodge in plaintiff's upper lip." In so doing the court evidently did not give credence to the admissions of Simonson to third persons that he fired the shots, which it was justified in doing. It thus determined that the negligence of both defendants was the legal cause of the injury--or that both were responsible. Implicit in such finding is the assumption that the court was unable to ascertain whether the shots were from the gun of one defendant or the other or one shot from each of them. The one shot that entered plaintiff's eye was the major factor in assessing damages and that shot could not have come from the gun of both defendants. It was from one or the other only.

It has been held that where a group of persons are on a hunting party, or otherwise engaged in the use of firearms, and two of them are negligent in firing in the direction of a third person who is injured thereby, both of those so firing are liable for the injury suffered by the third person, although the negligence of only one of them could have caused the injury. (Moore v. Foster, 182 Miss. 15 [180 So. 73]; Oliver v. Miles, 144 Miss. 852 [110 So. 666; 50 A.L.R. 357]; Reyher v. Mayne, 90 Colo. 586 [10 P.2d 1109]; Benson v. Ross, 143 Mich. 452 [106 N.W. 1120, 114 Am.St.Rep. 675].) The same rule has been applied in criminal cases (State v. Newberg, 129 Ore. 564 [278 P. 568, 63 A.L.R. 1225]), and both drivers have been held liable for the negligence of one where they engaged in a racing contest causing an injury to a third person (Saisa v. Lilja, 76 F.2d 380). These cases speak of the action of defendants as being in concert as the ground [85] of decision, yet it would seem they are straining that concept and the more reasonable basis appears in Oliver v. Miles, supra. There two persons were hunting together. Both shot at some partridges and in so doing shot across the highway injuring plaintiff who was travelling on it. The court stated they were acting in concert and thus both were liable. The court then stated: "We think that ... each is liable for the resulting injury to the boy, although no one can say definitely who actually shot him. To hold otherwise would be to exonerate both from liability, although each was negligent, and the injury resulted from such negligence." [Emphasis added.] (P. 668 [110 So.].) It is said in the Restatement: "For harm resulting to a third person from the tortious conduct of another, a person is liable if he ... (b) knows that the other's conduct constitutes a breach of duty and gives substantial assistance or encouragement to the other so to conduct himself, or (c) gives substantial assistance to the other in accomplishing a tortious result and his own conduct, separately considered, constitutes a breach of duty to the third person." (Rest., Torts, 876(b) (c).) Under subsection (b) the example is given: "A and B are members of a hunting party. Each of them in the presence of the other shoots across a public road at an animal, this being negligent as to persons on the road. A hits the animal. B's bullet strikes C, a traveler on the road. A is liable to C." (Rest., Torts, 876 (b), com., illus. 3.) An illustration given under subsection (c) is the same as above except the factor of both defendants shooting is missing and joint liability is not imposed. It is further said that: "If two forces are actively operating, one because of the actor's negligence, the other not because of any misconduct on his part, and each of itself is sufficient to bring about harm to another, the actor's negligence may be held by the jury to be a substantial factor in bringing it about." (Rest., Torts, 432.) Dean Wigmore has this to say: "When two or more persons by their acts are possibly the sole cause of a harm, or when two or more acts of the same person are possibly the sole cause, and the plaintiff has introduced evidence that the one of the two persons, or the one of the same person's two acts, is culpable, then the defendant has the burden of proving that the other person, or his other act, was the sole cause of the harm. (b) ... The real reason for the rule that each joint tortfeasor is responsible for the whole damage is the practical unfairness of denying the injured person redress simply because he cannot prove how [86] much damage each did, when it is certain that between them they did all; let them be the ones to apportion it among themselves. Since, then, the difficulty of proof is the reason, the rule should apply whenever the harm has plural causes, and not merely when they acted in conscious concert. ..." (Wigmore, Select Cases on the Law of Torts, 153.) Similarly Professor Carpenter has said: "[Suppose] the case where A and B independently shoot at C and but one bullet touches C's body. In such case, such proof as is ordinarily required that either A or B shot C, of course fails. It is suggested that there should be a relaxation of the proof required of the plaintiff ... where the injury occurs as the result of one where more than one independent force is operating, and it is impossible to determine that the force set in operation by defendant did not in fact constitute a cause of the damage, and where it may have caused the damage, but the plaintiff is unable to establish that it was a cause." (20 Cal.L.Rev. 406.)

When we consider the relative position of the parties and the results that would flow if plaintiff was required to pin the injury on one of the defendants only, a requirement that the burden of proof on that subject be shifted to defendants becomes manifest. They are both wrongdoers--both negligent toward plaintiff. They brought about a situation where the negligence of one of them injured the plaintiff, hence it should rest with them each to absolve himself if he can. The injured party has been placed by defendants in the unfair position of pointing to which defendant caused the harm. If one can escape the other may also and plaintiff is remediless. Ordinarily defendants are in a far better position to offer evidence to determine which one caused the injury. This reasoning has recently found favor in this court. In a quite analogous situation this court held that a patient injured while unconscious on an operating table in a hospital could hold all or any of the persons who had any connection with the operation even though he could not select the particular acts by the particular person which led to his disability. (Ybarra v. Spangard, 25 Cal.2d 486 [154 P.2d 687, 162 A.L.R. 1258].) There the court was considering whether the patient could avail himself of res ipsa loquitur, rather than where the burden of proof lay, yet the effect of the decision is that plaintiff has made out a case when he has produced evidence which gives rise to an inference of negligence which was the proximate cause of the injury. It is up to [87] defendants to explain the cause of the injury. It was there said: "If the doctrine is to continue to serve a useful purpose, we should not forget that 'the particular force and justice of the rule, regarded as a presumption throwing upon the party charged the duty of producing evidence, consists in the circumstance that the chief evidence of the true cause, whether culpable or innocent, is practically accessible to him but inaccessible to the injured person.' " (P. 490.) Similarly in the instant case plaintiff is not able to establish which of defendants caused his injury.

The foregoing discussion disposes of the authorities cited by defendants such as Kraft v. Smith, 24 Cal.2d 124 [148 P.2d 23], and Hernandez v. Southern California Gas Co., 213 Cal. 384 [2 P.2d 360], stating the general rule that one defendant is not liable for the independent tort of the other defendant, or that ordinarily the plaintiff must show a causal connection between the negligence and the injury. There was an entire lack of such connection in the Hernandez case and there were not several negligent defendants, one of whom must have caused the injury.

Defendants rely upon Christensen v. Los Angeles Electrical Supply Co., 112 Cal.App. 629 [297 P. 614], holding that a defendant is not liable where he negligently knocks down with his car a pedestrian and a third person then ran over the prostrate person. That involves the question of intervening cause which we do not have here. Moreover it is out of harmony with the current rule on that subject and was properly questioned in Hill v. Peres, 136 Cal.App. 132 [28 P.2d 946] (hearing in this Court denied), and must be deemed disapproved. (See, Mosley v. Arden Farms Co., 26 Cal. 2d 213 [157 P.2d 372, 158 A.L.R. 872]; Sawyer v. Southern California Gas Co., 206 Cal. 366 [274 P. 544]; 2 Cal.Jur. 10-Yr. Supp. Automobiles, 349; 19 Cal.Jur. 570-572.)

Cases are cited for the proposition that where two or more tort feasors acting independently of each other cause an injury to plaintiff, they are not joint tort feasors and plaintiff must establish the portion of the damage caused by each, even though it is impossible to prove the portion of the injury caused by each. (See, Slater v. Pacific American Oil Co., 212 Cal. 648 [300 P. 31]; Miller v. Highland Ditch Co., 87 Cal. 430 [25 P. 550, 22 Am.St.Rep. 254]; People v. Gold Run D. & M. Co., 66 Cal. 138 [4 P. 1152, 56 Am.Rep. 80]; Wade v. Thorsen, 5 Cal.App.2d 706 [43 P.2d 592]; California O. Co. v. Riverside P. C. Co., 50 Cal.App. 522 [195 P. 694]; [88] City of Oakland v. Pacific Gas & E. Co., 47 Cal.App.2d 444 [118 P.2d 328].) In view of the foregoing discussion it is apparent that defendants in cases like the present one may be treated as liable on the same basis as joint tort feasors, and hence the last-cited cases are distinguishable inasmuch as they involve independent tort feasors.

In addition to that, however, it should be pointed out that the same reasons of policy and justice shift the burden to each of defendants to absolve himself if he can--relieving the wronged person of the duty of apportioning the injury to a particular defendant, apply here where we are concerned with whether plaintiff is required to supply evidence for the apportionment of damages. If defendants are independent tort feasors and thus each liable for the damage caused by him alone, and, at least, where the matter of apportionment is incapable of proof, the innocent wronged party should not be deprived of his right to redress. The wrongdoers should be left to work out between themselves any apportionment. (See, Colonial Ins. Co., v. Industrial Acc. Com., 29 Cal.2d 79 [172 P.2d 884].) Some of the cited cases refer to the difficulty of apportioning the burden of damages between the independent tort feasors, and say that where factually a correct division cannot be made, the trier of fact may make it the best it can, which would be more or less a guess, stressing the factor that the wrongdoers are not in a position to complain of uncertainty. (California O. Co. v. Riverside P. C. Co., supra.)

It is urged that plaintiff now has changed the theory of his case in claiming a concert of action; that he did not plead or prove such concert. From what has been said it is clear that there has been no change in theory. The joint liability, as well as the lack of knowledge as to which defendant was liable, was pleaded and the proof developed the case under either theory. We have seen that for the reasons of policy discussed herein, the case is based upon the legal proposition that, under the circumstances here presented, each defendant is liable for the whole damage whether they are deemed to be acting in concert or independently.

The judgment is affirmed.

Gibson, C.J., Shenk, J., Edmonds, J., Traynor, J., Schauer, J., and Spence, J., concurred.

19.3.2 Sindell v. Abbott Laboratories 19.3.2 Sindell v. Abbott Laboratories

26 Cal.3d 588 (1980)
607 P.2d 924
163 Cal. Rptr. 132

JUDITH SINDELL, Plaintiff and Appellant,
v.
ABBOTT LABORATORIES et al., Defendants and Respondents. MAUREEN ROGERS, Plaintiff and Appellant,
v.
REXALL DRUG COMPANY et al., Defendants and Respondents.

Docket No. L.A. 31063.

Supreme Court of California.

March 20, 1980.

[592] COUNSEL

Donnenfeld & Brent, Jason G. Brent, Laurence M. Marks, Heily, Blase, Ellison & Wellcome and Jay H. Sorensen for Plaintiffs and Appellants.

[593] Wylie Aitken, Stephen Zetterberg, Robert E. Cartwright, Harry DeLizonna, Edward I. Pollack, J. Nick DeMeo, Sanford M. Gage, Leonard Sacks, David Rosenberg, Jeanne Baker, David J. Fine and Rosenberg, Baker & Fine as Amici Curiae on behalf of Plaintiffs and Appellants.

Morgan, Wenzel & McNicholas, Darryl L. Dmytriw, Lord, Bissel & Brook, Hugh L. Moore, Crosby, Heafey, Roach & May, Richard J. Heafey, Peter W. Davis, John E. Carne, Leonard M. Friedman, John G. Fleming, George Fletcher, Adams, Duque & Hazeltine, Richard C. Field, David L. Bacon, Haight, Dickson, Brown & Bonesteel, Robert L. Dickson, Roy G. Weatherup, Hall R. Marston and Jerry M. Custis for Defendants and Respondents.

OPINION

MOSK, J.

This case involves a complex problem both timely and significant: may a plaintiff, injured as the result of a drug administered to her mother during pregnancy, who knows the type of drug involved but cannot identify the manufacturer of the precise product, hold liable for her injuries a maker of a drug produced from an identical formula?

Plaintiff Judith Sindell brought an action against eleven drug companies and Does 1 through 100, on behalf of herself and other women similarly situated. The complaint alleges as follows:

Between 1941 and 1971, defendants were engaged in the business of manufacturing, promoting, and marketing diethylstilbesterol (DES), a drug which is a synthetic compound of the female hormone estrogen. The drug was administered to plaintiff's mother and the mothers of the class she represents,[1] for the purpose of preventing miscarriage. In 1947, the Food and Drug Administration authorized the marketing of DES as a miscarriage preventative, but only on an experimental basis, with a requirement that the drug contain a warning label to that effect.

[594] DES may cause cancerous vaginal and cervical growths in the daughters exposed to it before birth, because their mothers took the drug during pregnancy. The form of cancer from which these daughters suffer is known as adenocarcinoma, and it manifests itself after a minimum latent period of 10 or 12 years. It is a fast-spreading and deadly disease, and radical surgery is required to prevent it from spreading. DES also causes adenosis, precancerous vaginal and cervical growths which may spread to other areas of the body. The treatment for adenosis is cauterization, surgery, or cryosurgery. Women who suffer from this condition must be monitored by biopsy or colposcopic examination twice a year, a painful and expensive procedure. Thousands of women whose mothers received DES during pregnancy are unaware of the effects of the drug.

In 1971, the Food and Drug Administration ordered defendants to cease marketing and promoting DES for the purpose of preventing miscarriages, and to warn physicians and the public that the drug should not be used by pregnant women because of the danger to their unborn children.

During the period defendants marketed DES, they knew or should have known that it was a carcinogenic substance, that there was a grave danger after varying periods of latency it would cause cancerous and precancerous growths in the daughters of the mothers who took it, and that it was ineffective to prevent miscarriage. Nevertheless, defendants continued to advertise and market the drug as a miscarriage preventative. They failed to test DES for efficacy and safety; the tests performed by others, upon which they relied, indicated that it was not safe or effective. In violation of the authorization of the Food and Drug Administration, defendants marketed DES on an unlimited basis rather than as an experimental drug, and they failed to warn of its potential danger.[2]

Because of defendants' advertised assurances that DES was safe and effective to prevent miscarriage, plaintiff was exposed to the drug prior to her birth. She became aware of the danger from such exposure within one year of the time she filed her complaint. As a result of the DES ingested by her mother, plaintiff developed a malignant bladder [595] tumor which was removed by surgery. She suffers from adenosis and must constantly be monitored by biopsy or colposcopy to insure early warning of further malignancy.

The first cause of action alleges that defendants were jointly and individually negligent in that they manufactured, marketed and promoted DES as a safe and efficacious drug to prevent miscarriage, without adequate testing or warning, and without monitoring or reporting its effects.

A separate cause of action alleges that defendants are jointly liable regardless of which particular brand of DES was ingested by plaintiff's mother because defendants collaborated in marketing, promoting and testing the drug, relied upon each other's tests, and adhered to an industry-wide safety standard. DES was produced from a common and mutually agreed upon formula as a fungible drug interchangeable with other brands of the same product; defendants knew or should have known that it was customary for doctors to prescribe the drug by its generic rather than its brand name and that pharmacists filled prescriptions from whatever brand of the drug happened to be in stock.

Other causes of action are based upon theories of strict liability, violation of express and implied warranties, false and fraudulent representations, misbranding of drugs in violation of federal law, conspiracy and "lack of consent."

Each cause of action alleges that defendants are jointly liable because they acted in concert, on the basis of express and implied agreements, and in reliance upon and ratification and exploitation of each other's testing and marketing methods.

Plaintiff seeks compensatory damages of $1 million and punitive damages of $10 million for herself. For the members of her class, she prays for equitable relief in the form of an order that defendants warn physicians and others of the danger of DES and the necessity of performing certain tests to determine the presence of disease caused by the drug, and that they establish free clinics in California to perform such tests.

Defendants demurred to the complaint. While the complaint did not expressly allege that plaintiff could not identify the manufacturer of the precise drug ingested by her mother, she stated in her points and authorities [596] in opposition to the demurrers filed by some of the defendants that she was unable to make the identification, and the trial court sustained the demurrers of these defendants without leave to amend on the ground that plaintiff did not and stated she could not identify which defendant had manufactured the drug responsible for her injuries. Thereupon, the court dismissed the action.[3] This appeal involves only five of ten defendants named in the complaint.[4]

Plaintiff Maureen Rogers filed a complaint containing allegations generally similar to those made by Sindell. She seeks compensatory and punitive damages on her own behalf, and on behalf of a class described in substantially the same terms as in Sindell's complaint, as well as equitable relief comparable to that sought by Sindell. The trial court sustained demurrers of E.R. Squibb & Sons, the Upjohn Company, and Rexall Drug Company.[5] Subsequent to the dismissal of her action [597] against these defendants, Rogers amended the complaint to allege that Eli Lilly and Company, one of the defendants named in her complaint, had manufactured the drug used by her mother. Although Sindell's action and the present case have been consolidated on appeal, much of the discussion which follows will apply to Rogers only if she does not succeed in establishing that Eli Lilly and Company manufactured the DES taken by her mother. "Plaintiff" as used in this opinion refers to Sindell, and we discuss only the allegations of Sindell's complaint.

This case is but one of a number filed throughout the country seeking to hold drug manufacturers liable for injuries allegedly resulting from DES prescribed to the plaintiffs' mothers since 1947.[6] According to a note in the Fordham Law Review, estimates of the number of women who took the drug during pregnancy range from 1 1/2 million to 3 million. Hundreds, perhaps thousands, of the daughters of these women suffer from adenocarcinoma, and the incidence of vaginal adenosis among them is 30 to 90 percent. (Comment, DES and a Proposed Theory of Enterprise Liability (1978) 46 Fordham L.Rev. 963, 964-967 [hereafter Fordham Comment].) Most of the cases are still pending. With two exceptions,[7] those that have been decided resulted in judgments in favor of the drug company defendants because of the failure of the plaintiffs to identify the manufacturer of the DES prescribed to their mothers.[8] The same result was reached in a recent California case. (McCreery v. Eli Lilly & Co. (1978) 87 Cal. App.3d 77, 82-84 [150 Cal. Rptr. 730].) The present action is another attempt to overcome this obstacle to recovery.

(1) We begin with the proposition that, as a general rule, the imposition of liability depends upon a showing by the plaintiff that his or her injuries were caused by the act of the defendant or by an instrumentality under the defendant's control. The rule applies whether the injury [598] resulted from an accidental event (e.g., Shunk v. Bosworth (6th Cir.1964) 334 F.2d 309) or from the use of a defective product. (E.g., Wetzel v. Eaton Corporation (D.Minn. 1973) 62 F.R.D. 22, 29-30; Garcia v. Joseph Vince Co. (1978) 84 Cal. App.3d 868, 873-875 [148 Cal. Rptr. 843]; and see Annot. collection of cases in 51 A.L.R.3d 1344, 1351; 1 Hursh & Bailey, American Law of Products Liability (2d ed. 1974) p. 125.)

There are, however, exceptions to this rule. Plaintiff's complaint suggests several bases upon which defendants may be held liable for her injuries even though she cannot demonstrate the name of the manufacturer which produced the DES actually taken by her mother. The first of these theories, classically illustrated by Summers v. Tice (1948) 33 Cal.2d 80 [199 P.2d 1, 5 A.L.R.2d 91], places the burden of proof of causation upon tortious defendants in certain circumstances. The second basis of liability emerging from the complaint is that defendants acted in concert to cause injury to plaintiff. (2) There is a third and novel approach to the problem, sometimes called the theory of "enterprise liability," but which we prefer to designate by the more accurate term of "industry-wide" liability,[9] which might obviate the necessity for identifying the manufacturer of the injury-causing drug. We shall conclude that these doctrines, as previously interpreted, may not be applied to hold defendants liable under the allegations of this complaint. However, we shall propose and adopt a fourth basis for permitting the action to be tried, grounded upon an extension of the Summers doctrine.

I

Plaintiff places primary reliance upon cases which hold that if a party cannot identify which of two or more defendants caused an injury, the burden of proof may shift to the defendants to show that they were not responsible for the harm. This principle is sometimes referred to as the "alternative liability" theory.

The celebrated case of Summers v. Tice, supra, 33 Cal.2d 80, a unanimous opinion of this court, best exemplifies the rule. In Summers, the plaintiff was injured when two hunters negligently shot in his direction. It could not be determined which of them had fired the shot that [599] actually caused the injury to the plaintiff's eye, but both defendants were nevertheless held jointly and severally liable for the whole of the damages. We reasoned that both were wrongdoers, both were negligent toward the plaintiff, and that it would be unfair to require plaintiff to isolate the defendant responsible, because if the one pointed out were to escape liability, the other might also, and the plaintiff-victim would be shorn of any remedy. In these circumstances, we held, the burden of proof shifted to the defendants, "each to absolve himself if he can." (Id., p. 86.) We stated that under these or similar circumstances a defendant is ordinarily in a "far better position" to offer evidence to determine whether he or another defendant caused the injury.

In Summers, we relied upon Ybarra v. Spangard (1944) 25 Cal.2d 486 [154 P.2d 687, 162 A.L.R. 1258]. There, the plaintiff was injured while he was unconscious during the course of surgery. He sought damages against several doctors and a nurse who attended him while he was unconscious. We held that it would be unreasonable to require him to identify the particular defendant who had performed the alleged negligent act because he was unconscious at the time of the injury and the defendants exercised control over the instrumentalities which caused the harm. Therefore, under the doctrine of res ipsa loquitur, an inference of negligence arose that defendants were required to meet by explaining their conduct.[10]

The rule developed in Summers has been embodied in the Restatement of Torts. (Rest.2d Torts, § 433B, subd. (3).)[11] Indeed, the Summers facts are used as an illustration (p. 447).

[600] Defendants assert that these principles are inapplicable here. First, they insist that a predicate to shifting the burden of proof under Summers-Ybarra is that the defendants must have greater access to information regarding the cause of the injuries than the plaintiff, whereas in the present case the reverse appears.

(3) Plaintiff does not claim that defendants are in a better position than she to identify the manufacturer of the drug taken by her mother or, indeed, that they have the ability to do so at all, but argues, rather, that Summers does not impose such a requirement as a condition to the shifting of the burden of proof. In this respect we believe plaintiff is correct.

In Summers, the circumstances of the accident themselves precluded an explanation of its cause. To be sure, Summers states that defendants are "[o]rdinarily ... in a far better position to offer evidence to determine which one caused the injury" than a plaintiff (33 Cal.2d 80, at p. 86), but the decision does not determine that this "ordinary" situation was present. Neither the facts nor the language of the opinion indicate that the two defendants, simultaneously shooting in the same direction, were in a better position than the plaintiff to ascertain whose shot caused the injury. As the opinion acknowledges, it was impossible for the trial court to determine whether the shot which entered the plaintiff's eye came from the gun of one defendant or the other. Nevertheless, burden of proof was shifted to the defendants.

Here, as in Summers, the circumstances of the injury appear to render identification of the manufacturer of the drug ingested by plaintiff's mother impossible by either plaintiff or defendants, and it cannot reasonably be said that one is in a better position than the other to make the identification. Because many years elapsed between the time the drug was taken and the manifestation of plaintiff's injuries she, and many other daughters of mothers who took DES, are unable to make such identification.[12] Certainly there can be no implication that plaintiff [601] is at fault in failing to do so — the event occurred while plaintiff was in utero, a generation ago.[13]

On the other hand, it cannot be said with assurance that defendants have the means to make the identification. In this connection, they point out that drug manufacturers ordinarily have no direct contact with the patients who take a drug prescribed by their doctors. Defendants sell to wholesalers, who in turn supply the product to physicians and pharmacies. Manufacturers do not maintain records of the persons who take the drugs they produce, and the selection of the medication is made by the physician rather than the manufacturer. Nor do we conclude that the absence of evidence on this subject is due to the fault of defendants. While it is alleged that they produced a defective product with delayed effects and without adequate warnings, the difficulty or impossibility of identification results primarily from the passage of time rather than from their allegedly negligent acts of failing to provide adequate warnings. Thus Haft v. Lone Palm Hotel (1970) 3 Cal.3d 756 [91 Cal. Rptr. 745, 478 P.2d 465], upon which plaintiff relies, is distinguishable.[14]

It is important to observe, however, that while defendants do not have means superior to plaintiff to identify the maker of the precise drug [602] taken by her mother, they may in some instances be able to prove that they did not manufacture the injury-causing substance. In the present case, for example, one of the original defendants was dismissed from the action upon proof that it did not manufacture DES until after plaintiff was born.

Thus we conclude the fact defendants do not have greater access to information that might establish the identity of the manufacturer of the DES which injured plaintiff does not per se prevent application of the Summers rule.

(4) Nevertheless, plaintiff may not prevail in her claim that the Summers rationale should be employed to fix the whole liability for her injuries upon defendants, at least as those principles have previously been applied.[15] There is an important difference between the situation involved in Summers and the present case. There, all the parties who were or could have been responsible for the harm to the plaintiff were joined as defendants. Here, by contrast, there are approximately 200 drug companies which made DES, any of which might have manufactured the injury-producing drug.[16]

Defendants maintain that, while in Summers there was a 50 percent chance that one of the two defendants was responsible for the plaintiff's injuries, here since any one of 200 companies which manufactured DES [603] might have made the product that harmed plaintiff, there is no rational basis upon which to infer that any defendant in this action caused plaintiff's injuries, nor even a reasonable possibility that they were responsible.[17]

These arguments are persuasive if we measure the chance that any one of the defendants supplied the injury-causing drug by the number of possible tortfeasors. In such a context, the possibility that any of the five defendants supplied the DES to plaintiff's mother is so remote that it would be unfair to require each defendant to exonerate itself. There may be a substantial likelihood that none of the five defendants joined in the action made the DES which caused the injury, and that the offending producer not named would escape liability altogether. While we propose, infra, an adaptation of the rule in Summers which will substantially overcome these difficulties, defendants appear to be correct that the rule, as previously applied, cannot relieve plaintiff of the burden of proving the identity of the manufacturer which made the drug causing her injuries.[18]

II

The second principle upon which plaintiff relies is the so-called "concert of action" theory. Preliminarily, we briefly describe the procedure a drug manufacturer must follow before placing a drug on the market. Under federal law as it read prior to 1962, a new drug was defined as one "not generally recognized as ... safe." (§ 102, 76 Stat. 781 (Oct. 10, 1962).) Such a substance could be marketed only if a new drug application [604] had been filed with the Food and Drug Administration and had become "effective."[19] If the agency determined that a product was no longer a "new drug," i.e., that it was "generally recognized as ... safe," (21 U.S.C.A. § 321(p)(1) it could be manufactured by any drug company without submitting an application to the agency. According to defendants, 123 new drug applications for DES had been approved by 1952, and in that year DES was declared not to be a "new drug," thus allowing any manufacturer to produce it without prior testing and without submitting a new drug application to the Food and Drug Administration.

(5a) With this background we consider whether the complaint states a claim based upon "concert of action" among defendants. (6) The elements of this doctrine are prescribed in section 876 of the Restatement Second of Torts. The section provides, "For harm resulting to a third person from the tortious conduct of another, one is subject to liability if he (a) does a tortious act in concert with the other or pursuant to a common design with him, or (b) knows that the other's conduct constitutes a breach of duty and gives substantial assistance or encouragement to the other so to conduct himself, or (c) gives substantial assistance to the other in accomplishing a tortious result and his own conduct, separately considered, constitutes a breach of duty to the third person." With respect to this doctrine, Prosser states that "those who, in pursuance of a common plan or design to commit a tortious act, actively take part in it, or further it by cooperation or request, or who lend aid or encouragement to the wrongdoer, or ratify and adopt his acts done for their benefit, are equally liable with him. [¶] Express agreement is not necessary, and all that is required is that there be a tacit understanding...." (Prosser, Law of Torts (4th ed. 1971) § 46, p. 292.)

(5b) Plaintiff contends that her complaint states a cause of action under these principles. She alleges that defendants' wrongful conduct "is the result of planned and concerted action, express and implied agreements, collaboration in, reliance upon, acquiescence in and ratification, exploitation and adoption of each other's testing, marketing [605] methods, lack of warnings ... and other acts or omissions ..." and that "acting individually and in concert, [defendants] promoted, approved, authorized, acquiesced in, and reaped profits from sales" of DES. These allegations, plaintiff claims, state a "tacit understanding" among defendants to commit a tortious act against her.

In our view, this litany of charges is insufficient to allege a cause of action under the rules stated above. The gravamen of the charge of concert is that defendants failed to adequately test the drug or to give sufficient warning of its dangers and that they relied upon the tests performed by one another and took advantage of each others' promotional and marketing techniques. These allegations do not amount to a charge that there was a tacit understanding or a common plan among defendants to fail to conduct adequate tests or give sufficient warnings, and that they substantially aided and encouraged one another in these omissions.

The complaint charges also that defendants produced DES from a "common and mutually agreed upon formula," allowing pharmacists to treat the drug as a "fungible commodity" and to fill prescriptions from whatever brand of DES they had on hand at the time. It is difficult to understand how these allegations can form the basis of a cause of action for wrongful conduct by defendants, acting in concert. The formula for DES is a scientific constant. It is set forth in the United States Pharmacopoeia, and any manufacturer producing that drug must, with exceptions not relevant here, utilize the formula set forth in that compendium. (21 U.S.C.A. § 351(b).)

What the complaint appears to charge is defendants' parallel or imitative conduct in that they relied upon each others' testing and promotion methods. But such conduct describes a common practice in industry: a producer avails himself of the experience and methods of others making the same or similar products. Application of the concept of concert of action to this situation would expand the doctrine far beyond its intended scope and would render virtually any manufacturer liable for the defective products of an entire industry, even if it could be demonstrated that the product which caused the injury was not made by the defendant.

None of the cases cited by plaintiff supports a conclusion that defendants may be held liable for concerted tortious acts. They involve [606] conduct by a small number of individuals whose actions resulted in a tort against a single plaintiff, usually over a short span of time, and the defendant held liable was either a direct participant in the acts which caused damage,[20] or encouraged and assisted the person who directly caused the injuries by participating in a joint activity.[21]

Orser v. George (1967) 252 Cal. App.2d 660 [60 Cal. Rptr. 708], upon which plaintiff primarily relies, is also distinguishable. There, three hunters negligently shot at a mudhen in decedent's direction. Two of them shot alternately with the gun which released the bullet resulting in the fatal wound, and the third, using a different gun, fired alternately at the same target, shooting in the same line of fire, perhaps acting tortiously. It was held that there was a possibility the third hunter knew the conduct of the others was tortious toward the decedent and gave them substantial assistance and encouragement, and that it was also possible his conduct, separately considered, was a breach of duty toward decedent. Thus, the granting of summary judgment was reversed as to the third hunter.

The situation in Orser is similar to Agovino v. Kunze, supra, 181 Cal. App.2d 591, in which liability was imposed upon a participant in a drag race, rather than to the facts alleged in the present case. There is no allegation here that each defendant knew the other defendants' conduct was tortious toward plaintiff, and that they assisted and encouraged one another to inadequately test DES and to provide inadequate warnings. Indeed, it seems dubious whether liability on the concert of action theory can be predicated upon substantial assistance and encouragement given by one alleged tortfeasor to another pursuant to a tacit understanding to fail to perform an act. Thus, there was no concert of action among defendants within the meaning of that doctrine.

[607] III

A third theory upon which plaintiff relies is the concept of industry-wide liability, or according to the terminology of the parties, "enterprise liability." This theory was suggested in Hall v. E.I. Du Pont de Nemours & Co., Inc. (E.D.N.Y. 1972) 345 F. Supp. 353. In that case, plaintiffs were 13 children injured by the explosion of blasting caps in 12 separate incidents which occurred in 10 different states between 1955 and 1959. The defendants were six blasting cap manufacturers, comprising virtually the entire blasting cap industry in the United States, and their trade association. There were, however, a number of Canadian blasting cap manufacturers which could have supplied the caps. The gravamen of the complaint was that the practice of the industry of omitting a warning on individual blasting caps and of failing to take other safety measures created an unreasonable risk of harm, resulting in the plaintiffs' injuries. The complaint did not identify a particular manufacturer of a cap which caused a particular injury.[22]

The court reasoned as follows: there was evidence that defendants, acting independently, had adhered to an industry-wide standard with regard to the safety features of blasting caps, that they had in effect delegated some functions of safety investigation and design, such as labelling, to their trade association, and that there was industry-wide cooperation in the manufacture and design of blasting caps. In these circumstances, the evidence supported a conclusion that all the defendants [608] jointly controlled the risk. Thus, if plaintiffs could establish by a preponderance of the evidence that the caps were manufactured by one of the defendants, the burden of proof as to causation would shift to all the defendants. The court noted that this theory of liability applied to industries composed of a small number of units, and that what would be fair and reasonable with regard to an industry of five or ten producers might be manifestly unreasonable if applied to a decentralized industry composed of countless small producers.[23]

(7) Plaintiff attempts to state a cause of action under the rationale of Hall. She alleges joint enterprise and collaboration among defendants in the production, marketing, promotion and testing of DES, and "concerted promulgation and adherence to industry-wide testing, safety, warning and efficacy standards" for the drug. We have concluded above that allegations that defendants relied upon one another's testing and promotion methods do not state a cause of action for concerted conduct to commit a tortious act. Under the theory of industry-wide liability, however, each manufacturer could be liable for all injuries caused by DES by virtue of adherence to an industry-wide standard of safety.

In the Fordham Comment, the industry-wide theory of liability is discussed and refined in the context of its applicability to actions alleging injuries resulting from DES. The author explains causation under that theory as follows, "... [T]he industrywide standard becomes itself the cause of plaintiff's injury, just as defendants' joint plan is the cause of injury in the traditional concert of action plea. Each defendant's adherence perpetuates this standard, which results in the manufacture of the particular, unidentifiable injury-producing product. Therefore, each industry member has contributed to plaintiff's injury." (Fordham Comment, supra, at p. 997.)

The comment proposes seven requirements for a cause of action based upon industry-wide liability,[24] and suggests that if a plaintiff [609] proves these elements, the burden of proof of causation should be shifted to the defendants, who may exonerate themselves only by showing that their product could not have caused the injury.[25]

We decline to apply this theory in the present case. At least 200 manufacturers produced DES; Hall, which involved 6 manufacturers representing the entire blasting cap industry in the United States, cautioned against application of the doctrine espoused therein to a large number of producers. (345 F. Supp. at p. 378.) Moreover, in Hall, the conclusion that the defendants jointly controlled the risk was based upon allegations that they had delegated some functions relating to safety to a trade association. There are no such allegations here, and we have concluded above that plaintiff has failed to allege liability on a concert of action theory.

Equally important, the drug industry is closely regulated by the Food and Drug Administration, which actively controls the testing and manufacture of drugs and the method by which they are marketed, including the contents of warning labels.[26] To a considerable degree, therefore, the standards followed by drug manufacturers are suggested or compelled by the government. Adherence to those standards cannot, of course, absolve a manufacturer of liability to which it would otherwise be subject. (Stevens v. Parke, Davis & Co. (1973) 9 Cal.3d 51, 65 [107 [610] Cal. Rptr. 45, 507 P.2d 653, 94 A.L.R.3d 1059].) But since the government plays such a pervasive role in formulating the criteria for the testing and marketing of drugs, it would be unfair to impose upon a manufacturer liability for injuries resulting from the use of a drug which it did not supply simply because it followed the standards of the industry.[27]

IV

(8) If we were confined to the theories of Summers and Hall, we would be constrained to hold that the judgment must be sustained. Should we require that plaintiff identify the manufacturer which supplied the DES used by her mother or that all DES manufacturers be joined in the action, she would effectively be precluded from any recovery. As defendants candidly admit, there is little likelihood that all the manufacturers who made DES at the time in question are still in business or that they are subject to the jurisdiction of the California courts. There are, however, forceful arguments in favor of holding that plaintiff has a cause of action.

In our contemporary complex industrialized society, advances in science and technology create fungible goods which may harm consumers and which cannot be traced to any specific producer. The response of the courts can be either to adhere rigidly to prior doctrine, denying recovery to those injured by such products, or to fashion remedies to meet these changing needs. Just as Justice Traynor in his landmark concurring opinion in Escola v. Coca Cola Bottling Co. (1944) 24 Cal.2d 453, 467-468 [150 P.2d 436], recognized that in an era of mass production and complex marketing methods the traditional standard of negligence was insufficient to govern the obligations of manufacturer to consumer, so should we acknowledge that some adaptation of the rules of causation and liability may be appropriate in these recurring circumstances. The Restatement comments that modification of the Summers rule may be necessary in a situation like that before us. (See fn. 16, ante.)

The most persuasive reason for finding plaintiff states a cause of action is that advanced in Summers: as between an innocent plaintiff and [611] negligent defendants, the latter should bear the cost of the injury. Here, as in Summers, plaintiff is not at fault in failing to provide evidence of causation, and although the absence of such evidence is not attributable to the defendants either, their conduct in marketing a drug the effects of which are delayed for many years played a significant role in creating the unavailability of proof.

From a broader policy standpoint, defendants are better able to bear the cost of injury resulting from the manufacture of a defective product. As was said by Justice Traynor in Escola, "[t]he 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." (24 Cal.2d p. 462; see also Rest.2d Torts, § 402A, com. c, pp. 349-350.) The manufacturer is in the best position to discover and guard against defects in its products and to warn of harmful effects; thus, holding it liable for defects and failure to warn of harmful effects will provide an incentive to product safety. (Cronin v. J.B.E. Olson Corp. (1972) 8 Cal.3d 121, 129 [104 Cal. Rptr. 433, 501 P.2d 1153]; Beech Aircraft Corp. v. Superior Court (1976) 61 Cal. App.3d 501, 522-523 [132 Cal. Rptr. 541].) These considerations are particularly significant where medication is involved, for the consumer is virtually helpless to protect himself from serious, sometimes permanent, sometimes fatal, injuries caused by deleterious drugs.

Where, as here, all defendants produced a drug from an identical formula and the manufacturer of the DES which caused plaintiff's injuries cannot be identified through no fault of plaintiff, a modification of the rule of Summers is warranted. As we have seen, an undiluted Summers rationale is inappropriate to shift the burden of proof of causation to defendants because if we measure the chance that any particular manufacturer supplied the injury-causing product by the number of producers of DES, there is a possibility that none of the five defendants in this case produced the offending substance and that the responsible manufacturer, not named in the action, will escape liability.

But we approach the issue of causation from a different perspective: we hold it to be reasonable in the present context to measure the likelihood that any of the defendants supplied the product which allegedly injured plaintiff by the percentage which the DES sold by each of them for the purpose of preventing miscarriage bears to the entire production [612] of the drug sold by all for that purpose. Plaintiff asserts in her briefs that Eli Lilly and Company and five or six other companies produced 90 percent of the DES marketed. If at trial this is established to be the fact, then there is a corresponding likelihood that this comparative handful of producers manufactured the DES which caused plaintiff's injuries, and only a 10 percent likelihood that the offending producer would escape liability.[28]

If plaintiff joins in the action the manufacturers of a substantial share of the DES which her mother might have taken, the injustice of shifting the burden of proof to defendants to demonstrate that they could not have made the substance which injured plaintiff is significantly diminished. While 75 to 80 percent of the market is suggested as the requirement by the Fordham Comment (at p. 996), we hold only that a substantial percentage is required.

The presence in the action of a substantial share of the appropriate market also provides a ready means to apportion damages among the defendants. Each defendant will be held liable for the proportion of the judgment represented by its share of that market unless it demonstrates that it could not have made the product which caused plaintiff's injuries. In the present case, as we have seen, one DES manufacturer was dismissed from the action upon filing a declaration that it had not manufactured DES until after plaintiff was born. Once plaintiff has met her burden of joining the required defendants, they in turn may cross-complain against other DES manufacturers, not joined in the action, which they can allege might have supplied the injury-causing product.

Under this approach, each manufacturer's liability would approximate its responsibility for the injuries caused by its own products. Some minor discrepancy in the correlation between market share and liability is inevitable; therefore, a defendant may be held liable for a somewhat different percentage of the damage than its share of the appropriate [613] market would justify. It is probably impossible, with the passage of time, to determine market share with mathematical exactitude. But just as a jury cannot be expected to determine the precise relationship between fault and liability in applying the doctrine of comparative fault (Li v. Yellow Cab Co. (1975) 13 Cal.3d 804 [119 Cal. Rptr. 858, 532 P.2d 1226, 78 A.L.R.3d 393]) or partial indemnity (American Motorcycle Assn. v. Superior Court (1978) 20 Cal.3d 578 [146 Cal. Rptr. 182, 578 P.2d 899]), the difficulty of apportioning damages among the defendant producers in exact relation to their market share does not seriously militate against the rule we adopt. As we said in Summers with regard to the liability of independent tortfeasors, where a correct division of liability cannot be made "the trier of fact may make it the best it can." (33 Cal.2d at p. 88.)

We are not unmindful of the practical problems involved in defining the market and determining market share,[29] but these are largely matters of proof which properly cannot be determined at the pleading stage of these proceedings. Defendants urge that it would be both unfair and contrary to public policy to hold them liable for plaintiff's injuries in the absence of proof that one of them supplied the drug responsible for the damage. Most of their arguments, however, are based upon the assumption that one manufacturer would be held responsible for the products of another or for those of all other manufacturers if plaintiff ultimately prevails. But under the rule we adopt, each manufacturer's liability for an injury would be approximately equivalent to the damage caused by the DES it manufactured.[30]

The judgments are reversed.

Bird, C.J., Newman, J., and White, J.,[31] concurred.

[614] RICHARDSON, J.

I respectfully dissent. In these consolidated cases the majority adopts a wholly new theory which contains these ingredients: The plaintiffs were not alive at the time of the commission of the tortious acts. They sue a generation later. They are permitted to receive substantial damages from multiple defendants without any proof that any defendant caused or even probably caused plaintiffs' injuries.

Although the majority purports to change only the required burden of proof by shifting it from plaintiffs to defendants, the effect of its holding is to guarantee that plaintiffs will prevail on the causation issue because defendants are no more capable of disproving factual causation than plaintiffs are of proving it. "Market share" liability thus represents a new high water mark in tort law. The ramifications seem almost limitless, a fact which prompted one recent commentator, in criticizing a substantially identical theory, to conclude that "Elimination of the burden of proof as to identification [of the manufacturer whose drug injured plaintiff] would impose a liability which would exceed absolute liability." (Coggins, Industry-Wide Liability (1979) 13 Suffolk L.Rev. 980, 998, fn. omitted; see also, pp. 1000-1001.) In my view, the majority's departure from traditional tort doctrine is unwise.

The applicable principles of causation are very well established. A leading torts scholar, Dean Prosser, has authoritatively put it this way: "An essential element of the plaintiff's cause of action for negligence, or for that matter for any other tort, is that there be some reasonable connection between the act or omission of the defendant and the damage which the plaintiff has suffered." (Prosser, Torts (4th ed. 1971) § 41, p. 236, italics added.) With particular reference to the matter before us, and in the context of products liability, the requirement of a causation element has been recognized as equally fundamental. "It is clear that any holding that a producer, manufacturer, seller, or a person in a similar position, is liable for injury caused by a particular product, must necessarily be predicated upon proof that the product in question was one for whose condition the defendant was in some way responsible. Thus, for example, if recovery is sought from a manufacturer, it must be shown that he actually was the manufacturer of the product which caused the injury; ..." (1 Hursh & Bailey, American Law of Products Liability (2d ed. 1974) § 1:41, p. 125, italics added; accord, Prosser, supra, § 103, at pp. 671-672; 2 Dooley, Modern Tort Law (1977) § 32.03, p. 243.) Indeed, an inability to prove this causal link between defendant's conduct and plaintiff's injury has proven fatal in prior cases [615] brought against manufacturers of DES by persons who were situated in positions identical to those of plaintiffs herein. (See McCreery v. Eli Lilly & Co. (1978) 87 Cal. App.3d 77, 82 [150 Cal. Rptr. 730]; Gray v. United States (S.D.Tex. 1978) 445 F. Supp. 337, 338.)

The majority now expressly abandons the foregoing traditional requirement of some causal connection between defendants' act and plaintiffs' injury in the creation of its new modified industry-wide tort. Conceptually, the doctrine of absolute liability which heretofore in negligence law has substituted only for the requirement of a breach of defendant's duty of care, under the majority's hand now subsumes the additional necessity of a causal relationship.

According to the majority, in the present case plaintiffs have openly conceded that they are unable to identify the particular entity which manufactured the drug consumed by their mothers. In fact, plaintiffs have joined only five of the approximately two hundred drug companies which manufactured DES. Thus, the case constitutes far more than a mere factual variant upon the theme composed in Summers v. Tice (1948) 33 Cal.2d 80 [199 P.2d 1], wherein plaintiff joined as codefendants the only two persons who could have injured him. As the majority must acknowledge, our Summers rule applies only to cases in which "... it is proved that harm has been caused to the plaintiff by ... one of [the named defendants], but there is uncertainty as to which one has caused it, ..." (Rest.2d Torts, § 433B, subd. (3).) In the present case, in stark contrast, it remains wholly speculative and conjectural whether any of the five named defendants actually caused plaintiffs' injuries.

The fact that plaintiffs cannot tie defendants to the injury-producing drug does not trouble the majority for it declares that the Summers requirement of proof of actual causation by a named defendant is satisfied by a joinder of those defendants who have together manufactured "a substantial percentage" of the DES which has been marketed. Notably lacking from the majority's expression of its new rule, unfortunately, is any definition or guidance as to what should constitute a "substantial" share of the relevant market. The issue is entirely open-ended and the answer, presumably, is anyone's guess.

Much more significant, however, is the consequence of this unprecedented extension of liability. Recovery is permitted from a handful of defendants each of whom individually may account for a comparatively [616] small share of the relevant market, so long as the aggregate business of those who have been sued is deemed "substantial." In other words, a particular defendant may be held proportionately liable even though mathematically it is much more likely than not that it played no role whatever in causing plaintiffs' injuries. Plaintiffs have strikingly capsulated their reasoning by insisting "... that while one manufacturer's product may not have injured a particular plaintiff, we can assume that it injured a different plaintiff and all we are talking about is a mere matching of plaintiffs and defendants." (Counsel's letter (Oct. 16, 1979) p. 3.) In adopting the foregoing rationale the majority rejects over 100 years of tort law which required that before tort liability was imposed a "matching" of defendant's conduct and plaintiff's injury was absolutely essential. Furthermore, in bestowing on plaintiffs this new largess the majority sprinkles the rain of liability upon all the joined defendants alike — those who may be tortfeasors and those who may have had nothing at all to do with plaintiffs' injury — and an added bonus is conferred. Plaintiffs are free to pick and choose their targets.

The "market share" thesis may be paraphrased. Plaintiffs have been hurt by someone who made DES. Because of the lapse of time no one can prove who made it. Perhaps it was not the named defendants who made it, but they did make some. Although DES was apparently safe at the time it was used, it was subsequently proven unsafe as to some daughters of some users. Plaintiffs have suffered injury and defendants are wealthy. There should be a remedy. Strict products liability is unavailable because the element of causation is lacking. Strike that requirement and label what remains "alternative" liability, "industry-wide" liability, or "market share" liability, proving thereby that if you hit the square peg hard and often enough the round holes will really become square, although you may splinter the board in the process.

The foregoing result is directly contrary to long established tort principles. Once again, in the words of Dean Prosser, the applicable rule is: "[Plaintiff] must introduce evidence which affords a reasonable basis for the conclusion that it is more likely than not that the conduct of the defendant was a substantial factor in bringing about the result. A mere possibility of such causation is not enough; and when the matter remains one of pure speculation or conjecture, or the probabilities are at best evenly balanced, it becomes the duty of the court to direct a verdict for the defendant." (Prosser, supra, § 41, at p. 241, italics added, fns. [617] omitted.) Under the majority's new reasoning, however, a defendant is fair game if it happens to be engaged in a similar business and causation is possible, even though remote.

In passing, I note the majority's dubious use of market share data. It is perfectly proper to use such information to assist in proving, circumstantially, that a particular defendant probably caused plaintiffs' injuries. Circumstantial evidence may be used as a basis for proving the requisite probable causation. (Id., at p. 242.) The majority, however, authorizes the use of such evidence for an entirely different purpose, namely, to impose and allocate liability among multiple defendants only one of whom may have produced the drug which injured plaintiffs. Because this use of market share evidence does not implicate any particular defendant, I believe such data are entirely irrelevant and inadmissible, and that the majority errs in such use. In the absence of some statutory authority there is no legal basis for such use.

Although seeming to acknowledge that imposition of liability upon defendants who probably did not cause plaintiffs' injuries is unfair, the majority justifies this inequity on the ground that "each manufacturer's liability for an injury would be approximately equivalent to the damages caused by the DES it manufactured." (Ante, p. 613.) In other words, because each defendant's liability is proportionate to its market share, supposedly "each manufacturer's liability would approximate its responsibility for the injuries caused by his own products." (Ante, p. 612.) The majority dodges the "practical problems" thereby presented, choosing to describe them as "matters of proof." However, the difficulties, in my view, are not so easily ducked, for they relate not to evidentiary matters but to the fundamental question of liability itself.

Additionally, it is readily apparent that "market share" liability will fall unevenly and disproportionately upon those manufacturers who are amenable to suit in California. On the assumption that no other state will adopt so radical a departure from traditional tort principles, it may be concluded that under the majority's reasoning those defendants who are brought to trial in this state will bear effective joint responsibility for 100 percent of plaintiffs' injuries despite the fact that their "substantial" aggregate market share may be considerably less. This undeniable fact forces the majority to concede that, "a defendant may be held liable for a somewhat different percentage of the damage than its share of the appropriate market would justify." (Ante, pp. 612-613.) [618] With due deference, I suggest that the complete unfairness of such a result in a case involving only five of two hundred manufacturers is readily manifest.

Furthermore, several other important policy considerations persuade me that the majority holding is both inequitable and improper. The injustice inherent in the majority's new theory of liability is compounded by the fact that plaintiffs who use it are treated far more favorably than are the plaintiffs in routine tort actions. In most tort cases plaintiff knows the identity of the person who has caused his injuries. In such a case, plaintiff, of course, has no option to seek recovery from an entire industry or a "substantial" segment thereof, but in the usual instance can recover, if at all, only from the particular defendant causing injury. Such a defendant may or may not be either solvent or amenable to process. Plaintiff in the ordinary tort case must take a chance that defendant can be reached and can respond financially. On what principle should those plaintiffs who wholly fail to prove any causation, an essential element of the traditional tort cause of action, be rewarded by being offered both a wider selection of potential defendants and a greater opportunity for recovery?

The majority attempts to justify its new liability on the ground that defendants herein are "better able to bear the cost of injury resulting from the manufacture of a defective product." (Ante, p. 611.) This "deep pocket" theory of liability, fastening liability on defendants presumably because they are rich, has understandable popular appeal and might be tolerable in a case disclosing substantially stronger evidence of causation than herein appears. But as a general proposition, a defendant's wealth is an unreliable indicator of fault, and should play no part, at least consciously, in the legal analysis of the problem. In the absence of proof that a particular defendant caused or at least probably caused plaintiff's injuries, a defendant's ability to bear the cost thereof is no more pertinent to the underlying issue of liability than its "substantial" share of the relevant market. A system priding itself on "equal justice under law" does not flower when the liability as well as the damage aspect of a tort action is determined by a defendant's wealth. The inevitable consequence of such a result is to create and perpetuate two rules of law — one applicable to wealthy defendants, and another standard pertaining to defendants who are poor or who have modest means. Moreover, considerable doubts have been expressed regarding the ability of the drug industry, and especially its smaller members, to bear the substantial economic costs (from both damage awards and [619] high insurance premiums) inherent in imposing an industry-wide liability. (See Coggins, supra, 13 Suffolk L.Rev. at pp. 1003-1006, 1010-1011.)

An important and substantial countervailing public policy in defendants' favor was very recently expressed in a similar DES case, McCreery v. Eli Lilly & Co., supra, 87 Cal. App.3d 77, 86-87. Although the majority herein impliedly rejects the appellate court's holding, in my opinion pertinent language of the McCreery court, based upon the Restatement of Torts and bearing on the majority's "market share" theory, is well worth repeating: "Application of the comments to the Restatement Second of Torts, section 402A, to this situation compels a rejection of the imposition of liability. As the comment states, `... It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk. The seller of such products, again, with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.' (Rest. 2d Torts, § 402A, com. k.) This section implicitly recognizes the social policy behind the development of new pharmaceutical preparations. As one commentator states, `[t]he social and economic benefits from mobilizing the industry's resources in the war against disease and in reducing the costs of medical care are potentially enormous. The development of new drugs in the last three decades has already resulted in great social benefits. The potential gains from further advances remain large. To risk such gains is unwise. Our major objective should be to encourage a continued high level of industry investment in pharmaceutical R & D [research and development].' (Schwartzman, The Expected Return from Pharmaceutical Research: Sources of New Drugs and the Profitability of R & D Investment (1975) p. 54.)" (McCreery v. Eli Lilly & Co., supra, 87 Cal. App.3d 77, 86-87, italics added; see also Coggins, supra, 13 Suffolk L.Rev. at p. 1004.)

In the present case the majority imposes liability more than 20 years after ingestion of drugs which at the time they were used, after careful [620] testing, had the full approval of the United States Food and Drug Administration. It seems to me that liability in the manner created by the majority must inevitably inhibit, if not the research or development, at least the dissemination of new pharmaceutical drugs. Such a result, as explained by the Restatement, is wholly inconsistent with traditional tort theory.

I also suggest that imposition of so sweeping a liability may well prove to be extremely shortsighted from the standpoint of broad social policy. Who is to say whether, and at what time and in what form, the drug industry upon which the majority now fastens this blanket liability, may develop a miracle drug critical to the diagnosis, treatment, or, indeed, cure of the very disease in question? It is counterproductive to inflict civil damages upon all manufacturers for the side effects and medical complications which surface in the children of the users a generation after ingestion of the drugs, particularly when, at the time of their use, the drugs met every fair test and medical standard then available and applicable. Such a result requires of the pharmaceutical industry a foresight, prescience and anticipation far beyond the most exacting standards of the relevant scientific disciplines. In effect, the majority requires the pharmaceutical research laboratory to install a piece of new equipment — the psychic's crystal ball.

I am not unmindful of the serious medical consequences of plaintiffs' injuries, and the equally serious implications to the class which she purports to represent. In balancing the various policy considerations, however, I also observe that the incidence of vaginal cancer among "DES daughters" has been variously estimated at one-tenth of 1 percent to four-tenths of 1 percent. (13 Suffolk L.Rev., supra, p. 999, fn. 92.) These facts raise some penetrating questions. Ninety-nine plus percent of "DES daughters" have never developed cancer. Must a drug manufacturer to escape this blanket liability wait for a generation of testing before it may disseminate drugs similar to DES? If a drug has beneficial purposes for the majority of users but harmful side-effects are later revealed for a small fraction of consumers, will the manufacturer be absolutely liable? If adverse medical consequences, wholly unknown to the most careful and meticulous of present scientists, surface in two or three generations, will similar liability be imposed? In my opinion, common sense and reality combine to warn that a "market share" theory goes too far. Legally, it expects too much.

[621] I believe that the scales of justice tip against imposition of this new liability because of the foregoing elements of unfairness to some defendants who may have had nothing whatever to do with causing any injury, the unwarranted preference created for this particular class of plaintiffs, the violence done to traditional tort principles by the drastic expansion of liability proposed, the injury threatened to the public interest in continued unrestricted basic medical research as stressed by the Restatement, and the other reasons heretofore expressed.

The majority's decision effectively makes the entire drug industry (or at least its California members) an insurer of all injuries attributable to defective drugs of uncertain or unprovable origin, including those injuries manifesting themselves a generation later, and regardless of whether particular defendants had any part whatever in causing the claimed injury. Respectfully, I think this is unreasonable overreaction for the purpose of achieving what is perceived to be a socially satisfying result.

Finally, I am disturbed by the broad and ominous ramifications of the majority's holding. The law review comment, which is the wellspring of the majority's new theory, conceding the widespread consequences of industry-wide liability, openly acknowledges that "The DES cases are only the tip of an iceberg." (Comment, DES and a Proposed Theory of Enterprise Liability (1978) 46 Fordham L.Rev. 963, 1007.) Although the pharmaceutical drug industry may be the first target of this new sanction, the majority's reasoning has equally threatening application to many other areas of business and commercial activities.

Given the grave and sweeping economic, social, and medical effects of "market share" liability, the policy decision to introduce and define it should rest not with us, but with the Legislature which is currently considering not only major statutory reform of California product liability law in general, but the DES problem in particular. (See Sen. Bill No. 1392 (1979-1980 Reg. Sess.), which would establish and appropriate funds for the education, identification, and screening of persons exposed to DES, and would prohibit health care and hospital service plans from excluding or limiting coverage to persons exposed to DES.) An alternative proposal for administrative compensation, described as "a limited version of no-fault products liability" has been suggested by one commentator. (Coggins, supra, 13 Suffolk L.Rev. at pp. 1019-1021.) Compensation under such a plan would be awarded by an administrative [622] tribunal from funds collected "via a tax paid by all manufacturers." (P. 1020, fn. omitted.) In any event, the problem invites a legislative rather than an attempted judicial solution.

I would affirm the judgments of dismissal.

Clark, J., and Manuel, J., concurred.

Respondents' petitions for a rehearing were denied May 7, 1980. Tobriner, J., did not participate therein. White, J.,[32] participated therein. Clark, J., Richardson, J., and Manuel, J., were of the opinion that the petitions should be granted.

[1] The plaintiff class alleged consists of "girls and women who are residents of California and who have been exposed to DES before birth and who may or may not know that fact or the dangers" to which they were exposed. Defendants are also sued as representatives of a class of drug manufacturers which sold DES after 1941.

[2] It is alleged also that defendants failed to determine if there was any means to avoid or treat the effects of DES upon the daughters of women exposed to it during pregnancy, and failed to monitor the carcinogenic effects of the drug.

[3] There are minor variations in the procedures employed as to the various defendants. Thus, for example, Eli Lilly and Company filed a motion for summary judgment, or alternatively judgment on the pleadings, rather than a demurrer; the court treated the motion as a demurrer.

The demurrer of Abbott Laboratories, the first defendant to file a demurrer and the first to secure a dismissal, was sustained with leave to amend on the ground that plaintiff had failed to allege that a product manufactured by Abbott had caused her injuries (as opposed to the reason given by the trial court for sustaining the demurrers of the other defendants that plaintiff expressly stated that she could not identify a particular manufacturer). Upon plaintiff's failure to amend the complaint, the action was dismissed as to Abbott. A few days after the dismissal, plaintiff stated in a brief in opposition to the demurrers filed by defendants other than Abbott that she could not make the identification.

Abbott asserts that as to it the issue we consider on the appeal is not properly raised because plaintiff's statement that she could not identify the manufacturer was not made until after the action had been dismissed as to Abbott. This contention is without merit. Plaintiff's failure to amend her complaint after Abbott's demurrer was sustained with leave to amend was based upon her inability to identify a specific manufacturer. Clearly, Abbott interpreted the complaint in this fashion, for it moved for dismissal on the ground that the complaint alleges that plaintiff "does not know the identity of the drug ... ingested" by her mother. Thus, Abbott may not now claim that the complaint is insufficient to raise the issue involved in this appeal.

The trial court did not determine other issues raised by the complaint, such as whether the case was properly brought as a class action.

[4] Abbott Laboratories, Eli Lilly and Company, E.R. Squibb and Sons, the Upjohn Company, and Rexall Drug Company are respondents. The action was dismissed or the appeal abandoned on various grounds as to other defendants named in the complaint; e.g., one defendant demonstrated it had not manufactured DES during the period plaintiff's mother took the drug.

[5] While the trial court did not specify the ground upon which the demurrers were sustained, the points and authorities filed by the parties emphasized the failure of Rogers to identify a particular manufacturer as the source of her injuries, and we may assume for the purpose of this appeal that this was the basis of the court's order.

[6] DES was marketed under many different trade names.

[7] In a recent New York case a jury found in the plaintiff's favor in spite of her inability to identify a specific manufacturer of DES. An appeal is pending. (Bichler v. Eli Lilly and Co. (Sup.Ct.N.Y. 1979).) A Michigan appellate court recently held that plaintiffs had stated a cause of action against several manufacturers of DES even though identification could not be made. (Abel v. Eli Lilly and Co. (decided Dec. 5, 1979) Dock. No. 60497.) That decision is on appeal to the Supreme Court of Michigan.

[8] E.g., Gray v. United States (S.D. Tex. 1978) 445 F. Supp. 337. In their briefs, defendants refer to a number of other cases in which trial courts have dismissed actions in DES cases on the ground stated above.

[9] The term "enterprise liability" is sometimes used broadly to mean that losses caused by an enterprise should be borne by it. (Klemme, Enterprise Liability Theory of Torts (1976) 47 Colo. L.Rev. 153, 158.)

[10] Other cases cited by plaintiff for the proposition stated in Summers are only peripherally relevant. For example, in Ray v. Alad Corp. (1977) 19 Cal.3d 22 [136 Cal. Rptr. 574, 560 P.2d 3], the plaintiff brought an action in strict liability for personal injuries sustained when he fell from a defective ladder manufactured by the defendant's predecessor corporation. We held that, although under the general rule governing corporate succession the defendant could not be held responsible, nevertheless a "special departure" from that rule was justified in the particular circumstances. The defendant had succeeded to the good will of the manufacturer of the ladder, and it could obtain insurance against the risk of liability, whereas the plaintiff would be left without redress if he could not hold the defendant liable. The question whether one corporation should, for policy reasons, be answerable for the products manufactured by its predecessor is a different issue than that we describe above.

[11] Section 433B, subdivision (3) of the Restatement provides: "Where the conduct of two or more actors is tortious, and it is proved that harm has been caused to the plaintiff by only one of them, but there is uncertainty as to which one has caused it, the burden is upon each such actor to prove that he has not caused the harm." The reason underlying the rule is "the injustice of permitting proved wrongdoers, who among them have inflicted an injury upon the entirely innocent plaintiff, to escape liability merely because the nature of their conduct and the resulting harm has made it difficult or impossible to prove which of them has caused the harm." (Rest.2d Torts, § 433B, com. f, p. 446.)

[12] The trial court was not required to determine whether plaintiff had made sufficient efforts to establish identification since it concluded that her failure to do so was fatal to her claim. The court accepted at face value plaintiff's assertion that she could not make the identification, and for purposes of this appeal we make the same assumption.

[13] Defendants maintain that plaintiff is in a better position than they are to identify the manufacturer because her mother might recall the name of the prescribing physician or the hospital or pharmacy where the drug originated, and might know the brand and strength of dosage, the appearance of the medication, or other details from which the manufacturer might be identified, whereas they possess none of this information. As we point out in footnote 12, we assume for purposes of this appeal that plaintiff cannot point to any particular manufacturer as the producer of the DES taken by her mother.

[14] In Haft, a father and his young son drowned in defendants' swimming pool. There were no witnesses to the accident. Defendants were negligent in failing to provide a lifeguard, as required by law. We held that the absence of evidence of causation was a direct and foreseeable result of the defendants' negligence, and that, therefore, the burden of proof on the issue of causation was upon defendants. Plaintiff attempts to bring herself within this holding. She asserts that defendants' failure to discover or warn of the dangers of DES and to label the drug as experimental caused her mother to fail to keep records or remember the brand name of the drug prescribed to her "since she was unaware of any reason to do so for a period of 10 to 20 years." There is no proper analogy to Haft here. While in Haft the presence of a lifeguard on the scene would have provided a witness to the accident and probably prevented it, plaintiff asks us to speculate that if the DES taken by her mother had been labelled as an experimental drug, she would have recalled or recorded the name of the manufacturer and passed this information on to her daughter. It cannot be said here that the absence of evidence of causation was a "direct and forseeable result" of defendants' failure to provide a warning label.

[15] Plaintiff relies upon three older cases for the proposition that the burden of proof may be shifted to defendants to explain the cause of an accident even if less than all of them are before the court. (Benson v. Ross (1906) 143 Mich. 452 [106 N.W. 1120]; Moore v. Foster (1938) 182 Miss. 15 [180 So. 73]; Oliver v. Miles (1927) 144 Miss. 852 [110 So. 666].) These cases do not relate to the shifting of the burden of proof; rather, they imposed liability upon one of two or more joint tortfeasors on the ground that they acted in concert in committing a negligent act. This theory of concerted action as a basis for defendants' liability will be discussed infra. In Summers, we stated that these cases were "straining" the concept of concerted action and that the "more reasonable" basis for holding defendants jointly liable when more than one of them had committed a tort and plaintiff could not establish the identity of the party who had caused the damage was the danger that otherwise two negligent parties might be exonerated. (Summers, 33 Cal.2d 80, at pp. 84-85.)

[16] According to the Restatement, the burden of proof shifts to the defendants only if the plaintiff can demonstrate that all defendants acted tortiously and that the harm resulted from the conduct of one of them. (Rest.2d Torts, § 433B, com. g, p. 446.) It goes on to state that the rule thus far has been applied only where all the actors involved are joined as defendants and where the conduct of all is simultaneous in time, but cases might arise in which some modification of the rule would be necessary if one of the actors is or cannot be joined, or because of the effects of lapse of time, or other circumstances. (Id., com. h, p. 446.)

[17] Defendants claim further that the effect of shifting the burden of proof to them to demonstrate that they did not manufacture the DES which caused the injury would create a rebuttable presumption that one of them made the drug taken by plaintiff's mother, and that this presumption would deny them due process because there is no rational basis for the inference.

[18] Garcia v. Joseph Vince Co., supra, 84 Cal. App.3d 868, relied upon by defendants, presents a distinguishable factual situation. The plaintiff in Garcia was injured by a defective saber. He was unable to identify which of two manufacturers had produced the weapon because it was commingled with other sabers after the accident. In a suit against both manufacturers, the court refused to apply the Summers rationale on the ground that the plaintiff had not shown that either defendant had violated a duty to him. Thus in Garcia, only one of the two defendants was alleged to have manufactured a defective product, and the plaintiff's inability to identify which of the two was negligent resulted in a judgment for both defendants. (See also Wetzel v. Eaton Corporation, supra, 62 F.R.D. 22.) Here, by contrast, the DES manufactured by all defendants is alleged to be defective, but plaintiff is unable to demonstrate which of the defendants supplied the precise DES which caused her injuries.

[19] A new drug application became "effective" automatically if the Secretary of Health, Education and Welfare failed within a certain period of time to disapprove the application. If the agency had insufficient information to decide whether the drug was safe or had information that it was unsafe, the application was denied. (§ 505, 52 Stat. 1052 (June 25, 1938).) Since 1962, affirmative approval of an application has been required before a new drug may be marketed. (21 U.S.C.A. § 355(c).)

[20] Weinberg Co. v. Bixby (1921) 185 Cal. 87, 103 [196 P. 25], involved a husband who was held liable with his wife for wrongful diversion of flood waters although he had given his wife title to the land upon which the outlet causing the diversion was constructed. He not only owned land affected by the flood waters, but he was his wife's agent for the purpose of reopening the outlet which caused the damage. In Meyer v. Thomas (1936) 18 Cal. App.2d 299, 305-306 [63 P.2d 1176], both defendants participated in the conversion of a note and deed of trust.

[21] In Agovino v. Kunze (1960) 181 Cal. App.2d 591, 599 [5 Cal. Rptr. 534], a participant in a drag race was held liable for injuries to a plaintiff who collided with the car of another racer. In Loeb v. Kimmerle (1932) 215 Cal. 143, 151 [9 P.2d 199], a defendant who encouraged another defendant to commit an assault was held jointly liable for the plaintiff's injuries. Also see Weirum v. RKO General, Inc. (1975) 15 Cal.3d 40 [123 Cal. Rptr. 468, 539 P.2d 36].

[22] We deliberately employ the term "suggested" to describe the effect of the Hall opinion because of the uncertain posture of the decision as authority. The defendants moved to dismiss the action on the ground that the plaintiffs had not stated a claim, and they also sought to sever the claims of the various plaintiffs and transfer them to the district court in the place where each accident occurred. The opinion discusses various possible bases of liability, including industry-wide liability, upon the assumption that there existed a national body of state tort law. (345 F. Supp. at p. 360.) At the conclusion of its opinion, the court called for briefs on the choice-of-law issues involved in the case. In a subsequent opinion, the same court decided, after briefs had been filed on the choice-of-law question, that the plaintiffs' claims should be severed, and it transferred each one to the federal court sitting in the district where the accident occurred. (Chance v. E.I. Du Pont de Nemours & Co., Inc. (E.D.N.Y 1974) 371 F. Supp. 439.) Thereafter, the transferred cases resulted in judgments for defendants upon various grounds unrelated to the theory of industry-wide liability. (Lehtonen v. E.I. Du Pont de Nemours & Co., Inc. (D.Mont. 1975) 389 F. Supp. 633 [failure to amend complaint within 30 days]; Davis v. E.I. Du Pont de Nemours & Co., Inc. (W.D.N.C. 1974) 400 F. Supp. 1347 [statute of limitations]; Ball v. E.I. Du Pont de Nemours & Co., Inc. (6th Cir.1975) 519 F.2d 715 [jury verdict in favor of defendant after plaintiff identified the manufacturer of the blasting cap which caused his injuries].) The parties have not indicated the status of the remaining cases transferred.

[23] In discussing strict liability, the Hall court mentioned the drug industry, stating, "In cases where manufacturers have more experience, more information, and more control over the risky properties of their products than do drug manufacturers, courts have applied a broader concept of forseeability which approaches the enterprise liability rationale." (345 F. Supp. 353 at p. 370.)

[24] The suggested requirements are as follows:

1. There existed an insufficient, industry-wide standard of safety as to the manufacture of the product.

2. Plaintiff is not at fault for the absence of evidence identifying the causative agent but, rather, this absence of proof is due to defendant's conduct.

3. A generically similar defective product was manufactured by all the defendants.

4. Plaintiff's injury was caused by this defect.

5. Defendants owed a duty to the class of which plaintiff was a member.

6. There is clear and convincing evidence that plaintiff's injury was caused by a product made by one of the defendants. For example, the joined defendants accounted for a high percentage of such defective products on the market at the time of plaintiff's injury.

7. All defendants were tortfeasors.

[25] The Fordham Comment takes exception to one aspect of the theory of industry-wide liability as set forth in Hall, i.e., the conclusion that a plaintiff is only required to show by a preponderance of the evidence that one of the defendants manufactured the product which caused her injury. The comment suggests that a plaintiff be required to prove by clear and convincing evidence that one of the defendants before the court was responsible and that this standard of proof would require that the plaintiff join in the action the producers of 75 or 80 percent of the DES prescribed for prevention of miscarriage. It is also suggested that the damages be apportioned among the defendants according to their share of the market for DES. (Fordham Comment, supra, at pp. 999-1000.)

[26] Federal regulations may specify the type of tests a manufacturer must perform for certain drugs (21 C.F.R. § 436.206 et seq.), the type of packaging used (§ 429.10), the warnings which appear on labels (§ 369.20), and the standards to be followed in the manufacture of a drug (§ 211.22 et seq.).

[27] Abel v. Eli Lilly and Company, the Michigan case referred to above which held that the plaintiffs had stated a cause of action against several manufacturers of DES even though they could not identify a particular manufacturer as the source of a particular injury (see fn. 7, ante), relied upon the theories of concerted action and alternative liability.

[28] The Fordham Comment explains the connection between percentage of market share and liability as follows: "[I]f X Manufacturer sold one-fifth of all the DES prescribed for pregnancy and identification could be made in all cases. X would be the sole defendant in approximately one-fifth of all cases and liable for all the damages in those cases. Under alternative liability. X would be joined in all cases in which identification could not be made, but liable for only one-fifth of the total damages in these cases. X would pay the same amount either way. Although the correlation is not, in practice, perfect [footnote omitted], it is close enough so that defendants' objections on the ground of fairness lose their value." (Fordham Comment, supra, at p. 994.)

[29] Defendants assert that there are no figures available to determine market share, that DES was provided for a number of uses other than to prevent miscarriage and it would be difficult to ascertain what proportion of the drug was used as a miscarriage preventative, and that the establishment of a time frame and area for market share would pose problems.

[30] The dissent concludes by implying the problem will disappear if the Legislature appropriates funds "for the education, identification, and screening of persons exposed to DES." While such a measure may arguably be helpful in the abstract, it does not address the issue involved here: damages for injuries which have been or will be suffered. Nor, as a principle, do we see any justification for shifting the financial burden for such damages from drug manufacturers to the taxpayers of California.

[31] Assigned by the Chairperson of the Judicial Council.

[32] Assigned by the Chairperson of the Judicial Council.

19.3.3 Hamilton v. Beretta U.S.A. Corp., 750 N.E.2d 1055 (N.Y. 2001) 19.3.3 Hamilton v. Beretta U.S.A. Corp., 750 N.E.2d 1055 (N.Y. 2001)

WESLEY, J.

          In January 1995 plaintiffs—relatives of people killed by handguns—sued 49 handgun manufacturers in Federal court alleging negligent marketing, design defect, ultra-hazardous activity and fraud. A number of defendants jointly moved for summary judgment. The United States District Court for the Eastern District of New York (Weinstein, J.), dismissed the product liability and fraud causes of action, but retained plaintiffs' negligent marketing claim (see, Hamilton v Accu-Tek, 935 F Supp 1307, 1315). Other parties intervened, including plaintiff Stephen Fox, who was shot by a friend and permanently disabled. The gun was never found; the shooter had no recollection of how he obtained it. Other evidence, however, indicated that he had purchased the gun out of the trunk of a car from a seller who said it came from the "south." Eventually, seven plaintiffs went to trial against 25 of the manufacturers.

          Plaintiffs asserted that defendants distributed their products negligently so as to create and bolster an illegal, underground market in handguns, one that furnished weapons to minors and criminals involved in the shootings that precipitated this 230*230 lawsuit. Because only one of the guns was recovered, plaintiffs were permitted over defense objections to proceed on a market share theory of liability against all the manufacturers, asserting that they were severally liable for failing to implement safe marketing and distribution procedures, and that this failure sent a high volume of guns into the underground market.

          After a four-week trial, the jury returned a special verdict finding 15 of the 25 defendants failed to use reasonable care in the distribution of their guns. Of those 15, nine were found to have proximately caused the deaths of the decedents of two plaintiffs, but no damages were awarded. The jury awarded damages against three defendants—American Arms, Beretta U.S.A. and Taurus International Manufacturing—upon a finding that they proximately caused the injuries suffered by Fox and his mother (in the amounts of $3.95 million and $50,000, respectively). Liability was apportioned among each of the three defendants according to their share of the national handgun market: for American Arms, 0.23% ($9,000); for Beretta, 6.03% ($241,000); and for Taurus, 6.80% ($272,000).

          Defendants unsuccessfully moved for judgment as a matter of law pursuant to Federal Rules of Civil Procedure rule 50 (b). The District Court articulated several theories for imposing a duty on defendants "to take reasonable steps available at the point of * * * sale to primary distributors to reduce the possibility that these instruments will fall into the hands of those likely to misuse them" (Hamilton v Accu-Tek, 62 F Supp 2d 802, 825). The court noted that defendants, as with all manufacturers, had the unique ability to detect and guard against any foreseeable risks associated with their products, and that ability created a special "protective relationship" between the manufacturers and potential victims of gun violence (id., at 821). It further pointed out that the relationship of handgun manufacturers with their downstream distributors and retailers gave them the authority and ability to control the latter's conduct for the protection of prospective crime victims. Relying on Hymowitz v Eli Lilly & Co. (73 NY2d 487, cert denied 493 US 944), the District Court held that apportionment of liability among defendants on a market share basis was appropriate and that plaintiffs need not connect Fox's shooting to the negligence of a particular manufacturer.

          On appeal, the Second Circuit certified the following questions to us:

"(1) Whether the defendants owed plaintiffs a duty 231*231 to exercise reasonable care in the marketing and distribution of the handguns they manufacture?
"(2) Whether liability in this case may be apportioned on a market share basis, and if so, how?" (see, Hamilton v Beretta U.S.A. Corp., 222 F3d 36, 39).

          We accepted certification (95 NY2d 878) and now answer both questions in the negative.

Parties' Arguments

 

          Plaintiffs argue that defendant-manufacturers have a duty to exercise reasonable care in the marketing and distribution of their guns based upon four factors: (1) defendants' ability to exercise control over the marketing and distribution of their guns, (2) defendants' general knowledge that large numbers of their guns enter the illegal market and are used in crime, (3) New York's policy of strict regulation of firearms and (4) the uniquely lethal nature of defendants' products.

          According to plaintiffs, handguns move into the underground market in New York through several well-known and documented means including straw purchases (a friend, relative or accomplice acts as purchaser of the weapon for another), sales at gun shows, misuse of Federal firearms licenses and sales by non-stocking dealers (i.e., those operating informal businesses without a retail storefront). Plaintiffs further assert that gun manufacturers have oversaturated markets in states with weak gun control laws (primarily in the Southeast), knowing those "excess guns" will make their way into the hands of criminals in states with stricter laws such as New York, thus "profiting" from indiscriminate sales in weak gun states. Plaintiffs contend that defendants control their distributors' conduct with respect to pricing, advertising and display, yet refuse to institute practices such as requiring distribution contracts that limit sales to stocking gun dealers, training salespeople in safe sales practices (including how to recognize straw purchasers), establishing electronic monitoring of their products, limiting the number of distributors, limiting multiple purchases and franchising their retail outlets.

          Defendants counter that they do not owe a duty to members of the public to protect them from the criminal acquisition and misuse of their handguns. Defendants assert that such a duty— potentially exposing them to limitless liability—should not be imposed on them for acts and omissions of numerous and 232*232 remote third parties over which they have no control. Further, they contend that, in light of the comprehensive statutory and regulatory scheme governing the distribution and sale of firearms, any fundamental changes in the industry should be left to the appropriate legislative and regulatory bodies.

The Duty Equation

          The threshold question in any negligence action is: does defendant owe a legally recognized duty of care to plaintiff? Courts traditionally "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 Mgt. Servs. Corp., 83 NY2d 579, 586; see also, Strauss v Belle Realty Co., 65 NY2d 399, 402-403). Thus, in determining whether a duty exists, "courts must be mindful of the precedential, and consequential, future effects of their rulings, and `limit the legal consequences of wrongs to a controllable degree'" (Lauer v City of New York, 95 NY2d 95, 100 [quoting Tobin v Grossman, 24 NY2d 609, 619]).

          Foreseeability, alone, does not define duty—it merely determines the scope of the duty once it is determined to exist (see, Pulka v Edelman, 40 NY2d 781, 785, rearg denied 41 NY2d 901; see also, Eiseman v State of New York, 70 NY2d 175, 187). The injured party must show that a defendant owed not merely a general duty to society but a specific duty to him or her, for "[w]ithout a duty running directly to the injured person there can be no liability in damages, however careless the conduct or foreseeable the harm" (Lauer, supra, at 100). That is required in order to avoid subjecting an actor "to limitless liability to an indeterminate class of persons conceivably injured by any negligence in that act" (Eiseman, supra, at 188). Moreover, any extension of the scope of duty must be tailored to reflect accurately the extent that its social benefits outweigh its costs (see, Waters v New York City Hous. Auth., 69 NY2d 225, 230).

          The District Court imposed a duty on gun manufacturers "to take reasonable steps available at the point of * * * sale to primary distributors to reduce the possibility that these instruments will fall into the hands of those likely to misuse them" (Hamilton v Accu-Tek, supra, 62 F Supp 2d, at 825). We have been cautious, however, in extending liability to defendants for 233*233 their failure to control the conduct of others. "A defendant generally has no duty to control the conduct of third persons so as to prevent them from harming others, even where as a practical matter defendant can exercise such control" (D'Amico v Christie, 71 NY2d 76, 88; see also, Purdy v Public Adm'r of County of Westchester, 72 NY2d 1, 8, rearg denied 72 NY2d 953). This judicial resistance to the expansion of duty grows out of practical concerns both about potentially limitless liability and about the unfairness of imposing liability for the acts of another.

          A duty may arise, however, where there is a relationship either between defendant and a third-person tortfeasor that encompasses defendant's actual control of the third person's actions, or between defendant and plaintiff that requires defendant to protect plaintiff from the conduct of others. Examples of these relationships include master and servant, parent and child, and common carriers and their passengers.

          The key in each is that the defendant's relationship with either the tortfeasor or the plaintiff places the defendant in the best position to protect against the risk of harm. In addition, the specter of limitless liability is not present because the class of potential plaintiffs to whom the duty is owed is circumscribed by the relationship. We have, for instance, recognized that landowners have a duty to protect tenants, patrons or invitees from foreseeable harm caused by the criminal conduct of others while they are on the premises (see, e.g., Nallan v Helmsley-Spear, Inc., 50 NY2d 507, 518-519). However, this duty does not extend beyond that limited class of plaintiffs to members of the community at large (see, Waters v New York City Hous. Auth., supra, 69 NY2d, at 228-231). In Waters, for example, we held that the owner of a housing project who failed to keep the building's door locks in good repair did not owe a duty to a passerby to protect her from being dragged off the street into the building and assaulted. The Court concluded that imposing such a duty on landowners would do little to minimize crime, and the social benefits to be gained did "not warrant the extension of the landowner's duty to maintain secure premises to the millions of individuals who use the sidewalks of New York City each day and are thereby exposed to the dangers of street crime" (id., at 230).

          A similar rationale is relevant here. The pool of possible plaintiffs is very large—potentially, any of the thousands of 234*234 victims of gun violence.[1] Further, the connection between defendants, the criminal wrongdoers and plaintiffs is remote, running through several links in a chain consisting of at least the manufacturer, the federally licensed distributor or wholesaler, and the first retailer. The chain most often includes numerous subsequent legal purchasers or even a thief.[2] Such broad liability, potentially encompassing all gunshot crime victims, should not be imposed without a more tangible showing that defendants were a direct link in the causal chain that resulted in plaintiffs' injuries, and that defendants were realistically in a position to prevent the wrongs. Giving plaintiffs' evidence the benefit of every favorable inference, they have not shown that the gun used to harm plaintiff Fox came from a source amenable to the exercise of any duty of care that plaintiffs would impose upon defendant manufacturers.

          Plaintiffs make two alternative arguments in support of a duty determination here. The first arises from a manufacturer's "special ability to detect and guard against the risks associated with [its] products [and] warrants placing all manufacturers, including these defendants, in a protective relationship with those foreseeably and potentially put in harm's way by their products" (Hamilton v Accu-Tek, supra, 62 F Supp 2d, at 821 [emphasis added]). Plaintiffs predicate the existence of this protective duty—particularly when lethal or hazardous products are involved—on foreseeability of harm and our products liability cases such as MacPherson v Buick Motor Co. (217 NY 382).

          235*235 As we noted earlier, a duty and the corresponding liability it imposes do not rise from mere foreseeability of the harm (see, Pulka, supra, 40 NY2d, at 786). Moreover, none of plaintiffs' proof demonstrated that a change in marketing techniques would likely have prevented their injuries. Indeed, plaintiffs did not present any evidence tending to show to what degree their risk of injury was enhanced by the presence of negligently marketed and distributed guns, as opposed to the risk presented by all guns in society (see generally, Twerski & Sebok, Liability Without Cause? Further Ruminations on Cause-in-Fact as Applied to Handgun Liability, 32 Conn L Rev 1379).

          The cases involving the distribution or handling of hazardous materials, relied upon by plaintiffs, do not support the imposition of a duty of care in marketing handguns. The manufacturer's duty in each case was based either on a products liability theory—that is, the product was defective because of the failure to include a safety feature—or on a failure to warn (see, e.g., Hunnings v Texaco, Inc., 29 F3d 1480 [11th Cir 1994] [defectively packaged hazardous substance accompanied by lack of adequate warnings]; Blueflame Gas v Van Hoose, 679 P2d 579 [Colo 1984] [insufficiently odorized propane gas]; Flint Explosive Co. v Edwards, 84 Ga App 376, 66 SE2d 368 [1951] [defective dynamite]). Certainly too, a manufacturer may be held liable for complicity in dangerous or illegal activity (see, e.g., Suchomajcz v Hummel Chem. Co., 524 F2d 19 [3d Cir 1975] [manufacturer sold chemicals to retailer with knowledge that retailer intended to use them in making and selling illegal firecracker assembly kits]). Here, defendants' products are concededly not defective—if anything, the problem is that they work too well. Nor have plaintiffs asserted a defective warnings claim or presented sufficient evidence to demonstrate that defendants could have taken reasonable steps that would have prevented their injuries. Likewise, this case can hardly be analogized to those in which a duty has been imposed upon owners or possessors of hazardous substances to safeguard against unsupervised access by children (see, Kush v City of Buffalo, 59 NY2d 26, 31Kingsland v Erie County Agric. Socy., 298 NY 409, 426).

          Plaintiffs also assert that a general duty of care arises out of the gun manufacturers' ability to reduce the risk of illegal gun trafficking through control of the marketing and distribution of their products. The District Court accepted this proposition and posited a series of structural changes in defendants' 236*236 marketing and distribution regimes that might "reduce the risk of criminal misuse by ensuring that the first sale was by a responsible merchant to a responsible buyer" (Hamilton v Accu-Tek, supra, 62 F Supp 2d, at 820). Those changes, and others proposed by plaintiffs that a jury might reasonably find subsumed in a gun manufacturer's duty of care,[3] would have the unavoidable effect of eliminating a significant number of lawful sales to "responsible" buyers by "responsible" Federal firearms licensees (FFLs) who would be cut out of the distribution chain under the suggested "reforms." Plaintiffs, however, presented no evidence, either through the testimony of experts or the submission of authoritative reports, showing any statistically significant relationship between particular classes of dealers and crime guns.[4] To impose a general duty of care upon the makers of firearms under these circumstances because of their purported ability to control marketing and distribution of their products would conflict with the principle that any judicial recognition of a duty of care must be based upon an assessment of its efficacy in promoting a social benefit as against its costs and burdens (see, Waters v New York City Hous. Auth., 69 NY2d 225, supra). Here, imposing such a general duty of care would create not only an indeterminate class of plaintiffs but also an indeterminate class of defendants whose liability might have little relationship to the benefits of controlling illegal guns (see, Waters, supra, 69 NY2d, at 230).

          Finally, plaintiffs and the District Court identify an alternative basis for imposing a duty of care here under the negligent entrustment doctrine, arising out of the firearms manufacturers' authority over "downstream distributors and retailers" to whom their products are delivered (see, Hamilton v Accu-Tek, supra, 62 F Supp 2d, at 821). The owner or possessor of a dangerous instrument is under a duty to entrust it to a responsible person whose use does not create an unreasonable risk of harm to others (see, Rios v Smith, 95 NY2d 647237*237 Splawnik v Di Caprio, 146 AD2d 333, 335; Restatement [Second] of Torts § 390). The duty may extend through successive, reasonably anticipated entrustees (see, Rios v Smith, supra). There are, however, fatal impediments to imposing a general duty of care here under a negligent entrustment theory.

          The tort of negligent entrustment is based on the degree of knowledge the supplier of a chattel has or should have concerning the entrustee's propensity to use the chattel in an improper or dangerous fashion. Gun sales have subjected suppliers to liability under this theory (see, Splawnik, supra; see also, Cullum & Boren-McCain Mall v Peacock, 267 Ark 479, 592 SW2d 442 [1980]Semeniuk v Chentis, 1 Ill App 2d 508, 117 NE2d 883 [1954]). Of course, without the requisite knowledge, the tort of negligent entrustment does not lie (see, Earsing v Nelson, 212 AD2d 66 [dismissing a negligent entrustment claim against the manufacturer of a BB gun because a dealer's knowledge of the individual's ability to use the gun safely could not be imputed to the manufacturer]).

          The negligent entrustment doctrine might well support the extension of a duty to manufacturers to avoid selling to certain distributors in circumstances where the manufacturer knows or has reason to know those distributors are engaging in substantial sales of guns into the gun-trafficking market on a consistent basis.[5] Here, however, plaintiffs did not present such evidence. Instead, they claimed that manufacturers should not engage in certain broad categories of sales. Once again, plaintiffs' duty calculation comes up short. General statements about an industry are not the stuff by which a common-law court fixes the duty point. Without a showing that specific 238*238 groups of dealers play a disproportionate role in supplying the illegal gun market, the sweep of plaintiffs' duty theory is far wider than the danger it seeks to avert.[6]

          At trial, plaintiffs' experts did surmise that since manufacturers receive crime gun trace requests conducted by the Bureau of Alcohol, Tobacco and Firearms, they could analyze those requests to locate retailers who disproportionately served as crime gun sources, and cut off distributors who do business with them. In essence, plaintiffs argue that defendants had an affirmative duty to investigate and identify corrupt dealers. This is neither feasible nor appropriate for the manufacturers.

          Plaintiffs' experts explained that a crime gun trace is the means by which the BATF reconstructs the distribution history of a gun used in a crime or recovered by the police.[7] While manufacturers may be generally aware of traces for which they are contacted, they are not told the purpose of the trace, nor 239*239 are they informed of the results.[8] The BATF does not disclose any subsequently acquired retailer or purchaser information to the manufacturer. Moreover, manufacturers are not in a position to acquire such information on their own. Indeed, plaintiffs' law enforcement experts agreed that manufacturers should not make any attempt to investigate illegal gun trafficking on their own since such attempts could disrupt pending criminal investigations and endanger the lives of undercover officers.

          Federal law already has implemented a statutory and regulatory scheme to ensure seller "responsibility" through licensing requirements and buyer "responsibility" through background checks.[9] While common-law principles can supplement a 240*240 manufacturer's statutory duties, we should be cautious in imposing novel theories of tort liability while the difficult problem of illegal gun sales in the United States remains the focus of a national policy debate (see, Lytton, Tort Claims Against Gun Manufacturers, supra, 65 Mo L Rev, at 52-54 [analyzing courts' capacities and limitations in analyzing complex statistical data]).

          In sum, analysis of this State's longstanding precedents demonstrates that defendants—given the evidence presented here—did not owe plaintiffs the duty they claim; we therefore answer the first certified question in the negative.

Market Share Liability

          The Second Circuit has asked us also to determine if our market share liability jurisprudence is applicable to this case. Having concluded that these defendant-manufacturers did not owe the claimed duty to these plaintiffs, we arguably need not reach the market share issue. However, because of its particularly significant role in this case, it seems prudent to answer the second question.

          Market share liability provides an exception to the general rule that in common-law negligence actions, a plaintiff must prove that the defendant's conduct was a cause-in-fact of the injury. This Court first examined and adopted the market share theory of liability in Hymowitz v Eli Lilly & Co. (73 NY2d 487, supra). In Hymowitz, we held that plaintiffs injured by the drug DES were not required to prove which defendant manufactured the drug that injured them but instead, every manufacturer would be held responsible for every plaintiff's injury based on its share of the DES market. Market share liability was necessary in Hymowitz because DES was a fungible product and identification of the actual manufacturer that caused the injury to a particular plaintiff was impossible. The Court carefully noted that the DES situation was unique. Key to our decision were the facts that (1) the manufacturers acted in a parallel manner to produce an identical, generically marketed product; (2) the manifestations of injury were far removed from the time of ingestion of the product; and (3) the Legislature made a clear policy decision to revive these time-barred DES claims (see, id., at 508).

          Circumstances here are markedly different. Unlike DES, guns are not identical, fungible products. Significantly, it is often possible to identify the caliber and manufacturer of the 241*241 handgun that caused injury to a particular plaintiff.[10] Even more importantly—given the negligent marketing theory on which plaintiffs tried this case—plaintiffs have never asserted that the manufacturers' marketing techniques were uniform. Each manufacturer engaged in different marketing activities that allegedly contributed to the illegal handgun market in different ways and to different extents. Plaintiffs made no attempt to establish the relative fault of each manufacturer, but instead sought to hold them all liable based simply on market share.[11]

          In Hymowitz, each manufacturer engaged in tortious conduct parallel to that of all other manufacturers, creating the same risk to the public at large by manufacturing the same defective product. Market share was an accurate reflection of the risk they posed. Here, the distribution and sale of every gun is not equally negligent, nor does it involve a defective product. Defendants engaged in widely-varied conduct creating varied risks. Thus, a manufacturer's share of the national handgun market does not necessarily correspond to the amount of risk created by its alleged tortious conduct. No case has applied the market share theory of liability to such varied conduct and wisely so.

          We recognize the difficulty in proving precisely which manufacturer caused any particular plaintiff's injuries since crime guns are often not recovered. Inability to locate evidence, however, does not alone justify the extraordinary step of applying market share liability (see, Healey v Firestone Tire & Rubber Co., 87 NY2d 596, 601 [loss of an allegedly defective multipiece truck tire rim which caused the plaintiff's injuries did not 242*242 obviate the requirement that the plaintiff identify its exact manufacturer]; see also, Matter of New York State Silicone Breast Implant Litig., 166 Misc 2d 85, 90 [refusal to apply market share liability to silicone breast implants; "(t)he reality of a plaintiff's plight when product identification cannot be made is like any other plaintiff who claims injury from a product that has been lost or destroyed"], affd for reasons stated 234 AD2d 28). Rather, a more compelling policy reason—as was shown in the DES cases—is required for the imposition of market share liability.

          Notably, courts in New York and other jurisdictions have refused to extend the market share theory where products were not fungible and differing degrees of risk were created (see, e.g., Brenner v American Cyanamid Co., 263 AD2d 165 [lead pigment used in paint]; Matter of New York State Silicone Breast Implant Litig., supra [silicone breast implants]; DaSilva v American Tobacco Co., 175 Misc 2d 424 [cigarettes]; see also, Sanderson v International Flavors & Fragrances, 950 F Supp 981 [CD Cal 1996] [perfumes containing different aldehydes]; Doe v Cutter Biological, 852 F Supp 909 [D Idaho 1994] [blood clotting agent]; 210 E. 86th St. Corp. v Combustion Eng'g, 821 F Supp 125 [SD NY 1993] [asbestos]; Skipworth v Lead Indus. Assn., 547 Pa 224, 690 A2d 169 [1997] [lead paint pigments]). Similarly, plaintiffs here have not shown a set of compelling circumstances akin to those in Hymowitz justifying a departure from traditional common-law principles of causation.

          This case challenges us to rethink traditional notions of duty, liability and causation. Tort law is ever changing; it is a reflection of the complexity and vitality of daily life. Although plaintiffs have presented us with a novel theory—negligent marketing of a potentially lethal yet legal product, based upon the acts not of one manufacturer, but of an industry—we are unconvinced that, on the record before us, the duty plaintiffs wish to impose is either reasonable or circumscribed. Nor does the market share theory of liability accurately measure defendants' conduct. Whether, in a different case, a duty may arise remains a question for the future.

          Accordingly, both certified questions should be answered in the negative.

          Following certification of questions by the United States Court of Appeals for the Second Circuit and acceptance of the 243*243 questions by this Court pursuant to section 500.17 of the Rules of the Court of Appeals (22 NYCRR 500.17), and after hearing argument by counsel for the parties and consideration of the briefs and the record submitted, certified questions answered in the negative.

          [1] According to the U.S. Census Bureau's Statistical Abstract for the U.S., there were 7,402 murders by handguns in 1998 (see, U.S. Census Bureau, Statistical Abstract of the United States: 2000, Table No. 333). This figure does not separately identify legal/illegal handgun deaths. In 1997, there were 39,400 gunshot wounds treated in hospital emergency rooms. For 59% of the victims of nonfatal gunshot wounds, the type of firearm was unknown. Where the firearm was known, 82% were shot by handguns, but additional details about the firearm used are not given (see, Firearms and Crime Statistics, U.S. Department of Justice, Bureau of Justice Statistics ; see also, Zawitz and Strom, Firearm Injury and Death From Crime, 1993-1997, Bureau of Justice Statistics: Selected Findings, at 4 [Oct. 2000] ).

          [2] One of the original plaintiffs was Katina Johnstone. Her husband was killed with a Smith & Wesson revolver. The gun was recovered and traced to its lawful owner, who had reported it missing after a burglary of his home two weeks before the shooting. Johnstone's case was transferred to Federal court in California (Hamilton v Accu-Tek, 47 F Supp 2d 330).

          [3] For example, limiting the volume of sales in states with weak gun controls to insure against circulation of the oversupply to strong gun control states such as New York; restricting distribution entirely to established retail stores carrying stocks of guns; franchising of retail outlets; and barring distribution to dealers who sell at unregulated gun shows (see, Hamilton v Accu-Tek, 62 F Supp 2d 802, at 826, 829-832).

          [4] See, Lytton, Tort Claims Against Gun Manufacturers For Crime-Related Injuries: Defining a Suitable Role for the Tort System in Regulating the Firearms Industry, 65 Mo L Rev 1, 41.

          [5] An analysis of Bureau of Alcohol, Tobacco and Firearms (BATF) data for 1998 reveals that a very small number of FFLs do account for a significant portion of guns used in crimes. "Just 1.2 percent of dealers—1,020 of the approximately 83,200 licensed retail dealers and pawnbrokers—accounted for over 57 percent of the crime guns traced to current dealers in 1998" (see, Commerce in Firearms in the United States, BATF Document, at 2 [Feb. 2000] ). However, the data does not reveal whether any given FFL's high incidence of crime gun sales is attributable to irresponsible conduct, or merely reflects a high volume of legal sales or some other activity (such as theft) over which the FFL has no control. BATF has "targeted" those dealers to "determine the reasons for diversion of firearms from this relatively small proportion of dealers" (id.). Because of BATF's continued pursuit in identifying how handguns enter the illegal market, it may well be that a core group of corrupt FFLs will emerge at some future time. This might alter the duty equation.

          [6] Our decision is in accord with most jurisdictions that have considered this issue (see, e.g., Armijo v Ex Cam, 843 F2d 406 [10th Cir 1998], affg 656 F Supp 771First Commercial Trust Co. v Colt's Mfg. Co., 77 F3d 1081 [8th Cir 1996]Shipman v Jennings Firearms, 791 F2d 1532 [11th Cir 1986]City of Philadelphia v Beretta U.S.A., Corp., 126 F Supp 2d 882 [ED Pa 2000]Adkinson v Rossi Arms Co., 659 P2d 1236 [Alaska 1983]First Commercial Trust Co. v Lorcin Eng'g, 321 Ark 210, 900 SW2d 202 [1995]Delahanty v Hinckley, 564 A2d 758 [DC Ct App 1989]; Trespalacios v Valor Corp., 486 So 2d 649 [Fla Dist Ct App 1986]; Riordan v International Armament Corp., 132 Ill App 3d 642, 477 NE2d 1293 [1985]Linton v Smith & Wesson, 127 Ill App 3d 676, 469 NE2d 339 [1984]Resteiner v Sturm, Ruger & Co., 223 Mich App 374, 566 NW2d 53 [1997]King v R.G. Indus., 182 Mich App 343, 451 NW2d 874 [1990]City of Cincinnati v Beretta U.S.A. Corp., 2000 WL 1133078 [Ohio Ct App 2000]; Knott v Liberty Jewelry & Loan, 50 Wash App 267, 748 P2d 661 [1988]; cf., City of Boston v Smith & Wesson Corp., 2000 WL 1473568, 2000 Mass Super LEXIS 352 [Mass Sup Ct 2000]). There are two notable exceptions, both of which involved different factual contexts and different theories of negligent marketing not relevant here (see, Halberstam v S. W. Daniel, Inc., No. 95-C3323 [ED NY 1998]; Merrill v Navegar, Inc., 75 Cal App 4th 500, 89 Cal Rptr 2d 146 [1999], superseded by grant of review 991 P2d 755).

          [7] Tracing involves the process of tracking a recovered crime gun's history from its source through the chain of distribution to its first retail purchaser. If the BATF is unable to trace the gun from its own records, it contacts the manufacturer and asks for the identity of the federally licensed distributor to whom the gun was sold. The BATF then follows up with the named distributor and the subsequently named retailer to determine the identity of the first purchaser (see, Commerce in Firearms in the United States, BATF Document, at 19-20 [Feb. 2000] ; Crime Gun Trace Analysis Reports: The Illegal Youth Firearms Market in 27 Communities, 1998 Youth Crime Gun Interdiction Initiative, BATF Document, at 5 [Feb. 1999] ).

          [8] In fact, the "ATF emphasizes that the appearance of [an FFL] or a first unlicensed purchaser of record in association with a crime gun or in association with multiple crime guns in no way suggests that either the FFL or the first purchaser has committed criminal acts. Rather, such information may provide a starting point for further and more detailed investigation" (Youth Crime Gun Interdiction Initiative, supra, at 17 ).

          [9] Gun manufacturers must be licensed by the Federal government in order to produce, deal and ship firearms in interstate commerce (see, 18 USC § 922 [a] [1] [A]; § 923 [a]; 27 CFR 178.41 [a]). Manufacturers may sell only to licensed importers, licensed dealers, or licensed collectors (see, 18 USC § 922 [a] [2]). Manufacturers must keep records of each firearm they make and sell, including the firearm's type, model, caliber, serial number, as well as information about the purchaser (see, 18 USC § 923 [g] [1] [A]; 27 CFR 178.123 [a], [b]). Any firearm shipped must bear a unique and permanent serial number and the manufacturer's identity (see, 18 USC § 922 [k]; § 923 [i]; 27 CFR 178.34, 178.92 [a] [1]).

          Like manufacturers, firearms dealers must also be licensed by the Federal government (see, 18 USC § 922 [a] [1] [A]; § 923 [a]; 27 CFR 178.41 [a]). As the "principal agent of federal enforcement" (Huddleston v United States, 415 US 814, 824-825), licensed dealers must initiate criminal background checks on purchasers and may sell only to those who have been cleared by the FBI or other appropriate law enforcement agencies (see, 18 USC § 922 [c], [s] [1]; [t] [1]). Licensed dealers may not sell firearms to individuals who fall within certain at-risk categories (felons, drug users, individuals previously committed to mental institutions and individuals subject to domestic restraining orders, or convicted of crimes of domestic violence, among others) (see, id., § 922 [d]). Federal law also establishes age limits for gun purchasers and sales cannot be made to juveniles (see, id., § 922 [b] [1]; [x] [1]).

          Licensees must keep records of all multiple sales to unlicensed persons (see, 18 USC § 923 [g] [3] [A]). Additionally, all licensees must report any theft or loss of a firearm to appropriate authorities within 48 hours (see, id., § 923 [g] [6]). The BATF oversees compliance with Federal requirements and is charged with enforcing this entire regulatory scheme (see generally, 27 CFR parts 178 and 179). Dealers face criminal penalties and license revocation for intentional unlawful sales (see, 18 USC §§ 924, 923 [e]; 27 CFR 178.73 [a]).

          [10] We note that New York has recently become the second State in the nation to establish a new "fingerprinting" system for identifying guns by the distinctive marks on their shell casings (see, General Business Law § 396-ff).

          [11] Plaintiffs do not contend that negligent marketing of handguns is the sole source of handguns used in crime. They acknowledge that some injuries from handguns will still occur. Indeed, the District Court, using BATF data, assessed the enhanced risk at 33%, leaving a significant probability that plaintiffs' injuries from unidentified weapons came from guns that had not been negligently marketed (see, Hamilton v Accu-Tek, supra, 62 F Supp 2d, at 826 [noting that only one third of all guns used in juvenile crimes come directly from FFLs]). Nonetheless, the District Court assessed damages as if the risk enhancement were 100% (see, id., at 845). It would seem that even if plaintiffs had established a duty here in conjunction with market share liability, they would be limited to damages calculated on the proportion to which defendants enhanced the risk (see, Twerski & Sebok, Liability Without Cause? Further Ruminations on Cause-in-Fact as Applied to Handgun Liability, supra, 32 Conn L Rev, at 1398-1404).