55 N.Y.2d 571 | NY | 1982
To the extent the issue has been preserved for our review, the trial court’s instructions concerning defendant pharmaceutical manufacturer’s liability on a concerted action theory for injuries caused by prenatal exposure to diethylstilbestrol (DES) were not erroneous as a matter of law. Evaluating the evidence in light of those instructions, which became the governing law, we cannot say that the jury’s verdict is without a sufficient factual foundation. The order of the Appellate Division should, therefore, be affirmed.
I
DES is a powerful synthetic substance that duplicates the activity of estrogen, a female sex hormone naturally present in all women and, in lesser amounts, present also in men. Invented in 1937 by British researchers, DES was never patented. As a result, it was available for production and marketing to any pharmaceutical manufacturer who obtained Federal Food and Drug Administration (FDA) approval.
DES was first approved for use in the United States in 1941. In that year, 12 pharmaceutical manufacturers, including defendant Eli Lilly and Company, submitted separate new drug applications (NDA’s)
In the past decade the link between prenatal DES exposure and the later development in female offspring of clear cell cervical or vaginal adenocarcinoma, a hitherto rare disease involving cancerous growth in glandular tissue, has been unquestionably confirmed (see L 1978, ch 715, § 1; Note, Market Share Liability: An Answer to the DES Causation Problem, 94 Harv L Rev 668, 669, n 8, and authorities cited therein). In addition, the FDA estimated in 1975 that 30 to 90% of these offspring develop vaginal adenosis, a noncancerous condition in which glandular tissue normally found only in the cervix is also found in the vagina (Sheiner, DES and a Proposed Theory of Enterprise Liability, 46 Ford L Rev 963, 965, n 10). Because of the “paramount public importance” of identifying, screening, diagnosing, caring for and treating the estimated more than 100,000 New York women whose health has been endangered by prenatal exposure to DES (L 1978, ch 715, § 1), the Legislature has enacted section 2500-c of the Public Health Law aimed at locating, monitoring and establishing special programs for these young women.
Plaintiff Joyce Bichler is a DES daughter. Stricken by cervical and vaginal cancer at age 17, she brought suit against Lilly in 1974 for damages sustained in surgically arresting the disease.
At Lilly’s request, the trial was conducted in two stages. The first stage of the trial concerned the identity of the manufacturer of the DES tablets taken by plaintiff’s mother. The jury found that plaintiff had not established by a preponderance of the evidence that Lilly was that manufacturer. The second stage of the trial concerned Lilly’s liability upon a theory of concerted action. The jury determined that Lilly and other DES manufacturers wrongfully marketed the drug for use in preventing miscarriage without first performing laboratory tests upon pregnant mice. Had those tests been performed, the jury found, the pharmaceutical companies would have learned that DES was capable of causing cancer to develop in female offspring and would not have marketed the drug for problems of pregnancy. The jury awarded plaintiff $500,000 and the Appellate Division unanimously affirmed the judgment entered upon the jury’s verdict.
We dismissed Lilly’s appeal taken as of right on constitutional grounds (54 NY2d 752), but granted its motion for
II
In the wake of knowledge about the devastation wrought by DES upon the female offspring of the several million pregnant women who ingested the drug over a 25-year period, an estimated 1,000 individual or class action products liability lawsuits have been lodged against pharmaceutical manufacturers (Note, 94 Harv L Rev, at p 669). Where the identity of the drug company that manufactured the DES which caused plaintiff’s injuries is known, these lawsuits can be prosecuted within well-established principles of products liability as those principles have been adapted to the manufacturing and marketing of prescription drugs. It is, however, the far more usual case that the identity of the drug company whose DES tablets were taken by a plaintiff’s mother is unknown and can never accurately be determined. This is because all DES prescribed for pregnant mothers was produced under the identical chemical formula and most of this DES was manufactured and prescribed generically. With the passage of the many years needed for DES-caused vaginal tract abnormalities to appear in prenatally exposed offspring, the patient, physician, pharmacist and drug company records which could have identified the source of the DES have usually disappeared. This same lapse of time has commonly obliterated the individual recollections of those surviving witnesses of any underlying DES transaction. The result is that as a group DES daughters face a dilemma: They have, if their claim is upheld, been injured by parallel conduct of a group of pharmaceutical manufacturers. But the practical impossibility for most victims of pinpointing the manufacturer directly responsible for their particular injury threatens to bar any recovery.
Products liability law cannot be expected to stand still where innocent victims face “inordinately difficult prob
Concerted action liability rests upon the principle that “[a]ll 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” (Prosser, Torts
Although Lilly claims it is jurisprudentially unsound to permit full recovery on a concerted action theory against one DES manufacturer for injuries probably sustained by ingestion of DES manufactured by another manufacturer, no motion was ever made by Lilly to dismiss the complaint for failure to state a cause of action, for partial summary judgment limiting plaintiff’s recovery to a percentage amount of her injuries corresponding to Lilly’s market share, or to join other DES manufacturers as necessary parties. Nor were these issues raised in Lilly’s motions to dismiss for failure to make out a prima facie case or for a directed verdict. Rather, Lilly proceeded to trial on a complaint seeking full recovery against Lilly alone among the manufacturers on the basis of concerted action. This, then, has become the controlling law and we look only to the trial court’s instructions on concerted action to determine whether, to the extent the issue has been preserved, those instructions were erroneous.
The totality of the trial court’s instructions on concerted action was as follows:
“[B]y ‘concerted action,’ we mean one of two things. First, action taken jointly by the drug companies as a result of an express or implied understanding. In this case,
“By the second definition of concerted action, we mean persons acting independently of each other in committing the same wrongful act, but although acting independently, their acts have the effect of substantially encouraging or assisting the wrongful conduct of the other, which, in this case, was the alleged failure to adequately test.
“Thus, if you find that defendant and the other drug companies either consciously paralleled each other in failing to test D. E. S. on pregnant mice, as a result of some implied understanding, or that they acted independently of each other in failing to do such testing, but that such independent actions had the effect of substantially aiding or encouraging the failure to test by the others, then you should find that the defendant wrongfully acted in concert with the other drug manufacturers in the testing and marketing of D. E. S. for use in accidents of pregnancy. Of course, you must also have found that it was wrongful for the defendant and the other drug companies not to have tested D. E. S. in pregnant mice because of the state of knowledge that was available to them in 1953.”
Lilly’s challenge to these instructions separately addresses concerted action by agreement and concerted action by substantial assistance, the two branches of the court’s quoted charge. With respect to concerted action by agreement, Lilly contends that the jury should have been instructed that (1) direct evidence or some “plus factor” was needed in addition to conscious parallelism to support a finding of agreement; (2) concerted action liability required every drug company that might have manufactured the DES tablets taken by plaintiff’s mother be a party to
We need not decide the merits of these claims, for none has been preserved for our review by appropriate request or exception. Before the court delivered its charge, Lilly handed up a series of more .than 20 requests to charge, including one on concerted action, covering virtually every aspect of the case. The court accepted this submission without ruling on what requests, if any, were accepted and what, if any, were rejected. At the conclusion of the charge, which covered the same ground as many of Lilly’s requests, Lilly’s trial counsel was given an opportunity to make specific requests and note specific exceptions. Several specifically numbered requests previously handed up, not including the concerted action request, were thus expressly brought to the trial court’s attention. Each was expressly denied. We can only conclude that any request previously handed to the court which was not at this time specifically renewed, including the concerted action request, was either abandoned or withdrawn. As for exceptions, the only exception taken to the concerted action portion of the charge was as follows: “[0]n the issue of concerted action. In accordance with our specific request to charge, and I’m sorry, Your Honor, I don’t have the number, I believe there must be proof of intent.”
The request to charge apparently referred to by this remark was the concerted action request already mentioned. It is quoted in its entirety in the margin.
Ill
Because the trial court submitted two theories of concerted action upon which Lilly’s liability for plaintiff’s injuries could be premised — concerted action by agreement and concerted action by substantial assistance — and we do not know which theory was accepted by the jury, we must evaluate the sufficiency of the evidence to support recovery under either (Davis v Caldwell, 54 NY2d 176, 179-180). As we read the trial court’s instructions on concerted action by agreement, the jury is permitted to infer from evidence of consciously parallel behavior that an implied agreement existed between Lilly and other drug companies to market DES for problems of human pregnancy without first conducting tests with DES upon pregnant mice. No “direct evidence” or “plus factor” is required. Consciously parallel conduct by itself is enough. Similarly, the trial court’s charge on concerted action by substantial assistance required the jury to find only that Lilly’s failure to test DES on pregnant mice before marketing the drug for use by pregnant women substantially aided or encouraged other DES manufacturers to do the same. No express agreement is required. Nor is it necessary for the jury to
Review of the evidence, solely on the basis of events beginning in 1947,
IV
Although this analysis disposes of Lilly’s principal contentions, there are two remaining issues raised by Lilly
Concerning proof of foreseeability, Lilly conceded at trial that it was aware by 1947 that DES posed the threat of cancer to the user, that DES had been shown to cross the placental barrier and that DES had caused malformations in the offspring of pregnant mice to which the drug had been administered. Lilly contends, however, that because no human transplacental carcinogen was discovered until 1962, when the first thalidomide babies were born, it could not have foreseen the occurrence of DES-caused cancer in human offspring. Although Lilly’s experts supported this position, plaintiff’s experts testified to the contrary conclusion, which the jury accepted and which we have no reason to disturb. We note, moreover, that the proof shows that a researcher had in 1947 conducted an experiment in which pregnant mice were injected with urethane, an anesthetic administered to women during delivery, in order to determine if the offspring developed cancer from the drug.
Concerning the duty to warn, Lilly’s argument has two branches. First, Lilly contends that since all drugs are inherently unsafe, liability for a “side-effect” can only be imposed if the side-effect was foreseeable and if the manufacturer failed to include a warning about it in the literature accompanying the drug (see Restatement, Torts 2d, § 402A, Comment k). Second, Lilly contends that the jury should have been instructed that no liability can be found against a drug manufacturer if the physician did not rely upon or consider product literature and warnings in prescribing the drug (see Wolfgruber v Upjohn Co., 52 NY2d 768, affg on 72 AD2d 59). We have, however, no opportunity to consider the application of these principles to this case because plaintiff’s theory of liability went far beyond
We have considered Lilly’s remaining arguments and find them to be either unpreserved or without merit. The order of the Appellate Division should therefore be affirmed, with costs.
Chief Judge Cooke and Judges Jasen, Gabrielli, Jones, Wachtler and Fuchsberg concur.
Order affirmed.
. A “new drug” is defined as: “Any drug the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of drugs, as safe for use under the conditions prescribed, recommended, or suggested in the labeling thereof” (Federal Food, Drug, and Cosmetic Act, ch 675, § 201, subd [p], par [1], 52 Stat 1040,1041-1042 [current version at US Code, tit 21, § 321, subd (p), par (1)]).
. Plaintiff’s father’s derivative claims were dismissed as time barred and are not before us.
. Also named as defendants were the physician who prescribed the DES for plaintiff’s mother in 1953 and the hospital where the 1972 surgery was conducted. In a separate action, subsequently consolidated with this action, plaintiff sued the pharmacist who filled the 1953 prescription. The action against the physician was settled. The action as against the hospital was voluntarily discontinued after a finding in favor of the hospital by a medical malpractice panel. The action as against the pharmacist was dismissed upon motion for summary judgment (see Bichler v Willing, 58 AD2d 331, app dsmd [May 12, 1978]). A third action for the same damages by plaintiff against Lilly and the three other companies whose DES products were sold by the pharmacist in 1953 is now pending in Supreme Court.
. Reduced by the amount of the physician’s settlement (see n 3, supra), the verdict resulted in judgment for plaintiff of $492,842.39.
. “Alternative liability,” like concerted action liability, is joint and several. It applies “[w]here 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” (Restatement, Torts 2d, § 433B, subd [3]). In such a case, “the burden is upon each such actor to prove that he has not caused the harm” (id.). It is classically illustrated by Summers v Tice (33 Cal 2d 80) where two hunters negligently fired simultaneously in plaintiff’s direction, but plaintiff was struck by only one bullet (see, also, Hawkes v Goll, 256 App Div 940, affd 281 NY 808; and NY PJI 2:307). Recovery under an alternative liability theory requires joinder of all the parties who could have been responsible for a plaintiff’s injuries (Restatement, Torts 2d, § 433B, subd [3], Comment h). It has been accepted as a basis for proceeding to trial against DES manufacturers in a multidefendant products liability action (e.g., Abel v Lilly & Co., 94 Mich App 59). “Enterprise liability,” also joint and several, derives from the opinion in Hall v Du Pont de Nemours & Co. (345 F Supp 353). In that case, plaintiffs were unable to identify the manufacturers of allegedly unsafe blasting caps for the simple reason that the caps had been obliterated by explosion. Since the six defendants in that case did, however, comprise virtually the entire American blasting cap industry and since it appeared that their blasting caps were manufactured to meet industry-wide safety standards set by their own trade association, the court held that defendants could be liable for the joint control of the risk of accidental explosion. It has been suggested that this basis of liability is applicable to the DES cause (see 46 Ford L Rev 963). “Market share liability,” accepted by the Supreme Court of California in Sindell v Abbott Labs. (26 Cal 3d 588, cert den 449 US 912), is a hybrid of alternative and enterprise liability. Sindell held that a DES plaintiff need only join as defendants a sufficient number of DES manufacturers to embrace a “substantial share” of the DES market at the time plaintiff’s mother ingested the drug. Any defendant could avoid liability by proving that it could not have manufactured the tablets in question, but failing that, will be held liable only for that percentage of the plaintiff’s injuries that corresponds to its percentage share of the market, not for the entire damage suffered by plaintiff.
. “In order to impose liability on Lilly for ‘concerted action,’ you must find four separate things: (1) Lilly and other companies that have been specifically identified had a' common intention or an agreement by which the members of the group acted together
“If you do not find all of these things, then you cannot find Lilly liable for ‘concerted action.’ Mere knowledge by Lilly of what the other manufacturers were doing is not sufficient to make Lilly liable for the acts of another manufacturer. You are further
. We agree with Lilly that its 1941 collaboration with other pharmaceutical manufacturers to secure initial FDA approval of DES for certain non-pregnancy-related conditions has no bearing upon the concerted action which plaintiff must establish in connection with Lilly’s 1947 supplemental application to produce and market DES for problems of pregnancy (see Morton v Abbott Labs., 538 F Supp 593; Ryan v Lilly & Co., 514 F Supp 1004; Payton v Abbott Labs, 512 F Supp 1031; Lyons v Premo Pharm. Labs., 170 NJ Super 183, certification den 82 NJ 267).
. (Kamaky, Use of Stilbestrol for the Treatment of Threatened and Habitual Abortion and Premature Labor, 35 So Med J 838 [Sept., 1942]; Kamaky, Estrogenic Tolerance in Pregnant Women, 53 Amer J Obstet & Gynec 312 [Feb., 1947]; Rosenblum & Melinkoff, Preservation of the Threatened Pregnancy with Particular Reference to the Use of Diethylstilbestrol, 55 West. J Surg Obstet & Gynec 597 [1947]; Smith & Smith, Increased Excretion of Pregnanediol in Pregnancy from Diethylstilbestrol with Special Reference to the Prevention of Late Pregnancy Accidents, 51 Amer J Obstet & Gynec 411 [1946].)
. (Larsen, Weed & Rhodes, Pulmonary Tumor Induction by Transplacental Exposure to Urethane, 8 J Nat Cancer Inst 63 [1947].)
. The interrogatories, all of which were answered in plaintiff’s favor, were as follows: “(1) Was DES reasonably safe in the treatment of accidents of pregnancy when it was ingested by plaintiff’s mother in 1953? (2) Was DES a proximate cause of plaintiff’s cancer? (3) In 1953 when plaintiff’s mother ingested DES, should the defendant, as a reasonably prudent drug manufacturer, have foreseen that DES might cause cancer in the offspring of pregnant women who took it? (4) Foreseeing that DES might cause cancer in the offspring of pregnant women who took it, would a reasonably prudent drug manufacturer test it on pregnant mice before marketing it? (5) If DES had been tested on pregnant mice, would the tests have shown that DES causes cancer in their offspring? (6) Would a reasonably prudent drug manufacturer have marketed DES for use in treating accidents of pregnancy at the time it was ingested by the plaintiff’s mother if it had known that DES causes cancer in the offspring of pregnant mice? (7) Did defendant and the other drug manufacturers act in concert with each other in the testing and marketing of DES for use in treating accidents of pregnancy?”