Bichler v. Eli Lilly and Co.

• Decision Date: 11 May 1982
• Citation: 450 N.Y.S.2d 776,55 N.Y.2d 571
• Parties: , 436 N.E.2d 182, 22 A.L.R.4th 171 Joyce BICHLER, Respondent, et al., Plaintiff, v. ELI LILLY AND COMPANY, Appellant, et al., Defendants.
• Court: New York Court of Appeals Court of Appeals

Page 776

450 N.Y.S.2d 776

55 N.Y.2d 571, 436 N.E.2d 182, 22

A.L.R.4th 171

Joyce BICHLER, Respondent, et al., Plaintiff, v. ELI LILLY AND COMPANY, Appellant, et al., Defendants.

Court of Appeals of New York.

May 11, 1982.

Russel H. Beatie, Jr., Blair C. Fensterstock, Colin W. Ewing, New York City, and Helen E. Hoens, Roselle Park, N. J., for appellant

Alfred S. Julien, New York City, for respondent.

Robert J. Sisk, Naomi F. Sheiner and Julian S. Millstein, New York City, for Merck & Co., Inc., amicus curiae.

Timothy L. Harker, Jeffrey N. Martin, William E. Blasier, Gary D. Lipkin, Michael W. Faber and Lewis A. Rivlin, Washington, D. C., of the Washington, D. C. Bar, admitted pro hac vice, for National Ass'n of Manufacturers, amicus curiae.

Karen S. Burstein and Kathy Ann Bennett, New York City, for New York State Consumer Protection Bd., amicus curiae.

OPINION OF THE COURT

MEYER, Judge.

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) ¹ to the FDA requesting approval of the marketing of DES for the treatment of vaginitis, engorgement of the breasts excessive menstrual bleeding and symptoms of menopause. Each separate application, however, relied upon a master file of reports and studies compiled by a committee of four drug companies, known as the "Small Committee," which was chaired by Lilly. Three years later the FDA approved several additional NDA's for use of DES in treating cancer of the prostate in males. DES continues to be used to treat some of these non-pregnancy-related medical problems today.

Not until 1947 did the FDA approve DES for the treatment of human miscarriage. Lilly's NDA was the second such application to be approved. Five years later, in 1952, the FDA did away with the need for additional NDA's, at least for previously approved uses, when it declared DES to be "generally recognized * * * as safe." In 1971, however, in the face of mounting evidence that DES was ineffective in preventing miscarriage and dangerous to the unborn child as well, the FDA reversed itself and banned the use of DES for the treatment of problems of pregnancy. By that time DES had been taken by perhaps several million pregnant mothers.

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. ² All of plaintiff's internal reproductive organs and more than half of her vagina were removed. As a result, she can never bear children and will never enjoy normal sexual relations.

In her complaint plaintiff alleged that her 1953 prenatal exposure to DES, ingested by her mother while pregnant with plaintiff, was the proximate cause of the cancer that developed 17 years after her birth in 1954. Lilly, a major American manufacturer of DES, was the only pharmaceutical manufacturer named as defendant, ³ although the pharmacist who filled plaintiff's mother's 1953 prescription stocked DES supplied by at least three of the other 147 drug companies then manufacturing and marketing DES for pregnancy-related problems.

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, 79 App.Div.2d 317, 436 N.Y.S.2d 625, unanimously affirmed the judgment entered upon the jury's verdict. ⁴

We dismissed Lilly's appeal taken as of right on constitutional grounds (54 N.Y.2d 752, 443 N.Y.S.2d 1033, 426 N.E.2d 757), but granted its motion for leave to appeal to our court (54 N.Y.2d 610, 446 N.Y.S.2d 1023, 430 N.E.2d 923). Lilly seeks reversal on two principal grounds: that the trial court's instructions on concerted action liability were erroneous, and that the evidence before the jury was legally insufficient to support a verdict in plaintiff's favor on the issue of concerted action. For the reasons which follow, we reject these arguments.

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 problems of proof" (Caprara v. Chrysler Corp., 52 N.Y.2d 114, 123, 436 N.Y.S.2d 251, 417 N.E.2d 545). Thus, courts as well as commentators have proposed means which permit recovery by prenatally exposed DES daughters. The proposals involve the application of already accepted tort principles of "concerted action" and "alternative liability" to the unusual DES fact pattern as well as resort to more novel theories of "enterprise" and "market share" liability. ⁵ Here, because only concerted action was pleaded and submitted to the jury, we address only this basis of liability. We expressly leave for another day consideration of whether other theories of liability may in the DES context establish a cause of action.

Concerted action liability rests upon the principle 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" (Prosser, Torts § 46, at p. 292; see, also, Restatement, Torts 2d, § 876). An injured plaintiff may pursue any one joint tort-feasor on a concerted action theory (see Graphic Arts Mut. Ins. Co. v. Bakers Mut. Ins. Co. of N. Y., 45 N.Y.2d 551, 410 N.Y.S.2d 571, 382...