“ Plaintiffs in these appeals allege that they were injured by the drug diethylstilbestrol (DES) ingested by their mothers during pregnancy. They seek relief against defendant DES manufacturers. While not class actions, these cases are representative of nearly 500 similar actions pending in the courts in this State; the rules articulated by the court here, therefore, must do justice and be administratively feasible in the context of this mass litigation. With this in mind, we now resolve the issue twice expressly left open by this court, and adopt a market share theory, using a national market, for determining liability and apportioning damages in DES cases in which identification of the manufacturer of the drug that injured the plaintiff is impossible (see, Kaufman v Lilly & Co., Bichler v Lilly & Co.,. We also hold that the Legislature’s revival for one year of actions for injuries caused by DES that were previously barred by the Statute of Limitations is constitutional under the State and Federal Constitutions.
HYMOWITZ v. ELI LILLY & CO., Leagle, 198956073NY2d487_1518, April 4, 1989.
The history of the development of DES and its marketing in this country has been repeatedly chronicled. Briefly, DES is a synthetic substance that mimics the effect of estrogen, the naturally formed female hormone. It was invented in 1937 by British researchers, but never patented.
Hymowitz v. Eli Lilly and Company case brief, lawschoolcasebriefs, January 31, 2013.
In 1941, the Food and Drug Administration (FDA) approved the new drug applications (NDA) of 12 manufacturers to market DES for the treatment of various maladies, not directly involving pregnancy. In 1947, the FDA began approving the NDAs of manufacturers to market DES for the purpose of preventing human miscarriages; by 1951, the FDA had concluded that DES was generally safe for pregnancy use, and stopped requiring the filing of NDAs when new manufacturers sought to produce the drug for this purpose. In 1971, however, the FDA contraindicated the use of DES as a miscarriage preventative, when studies established the harmful latent effects of DES upon the offspring of mothers who took the drug. Specifically, tests indicated that DES caused vaginal adenocarcinoma, a form of cancer, and adenosis, a precancerous vaginal or cervical growth.
Although strong evidence links prenatal DES exposure to later development of serious medical problems, plaintiffs seeking relief in court for their injuries faced two formidable and fundamental barriers to recovery in this State;
- not only is identification of the manufacturer of the DES ingested in a particular case generally impossible,
- but, due to the latent nature of DES injuries, many claims were barred by the Statute of Limitations before the injury was discovered.
The identification problem has many causes. All DES was of identical chemical composition. Druggists usually filled prescriptions from whatever was on hand. Approximately 300 manufacturers produced the drug, with companies entering and leaving the market continuously during the 24 years that DES was sold for pregnancy use. The long latency period of a DES injury compounds the identification problem; memories fade, records are lost or destroyed, and witnesses die. Thus the pregnant women who took DES generally never knew who produced the drug they took, and there was no reason to attempt to discover this fact until many years after ingestion, at which time the information is not available.
We recognized this predicament in Bichler v Lilly & Co., where the court stated that in DES cases it is a “practical impossibility for most victims to pinpoint * * * the manufacturer directly responsible for their particular injury”. We allowed plaintiff’s recovery in that case, however, notwithstanding the failure of the plaintiff to identify the manufacturer of the injurious DES, on the limited basis that “the evidence was legally sufficient to support the jury verdict for the plaintiff” on the law as charged to the jury, and unobjected to by the defendant (see, Kaufman v Lilly & Co.,). The question, therefore, of whether nonidentification of the manufacturer precludes plaintiffs from recovering for DES caused injuries, remained unresolved after Bichler v Lilly & Co. (supra).
The second barrier to recovery, involving the Statute of Limitations, arose from the long-standing rule in this State that the limitations period accrued upon exposure in actions alleging personal injury caused by toxic substances (Fleishman v Lilly & Co. In Fleishman v Lilly & Co. (supra) it became clear that this exposure rule led to many DES cases being barred by the Statute of Limitations before the discovery of injury; we held, however, that any change in the accrual date from exposure to discovery was more properly the prerogative of the Legislature. Two years after Fleishman v Lilly & Co. the Legislature addressed the Statute of Limitations problem, and instituted a discovery rule for “the latent effects of exposure to any substance” . The Legislature also, for one year, revived causes of action for exposure to DES that had been time barred.
It is estimated that eventually 800 DES cases will be brought under the revival portion of this recent statute. Moreover, as indicated in Bichler v Lilly & Co. (supra), and as apparent from the record now before the court, in the vast majority of these cases identification of the manufacturer of the DES that injured the plaintiff will be impossible. The Legislature, however, while reviving these time-barred actions, did not resolve the identification problem.
The present appeals are before the court in the context of summary judgment motions. In all of the appeals defendants moved for summary judgment dismissing the complaints because plaintiffs could not identify the manufacturer of the drug that allegedly injured them. In three of the appeals defendants also moved on Statute of Limitations grounds, arguing that the revival of the actions was unconstitutional under the State and Federal Constitutions, and that the complaints, therefore, are time barred and should be dismissed. The trial court denied all of these motions. On the Statute of Limitations issue, the trial court also granted plaintiffs’ cross motions, dismissing defendants’ affirmative defenses that the actions were time barred. The Appellate Division affirmed in all respects and certified to this court the questions of whether the orders of the trial court were properly made. We answer these questions in the affirmative.” …
…continue reading the full paper HYMOWITZ v. ELI LILLY & CO., on Leagle.