New York Law Review

Tag: DES Litigation

  • Enright v. Eli Lilly & Co., 77 N.Y.2d 377 (1991): Limits on DES Manufacturer Liability to Grandchildren

    Enright v. Eli Lilly & Co., 77 N.Y.2d 377 (1991)

    A manufacturer’s liability for injuries caused by a drug does not extend to a “third generation” plaintiff (grandchildren) whose injuries allegedly resulted from their mother’s in utero exposure to the drug, due to policy considerations regarding the limits of liability and potential for limitless claims.

    Summary

    Karen Enright, born prematurely with cerebral palsy, sued DES manufacturers, claiming her injuries stemmed from her maternal grandmother’s ingestion of DES during pregnancy with Karen’s mother, Patricia. Patricia allegedly suffered reproductive system abnormalities due to DES exposure, leading to Karen’s premature birth. The New York Court of Appeals held that the manufacturers’ liability did not extend to Karen. The court reasoned that allowing such claims would expand tort liability beyond manageable limits and create the potential for limitless claims across generations, echoing concerns raised in Albala v. City of New York. The court emphasized that while DES litigation has received special consideration, it doesn’t justify abandoning traditional limits on tort liability.

    Facts

    Karen Enright’s maternal grandmother ingested DES during pregnancy in 1960.
    Patricia Enright, Karen’s mother, was born with reproductive system abnormalities allegedly due to her in utero DES exposure.
    Patricia experienced multiple miscarriages, and Karen was born prematurely in 1981, suffering from cerebral palsy and other disabilities.
    Karen and her parents sued several DES manufacturers, claiming Karen’s injuries resulted from her grandmother’s DES ingestion.

    Procedural History

    The Supreme Court dismissed Karen’s claims, relying on Albala v. City of New York, which limited preconception tort liability.
    The Appellate Division modified, reinstating Karen’s strict products liability claim, arguing public policy favored a remedy for DES victims.
    The Court of Appeals granted leave to appeal, certifying the question of whether the Appellate Division erred in reinstating the strict products liability claim.

    Issue(s)

    Whether a drug manufacturer’s liability in a strict products liability action extends to a “third generation” plaintiff whose injuries are allegedly caused by their mother’s in utero exposure to the drug ingested by the grandmother.

    Holding

    No, because extending liability to “third generation” plaintiffs would expand traditional tort concepts beyond manageable bounds, creating the potential for limitless claims and raising concerns about speculative and remote damages, as previously established in Albala v. City of New York.

    Court’s Reasoning

    The court relied heavily on its decision in Albala v. City of New York, which declined to recognize a cause of action for a child injured due to a preconception tort against the mother. The court found no meaningful distinction between Albala (medical malpractice) and the current case (DES exposure) to justify a different rule.
    While acknowledging legislative and judicial solicitude for DES victims (e.g., CPLR 214-c and Hymowitz v. Lilly & Co.), the court emphasized that these measures addressed unique procedural barriers in DES litigation, not an intent to create a favored class of plaintiffs.
    The court rejected the argument that strict products liability warranted a different outcome than negligence, stating that the concerns about limitless liability and artificial boundaries remained compelling. The court noted: “For all we know, the rippling effects of DES exposure may extend for generations. It is our duty to confine liability within manageable limits”.
    The court also considered the potential for overdeterrence, which could discourage pharmaceutical research and development, and the role of the FDA in regulating drug safety.
    Liability was limited to those who ingested DES or were exposed to it in utero, balancing the need for redress with the need to confine liability within manageable limits. The court quoted Tobin v. Grossman, stating, “It is our duty to confine liability within manageable limits”.

  • Bichler v. Eli Lilly and Co., 55 N.Y.2d 571 (1982): Concerted Action Liability for DES Manufacturers

    55 N.Y.2d 571 (1982)

    A pharmaceutical manufacturer can be held liable under a concerted action theory for injuries caused by prenatal exposure to diethylstilbestrol (DES) if it acted in concert with other manufacturers, either through an express or implied agreement or by providing substantial assistance to the wrongful conduct of others, even if the plaintiff cannot identify the specific manufacturer of the DES ingested by their mother.

    Summary

    Joyce Bichler, a DES daughter, sued Eli Lilly and Co. for cancer resulting from her mother’s ingestion of DES during pregnancy in 1953. Unable to prove Lilly manufactured the specific DES her mother took, Bichler pursued a concerted action theory. The jury found Lilly liable for wrongfully marketing DES without adequate testing, awarding Bichler $500,000. The New York Court of Appeals affirmed, holding that the trial court’s instructions on concerted action were not erroneous and that sufficient evidence supported the verdict, even without proof that Lilly manufactured the specific DES or direct evidence of an agreement among manufacturers. The court emphasized that conscious parallelism in conduct and substantial assistance in encouraging wrongful conduct could establish concerted action liability.

    Facts

    Diethylstilbestrol (DES), a synthetic estrogen, was approved for use in the U.S. in 1941. Initially, 12 manufacturers, including Eli Lilly, submitted separate New Drug Applications (NDAs) relying on a master file compiled by a committee chaired by Lilly. In 1947, the FDA approved DES for miscarriage treatment. In 1971, the FDA banned DES for pregnancy-related issues due to its ineffectiveness and dangers to offspring. Plaintiff Joyce Bichler, exposed to DES prenatally, developed cervical and vaginal cancer. She sued Lilly, alleging her mother’s 1953 DES ingestion caused her cancer in 1971.

    Procedural History

    Bichler sued Lilly in 1974. The trial was bifurcated: first to determine the manufacturer, then to assess liability under a concerted action theory. The jury found Bichler had not proven Lilly was the manufacturer. In the second phase, the jury found Lilly liable under a concerted action theory, awarding $500,000. The Appellate Division affirmed. Lilly’s appeal as of right was dismissed, but the Court of Appeals granted leave to appeal.

    Issue(s)

    1. Whether the trial court’s instructions on concerted action liability were erroneous as a matter of law.

    2. Whether the evidence presented at trial was legally sufficient to support a verdict in the plaintiff’s favor on the issue of concerted action.

    Holding

    1. No, because the trial court’s instructions concerning the pharmaceutical manufacturer’s liability on a concerted action theory for injuries caused by prenatal exposure to DES were not erroneous as a matter of law.

    2. Yes, because, evaluating the evidence in light of those instructions, which became the governing law, the jury’s verdict is supported by a sufficient factual foundation.

    Court’s Reasoning

    The Court of Appeals reasoned that concerted action liability applies when parties act in pursuance of a common plan or design to commit a tortious act. It is sufficient if they actively participate, further the act by cooperation, aid or encourage the wrongdoer, or ratify and adopt the acts for their benefit. The court referenced the Restatement (Second) of Torts § 876. The court noted that Lilly did not properly preserve objections to the jury instructions. Therefore, the instructions became the law of the case. The court found sufficient evidence to support the jury’s findings of both conscious parallelism and substantial assistance. Eight companies filed NDAs to market DES for pregnancy problems between 1947 and 1948, relying on the same studies. Each sought approval for 25mg tablets, stronger than previously approved dosages. The court concluded this parallel conduct and Lilly’s participation in the first wave of filings could support a finding that Lilly substantially encouraged the other 140 manufacturers engaged in marketing DES for the same purpose. The court also rejected Lilly’s argument about the lack of foreseeability, citing expert testimony and evidence of related research. Finally, the court stated that because the case was pleaded and proved exclusively on a failure to test theory, duty to warn arguments did not apply. “All 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”.