Brief Fact Summary. The Appellate Division of the Supreme Court in the First Judicial Department (New York) denied summary judgment to Defendants, drug manufacturers in products liability action arising from injuries plaintiffs suffered as result of plaintiffs’ mothers’ use of diethylstilbestrol (DES) during pregnancy. The manufacturer appealed.
Synopsis of Rule of Law. Where identification of the manufacturer of a drug that injures a plaintiff is impossible, New York courts will apply a market share theory, using a national market, to determine liability and apportionment of damages.
The Food and Drug Administration approved the manufacture and marketing of the drug diethylstilbestrol (DES) in 1941 for use as a generic drug in the prevention of miscarriages. Approximately 300 companies manufactured the drug, and as it was generic no single company held patent. It was found later that DES created a high risk of vaginal cancer in some female children of women who had used the drug. Because so many companies manufactured and marketed the drug, over several years and for varying lengths of time, it was often impossible for potential plaintiffs to identify exactly which company had manufactured the particular batch that the plaintiff had ingested.
The cases at bar were brought by multiple plaintiffs, the daughters of women who had used DES. At trial, the manufacturers moved for summary judgment on the grounds that it could not be determined with specificity they any one of them was responsible for the injuries sustained by a particular plaintiff. The motions were denied and the Appellate Division affirmed. New York’s highest court reviewed.
Issue. What is the method to be employed to apportion liability in a products liability case involving a generic drug when it is impossible to determine which manufacturer produced the drug that caused the harm suffered by plaintiffs?
Held. The court affirmed the lower courts’ denial of summary judgment and adopted a national market-share theory for apportioning liability.
Dissent. Points of Law - for Law School Success
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In dissent, New York Court of Appeals Judge Mollen writes, “I respectfully disagree with the majority’s conclusion that there should be no exculpation of those defendants who produced and marketed DES for pregnancy purposes, but who can prove, by a preponderance of the evidence, that they did not produce or market the particular pill ingested by the plaintiff’s mother,” but instead “would retain the principle of imposing joint and several liability upon those defendants which cannot exculpate themselves.” Mollen believes that the majority’s approach “I would retain the principle of imposing joint and several liability upon those defendants which cannot exculpate themselves.” Thus, he dissents. Discussion.
The modern template for the adjudication of products liability claims was provided in MacPherson v. Buick Motor Co., 111 N.E. 1050 (N.Y. 1916), where the New York Court of Appeals held that the manufacturer of any negligently manufactured product capable of serious harm owed a duty of care in the design, inspection, and fabrication of the product, a duty owed not only to the immediate purchaser but to all persons who might foreseeably come into contact with the product. The DES case, however, presented a unique problem: the identification, for purposes of determining liability, of the exact manufacturer responsible for the plaintiffs’ harm.
Generally, as the court in Hymowitz observed, “In a products liability action, identification of the exact defendant whose product injured the plaintiff is generally required.” However, as here, such identification is sometimes difficult. The court thus concluded, “Where two defendants breach a duty to the plaintiff, but there is uncertainty regarding which one caused the injury, the burden is upon each such actor to prove that he has not caused the harm.” As a result, there may be broad apportionment of blame. As the court states, “Successive tort-feasors may be held jointly and severally liable for an indivisible injury to a plaintiff.”
The court must then evaluate different approaches to in assigning responsibility, beginning first with alternative liability: “Use of the alternative liability doctrine generally requires that the defendants have better access to information than does the plaintiff, and that all possible tort-feasors be before the court. It is also recognized that alternative liability rests on the notion that where there is a small number of possible wrongdoers, all of whom breached a duty to the plaintiff, the likelihood that one of them injured the plaintiff is relatively high, so that forcing them to exonerate themselves, or be held liable, is not unfair.” The high number of possible tort-feasors in Hymowitz makes this approach impractical, however. Similarly, the theory of concerted action falls short: “The theory of concerted action, in its pure form provides for joint and several liability on the part of all defendants having an understanding, express or tacit, to participate in a common plan o
r design to commit a tortious act.” However, the fact that the manufacturers were simultaneously engaged in the manufacture of the drug is not indicative of communal interest or action, as the court states, “Parallel activity, without more, is insufficient to establish the agreement element necessary to maintain a concerted action claim.”
Recognizing the circumstances of the case at bar, the court thus crafts a new approach for apportionment of responsibility: “Given this unusual scenario, it is more appropriate that the loss be borne by those that produced the drug for use during pregnancy, rather than by those who were injured by the use, even where the precise manufacturer of the drug cannot be identified in a particular action.” Thus, the court adopted a market share theory, using a national market, for determining liability and apportioning damages in the diethylstilbestrol (DES) cases.