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The authors state that the U.S. Supreme Court’s preemption ruling in Mutual Pharmaceutical Co. v. Bartlett, which generally shields generic drug manufacturers from state-law damages liability for design-defect claims, may also have broader implications for preemption jurisprudence. In this article they describe the Supreme Court’s decision in Mutual and evaluate how it may affect future products-liability litigation.

Part I provides an overview of the case’s factual background and of federal generic drug regulation, while Part II discusses the Court’s majority opinion and the dissents. Part III analyzes the implications of the decision, offering ideas on how plaintiffs injured by defective or mislabeled generic prescription drugs may seek compensation after Mutual and how federal regulators and Congress may respond. Part III also briefly assesses Mutual’s potential impact on federal preemption doctrine.


Reproduced with permission from the ABA/BNA The United States Law Week, Vol. 82, No. 17, (Nov. 5, 2013). Copyright 2013 by The Bureau of National Affairs, Inc. (800-372-1033)

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82 U.S. Law Week (BNA), at 1-18 (Nov. 5, 2013)