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Mutual Pharmaceutical Co. V. Bartlett And Its Implications, Brian Wolfman, Anne King
Mutual Pharmaceutical Co. V. Bartlett And Its Implications, Brian Wolfman, Anne King
Georgetown Law Faculty Publications and Other Works
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 …
Wyeth V. Levine And Its Implications, Brian Wolfman
Wyeth V. Levine And Its Implications, Brian Wolfman
Georgetown Law Faculty Publications and Other Works
The U.S. Supreme Court’s decision in Wyeth v. Levine sharply limited the availability of implied preemption as a defense in pharmaceutical cases. In this Analysis & Perspective, attorney Brian Wolfman discusses the decision and its implications for prescription drug litigation as well as litigation in other areas that are regulated by the federal government.
After Wyeth, Wolfman says, a defendant in a prescription drug case must demonstrate a ‘‘tight fit between the labeling change proposed by the manufacturer (and rejected by the FDA) and the labeling change that the plaintiff contends would have prevented her injuries.’’ Moreover, he says, …