Justice Kagan and the Future of Generic Drug Preemption


US Supreme Court Will Decide Fate of Preemption Defense for Generic Companies this Term

Since the decision of the Supreme Court in Wyeth v. Levine, 129 S.Ct. 1187 (2009), the Eighth Circuit (in Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009)) and the Fifth Circuit (in DeMahy v. Actavis, Inc., 593 F.3d 428 (5th Cir. 2010)) have both concluded that failure-to-warn claims against generic drug manufacturers are not automatically preempted by the federal Food, Drug and Cosmetic Act’s (FDCA) requirement that generic labeling conform to the approved labeling for the innovator drug. Last Friday, the United States Supreme Court agreed to decide whether a plaintiff’s state-law failure-to-warn claim against a generic drug manufacturer for failing to modify its labeling to include warnings that differ from the name-brand equivalent is preempted by the FDCA’s requirement that the label for a generic drug be the same as the label for the brand-name counterpart. Against the advice of acting solicitor general, Neil Katyal, the Court agreed to address the issue in three cases Pliva v. Mensing, 09-993; Actavis v. Mensing, 09-1039; and Actavis v. DeMahy, 09-1501 and consolidated them for review.

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