The Supreme Court Considers Implied Preemption of Failure-to-Warn Claims Against Generic Drug Manufacturers
This week, the Supreme Court heard oral argument in three consolidated cases—Pliva, Inc. v. Mensing, No. 09-993, Actavis Elizabeth, L.L.C. v. Mensing, No. 09-1039, and Actavis, Inc. v. Demahy, No. 09-1501—in which the Court is expected to address whether failure-to-warn claims against generic drug manufacturers are impliedly preempted by federal drug labeling law. The case specifically involves the Drug Price Competition and Patent Term Restoration Act , which amended the Federal Food, Drug, and Cosmetic Act to simplify the process for generic drug approval and requires labels on generic drugs to be substantively identical to their brand-name counterparts.