The Supreme Court Finds State Failure-to-Warn Claims Against Generic Drug Manufacturers Impliedly Preempted
Yesterday, the Supreme Court, in a 5-4 decision, ruled 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 (collectively, “Mensing/Demahy”)—that state law failure-to-warn claims against generic drug manufacturers that would require greater warnings than those approved by the Food & Drug Administration (“FDA”) for the original branded version of the drug are preempted by the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (the “FDCA”), which require that the generic drug’s label warnings must be the same as those of the originally approved branded drug. The Court specifically found implied conflict preemption here because “[i]f the [defendants] had independently changed their labels to satisfy their state-law duty,” according to the Court, “they would have violated federal law.”