On March 30, the U.S. Supreme Court will hear argument in three consolidated cases involving injury allegedly caused by generic versions of the prescription drug Reglan (metoclopramide): Pliva v. Mensing, U.S., No. 09-993, Actavis Elizabeth LLC v. Mensing, U.S., No. 09-1039, and Actavis Inc. v. Demahy, U.S., No. 09-1501. This controversy will again require the Court to reconcile overlapping federal and state standards for regulating prescription-drug label warnings.
In its landmark decision in Wyeth v. Levine, 129 S. Ct. 1187 (2009), the Court held that state-law-based products liability claims based on inadequate labeling of branded prescription drugs did not conflict with, and were not pre-empted by, the U.S. Food and Drug Administration’s authority under the Federal Food, Drug, and Cosmetic Act to regulate drug labeling. Justice John Paul Stevens’ opinion for the court — observing that primary responsibility for labeling rested with manufacturers — reasoned that manufacturers could comply with both federal and state jury-imposed labeling standards because FDA regulations permitted pioneer manufacturers like Wyeth to make certain safety-related labeling changes without prior FDA approval.
