Supreme Court rules for preemption on generics

The U.S. Supreme Court ruled 5-4 on Thursday in Pliva Inc., et al. v. Mensing that FDA-approved labeling for generic drugs preempts claims under state tort law because federal regulations prevent generic drug manufacturers from independently changing a drug's label.

In the court's opinion, Justice Clarence Thomas wrote that today's ruling does not conflict with a 2009 decision in Wyeth v. Levine because branded drug manufacturers can add to or strengthen a drug's label without preapproval from FDA. In that case, the court held that an FDA-approved label for Phenergan promethazine from Wyeth did not preempt state tort law in a product liability suit (see BioCentury, March 9, 2009). ...