Practice Tip: Pliva, Inc. v. Mensing

In 2009, the United States Supreme Court issued a 6-3 opinion rejecting the argument that FDA approval of brand-name prescription drug labeling preempts state tort law claims in pharmaceutical product liability litigation premised on the alleged inadequacy of those same labels. See Wyeth v. Levine, 129 S. Ct. 1187 (2009). In so ruling, the Court relied on the FDA's “changes being effected” or CBE regulations, whereby brand name prescription drug manufacturers are permitted to make certain changes to their labels before receiving the FDA's approval. Id. at 1196. The Court also held that, at least based on the facts presented in that case, the imposition of state tort law liability against the prescription drug manufacturer did not frustrate federal objectives in the regulation of prescription drugs. Id. at 1204.