Supreme Court Strengthens Preemption Defense for Manufacturers

In Wyeth v. Levine, 555 U.S. 555 (2009), the United States Supreme Court held that certain failure to warn claims against manufacturers of brand-name pharmaceuticals were not preempted by the Federal Food, Drug and Cosmetic Act. Recently, the Supreme Court reached the opposite conclusion with respect to manufacturers of generic pharmaceuticals. In so holding, the Court clarified that “impossibility” preemption (where it is impossible to comply with both federal and state law) may preclude state law claims unless a manufacturer can unilaterally comply with both federal and state law. This Alert discusses the recent ruling.