State-law design-defect claims that turn on the adequacy of a drug's warnings are pre-empted by federal law under PLIVA Inc. v. Mensing, which held that failure-to-warn claims against generic manufacturers are pre-empted by the FDCA's prohibition on changes to generic drug labels.
U.S. SUPREME COURT
Mutual Pharmaceutical Co. Inc. v. Bartlett
New Jersey Law Journal
June 27, 2013