Mutual Pharmaceutical Co., Inc. v. Bartlett
The generic pharmaceutical industry faced a Catch-22 when a serious adverse reaction arose from use of a generic drug product, and the manufacturer was restrained from unilaterally amending the product label to conform to state requirements, due to the Supreme Court’s decision in PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011). PLIVA held that state requirements to change a label are pre-empted by the Federal Food, Drug and Cosmetic Act’s prohibition of changing labeling without authorization by the FDA.