Generic Heart Drug Maker Zydus Beats Failure-to-Warn Claims

Zydus Pharms. USA Inc. brushed off claims that it failed to adequately warn of the risks of the generic drug Amiodarone because the state law claims are preempted by the federal Food, Drug and Cosmetic Act, a federal appeals court ruled Monday.

“A state law failure-to-warn claim against a generic drug manufacturer is preempted by the FDCA when the alleged state law duty would violate the duty of sameness by requiring the manufacturer to unilaterally strengthen or alter its label,” the US Court of Appeals for the Third Circuit ruled in an unpublished opinion.

The duty of sameness requires that ...