Stacey Lee on Federal Preemption of Generic-Drug Failure-to-Warn Claims

Professor Stacey Lee (Johns Hopkins, Carey School of Business) has posted to SSRN her article, Pliva v. Mensing: Generic Consumers' Unfortunate Hand, Yale J. Health Pol'y L. & Ethics (forthcoming 2012).  Here's the abstract:

The United States Supreme Court held in PLIVA v. Mensing that federal preemption immunizes generic drug manufacturers from liability for state law failure-to-warn claims. As a result, consumers harmed by a mislabeled generic drug will be unable to bring actions against generic manufacturers under state law. The Court confessed that the resulting federal drug-labeling scheme dealt consumers an “unfortunate hand.” By removing generic manufacturers’ duty to improve the adequacy of their products’ warning labels, the Supreme Court calls into question the safety of generic drugs.

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