Stacy B. Lee


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.

This Article explores the unfortunate hand that PLIVA dealt generic drug consumers and proposes a framework to increase the odds that generic drug consumers are provided with safe, effective, and adequately labeled generic drugs. To fully understand how PLIVA recasts the generic manufacturers' safety obligations to consumers, this Article begins with a discussion about the approval process for brand-name and generic drugs and the corresponding manufacturer responsibilities. In particular, this Article focuses on manufacturers' postapproval responsibilities. Next, the discussion examines how PLIVA substantively alters generic manufacturers' post-approval responsibilities and weakens the safety provisions in the drug-labeling framework. This Article then explores the implications this compromised framework could have on consumers, patients, physicians, pharmacists, and states. This Article offers a regulatory framework to remedy the deficiencies created by PLIVA. In doing so, the argument addresses anticipated criticisms and illustrates how the proposed framework fulfills the Hatch-Waxman Act's goal of providing consumers with safe generic drugs.