April 27, 2016 Top Story

Federal Preemption Precludes Challenge to FDA-Approved Drug

Impossibility preemption precludes drug manufacturer from changing FDA-approved formulation

Adam E. Lyons

For the first time, a circuit court has taken the U.S. Supreme Court’s invitation and extended impossibility preemption to preclude a claim against a name-brand pharmaceutical manufacturer. Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc. Impossibility preemption is the principle that state law cannot require a drug manufacturer to take an act that the drug’s federal approval precludes. ABA Section of Litigation leaders say the decision now forces plaintiffs to develop “safer alternative” type proof to defeat future state-law design defect claims whenever the challenged formulation was approved by the FDA.

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