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Undoing Pliva Inc. v. Mensing
As always, Congress and the FDA retain the authority to change the law and the regulations if they so desire.” Pliva, Inc. v. Mensing, 131 S.Ct. 2567, 2581 (2011). These were the final words of Justice Thomas's majority opinion in a Supreme Court decision effectively shielding manufacturers of generic drugs from state law tort claims alleging harm resulting from inadequate drug labeling. Criticism of Pliva has been widespread in some circles, with the critics arguing that Pliva's holding creates a double standard in which brand-name prescription drug manufacturers can be held liable for inadequate drug labeling, but claims against generic drug manufacturers are preempted by federal law.
With Justice Thomas's words seemingly in mind, several U.S. Senators have introduced the Patient Safety and Generic Labeling Improvement Act (S. 2295, 112th Cong. (2d Sess. 2012)), a bill seeking to undo Pliva and hold generic drug manufacturers to the same labeling obligations as their brand-name counterparts. This article examines the relationship between Pliva and the Patient Safety and Generic Labeling Improvement Act, and discusses the potential ramifications for generic drug manufacturers should the Act be signed into law.
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