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Preemption Defense Available to Generic Drug Manufacturers

29 June 2011

Hogan Lovells Alert

On June 23, 2011, the United States Supreme Court held in Pliva, Inc. v. Mensing that the Food, Drug, and Cosmetic Act (FDCA) and federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, state tort-law failure-to-warn claims.According to the Court, because federal law requires the labeling for generic drugs to conform with the FDA-approved labeling of the corresponding brand-name drug (the package insert), it would be impossible for generic manufacturers to simultaneously comply with a state tort-law duty that would require them to use different, stronger warnings in their labeling. The Court held that the plaintiffs' state tort claims in this case were thus pre-empted. That ruling contrasts sharply with the Court's decision from a few years ago in Wyeth v. Levine, 129 S. Ct. 1187 (2009), in which it held that failure-to-warn claims against brand-name manufacturers are not pre-empted by the FDCA. The Court's decision in PLIVA is consistent, however, with the vast majority of lower courts that have addressed this issue previously and makes clear that consumers of generic drugs will largely be unable to bring state tort failure-to-warn claims with respect to generic drug labeling that mirrors approved labeling of their brand-name counterparts.



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