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Congress is discussing taking away generic drug manufacturers' labeling litigation shield.
Introduction
“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.
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