Seven months ago, the U.S. Supreme Court issued a landmark decision finding that claims by injured plaintiffs alleging that generic drug manufacturers failed to warn adequately of the risks of their products are preempted, and thus forbidden, by federal law. In PLIVA, Inc. v. Mensing, the Court held that under the complex scheme of federal law governing brand and generic drugs, it was impossible for generics to change (much less strengthen) the safety warnings on their labels to comply with state law and still comply with the federal law's requirement that their labeling be and remain “the same as” brand drug labeling approved by the FDA. Under the U.S. Constitution's Supremacy Clause, America's highest court concluded, any conflicting state law must give way.
The effect of Mensing is that consumers of generic drugs are prohibited from bringing “failure to warn” claims that have been the crux of pharmaceutical litigation for over 30 years. Indeed, of all potential theories of liability against drug manufacturers, a claim for “failure to warn” is the lead and, in many cases, the only card played. Recognizing the import of its ruling – that because of differences in federal regulations for generic and brand drugs, brand drug patients can bring “failure to warn” claims that consumers of generic drugs cannot – the Supreme Court in its Mensing opinion “acknowledge[d] the unfortunate hand that federal drug regulation has dealt” consumers of generic drugs.
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