How Plaintiffs are Playing their “Unfortunate Hand”: the Impact of PLIVA v. Mensing on Personal Injury Claims against Generic Drug Manufacturers by Lauren DeBruicker and James J. Halligan


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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Published In: Civil Procedure Updates, Civil Remedies Updates, Conflict of Laws Updates, Personal Injury Updates, Products Liability Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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