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PLIVA v. Mensing

This Supreme Court case presents the question whether generic drug manufacturers can be held accountable for failure to take reasonable care to ensure that their products contain appropriate warnings. In Wyeth v. Levine, 129 S. Ct. 1187 (2009), the Supreme Court held that the Food and Drug Administration’s approval of a prescription drug and its labeling does not preempt state-law claims against the drug manufacturer for failure to warn about the drug’s dangers. In this case, however, the manufacturers of generic metoclopramide – a drug used to treat gastrointestinal disorders, long-term use of which has been linked with the debilitating neurological disorder tardive dykinesia – are arguing that such claims are preempted when they are against generic drug companies. Public Citizen filed an amicus on behalf of itself and AARP explaining that holding state-law actions against generic drug companies preempted would be inconsistent with the goals of the Hatch-Waxman Act, which sets up the system for federal approval of generic drugs. The amicus brief also explains that it is vital for all drug manufacturers, including generic drug manufacturers, to have incentives to respond to safety risks as they become known, because risks often do not become apparent until long after a drug has been on the market.

The Supreme Court ruled 5-4 in favor of the petitioner on June 23, 2011.