Acting Solicitor General Gives Government’s Position on Generic-Pharma Preemption to U.S. Supreme Court


In a brief filed in the U.S. Supreme Court on November 2, 2010, Acting U.S. Solicitor General Neal Katyal provided the federal government's position on federal preemption of state laws regarding the labeling of generic drugs. The amicus brief addressed the question of whether "federal law preempts a tort claim under state law that a generic drug approved by the Food and Drug Administration was inadequately labeled." The brief was submitted in response to the Supreme Court's invitation for the U.S. government's views on this significant issue in the context of petitions for certiorari in cases on appeal from the Eighth Circuit, Mensing v. Wyeth, Inc. and Mensing v. Actavis Elizabeth, LLC.1 The Acting Solicitor General urged the Supreme Court to deny the petitions, and, in so doing, provided the U.S. government's position on whether the Mensing plaintiffs' state-law based failure-to-warn claims brought against generic drug manufacturers are preempted by the Hatch-Waxman Amendments and other federal drug laws and regulations.

The U.S. government's views have been much anticipated since the U.S. Supreme Court's landmark March 2009 opinion in Wyeth v. Levine.2 Since Levine, state and federal courts have struggled with how to apply the decision to products liability claims against generic pharmaceutical manufacturers. Because Levine involved a brand and not a generic drug, and because generic drug manufacturers' preemption arguments differ from those of brand drug companies, courts in the wake of Levine have been unable to reach a consensus on whether and the extent to which Levine applies to generic drugs.

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