Supreme Court Will Review Generic Drug Preemption Cases

December 10, 2010

By Kurt R. Karst –      

Earlier today, the U.S. Supreme Court granted certiorari in three cases concerning generic drug preemption - PLIVA Inc. v. Mensing (09-993), Actavis v. Mensing (09-1039), and Actavis v. Demahy (09-1501).  As we previously reported, the petitions presented almost identical questions for the Supreme Court’s consideration: “Whether the Eighth Circuit [, in its November 27, 2009 decision in Mensing v. Wyeth, Inc.], abrogated the Hatch-Waxman Amendments by allowing state tort liability for failure to warn in direct contravention of the Act’s requirement that a generic drug’s labeling be the same as the FDA-approved labeling for the listed (or branded) drug.”

The Court decided to hear the cases notwithstanding a recommendation from the U.S. Department of Justice (Solicitor General of the United States), which filed an amicus brief in November, that the Court deny review given the current lack of a split of authority among the circuits on the issue of preemption and state law failure-to-warn claims against generic drug manufacturers, as well as several uncertainties in Mensing that “further counsel against review at this time.”