U.S. Supreme Court Invites Solicitor General to Express the Views of the United States in Generic Drug Preemption Cases

By Kurt R. Karst

In a somewhat unusual move, the U.S. Supreme Court has asked the U.S. Department of Justice (Solicitor General of the United States) to weigh in on generic drug preemption. The move signals that the Court has continued interest in this issue, and comes in the context of two Petitions for Writ of Certiorari in which various generic drug manufacturers have appealed the U.S. Court of Appeals for the Eighth Circuit’s November 27, 2009 decision in Mensing v. Wyeth, Inc.

As we previously reported, Mensing addressed, among other things, whether the FDC Act preempts failure to warn claims against generic drug manufacturers – specifically, generic REGLAN (metoclopramide). In reversing an October 2008 decision from the U.S. District Court for the District of Minnesota in which the court dismissed certain failure to warn claims against generic manufacturers on the basis of federal preemption, the Eighth Circuit, relying on the Supreme Court’s 2009 decision in Wyeth v. Levine, rejected arguments that failure to warn claims against generic manufacturers are preempted by the FDC Act (and the Hatch-Waxman Amendments in particular) because they create an impermissible conflict with federal law.

The two Petitions for Writ of Certiorari (here and here) were filed in February 2010 and present almost identical questions for the Supreme Court’s consideration:

Whether the Eighth Circuit 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 first Petition is docketed as Docket No. 09-993 and was filed by PLIVA, Inc., Teva Pharmaceuticals USA, Inc., and UDL Laboratories, Inc. The second Petition is docketed as Docket No. 09-1039 and was filed by Actavis Elizabeth, LLC. Opposition and reply briefs have been submitted in both cases (as well as an amicus brief from GPhA) and are available on SCOTUSBlog here (scroll down to the bottom of the page).

Shortly after the Eighth Circuit issued its decision in Mensing, the U.S. Court of Appeals for the Fifth Circuit came to a similar conclusion in Demahy v. Actavis. That decision has not (yet) been appealed to the Supreme Court. (For a nice overview of the current generic drug preemption landscape, see the Washington Legal Foundation’s recent Legal Backgrounder on the topic.)