Solicitor General Files Amicus Brief in Mensing Cases on Generic Drug Preemption; Recommends that the Supreme Court Deny Review

November 3, 2010

By Kurt R. Karst –      

Hot off the presses!  The U.S. Department of Justice (Solicitor General of the United States) filed its highly anticipated amicus brief in response to the U.S. Supreme Court’s invitation to weigh in on generic drug preemption.  The Court’s request was made in the context of two Petitions for Writ of Certiorari (here and here) 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.  The Solicitor General’s recommendation is that the Supreme Court deny review given the current lack of a split of authority among the Circuit Courts 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.”

As we previously reported, Mensing addressed, among other things, whether the FDC Act preempts failure to warn claims against generic drug manufacturers.  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 drug 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, which were filed in February 2010 and are docketed as Docket Nos. 09-993 and 09-1039, 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.”

Although we are still pouring over the Solicitor General’s brief, here is the bottom line on the government’s position:

The court of appeals correctly rejected petitioners’ contention that respondent’s failure-to-warn claims are categorically preempted by the FDCA, and its decision is consistent with the decision of the only other court of appeals to address the question since Wyeth v. Levine, 129 S. Ct. 1187, 1196 (2009).  The court of appeals misunderstood FDA’s regulations in some respects, but its decision correctly reflects the essential point that federal law may circumscribe, but does not outright bar, possible theories of recovery by respondent.  Moreover, because those theories are at present undeveloped, this case’s interlocutory posture makes it an unsuitable vehicle for considering the preemption questions petitioners raise.  Accordingly, the Court should deny review. . . .  

The court of appeals correctly held that respondent’s failure-to-warn claims are not categorically preempted, because a generic pharmaceutical manufacturer, like a brand-name manufacturer, can (and indeed, must) inform FDA of new information about risks that may require a change in the labeling of its drug.  The court of appeals also correctly concluded that petitioners could have asked FDA to coordinate appropriate [Dear Health Care Professional (DHCP)] letters (or, by extension, to take other action with respect to labeling).  Furthermore, the district court correctly concluded that the [Changes Being effected (CBE)] process was unavailable to petitioners, and that holding was undisturbed by the court of appeals.  The court of appeals incorrectly concluded that the [Prior Approval Supplement (PAS)] process was intended for petitioners’ use, but that error is unlikely to affect future proceedings.  Finally, the court of appeals correctly concluded that holding a generic pharmaceutical manufacturer liable on a failure-to-warn theory would not unacceptably frustrate the purposes of the Hatch-Waxman Amendments.

The Solicitor General’s brief, although short, is full of other tidbits that are sure to be of interest to FDA Law Blog readers. 

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