The Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. 301 et seq., sets out the process through which generic drug manufacturers receive approval to market their products. First, a name-brand manufacturer must have obtained FDA approval of the drug and the drug’s proposed labeling. Then, manufacturers seeking to market generic forms of the previously approved drug may submit an abbreviated application, which must demonstrate, among other things, that the generic drug’s labeling will be identical to that approved by the FDA for its name-brand equivalent.

The Supreme Court granted certiorari in and consolidated PLIVA, Inc. v. Mensing, No. 09-993, Activas Elizabeth, LLC v. Mensing, No. 09-1039, and Activas, Inc. v. Demahy, No. 09-1501,to decide whether these federal labeling requirements preempt state-law failure-to-warn claims against generic drug manufacturers. The Court has previously held, in Wyeth v. Levine, 129 S. Ct. 1187 (2009), that similar claims against name-brand manufacturers are not preempted.

Mensing and Demahy, the respondents in the Supreme Court, allegedly developed tardive dyskinesia after taking metoclopramide, the generic form of the drug Reglan, for several years. Each sued the generic manufacturers of metoclopramide, asserting that the drug’s labeling contained insufficient warnings about the risk of tardive dyskinesia, and that this violated the manufacturers’ state-law duty to warn. 

The generic manufacturers argued that, because the FDCA requires their labeling to be the same as the name-brand’s labeling, they were incapable of changing the labeling to satisfy any duty imposed by state law. According to the generic manufacturers, this conflict between the FDCA and state-law duties meant that the FDCA preempted the plaintiffs’ state-law failure-to-warn claims.

In their respective decisions below, the Fifth and Eighth Circuits each disagreed, and held that the FDCA did not preempt claims against the generic manufacturers. According to the Eighth Circuit, “a generic manufacturer must take steps to warn its customers when it learns it may be marketing an unsafe drug.” 588 F.3d 603, 608. While FDCA regulations dictated that these steps could not include unilaterally altering a drug’s labeling, a generic manufacturer could propose a labeling change to the FDA or propose that the FDA issue a warning letter to doctors. Thus, the Eighth Circuit held, state law failure-to-warn claims based on a manufacturer’s failure to make such proposals are not preempted.

The Fifth Circuit agreed, but also held that the FDCA did not prevent a generic manufacturer from unilaterally altering a previously approved generic drug’s labeling; in the court’s view, such labeling must be identical to the name-brand equivalent only at the initial approval stage. Accordingly, the Fifth Circuit held, failure-to-warn claims based on a manufacturer’s failure to alter its labels unilaterally also would not be preempted.

After the generic manufacturers petitioned for certiorari, the Supreme Court requested the views of the Solicitor General. The Solicitor General’s amicus brief generally agreed with the Eighth Circuit’s analysis, but rejected the Fifth Circuit’s conclusion that the FDCA permits unilateral labeling changes to generic drugs. The Solicitor General urged against a grant of certiorari, however, observing that there is no conflict in the courts of appeals. The Supreme Court nevertheless granted the petitions.

Absent extensions, amicus briefs in support of the petitioners will be due on January 31, 2011, and amicus briefs in support of the respondents will be due on March 2, 2011.

If you have any questions or require specific advice on any matter discussed in this Legal Update, please contact Henninger S. Bullock at +1 212 506 2528.

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