June 23, 2011

Supreme Court Decides Generic Pharmaceutical Pre-emption Case: PLIVA, Inc. v. Mensing

On June 23, 2011, the Supreme Court decided Pliva, Inc. v. Mensing, No. 09-993, holding that failure-to-warn claims brought against manufacturers of generic medications under state law are pre-empted by federal law.

Respondents in two consolidated cases, Actavis Elizabeth, LLC v. Mensing, No. 09-1039 and Actavis, Inc. v. Demahy, No. 09-1501, both took metaclopramide, a generic medication.  After taking metaclopramide for several years, both respondents developed tardive dyskinesia and sued the manufacturers of the medication that they took. The suits were based on failure-to-warn theories under state law. The defendant manufacturers in both cases argued that federal statutes and FDA regulations pre-empted respondents' state law claims by requiring generic manufacturers to provide the same labeling that was in use for the name-brand medication, Reglan®. The Fifth and Eighth Circuits both held that state law failure-to-warn claims against generic medication manufacturers were not pre-empted by federal law.

The Supreme Court reversed. The court held that "federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt," state-law claims for inadequate warnings. First, the court reviewed the statutory framework governing generic medications and the Food and Drug Administration's interpretation of its regulations.  The Court deferred to the FDA's interpretations (1) that generic labeling "must always be the same" as that of the name-brand medication so that the Changes Being Effected (CBE) process was unavailable to generic manufacturers and (2) that the generic manufacturers could not have unilaterally issued "Dear Doctor" letters that provided additional warnings. The remaining issue was whether the state law requirements to provide warnings conflicted with the federal regulations that prevented the manufacturers from independently altering their warnings. Determining that compliance with both requirements was "impossible," the court held that respondents' claims were pre-empted under federal law. The court rejected respondents' argument that the "possibility" that generic manufacturers could have negotiated with the FDA to develop different warnings for the medication was sufficient to defeat preemption. The court reasoned that adoption of such a theory would render most conflicts "illusory" and made it difficult to imagine a scenario in which the Supremacy Clause of the Constitution would have "any force." In a subpart of the decision that was not joined by a majority of the court, Justice Thomas reasoned that the text of the Supremacy Clause "suggests that pre-emption analysis should not involve speculation about ways in which federal agency and third-party actions could potentially reconcile federal duties with conflicting state duties."  Finally, the court distinguished its decision in Wyeth v. Levine, 555 U.S. 555 (2009), as interpreting the statute and regulations applicable to manufacturers of name-brand medications.

Justice Thomas delivered the opinion of the court except for one subpart. Chief Justice Roberts and Justices Scalia and Alito joined the opinion in full; Justices Kennedy joined the opinion except as to Part III-B-2. Justice Sotomayor filed a dissenting opinion, in which Justices Ginsburg, Breyer and Kagan joined. 

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