Thursday, June 23, 2011

SCOTUS Decision in PLIVA v. Mensing: Federal Preemption & Generic Drugs

Today the Supreme Court issued its decision in PLIVA v. Mensing (No. 09-993), which is actually three consolidated cases about federal preemption of state-law tort liability in claims involving generic drugs. Justice Thomas writes the majority opinion, joined by Chief Justice Roberts and Justices Scalia, Kennedy (in part), and Alito. Justice Sotomayor writes a dissenting opinion, joined by Justices Ginsburg, Breyer, and Kagan. Justice Thomas’s majority opinion begins:

These consolidated lawsuits involve state tort-law claims based on certain drug manufacturers’ alleged failure to provide adequate warning labels for generic metoclopramide. The question presented is whether federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, these state-law claims. We hold that they do.

Justice Sotomayor’s dissent begins:

The Court today invokes the doctrine of impossibility pre-emption to hold that federal law immunizes generic drug manufacturers from all state-law failure-to-warn claims because they cannot unilaterally change their labels. I cannot agree. We have traditionally held defendants claiming impossibility to a demanding standard: Until today, the mere possibility of impossibility had not been enough to establish pre-emption.

Although Justice Kennedy provides the fifth vote in support of preemption, he does not join Part III-B-2 of Justice Thomas's opinion. That section of the opinion (which starts on p.15 of the slip op.) argues that “the text of the [Supremacy] Clause—that federal law shall be supreme, ‘any Thing in the Constitution or Laws of any State to the Contrary notwithstanding’—plainly contemplates conflict pre-emption by describing federal law as effectively repealing contrary state law.” Justice Thomas explains:

The phrase “any [state law] to the Contrary notwithstanding” is a non obstante provision. . . . A non obstante provision in a new statute acknowledged that the statute might contradict prior law and instructed courts not to apply the general presumption against implied repeals. The non obstante provision in the Supremacy Clause therefore suggests that federal law should be understood to impliedly repeal conflicting state law. Further, the provision suggests that courts should not strain to find ways to reconcile federal law with seemingly conflicting state law.

For our earlier coverage of the case, see here and here.


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