Preemption Update: Wyeth v. Levine

Yesterday, in a 6-3 decision handed down in Wyeth v. Levine, No. 06-1249, the United States Supreme Court struck a thunderous blow to Big Pharma’s most treasured defense tactic: conflict preemption.

The High Court’s much anticipated opinion affirmed the earlier opinion of the Vermont Supreme Court, which also had rejected the drug maker’s implied preemption argument and upheld a $7 million jury verdict in favor of Plaintiff Diana Levine. Justice Stevens delivered the Court’s majority opinion, which was joined by Justices Kennedy, Souter, Ginsburg, and Breyer. Justices Breyer and Thomas also wrote separate concurring opinions, although Justice Thomas concurred only in the result. The dissent, authored by Justice Alito, was joined by Chief Justice Roberts and Justice Scalia.

The majority declined to find implied conflict preemption in the prescription drug labeling arena, roundly rejecting both of Wyeth’s implied preemption arguments: (1) that it would have been impossible for the company to comply with both its federal labeling obligations for the drug in question (Phenergen) and a state tort claim alleging the inadequacy of that drug’s label, and (2) that a state tort claim challenging the adequacy of a drug’s labeling stands as an obstacle to the accomplishment of the federal prescription drug regulatory scheme.

In jettisoning industry’s oft-relied-upon “impossibility” argument, the majority explained:

[P]rior to 2007, the FDA lacked authority to order manufacturers to revise their labels. When Congress granted the FDA this authority, it reaffirmed the manufacturer’s obligations and referred specifically to the [Changes Being Effected] regulation [21 C.F.R. 314.70(c)(6)(iii)(A), (C)], which both reflects the manufacturer’s ultimate responsibility for its label and provides a mechanism for adding safety information to the label prior to FDA approval.


Of course, the FDA retains authority to reject labeling …. But absent clear evidence that the FDA would not have approved a change to [the drug’s] label, we will not conclude that it was impossible for Wyeth to comply with both federal and state requirements.

Slip op., at 14-15. And in disposing of the “obstacle” argument, the majority reasoned:

If Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express preemption provision at some point during the FDCA’s 70-year history. … Its silence on the issue, coupled with its certain awareness of the prevalence of state tort litigation, is powerful evidence that Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.

Slip op., at 18.

While some prognosticators might certainly have foreseen Justices Stevens, Souter, and Ginsburg positioning themselves against implied preemption here – and some might even have guessed the same of Justices Breyer and Kennedy – it would have been difficult for anyone to predict the extent to which Justice Thomas joined the crowd. In a 24-page opinion joining only in the judgment, Justice Thomas voiced his agreement with the majority’s general observance that the FDA’s mere approval of Wyeth’s drug labeling did not operate to preempt Diana Levine’s state-law jury verdict. But he went much further, explaining at length that he could not join the majority’s “implicit endorsement of far-reaching implied pre-emption doctrines,” which in his view “routinely invalidates state laws based on perceived conflicts with broad federal policy objectives, legislative history, or generalized notions of congressional purposes that are not embodied within the text of federal law.” Slip op. (Thomas, J. concurring), at 2.

And in a forceful conclusion to his dissertation, Justice Thomas offered this:

The origins of this Court’s “purposes and objectives” pre-emption jurisprudence … and its broad application … illustrate that this brand of the Court’s pre-emption jurisprudence facilitates freewheeling, extratextual, and broad evaluations of the “purposes and objectives” embodied within federal law.


Because such a sweeping approach to pre-emption leads to illegitimate – and thus, unconstitutional – invalidation of state laws, I can no longer assent to a doctrine that pre-empts state laws merely because they “stan[d] as an obstacle to the accomplishment and execution of the full purposes and objectives” of federal law … as perceived by this Court.

Id. at 23-24 (emphasis added).

Of course, Justice Thomas’ view obviously did not garner a majority, and his opinion here has no precedential value. But his staunch and complete opposition to an entire body of implied conflict preemption doctrine – i.e., the congressional purposes and objectives test – may portend the future contours of implied preemption battles in the Court. Certainly, that Justice Thomas comes down indisputably in opposition to implied preemption principles is a clear signal that future defendants seeking to avail themselves of preemption in the absence of clear legislative or regulatory text will need to add two justices – not just one – to their tally.

The majority opinion in Levine marks a decisive victory for tens of thousands of consumer lawsuits that arise – or will arise – from prescription drug injuries. It is unlikely that Big Pharma will go down without a fight on this issue – indeed, defense attorneys are no doubt hard at work already in crafting arguments to distinguish or marginalize Levine in other cases – but to be sure, the Court’s holding in Levine tips the litigation scale decidedly back in favor of consumer plaintiffs.