Court Rejects Wyeth's Preemption Claim:

This morning, in Wyeth v. Levine, the Supreme Court held, 6-3, that federal approval of warnings on prescription drug labels does not preempt state law tort suits alleging that such warnings were inadequate. Justice Stevens wrote the majority opinion, joined by the usual suspects and Justice Kennedy. Justice Thomas concurred in the judgment. Justice Alito dissented, joined by the Chief Justice and Justice Scalia.

This is the second time this term in which the Court has rejected industry arguments that federal law preempts state tort law claims. The Court also rejected a preemption claim in Altria v. Good. This is interesting because preemption claims fared quite well during the first three years of the Roberts Court, lending support to the idea that this Court is "pro-business." Until this year, the only preemption claim the Roberts Court had rejected was the argument that the Clean Water Act preempts punitive damages in Exxon Shipping v. Baker, but this was not much of a loss for business as, in the same decision, the Court limited the extent of such damages under the federal common law of maritime. I don't think Wyeth and Altria signal a dramatic shift in the Court's jurisprudence, but I do believe these decisions are evidence that early proclamations that the Roberts Court is a "pro-business" court were premature.

Wyeth and Deference to Agencies:

One interesting aspect of the Supreme Court's Wyeth decision is its refusal to defer to the FDA's conclusion that state tort suits, of the sort at issue here, conflict with the FDA's regulatory scheme. While the Court does not foreclose deferring to similar agency determinations in the future, Justice Stevens makes clear that it is for courts, not agencies, to determine whether such a conflict exists. While this might not matter much in the immediate future, as I doubt the Obama Administation will be all that aggressive in urging preemption, it will raise the bar for future, pro-preemption administrations.

Here is a portion of the relevant language in the opinion.

In prior cases, we have given "some weight" to an agency's views about the impact of tort law on federal objectives when "the subject matter is technica[l] and the relevant history and background are complex and extensive." . . . Even in such cases, however, we have not deferred to an agency's conclusion that state law is pre-empted. Rather, we have attended to an agency's explanation of how state law affects the regulatory scheme. While agencies have no special authority to pronounce on pre-emption absent delegation by Congress, they do have a unique understanding of the statutes they administer and an attendant ability to make informed determinations about how state requirements may pose an "obstacle to the accomplishment and execution of the full purposes and objectives of Congress." . . . The weight we accord the agency's explanation of state law's impact on the federal scheme depends on its thoroughness, consistency, and persuasiveness. . . .

. . . we have no occasion in this case to consider the pre-emptive effect of a specific agency regulation bearing the force of law. And the FDA's newfound opinion, expressed in its 2006 preamble, that state law "frustrate[s] the agency's implementation of its statutory mandate," . . . does not merit deference for the reasons we have explained. . . .

In short, Wyeth has not persuaded us that failure-to-warn claims like Levine's obstruct the federal regulation of drug labeling. Congress has repeatedly declined to pre-empt state law, and the FDA's recently adopted position that state tort suits interfere with its statutory mandate is entitled to no weight. Although we recognize that some state-law claims might well frustrate the achievement of congressional objectives, this is not such a case.

The folks at the Drug and Device Law blog have some initial thoughts on the decision here.