United States: Supreme Court Docket Report - Decision Alert - March 4, 2008

Originally published March 4, 2009

Keywords: Wyeth, Food and Drug Administration, FDA, FDCA, federal preemption, drug labeling, failure to warn

Today the Supreme Court issued a decision, described below, of interest to the business community.

Wyeth v. Levine, No. 06-1249 (previously discussed in the January 21, 2008 Docket Report).

Under the Federal Food, Drug and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq., a manufacturer must receive the approval of the Food and Drug Administration (FDA) before marketing a new drug. See 21 U.S.C. § 355(b). The FDA exercises continuing regulatory authority over approved drugs, and it normally must pre-approve any change in drug labeling. See 21 C.F.R. § 314.70. In order to resolve a dispute among the lower courts regarding the preemptive effect of FDA approval, the Supreme Court granted certiorari in Wyeth v. Levine, No. 06-1249, to determine "whether FDA drug labeling judgments preempt state-law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use." Slip op. 6. Today, in a 6-3 decision that rested at least in part on the particular facts presented, the Court answered that question in the negative. 

The plaintiff (respondent in the Supreme Court) alleged that she was injured when a drug manufactured by defendant Wyeth was injected directly into her vein.  She asserted state-law tort claims against the drug manufacturer, alleging that her injury was a result of its failure to provide adequate warning of the dangers of the drug when administered in this manner. Wyeth contended that the plaintiff's failure-to-warn claims were preempted by federal law because the drug's label had been approved by the FDA.

In an opinion by Justice Stevens, the Supreme Court held that FDA approval of a drug label does not impliedly preempt a failure-to-warn claim when the FDA has not specifically rejected the warning that the plaintiff contends was required under state law.  Placing considerable emphasis on an FDA regulation that allows manufacturers to unilaterally strengthen warnings under certain circumstances, subject to subsequent FDA ratification, the Court first rejected—on a factual basis—the contention that it was "impossible" for the defendant to comply with both the state-law duties underlying the failure-to-warn claim and federal labeling duties under the FDCA.  The Court also rejected the defendant's argument that state-law failure-to-warn claims are, by interfering with the agency's expert balancing of risks and benefits associated with a drug, an "obstacle" to the FDCA's regulatory scheme. Declining to give deference to the FDA's interpretation of the preemptive effect of the statute, the Court concluded that Congress had not intended to implicitly preempt state-law duty-to-warn cases.  In its decision, the Court emphasized that "the purpose of Congress is the ultimate touchstone in every pre-emption case," and that "in all pre-emption cases ... we start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress."  Slip. op. 8 (internal quotation marks and alterations omitted). 

Justice Breyer concurred in the judgment, emphasizing that the Court did not decide whether "a specific agency regulation bearing the force of law" might preempt state-law actions. Slip op. 1 (opinion concurring in the judgment).  Justice Thomas, also concurring in the judgment, would have further reined in the Court's doctrine of implied preemption.  Justice Alito wrote a dissent, joined by Chief Justice Roberts and Justice Scalia, rejecting the notion that "a state tort jury, rather than the [FDA], is ultimately responsible for regulating warning labels for prescription drugs." Slip op. 1 (dissenting opinion).  In the dissent's view, Congress intended to rest decisions regarding the adequacy of a drug label in the hands of the FDA, and the doctrine of conflict preemption prohibits the States from countermanding the FDA's determination.

Mayer Brown filed an amicus brief in support of the defendant, Wyeth, on behalf of the Product Liability Advisory Council (PLAC) at the merits stage; at the petition stage, Mayer Brown filed an amicus brief, also in support of Wyeth, on behalf of PLAC and the United States Chamber of Commerce.

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