The Supreme Court’s decision this week in Wyeth v. Levine is a major blow to pharmaceutical manufacturers. The Court’s holding that the FDA’s approval of a drug label does not necessarily preempt state law failure to warn claims means that pharmaceutical companies can no longer rely on the FDA’s approval of its label and must constantly second-guess the adequacy of their warnings, Now, whether a particular warning is sufficient will no longer be decided by the FDA in conjunction with the manufacturer, but will be decided by civil juries.
Because the Court was careful to limit its holding in Levine to the specific facts of the case and the specific provisions of the Federal Food, Drug, and Cosmetic Act, it remains to be seen what the impact of the decision will be for other products subject to extensive federal regulation. Two of the Court’s bases for its decision in Levine, however, may be instructive.
First, the Court reaffirmed the strong presumption against preemption unless Congressional intent to do so is “clear and manifest” as reflected by the language of the federal statute and its history. Second, unlike in Geier v. American Honda Motor Co., the Court refused to give any weight to the agency’s own views (expressed in an amicus brief and a regulatory preamble) as to whether preemption of state tort suits is necessary to fulfill the statutory objectives.
Thus, in the absence of an express preemption provision, a manufacturer in a regulated industry may be left with little guidance as to whether it can rely on its compliance with federal law to avoid state tort liability on preemption grounds. As in Geier, the availability of implied preemption of state tort suits may be available only where the Supreme Court finds that Congress intended that the agency should be trusted to use its expertise to make complex decisions striking a balance between competing objectives of the statute.