Judicial Review of FDA Preemption Determinations

Amanda Frost


In Medtronic v. Lohr, the U.S. Supreme Court held that the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) did not preempt Lohr's state tort claim for damages. Although the decision has caused lower courts to think twice before holding that state tort laws are preempted by Food and Drug Administration (FDA) regulations, it hardly has settled this area of law. In the time since the Lohr decision, courts have disagreed sharply on the question of whether or not FDA approval of medical devices preempts state law. FDA has taken an active role in the debate. Most significantly, the agency has issued regulations narrowly interpreting the scope of section 360k(a) of title 21 of the United States Code - the express preemption provision at issue in the case - and has filed amicus curiae briefs, in Lohr and in other cases, in support of its interpretation of section 360k(a). Recently, FDA issued a proposed regulation clarifying the narrow reach of section 360k(a), but then rescinded its proposal in response to unfavorable comments. It is unclear, however, what weight should be given to FDA's construction of the preemption provisions in the FDCA. Normally an agency's interpretation of its own statute is granted Chevron deference: if the statute is ambiguous, courts will defer to an agency's reasonable interpretation, even if the court itself would have reached a different conclusion. In Lohr, the majority relied heavily on FDA's interpretation of section 360k(a), commenting that FDA's narrow interpretation of the section's preemptive reach "substantially informed" the Court's conclusion. As the four dissenting justices pointed out, however, the majority never explicitly granted "Chevron deference" to FDA's interpretation of the statute." In the dissenters' view, the majority shied away from applying Chevron because "it is not certain that an agency regulation determining the preemptive effect of any federal statute is entitled to deference."