Why the FDA Must Preempt Tort Litigation: A Critique of Chevron Deference and a Response to Richard Nagareda

This article critiques Richard Nagareda's proposal to use the promise of the legal preemption of tort suits as a carrot to stimulate pharmaceutical companies to generate more information about the adverse side effects of their drugs. Its first section critiques the traditional view that FDA warnings function as an initial form of consumer protection that is thereafter backstopped by tort remedies. The chief vice of this system is systematic overdeterrence of drug use, by treating FDA warnings as though they were only minimums when in many cases they were too severe. The article examines the modern "presumption against preemption" and urges the adoption of a contrary position whereby the comprehensive nature of FDA regulation should be treated as occupying the field. The article then discusses the recent FDA efforts to secure that result through its own interpretive preamble. That approach might yield the correct approach in any individual case, based on a presumption of judicial deference to administrative decisions under the Chevron doctrine. On balance, however, the Chevron approach runs the enormous risk of agency flip-flop, driven by powerful political forces. Accordingly, the wiser approach treats preemption as a matter of law to be decided by judges without deference. The article also contains an evaluation of the modern decisions that have examined federal preemption in duty to warn cases, and concludes that modern technology provides so many sources of information about drug side effects that we should reject the Nagareda proposal to tie FDA protection against tort suits to the provision of additional information to the FDA.