What Riegel Portends for FDA Preemption of State Law Products Liability Claims

Abstract:     
Riegel v. Medtronic, the Court's latest pro-preemption decision shielding manufacturers of certain FDA-approved medical devices from common law tort liability, can be fairly characterized as a narrow, textual interpretation of the preemption clause of a congressionally enacted statute. More typically in products statutes (governing motor vehicles, recreational boats, or consumer products, for example) Congress creates confusion by including both a preemption clause, which mandates displacement of competing or conflicting state law standards, and a savings clause, which purports not to upend existing state common law liability. Where statutory text is indeterminate, where are courts to look?

Drawing upon some suggestive gestures toward agency input in Riegel, this Essay applies what I have termed the "agency reference model" to the concrete setting of the regulation of pharmaceutical drugs and extends the model by specifying searching judicial review of evidence taken from the FDA's regulatory record to substantiate FDA findings of implied conflicts between state common law failure-to-warn claims and the federal regulation of the safety and efficacy of drugs.

On this account, what emerges as key to the preemption inquiry is setting the parameters for legitimate agency claims to authority both for its substantive determinations and for its interpretation of the governing statute. To whom much is given, much is required. Under the agency reference model, the FDA would be given an enhanced role, partnering so to speak with the courts in making preemption determinations; for this reason, courts must ensure that the actions and positions taken by the FDA merit deference. Redirecting the preemption inquiry in these directions would go a long way towards helping courts make implied conflict preemption decisions in products liability cases, where statutory text provides scant guidance.

Number of Pages in PDF File: 27

Keywords: FDA, preemption, Supreme Court, Riegel, Wyeth, products

JEL Classification: K41

Accepted Paper Series