Products Liability Preemption: An Institutional Approach

74 Pages Posted: 17 Jan 2008 Last revised: 2 Jun 2013


The Supreme Court's products liability preemption jurisprudence is a small but expanding area that traces its beginnings to the early 1990s with Cipollone v. Liggett Group, Inc., and continues, most recently, through the 2008 decision of Riegel v. Medtronic, Inc. At first glance, the United States Supreme Court's preemption jurisprudence in the realm of products liability cases is a nearly incoherent muddle. But a closer view actually reveals an unmistakable pattern: in every case, the Court, with only one exception, has adopted the position of the relevant federal agency as to whether the plaintiff's state law claims should be preempted by that agency's regulations. The Court is hardly forthright about its dependence upon agencies.

My article proposes a new agency reference model to fill the doctrinal gap. The model serves two functions: a lens through which we might better understand what the Court has been doing, for the past fifteen years, in the product liability preemption cases that it has decided, and a prescriptive approach for the cases that it, and lower courts, will face down the road. The thorniest preemption cases arise where Congress has been silent as to the preemptive effect of its own legislation; where a statute that it has issued says nothing or else says contradictory things about the relationship of that law to state law claims. The tall interpretive task is left to courts and to agencies. The agency reference model is an effort to clarify the relationship between these two actors; a relationship that needs direction and parameters, not only to provide coherence and predictability to the law in this area, but, this article suggests, to guide courts to the optimal result in preemption cases.

Under this model, courts should look to agencies to supply the data and analysis necessary to determine if preemption is appropriate; i.e., to determine when a uniform, national regulatory policy with respect to a certain product makes the most sense or, instead, whether such regulation is better left to the states, in which case a plaintiff's common law claim should be permitted to proceed. This model simply acknowledges and exploits the fact that agencies are best equipped to provide the information central to this determination (a fact that the Court apparently already recognizes).

The role played by an agency might be significant in two respects. First, there is a degree of regulatory scrutiny employed by the agency in its review and approval of products. In addition, an agency often weighs in contemporaneously on factors that arguably determine the preemptive effect of its regulatory actions. Second, an agency may assume a distinct interpretive role as administrator of the congressional legislation, and has a variety of means at its disposal to express its position on preemption, from formal notice-and-comment rulemaking to less formal interpretive statements and preambles to litigation briefs. Finally, an agency may share its views before courts (including the Supreme Court) tasked with deciding preemption questions.

The model acknowledges that there is good reason to be chary of agencies acting in their interpretive, as distinct from regulatory, capacity. Most of the arguments in favor of agencies' comparative expertise speak to the rigor of the product review and approval process. While it is certainly the case that an agency might manipulate its regulatory record at the time of its product review, that danger pales in comparison to the risk of an agency's post hoc rationalization of its actions in litigation briefs, or promulgation of interpretive rules and preambles. For this reason, the model incorporates various checks on agency preemptive power.

Keywords: preemption, products liability, FDA, pharmaceuticals, tort, regulation

JEL Classification: K13, K41

Suggested Citation

Sharkey, Catherine M., Products Liability Preemption: An Institutional Approach. George Washington Law Review, Vol. 76, No. 449, 2008, NYU Law School, Public Law Research Paper No. 08-05, NYU Law and Economics Research Paper No. 08-11, Available at SSRN:

Catherine M. Sharkey (Contact Author)

New York University School of Law ( email )

40 Washington Square South
New York, NY 10012-1099
United States
212-998-6729 (Phone)


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