Federalism in Action: FDA Regulatory Preemption in Pharmaceutical Cases in State versus Federal Courts

Abstract:     
This Essay focuses on an illustration of "federalism in action" - namely, the divergent approaches of state and federal courts in deciding whether the Federal Food Drug and Cosmetic Act (FDCA), and accompanying regulations promulgated by the Food and Drug Administration (FDA), preempt state failure-to-warn claims brought against pharmaceutical companies.

The Essay explores two salient factors that might affect state and federal courts' respective approaches to the FDA drug labeling preemption analysis: (1) the radical shift in the debate from regulatory compliance to preemption; and (2) the role and influence of the FDA. First, the recurrent debate - in the academy and the courts - regarding the interplay between federal regulations and state common law tort actions has, in less than a decade, radically shifted from regulatory compliance to federal preemption. If state courts have an institutional interest in preserving the autonomy of state common law from broad federal overrides, then presumably one should expect the same resistance to claims of outright preemption. Second, a myopic institutional focus on the courts alone misses the critical role and influence of federal agencies. Thus far largely overlooked is the extent to which federal agencies' role and influence may be a driving force behind the state-federal disparity in preemption determinations. In the realm of FDA prescription drug preemption, not only are federal courts more likely to defer to federal agencies, but - equally important in terms of explaining the decision-making process of courts - federal courts are more likely than state courts to solicit the views of the FDA and the FDA is more apt to intervene on its own in federal court cases.

The Essay concludes with some thoughts regarding the federalism implications of state-federal court differences in approach to the preemption inquiry.

Keywords: preemption, drug, pharmaceutical, federalism, tort, regulation

JEL Classifications: K13, K41

Accepted Paper Series