OPENING THE DOOR TO "HARD-LOOK" REVIEW OF AGENCY PREEMPTION

Preemption of state tort actions by federal regulatory schemes, especially products liability actions, poses recurring federalism concerns. This essay revisits the problem, with a focus on the challenging issue of identifying whether a particular case of asserted preemption should be attributable to Congress or to the agency. The issue is important because characterizing a case as one of preemption by the agency can open the door to an appropriate level of scrutiny into the decision to preempt: a mode of review akin to the hard-look review used in other areas of judicial review of agency action. In an earlier article, the author analyzed key Supreme Court cases and concluded that courts should use a totality of the circumstances approach when trying to identify the source of the intent to preempt. A totality of the circumstances approach would allow a court to take into account any relevant evidence, but especially evidence relating to whether the precise agency activity giving rise to the preemption was devised or envisioned by Congress - or by the agency itself, through a regulatory scheme clearly going beyond specific directives detailed by Congress. In this essay, using the FDA's recent assertions of preemption arising from its market-approval decisions for prescription drugs, the author illustrates in more detail how a totality of the circumstances analysis can lead to an appropriate characterization of the source of the intent to preempt. The analysis probes the evolution of federal drug regulation, contrasting the limited nature of Congress' role with the ever-expanding nature of the agency's role in the regulation of prescription drug labeling. Additionally, the analysis takes into account, in a meaningful way, the frequently emphasized fact that the agency recently changed its view of the preemption issue - a fact which is often discounted in a traditional preemption analysis. In the case of the FDA's assertion of preemption, a totality of the circumstances analysis points strongly to the appropriateness of characterizing the agency as the source of preemption. Notably, that conclusion has failed to surface in the plethora of recent lower court cases addressing the issue of preemption arising from FDA approval decisions. It has failed to surface because courts and litigators have followed the agency's lead in characterizing the issue as a matter of congressional intent to preempt. Permitting the agency to frame the issue in that manner enables the agency to side-step accountability for preemption decisions made by the agency. Instead, in cases involving preemption arising from an agency's regulatory activity, it is crucial to carefully analyze the circumstances and to properly identify those instances when, realistically, it is the agency which is the source of the intent to preempt. The essay also briefly demonstrates the importance of hard-look review when the source of the intent to preempt is the agency. Hard-look review requires courts to engage in a rigorous scrutiny of the agency's authority. In the case of the FDA, careful historical analysis of federal drug regulation brings to light issues relating to the authority of the FDA to regulate prescription drug labeling, at least in the comprehensive way that the FDA today regulates such labeling. Specifically, careful analysis reveals that the delegation of authority to the FDA relating to the content of prescription drug labeling is largely a matter of inference and acquiescence. Because a hard-look review can serve as a proxy for a "presumption against preemption," such evidence can provide sound reasons for a court to decline to uphold the agency's decision that preemption of state tort law is warranted. Importantly, the key points made in this essay have ramifications beyond the context of the FDA's recent assertion of preemption. The issues arise in any case involving an assertion of preemption of state law due to agency regulatory activity. The issues are important because, if the source of preemption in reality is the agency, rigorous judicial review becomes a necessary safeguard for federalism concerns.