Agency Preemption and the Shimer Analysis: Unmasking Strategic Characterization By Agencies and Giving Effect to the Presumption Against Preemption

Abstract

Key federalism concerns are raised by the specter of of state products liability actions by federal regulatory schemes. For example, the FDA has recently taken the position that its approval of the labeling on prescription drugs preempts civil tort claims grounded in a manufacturer's failure to warn. Using the FDA's recent stance on the issue of preemption, this Article demonstrates that federal agencies can engage in strategic characterization by pointing to Congress as the source of preemption, rather than the agency itself. In doing so, agencies avoid political and judicial scrutiny of agency action. This Article proposes that courts use a more realistic, totality of the circumstances approach when deciding whether Congress or an agency is the source of preemption. Further, the Article demonstrates that properly identifying a case as one of by the agency can result in a type of hard look review of the agency activity which purportedly preempts state law. Use of a hard-look review can serve as a proxy - in cases of agency - for the presumption against preemption which is used in all other categories of analysis.