Title

  • Agency Preemption and the Shimer Analysis: Unmasking Strategic Characterization by Agencies and Giving Effect to the Presumption against Preemption

Creator

Published In

Date

  • 2008

Volume

  • 2008

Issue

  • 1

Bibliographic Citation

  • 2008 Wis. L. Rev. 69 (2008)

Abstract

  • Significant federalism concerns are raised when state productsliability actions are preempted by federal regulatory schemes. For example,
    the FDA has recently taken the position that its approval of the labels 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 preemption by the
    agency can result in a type of hard-look review of the agency's decision to
    preempt. Use of a hard-look review can serve as a proxy-in cases of
    agency preemption-for the presumption against preemption that is used in
    all other categories of preemption analysis.

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