Reassessing Regulatory Compliance

Abstract:     
The regulatory compliance defense stands at the intersection between tort law and administrative regulation of health and safety concerns. In contrast to judicial treatment of violations of regulatory standards, compliance with regulatory requirements traditionally has not been regarded as the occasion for deference in tort cases (in the absence of legislative preemption). As entrepreneurial systems of production and transport have grown in complexity and sophistication, critics of tort law have challenged the continuing reluctance of courts to adopt a more deferential stance when tort defendants have complied with regulatory requirements - particularly when the claims for recognition of administrative expertise are linked with the perceived benefits of nationally uniform standards.

This paper reassesses the case for a regulatory compliance defense by considering a variety of perspectives on comparative institutional competence of court and agency, including attending to non-efficiency goals such as compensation, acknowledging dynamic social utility goals such as monitoring business ethics, identifying the often unanticipated circumstances under which risks come to fruition, along with respecting claims for state autonomy. The paper also provides a particularized discussion of FDA regulation of prescription drugs, a regulatory field often designated by tort critics as the strongest candidate for recognition of a regulatory compliance defense. Overall, the paper argues that the case for recognizing a defense, as distinguished from highly selective deference to regulatory standards, remains open to serious reservations.

Note: A revised version of this working paper is forthcoming in the Georgetown Law Journal, Vol. 88, No. 6, 2000.

Number of Pages in PDF File: 60

working papers series