SYMPOSIUM: REGULATORY COMPLIANCE AS A DEFENSE TO PRODUCTS LIABILITY: Rewarding Regulatory Compliance: The Pursuit of Symmetry in Products Liability Skip over navigation
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Copyright (c) 2000 Georgetown Law Journal
Georgetown Law Journal

SYMPOSIUM: REGULATORY COMPLIANCE AS A DEFENSE TO PRODUCTS LIABILITY: Rewarding Regulatory Compliance: The Pursuit of Symmetry in Products Liability

July, 2000

88 Geo. L.J. 2147

Author

Lars Noah *

Excerpt

INTRODUCTION

Professor Rabin starts from the perspective of the tort system and asks what, if anything, federal health and safety agencies might have to offer the courts in resolving products liability claims. He discusses the regulation of pharmaceutical products by the Food and Drug Administration (FDA) almost as an after-thought, paying nearly as much attention to automobile design cases. No wonder the compliance defense gets little respect. Only after developing a proper appreciation of the rigors of the regulatory process of a particular agency can one decide whether an inevitably qualified government standards defense makes any sense. In addition to starting at the beginning (and not becoming distracted by highly visible regulatory failures such as breast implants or fenfluramine, which would not benefit from a compliance defense to tort claims in any event), I will emphasize regulatory standards that emerge from a structured and public rulemaking process. Such an emphasis differs from the individualized product licensing decisions that normally frame this debate and on which Professor Rabin focuses his critique, though he ultimately concedes that compliance with regulations should count in certain circumstances. 1

Before responding directly to Professor Rabin's points about the comparative institutional competence of the tort system, I will attempt to lay the groundwork necessary to justify an FDA compliance defense. Part I uses a hypothetical drug labeling problem to highlight the contrasting approaches to regulation by agencies and courts, and then it describes the historical origins of the asymmetrical judicial treatment of compliance and noncompliance. ...
 
 
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