Statutory Compliance and Tort Liability: Examining the Strongest Case

Professor Green addresses the matter of the proper balance between the tort system and regulation in the context of prescription drugs and the FDA’s vigorous oversight of the industry. He articulates several reasons why a regulatory compliance defense, in which tort law would defer to FDA regulation, is quite attractive. Despite the superior expertise of the FDA in assessing the benefits and risks of a drug, a regulatory compliance defense is considerably more problematical than might appear at first glance. Ascertaining compliance with FDA requirements could be a lengthy and complicated inquiry that would either replace or supplement the issues that arise in current drug product liability litigation. Particularly in the period after a drug is approved and marketed, yet when additional risks emerge, a regulatory compliance defense might impede efforts to assure that current information is promptly disseminated to physicians who make prescribing decisions. Professor Green concludes by suggesting that a regulatory compliance defense may have an impact on the types of drug litigation that occur but expresses doubt that drug litigation would disappear.