Addressing the Conflict: FDA vs. Torts

Our legal system supports two regulators of the safety of prescription drugs ' the U.S. Food and Drug Administration and courts applying the tort liability regime. The FDA's mission, while narrowly circumscribed in its early years, grew dramatically over the last half of the twentieth century. Today, the FDA administers the most comprehensive drug regulatory system in the world. (See Jeffrey E. Shuren, The Modern Regulatory Administrative State: A Response to Changing Circumstances, 38 Harvard J. on Legis. 291, 299-315 (2001); Michael D. Green, Statutory Compliance and Tort Liability: Examining the Strongest Case, 30 U. Mich. J.L. Ref. 461, 464 (1997); Charles J. Walsh et al., Rationalizing the Regulation of Prescription Drugs and Medical Devices: Perspectives on Private Certification and Tort Reform, 48 Rutgers Law Rev. 883, 890-929 (1996) (detailing the 'pervasive' reach of FDA regulation as controlling 'nearly every aspect of the development and marketing of a prescription drug or medical device, from the earliest clinical testing to the contents of the final advertisements used to present the final product to health care providers.').