The Final Battle for Preemption: The FDA and Prescription Drug Labeling Product Liability Actions


The Food and Drug Administration (FDA) has promulgated a new regulation which revises the format for prescription drug labeling, and, in the process, has taken the position that the regulation displaces, or preempts, state products liability laws that seek to assess liability on the manufacturer for a label’s warning adequacy. In the FDA’s 100 year history, it has not taken the position that federal prescription drug labeling regulations preempt common law tort claims until the last few years, beginning with Motus v. Pfizer in 2002. This position, radical to many and rational to others, places federal preemption of prescription drug labeling actions directly in the center of the debate over the proper roles of federal regulation and state tort laws in effecting product safety. The Supreme Court has added to that debate with a number of product liability preemption decisions in the past two decades. Seeking to promote both understanding and balance regarding the operation of preemption doctrine within products liability, this Article provides a comprehensive explanation of the applicability of preemption doctrine to prescription drug product liability actions. This Article explores the history of preemption doctrine specifically as it relates to the food and drug laws, evaluates the importance of the FDA’s position on the application of that doctrine to current litigation, and provides direction to courts seeking to navigate the battlefield of federal preemption.


Consumer Protection Law | Food and Drug Law | Jurisprudence | Medical Jurisprudence | Torts

Date of this Version

August 2006