Discovering the Boundaries: Federal Preemption of Pharmaceutical Labeling Product Liability Actions


Federally approved prescription drug labeling has not been considered conclusive on the reasonableness or adequacy of the label for assessing tort liability on the manufacturer because federal regulations in this field set a minimum standard rather than an optimal one. That fundamental statement of black-letter tort law is under attack. The Food and Drug Administration (FDA) has promulgated a 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 regulations preempt common law tort claims based on prescription drug labeling until now. This Article explains the applicability of preemption doctrine to prescription drug product liability actions, explores the importance of the change in FDA position on that doctrine, and provides direction to courts seeking to discover the boundaries of federal preemption in this critical area.


Consumer Protection Law | Food and Drug Law | Torts

Date of this Version

April 2006