The Eastern District of Pennsylvania U.S. District Court recently held that the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C.S. § 301 et seq.) and FDA regulations do not preempt victims of pharmaceutical manufacturer misconduct from bringing state failure-to-warn tort claims. This landmark ruling is being held as a major victory for this class of plaintiffs.
In the preamble to the January 2006 FDA regulation on drug labeling, the FDA claimed that the regulations impliedly preempt most state failure-to-warn claims against pharmaceutical manufacturers. The Court held that while the FDA is entitled to great deference in interpreting the ambiguities in its governing statutes and regulations, such deference is not accorded when the FDA is attempting to provide the “clear legislative statement of intent needed to overcome the presumption against preemption” on the behalf of Congress.
The Court held that some state failure-to-warn claims were preempted, specifically claims where the FDA has made a determination regarding the danger of the drug. The Court held that states are permitted to require the addition of warnings to drug labels as long as the FDA has made no specific determination regarding the sufficiency of the scientific evidence used to support a particular warning. Where the FDA has remained silent, such claims are not preempted.
The case is Perry v. Novartis Pharma. Corp., 2006 WL 2979388 (E.D.Pa).
Contact this Author: James Stanley
