Product Liability -- 2017



Cerveny v. Aventis, Inc.   (10th Circuit)

Preemption of drug labeling challenge

The NAM filed an amicus brief to support manufacturers rights in complying with federal labeling regulation in a pharmaceutical litigation suit. The plaintiffs alleged that the drug Clomid failed to provide sufficient warning labels about use before pregnancy. This decision would have imposed dueling labeling requirements on manufacturers subjected to product labeling litigation. The NAM’s brief argued that the Food, Drug & Cosmetic Act (FDCA) preempted any state-law requirement that would require a company to change a label without complying with federal law. In a win for manufacturers, the court determined that the claims regarding the failure to warn are preempted by federal law; however, the case was remanded back to the lower court to further address claims related to the FDA’s prior language on Clomid’s risk.


Related Documents:
NAM brief  (September 19, 2016)