Product Liability -- 2017

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

Preemption of drug labeling challenge

The NAM filed an amicus brief 9/19/16 in the Tenth Circuit supporting Aventis, Inc. in the defense of suit claiming that the drug Clomid for infertility should have been labeled with an additional warning about use before pregnancy. We filed an amicus brief arguing that the Food, Drug & Cosmetic Act has strict requirements for changes to FDA-approved labels, and the Act preempts any state-law requirement that would require a company to change a label without complying with federal law.

FDA's regulation of drug labeling requires that companies may add or strengthen a warning only if there is sufficient evidence of a causal association between the drug and risks of a different type or greater severity or frequency than already addressed in the label. The FDA rejected efforts to change the labels at issue in this case, and until there is sufficient evidence, it is illegal for a company to change the label as demanded in the law suit.

Joining in the brief were Chamber of Commerce of the U.S. and the American Tort Reform Association.

On May 2, 2017, the Tenth Circuit reversed the lower court’s grant of summary judgment to Aventis. While the court determined that the claims regarding the failure to warn are preempted by federal law, the court remanded that case to further address claims related to the FDA’s prior language on Clomid’s risks. The court also determined that the lower court needed to directly address preemption relating to the claims involving fraud, negligent misrepresentation, and breach of an implied warranty.

Related Documents:
NAM amicus brief  (September 19, 2016)


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