STORY FROM: Drugs & Medical Devices

10th Cir. Reverses Award of Summary Judgment to Aventis in Clomid Birth Defect Action

DENVER — A federal appeals court has reversed an award of summary judgment to the maker of Clomid and remanded the action so the lower court can address the drug maker’s failure to adopt the FDA’s proposed warning regarding the risk of harm to the fetus when the drug is taken during pregnancy.

On May 2, the 10th Circuit U.S. Court of Appeals also directed the lower court to explain why federal law preempts the plaintiffs’ claims for fraud, negligent misrepresentation, and breach of an implied warranty.

In 1967, the FDA approved Clomid (clomiphene citrate), a selective-estrogen-receptor modulator, for the ...

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