STORY FROM: Drugs & Medical Devices

Proposed Claims Against Hormone Replacement Therapy Drug Maker Preempted, 11th Cir. Affirms

ATLANTA — A plaintiff in a hormone replacement therapy case may not amend her complaint to allege the defendant drug maker failed to notify the FDA of scientific studies that connected its drug to breast cancer, because such a claim would be impliedly preempted, a federal appeals court has affirmed.

On Nov. 21, the 11th Circuit U.S. Court of Appeals said the plaintiff’s proposed claim against the generic drug maker is preempted pursuant to Buckman Co. v. Plaintiff’s Legal Committee because it would “conflict with the FDA’s responsibility to police fraud.” As such, amendment would be futile, the appellate court ...

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