STORY FROM: Drugs & Medical Devices

Clomid Birth Defect Claims Asserted Against Aventis Preempted, Utah Federal Judge Rules

SALT LAKE CITY — Claims that Aventis Inc. failed to adequately warn that its infertility drug Clomid causes birth defects when ingested before pregnancy are preempted because there is clear evidence that the FDA would not have allowed the drug maker to add such a warning to the drug’s label, a Utah federal judge has ruled.

On March 14, Judge Dee Benson of the U.S. District Court for the District of Utah held that the clear evidence consists of the FDA’s denial of a citizen’s petition calling for stronger warnings coupled with the agency’s continued approval of Clomid labeling that ...

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