STORY FROM: Drugs & Medical Devices

Plaintiff’s Failure to Exhaust Administrative Remedies Bars Lawsuit Against FDA, Mo. Federal Judge Rules

ST. LOUIS — A plaintiff’s failure to exhaust administrative remedies before suing the Food and Drug Administration for allegedly failing to ensure that generic drug makers warn consumers of their products’ risks necessitates dismissal of the action, a Missouri federal judge has ruled.

On March 8, Judge Steven N. Limbaugh Jr. of the U.S. District Court for the Eastern District of Missouri held that the FDA should have been given an opportunity to consider and potentially resolve the plaintiff’s concerns through the administrative process.

Michelle Laxton originally filed the instant action in the Cape Girardeau County (Mo.) Circuit Court, alleging ...

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