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June 6, 2006

FDA Approval of Warning Preempts State Tort Claims

A suit on behalf of a woman who committed suicide after taking a generic version the anti-depressant Paxil, has been dismissed by a Pennsylvania federal district court.  The plaintiff claimed that the drug was defective for failure to warn of suicide risks associated with its use.  The court ruled that the FDA strictly controls the contents of such warnings, did not require such a warning at the time, and that the claim was therefore preempted by the Food, Drug and Cosmetic Act.

The plaintiffs argued that the FDCA sets only minimum standards for warnings and permits drug manufacturers to unilaterally strengthen such warnings.  The defendants, supported by the FDA, argued that at the time the plaintiff alleged that a warning should have been given there was not reasonble evidence of an association between use of the drug and suicidality.  Such a warning would have been false and misleading and thus contrary to federal law, according to the FDA's brief.

The court agreed, saying that "we must afford deference to the FDA's position that the claims are pre-empted."  See Shannon Duffy's story in The Legal Intelligencer.


June 6, 2006 | Permalink


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