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June 15, 2006

FDA Approval of Warning Does Not Preempt State Tort Claims

A federal judge in Nebraska has ruled that the FDA's new labelling rule does not preempt state tort failure-to-warn claims.  The ruling is contrary to one made only five days ealier by a federal district court in Pennsylvania which found that the FDA regulations are preemptive of failure to warn claims.  In the Nebraska case, the parents of a child who committed suicide sued Pfizer and Wyeth Pharmaceuticals.  Their son had been prescribed anti-depressants manufactured by both companies.  Although the drugs were accompanied by a warning of suicide risks, the plaintiff's claimed that the warning was inadequate.  Noting that several courts have found the FDA regulations establish only minimum standards, do not require manufacturer's to seek FDA approval before strengthening warnings, and that state tort law complements the federal regulatory scheme, Judge Joseph F. Bataillon concluded that the FDA's recent pronouncement that its labelling regulations were preemptive is not persuasive.  Jackson v. Pfizer, 2006 WL 1506886, D. Neb., May 31, 2006.


June 15, 2006 | Permalink


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