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January 30, 2008

Preemption of Prescription Drug Failure to Warn Claim Adds Emphasis to Supreme Court Term

A federal trial court in Okalahoma has concluded that a the claim of a widow, whose husband committed suicide while taking an anti-depressant medication, is preempted by federal law, Dobbs v. Wyeth Pharmaceuticals, 2008 WL 169021 (W.D. Okla.).  Annabel Dobbs alleges that the drug maker Wyeth failed to warn adequately about the increased risk of suicide in patients like her husband taking its drug Effexor.  The court ruled, however, that the Food & Drug Administration (FDA) had considered and rejected a warning about suicidality at the time Dobbs' husband used the drug.  The court, citing the FDA's rule governing prescription drug labelling and its preamble in which the agency says that its rules are preemptive on the question of drug labelling content, said that the agency's position on preemption was entitled to considerable deference.

On the day following this decision, the U.S. Supreme Court agreed to hear Wyeth v. Levine, 2006 WL 3041078 (Vt. 2006, cert. granted 1/18/08, U.S. No. 06-1249), in which the Vermont Supreme Court ruled that federal law did not preempt a claim that a drug manufacturer should have warned about a particular method of administering a prescription drug for which the FDA had approved the label without such warning.

JDP

January 30, 2008 | Permalink

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