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FDA Pre-emption Wins On Appeal, But Coming Supreme Court Case May Mean More For Drug Liability Risks

This article was originally published in The Pink Sheet Daily

Executive Summary

Third Circuit Court of Appeals tosses failure-to-warn claims against GSK and Pfizer.

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Pre-emption: Obama Administration Creeps Towards Reversing FDA Stance

FDA has not yet altered its support of pre-emption in product liability suits but there are signs it may do so under the Obama administration

Pre-emption: Obama Administration Creeps Towards Reversing FDA Stance

FDA has not yet altered its support of pre-emption in product liability suits but there are signs it may do so under the Obama administration

Third Circuit to rehear pre-emption cases

The U.S. Supreme Court's recent ruling in Wyeth v. Levine is already having repercussions for other pre-emption cases. On March 9, the Supreme Court vacated the Third Circuit U.S. Court of Appeals' ruling in Colacicco v. Apotex, which found that state tort claims alleging Apotex and GlaxoSmithKline failed to adequately warn of the risk of suicidal behavior with their antidepressants were pre-empted by FDA-approved labeling (1"The Pink Sheet" DAILY, April 10, 2008). The Supreme Court also vacated and remanded the Third Circuit's ruling in Pennsylvania Employees Benefit Trust Fund v. Zeneca, in which a third party payer claimed AstraZeneca falsely advertised Nexium (esomeprazole) as superior to Prilosec (omeprazole). The Third Circuit ruled that since the ads complied with FDA-approved labeling, they were not subject to state consumer fraud laws (2"The Pink Sheet," Sept. 3, 2007, p. 9)

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