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Federal Pre-emption of Failure to Warn Claims in Recent Drug Cases

By Beth L. Kaufman and David Black
June 27, 2005

In 2004, four drug cases, which were decided in different jurisdictions, effectively split on the issue of whether FDA labeling regulations pre-empt state common law failure to warn claims. Fisher v. Professional Compounding Centers of America, Inc., 311 F. Supp. 2d 1008 (D. Nev. 2004) and Kurer v. Parke, Davis & Co., 272 Wis. 2d 390, 679 N.W.2d 867 (Wis. Ct. App. 2004) endorsed the view that FDA labeling regulations did not pre-empt common law failure to warn claims in drug cases, while Dusek v. Pfizer Inc., 2004 WL 2191804 (S.D. Tex., Feb. 20, 2004) and Needleman v. Pfizer Inc., 2004 WL 1773697 (N.D.Tex., Aug. 6, 2004) held that FDA regulations do pre-empt failure to warn claims, at least in certain circumstances.

Federal Pre-emption Doctrine and FDA Regulations

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