September 4, 2008
Paxil Suit Not Pre-Empted
A suit brought by the family of a teenager who committed suicide in 2002 after taking the anti-depressant drug Paxil may proceed because the U.S. Food and Drug Administration (FDA) had not yet taken a position on whether there was a link between the use of such drugs by pediatric patients and suicidality. In his opinion in Knipe v. SmithKline Beecham, Senior U.S. District Judge Ronald Buckwalter concluded that the suit was not pre-empted by the FDA labelling requirements in effect at the time because those requirements did not require suicide warnings for pediatric patients using Paxil and similar drugs. Consequently, a jury could decide that the manufacturer should have provided such warnings without imposing on the drug manufacturer a requirement in conflict with federal law.
Judge Buckwalter found that the Third Circuit U.S. Court of Appeals ruling earlier this year in Colacicco v. Apotex was not controlling in the Knipe case. In Colacicco, the court had ruled that the makers of Paxil and Zoloft cannot be sued for failure to warn of adult suicide risks after the FDA had explicitly refused to order such warnings. However, Buckwalter found, Paxil has never been approved for pediatric use, and the FDA never reviewed any safety data regarding pediatric use prior to its approval of the drug.
September 4, 2008 | Permalink
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