FDA Pre-emption Halts Suit Over Anti-Depressant
The Legal Intelligencer - June 6, 2006
By Shannon P. Duffy
The widower of a woman who committed suicide after taking a generic version of the anti-depressant drug Paxil may not pursue product liability claims premised on an alleged failure to warn of suicide risks because the Food & Drug Administration strictly controls the content of such warnings and did not demand it at the time, a Pennsylvania federal judge has ruled.
In his 66-page opinion in Colacicco v. Apotex Inc., U.S. District Judge Michael M. Baylson found that the plaintiffs' state law tort claims are pre-empted by the federal Food, Drug & Cosmetic Act.
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