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May 7, 2008

Trial Court Adopts Colacicco Preemption Ruling

Adopting the recent ruling by the Third Circuit in Colacicco v. Apotex, Inc., 521 F.3d 523 (3rd CIr. 2008), a federal trial judge in Illinois has ruled that the U.S. Food & Drug Administration's repeated rejection of a scientific basis for suicidality warnings on the prescription drug Paxil, preempted the plaintiff's state law failure-to-warn claim brought against the drug's manufacturer, SmithKlineBeecham (Mason v. SmithKlineBeecham Corp., C.D. Ill., No. 05-1252, 4/23/08).  Paxil is an antidepressant, one of several selective serotonin reuptake inhibitors (SSRIs).  The FDA has monitored the possible connection between SSRIs and suicide for nearly 20 years and has concluded that the suicide warnings desired by the plaintiff in Mason are without scientific basis and would therefore be false and misleading.  The plaintiff's state tort law claims that, without such warnings, the drug's labelling and use information were false and misleading directly contradicts the FDA's express conclusion to the contrary.  The plaintiff's information defect claim is thus preempted.  See the report in Product Liability Daily.


May 7, 2008 | Permalink


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