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November 2, 2007

Drug Research Firm Sued for Negligence and Fraud

A federal judge refused to dismiss negligence and fraud claims against a research firm that allegedly conspired with a drug manufacturer to mislead the Food and Drug Administration.  As a consequence, the plaintiff in Wawrzynek v. Statprobe, Inc., 2007 WL 3146792 (E.D. Pa. 2007) alleges, the FDA approved a drug used during her spinal surgery that was ineffective, caused complications, required a second surgery and left her permanently disabled.  The complaint alleges that Statprobe conspired with the Gliatech, the drug manufacturer, to manipulate study data that formed the basis for the FDA's conditional approval of the drug.  Gliatech later plead guilty to a number of federal criminal charges including submission of a false and misleading report regarding a medical device.

U.S. District Judge Gene Pratter rejected Stratprobe's argument that it owed no duty to the plaintiff, noting that the research lab "appears to have assumed a role in the U.S. clinical study . . . that involved much more than simple, remote 'number crunching.'  Specifically, in light of the fact that [the defendant] knew that ADCON-L had a tendency to cause CSF leaks, Mrs. Wawrzynek cannot be said to be out of the foreseeable orbit of potential planitffs . . . ." 

Statprobe also argued that Wawrzynek's claims were pre-empted because they amounted to a fraud on the FDA claim of the kind barred by the U.S. Supreme Court's 2001 opinion in Buckman Co. v. Plaintiff's Legal Committee.  Judge Pratter ruled, however, that the plaintiff's claim fell within the exception to the Buckman rule carved out in the concurring opinion in that case.  "Where prior to the state litigation, the FDA determines that a manufacturer committed fraud and had taken steps to remove the harm-causing product from the market, the state-law fraud claim would not 'depend upon speculation as to the FDA's behavior in a counterfactual situation, but would be grounded in the agency's explicit actions.'  The claim would therefore be permissible and, indeed, 'would supplement and facilitate the federal  enforcement scheme.

JDP

November 2, 2007 | Permalink

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