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Judge Won't Stop Suit Against Clinical Lab

By Shannon P. Duffy
October 05, 2005

In a ruling that breaks new ground in the area of drug products liability, a federal judge has refused to dismiss negligence and fraud claims against a clinical laboratory for allegedly conspiring with a drug manufacturer to mislead the FDA.

The suit alleges that the conspiracy was designed to win approval of a drug which, the plaintiff claimed, later caused complications during her spinal surgery and left her wheelchair-bound. In her 20-page opinion in Wawrzynek v. Statprobe Inc., U.S. District Judge for the Eastern District of Pennsylvania Gene E.K. Pratter rejected a defense argument that a laboratory cannot be held liable for the work it performs in assisting a pharmaceuticals company in conducting its clinical trials.

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