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Breaking new ground in the area of drug products liability, a federal judge has 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.

In her 25-page opinion in Wawrzynek v. Statprobe Inc., U.S. District Judge Gene E.K. Pratter rejected the argument that a research firm owes no duty of care to a patient who was later harmed by a drug that won FDA approval as a result of falsified test results.

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