STORY FROM: Drugs & Medical Devices

Pa. Federal Judge Allows FDA Clearance Evidence to be Presented at Bard IVC Filter Trial

PHILADELPHIA — A Pennsylvania federal judge has refused to bar evidence of the FDA’s clearance of C.R. Bard’s G2 IVC filters from being presented at an upcoming IVC filter trial, ruling that the information is relevant to whether defendants took reasonable and appropriate steps in bringing the device to market.

In an Aug. 19 order, Judge Gene E.K. Pratter of the U.S. District Court for the Eastern District of Pennsylvania also denied the plaintiff’s motion in limine to exclude references to IVC filters as lifesaving devices and to exclude statistics concerning thrombi and pulmonary emboli.

Harry Keen III was ...

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