STORY FROM: Drugs & Medical Devices

Plaintiff Directed to Ask FDA to Investigate Alleged Use of Counterfeit Resin in Transvaginal Mesh Devices

CHARLESTON, W. Va. — A West Virginia federal judge has directed a plaintiff to ask the Food and Drug Administration to investigate Boston Scientific's use of allegedly counterfeit polypropylene resin in its transvaginal mesh devices, explaining that the agency should be given the first opportunity to decide whether the mesh should be banned for use in such devices.

Pursuant to the doctrine of primary jurisdiction, Judge Joseph R. Goodwin of the U.S. District Court for the Southern District of West Virginia stayed the case on Jan. 26 pending the FDA’s determination of technical matters.

Teresa Stevens filed a class action ...

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