STORY FROM: Drugs & Medical Devices

Ind. Federal Judge Dismisses Negligent Failure-To-Warn Claim in Pelvic Mesh Case

INDIANAPOLIS — A negligent failure-to-warn claim in an Ethicon pelvic mesh case is barred under the learned intermediary doctrine because the surgeon would still have implanted the device had she been presented with an enhanced warning, an Indiana federal judge has ruled.

However, in a March 10 order, Chief Judge Jane Magnus-Stinson of the U.S. District Court for the Southern District of Indiana allowed the negligence claim to proceed to the extent it is based upon a design defect theory.

Barbara Hull underwent implantation of an Ethicon TVT-Secur transvaginal mesh device to treat pelvic organ prolapse and stress urinary incontinence. ...

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