STORY FROM: Drugs & Medical Devices

High Court Asked to Review $3.27 Million Verdict in Gynecare TVT-O Transvaginal Mesh Action

CHARLESTON, W. Va. — Ethicon Inc. has asked the U.S. Supreme Court to review an appellate ruling upholding a $3.27 million verdict in a Gynecare TVT Obturator transvaginal mesh action, maintaining that the trial court improperly excluded certain evidence.

Ethicon filed its petition for a writ of certiorari on May 23, challenging a 4th Circuit U.S. Court of Appeal’s determination that that the trial court properly excluded evidence of the TVT-O’s compliance with the Food and Drug Administration’s 510(k) process. The appellate court held that the 510(k) process only “tangentially” examines the safety of the product going through the process.


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