Ethicon Execs Negligent According to Pharmaceutical Regulations Expert Testimony, the Rottenstein Law Group Reports
Ethicon executives’ decision to market and sell the company’s Gynecare Prolift vaginal mesh product without first obtaining FDA clearance was negligent, according to the testimony of Dr. Peggy Pence, a pharmaceutical regulations expert who testified this week at the trial of a vaginal mesh lawsuit alleging the Prolift caused 47-year-old Linda Gross serious injury.
The Gynecare Prolift—which internal Ethicon e-mails described as representing a “major mind shift” over a previously-released Ethicon vaginal mesh product known as the Gynecare PS—contained new features that could significantly affect the safety or effectiveness of the device, Dr. Pence testified on Jan. 22 at the trial in New Jersey Superior Court. Federal regulations therefore obligated Ethicon’s executives to obtain FDA clearance for the Gynecare Prolift before the company put it on the market, Dr. Pence said.
Ethicon executives further violated federal regulations by failing to specify on the Prolift’s “Instructions for Use” and in its brochure many of the device’s risks, including the fact that there was no long-term data to support its safety or efficacy.
Read full story at WebWire.com: Ethicon Execs Negligent According to Pharmaceutical Regulations Expert Testimony, the Rottenstein Law Group Reports