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.
The case in which Dr. Pence delivered this testimony is the first of 1,800 lawsuits against Ethicon pending in New Jersey Superior Court to go to trial. As the representative of women who claim they’ve been harmed by Ethicon’s products, Rochelle Rottenstein, the Rottenstein Law Group’s principal, implores women who believe they’ve been hurt by these implants to call the Rottenstein Law Group’s offices for a free evaluation of their ability to file a lawsuit right away.
“For most women who’ve been injured, it’s still not too late to file a claim,” Rottenstein says.
The Rottenstein Law Group’s Vaginal Mesh Lawsuit Information Center at ww.vaginalmeshlawsuitcenter.us describes all of the issues vaginal mesh patients face and explains their options.
About the Rottenstein Law Group
The Rottenstein Law Group is a New York-based law firm that represents clients in mass tort actions. The firm was founded by Rochelle Rottenstein, a lawyer with over two decades of experience in compassionate representation of clients in consumer product injury, mass tort, and class action lawsuits. For more information, please visit the firm’s web site, or call (888) 9-ROT-LAW. (Attorney advertising. Prior results do not guarantee a similar outcome.)
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