Court Hears Testimony in Gynecare Bellwether Trial
A bellwether trial in the Gynecare vaginal mesh MDL, Gross v. Ethicon, is underway in the Atlantic Superior Court of New Jersey under Judge Carol Higbee. The MDL consolidates vaginal mesh lawsuits involving the Gynecare line of mesh products. The plaintiff alleges that Ethicon marketed and sold a defective vaginal mesh device, the Gynecare Prolift, that caused her to suffer serious complications.
Regulatory expert testifies that Ethicon was negligent
On January 22, 2013, regulatory expert Dr. Peggy Pence testified before the court, and video depositions were shown from Dr. Charlotte Owens, Ethicon’s Worldwide Medical Director, and Dr. Patrick Retterath, a pain management specialist who has been treating the plaintiff.
Dr. Pence has more than 40 years of experience in regulatory consulting for medical device and pharmaceutical companies and was presented as an expert witness for the plaintiff. In her testimony, she explained that defendant Ethicon did not seek FDA clearance when the Gynecare Prolift was first marketed in 2005, because Ethicon claimed that the product was not significantly different from existing products that had already been approved. Thus, the FDA was not aware of the product’s launch.
But Dr. Pence stated that contrary to the defendant’s claims, the Prolift was in fact significantly different from earlier models, and that the defendant was therefore negligent for failing to seek FDA approval. In addition, Dr. Pence said, the Prolift Patient Brochure failed to adequately identify nor disclose all of the product’s potential risks, and thus violated applicable regulations. During cross-examination, the defendant’s counsel suggested that physicians were responsible for informing patients of risks involved with healthcare products. Dr. Pence replied that even so, the Patient Brochure still violated regulations.
The court also heard video testimony from Dr. Owens, who was Ethicon’s Worldwide Medical Director from 2003 to 2005. Dr. Owens had no direct experience in implanting the Prolift vaginal mesh in a patient. She admitted that the Prolift was not evaluated in clinical studies before being put on the market, that it carried the risk of infection, erosion, inflammation, and other complications, and that its design was potentially defective.
Plaintiff’s doctor details pain problems
Additionally, the court heard a video depostion from the plaintiff’s pain management specialist, Dr. Retterath, who stated that the patient presented with pelvic pain on the left side caused by inflammation of the vaginal mesh implant. The doctor injected pain medication, but after only three days, the pain returned. Dr. Retterath told the court that the patient suffers significant ongoing pain that disrupts her ability to work and causes her severe mental anguish.
There has been no official recall of the Prolift system, but Ethicon stopped selling it in 2012.