The second vaginal mesh trial in the United States, and the first involving Ethicon (a Johnson & Johnson subsidiary), is currently underway in Atlantic City, New Jersey. The case, referred to as Gross v. GyneCare Inc., Atl-L-6966-10, was filed by Linda Gross, age 47, who is a South Dakota resident. Gross claims that Ethicon did not properly warn people of the side effect risks linked with the vaginal mesh implant, which is used as a treatment option for pelvic organ prolapse (POP) and stress urinary incontinence. Gross received a GyneCare Prolift after suffering from POP in 2006. Since the implantations, Mrs. Gross has undergone 18 surgeries in order to correct injuries she sustained after receiving the vaginal mesh implant. Mrs. Gross is currently unable to sit more than a few minutes at a time because of the immense pain from the implant. The pain is so intense that Mrs. Gross has to use an internal pain pump to deliver narcotics.
This “bellwether” trial is extremely important to the thousands of other women who are suing for injuries they received as a result of vaginal mesh implants. The first trial resulted in a $5.5 million dollar verdict for the plaintiff. A similar result here could force the mesh manufacturers to reevaluate their position of trying additional mesh cases. Mrs. Gross’ lawsuit is one of 1,974 pending in the Superior Court of Atlantic County, New Jersey. There are thousands of additional cases in the five MDLs (multi-district litigation) pending in the U.S. District Court for the Southern District of West Virginia.
The trial, which started on Thursday January 10, 2013, has included some riveting testimony. On Day #2 of the trial, counsel for Mrs. Gross presented evidence that Ethicon/Gynecare was in a rush to get the Prolift kit to the market. The evidence presented indicated that to get to market as quickly as possible, Ethicon decided to use the 510k FDA approval process which would allow the company to skirt some of the pre-release safety and efficacy testing typically required of medical products. Under the 510k process, a new medical product may be introduced to market without pre-market testing, if the product is substantially similar to a product already on the market (a so-called “predicate device”). Ethicon applied for the 510k application by asserting that Prolift was “substantially similar” to Gynemesh, which is a mesh product developed by Ethicon a few years earlier.
On Day #3 of the trial, Dr. Clark Likness of Watertown, South Dakota, testified about his treatment of Mrs. Gross and the extent of her injuries after 18 surgical procedures to repair the damage from the mesh implant. Dr. Likness testified that the severe pain suffered by Mrs. Gross is a result of the prolift implant and that these injuries were permanent in nature. Dr. Likness and a consulting physician opined that one of the reasons for the severe damage was that Mrs. Gross was having an immunologic reaction to the plastic mesh which caused profound irritation, inflammation and swelling as the body rejected the implant.
On Day #5 of the trial, counsel for the Plaintiff presented numerous internal Ethicon documents which indicated there was dissension among Ethicon’s medical experts over whether the Gynemesh PS was the best mesh material to use in the Prolift. There were some Ethicon scientists who believed a different type of mesh product (called “Ultrapro”) would be more reliable and efficacious than Gynemesh.
On Days #6 and #7, Dr. Anne Weber, a urogynecologist, testified as an expert on behalf of the Plaintiff. Dr. Weber testified that the risks of Prolift outweigh any benefits as well as testifying that Ethicon failed to disclose to physicians all of the risks of vaginal mesh implants. Dr. Weber also gave graphic testimony of the Prolift procedure and some of the common complications such as erosion and perforation.
We will continue to provide updates on this extremely important “bellwether” trial.