A transvaginal mesh lawsuit involving the Gynecare Prolift pelvic mesh system went to trial this week in New Jersey’s Atlantic County Superior Court. The case, filed by a woman who underwent 18 corrective surgeries after receiving Prolift mesh, is the first transvaginal mesh lawsuit filed against Johnson & Johnson and its Ethicon division to go to trial.
Johnson & Johnson and Ethicon are facing some 1,800 transvaginal mesh lawsuits in a consolidated proceeding in Atlantic County (In re Pelvic Mesh/Gynecare Litigation, No. 6341-10). Hundreds of other additional claims involving Ethicon pelvic mesh products have been filed in a multidistrict litigation underway in U.S. District Court, Southern District of West Virginia (MDL No. 2327). The outcome of this bellwether trial will help assess how juries might rule in thousands of similar claims involving transvaginal mesh products marketed by Johnson & Johnson and other manufacturers.
The plaintiff, a 47-year-old woman who received the Prolift device in 2006, claims she is no longer able to sit comfortably for more than a few minutes without having to either stand up or lay down, according to a report from Bloomberg.com. As such, she requires various daily medications to treat her sever chronic pain. The plaintiff further alleges that Johnson & Johnson and Ethicon failed to provide adequate warnings about the risks associated with the Prolift device.
Prolift was brought to market in 2005. In testimony on Friday, a company official revealed that even before its launch, a prototype for Prolift failed in 20 percent of women within six months. According to Bloomberg.com, the witness also testified that the prototype failed in 27 percent of women within a year.
Last March, Bloomberg.com reported that Johnson & Johnson and Ethicon had marketed the Prolift device for four years without obtaining approval from the U.S. Food & Drug Administration (FDA). In fact, the FDA only learned of Prolift in 2007, when Johnson & Johnson sought approval for a related product. Johnson & Johnson maintained that it could market Prolift without approval because it was so similar to an approved device, the Gynecare Gynemesh. The FDA disagreed, and Prolift wasn’t officially cleared for sales until 2008.
Prolift was one of four Gynecare pelvic mesh devices Ethicon stopped selling last June. However, the company has maintained that the decision to end sales of those products was not motivated by safety concerns.
The FDA is currently reviewing the safety of transvaginal mesh used in the surgical repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). In July 2011, the agency revealed that it had received more than 2,800 reports of serious complications associated with the use of transvaginal mesh to treat POP. In September of that year, an FDA advisory panel recommended that pelvic mesh used for transvaginal repair of POP be reclassified as a high-risk medical device. This would make the products ineligible for 510(K) approvals, which do not require that a medical device undergo human testing if the product is “substantially equivalent” to a previously-approved device. Last January, the FDA ordered Johnson & Johnson and other manufacturers of transvaginal mesh devices used in POP repair to conduct post-market studies of their products in order to help the agency better understand their safety issues.
Since then, thousands of women have filed transvaginal mesh lawsuits against the makers of these devices. A second consolidated proceeding involving C.R. Bard, Inc. products is underway in Atlantic County (In re Pelvic Mesh Litigation/Bard No. L-6339-10). Four other federal multidistrict litigations have been established in the Southern District of West Virginia for lawsuits involving vaginal mesh devices marketed by American Medical Systems, Inc. (MDL No. 2327), C.R. Bard (MDL No. 2187), (Boston Scientific Corp. MDL No. 2187), and Coloplast Corp. (MDL 2387). The first trial in the federal litigation, a case involving a C.R. Bard product, will go to trial next month.