Settlement Reached in Bellwether Pelvic Mesh CaseNov 16, 2015
Settlement Deal for The Complainant of Defective Device
Mentor Corp., a unit of Johnson & Johnson is accused of making defective pelvic mesh implants that cause painful infections and other complication, has reached a settlement before a trial that was scheduled to begin at the end of this month.
A filing last week in Georgia federal court indicates that Mentor Corp. reached a deal with a couple, whose complaint involved the company's ObTape sling. The case was among six cases designated as bellwethers by U.S. District Judge Clay D. Land, Law360 reports. The jury trial was scheduled to begin on November 30.
Pelvic mesh (also called transvaginal mesh) devices are used to treat pelvic organ prolapse (POP) and stress urinary incontinence in women. POP occurs, the Food and Drug Administration (FDA) explains, when the internal structures that support the bladder, uterus and bowel, become weak, stretched, or broken and the organs drop from their normal position and bulge (prolapse) into the vagina. Women with POP often experience pelvic discomfort, disruption of their sexual, bladder, and bowel functions, and an overall reduction in quality of life. But many women have experienced complications from transvaginal mesh devices, including erosion of the mesh through the vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse or incontinence. The FDA has also received reports of bowel, bladder, and blood vessel perforation during insertion of the mesh. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain.
Proposed Orders Addressing Health Risk Associated With Transvaginal Mesh
In 2014, the FDA issued two proposed orders to address the health risks associated with transvaginal mesh. These orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.
A woman who was implanted with the ObTape device in 2004, and her husband brought the case that was to have been heard in the bellwether trial. In 2001, she, like many other recipients, claimed that she suffered infections, abscesses and scarring, requiring multiple surgeries, according to Law360.
The bellwether trial is an approach sometimes used when large numbers of plaintiffs have brought similar claims, creating a large caseload. A group of plaintiffs is chosen to represent all the plaintiffs. These representative cases go to trial and the results can be an indication of likely results in other plaintiffs' trials. Bellwether cases sometimes provide the basis for reaching a settlement for other cases.
The day before the U.S. Judicial Panel on Multidistrict Litigation consolidated the ObTape suits into a multidistrict litigation (MDL), the company settled 111 claims, agreeing to establish a trust to manage and distribute funds agreed upon in 2014. In 2013, Mentor had settled another proposed bellwether case in July 2013 shortly before trial.
In the ObTape cases, Mentor faces claims of negligence, fraudulent concealment, breaches of express and implied warranties and failure to warn, Law360 reports. In one of the potential bellwether cases, the judge initially threw out the plaintiff's fraudulent concealment claim but vacated that order in September.
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