Mentor Corp, a unit of Johnson & Johnson, has settled a transvaginal mesh case less than three weeks before the bellwether trial was scheduled to begin.
Mentor filed settlement documents in Georgia federal court last week, settling a case involving the company’s ObTape vaginal sling. According to the documents, the company was accused of making defective pelvic mesh implants that cause painful infections and other complication, Law360 reports. The trial would have started on November 30.
The case was among six cases designated as bellwethers by U.S. District Judge Clay D. Land, Law360 reports. A bellwether trial is one in which the plaintiff’s claims are similar to claims brought by a number of other plaintiffs. To manage a large caseload of similar cases, the parties choose a group of plaintiffs to represent all the plaintiffs. The representative cases go to trial and the results of the bellwether cases can indicate trends in the litigation. Bellwether cases often provide the basis for reaching a settlement in other cases.
Pelvic mesh (transvaginal mesh) is surgically implanted to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women. POP occurs when the pelvic structures that support the bladder, uterus and bowel, become weak, stretched, or torn and the organs can slip from their normal position and bulge (prolapse) into the vagina, the Food and Drug Administration (FDA) explains. POP can cause pain and disruption of sexual, bladder, and bowel functions. Loss of bladder control (SUI) is embarrassing and has tremendous negative impact on the woman’s life. But many women experience serious injuries and complications from the device that supposed to correct POP and SUI. Women experience erosion of the mesh through the vaginal lining, urinary problems, infection, pain, and recurrence of prolapse or incontinence. The bowel, bladder, and blood vessels have been perforated during insertion of the mesh device, the FDA reports.
In the ObTape cases, Mentor faces claims of negligence, fraudulent concealment, breaches of express and implied warranties and failure to warn, Law360 reports. The woman plaintiff in the settled case was implanted with the ObTape device in 2004. By 2011, she had suffered infections, abscesses and scarring that required multiple surgeries, according to Law360.
In 2014, the FDA issued two proposed orders to address the health risks associated with transvaginal mesh. If the orders become final, transvaginal mesh devices would be reclassified from the FDA’s moderate-risk device (Class 2) to the high-risk Class 3. Manufacturers would have to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.
Mentor settled 111 ObTape cases the day before the U.S. Judicial Panel on Multidistrict Litigation consolidated the ObTape suits into a multidistrict litigation (MDL), Law360 reports. The agreed to establish a trust to manage and distribute funds agreed upon in 2014. Transvaginal mesh manufacturers C.R. Bard, Boston Scientific, Ethicon (Johnson & Johnson division), Coloplast, and Cook Medical are involved in multidistrict litigations in New Jersey and West Virginia.