C.R. Bard recently agreed on transvaginal mesh settlements on more than 500 transvaginal mesh lawsuits over its Avaulta implant and several others. C.R. Bard agreed to resolve the complaints in the second quarter of 2014 but Bard did not disclose how much the transvaginal mesh settlements were for. However, C.R. Bard did acknowledge payments around $259 million during the first quarter for “product liability matters.” Lawsuits that were resolved in the first quarter similarly allege injuries caused by the company’s surgical mesh, which has been associated with mesh erosion, chronic pain, pain during sexual intercourse, scarring, infection and other side effects. According to a regulatory filing with the U.S. Securities and Exchange Commission, C.R. Bard said it “anticipates that multiple additional trials, including a possible consolidated trial, may occur in early 2015. Additional state court trials are scheduled throughout the second half of 2014.”
“During the 2nd quarter of 2014, the company reached an agreement with 2 plaintiffs’ law firms to settle their inventory of cases, representing more than 500 of the filed or asserted Women’s Health Product Claims,” according to a recent Bard regulatory filing. “The company also settled one [multi-district litigation] case that was originally scheduled for trial in May 2014.”
The company is also talking with other plaintiffs to explore settlement options. There are no MDT trials scheduled for the rest of this year, but Bard “anticipates that multiple additional trials, including a possible consolidated trial, may occur in early 2015. Additional state court trials are scheduled throughout the second half of 2014.”
As of July 7, 2014, Bard tallied more than 12,400 plaintiffs had filed or asserted claims against the company for its various surgical continence products, including the Avaulta mesh. The company also counted 5 putative class actions in the U.S. and 4 in Canada already filed. Bard noted that about half of the total complaints should be shifted to one of its unnamed suppliers who “has an obligation to defend and indemnify the company with respect to any product defect liability.”
Bard has already had more than one day in court. The company settled its 1st state court trial in 2012 with a judgment against the company in the amount of $3.6 million. The 1st MDT trial in 2013 also resulted in judgment against the company and a payment of about $2 million. Bard has already appealed the 2012 decision and plans to appeal the 2013 one as well, the company said.
Pelvic mesh lawsuits have garnered worldwide attention as various campaigns have painted the devices as extremely harmful to women. FDA regulators have rejected petitions to ban the mesh outright, but have tentatively agreed that reclassifying the implants to a higher-risk category may be in order.
Other countries have been eying the implants with increased scrutiny as well. Earlier this year, Scotland’s regional health boards agreed to suspend use of transvaginal mesh implants pending an investigation into complaints that the devices scar women for life.
Pelvic mesh devices have been the subject of much public outcry over concerns that they may do more harm than good, especially since the FDA’s 2011 warning that the implants may expose patients to unnecessary risk. The product is used to treat pelvic organ prolapse, which occurs when internal organ support structures become so weak or stretched that organs, like the uterus, bladder or bowels, sag from their normal position and bulge or prolapse into the vagina.
The mesh controversy has expanded over the years, with patient and consumer groups calling for recalls and for action against medical device makers responsible for manufacturing the devices. Earlier this year the Corporate Action Network asked state Attorney Generals to investigate Johnson & Johnson and its leadership for potential misconduct related to the manufacture and sale of pelvic mesh devices.
Reported by: Arezu Sarvestani, Mass Device