Five vaginal mesh implant manufacturers, including C.R. Bard, are in settlement talks concerning lawsuits brought over alleged injuries tied to their devices, according to people familiar with the negotiations.
Attorneys for C.R. Bard, Endo Health Solutions Inc., Boston Scientific Corp., Coloplast A/S, and Cook Medical Inc., which manufacture mesh inserts meant to support women’s pelvic muscles and treat incontinence, have begun talks about settling all of the lawsuits brought over their products, according to the people, according to Bloomberg.com. Johnson & Johnson, which also faces lawsuits over its transvaginal mesh products, is not involved with the settlement talks, according to the people, who have requested anonymity as they are not authorized to discuss the matter.
Plaintiff attorneys want the judge overseeing the federal lawsuits, U.S. District Judge Joseph Goodwin in Charleston, West Virginia, to appoint a settlement committee, the people said. “I know you all are considering settlement protocols and the possibility of resolutions,” Goodwin said at a September 18th court hearing, noting that talks were occurring “behind the scenes,” according to Bloomberg.com. The talks seek to resolve more than 30,000 implant suits that have been filed and consolidated before Judge Goodwin for pre-trial processing, the people told Boomberg.com. As other claimants are looking to join the potential settlement, the number of lawsuits could reach more than 50,000, according to the people.
“The liability seems pretty clear on these cases, so settlement makes sense,” Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia, told Bloomberg.com. “Given how serious the injuries are and the number of cases, when you do the math, you can easily come up with a multibillion dollar settlement.”
Bard’s implants have been the focus of more than 12,000 cases, Boston Scientific indicated in an August regulatory filing that it faces more than 12,000 lawsuits, Endo’s American Medical Systems Inc. unit faces 13,500 claims between state and federal lawsuits, and Coloplast and Cook face some 1,000 claims combined, the people told Bloomberg.com. As of June 30th, J&J was facing 12,250 claims, according to a regulatory filing.
Meanwhile, we recently wrote that a new study revealed that no difference in cure rates exists between vaginal prolapse repair with and without use of mesh. This, after three years of follow-up.
Thousands of women were recipients of transvaginal mesh devices, which were approved to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP), conditions most commonly caused by weakened pelvic muscles. The devices are meant to help correct these conditions by providing additional strength to the pelvic walls.
The U.S. Food and Drug Administration (FDA) has stated that complications linked to transvaginal mesh implants are “not rare,” warning that use of these devices may actually be more harmful when compared to alternative methods for treating POP. The agency also recently reported that the most common complications associated with these devices may include:
- Dyspareunia (pain during sexual intercourse)
- Exposure, extrusion, or protrusion (mesh erosion through the vagina)
- Organ perforation
- Urinary problems