Transvaginal Mesh Settlements Underway
Several manufacturers of vaginal mesh implants, including C.R. Bard, are in talks to settle thousands of lawsuits pending in multidistrict litigation, according to sources close to the litigation. The companies are accused of designing and manufacturing defective and dangerous products that were intended to treat pelvic organ prolapse and stress urinary incontinence, but in many cases resulted in vaginal erosion and other complications.
Bloomberg reports that lawyers representing the five companies have begun talks with plaintiffs, who are demanding the assembly of a vaginal mesh lawsuit settlement committee. Plaintiffs want proceedings to be overseen by U.S. District Judge Joseph Goodwin in Charleston, West Virginia. The aim is to resolve thousands of lawsuits concerning vaginal mesh products – although the total number of suits could grow to more than 50,000 as more women become aware of the litigation and are diagnosed with complications.
Bard’s pelvic mesh products are at the center of more than 12,000 lawsuits. Boston Scientific is facing a similar number of claims, and American Medical Systems is looking at around 13,500 lawsuits. Coloplast and Cook have around 1,000 claims between them.
Some tranvaginal mesh settlements already reached
Bard and Endo have already reached some transvaginal mesh settlements, the latter paying out a total of $54.5 million to settle an unspecified number of cases. Coloplast is closest to settling all 600 cases, and is aiming to resolve all lawsuits by year’s end.
Bard has settled some cases after losing two trials regarding their Avaulta mesh devices. In 2012, in what was the first vaginal mesh case to reach court, a California jury found Bard liable for a woman’s injuries related to their Avaulta mesh. Jurors ruled Bard should pay the plaintiff $5.5 million in damages.
Bard withdrew the Avaulta mesh from the market last year after the FDA ordered all makers of such devices to study links between vaginal mesh implants and organ damage, infection and pain during sex.
The FDA has found there was no evidence that transvaginal mesh products provide any additional benefits compared to other, safer pelvic organ prolapse treatments. The agency received more than a thousand adverse event reports over a three year period and reported a five-fold increase in complaints during 2011. In addition, the FDA announced that injuries associated with vaginal mesh products were no longer considered a rare occurrence, and that as many as one in ten recipients suffered problems. Between 2005 and 2010, three deaths linked to surgical mesh implants have been reported.
After issuing the report, the FDA was urged by the Public Citizen’s Health Research Group to recommend a recall of all devices. No such recall has been forthcoming.
American Medical Systems pelvic mesh litigation
Due to the large number of pelvic mesh lawsuits pending against several manufacturers, five separate multidistrict litigations (MDL) were established in the U.S. District Court for the Southern District of West Virginia, presided over by Judge Goodwin. American Medical Systems is the defendant in one of the coordinated proceedings, which in a pretrial order issued in July, has selected four cases for bellwether hearings. The first AMS trial is scheduled to begin in December unless transvaginal mesh settlements are reached beforehand.