The litigation over C.R. Bard’s Avaulta transvaginal mesh pushes forward, as 200 cases are to be selected for trial. The January 16th order was given by Judge Joseph Goodwin, who is overseeing the multidistrict litigation (In re C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, MDL No. 2187). Attorneys from each side are to pick 100 lawsuits each. Court documents indicate that C.R. Bard is facing almost 7,000 lawsuits.
The plaintiffs in the lawsuits allege that the Avaulta, a transvaginal mesh implant, is defective and caused painful complications. In some cases, women allege that the mesh has burrowed into the tissues of the body, causing severe pain, organ perforation, bleeding and a host of other painful problems. Transvaginal mesh devices are implanted to treat stress urinary incontinence and pelvic organ prolapse, problems that are most often seen after a woman has given birth. According to thousands of lawsuits, these devices only caused more problems.
A number of the lawsuits point out the fact that transvaginal mesh devices as a whole were not clinically tested before being sold on the market. This is because they went through a review process where manufacturers could forego testing under the argument that this device is similar enough to a previously approved device. At least in part due to litigations such as this, this review process is now being reconsidered.
The first two Avaulta bellwether trials ended in favor of the plaintiff; the first ended in a $2 million verdict and the second was settled just before the trial began.
On the whole, transvaginal mesh implants have been under scrutiny due to safety concerns. Johnson & Johnson, American Medical Systems and Boston Scientific are also facing thousands of cases over the devices. J&J and its subsidiary Gynecare lost their first bellwether trial in March, with an $11 million verdict in favor of the plaintiff.
The U.S. Food and Drug Administration has also investigated the safety issues surrounding transvaginal mesh. The agency has said the device might have more risks compared to other alternatives for treating urinary incontinence and pelvic organ prolapse.