The federal judge overseeing thousands of transvaginal mesh lawsuits has ordered 200 lawsuits to be selected for trial, which will either take place in the U.S. District Court for the Southern District of West Virginia or in the plaintiffs’ home districts. The Order, which was issued on January 16th by Judge Joseph Goodwin, required each side of the litigation to select 100 cases.
There are nearly 7,000 lawsuits filed into the C.R. Bard multidistrict litigation (In re C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, MDL No. 2187). Plaintiffs in the case allege that the recalled Avaulta transvaginal mesh caused a number of injuries, including mesh erosion (where the mesh moves through the tissues), infection, bleeding, urinary problems, and organ perforation. C.R. Bard’s Avaulta and other transvaginal mesh implants are supposed to help women who suffer from urinary incontinence and/or organ perforation. According to women in the litigation, these devices only caused more complications.
The first bellwether trial in the C.R. Bard litigation concluded in August, and the company was forced to pay $2 million to the Plaintiff. The second bellwether trial ended in a settlement on the day that it was slated to begin.
C.R. Bard is only one of several manufacturers that are facing legal issues over their transvaginal mesh products. Johnson & Johnson, Boston Scientific and American Medical Systems are also facing thousands of cases over the device. As with the Avaulta litigation, these lawsuits allege that the transvaginal mesh implant is defective and caused a number of painful, sometimes life-changing complications. In March, the first trial against Ethicon and Johnson & Johnson ended with an $11 million verdict for the Plaintiff.
As many of the lawsuits point out, transvaginal mesh implants were sold with little to no clinical testing. This is because the devices were approved through a process known as 510(k), which waives the need for testing if the manufacturer could show that the product was “substantially equivalent” to an older device, even if that device had safety issues.
According to the U.S. Food and Drug Administration (FDA), complications from transvaginal mesh are not uncommon. In fact, the agency has warned that these devices may be more harmful compared to other alternatives for treating urinary incontinence and organ prolapse.