Three multidistrict litigations (MDL) involving transvaginal mesh lawsuits will be consolidated in a single MDL in the U.S. District Court for the Southern District of West Virginia. In an order issued February 7, the U.S. Judicial Panel on Multidistrict Litigation ordered transvaginal mesh lawsuits filed against Boston Scientific, American Medical Systems and Johnson & Johnson’s Ethicon Inc. to be centralized before U.S. District Chief Judge Joseph R. Goodwin, who is also presiding over another MDL involving Avaulta vaginal mesh litigation initiated against C.R. Bard.
In its Transfer Order, the Panel stated that the Southern District of West Virginia will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the transvaginal mesh litigation. An MDL allows lawsuits associated with a particular product to be coordinated under one judge for pretrial litigation to avoid duplicative discovery, inconsistent rulings and to conserve the resources of the parties, witnesses and the court. When lawsuits are consolidated as a multidistrict litigation, each retains its own identity. If the multidistrict litigation process does not resolve the cases, they are transferred back to the court where they originated for trial.
All of the lawsuits now consolidated in West Virginia allege the defendants recklessly and negligently marketed transvaginal mesh products for surgical treatment of pelvic organ prolapse and stress urinary incontinence and put the companies’ interest in making profits ahead of the safety of women. All charge that the transvaginal mesh products made by these companies have unacceptably high rate of side effects and complications.
Transvaginal mesh devices are used in the surgical repair of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). This past July, the U.S. Food & Drug Administration (FDA) said in a Safety Communication that it had received 2,874 new reports of complications associated with transvaginal surgical mesh procedures from January 2008 through December 2010. Of these, 1,503 reports were associated with POP repairs and 1,371 associated with SUI repairs. Injuries attributed to the use of transvaginal mesh devices include inflammation and infection. The implanted mesh also can shrink and cause chronic pain. Frequently, the mesh will start to extrude through the vaginal wall causing bleeding and pain. According to the FDA, even when women undergo surgery, even multiple surgeries, to have defective mesh removed, complications continue because it is almost always impossible to completely remove the device.
Transvaginal mesh devices were mostly approved through the agency’s 510(k) fast-track approval process, which grants access to the market without much pre-market safety testing, based on the idea that the products were similar in design to a previously-approved device. However, the FDA is considering rescinding 510(k) approvals for transvaginal mesh devices used in POP repair, and has asked the makers of such devices to conduct safety studies of the products.