Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, has filed a lawsuit alleging that two types of transvaginal mesh implants are responsible for a woman’s injuries. The suit was filed on July 12th in the U.S. District Court for the Southern District of West Virginia, Charleston Division (Case No. 2:12-cv-03113) where it is one of the many cases pending in the multidistrict litigation as part of the In Re: Ethicon, Inc. Pelvic Repair System Products Liability Litigation (MDL No. 2327).
According to the Complaint, the Plaintiff is a woman from Pinellas County, Florida who claims that her painful injuries are caused by two transvaginal mesh implants intended to treat her pelvic organ prolapse and stress urinary incontinence. She received the Pelvilace To Trans-Obturator Biourethral Support System and a Gynecare TVT Device in April 2006 and February 2008, respectively. The lawsuit alleges that these devices caused the Plaintiff to suffer from significant mental and physical pain and suffering, permanent injury, permanent and substantial physical deformity and the loss of her bodily organ systems.
The lawsuit states that the devices were approved without adequate testing to demonstrate safety or efficacy because they were approved through the 510(k) route. This process exempts medical devices from clinical trials if the manufacturer can show that it is “substantially equivalent” to a previously approved product.
According to the lawsuit, the mesh is defective because it reacts with the tissues in the body, which allegedly creates an unreasonable risk of vaginal erosion, infection, extrusion, perforation, chronic pain and/or abscess. The suit also alleges that the Defendants were aware of these defects, and the risk of serious injury; instead of warning consumers and the public however, the Defendants continued to market the device. The lawsuit further alleges that they made false statements about the products’ safety and misrepresented it to the U.S. Food and Drug Administration (FDA).
Last July, the FDA warned that, contrary to previous notions, complications associated with transvaginal mesh were “not rare” and that the devices may pose additional dangers with no benefit over alternative non-mesh methods. The agency has asked 33 manufacturers, including C.R. Bard and Johnson & Johnson, to conduct post-market safety studies on the device.
Johnson & Johnson has decided to stop selling four types of transvaginal mesh, including the Prolift, Prolift + M, TVT Secur and Prosima.
Last week, C.R. Bard lost the first transvaginal mesh personal injury lawsuit to go trial. In a landmark verdict, a California couple was awarded a total of $5.5 million for the injuries and adverse consequences that occurred after the Plaintiff received the Avaulta Plus.
Parker Waichman LLP continues to offer free lawsuit consultations to victims of transvaginal mesh injuries. If you or a loved one experienced complications following POP and SUI surgery with transvaginal mesh, please visit the firm’s transvaginal mesh injury page at yourlawyer.com. Free case evaluations are also available by calling 1-800-YOURLAWYER (1-800-968-7529).
Contact: Parker Waichman LLP
Gary Falkowitz, Managing Attorney