The first federal lawsuit involving the claim that a transvaginal mesh device harmed a patient began trial for the second time last week. The first trial in the case was declared a mistrial in mid-July. A federal court is overseeing a total of nearly 23,000 cases that claim the surgical mesh devices caused serious injuries to female patients.
Vaginal mesh is a medical implant that is often used to repair pelvic organ prolapse or stress urinary incontinence in women. However, in recent years, thousands of women who received the implants have come forward with reports of serious complications with the products, including injury, death and malfunction. The U.S. Food & Drug Administration has issued warnings to the public concerning the safety of the devices.
In the first federal case, the plaintiff is suing C.R. Bard Inc., the manufacturer of the vaginal mesh product Avaulta Plus, claiming that the product caused bleeding and internal pain, and had to be removed through several surgeries. The lawsuit states that Bard was warned that the device was not intended for permanent use in humans, but Bard decided to market the products anyway.
Numerous other manufacturers of transvaginal mesh devices have also been sued with similar claims, including Boston Scientific, Cook Medical and the Johnson & Johnson subsidiary Ethicon. Because this is the first of more than 3,300 federal claims against the manufacrurers, many are looking at the case as an indicator of future rulings.
The orignal trial was declared a mistrial on the second day of testimony when an expert witness testified that the transvaginal mesh products are no longer being manufactured or sold. Attorneys for Bard immediately objected and asked for a mistrial, saying that the statement was prejudicial to the jury.
Source: DrugWatch.com, “After Mistrial, Bellwether Transvaginal Mesh Lawsuit Resumes,” Doug Allen, July 29, 2013