With thousands of lawsuits still cuing up for the foreseeable future, makers of mesh vaginal implants have recently suffered serious setbacks in the courtroom.
Boston Scientific was ordered to pay a Texas woman more than $70 million after a device left her with permanent damages. The same week, Johnson & Johnson was ordered to pay a West Virginia woman more than $3 million.
Transvaginal mesh is a net-like fabric that is used to help shore up muscles across a woman’s pelvic opening when they begin to fail. The muscles – known as the “pelvic floor” – help support organs including the uterus, vagina, bladder, small bowel and rectum. When the muscles fail through age or damage during childbirth, some of the organs are affected to the point of not working.
Devices made from the mesh include those known as a bladder sling or Obtryx sling.
The U.S. Food and Drug Administration (FDA) issued a caution to doctors in 2008 that warned “over 1,000 reports from nine surgical mesh manufacturers of complications” when mesh was used to treat pelvic floor problems or urinary incontinence.
In 2011 the FDA strengthened its warning to say that serious complications from the use of the mesh were “not rare” and that physicians and their patients should be aware of problems that had arisen from its use.
As of today, more than 60,000 cases against mesh and mesh device manufacturers are pending. That number does not include many other cases that were settled out of court. In an effort to head off major litigation, American Medical Systems offered patients $830 million to settle its mesh injury claims. Coloplast spent $16 million settling a few cases.
Companies facing the most litigation include American Medical Systems and Johnson & Johnson subsidiary Ethicon. Other manufacturers with pending cases are Boston Scientific, C.R. Bard, Coloplast, Cook Medical and Neomedic.
In the recent Texas case Martha Salazar, a 42-year-old real estate employee, won $73.5 million after the jury found that Boston Scientific was liable for her extreme pain after a vaginal mesh implant.
The award included $23 million in compensatory damages and $50 million in punitive damages from the company – maker of the Obtryx bladder sling that caused Salazar’s injuries.
Salazar told the court she could no longer walk or sit normally and suffered severe pain after she was implanted with the mesh sling intended to treat mild incontinence. What followed what many believed would be a simple procedure wound up in more than three dozen additional physical procedures and four surgeries.
“This woman was seeking help with minor urine leakage and wound up with a catastrophic, life-altering injury that required four major surgeries. It’s a tragedy that these slings are still on the market.” Salazar’s lawyer Dave Matthews told Bloomberg.
In Charleston, W.V., a jury awarded $3.27 million to the plaintiff in a lawsuit against Johnson & Johnson. Jo Huskey, 52 at the time, had been implanted with the device to treat stress urinary incontinence.
Jurors came back after a two-week trial and awarded Huskey $100,000 for past medical care; $470,000 for prior pain and suffering; $2.5 million for future disability or loss of enjoyment of life; and $200,000 to fairly compensate Huskey’s husband for loss of consortium.
“It is a very important day for women who have been implanted with this device and have had so many problems,” plaintiff’s attorney Harry Bell told the West Virginia Record. “Obviously, the jury was persuaded by the significant evidence that continues to mount against defendants.”
Other jury findings have resulted in plaintiffs’ awards of $11.1 million in New Jersey, $5.5 million in California, and $2 million in another West Virginia suit.
According to online watchdog Drugwatch, “Women who filed transvaginal mesh lawsuits allege that mesh manufacturers “had a legal duty to ensure the safety and effectiveness of their pelvic mesh products,” but instead provided patients with “false and misleading information” about the products’ effectiveness and safety.
Other lawsuits against mesh manufacturers contend that they:
- Actively and intentionally misleading the FDA, the medical community, patients and the public at large with respect to the safety and effectiveness of transvaginal mesh products.
Failing to conduct proper testing and research to determine the risks of surgical mesh for use to treat female pelvic floor disorders.
Failing to establish safe and effective methods for removal of transvaginal mesh.
Failing to adequately warn of potential complications and injury.