The first case involving Johnson & Johnson’s allegedly defective vaginal mesh went before a jury this week. A woman and her attorney in South Dakota told a jury that Johnson & Johnson sold the defective implant after failing to properly test it and warn patients of possible risks.
The plaintiff, Linda Gross, is the first of nearly 1,800 such cases to go to trial. Gross claims she underwent a shocking 18 different operations to repair damage caused by the Gynecare Prolift device implanted in her pelvis. Her attorneys argued that Johnson & Johnson knew that patients were at risk for chronic pain and other problems before any implants were sold. Gross has sued for defective design, deceit and negligence.
Plaintiffs across the country will try to argue that Johnson & Johnson failed to warn of the risks associated with the device. Some are arguing the company did not conduct enough testing to understand what could happen when the devices were actually implanted in a woman’s body. Plaintiffs claim the mesh hardens and contracts as tissue grows around it, leading to scarring and chronic inflammation. Removing the devices if and when something goes wrong becomes nearly impossible as tissue surrounds the implant.
Lawyers for the medical device company have fired back saying that the claims advanced by Gross and similar plaintiffs’ attorneys are untrue. Instead, J&J says that Gross and her surgeon were warned of the risks associated with the Prolift device and that the implant did exactly what it was supposed to do by holding internal organs in place.
That being said, J&J announced in August that it would stop selling four different vaginal mesh devices, including the Prolift. The company says it made the decision not based on issues of safety or effectiveness, but instead based on the products’ commercial viability.
Prior to the company’s decision to pull the devices from the market the U.S. Food and Drug Administration told J&J, as well as dozens of other manufacturers of vaginal mesh implants, to study the rates of organ damage and complications associated with the products. The problems associated with the devices are widespread given that 70,000 devices were implanted in American women in 2010.
It’s troubling that J&J’s Prolift device was initially sold without ever filling out a new application for approval by the FDA. Instead, the device was cleared through the 510(k) process which only requires a company to show that the device is “substantially similar” to others already on the market. J&J decided on its own that it was similar to one of its devices already on the market. In 2007, the FDA said sales had begun “without appropriate” clearance and made J&J resubmit the device for clearance, which was finally granted approval nine months later.
If you or someone you know have been injured by a defective product and you would like to discuss your case with an attorney, please contact the Georgia product liability litigation attorneys at Pope, McGlamry, Kilpatrick, Morrison & Norwood, P.C. today to schedule a free consultation.
Source: “J&J Failed to Warn of Vaginal Mesh Risks, Lawyer Says,” by David Voreacos, published at Bloomberg.com.
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