J&J's first vaginal mesh trial revs up this week
|Gynecare Prolift--courtesy of Ethicon.|
For Johnson & Johnson ($JNJ), jury selection is scheduled to begin Jan. 7 for one of 1,800 lawsuits in New Jersey state court accusing the company of selling unsafe vaginal mesh implants without warning patients of the dangers.
As Bloomberg reports, a South Dakota woman's lawsuit is the first trial in the matter to get under way in New Jersey; J&J's headquarters is in New Brunswick, NJ. On Jan. 9, lawyers are expected to choose a jury panel and then the trial itself--which should continue for a month or more--will likely begin on Jan. 10.
In this case, the plaintiff alleges that J&J's Ethicon division didn't properly warn patients about the risks behind the Gynecare Prolift, that the product is defective. She also claims the implant left her debilitated with severe chronic pain and the need for 18 additional operations to try to address it. J&J denies the charges and asserts it has done nothing wrong.
This lawsuit will be watched closely, being the first out of the gate and all. Its success or failure will set the tone for the other thousands of lawsuits waiting for consideration, and the results could lead to a massive settlement or a grueling sequence of trials in the coming years. Many companies face similar legal challenges, including Boston Scientific ($BSX), C.R. Bard ($BCR) and Covidien ($COV). The FDA is seeking three-year study data from these and other manufacturers so it can gauge the rate of organ damage and related complications that patients with the implants are facing.
Johnson & Johnson/Ethicon disclosed to a U.S. District Court Judge in West Virginia in June that it would stop selling four vaginal mesh implants, including the Gynecare Prolift, in the face of 600-plus lawsuits in that venue (though J&J said it would pursue FDA permission to keep selling Gynecare Gynemesh with a new label and restrictions).
Lawsuits regarding the company's Gynecare Prolift have taken on a new dimension since March, when news broke that the FDA determined the company sold the device for three years before gaining FDA clearance.
- read the Bloomberg story
Boston Scientific facing 2,500 lawsuits over vaginal mesh
Report: J&J kept selling vaginal mesh after FDA halt
J&J/Ethicon to stop selling four vaginal mesh implants
J&J lawsuit bombshell: Company marketed vaginal mesh minus FDA nod