A trial is now underway in which pharmaceutical giant Johnson & Johnson is defending itself in court against a transvaginal mesh lawsuit filed by a former nurse who is living in almost constant pain she attributes to one of the company’s products.
The transvaginal mesh lawsuit filed by the 47-year-old South Dakota woman is one of nearly 1,800 state court cases in line in a group of similar cases consolidated in New Jersey.
Legal experts say that billions of dollars could be at stake eventually in the cases because there are several other groups of similar lawsuits in federal courts across the country in which Johnson & Johnson and other manufacturers are being taken to court.
These experts say it is common in such mass litigation for large companies to weigh the outcome of the first set of trials before deciding whether to offer mass settlements or continue the legal expenses of defending individual cases.
In addition, there may be more cases filed because transvaginal mesh lawyers are still offering free consultations to victims of mesh failures in other women who have suffered from pelvic organ prolapse and urinary incontinence.
The South Dakota woman is suing Johnson & Johnson over the company’s subsidiary Ethicon’s Gynecare Prolift mesh, which was implanted in her in 2006. Her complications have forced her to undergo 18 subsequent operations and she has been unable to work or live without pain, according to her claims.
“She can no longer sit comfortably for more than a few minutes without having to either stand up or lay down to try to reduce the level of pain,” the woman’s attorneys said in court papers filed in the case. “She requires various daily medications to treat her severe chronic pain.”
Bloomberg News reported that the U.S. Food and Drug Administration told J&J, C.R. Bard Inc. and 31 other manufacturers last January to study rates of organ damage and complications linked to implants.
Bloomberg said doctors implanted more than 70,000 mesh devices in U.S. women in 2010, threading them through incisions in the vagina to fortify pelvic muscles that failed to support internal organs.
The news agency also reported that Johnson & Johnson steered the Prolift device through unusual procedures to get it to the marketplace in 2005:
“J&J began selling the Prolift without filing a new application under the agency’s so-called 510(k) application process, which requires companies to show that a device is ‘substantially similar’ to others on the market.
The company determined on its own that it was substantially similar to the Gynecare Gynemesh, one of the company’s devices already approved by the FDA, J&J said last year in an e-mail.
The FDA disagreed with J&J’s interpretation and required a new application in August 2007, saying Prolift sales began ‘without appropriate’ clearance, an agency spokeswoman, Morgan Liscinsky, said last year in an e-mail.
J&J has said it began sales after citing an agency guidance document, “Deciding When to Submit a 510(k) for a Change to an Existing Device,” according to Liscinsky and Johnson.”
Bloomberg reported that Johnson & Johnson faced no sanctions because the FDA determined that it applied the guidance in good faith and promptly complied when the agency required a new application, Liscinsky said. The FDA cleared the device in May 2008 after nine months of negotiations with Johnson & Johnson.