Kentucky’s attorney general is suing health-care giant Johnson & Johnson for millions of dollars, saying the company “concealed and misrepresented” the risk of its transvaginal mesh products to doctors and patients.
Johnson & Johnson called the lawsuit unjustified.
Attorney General Andy Beshear said more than 15,000 women in Kentucky had transvaginal mesh implanted but Johnson & Johnson, through its medical device company, Ethicon, didn’t provide enough information about adverse effects.
The lawsuit says women have reported chronic pelvic pain, pain associated with intercourse and/or the loss sexual function, and other health problems.
“The way this company clearly chose profits over people is outrageous,” Beshear said in a written statement. “My office has talked to victims whose lives have been devastated by this company’s deceitful practices. We may not be able to give them back the lives they once had, but my office will do everything we can to hold this company accountable.”
The lawsuit says one of the misrepresentations the company made was that it said its products were approved by the Food and Drug Administration. It adds the surgical mesh devices were FDA cleared, not approved.
Johnson & Johnson denied it was deceitful.
“The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products,” It said. “The use of implantable mesh is often the preferred option to treat certain female pelvic conditions, including pelvic organ prolapse and stress urinary incontinence, and is backed by years of clinical research.”
The company, which is headquartered in New Jersey, said it was concerned that women will be deterred by the lawsuit and not get treatment for stress urinary incontinence.
Johnson & Johnson sold $6.4 billion worth of medical devices worldwide in the second quarter of 2016, according to a company report posted online.
Just two months ago, California and Washington became the first two states to sue Johnson & Johnson over the marketing of transvaginal mesh products. A statement announcing California’s lawsuit said more than 780,000 devices were sold by Johnson & Johnson between 2008 and 2014. It also said there are more than 35,000 personal lawsuits against the company.
According to the FDA, surgical mesh has been used in the transvaginal repair of pelvic organ prolapse since the 1990s. In 2002, the FDA cleared mesh devices as a moderate-risk device. In January, the FDA reclassified the devices into the high-risk category and gave companies 30 months to submit applications for premarket approval.
Five manufacturers sell such products.