California Attorney General Kamala Harris has filed a lawsuit against Johnson & Johnson accusing the company of false advertising and deliberately concealing the risks associated with transvaginal mesh implants. According to an NBC News report, the mesh implants are used to treat health conditions in older women such as pelvic organ prolapse and stress urinary incontinence. Harris joined Washington State Attorney General Bob Ferguson and filed two separate consumer lawsuits against the pharmaceutical giant.
The lawsuits state that J & J failed to inform both patients and doctors about the risk of severe complications these products pose and misrepresenting the frequency and severity of those risks. The complaint also alleges that the corporation hid the possibility of serious and irreversible complications caused by the mesh including chronic pain during sexual intercourse and permanent urinary dysfunction.
Millions of Women Affected
More than 3,000 women have filed complaints with the U.S. Food and Drug Administration (FDA) about serious side effects related to the transvaginal mesh. Harris said J & J has “put millions of women at risk of severe health problems by failing to provide critical information to doctors and patients about its surgical mesh products.” She also said the company’s deceptive actions denied women the ability to make informed decisions about their own health and well-being.
California co-led an investigation that included 45 other states and the District of Columbia. The attorney general’s lawsuit seeks injunctive relief as well as monetary penalties. According to Harris’ office, J & J sold 787,232 devices nationally from 2008 to 2014, including more than 42,000 in California for that same time period. Worldwide, more than 2 million women had been implanted with these mesh products.
Failure to Warn
Manufacturers of medical devices, like all product manufacturers, have a legal obligation to make items that are safe for consumers to use. Particularly with medical devices that are placed inside the body, there is an increased responsibility for manufacturers to warn consumers about potential risks because of the dangerous side effects that could occur. In this case, J & J knew about the dangers and risks posed by the vaginal mesh implants.
And yet, they encouraged doctors to recommend these devices to patients touting them as products with minimal side effects – which wasn’t true at all. Women who got these mesh implants suffered not only severe pain, but other issues such as nerve and tissue damage as the implants dug into the vaginal wall and surrounding tissues and nerves. As California defective medical device lawyers who have represented the rights of women who have been seriously harmed by these defective medical devices, we welcome the attorney general’s lawsuit against J & J. This corporation should be held accountable.