SEATTLE (AP) - Washington state and California sued Johnson & Johnson on Tuesday, saying for years the company misrepresented the risks of vaginal mesh implants it sold to repair pelvic collapse.
In the latest legal actions over the problem-prone devices, Attorneys General Bob Ferguson, of Washington, and Kamala Harris, of California, accused the New Jersey-based health care giant of neglecting to tell patients and doctors about the risks and occurrences of dire, sometimes irreversible complications. Those include urinary dysfunction, loss of sexual function, constipation and severe pain.
"For many victims, their health and their quality of life were forever changed as a result of this deception," Ferguson told a news conference. "Sitting upright, lying on their side, walking all became incredibly painful. These women were robbed of their ability to live and work in the way they once did."
Dawna Hankins, a Seattle woman who attended the news conference, said she was scheduled to have a partial hysterectomy in 2008 when her doctor suggested implanting the mesh at the same time to deal with minor incontinence.
After three years of pain, itching and urinary tract infections, Hankins underwent three surgeries related to removing the mesh, but she still has some of it in her body, and her incontinence has only gotten worse, forcing her to sometimes leave work after accidents. She now keeps extra clothes at work so she doesn't have to leave.
"There is a foreign, plastic object remaining in my body," Hankins said. "There may be more pelvic pain, more infection and more unknown complications."
Patients have already filed tens of thousands of lawsuits against mesh manufacturers, including New Jersey-based Johnson & Johnson, Massachusetts-based Boston Scientific and Ireland-based Endo International. In 2014, Endo said it would pay $830 million to settle more than 20,000 personal injury lawsuits. Johnson & Johnson faces more than 35,000 lawsuits, Harris said.
The plastic mesh is used to treat pelvic organ prolapse, a condition that involves organs such as the bladder, bowel and uterus shifting, often after childbirth, a hysterectomy or menopause. In response to thousands of injuries from the mesh, the U.S. Food and Drug Administration early this year re-labeled the products high risk instead of moderate and announced new federal scrutiny for them. The agency had already concluded women getting vaginal mesh have more complications than women who undergo traditional surgery with stitches.
In an emailed statement, Johnson & Johnson subsidiary Ethicon Inc., which marketed the mesh, called the lawsuits unjustified.
California and Washington led a group of 46 states and the District of Columbia in investigating the company's practices. California's lawsuit alleges false advertising and deceptive marketing. In a news release, Harris noted Johnson & Johnson sold nearly 790,000 of the devices nationwide from 2008 to 2014, including more than 42,000 in California.