NEW YORK (Reuters) - California has accused Johnson & Johnson of failing to warn doctors and patients about the severity and frequency of complications associated with its pelvic mesh devices.
According to the lawsuit filed by the state's attorney general on Tuesday, J&J and its Ethicon unit falsely marketed the devices as a safe and superior option to non-mesh treatments for pelvic floor disorders, when it was aware that they could cause pain, bleeding, loss of sexual function and other side effects.
"Johnson & Johnson 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," California Attorney General Kamala Harris said in a statement. Her office led a multi-state investigation into J&J's mesh products, which included 46 states and the District of Columbia.
The lawsuit seeks monetary penalties and an order halting any unfair advertising for mesh.
J&J said in a statement that the lawsuit was "unjustified" and could discourage women from seeking treatment for incontinence symptoms.
"The evidence will show that Ethicon acted appropriately and responsibly in the marketing of our pelvic mesh products," said spokeswoman Samantha Lucas.
J&J is one of several manufacturers that sold the devices to treat conditions like stress urinary incontinence and pelvic organ prolapse in women. Those companies are facing tens of thousands of individual lawsuits from plaintiffs who said they were injured by the mesh's poor design and substandard materials, which plaintiffs say led to serious complications that require surgery to repair.
According to California's attorney general, J&J sold more than 787,000 pelvic mesh devices in the United States from 2008 until 2014, including more than 42,000 in California.
Also on Tuesday, Washington state's attorney general, Bob Ferguson, filed a similar consumer-protection lawsuit against J&J over its marketing of pelvic mesh devices.
Over the past several years, the devices have come under increasing scrutiny by regulators as well as private litigants. The U.S. Food and Drug Administration says it has received thousands of reports of complications in connection with mesh used to treat pelvic organ prolapse.
Earlier this year, the Food and Drug Administration said it was reclassifying mesh used to treat pelvic organ prolapse transvaginally from class II, or moderate risk, to class III, for high-risk devices, which will require manufacturers to submit extensive data to establish the devices' safety.
Additional reporting Nate Raymond n New York; Editing by Bernard Orr and Matthew Lewis