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SACRAMENTO – California Attorney General Xavier Becerra and Washington Attorney General Bob Ferguson today announced a bipartisan, multistate settlement against medical technology company, C.R. Bard, Inc. (Bard) and its parent company, Becton, Dickinson and Company. The settlement requires Bard to pay $60 million to 48 states and the District of Columbia to resolve allegations that it deceptively marketed transvaginal surgical mesh devices to patients. California’s share of the settlement is $5.02 million.
“Women should be able to trust that the health products they use are safe,” said Attorney General Becerra. “Misleading patients and neglecting to disclose risks or side effects of medical products is dangerous, irresponsible, even deadly. Bard was caught engaging in these shameful practices, and for that, they now pay.”
Surgical mesh is a synthetic woven fabric that is implanted in the pelvic floor through the vagina to treat pelvic organ prolapse and stress urinary incontinence. These are common conditions faced by women due to a weakening in their pelvic floor muscles caused by childbirth, age, or other factors.
Attorney General Becerra alleges that thousands of women implanted with surgical mesh have suffered serious complications resulting from these devices. Although use of surgical mesh involves the risk of serious complications and is not proven to be any more effective than traditional tissue repair, millions of women were implanted with the device.
Attorney General Becerra also alleges Bard misled women about serious and life-altering risks of surgical mesh devices, such as chronic pain, scarring and shrinking of body tissue, painful sexual relations, and recurring infections, among other complications. As a result of the investigation and the settlement, Bard must pay a total of $60 million to 48 states and DC.
Bard stopped selling and promoting its surgical mesh products in the United States by December 31, 2016. Under the terms of the settlement, Bard and its parent company Becton, Dickinson and Company, will be subject to the following injunctive terms if the companies reenter the domestic surgical mesh market:
Clinical Trial Reforms:
The settlement with Bard comes on the heels of Attorney General Becerra securing a $344 Million Superior Court judgment in January against Johnson & Johnson for false and deceptive marketing of its pelvic mesh products for women. The California Department of Justice sued Johnson & Johnson in May 2016 after a years-long multistate investigation revealed the company had neglected to inform both patients and doctors of possible severe complications from the products and misrepresented the frequency and severity of risks the products posed.
The investigation that resulted in today’s settlement was led by California and Washington along with Florida, Indiana, Maryland, Ohio, South Carolina, and Texas. Joining this multistate settlement are Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Dakota, Tennessee, Utah, Vermont, Virginia, Wisconsin, and the District of Columbia.
A copy of the complaint is here and the stipulated judgment submitted for court approval is here.