Attorney General Becerra Announces $60 Million Multistate Settlement with Medical Technology Company, C.R. Bard, Inc.
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:
- Must disclose certain complications in any training in which Bard provides risk information; and
- Must ensure that its practices regarding the reporting of patient complaints of adverse events are consistent with FDA requirements for Medical Device Reporting.
- Must include descriptions of complications in terms reasonably understandable to a patient in marketing materials that are intended to reach patients or consumers;
- Must include a list of certain complications in all marketing materials that address the subject of complications; and
- Must adequately inform and train independent contractors, agents, and employees who sell, market, or promote mesh, regarding their obligations to report all patient complaints and adverse events to the company.
Clinical Trial Reforms:
- When submitting a clinical study, clinical data, or preclinical data for publication, must disclose the company’s role as a sponsor and any author’s potential conflict of interest;
- Must not cite any clinical study, clinical data, or preclinical data regarding mesh for which the company has not complied with the disclosure requirements in the injunction;
- Must include a sponsorship disclosure provision in contracts that requires a consultant to agree to disclose in any public presentation or submission for publication, Bard’s sponsorship of the contracted activity; and
- Must register all Bard-sponsored clinical studies regarding mesh with ClinicalTrials.gov.
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.