The following is a press release from the Massachusetts Attorney General’s office
BOSTON – Massachusetts will receive $1.1 million as part of a $60 million multistate settlement involving 49 attorneys general resolving allegations that a national medical device developer engaged in dangerous deceptive marketing of surgical mesh devices, Attorney General Maura Healey announced today, September 24.
In a consent judgment filed with a complaint in Suffolk Superior Court today and that is pending court approval, C.R. Bard and its parent company Becton, Dickinson and Company agreed to resolve the Commonwealth’s claims that C.R. Bard misrepresented or failed to adequately disclose serious and life-altering risks of surgical mesh devices, such as chronic pain, scarring and shrinking of bodily tissue, and recurring infections.
“Companies cannot use deceptive practices to put profits over the safety and well-being of patients,” said AG Healey. “This settlement brings more than $1 million back to Massachusetts and secures significant injunctive relief from these companies.”
According to the complaint, thousands of women implanted with C.R. Bard’s surgical mesh devices to treat pelvic organ prolapse and other conditions have made claims that they suffered serious complications resulting from these devices. The suit alleges that C.R. Bard misrepresented the full range of risks and complications associated with the devices, including failing to disclose that surgical mesh is not proven to be more effective than traditional tissue repair.
In addition to the $60 million payment to the multistate coalition, C.R. Bard and Becton, Dickinson and Company have agreed to:
- Provide patients with easy to understand descriptions of complications associated with their devices and include a list of those complications in marketing materials.
- Train independent contractors, agents, and employees who sell, market, or promote mesh about the complications associated with the devices and inform them of their obligation to report all patient complaints related to the devices to C.R. Bard.
- Disclose C.R. Bard’s sponsorship of clinical trials of surgical mesh when they are mentioned in marketing materials and register all clinical studies sponsored by C.R. Bard regarding mesh with ClinicalTrials.gov.
- Ensure that C.R. Bard’s practices regarding the reporting of patient complaints are consistent with FDA requirements.
C.R. Bard no longer sells surgical mesh devices.
Joining AG Healey in this multistate settlement are the attorneys general from Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, and Wisconsin.
This matter was handled by Assistant Attorney General Michael Wong of the AG’s Health Care Division.