FRANKFORT, Ky. (September 28, 2020)
Attorney General Daniel Cameron today announced a settlement by 48 states and the District of Columbia with C.R. Bard, Inc. and its parent company Becton, Dickinson and Company (BD), requiring payment of $60 million for the deceptive marketing of transvaginal surgical mesh devices.
C.R. Bard and BD have agreed to pay $60 million to 48 states and the District of Columbia. Kentucky will receive $918,583.00.
“C.R. Bard violated Kentucky’s consumer protection laws by failing to disclose severe side effects associated with its permanently implanted surgical mesh product,” said Attorney General Cameron. “This settlement provides more than $900,000.00 to the Commonwealth and prevents the company from irresponsibly marketing mesh devices to future consumers.”
Surgical mesh is a synthetic knitted or woven fabric permanently implanted in the pelvic floor through the vagina to treat pelvic organ prolapse and stress urinary incontinence. Thousands of women implanted with surgical mesh have claimed that they suffered serious complications resulting from these devices. Although use of surgical mesh involves the risk of these serious complications and is not proven to be more effective than traditional tissue repair, millions of women were implanted with these devices.
The attorneys general allege 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, painful sexual intercourse, and recurring infections, among other complications.
C.R. Bard and BD have agreed to pay $60 million to the 48 participating states and the District of Columbia. Although C.R. Bard stopped selling transvaginal mesh, the settlement provides injunctive relief, requiring both C.R. Bard and BD to adhere to certain injunctive terms if they reenter the transvaginal mesh market.
Under the terms of the settlement, the companies are required to:
- Provide patients with understandable descriptions of complications in marketing materials.
- Include a list of certain complications in all marketing materials that address complications.
- Disclose complications related to the use of mesh in any training provided, including risk information.
- Disclose sponsorship in clinical studies, clinical data, or preclinical data for publication.
- Refrain from citing any clinical study, clinical data, or preclinical data regarding mesh, for which the company has not complied with the disclosure requirements.
- Require consultants to agree to disclose Bard’s sponsorship of the contracted for activity in any public presentation or submission for publication.
- Register all Bard-sponsored clinical studies regarding mesh with ClinicalTrials.gov.
- 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.
- Ensure that its practices regarding the reporting of patient complaints are consistent with FDA requirements.
Attorney General Cameron was joined by attorneys general of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, 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 in the settlement.
To read the terms of the settlement, click here.