Attorney General James Helps Recover $60 Million from Company That Endangered Women’s Health

 

Consumers Misled About Safety, Effectiveness, and Potential Risks of Transvaginal Mesh Devices

 New York Attorney General Letitia James, as part of a coalition of 49 attorneys general from around the country, today announced a multistate agreement that requires C.R. Bard, Inc. and its parent company, Becton, Dickinson and Company, to pay $60 million for the deceptive marketing of transvaginal surgical mesh devices that endangered the health of women across New York and the rest of the nation. A multistate investigation found that the companies violated state consumer protection laws by misrepresenting the safety and effectiveness of the devices and failing to sufficiently disclose risks associated with their use.

“We will continue to fight on behalf of women when companies prioritize profits over the health and safety of women,” Attorney General James said. “While C. R. Bard was putting income before the health of customers in need of care, women were put in danger. My office will never waver in its efforts to hold companies accountable for risking the health of its consumers.”

Transvaginal surgical mesh is a synthetic material that is surgically implanted through the vagina to support the pelvic organs of women who suffer from stress urinary incontinence or pelvic organ prolapse. 

The multistate investigation found 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 relations, and recurring infections, among other complications. Evidence shows that C. R. Bard was aware of the possibility for serious medical complications but did not provide sufficient warnings to consumers or surgeons who implanted the devices.

Under today’s agreement, C. R. Bard and its parent company have agreed to pay $60 million to the 48 participating states and the District of Columbia. New York state will receive $2,160, 246. Although C.R. Bard stopped selling transvaginal mesh devices, the agreement lays out injunctive relief, requiring both C.R. Bard and Becton, Dickinson and Company to adhere to certain injunctive terms if they reenter the transvaginal mesh market.

Under the terms of the agreement, the companies must:

• 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 that includes risk information.
• Disclose sponsorship in clinical studies, clinical data, or preclinical data for publication.
• Refrain from citing to 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 — in any public presentation or submission for publication — Bard’s sponsorship of the contracted for activity.
• Register all Bard-sponsored clinical studies regarding mesh on ClinicalTrials.gov.
• Train independent contractors, agents, and employees who sell, market, or promote mesh about 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 Food and Drug Administration requirements. 

Joining Attorney General James in filing today’s multistate agreement are the attorneys general of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin, and the District of Columbia.

Today’s agreement follows an earlier, similar agreement from October 2019 with Johnson & Johnson, and its subsidiary, Ethicon, Inc., concerning their deceptive marketing of transvaginal surgical mesh devices.