NEW YORK – New York Attorney General Letitia James, as part of a coalition of 49 attorneys general from across the country, announced a multi-state agreement requiring CR Bard, Inc. and its parent company, Becton, Dickinson and Company, to pay $ 60 million for the deceptive marketing of transvaginal surgical mesh devices that have endangered women’s health throughout New York and the rest of the nation. A multi-state investigation found that companies violated state consumer protection laws by misrepresenting the safety and effectiveness of devices and not disclosing sufficiently the risks associated with their use.
“We will continue to fight for women when companies prioritize profits over women’s health and safety,” said Attorney General James. “While CR Bard put income before the health of clients in need of care, women were in danger. My office will never hesitate in its efforts to hold companies responsible for the health risk of its consumers. “
Transvaginal Surgical Mesh is a synthetic material that is surgically implanted through the vagina to support the pelvic organs of women suffering from stress urinary incontinence or pelvic organ prolapse.
The multistate investigation found that CR Bard misrepresented or failed to adequately disclose serious and life-altering risks of mesh surgical devices, such as chronic pain, scarring and shrinking of body tissue, painful sexual intercourse and recurrent infections, including the other complications. Evidence shows that CR Bard was aware of the possibility of serious medical complications, but did not provide sufficient warnings to consumers or surgeons who implanted the devices.
Under the agreement, CR Bard and its parent company agreed to pay $ 60 million to the 48 participating states and the District of Columbia. The state of New York will receive $ 2,160.246. Although CR Bard has stopped selling transvaginal network devices, the agreement includes an injunction, requiring both CR Bard and Becton, Dickinson and Company to adhere to certain injunctive terms if they fall within the market of transvaginal networks.
Under the terms of the agreement, companies must:
* Provide patients with understandable descriptions of complications in marketing materials.
* Include a list of some complications in all marketing materials that address complications.
* Disclose the complications of using the network in any training provided that includes risk information.
* Disclose sponsorship in clinical trials, clinical data, or preclinical data for publication.
* Refrain from citing clinical studies, clinical data, or preclinical data relating to meshes for which the company has not met the disclosure requirements.
* Require consultants to agree to disclose, in any public submission or submission for publication, Bard’s sponsorship of the contracted business.
* Register all Bard-sponsored clinical trials involving mesh at ClinicalTrials.gov.
* Train independent contractors, agents and employees who sell, market or promote the mesh on their obligations to report all patient complaints and adverse events to the company.
* Ensure that its practices relating to patient complaint reporting are consistent with Food and Drug Administration requirements.
Joining Attorney General James in filing today’s multi-state 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 District of Columbia.
The deal follows a previous similar October 2019 deal with Johnson & Johnson and its subsidiary, Ethicon, Inc., regarding their misleading marketing of transvaginal surgical mesh devices.
The matter was handled by Assistant Attorney General Carol Hunt of the Health Bureau, under the supervision of Bureau Chief Lisa Landau; as well as Special Adviser Mary Alestra of the Bureau of Fraud and Consumer Protection, under the supervision of Deputy Bureau Chief Laura J. Levine and Bureau Chief Jane Azia. The Health Care Bureau is a part of the Division of Social Justice, which is headed by Deputy Attorney General Meghan Faux, and the Office of Fraud and Consumer Protection is part of the Division of Economic Justice, headed by Deputy Attorney general Chris D’Angelo. Both the Division of Social Justice and the Division of Economic Justice are overseen by First Deputy Attorney General Jennifer Levy.