PHOENIX -- Attorney General Mark Brnovich today announced that C.R. Bard, Inc. and its parent company Becton, Dickinson and Company have agreed to pay $1.15 million to Arizona in penalties. The settlement with the Arizona Attorney General’s Office is part of a $60 million settlement with 48 states and the District of Columbia to resolve allegations that C.R. Bard deceptively marketed its transvaginal surgical mesh devices.
The lawsuit filed by the Arizona Attorney General’s Office alleges that C.R. Bard engaged in unfair and deceptive practices promoting its transvaginal surgical mesh devices by misrepresenting or failing to adequately disclose serious and life-altering risks arising from the devices, such as chronic pain, scarring and shrinking of bodily tissue, painful sexual relations, and recurring infections, among other complications.
Pursuant to the Consent Judgment, C.R. Bard and its parent company, Becton, Dickinson and Company, 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 Becton, Dickinson and Company to adhere to certain injunctive terms if they reenter the transvaginal mesh market. Should that happen, the companies must, among other things:
- 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.
- 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.
Joining Arizona in this multistate settlement are Alabama, Alaska, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, 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, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, and Wisconsin.
Assistant Attorney General Kaitlin Hollywood handled this case for Arizona.
Copy of the consumer fraud complaint.
Copy of the consent judgment.