Commonwealth of Virginia
Office of the Attorney General
202 North Ninth Street
For media inquiries only, contact:
Charlotte Gomer, Press Secretary
Mobile: (804) 512-2552
ATTORNEY GENERAL HERRING REACHES $60 MILLION MULTISTATE SETTLEMENT WITH C.R. BARD
~ Virginia to receive approximately $1.25 million as part of settlement resolving allegations surrounding deceptive marketing of transvaginal surgical mesh devices ~
RICHMOND – Attorney General Mark R Herring announced today that the Virginia, along with 47 other states and the District of Columbia, has reached a $60 million settlement with C.R. Bard, Inc.("C.R. Bard”) and its parent company Becton, Dickinson and Company, to resolve allegations surrounding the deceptive marketing of transvaginal surgical mesh devices. As its part of the settlement, Virginia will receive approximately $1.25 million.
"We will not tolerate deceptive or untrue marketing of any products in Virginia, but especially when it involves medical devices that can drastically impact the health and safety of a patient,” said Attorney General Herring. "As part of this settlement, C.R. Bard must not only fully disclose the risks and complications associated with its products, but it must also explain them in terms that can be understood by patients and doctors alike, allowing Virginians to make informed decisions about their health.”
In the Complaint, filed today in Richmond Circuit Court, Attorney General Herring alleges that C.R. Bard, in marketing and promoting its transvaginal surgical mesh (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), misrepresented or failed to adequately disclose serious and life-altering risks or complications of surgical mesh devices. These risks or complications include:
- chronic pain;
- scarring and shrinking of bodily tissue;
- painful sexual relations; and
- recurring infections.
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.
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 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 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.
The settlement, which is in the form of a Consent Judgment, has been filed with the Circuit Court for the City of Richmond for approval.
This matter is being handled by Attorney General Herring's Consumer Protection Section. In 2016, Attorney General Herring announced the completion of a reorganization of the Consumer Protection Section to more efficiently and effectively enforce Virginia's consumer protection laws, provide exceptional customer service in resolving complaints and disputes, and provide robust consumer education to keep Virginians from being victimized by fraud, scams, or illegal or abusive business practices. During Attorney General Herring's administration, the Attorney General's Consumer Protection Section has recovered more than $334 million in relief for consumers and payments from violators.
If you have any consumer-related inquiries, the Office of the Attorney General's Consumer Protection Hotline telephone counselors are available to assist you with your consumer questions. Please call the Consumer Protection Hotline at 1-800-552-9963 if calling from Virginia, or 804-786-2042 if calling from the Richmond area. You can also subscribe to the Consumer Protection Quarterly Newsletter here.
Joining Virginia in this multistate settlement are Alabama, Alaska, Arizona, 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, Washington, and Wisconsin.
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