AG Donovan settles deceptive marketing claims with C.R. Bard, Inc.
Vermont Business Magazine Attorney General TJ Donovan today announced that CR Bard, Inc, and its parent company Becton, Dickinson and Company, will pay the State of Vermont $600,000 for misrepresenting the safety and effectiveness of its transvaginal surgical mesh devices. Bard’s devices were used to treat pelvic organ prolapse and urinary incontinence in women, often caused by childbirth, age, and other factors. Thousands of women implanted with transvaginal surgical mesh have suffered serious complications resulting from the devices.
Today’s multistate settlement resolves allegations, brought by a coalition of attorneys general, that Bard misrepresented or failed to adequately disclose serious and life-altering risks of surgical mesh devices.
“Bard’s misrepresentations deprived women of the ability to make informed decisions about their healthcare, including whether to permanently implant surgical mesh into their bodies,” said Attorney General Donovan. “I will continue to hold companies who harm Vermonters accountable for misrepresenting the safety and efficacy of their products.”
Under the terms of the multistate settlement, Bard must pay a total of $60 million, of which Vermont will receive $600,000, for the deceptive marketing of transvaginal surgical mesh devices. Additionally, Bard and its parent company, who have stopped selling transvaginal mesh, are required to adhere to certain injunctive terms if they reenter the transvaginal mesh market, including:
- Providing patients with understandable descriptions of complications in marketing materials;
- Disclosing complications related to the use of mesh in any training provided that includes risk information;
- Registering all Bard-sponsored clinical studies regarding mesh with ClinicalTrials.gov; and
- Training 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, and ensuring that its practices regarding the reporting of patient complaints are consistent with FDA requirements.
Joining Attorney General Donovan in this multistate settlement are the attorneys general of 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, Virginia, Washington, and Wisconsin.
Consumers who believe they have suffered an injury and wish to pursue legal remedies may visit the following link for more information about the Bard surgical mesh litigation: https://www.wvsd.uscourts.gov/MDL/2187/index.html.
Source: MONTPELIER — Attorney General 9.24.2020