Colorado to receive more than $1 million in multistate settlement with C.R. Bard, Inc., for the deceptive marketing of transvaginal surgical mesh devices
Sept. 24, 2020 (DENVER, Colo.)—Attorney General Phil Weiser today announced Colorado will receive $1,025,555 in a settlement with C.R. Bard, Inc. and its parent company Becton, Dickinson and Company for the deceptive marketing of transvaginal surgical mesh devices.
The settlement, which was reached between the attorneys general of 48 states and the District of Columbia and the companies, requires a total payment of $60 million. The attorneys general alleged 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.
“Bard knew that its product was defective, but failed to share that information with patients, many of whom now suffer a lifetime of pain,” said Weiser. “By requiring the companies to agree to the terms of this settlement, we will work to ensure that, if C.R. Bard or its parent company decide to resume selling surgical mesh, they will never again cause women such harm.”
Surgical mesh is a synthetic knitted or woven fabric that is permanently implanted in the pelvic floor through the vagina to treat pelvic organ prolapse and stress urinary incontinence. These are common conditions faced by women due to a weakening in their pelvic floor muscles caused by childbirth, age, and other factors.
Thousands of women implanted with surgical mesh have made claims that they suffered serious complications resulting from these devices, including erosion of mesh through organs, pain during sexual intercourse, and voiding dysfunction. Although use of surgical mesh involves the risk of these serious complications and is not proven to be more effective than traditional tissue repair, millions of women were implanted with these devices.
Many women have previously received compensation through personal lawsuits. Settlements and court judgments against surgical mesh companies have resulted in hundreds of millions of dollars going to women harmed by this product in what has been described as one of the nation’s largest mass tort actions. The more than $1 million Colorado received in the settlement announced today will support deterrence and go toward further consumer protection efforts as well as the public welfare.
C.R. Bard and its parent company agreed to adhere to certain injunctive terms if they reenter the transvaginal mesh market, including the following:
- 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;
- 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; and
- 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.
In October 2019, Colorado also announced a $116.9 million settlement against Johnson & Johnson’s subsidiary Ethicon in another multistate investigation involving a company that marketed surgical mesh. Colorado received $2,298,488 from that settlement and that settlement also provided for injunctive terms to assure proper conduct going forward.