Indiana Attorney General Curtis Hill on Thursday announced a settlement by Indiana, 47 other states and the District of Columbia with C.R. Bard Inc. and its parent company, Becton, Dickinson and Co., requiring payment of $60 million for the allegedly deceptive marketing of transvaginal surgical mesh devices. Under the settlement, Indiana receives just over $1.7 million.
Hill
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.
The attorneys general allege 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.
“Companies have the legal and ethical obligation to provide accurate and truthful information to consumers,” Hill said. “Whenever businesses fail to meet this basic obligation, we must hold them accountable.”
C.R. Bard and its parent 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 Co. 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 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.