By Tom Latek
Kentucky Today
Kentucky will receive more than $900,000 as its share of a $60 million settlement by 48 states and the District of Columbia with C.R. Bard, Inc. and its parent company Becton, Dickinson and Company, for the deceptive marketing of transvaginal surgical mesh devices.
Daniel Cameron
Kentucky’s share is $918,583, Attorney General Daniel Cameron announced on Monday.
“C.R. Bard violated Kentucky’s consumer protection laws by failing to disclose severe side effects associated with its permanently implanted surgical mesh product,” he said. “This settlement provides more than $900,000 to the commonwealth and prevents the company from irresponsibly marketing mesh devices to future consumers.”
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 intercourse and recurring infections, among other complications.
C.R. Bard and BD 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 BD to adhere to certain injunctive terms if they reenter the transvaginal mesh market.
Under the terms of the settlement, the companies are required to:
• 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, including risk information.
• Disclose sponsorship in clinical studies, clinical data or preclinical data for publication.
• Refrain from citing 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 Bard’s sponsorship of the contracted for activity in any public presentation or submission for publication.
• 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.
Surgical mesh is a synthetic knitted or woven fabric permanently implanted in the pelvic floor through the vagina to treat pelvic organ prolapse and stress urinary incontinence. Thousands of women implanted with surgical mesh have claimed that they suffered serious complications resulting from these devices. Although the 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.
To read the terms of the settlement, visit ag.ky.gov.
