Attorney General Fox Announces Settlement with Surgical Mesh Manufacturer
HELENA — Attorney General Tim Fox today announced a multistate settlement with C.R. Bard, Inc., and its parent company Becton, Dickinson and Company requiring payment of $60 million to 48 states for the deceptive marketing of transvaginal surgical mesh devices. Montana 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.
Surgical mesh is a synthetic knitted or woven fabric that is permanently implanted in the pelvic floor 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. Although use of surgical mesh is not proven to be more effective than traditional tissue repair, millions of women were implanted with these devices; many experienced complications like erosion of mesh through organs, pain during sexual intercourse, and voiding dysfunction.
“This settlement marks the second time my attorneys general colleagues and I have held companies accountable for placing profit before patient safety by using deceptive marketing tactics for their surgical mesh products,” Attorney General Tim Fox said. “Failure to warn consumers about possible life-altering health risks related to surgical products is unacceptable, and a clear violation of our state consumer protection laws. Today’s announcement is an acknowledgement of the pain thousands of American women implanted with surgical mesh have suffered as a result of these devices, and a step forward for future patients, who will now be able to make informed decisions thanks to the transparency stipulated in the settlement,” Fox added.
Last fall, Fox announced a $116.9 million multistate settlement with Johnson & Johnson and Ethicon, Inc. for their deceptive marketing of transvaginal surgical mesh devices. Under that settlement, Montana received $1,460, 022 to be used by the Office of Consumer Protection for education, investigations, and enforcement of Montana’s consumer protection laws.
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 its patient complaints reporting practices are consistent with FDA requirements.
Montana’s total share of the settlement is expected to be $639,966, which will be used for ongoing consumer protection work. The money will be paid over a one-year period; the first of three payments will be made next month.
Read more about the settlement here.