PHOENIX — Arizona is getting a payout for penalties in a pelvic mesh marketing lawsuit.
Arizona Attorney General Mark Brnovich said Thursday that C.R. Bard, Inc. and its parent company Becton, Dickinson and Company have agreed to pay Arizona $1.15 million in penalties after a multi-state lawsuit.
Arizona is part of the $60 million settlement with 48 states and the District of Columbia over allegations that C.R. Bard deceptively marketed its transvaginal surgical mesh devices.
Transvaginal mesh is an implant used to treat weak or damaged tissue in a woman's bladder or pelvis. It helps with some causes of incontinence and pelvic organ prolapse.
The lawsuit filed by Brnovich's office alleged C.R. Bard used unfair and deceptive practices promoting its transvaginal surgical mesh devices by misrepresenting or failing to adequately disclose serious and life-altering risks arising from their devices, which includes chronic pain, scarring and shrinking of bodily tissue, painful sex, and recurring infections. Other complications were also reported.
C.R. Bard stopped selling transvaginal mesh, but the settlement provides injunctive relief, requiring both C.R. Bard and Becton, Dickinson and Company to adhere to certain terms if they want to sell transvaginal mesh products again.
Below are the requirements if the companies choose to reenter that market, according to Brnovich's office:
- 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.
- 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.
The full consumer fraud complaint can be read here.
