LITTLE ROCK, Ark. – Arkansas Attorney General Leslie Rutledge announced a multistate settlement with Boston Scientific Corporation (Boston) to resolve allegations of the company engaging in deceptive marketing of its surgical mesh products for women.
The settlement would require Boston to pay $188.6 million to 47 states and the District of Columbia to resolve allegations that it deceptively marketed transvaginal surgical mesh devices to patients. Arkansas will receive $2,776,500 from the settlement with Boston Scientific Corporation.
“Our mothers, sisters and daughters have been deceived by Boston Scientific Corporation, and now they must live with permanent damage to their bodies,” Arkansas Attorney General Rutledge said. “The settlement ensures impacted Arkansans’ voices have been heard and Boston Scientific will do no further harm to future generations in the state.”Attorney General Rutledge
The complaint alleges that Boston misrepresented the safety of these products by failing to disclose the full range of potentially serious and irreversible complications caused by mesh, including chronic pain, voiding dysfunction, and new onset of incontinence.
The settlement provides comprehensive injunctive relief. Under the terms of the settlement, Boston must comply with the following:
- For marketing materials intended for consumers, describe complications in understandable terms;
- For certain marketing materials, disclose significant complications, including the inherent risks of mesh;
- Refrain from representing that any inherent risks of mesh are risks common to any pelvic floor or other surgery not involving mesh;
- Refrain from representing that the inherent mesh complications can be eliminated with surgical experience or technique;
- Refrain from representing that surgical mesh does not cause a foreign body reaction;
- Refrain from representing that surgical mesh remains soft, supple, or pliable after the mesh is implanted inside the body;
- Refrain from representing that surgical mesh does not potentiate infection or does not increase the likelihood of infection;
- Refrain from representing that surgical mesh repair is superior to native tissue repair unless such representations are supported by valid scientific evidence;
- Inform healthcare providers of significant complications when providing training regarding procedures for insertion and implantation;
- Maintain policies requiring that its independent contractors, agents, and employees who sell, market, or promote mesh are adequately trained to report patient complaints and adverse events to the company;
Clinical Trial Reforms
- When submitting a clinical study or clinical data regarding mesh for publication, disclose the company’s role as a sponsor and any author’s potential conflict of interest;
- Refrain from citing any clinical study, clinical data, preclinical data, research, or article regarding mesh for which the company has not complied with the disclosure requirements in the injunction;
- Include a sponsorship disclosure provision requiring consultants to contractually agree to disclose in any public presentation or submission for publication any sponsorships by Boston related to the contracted-for activity;
- Register all Boston-sponsored clinical studies regarding mesh with ClinicalTrials.gov.
In addition to Attorney General Rutledge, the investigation that resulted in today’s settlement was led by California and Washington along with Florida, Indiana, Maryland, Ohio, South Carolina, and Texas. Joining this multistate settlement are Alabama, Alaska, Arizona, Colorado, Connecticut, Delaware, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Utah, Vermont, Virginia, Wisconsin, and the District of Columbia.