Attorney General Ellison announces nearly $190 million multistate settlement with Boston Scientific
Holds Boston Scientific accountable for misrepresenting risks of its surgical mesh devices, in second settlement of its kind; company to pay Minnesota more than $3.3 million, agrees to significant reforms
March 23, 2021 (SAINT PAUL) — Minnesota Attorney General Keith Ellison today announced that his office and a broad multistate coalition of states have reached a $188.6 million multistate settlement with Boston Scientific Corporation over allegations that Boston Scientific deceptively marketed its transvaginal surgical mesh devices, which harmed consumers nationwide. Minnesota will receive more than $3.3 million from the settlement. As part of the settlement, Boston Scientific also agrees to significant marketing, training, and clinical-trial reforms.
The settlement, reached between Boston Scientific and the attorneys general of 47 states and the District of Columbia, concludes a multistate investigation into Boston Scientific’s alleged misrepresentations and failure to adequately disclose serious and life-altering risks of surgical mesh devices, such as chronic pain, voiding dysfunction, and incontinence, among other complications.
This is the second multistate settlement of its kind that Minnesota has joined that holds a manufacturer of transvaginal surgical mesh devices accountable for deceptive marketing. On September 25, 2020, Attorney General Ellison announced a similar settlement with C.R. Bard in which Minnesota received more than $1 million.
Surgical mesh is a synthetic woven fabric that is permanently implanted in the pelvic floor through the vagina to treat conditions in women such as 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 any more effective than traditional tissue repair, millions of women were implanted with these devices.
“All Minnesotans should be able to trust that the medical procedures they undergo are safe and reliable,” said Attorney General Ellison. “That is essential to affording your life and living with dignity, safety, and respect. Boston Scientific falsely touted the safety of its surgical mesh products despite the severe risks these products presented. By reforming Boston Scientific’s practices and holding the company accountable for its misconduct, this settlement is a win for all Minnesotans.”
Boston Scientific Corporation has agreed to pay $188.6 million to the 47 participating states and the District of Columbia. Minnesota’s share of the settlement is $3,377,302.
Under the terms of the consent judgment, which will be filed with the Ramsey County District Court, Boston Scientific has also agreed to strong injunctive relief, including:
Marketing Reforms
- 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 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 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.
Training Reforms
- 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.
Attorney General Ellison encourages consumers who have been implanted with a transvaginal surgical mesh device and have questions about this settlement to contact the Minnesota Attorney General’s Office by calling (651) 296-3353 (Metro area) or (800) 657-3787 (Greater Minnesota), or by submitting a complaint on the Attorney General’s website.
In addition to Minnesota, the multistate group is comprised of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, and Wisconsin.
