California Department of Justice Announces $188.6 Million Multistate Settlement with Medical Device Manufacturer Boston Scientific Corporation
SACRAMENTO – The California Department of Justice and Washington Attorney General Bob Ferguson today announced a multistate settlement with Boston Scientific Corporation (Boston) to resolve allegations of deceptive marketing of its surgical mesh products for women. The settlement requires 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. California’s share of the settlement is $19.3 million.
Surgical mesh is a synthetic woven fabric that is implanted in the pelvic floor through the vagina to treat common health conditions in women such as stress urinary incontinence and pelvic organ prolapse. These are common conditions faced by women due to a weakening in their pelvic floor muscles caused by childbirth, age, or other factors. Although use of surgical mesh involves the risk of serious complications and is not proven to be any more effective than traditional tissue repair, millions of women were implanted with the device and thousands of women are alleged to have suffered serious complications resulting from these devices.
The complaint alleges that Boston misrepresented the safety of these products by failing to disclose the full range of potential serious and irreversible complications caused by mesh, including chronic pain, voiding dysfunction, and new onset of incontinence. The settlement with Boston follows a $344 million California Superior Court judgment in January 2020 against surgical mesh manufacturer Johnson & Johnson and a $60 million multistate settlement with C.R. Bard Inc. in September 2020 to resolve an investigation into Bard’s marketing of its pelvic mesh products for women.
The settlement provides comprehensive injunctive relief. Boston has agreed to the settlement’s injunctive terms which include but are not limited to the following reforms:
- Disseminate marketing materials for consumers describing complications in understandable terms;
- Disclose significant complications in certain marketing materials, including the inherent risks of mesh;
- Inform healthcare providers of significant complications during Boston trainings regarding procedures for insertion and implantation;
- Maintain policies requiring independent contractors, agents, and employees who sell, market, or promote mesh to be adequately trained to report patient complaints and adverse events to the company;
Clinical Trial Reforms:
- Disclose its role as a sponsor and any author’s potential conflict of interest when submitting a clinical study or clinical data regarding mesh for publication; and
- Register all Boston-sponsored clinical studies regarding mesh with ClinicalTrials.gov.
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, Arkansas, 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.