A coalition of 48 attorneys general entered into a $188 million settlement with Boston Scientific Corporation, resolving allegations that the company deceptively marketed its transvaginal surgical mesh products. The settlement is a result of multistate investigation which found that Boston Scientific violated state consumer protection laws by misrepresenting the safety and effectiveness of the devices and by failing to sufficiently disclose risks associated with their use.
In the complaint filed by the New York Attorney General, for example, the NYAG alleged that Boston Scientific "misrepresented and failed to disclose the full range of risks and complications associated with the devices, including misrepresenting the risks of Surgical Mesh as compared with the risks of other surgeries or surgically implantable materials" and "continually failed to disclose risks and complications it knew to be inherent in the devices and/or misrepresented those inherent risks and complications as caused by physician error, surgical technique, or perioperative risks."
In announcing the settlement, NYAG Letitia James said, "We will never allow corporate profits to come above the health of New Yorkers . . . . My office will never waver in its efforts to hold companies accountable for risking the health of its consumers."
In addition to the payment that is required, the settlement order places extensive restrictions on Boston Scientific's future marketing, including, for example, that the company:
- Describe complications in understandable terms for marketing materials intended for consumers;
- Disclose significant complications, including the inherent risks of mesh, for certain marketing materials;
- 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; and
- Refrain from representing that surgical mesh repair is superior to native tissue repair, unless such representations are supported by valid scientific evidence.
The other states settling with Boston Scientific were Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin, and the District of Columbia.
"My office will never waver in its efforts to hold companies accountable for risking the health of its consumers" -- New York Attorney General Letitia James