Johnson & Johnson and its subsidiary Ethicon, Inc. will pay Vermont $1.37 million for misrepresenting the safety and effectiveness of transvaginal surgical mesh devices and failing to sufficiently disclose risk associated with their use. Following a multistate investigation, Johnson & Johnson and Ethicon agreed to pay 41 states, including Vermont, and the District of Columbia a total of $116.86 million for their deceptive marketing of transvaginal surgical mesh devices. Restitution for affected consumers is still pending in class action cases.
“Johnson & Johnson’s deceptive acts caused women to suffer in profoundly personal ways,” said Attorney General Donovan. “My office will continue to hold companies who harm Vermonters accountable for misrepresenting the safety and efficacy of their products.”
Transvaginal surgical mesh is a synthetic polypropylene material that is surgically implanted to support the pelvic organs of women who suffer from stress urinary incontinence or pelvic organ prolapse. The multistate investigation found the companies misrepresented or failed to adequately disclose the products’ possible side effects, including the risk of chronic pain and inflammation, mesh erosion through the vagina, incontinence developing after surgery, painful sexual relations, and vaginal scarring. Evidence shows the companies were aware of the possibility for serious medical complications but did not provide sufficient warnings to consumers or surgeons who implanted the devices.
In addition to paying $116.86 million, Johnson & Johnson and Ethicon, Inc. must also provide full disclosure of the devices’ risks and accurate information on promotional material, in addition to the product’s “information for use” package inserts. Among the specific requirements, the companies must also refrain from referring to the mesh as “FDA approved.”
Joining Vermont in this multistate settlement are Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, and the District of Columbia.