LITTLE ROCK — Arkansas Attorney General Leslie Rutledge today announced a multistate settlement requiring Johnson & Johnson and its subsidiary Ethicon, Inc. to pay nearly $117 million for their deceptive marketing of the transvaginal surgical mesh device. An investigation of the company found violations of state consumer protection laws by misrepresenting the safety and effectiveness of the device and failing to sufficiently disclose risks associated with its use. Arkansas will receive $1,855,302.53 under the settlement.
“Arkansas moms, sisters and daughters have been deceived by false claims of Johnson & Johnson, and now they must endure irrevocable damage to their bodies,” Arkansas Attorney General Rutledge said. “This settlement confirms these victims have been heard, and I will remain diligent to protect Arkansans from companies not following the law.”
The multistate investigation found the companies misrepresented or failed to adequately disclose the product’s possible side effects, including the risk of chronic pain and inflammation, mesh erosion, incontinence developing after surgery and other complications related to the implantation of the device. 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 device.
Under the settlement, Johnson & Johnson has agreed to pay $116.86 million to the 41 participating states and District of Columbia. The settlement also provides injunctive relief, requiring full disclosure of the device’s 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:
- Refrain from referring to the mesh as “FDA approved” when that is not the case
- Refrain from representing in promotions that risks associated with mesh can be eliminated with surgical experience or technique alone
- Ensure that product training provided to medical professionals covers the risks associated with the mesh
- Omit claims that surgical mesh stretches after implantation, that it remains soft after implantation, that foreign body reactions are transient and that foreign body reactions “may” occur (when in fact they will occur)
- Disclose that mesh risks include: fistula formation, inflammation, as well as mesh extrusion, exposure and erosion into the vagina and other organs
- Disclose risks of tissue contraction, pain with intercourse, loss of sexual function, urge incontinence, de novo incontinence, infection following transvaginal implantation and vaginal scarring
- Disclose that risks include that revision surgeries may be necessary to treat complications, that revision surgeries may not resolve complications and that revision surgeries are also associated with a risk of adverse reactions
Joining Arkansas in this multistate settlement are Alabama, Alaska, Arizona, Colorado, Connecticut, Delaware, District of Columbia, 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, Vermont, Virginia, and Wisconsin.
For Arkansans who have a consumer complaint or questions please contact the office at (800) 482-8982 or visit ArkansasAG.gov.