BATON ROUGE, LA – Johnson & Johnson and its subsidiary Ethicon Inc. will pay states nearly $117 million – including more than $2 million to Louisiana – for their deceptive marketing of transvaginal surgical mesh devices, Attorney General Jeff Landry announced today.
This settlement announcement follows a multistate investigation by 40 states and the District of Columbia, which found the companies violated state consumer protection laws by misrepresenting the safety and effectiveness of their devices and by failing to sufficiently disclose risks associated with their use.
“It is imperative that companies operate with transparency and provide consumers with proper informed consent of the risks taken by using their products,” said General Landry. “Evidence shows Johnson & Johnson and Ethicon were aware of the possibility for serious medical complications but did not provide sufficient warnings to consumers or surgeons who implanted these devices.”
“I am proud of our office’s work on this case to protect consumers and get justice,” added General Landry. “I hope this settlement serves as a warning to companies that we take seriously our duty to defend Louisiana’s consumers from harm.”
Under the terms of settlement, Johnson & Johnson has agreed to pay $116.86 million to the 40 participating states and District of Columbia. Louisiana will receive $2,188,730.41 under the settlement. 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 Louisiana in this multistate settlement are Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, 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.