BATON ROUGE, La. (WAFB) - Johnson & Johnson and its subsidiary, Ethicon, Inc., are paying out nearly $117 million in settlement money to multiple states, and more than $2 million of that is headed to Louisiana.
The settlement is for “deceptive marketing” of transvaginal surgical mesh devices.
Louisiana Attorney General Jeff Landry made the announcement Thursday, Oct. 17, applauding the consumer protection efforts. The announcement comes after an investigation by 40 states and Washington, D.C., which found the companies violated state consumer protection laws by misrepresenting the safety and effectiveness of their products and by failing to sufficiently disclose risks associated with the products’ use.
“It is imperative that companies operate with transparency and provide consumers with proper informed consent of the risks taken by using their products. 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,” said Landry. “I am proud of our office’s work on this case to protect consumers and get justice. I hope this settlement serves as a warning to companies that we take seriously our duty to defend Louisiana’s consumers from harm."
Per the settlement, Johnson & Johnson has agreed to pay $116.86 million to the 40 states that were part of the lawsuit. Louisiana will receive $2,188,730.41. The settlement also requires the companies provide sufficient information about its products’ risks. 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
The other states included in the settlement are:
- District of Columbia
- New Jersey
- New Mexico
- New York
- North Carolina
- North Dakota
- Rhode Island
- South Carolina
- South Dakota