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Attorney General Frey Announces $116.9 Million Multistate Settlement with Johnson & Johnson and Ethicon, Inc.
October 17, 2019
Attorney General's Office
AUGUSTA - Attorney General Aaron M. Frey today announced a multistate settlement with 41 states and the District of Columbia that requires Johnson & Johnson and its subsidiary Ethicon, Inc. to pay nearly $116.9 million for their deceptive marketing of transvaginal surgical mesh devices. Maine's share of the settlement is $1,515,946.44.
Transvaginal surgical mesh is a synthetic material that is surgically implanted through the vagina 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 devices 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.
"It is important for manufacturers of medical devices to accurately disclose the risks and possible side effects of their products," said Frey. In this case, patients suffered because Johnson & Johnson and its subsidiary, Ethicon, Inc, deceptively marketed their products. This settlement will hopefully lead to greater transparency and patient safety moving forward.
Under the settlement, the companies have agreed to pay $116.86 million to the participating states and the District of Columbia. The settlement also provides injunctive relief that requires full disclosure of a devices risks and accurate information on promotional material, in addition to a devices information for use package inserts. The companies must also:
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; and
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.