Missouri Attorney General issued the following announcement on Oct. 17.
Attorney General Eric Schmitt announced a multistate settlement involving 41 states and the District of Columbia that will require Johnson & Johnson and its subsidiary Ethicon, Inc. to pay nearly $116.9 million, including over $2.4 million for Missouri specifically, for their deceptive marketing of transvaginal surgical mesh devices.
A multistate investigation found the companies violated state consumer protection laws by misrepresenting the safety and effectiveness of the devices and failing to sufficiently disclose risks associated with their use.
“Selling products to Missourians while failing to disclose the potential dangers and side effects of those products is deception, plain and simple. Missouri’s consumer protection laws exist to ensure consumers are protected from fraud and misrepresentation, and Ethicon and Johnson & Johnson’s actions are a clear violation of those laws,” said Attorney General Schmitt. “I’m proud to stand with 41 other state attorneys general to hold Ethicon and Johnson & Johnson accountable for their actions.”
Transvaginal surgical mesh is a synthetic 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, incontinence developing after surgery, painful sexual relations, and 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.
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
Refrain from making 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 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
Original source can be found here.