NEW YORK – New York Attorney General Letitia James today announced a multistate settlement, along with 41 additional attorneys general, requiring Johnson & Johnson and its subsidiary Ethicon, Inc. to pay nearly $117 million for the deceptive marketing of transvaginal surgical mesh devices that endangered the health of women across New York and the rest of the nation. 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.
"Health and safety must come before profits," Attorney General James said. "While Johnson & Johnson and its subsidiary were putting income before the health of people in need of care, women were put in danger. My office will never waver in its efforts to hold companies accountable for risking the health of its consumers."
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.
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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 through the vagina, incontinence developing after surgery, painful sexual relations, and vaginal scarring. Evidence shows that Johnson & Johnson and its subsidiary 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 the District of Columbia. New York State will receive $5,203,122.50 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.