| Attorney General Mark R. Herring said Virginia has joined with 42 other attorneys general in a $116.9 million settlement with Johnson & Johnson and its subsidiary Ethicon, Inc. to resolve allegations that they deceptively marketed and promoted their transvaginal surgical mesh devices. Virginia will receive approximately $3 million of the settlement.
“We will not tolerate deceptive or false marketing of any products in Virginia, but especially when it involves medical devices that can negatively impact the health of a patient,” Herring said. “Under this settlement, going forward Johnson & Johnson must fully disclose the risks and side effects of their medical devices on all promotional materials, giving both doctors and patients confidence that they are making informed decisions about their health.”
The Complaint, filed in Richmond Circuit Court, alleges that Ethicon and Johnson & Johnson, the manufacturers of transvaginal surgical mesh, misrepresented or failed to adequately disclose the products’ possible side effects. 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. These side effects included:
risk of chronic pain and inflammation;
mesh erosion through the vagina;
incontinence developing after surgery;
painful sexual relations; and
vaginal scarring.
According to the complaint, 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 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;
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.
The settlement, which is in the form of a Consent Judgment, has been filed with the Circuit Court for the City of Richmond for approval.
For consumer-related inquiries, the Office of the Attorney General’s Consumer Protection Hotline telephone counselors are available to assist. Call the hotline at 1-800-552-9963 if calling from Virginia, or 804-786-2042 if calling from the Richmond area.
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