ATTORNEY GENERAL TONG, DEPARTMENT OF CONSUMER PROTECTION ANNOUNCE $116.9 MILLION MULTISTATE SETTLEMENT WITH JOHNSON & JOHNSON, ETHICON, INC.
Connecticut to receive $1.96 million under the settlement
(Hartford, CT) – Attorney General William Tong and Consumer Protection Commissioner Michelle H. Seagull today announced a multistate settlement along with 40 states and the District of Columbia requiring Johnson & Johnson and its subsidiary Ethicon, Inc. to pay nearly $116.9 million 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. Connecticut will receive $1.96 million under the settlement.
"Johnson & Johnson and Ethicon falsely marketed these devices as safe and failed to warn women of serious side effects. These practices were unlawful and unacceptable. This significant settlement—the fourth largest consumer protection health fraud multistate settlement in U.S. history—sends a clear message that states will aggressively pursue such deceptive medical marketing cases. In addition to the $116.9 million fine, the companies have agreed to a series of important changes to their marketing practices to ensure patients have knowledge about all relevant risks associated with these devices," said Attorney General Tong.
“Deceptive marketing practices are always troubling, but they become even more serious when those claims are related to products that are supposed to make us healthier – but actually have a risk of hurting us,” said Consumer Protection Commissioner Michelle H. Seagull. “I am pleased that this settlement has been reached, and hope that that this helps ensure that others will follow the law when advertising products like this in the future.”
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 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 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
• 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
Joining Connecticut in this multistate settlement are Alabama, Alaska, Arizona, Arkansas, Colorado, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, and Wisconsin.
Assistant Attorneys General Ann-Marie DeGraffenreidt, Brendan Flynn, and Consumer Protection Department Head Michael Wertheimer assisted the Attorney General with this matter.