Department of Commerce and Consumer Affairs

DEPARTMENT OF COMMERCE AND CONSUMER AFFAIRS

OFFICE OF CONSUMER PROTECTION

DAVID Y. IGE

GOVERNOR

CATHERINE P. AWAKUNI COLÓN

DIRECTOR

STEPHEN H. LEVINS

EXECUTIVE DIRECTOR, OFFICE OF CONSUMER PROTECTION

FOR IMMEDIATE RELEASE
October 17, 2019

Office of Consumer Protection Announces $116.9 Million Multistate Settlement

with Johnson & Johnson, Ethicon, Inc.

HONOLULU – The State of Hawaii Office of Consumer Protection 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. Hawaii will receive approximately $1.5 million under the settlement.

“This settlement holds Johnson & Johnson and Ethicon, Inc. accountable for engaging in the allegedly deceptive marketing of its surgical mesh products as safe when there was substantial evidence that these devices could expose women to a host of dangerous complications,” said Stephen Levins, executive director of the State of Hawaii Office of Consumer Protection.

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 Hawaii in this multistate settlement are Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, 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.

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Media Contact:
William Nhieu
Communications Officer
Department of Commerce and Consumer Affairs
Email: [email protected]
Phone: (808) 586-7582