By Susan Lasser, J.D.
Washington’s attorney general had asserted that the company failed to update information provided to consumers relating to its surgical mesh products, improperly represented that the products were safe, and omitted product risks and complications from consumer information materials.
Johnson & Johnson will pay $9.9 million to the state of Washington to settle claims by that state against the company for misrepresentations and failure to include serious risks in the instructions and marketing materials for surgical mesh devices, according to an agreement between the state’s attorney general, Bob Ferguson, and Johnson & Johnson and its Ethicon subsidiaries. A news release issued by the attorney general touts that Ferguson was the first state attorney general to file a complaint against Johnson & Johnson relating to its surgical mesh devices. The trial was scheduled to begin on Monday, April 22 (State of Washington v. Johnson & Johnson, consent decree approved and ordered April 22, 2019, Parisien, S.).
An estimated 14,000 women in Washington had the devices implanted. Although detailed information is not available, the attorney general’s office believes hundreds of the women have been adversely impacted thus far, ranging from having to go back for another procedure, to having their quality of life impacted dramatically.
The attorney general’s lawsuit against Johnson & Johnson was filed in May 2016 and alleged that the company violated Washington’s Consumer Protection Act by failing to include several serious and life-altering risks associated with its surgical mesh devices in materials for patients and doctors. Among the complications that Johnson & Johnson allegedly knew were associated with its mesh devices were chronic pain, pain with sexual intercourse, and many urinary issues. Moreover, the attorney general’s news release notes, the mesh is very difficult and sometimes impossible to remove.
The complaint asserted that the manufacturer omitted known risks from the devices’ marketing materials for patients and "Instructions for Use" packets for doctors. Instructions for Use inserts provide important information for doctors about a medical device, and the instructions should include any risks or adverse reactions associated with the device or its use. According to the complaint, Johnson & Johnson knowingly omitted debilitating complications associated with the mesh devices from the instructions included with every device sold from 1999 to late 2015. The lawsuit also alleged that Johnson & Johnson made omissions and misrepresentations in patient marketing materials distributed in Washington, and that the manufacturer downplayed some of the serious complications caused by some products.
Consent decree. Under the consent decree, Johnson & Johnson will pay $9.9 million in exchange for the state releasing all claims against Johnson & Johnson and its subsidiaries, Ethicon, Inc. and Ethicon US, LLC. Ferguson also announced that the manufacturer’s payment will be used to assist women who received pelvic mesh implants.
In addition to the $9.9 million payment, the settlement prohibits Johnson & Johnson from making unfair or deceptive statements regarding surgical mesh, including statements about risks associated with the devices. Further, the company must disclose any "new, significant risks" associated with its surgical mesh that it discovers. Under the agreement, Johnson & Johnson’s promotional materials must be truthful and accurate, and present a fair balance of the available information pertaining to safety, efficacy, risks, and complications of the mesh devices. If Johnson & Johnson sponsors a study or research and cites that study or research in promotional materials, it must disclose its sponsorship as well.
The case is No. 16-2-12186-1 SEA.
Attorneys: Daniel L. Allen, Office of the Attorney General, for State of Washington. Steve D. Brody (O'Melveny & Myers LLP) and Angelo J. Calfo (Calfo Eakes & Ostrovsky PLLC) for Johnson & Johnson, Ethicon, Inc. and Ethicon US, LLC.
Companies: Johnson & Johnson; Ethicon, Inc.; Ethicon US, LLC
MainStory: TopStory SettlementAgreementsNews MedicalDevicesNews DamagesNews WarningsNews WashingtonNews
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