Cook County Record

Monday, November 18, 2019

J&J, Ethicon make 'no admission of liability, misconduct' in mesh settlement with IL; State to get $3.8M


By Karen Kidd | Oct 23, 2019

Illinois capitol building
Illinois State Capitol

SOMERVILLE, N.J. – Johnson & Johnson and Ethicon, a subsidiary that recently settled multistate lawsuits, including one filed by Illinois, over former transvaginal surgical mesh marketing practices is trying to put those cases behind them, a spokeswoman said.

The settlements were about avoiding protracted litigation, rather than any admissions of liability amid the multistate lawsuits, Mindy Tinsley, a spokeswoman for Johnson & Johnson subsidiary Ethicon, said in an e-mail to the Cook County Record.

"Ethicon agreed to the settlement to avoid unnecessary expense and a prolonged and uncertain legal process," Tinsley said. "This settlement has no impact on ongoing product liability cases brought by individuals for pelvic mesh products in Illinois."

The settlements were announced Friday by Illinois Attorney General Kwame Raoul and 41 other U.S. state attorneys general.

In his news release, Raoul said Johnson & Johnson and Ethicon agreed to pay almost $116.9 million "for their deceptive marketing of transvaginal surgical mesh devices."

"Consumers have a right to have all the facts about a product before making a decision that could potentially put their health and safety at risk," Raoul said in the news release. "Johnson & Johnson violated these laws that are in place to protect consumers. I am committed to holding businesses accountable and ensuring that consumer protection laws are enforced."

Illinois' share in the settlement will be $3.8 million, according to the news release.

"The settlements announced last week with state attorneys general resolve a previously disclosed multi-state investigation of Ethicon’s sales and marketing practices for transvaginal mesh in the United States," Tinsley said. "This settlement with 41 states and the District of Columbia involves no admission of liability or misconduct on the part of Ethicon, which remains focused on meeting the significant surgical care needs of health care providers and patients."

Illinois filed its complaint against Johnson & Johnson and Ethicon in Cook County Circuit Court earlier this month, allowing the state to participate in the settlement.

"Ethicon marketed its surgical mesh to doctors and patients as minimally invasive with minimal risk, and as superior to traditional methods of treatment," Illinois' lawsuit said. "In marketing its surgical mesh devices, Ethicon misrepresented and failed to disclose the full range of risk and complications associated with the devices, as well as the frequency and severity of those risks and complications, including misrepresenting the risks of surgical mesh as compared with native tissue repair and other surgeries, including pelvice floor surgeries."

Surgical mesh was intended as an option for transvaginal repair of pelvic organ prolapse.

Johnson & Johnson and Ethicon stopped selling transvaginal mesh in 2012.

In 2016, the FDA reclassified surgical mesh as higher-risk, Class III devices and this past April ordered all manufacturers to stop selling surgical mesh.

Despite the controversy, transvaginal surgical mesh has helped many with often debilitating prolapse conditions, Tinsley said.

"Ethicon's pelvic mesh surgical devices have helped millions of women around the world find relief from the often debilitating impact of stress urinary incontinence and pelvic organ prolapse," she said. "In fact, Ethicon's devices for treatment of incontinence are recognized as the standard of care by medical professional societies around the world."

Injunctive relief in the settlement requires Ethicon and Johnson & Johnson to stop claiming surgical technique using the mesh can eliminate risks and to fully disclose risks in its promotional material. Those risks include loss of sexual function, the mesh eroding into the vagina and the possibility of corrective surgery required later.

In addition to Illinois, the settlement settles lawsuits filed by the District of Columbia and the states of Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, 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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Organizations in this Story

U.S. Food and Drug Administration (FDA)Ethicon, Inc.Johnson & JohnsonCook County Circuit CourtIllinois Attorney General

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