DC and 41 States Share $116M Pelvic Mesh Settlement
"Failing to adequately inform patients and doctors of the serious risks associated with these devices put in jeopardy the welfare of countless women," Georgia Attorney General Christopher Carr said. "That is unacceptable, and we think this settlement sends a strong message."
October 17, 2019 at 02:47 PM
3 minute read
The original version of this story was published on National Law Journal
Attorneys general around the country announced a multistate settlement in which Johnson & Johnson and its subsidiary Ethicon Inc. will pay roughly $116.9 million to resolve allegations of deceptive marketing of transvaginal surgical mesh devices.
Under the settlement, Johnson & Johnson has agreed to pay that total to 41 participating states and the District of Columbia, AGs said.
The deal also provides injunctive relief, requiring full disclosure of device risks and accurate information on promotional material, in addition to the product's "information for use" package inserts, the AGs said.
The AGs said the deal requires Johnson & Johnson and Ethicon to: Refrain from referring to the mesh as "FDA approved" when that is not the case or representing in promotions that risks associated with mesh can be eliminated with surgical experience or technique alone. The companies also agreed to disclose risks such as inflammation and infection.
Ethicon issued a statement Thursday: "The settlements announced today 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. 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."
O'Melveny & Myers is representing Johnson & Johnson and Ethicon in the matter.
According to the AGs, a multistate investigation found the companies violated state consumer protection laws by misrepresenting the safety and effectiveness of the devices and by failing to sufficiently disclose risks.
Participating in the settlement, in addition to the District of Columbia, are: Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, 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.
New York will receive $5.2 million from the settlement, state Attorney General Letitia James said in a statement.
"Health and safety must come before profits," James said. "While Johnson & Johnson and its subsidiary were putting income before the health of people in need of care, women were put in danger. My office will never waver in its efforts to hold companies accountable for risking the health of its consumers."
Georgia will receive $3.38 million.
"Failing to adequately inform patients and doctors of the serious risks associated with these devices put in jeopardy the welfare of countless women," Georgia Attorney General Christopher Carr said in a statement. "That is unacceptable, and we think this settlement sends a strong message."
Connecticut is to receive $1.96 million from the settlement, according to state Attorney General William Tong.
"Johnson & Johnson and Ethicon falsely marketed these devices as safe and failed to warn women of serious side effects," Tong said in a statement. "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."
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