Johnson & Johnson subsidiary, Ethicon, lost an appeal in a California court and has been ordered to pay $302 million to the state for engaging in misleading marketing practices with women who were implanted with transvaginal mesh.
Transvaginal mesh is a weave made from synthetic or organic materials that is surgically implanted in women who suffer from weakened pelvic muscles, sagging pelvic organs, and incontinence.
In 2019, the U.S. Food & Drug Administration (FDA) ordered all mesh manufacturers to stop selling or distributing surgical meshes intended for the transvaginal repair of pelvic organ prolapse.
The 3-0 ruling, announced April 11, confirms a 2020 non-jury trial decision, which originally called for Ethicon to pay a $344 million fine, the Associated Press reported.
In the 2020 trial, Superior Court Judge Eddie Sturgeon ruled that Ethicon “made misleading and potentially harmful statements in hundreds of thousands of advertisements and instructional brochures for nearly two decades.”
Approximately $42 million in penalties were chopped from the 2020 decision by California’s Fourth District Court of Appeal because of a lack of evidence detailing exactly what Ethicon’s sales representatives told individual doctors during sales pitch meetings.
But according to the San Francisco Chronicle, Judge Sturgeon received ample evidence that Ethicon knowingly deceived both physicians and patients about the risks posed by its products. The Chronicle added that a J&J spokesperson said in an interview that the company plans to appeal the decision to the California Supreme Court.
According to Presiding Justice Judith McConnell of the appeals court, Ethicon’s mesh instruction materials “falsified or omitted the full range, severity, duration, and cause of complications associated with Ethicon’s pelvic mesh products, as well as the potential irreversibility and catastrophic consequences.”
The California Department of Justice sued J&J in 2016 after a years-long, multistate investigation revealed the company had allegedly neglected to inform both patients and doctors of possible severe complications from the products and misrepresented the frequency and severity of risks the products posed.
The case eventually led to a nine-week trial brought by California against J&J beginning on July 15, 2019. After the trial, the California DOJ’s allegations were vindicated, according to an announcement by the office of the Attorney General for the state of California in 2020.
J&J, which has a net worth of over $70 billion, argued that the fine was excessive, but Justice McConnell countered that the penalty amounts to less than one percent of the company’s net worth. At the time of the 2020 ruling, J&J faced over 35,000 personal injury lawsuits because of allegedly faulty pelvic mesh devices.