A California judge ruled today that Johnson & Johnson and its Ethicon subsidiary must pay $344 million in penalties in a case claiming false and deceptive marketing of its pelvic mesh products for women.
The California Department of Justice said it sued Johnson & Johnson in May 2016 after a years-long multistate investigation revealed the company had 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.
San Diego Superior Court Judge Eddie Sturgeon issued the judgment requiring the company to pay $343.99 million in penalties, following a nine-week trial began July 15, 2019. The California Attorney General’s office said that today’s judgment marks the first time a court of law has issued findings of fact and ruled that Johnson & Johnson engaged in illegal false and deceptive business practices.
“Johnson & Johnson intentionally concealed the risks of its pelvic mesh implant devices. It robbed women and their doctors of their ability to make informed decisions about whether to permanently implant the products in patients’ bodies,” said attorney general Xavier Becerra in a news release. “Johnson & Johnson knew the danger of its mesh products but put profits ahead of the health of millions of women. Today we achieved justice for the women and families forever scarred by Johnson & Johnson’s dishonesty.”
The company said the state failed to present evidence that proved that any California doctor or patient was actually or likely to be misled by any communication from Ethicon. The state also failed to call as witnesses any California doctor who used an Ethicon mesh devices, or any California patient who saw a communication from Ethicon, according to a statement emailed to MassDevice. The company plans to appeal.
“Ethicon responsibly communicated the risks and benefits of its transvaginal mesh products to doctors and patients, and the decision disregards the company’s full compliance with U.S. Food and Drug Administration (FDA) laws on medical device communications and the appropriateness of its actions,” the company said.
In contrast, Ethicon said it called “numerous” California doctors who used its pelvic mesh devices to testify and those doctors uniformly disputed the state’s allegations. Another 82 California surgeons wrote to the California Attorney General that they were not misled by the company.
“Ethicon empathizes with women who suffer from pelvic organ prolapse and stress urinary incontinence, particularly those who have experienced surgical complications,” the company said. “We also recognize that millions of patients have benefitted from Ethicon’s devices for treatment of stress urinary incontinence, which are recognized as the standard of care by medical professional societies around the world.”
From 2008 to 2014, Johnson & Johnson sold more than 470,000 pelvic mesh products nationally, including more than 30,000 in California. Worldwide, more than 2 million women have had these mesh products implanted in their bodies.
Johnson & Johnson has faced more than 35,000 personal injury lawsuits related to its pelvic mesh products. It has settled claims similar to those brought by Becerra with the state of Washington for $9.9 million and with a coalition of 42 other states for $117 million.
A copy of the judgment can be found here.