Johnson & Johnson has been ordered to pay $344 million in a landmark state court judgment over deceptive marketing practices for its pelvic mesh products.
One of the first rulings of its kind, the verdict is the culmination of a multistate investigation and a lawsuit brought by the California Department of Justice in May 2016—alongside thousands of individual lawsuits against different manufacturers of pelvic and transvaginal mesh after patients said the surgical implants eroded within their bodies and caused pain and other complications.
The California attorney general’s office said this judgment (PDF) is the first time a court has found that Johnson & Johnson misrepresented the potential harms of its mesh products to doctors and patients and omitted that information in its instructions and marketing materials.
“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,” Attorney General Xavier Becerra said in a statement, following the nine-week trial in San Diego Superior Court.
“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,” Becerra said.
According to the attorney general’s office, J&J and its Ethicon unit sold more than 470,000 pelvic mesh products nationwide from 2008 to 2014, with at least 30,000 implants in California.
The lawsuit claimed the company did not provide information about potentially irreversible complications such as urinary or defecatory dysfunction, chronic pain, pain with intercourse or loss of sexual function. The implants were designed to provide extra support to a woman’s pelvic organs to repair prolapses or stress urinary incontinence.
In a statement, J&J said the company plans to appeal the decision, a process it expects to take from one to three years.
"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," said a J&J spokesperson.
Last October, J&J and Ethicon reached a separate, $117 million settlement with the attorneys general of 41 states and the District of Columbia, including California, over claims of deceptive marketing and advertising.
That settlement required the company to fully disclose the risks of mesh products to physicians, surgeons and consumers, including that revision surgeries may be necessary to treat complications. It included no admissions of liability or misconduct.
J&J and Ethicon previously halted sales of transvaginal mesh in 2012. In 2019, the FDA ordered Boston Scientific and Coloplast, the two remaining U.S. manufacturers of vaginal mesh, to stop selling and distributing their products.
Editor's note: This story has been updated with comments from J&J.