Johnson & Johnson was ordered by a San Diego judge Thursday to pay nearly $344 million in civil penalties for its advertising that the judge ruled misrepresented and concealed the risks of its pelvic mesh products marketed to women.
The suit filed by the California Department of Justice is one of several the company has faced worldwide regarding the mesh products, which are intended to treat stress urinary incontinence and pelvic organ prolapse, according to court documents.
San Diego County Superior Court Judge Eddie C. Sturgeon ruled Johnson & Johnson knew their products carried risks of loss of sexual function, permanent pain during sexual intercourse, chronic pain, and permanent urinary or defecatory dysfunction, yet did not fully disclose these risks in educational or marketing materials advertising the products, deceiving both doctors and patients.
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Sturgeon's 88-page ruling notes that "complications could be so severe that mesh removal would be necessary but, unlike other implants, removal is difficult and harmful and can take multiple surgeries; J&J also knew that some of the most severe complications of mesh can be irreversible."
Sturgeon also wrote the marketing for the products "repeatedly touted mesh's benefits while misrepresenting, downplaying, and concealing its potential for serious, long-term complications."
According to the Attorney General's office, Johnson & Johnson has sold more than 470,000 pelvic mesh products in the United States, including 30,000 in California from 2008 to 2014. Worldwide, more than 2 million women have had the products implanted in their bodies, Attorney General Xavier Becerra's office said.
"Johnson & Johnson intentionally concealed the risks of its pelvic mesh implant devices," Becerra said. "It robbed women and their doctors of their ability to make informed decisions about whether to permanently implant the products in patients' bodies. 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."
In addition to the California suit, Johnson & Johnson has settled similar claims with the state of Washington for $9.9 million and a coalition of 42 other states for $117 million.
