A San Diego Superior Court judge ordered Johnson & Johnson to pay $343.99 million for hiding the dangers and risks of its surgical mesh product for women.
State court Judge Eddie Sturgeon released the landmark judgement Thursday in a suit filed by former California Attorney General Kamala Harris in May 2016.
The suit alleges that Johnson & Johnson knew that the surgical mesh, used to treat incontinence and pelvic organ prolapse, had serious medical impacts for women including severe pain during intercourse, permanent incontinence, loss of the ability to have sex, and other issues.
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The medical director for Ethicon, Johnson & Johnson’s subsidiary who designed and manufactured the mesh, testified that the company knew "that its mesh slings caused severe, long-term complications such as excessive contraction or shrinkage of tissue surrounding the mesh" and "debilitating and life-changing chronic pain, pain to their sexual partner," among other issues, according to Sturgeon’s ruling.
Thursday's judgement marks the first time a court has ruled that Johnson & Johnson failed to disclose the danger of their product. However, in recent years the company has opted to settle numerous similar civil complaints over the mesh products including settlement of $9.9 million in Washington and $117 million worth of settlements in 42 other states.
"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 current California Attorney General Xavier Becerra in a statement. "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 a statement, a spokesperson for Johnson & Johnson told NBC 7 that the company plans to appeal the decision.
"[Johnson & Johnson] empathizes with women who suffer from pelvic organ prolapse and stress urinary incontinence, particularly those who have experienced surgical complications. We also recognize that millions of patients have benefitted from [our] devices for treatment of stress urinary incontinence, which are recognized as the standard of care by medical professional societies around the world."
The spokesperson said the state failed to provide adequate evidence that the company mislead any patient or doctor recommending the mesh.
"[Johnson & Johnson] 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 attorney general’s office said the $344 million will be used to enforce and protect California’s consumers. According to Sturgeon’s ruling, additional injunctive relief may be ordered.