A California judge on Thursday ordered Johnson & Johnson to pay more than $340 million in penalties to the state after ruling that the company misled women over the safety of its pelvic mesh product.
The state alleged that the company’s Ethicon subsidiary 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 Johnson & Johnson to pay $343.99 million in penalties. California initially asked for $800 million.
The ruling said the company omitted risks and side effects from the products’ instructions for use, and omitted and misrepresented the risks in educational and marketing materials provided to doctors and patients.
“While J&J’s marketing vividly portrayed the benefits of the company’s products, J&J misstated, downplayed and omitted the risks of its pelvic mesh products,” Sturgeon wrote. “J&J knew the grievous risks and also knew full well why they should have disclosed them.”
The pelvic mesh products are permanent surgical implants designed to treat stress urinary incontinence and pelvic organ prolapse in women.
A spokeswoman said Johnson & Johnson will appeal, and noted that the process can take up 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 laws on medical device communications and the appropriateness of its actions,” Mindy Tinsley said in a statement to The Hill.
Last year the company agreed to a $117 million settlement with 41 states and the District of Columbia over similar allegations of deceptive marketing.