On Thursday this week, a California judge ordered personal care company Johnson & Johnson to pay nearly $344 million in penalties to the Golden State following a ruling that the company misled women over the inherent safety of its pelvic mesh products. These are permanent surgical implants initially designed for the treatment of stress-related urinary incontinence and pelvic organ prolapse (in women).
In the suit, the state alleged that Johnson & Johnson’s Ethicon subsidiary neglected to inform patients and doctors alike of the risk for severe complications related to use of its pelvic mesh product. Furthermore, the suit alleges that the company also misrepresented both the frequency and the severity of these inherent risks.
The Thursday ruling said the company willfully omitted the known risks and side effects from the products labels and use instructions. Also, the suit says the company both omitted and misrepresented these risks in all of the associated educational and marketing materials provided to doctors and consumers.
According to San Diego Superior Court Judge Eddie Sturgeon, “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. J&J knew the grievous risks and also knew full well why they should have disclosed them.”
The case concluded with Judge Sturgeon ordering Johnson & Johnson to pay a judgment of $343.99 million in penalties. This might seem like a lot but the state of California had originally asked for $800 million in damages. At the same time, it is more than twice with the company agreed to pay in a settlement last year, $117 million, to 41 states (and the District of Columbia) over similar deceptive marketing charges.
Unfortunately, health risks have been tied to vaginal mesh products for many years. The cases—which are well-documented—date back to 2011 and have led the US Food and Drug Administration to be criticized for their hand in approving the dangerous pelvic implant product. Alas, the surgical implant has been commonly found to cause excruciating pain and even death, in some rare cases. And it was not until July of 2019 that the FDA ordered the cessation of all implant sales.