The California Department of Justice sued Johnson & Johnson in May 2016, after a years-long multistate investigation revealed the company had neglected to inform both patients and doctors of possible severe complications from its mesh products and misrepresented the frequency and severity of risks the products posed. The products are permanent surgical implants designed to treat stress urinary incontinence and pelvic organ prolapse in women.
After a nine-week trial, a San Diego Superior Court Judge issued the 128 page Statement of Decision requiring Johnson & Johnson to pay $343.99 million in penalties. Additional injunctive terms may be added after further briefing.
The suit filed by the California Department of Justice is one of several the company has faced worldwide regarding the mesh products. This judgment marks the first time a court of law has issued findings of fact and ruled that Johnson & Johnson did indeed engage in illegal false and deceptive business practices.
The lawsuit alleged that Johnson & Johnson misrepresented the safety of these products by concealing and misleading consumers about the possibility of serious and irreversible complications caused by mesh, including permanent pain with intercourse, loss of sexual function, chronic pain, permanent urinary or defecatory dysfunction, and potentially devastating impact on overall quality of life.
The 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.”
The Judge also wrote the marketing for the products “repeatedly touted mesh’s benefits while misrepresenting, downplaying, and concealing its potential for serious, long-term complications.”
From 2008 to 2014, Johnson & Johnson sold more than 470,000 pelvic mesh products nationally, including more than 30,000 in California. Worldwide, more than 2 million women have had these mesh products implanted in their bodies.
The court affirmed that Johnson & Johnson and its subsidiaries Ethicon Inc. and Ethicon US LLC, violated California’s Unfair Competition Law and False Advertising Law.
Johnson & Johnson has faced over 35,000 personal injury lawsuits related to its pelvic mesh products. It has settled similar claims with the state of Washington for $9.9 million and with a coalition of 42 other states for $117 million.