Dive Brief:

• The California Department of Justice announced Thursday a judge ordered Johnson & Johnson pay $344 million for falsely and deceptively marketing now off-the-market mesh devices used to treat stress urinary incontinence and pelvic organ prolapse. Additional terms may be added, the attorney general's office said.
• California Attorney General Xavier Becerra​'s office claimed the ruling as the first time a court of law found Johnson & Johnson "did indeed engage in illegal false and deceptive business practices.”
• The sum dwarfs a $9.9 million settlement J&J reached with the state of Washington last April and a settlement with a coalition of more than 40 states for $117 million in October. AG offices in West Virginia and Oregon have filed their own lawsuits against J&J in recent months.

Dive Insight:

J&J and subsidiary Ethicon reportedly sold at least 470,000 pelvic mesh products in the U.S. between 2008 and 2014. After a multistate investigation found J&J neglected to inform patients and doctors of the potentially severe complications, California's DOJ sued J&J in May 2016 and began a nine-week trial last July.

San Diego Superior Court Judge Eddie Sturgeon ruled that J&J broke California’s Unfair Competition Law and False Advertising Law.

"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," Becerra said in a statement Thursday. "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."

Some of the two million patients implanted with J&J pelvic meshes experienced adverse effects such as chronic pain, loss of sexual function, and "potentially devastating impact on overall quality of life" — serious and sometimes irreversible possibilities, which Johnson & Johnson misrepresented, Becerra's office laid out in the lawsuit. There have been more than 35,000 personal injury lawsuits related to the products, according to Becerra.

Across the medical device industry, the meshes were fraught with safety problems. Almost all manufacturers of the devices bowed out of the market after FDA in 2012 decided to mandate postmarket surveillance studies. In April 2019, FDA ordered remaining products from Boston Scientific and Coloplast off the market.