SAN DIEGO - Four months after a protracted bench trial at San Diego Superior Court ended, Judge Eddie Sturgeon on Jan. 30 hit Johnson & Johnson with a $343,993,750 judgment over its pelvic mesh products designed to treat female incontinence.
Sturgeon found the company deceptively marketed its products and knew the devices were causing women injuries.
It was the first trial launched by a state attorney general seeking damages alleging unfair competition and false advertising. California's AG Xavier Becerra had sought a penalty of $798 million as the trial, which began July 15, ended on Sept. 27.
In an 88-page order, Sturgeon wrote, "J&J marketed its mesh products directly to a potential patient population through 'surround sound' marketing intended to 'create consumer demand' for mesh among women who would not otherwise seek a surgical solution to their condition."
He wrote that the company engaged in an aggressive campaign to create and grow its doctor market for mesh.
Sturgeon further held that rather than disclosing what it knew about some of the severe risks of pelvic mesh in its labeling and marketing materials, Johnson & Johnson instead "has taken active, willful measures for nearly twenty years to suppress information and conceal serious risk and complication information from physicians and patients."
Johnson & Johnson, which is expected to appeal the ruling, argued at trial that the state's claims were "categorically false." It said that a study of 90,000 women revealed a very low 3.3 percent removal (complications) rate.
The products are designed to help a sagging bladder condition called pelvic organ prolapse, or POP.
At closing, the company said the state failed to present a single doctor who said he or she was misled by the company.
It further pointed to findings of the Food and Drug Administration whose study ran counter to accusations made by the state. The company said the FDA found in 2011 that pelvic mesh slings were safe and effective, and requested no labeling changes.
"Maybe the state ought to sue the FDA?" its attorney William Gage said at closing.
The trial was streamed by Courtroom View Network.
The California Department of Justice on Becerra's behalf filed the suit in May 2016 over devices including Prolift, made by J&J subsidiary Ethicon. Prolift is a clear polypropylene mesh with eight thin connecting arms. Another product type at issue was TVT (tension-free vaginal tape) slings.
The company reportedly sold 42,000 Ethicon pelvic mesh devices between 2008 and 2014.
According to Sturgeon's order, the parties are to file supplemental briefs on the issue of injunctive relief by Feb. 18.
Becerra's office states in a press release that additional injunctive terms may be added to the $344 million civil penalty.
“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 stated. “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.”