Johnson & Johnson’s unit Ethicon Inc., was ordered to pay $344 million in civil penalties to the state of California for violating the state’s false advertising and unfair competition laws and misleading consumers about risks associated with its transvaginal mesh product, a California judge ruled.
San Diego Superior Court Judge Eddie Sturgeon found that the state had “proven by a preponderance of the evidence that defendants deceptively marketed their pelvic mesh products in the state of California and that their marketing was likely to deceive reasonable doctors and reasonable lay consumers, including potential patients and their friends and family, about the risks and dangers of these products.”
The issue centers on two Ethicon transvaginal mesh products made with polypropylene – Tension-free Vaginal Tape (TVT), marketed since 1998 as a treatment for stress urinary incontinence; and Prolift, sold from 2005-2012 to treat pelvic organ prolapse. California Attorney General Xavier Becerra argued that Johnson & Johnson knew that its mesh could cause women chronic and debilitating pain and injury but chose to put profits over patients’ well-being.
“Johnson & Johnson intentionally concealed the risks of its pelvic mesh implant devices,” Becerra said. “It robbed women and their doctors of their ability to make informed decisions about whether to permanently implant the product in patients’ bodies. Today we achieved justice for women and families forever scarred by Johnson & Johnson’s dishonesty.”
The $344 million verdict was less than half of the $800 million Becerra had asked for during the civil penalties trial. Judge Sturgeon said he sided with the state in part because of the testimony of former gynecologist Dr. Piet Hinoul. Dr. Hinoul, testifying for the state, said Johnson & Johnson knew when it first introduced its TVT mesh to the public that it could erode inside women’s bodies, puncture organs, and damage tissue resulting in chronic pain and painful sexual intercourse.
Judge Sturgeon wrote that by withholding this knowledge from doctors, Johnson & Johnson was giving “deceptively incomplete” information. “The evidence at trial shows that rather than disclose what it knew about some of the severe risks of pelvic mesh in its labeling and marketing material, J&J has instead taken active, willful measures for nearly 20 years to suppress information and conceal serious risk and complication information from physicians and patients,” he said.
In April 2019, the Food and Drug Administration ordered manufacturers of all remaining transvaginal mesh products for the repair of pelvic organ prolapse to immediately stop selling their products in the U.S. due to a history of adverse events.