SAN DIEGO (CN) – With a massive $344 million judgment Thursday against Johnson & Johnson over the marketing of its pelvic mesh devices to women and their doctors, California secured the first court finding that the medical device company engaged in false and deceptive business practices.
San Diego Superior Court Judge Eddie Sturgeon awarded California $343.99 million following a 9-week trial this past summer on claims Johnson & Johnson and its subsidiary Ethicon violated California’s unfair competition and false advertising laws by failing to disclose the risks and dangers associated with its pelvic mesh product. The device is used to treat urinary incontinence and organ prolapse in women.
The state had originally asked for $1 billion; Sturgeon’s civil penalty award represents a significant reduction in what the two companies – worth $72 billion combined, according to a court stipulation – must pay.
Sturgeon found a total of 153,351 unfair competition law violations and 121,844 false advertising law violations beginning in October 2008. The state was awarded $1,250 for each individual penalty.
Up to $2,500 per violation of each statute could have been awarded.
In a statement, California Attorney General Xavier Becerra said Johnson & Johnson “robbed women and their doctors of their ability to make informed decisions about whether to permanently implant the products in patients’ bodies.”
“Johnson & Johnson knew the dangers 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,” Becerra added.
Ethicon, which is part of Johnson & Johnson Medical Devices Company, vowed to appeal the award.
“Ethicon responsibly communicated the risks and benefits of its transvaginal mesh products to doctors and patients, and the decision disregards the company’s full compliance with U.S. Food and Drug Administration (FDA) laws on medical device communications and the appropriateness of its actions,” the company said in a statement.
The company also claimed the state did not present evidence any California doctor or patient had been harmed by its devices, while Ethicon called multiple California doctors who had used its devices to treat patients with stress urinary incontinence and pelvic organ prolapse.
It said the appeals process is likely to take up to three years.
In his 128-page order, Sturgeon found Johnson & Johnson has “taken active, willful measures for nearly 20 years to suppress information and conceal serious risk and complication information from physicians and patients.”
The judge also disputed the testimony offered by Johnson & Johnson’s medical experts during trial proved its products are safe.
“The opinions of J&J’s medical experts are inconsistent with and contradicted by the company’s own admissions and knowledge regarding their own products … there is substantial evidence from company documents and testimony confirming the dangerous properties of mesh and that these mesh properties can lead to multiple serious and long-term complications,” Sturgeon wrote.
He noted at the time its mesh slings were made available in 1998, Johnson & Johnson knew of serious risks such as lifelong and recurring risk of erosion into organs, shrinkage of tissue surrounding the mesh, chronic pain and other dysfunctions.
“Despite that knowledge, in 2000, two years after the TVT launch, defendants actively chose to conceal the fact that TVT mesh could cause complications so serious as to necessitate removal,” Sturgeon wrote.
“J&J marketing personnel made the decision not to publicize or share information with customers regarding techniques for TVT mesh removal because they believed it would be bad for business.”
Sturgeon noted trial evidence of Ethicon’s marketing director Laura Angelini saying “I do not want to dig my own grave” when advising against providing information to consumers about the potential need to remove the slings in some circumstances.
Trial evidence also showed Johnson & Johnson declined internal requests to improve its disclosures, Sturgeon found.
Dr. Meng Chen, an associate medical director for Ethicon, had warned Johnson & Johnson to update its disclosures in 2009, after the FDA issued a public health notification warning on pelvic mesh devices months earlier.
Chen testified of the 20,000 to 30,000 complaints regarding Ethicon devices she reviewed during her eight years with the company, a third – 8,000 to 10,000 – were related to pelvic mesh.
Despite Chen’s warnings in 2008-09, Johnson & Johnson did not update its disclosures to warn of the need for removals until 2015, Sturgeon wrote.
Over 35,000 personal injury lawsuits have been filed against Johnson & Johnson related to its pelvic mesh products.
The company has settled similar claims brought by Washington state for $9.9 million and a coalition of 42 other states for $117 million.
More than 30,000 women in California and 2 million women worldwide have had the products implanted in their bodies.