SAN DIEGO (Legal Newsline) – Johnson & Johnson has mostly lost its appeal of a nine-figure judgment against it over the marketing of its transvaginal pelvic mesh products.
The California Fourth Appellate District on April 11 sided with state Attorney General Rob Bonta in a closely watched case involving J&J’s Ethicon, which was hit with $344 million in civil penalties in a bench trial for circulating misleading medical device instructions.
The company also misstated and minimized the health risks of the mesh, San Diego Superior Court Judge Eddie Sturgeon found. He decided Ethicon had committed 153,351 violations of the Unfair Competition Law and 121,844 violations of the False Advertising Law, assessing a $1,250 civil penalty for each.
The Fourth District affirmed but struck $42 million worth of penalties.
“We conclude the trial court erred in just on respect,” the decision says. “In addition to penalizing Ethicon for its medical device instructions and printed marketing communications, the court penalized Ethicon for its oral marketing communications – specifically, for deceptive statements Ethicon purportedly made during one-on-one conversations with doctors, at Ethicon-sponsored lunch events and at health fair events.
“However, there was no evidence of what Ethicon’s employees and agents actually said in any – let alone all – of these oral marketing communications.”
The 82-page ruling leaves Ethicon with a $302,037,500 tab. The massive verdict drew the attention of the U.S. Chamber of Commerce, the American Tort Reform Association, the Washington Legal Foundation and medical groups.
WLF noted the penalty is larger than all other reported California awards combined. It said Ethicon’s statements accurately described the results of scientific studies as the company urged health care providers to prescribe its mesh.
The mesh was intended to help women with stress urinary incontinence and pelvic organ prolapse. Complications came to light in 2008 with the Food and Drug Administration issued a public health notification about complications.
Thousands of personal injury lawsuits followed, alleging pain, urinary problems and bowel, bladder and blood vessel perforation.
The communications at issue in the California AG’s case were instructions for use, marketing to California doctors and marketing to California patients. These all violated state unfair competition and advertising laws, the San Diego judge ruled.
Judge Sturgeon said Ethicon’s behavior over a 17-year span was “grave” and “egregious” and destroyed patients’ sexual, urinary and defecatory functions while causing debilitating pain.
His $344 million judgment was fair, given it was less than 1% of J&J’s net worth, he thought. The Fourth District found mostly no fault with his thinking.
“With respect to Ethicon’s written marketing communications, we conclude the trial court did not improperly assume that the communications were deceptive,” the appellate court wrote. “On the contrary, the court prepared a 23-page violations appendix cataloguing the precise manner by which each and every written or online marketing communication was likely to deceive doctors.”