A California appeals court has upheld a lower court ruling that Johnson & Johnson must pay penalties to the state for deceptively marketing pelvic mesh implants for women.
Johnson & Johnson had appealed in 2020 after superior court judge Eddie Sturgeon assessed the $344m in penalties against the US pharmaceutical company’s subsidiary, Ethicon.
Sturgeon found after a non-jury trial that the company made misleading and potentially harmful statements in hundreds of thousands of advertisements and instructional brochures over nearly two decades.
California’s fourth district court of appeals issued a ruling Monday that $42m in penalties assessed for the company’s sales pitches to doctors were unjustified because there was no evidence of what the sales representatives actually said. As a result, the court reduced the amount to $302m.
However, the appeals court said Sturgeon received ample evidence that Ethicon knowingly deceived both physicians and patients about the risks posed by its products, the San Francisco Chronicle reported.
Ryan Carbain, a Johnson & Johnson spokesperson, told the Chronicle that the company would appeal the appeals court ruling to the state supreme court.
“Ethicon responsibly communicated the risks and benefits of its trans-vaginal mesh products to doctors and patients and in full compliance with US Food and Drug Administration (FDA) laws,” he said.
The instructions for use in all of the company’s pelvic mesh implant packages “falsified or omitted the full range, severity, duration, and cause of complications associated with Ethicon’s pelvic mesh products, as well as the potential irreversibility and catastrophic consequences,” presiding justice Judith McConnell, of the appeals court, said in a 3-0 ruling upholding the $302m in penalties.
The court also said that the fines are not excessive, as “the court found that…Johnson & Johnson had a net worth of more than $70.4bn,” according to court documents.
“The civil penalty imposed by the trial court ($343,993,750) and the amended civil penalty award ($302,037,500) each constitute less than one half of one percent of Johnson & Johnson’s net worth. Given these figures, it is apparent that Ethicon has ample ability to pay the civil penalty award,” it continued.
Many women have sued the New Jersey-based company alleging that the mesh caused severe pain, bleeding, infections, discomfort during intercourse and the need for removal surgically.
The condition is estimated to affect 3% to 17% of women and it sometimes becomes severe after age 70.
Pelvic mesh is surgically inserted to treat conditions including stress-related urinary incontinence, bladder leakage and organ prolapse, which can cause pain and pressure during urinary movements and during sexual intercourse.
