Appeals Court Orders J&J to Pay $302M in Pelvic Mesh Case

The California justice system has shown J&J little mercy in its bid to dismiss a $344 million penalty for allegedly deceptively marketing pelvic mesh implants for women. 

A state appeals court this week upheld a lower court ruling establishing the fine against J&J subsidiary Ethicon Inc. but reduced the amount by $42 million, to $302 million. 

J&J appealed a 2020 non-jury trial decision that determined the company made misleading and potentially harmful statements for nearly 20 years in its pelvic mesh advertisements and instructional brochures. Transvaginal (pelvic) surgical mesh is a synthetic material that is surgically implanted through the vagina to support the pelvic organs of women who suffer from urinary incontinence or pelvic organ prolapse; side effects include chronic pain and inflammation risk, vaginal mesh erosion, post-surgical incontinence, painful sexual relations, and vaginal scarring. Numerous women have sued J&J over pelvic mesh complications and the subsequent need to surgically remove the implant.

The appeals court ruled that Ethicon’s written marketing communications for the pelvic mesh implant were deceptive, and the implants’ instructions for use (IFU) did not disclose the full range and severity of potential complications. In court documents, Ethicon cited evidence that doctors—particularly those who perform pelvic mesh implant procedures—are familiar with the range and severity of complications, as well as treatment options for those complications. Moreover, Ethicon claimed expert testimony showed its IFU was unlikely to deceive doctors. 

The appeals court rejected Ethicon’s arguments, but sided with the subsidiary about its sales pitches to doctors. The state Superior Court determined Ethicon sales representatives were trained to deliver the same messages relayed by the company’s print materials and IFUs, causing them to “convey deceptive or misleading information to healthcare professional customers in the field.” Thus, the lower court inferred that “[each] mesh-related sales conversation gave rise to a violation.”

The appeals court disagreed, contending there was no evidence of what sales represenatives said to customers. “…there was insufficient evidence from which a court could reasonably infer that each one of Ethicon’s oral communications with doctors, or any of them, included a false or misleading statement that was likely to deceive doctors,” the appelate decision read.   

Appellate judges rejected J&J’s complaint about the fine’s exorbitant amount, noting the amended fine constitutes less than 1 percent of the company’s $70.4 billion net worth. “Given these figures, it is apparent that Ethicon has ample ability to pay the civil penalty award,” the court said. 

J&J plans to appeal the ruling.