Dive Brief:
- A California appeals court ruled on Monday that Johnson & Johnson must pay $302 million for deceptive marketing of its pelvic mesh implants. A three-judge panel upheld a previous decision that found J&J subsidiary Ethicon minimized or omitted the health risks of its transvagical pelvic mesh products in its instructions and marketing to doctors and patients.
- Ethicon had appealed the case from the San Diego Superior Court, arguing that it had misapplied state law on competition and advertising. The appeals court held up the original decision, except for one piece. "We conclude the trial court erred in just one respect," the ruling stated, noting the court could not prove that Ethicon made deceptive oral statements about its devices in one-on-one conversations with doctors, at sponsored lunches and health fairs. As a result, Ethicon faces $42 million less in civil penalties than the original $344 million. The company still must pay penalties related to its medical device instructions and printed marketing communications.
- In an emailed statement, J&J indicated that it plans to appeal the case. "Ethicon responsibly communicated the risks and benefits of its transvaginal mesh products to doctors and patients and in full compliance with U.S. Food and Drug Administration (FDA) laws. While we acknowledge the partial reversal of penalties, we will seek a full reversal of the judgment in the California Supreme Court," the company stated.
Dive Insight:
The California Court of Appeal for the fourth district largely upheld the previous court's decision, which found that the J&J subsidiary violated California's unfair competition and false advertising laws. After a nine-week bench trial in 2020, San Diego Superior Court Judge Eddie Sturgeon wrote in a ruling that J&J touted the benefits of its mesh to doctors and patients "while misrepresenting, downplaying, and concealing its potential for serious, long-term complications."
The case is one of several filed against the company related to its pelvic mesh products. In 2019, Ethicon paid $117 million to resolve an investigation by 41 states. But California's case, filed in 2016, was separate. Other surgical mesh manufacturers, including Boston Scientific, also faced lawsuits.
Ethicon had been making mesh implants for urinary incontinence and pelvic organ prolapse, a condition where the pelvic floor muscles no longer support the pelvic organs, since the 1990s.
In 2008, the FDA issued a notification to healthcare providers about using pelvic mesh implants to treat these conditions. Although it said side effects were rare, the agency noted that the implants could lead to infection, pain, urinary problems, and in some cases, scarring and mesh erosion.
Three years later, the FDA updated those statements, noting that serious complications were actually not rare, and that surgical mesh for transvaginal repair of pelvic organ prolapse was "an area of continuing serious concern." In 2012, the FDA ordered Ethicon to conduct post-market surveillance studies on four of its mesh products, one for urinary incontinence and three for pelvic organ prolapse. Instead, the company stopped selling them, according to background provided in the court's judgment.
According to court documents, medical device instructions for Ethicon's mesh devices were misleading. For instance, instructions for the devices for urinary incontinence referred to potential "transitory" irritation at the wound site or a foreign body response, but did not disclose the risks of chronic irritation. Instructions for mesh implants for pelvic organ prolapse did not identify "debilitating or incapacitating" pain as a complication, and did not reference the possible need for mesh removal.
The case also outlines Ethicon's response to the FDA's public health notification around the risk of these mesh products. After the first one, Ethicon reportedly instructed its sales representatives to avoid initiating conversations about it with doctors. In 2012, when the FDA found that serious complications were not rare, Ethicon paid consultants to write an article refuting the update, according to court documents.
Since then, some of the devices have been pulled. In 2019, the FDA ordered mesh manufacturers to stop selling the devices for transvaginal repair of pelvic organ prolapse, noting the "benefits do not outweigh the risks."
