Supreme Court upholds $302M ruling against J&J over pelvic mesh implants

The Supreme Court on Tuesday denied an appeal by Johnson & Johnson of a ruling requiring the company to pay $302 million in penalties to California for deceptive marketing of pelvic mesh implants that can cause serious vaginal pain and physical damage.

Pelvic mesh is inserted surgically in women to treat two conditions. One is stress urinary incontinence or bladder leakage during actions such as coughing, sneezing or exercising. The other is organ prolapse, the collapse of pelvic organs into the vagina, causing pain and pressure in urinary and bowel movements and sexual intercourse.

Johnson & Johnson's Ethicon subsidiary began selling pelvic mesh in the late 1990s. A lawsuit by the state said the company had rejected suggestions by its own doctors in 2005 to inform consumers that the devices could cause vaginal harm when used to treat organ prolapse.

Ethicon later added language to its advertising and advisories to doctors and patients saying the mesh could cause “transitory” damage. A state appeals court said the company refused to change that language after the U.S. Food and Drug Administration amplified previous warnings in 2011 to say that complications in treating organ prolapse were not rare and were cause for “serious concern.”

Instead, the court said, the Johnson & Johnson subsidiary paid consultants to write a public rebuttal of the FDA's warning. Ethicon stopped most of its sales of mesh for organ prolapse after receiving an additional FDA warning in 2012. The federal agency barred all sales for organ prolapse in 2019 but still allows the product to be used for stress urinary incontinence.

Johnson & Johnson had previously paid $117 million to settle lawsuits by 41 other states and the District of Columbia over pelvic mesh, and other manufacturers have also paid substantial sums. In a ruling last April upholding the $302 million penalty in California, the Fourth District Court of Appeal in San Diego said there was ample evidence that Ethicon had knowingly deceived doctors and patients.

The instructions in every package “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 said in the 3-0 ruling.

Rejecting the company's claim that the fine was excessive, McConnell said it amounted to less than 1 percent of Johnson & Johnson's net worth of $70.4 billion. The ruling upheld most of the penalties awarded by a San Diego County judge after a nonjury trial.

After the state Supreme Court denied review of the case, the company appealed to the U.S. Supreme Court, arguing that California was misusing a broad consumer law to penalize the company for every communication it sent to the state, most of which never even reached consumers.

“Left unchecked, the possibility of enormous civil penalties can diminish venture financing and capital investment, especially in the life sciences sector, which impedes the development of new medical technologies,” attorney Joshua Rosenkranz wrote in a November filing asking the court to review and overturn the state ruling.

But the justices denied review Tuesday without comment.

“For years, Johnson & Johnson has refused to take responsibility for misleading patients and their doctors about the risks of a permanent and irreversible implant,” said state Attorney General Rob Bonta. “Today, those victims can rest easier, knowing the $302 million judgment we secured against the company is final.”

Lawyers for the company were not immediately available for comment.

The case is Johnson & Johnson v. California, No. 22-447.