J&J Seeks SCOTUS Review of $302 Million Fine in Pelvic Mesh Case

Johnson & Johnson and its Ethicon Inc. unit asked the US Supreme Court to review a $302 million civil fine stemming from allegations they misrepresented risks of pelvic mesh products, saying their due process rights were violated.

Then-California Attorney General Xavier Becerra filed an enforcement action in 2016, alleging the misrepresentations violated the state’s Unfair Competition Law and False Advertising Law. Each imposes a penalty up to $2,500 for each violation.

A trial court found that the companies committed 153,351 UCL violations and 121,844 FAL violations, based on the numbers of written and spoken marketing communications. It imposed a penalty of $1,250 for each one, arriving at a $344 million fine. The California Court of Appeal court largely affirmed but threw out violations based on spoken communications, which reduced the penalty to $302 million. The state’s top court declined review.

Ethicon says it lacked fair notice of how the California courts would count statutory violations and therefore lacked fair notice of the potentially massive award. The laws don’t define what constitutes a separate violation for purposes of penalty counting, leaving businesses “in the dark,” according to the petition, which was docketed Tuesday.

California courts punished Ethicon separately for every piece of marketing material containing purportedly deceptive statements, “based in significant part on communications not proven to have reached consumers at all,” the petition says.

The statute didn’t give Ethicon fair notice that it could be found liable based on marketing materials not established to have reached their audience, the petition says.

Businesses accused of failing to warn of a product’s risks used to be able to rely on certain basic common law protections, such as plaintiffs needing to offer individual proof of causation and actual injury, Ethicon says.

States have severely curtailed those protections with statutes that broadly prohibit unfair and deceptive acts and practices. “These statutes transform what were previously ordinary product liability claims into massive claims that require no such individualized proof of injury or causation,” the petition says.

Ethicon urged the Supreme Court to grant review and clarify that a robust due process fair notice standard applies to deceptive practices statutes like California’s.

Orrick, Herrington & Sutcliffe LLP represents J&J and Ethicon.

The case is Johnson & Johnson v. California, U.S., No. 22-447, cert. petition docketed 11/15/22.