The U.S. Supreme Court won’t review a $70 million verdict against a Johnson & Johnson unit for a Pennsylvania man who grew enlarged breasts from taking Risperdal.
The Justices denied cert for J&J subsidiary Janssen Pharmaceuticals Inc.’s appeal of the 2016 verdict, in which a Philadelphia jury found the drugmaker liable for not adequately warning Andrew Yount and his family that the drug could cause gynecomastia, or male breast growth, when prescribed to adolescent boys.
When Yount first started taking the drug in 2003, it was only approved for use in treating schizophrenia in adults, and warning labels indicated that gynecomastia was a “rare” side effect that occurred in fewer than one in 1,000 patients.
The drug later won approval from the U.S. Food and Drug Administration for use in treating symptoms of autism in adolescent patients, and the label was updated to show that gynecomastia occurred in 2.3% of children who used it.
Yount won a $70 million verdict at trial, which was upheld by Pennsylvania’s Superior Court over Janssen’s arguments the award was excessive, and the Supreme Court of Pennsylvania rejected an appeal in September 2020.
The company argued that warnings related to off-label use might be seen as the manufacturer promoting such uses, which was prohibited by the Food, Drug & Cosmetic Act. Instead, the FDA had to mandate such warnings only where experts found them necessary, so the state courts’ determination that Janssen should have included pediatric gynecomastia warnings was preempted by federal law.
Yount’s attorneys and the judges agreed that Janssen had known the risks were greater than their label admitted, yet the company was still “aggressively marketing” Risperdal for off-label use without updating the label or warning doctors.