The Pennsylvania Supreme Court won’t hear Johnson & Johnson’s appeal of the $2.5 million verdict awarded at the conclusion of the state’s first Risperdal gynecomastia trial.
The high court’s decision marks th latest set back for Johnson & Johnson and its Janssen Pharmaceutical subsidiary in connection with the massive Risperdal litigation now underway in the Philadelphia Court of Common Pleas.
Austin Pledger of Alabama, now 20, was prescribed Risperdal at the age of 8 to curb behavioral issues associated with autism, an off-label indication at the time. He claims side effects associated with the powerful antipsychotic drug caused his gynecomastia, a condition characterized by the permanent development of female-like breasts in men and boys.
Pledger was awarded $2.5 million in compensatory damages in February 2015, after the jury hearing his Risperdal lawsuit found that the defendants had failed to warn doctors and patients about the potential for gynecomastia.
In seeking to overturn the Risperdal verdict, Johnson & Johnson maintained the case should have ended in a mistrial when Pledger’s attorneys decided to switch expert witnesses halfway through the proceeding. But the Pennsylvania Superior Court had already rejected that argument in October 2018.
Johnson & Johnson turned to the state Supreme Court hoping for a reversal. But on August 2nd, the justices refused to even hear the case.
The setback comes just weeks after a three-judge panel of the Superior Court granted a new trial to another Risperdal gynecomastia plaintiff, reversing a Philadelphia trial judge’s decision to dismiss the case after just 11 days of testimony.
The U.S. Food & Drug Administration (FDA) initially approved Risperdal in 1993 to treat adults with schizophrenia and bipolar mania. The drug’s approved indications were expanded in October 2006 to include the treatment of autism-related behaviors in children, marking the first time the FDA endorsed Risperdal for pediatric use.
That same month, Janssen updated the Risperdal label to state that gynecomastia affected 2.3% of adolescent boys treated with the medication. Previously, the disfiguring condition was characterized as a rare side effect that only affected about 1 in 1,000 patients.
In November 2013, Johnson & Johnson and Janssen paid $2.2 billion to settle federal civil and criminal charges over their marketing tactics. The allegations included claims that the companies illegally promoted Risperdal for off-label uses, including the treatment of children years before the FDA approved the drug’s first pediatric indications.