The Superior Court of Pennsylvania has reinstated a Risperdal lawsuit that was dismissed in 2016, following just 11 days of testimony in the Philadelphia Court of Common Pleas.
Plaintiff Tommy Moroni of Texas was prescribed Risperdal in 2004, at the age of 7, to treat symptoms of ADHD, obsessive-compulsive disorder, anxiety, depression and suicidal ideation. He continued to take the powerful antipsychotic medication until he was 10 years old. In the interim, Moroni developed female-like breasts, a condition known as gynecomastia.
In 2013, he and his mother filed suit alleging Johnson & Johnson and its Janssen Pharmaceuticals subsidiary failed to provide adequate warnings regarding Risperdal’s potential to cause gynecomastia. The case was among thousands of similar claims consolidated in a Mass Tort program currently underway in Philadelphia.
Moroni’s Risperdal lawsuit went to trial in December 2016, but was ultimately dismissed when Judge Sean F. Kennedy granted Janssen’s motion for compulsory nonsuit. In doing so, Judge Kennedy asserted that, under Texas law, the plaintiffs’ expert witness had provided insufficient testimony showing Risperdal caused Moroni’s gynecomastia.
But on Tuesday, a 3-judge-panel of the Pennsylvania Superior Court ruled that the matter should have been evaluated under Pennsylvania law, since it was procedural. By that standard, the plaintiffs had provided sufficient evidence to overcome Janssen’s motion.
“Plaintiffs’ scientific evidence, much of which was based on Janssen’s own clinical trials and studies, the results of which were published in scientific journals and peer-reviewed, showed a statistically significant relationship between ingestion of Risperdal, elevated prolactin levels, and gynecomastia in young males like [the plaintiff],” the decision noted.
The panel remanded Moroni’s Risperdal lawsuit back to Philadelphia and ordered a new trial.
Risperdal was approved by the U.S. Food & Drug Administration (FDA) in 1993. However, the drug wasn’t cleared for use in children until October 2006, and has never been approved for any of the indications noted in Moroni’s Risperdal lawsuit.
In October 2006, Janssen also 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 complication 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 drug 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 its use in pediatric patients.