The latest lawsuit to go to trial in the Philadelphia Country Court of Common Pleas involving claims that the antipsychotic drug Risperdal caused an adolescent boy to grow disfiguring female breasts was axed mid-trial by the judge overseeing the case because the judge did not support the expert witness’ diagnosis of gynecomastia based solely on photographs. The family of the boy vowed to appeal.
The lawsuit is one of more than 5,700 claims in a mass tort program in Philadelphia County alleging Risperdal makers Johnson & Johnson and its subsidiary Janssen Pharmaceuticals withheld data showing that Risperdal use in adolescent boys could cause them to develop female-like breasts, a condition called gynecomastia.
The Hibbs case was the seventh bellwether to go to trial. The first began in January 2015 with J&J and Janssen getting hit with most of the losses, including a landmark $70 million verdict for a single plaintiff in July. Despite the multi-million dollar losses, Janssen has vowed to fight each case, refusing to offer a universal settlement.
Risperdal, known chemically as risperidone, is approved by the Food and Drug Administration (FDA) to treat symptoms associated with schizophrenia and bipolar disorder, as well as irritability with autism. In 2006, the FDA expanded the indication to include treatment for children. The medication is often prescribed off-label for behavioral conditions including ADHD and Tourette’s syndrome.
Studies have shown that Risperdal can increase levels of prolactin, the hormone that triggers breast growth and lactation in pregnant women. When prolactin levels increase in adolescent boys, it can lead to gynecomastia.