The sixth bellwether Risperdal trial as part of the Pennsylvania Mass Tort got underway in Philadelphia on December 2. The case, TM et al v. Janssen Pharmaceuticals, Inc. et al, was originally filed May 13, 2013 and concerns a Nebraska man who alleges that Risperdal is responsible for his growth of male breast tissue.
The plaintiff, who was seven years old when he was prescribed Risperdal in 2004, developed a condition known as gynecomastia as an adolescent. He alleges that had the Risperdal product label not been misleading, he would never have taken the medication.
What is Risperdal?
Risperdal was originally approved by the U.S. Food and Drug Administration (FDA) in 1993 for the treatment of schizophrenia in adults, was later approved for the treatment of bipolar disorder, and in 2006 approval was extended to include the treatment of autism-related irritability in children as young as five.
Janssen Pharmaceuticals and parent company Johnson & Johnson agreed to a $2.2 billion settlement in 2013 following an investigation by the U.S. Department of Justice over allegations that Janssen and J&J encouraged physicians to prescribe Risperdal to children prior to FDA approval for that age and indication. While physicians have the authority to prescribe medications for indications outside the recommendations of the FDA, manufacturers are not allowed to promote pharmaceuticals to doctors for off-label indications not sanctioned by the FDA.
Over 2,000 Risperdal lawsuits are currently pending in the Risperdal Mass Tort in Philadelphia. Thus far, trial outcomes have favored the plaintiffs, with the exception of one case in which the jury was unable to conclusively determine that Risperdal was responsible for that plaintiff’s gynecomastia, although the jury did conclude that safety warnings on the Risperdal label were inadequate.
This past summer, J&J was ordered to pay $70 million to the family of a 16-year-old boy who was prescribed Risperdal on an off-label basis to treat a psychiatric problem when he was just five years old, before Risperdal was approved for anyone under the age of 12. After several months of taking the drug, the boy developed female-like breasts.