The $2.5 million verdict awarded in Pennsylvania’s first products liability trial involving Risperdal and gynecomastia has been upheld, after a judge in Philadelphia refused Janssen Pharmaceutical’s motion seeking a new trial.
The Philadelphia Court of Common Pleas currently houses more than 5,000 Risperdal lawsuits, all of which were filed on behalf of men and boys who allegedly experienced excessive breast growth due to their use of the antipsychotic medication. The litigation’s first trial ended in February 2015, after a jury found that Janssen and its parent company, Johnson & Johnson, failed to warn the plaintiff and his doctors about the potential for Risperdal to cause gynecomastia.
Court records indicate that the plaintiff began taking Risperdal in 2002, when he was just 8 years old, to treat symptoms associated with autism. At the time, Risperdal had not been approved for autism, nor had it been approved for use in children.
According to Law360.com, Janssen argued in its post-trial motion that the plaintiff should not have been able to bring in a new causation expert after his original witness withdrew from the case. But Judge Ramy Djerassi disagreed, noting that the Missouri-based physician had only withdrawn after the defense suggested at the last minute that he may have violated the law by examining the plaintiff in Alabama despite not being licensed there.
“The timing of Janssen’s motion and the nature of their accusation were extraordinary and seemed calculated for maximum surprise,” Judge Djerassi wrote in his August 10th opinion. “If Janssen’s late motion were granted, plaintiff would have no choice but [to] move for voluntary nonsuit. If the motion were denied, then Dr. Goldstein would likely choose to take the Fifth Amendment or testify with predictable damage to his credibility. Either way, if the motion had been filed before trial, there would not have been extraordinary prejudice to plaintiff who would likely have moved for a continuance before undergoing the expense of trial.”
Risperdal is an atypical antipsychotic approved to treat adult and adolescent schizophrenia, bipolar disorder in adults and children ages 10-to-17, and irritability in children (5-to-16 years of age) with autistic disorder. It is also frequently prescribed off-label to treat children with ADHD.
Risperdal was first approved by the U.S. Food & Drug Administration (FDA) in 1993. In October 2006, the FDA approved Risperdal for use in children. That same month, the drug’s prescribing information was updated to note that 2.3% of male adolescents treated with Risperdal had developed gynecomastia. Prior to that, the label characterized the condition as a rare side effect that appeared in less than 1 in 1,000 patients.
According to a recent filing with the U.S. Securities and Exchange Commission, Johnson & Johnson has been named a defendant in at least 13,800 Risperdal lawsuits nationwide. In addition to Pennsylvania, claims are also pending in Missouri and California state courts.
The Pennsylvania Risperdal litigation has already concluded seven gynecomastia trials. Four of these cases resulted in plaintiffs’ verdicts and damage awards ranging from $500,000 to $70 million. Two Risperdal lawsuits were dismissed midtrial, while another ended with a partial verdict for the defense. Several other cases have settled just before trials were to begin.