A Pennsylvania judge has urged the state’s Superior Court to uphold a $70 million verdict awarded to a Risperdal gynecomastia plaintiff in 2016.
The case was the fifth to be tried in a mass tort program currently underway in the Philadelphia Court of Common Pleas that includes more than 6,000 similar Risperdal lawsuits. The verdict was the litigation’s largest thus far.
The plaintiff, who was a teenager when the case went before a jury, began taking Risperdal in 2003 to treat an unspecified psychiatric condition. At the time, the atypical antipsychotic drug had not been approved for us in children. The Risperdal lawsuit accused Johnson & Johnson and Janssen of failing to provide doctors and patients with adequate warnings regarding the potential for gynecomastia – a condition marked by the development of female-like breasts in men and boys — and charged that the companies illegally promoted the medication for off-label pediatric indications.
According to The Legal Intelligencer, Johnson & Johnson and Janssen have appealed the Risperdal verdict to the Pennsylvania Superior Court, arguing that the evidence presented at trial was insufficient and that the judgment was excessive.
However, in an opinion issued on Wednesday, Philadelphia Court of Common Pleas Judge Paula Patrick, who oversaw the 2016 Risperdal trial, refuted those arguments.
“This court did not invalidate the jury’s verdict because the award was not unreasonable,” she wrote. “Assessing damages in a case such as this is a difficult task. … Upon consideration of the evidence presented at trial and the damages sustained by plaintiffs, this court believes that the jury’s finding should not be disturbed.”
Risperdal is an atypical antipsychotic medication 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.
The U.S. Food & Drug Administration did not approve Risperdal for use in children until October 2006. That same month, the drug’s label was updated to indicate that gynecomastia had occurred in 2.3% of male adolescents prescribed the medication. Up until that point, the label described the condition as a rare side effect affecting just 1 in 1,000 patients.
There are currently more than 6,600 Risperdal lawsuits pending in the mass tort program underway in the Philadelphia Court of Common Pleas, the majority of which involve gynecomastia. The court has completed a total of 7 trials since February 2015, with juries awarding 5 plaintiffs judgments ranging from $2.5 million to $70 million.