A 3-judge panel of the Pennsylvania Superior Court has unanimously upheld the $2.5 million verdict awarded to a Risperdal lawsuit plaintiff in February 2015.
In a ruling issued earlier today, the panel also ordered the trial court to consider whether or not the plaintiff should be able to proceed with his punitive damage claims.
The case was the first Risperdal gynecomastia claim to go to trial in the mass tort program currently underway in the Philadelphia Court of Common Pleas.
The plaintiff, a 20-year-old Alabama resident, was prescribed the powerful antipsychotic drug when he was just 8 years old to curb behavioral problems associated with autism. Risperdal was not yet approved for use in children at the time, nor had it been approved to treat irritability associated with autism.
The jury convened to hear the case awarded the plaintiff $2.5 million in compensatory damages after finding that Johnson & Johnson and its Janssen Pharmaceuticals unit were negligent in failing to warn doctors that Risperdal could cause excessive breast growth in boys.
In its appeal, the defendants argued that a mistrial should have been declared when the plaintiff sought to change his expert witnesses midtrial. But the panel disagreed, stating in its 39-page decision that “the relief granted by the trial court was appropriate under the circumstances.”
Like other Risperdal plaintiffs in Pennsylvania, the Alabama man was initially barred from seeking punitive damages because of a trial court ruling that applied New Jersey law to his claim. Johnson & Johnson and Janssen Pharmaceuticals are headquartered in New Jersey, which prohibits punitive damages in product liability claims involving federally-approved medications.
However, that decision was reversed in January, when another Superior Court panel ruled that the trial court should have considered the law of each plaintiffs’ home state when deciding if punitive damages should be allowed.
More than 6,200 Risperdal gynecomastia claims are currently pending in the Philadelphia Court of Common Pleas. The mass tort program has convened 7 trials February 2015, with juries awarding 5 plaintiffs compensatory damages ranging from $2.5 million to $70 million.
Several cases have also settled on the eve of trial.
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.
While the U.S. Food & Drug Administration (FDA) initially approved Risperdal in the 1990s, its first pediatric indications weren’t approved until October 2006.
That same month, the Risperdal label was updated to note that gynecomastia had occurred in 2.3% of male adolescents prescribed the drug. Prior to the update, the label described the condition – which causes men and boys to develop female-like breasts – as a rare side effect seen in just 1 in 1,000 men.
In November 2013, Johnson & Johnson and Janssen agreed to pay $2.2 billion to settle federal charges that they had improperly marketed several medications. While the companies plead guilty to illegally marketing Risperdal for off-label use in elderly dementia patients, they did not admit to any wrongdoing in resolving claims that they had illegally promoted its use children prior to October 2006.