Johnson & Johnson and its Janssen Pharmaceuticals subsidiary have agreed to settle another Risperdal gynecomastia claim, just days before the lawsuit was set to go to trial in Pennsylvania’s Philadelphia Common Pleas Court.
The Plaintiff, a resident of Mississippi, was prescribed Risperdal in 2004 – when he was just a young boy — to treat bipolar disorder.
The Plaintiff subsequently experienced weight gain and gynecomastia, a disfiguring condition marked by the development of female-like breasts in men and boys. His lawsuit blames Risperdal for his excessive breast growth and alleges that the defendants had known for years that gynecomastia associated with its use was far more common among adolescent boys than they had actually disclosed.
Risperdal wasn’t approved for any pediatric indications until October 2006, while the U.S. Food & Drug Administration only cleared the powerful antipsychotic drug to treat adolescents with bipolar disorder in 2007.
This lawsuit would have gone to trial on Monday in the absence of the Risperdal settlement. As was the case with previous agreements resulting from the Pennsylvania litigation, the terms of this settlement remain confidential and defendants have not admitted any liability for the Plaintiff’s alleged injuries.
The Philadelphia Court of Common Pleas is home to a mass tort program that currently houses thousands of similar Risperdal lawsuits. The program has convened 7 Risperdal gynecomastia trials since February 2015, with juries awarding 5 plaintiffs compensatory damages ranging from $2.5 million to $70 million.
While several other cases have settled on the eve of trial, Johnson & Johnson and Janssen have not suggested any willingness to enter into a global settlement that would resolve the majority of Risperdal lawsuits involving male breast growth.
Last December, the Pennsylvania Superior Court ruled that Risperdal plaintiffs should be able to pursue punitive damages in accordance with the laws of their home state. The Philadelphia court has since ordered that two previously-decided Risperdal lawsuits begin preparations for new punitive damage trials.
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.
In October 2006, 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 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 improperly marketed Risperdal and other medications. While the companies pled guilty to illegally promoting the antipsychotic drug for off-label use in elderly dementia patients, they did not admit to any wrongdoing in resolving claims that they had illegally marketed Risperdal for use in children before the drug was approved for pediatric indications in 2006.