Janssen Pharmaceuticals has apparently agreed to settle a Risperdal lawsuit that helped open the door to punitive damages in similar cases.
Plaintiff Timothy Stange, a Wisconsin resident, was prescribed Risperdal as a child to control Tourette’s syndrome, an off-label use of the powerful antipsychotic medication. He claims that Risperdal caused his gynecomastia, a hormonal condition that causes men and boys to grow female-like breasts.
Stange’s Risperdal lawsuit was one of the first cases to go to trial in a mass tort program currently underway in the Philadelphia Court of Common Pleas. In December 2015, the jury hearing his case found that Janssen had failed to warn Stange and his doctors that Risperdal could elevated levels of prolactin, a hormone central to female breast development, and awarded him $500,000 in compensatory damage.
However, he was barred from pursuing punitive damages after the judge overseeing the Risperdal mass tort program determined that New Jersey law should apply to the cases. Janssen is headquartered in New Jersey, a state that forbids punitive damages in product liability lawsuits involving federally-approved prescription drugs.
Janssen ultimately appealed the Risperdal verdict to the Pennsylvania Superior Court, which upheld the jury’s failure-to-warn finding. However, the Court also determined that Stange should have had an opportunity to pursue punitive damages under the laws of his home state and ordered a new trial.
The ruling also meant that other Risperdal plaintiffs with cases pending in Philadelphia would have a chance to assert punitive damages claims in accordance with the laws of their own home states.
According to The Pennsylvania Record, Janssen issued a statement on Tuesday confirming the Risperdal settlement.
“We resolved this case and the terms are confidential,” the company said. “Risperdal (Risperidone), when used as part of a comprehensive treatment plan, continues to help millions of patients with mental illnesses and neurodevelopmental conditions.”
Janssen, a subsidiary of Johnson & Johnson, launched Risperdal in 1993. However, the U.S. Food & Drug Administration (FDA) has never approved the drug to treat Tourette’s syndrome, and did not clear the medication for use in children until October 2006.
That same month, the Risperdal label was modified to state that gynecomastia affected 2.3% of adolescent boy treated with the drug. Previously, the condition was characterized as a rare side effect that occurred in just 1 in 1,000 patients.
In November 2013, Johnson & Johnson and Janssen paid $2.2 billion to settle federal civil and criminal charges involving its drug marketing practices. Among other things, Justice Department prosecutors said the companies illegally promoted Risperdal for off-label uses, including the treatment of children long before the FDA approved the medication’s pediatric indications.