A Philadelphia jury issued the verdict after hearing that the company hid evidence that the antipsychotic drug could cause abnormal breast growth.
The lawsuit that went to trial was filed on behalf of a 20-year old man with autism. He started taking Risperdal in 2002 at the age of seven to treat behavioral symptoms and continued for five years. Allegedly, the drug caused him to develop large breasts. Janssen allegedly knew about these risks but failed to warn the plaintiff or his physician.
In fact, the company is accused of attempting to hide this information. During the trial, jurors heard testimony from former U.S. Food and Drug Administration (FDA) commissioner David Kessler.
He testified that he believes Janssen intentionally massaged data in studies to downplay the risks of gynecomastia in Risperdal users.
Risperdal had not been approved for use in children
Risperdal had not been approved for use in children when the plaintiff began taking it in 2002. When the drug gained approved for pediatric populations in 2006, the label was revised to state that gynecomastia was observed in 2.3 percent of pediatric patients.
Prior to this, the label described gynecomastia as being rare.
Jurors heard that the plaintiff’s pediatric neurologist was visited by Janssen sales representatives multiple times between 2002 and 2004 to distribute samples. Testimony during the trial stated that before the early 2000s, 20 percent of prescriptions for Risperdal’s were for children.
According to Law360, there are more than 1,250 Risperdal lawsuits pending as part of a mass tort docket in Philadelphia. Recently, a second trial got underway. There are an additional 700 cases pending in state court in Los Angeles.
J&J has settled several cases alleging that the company improperly marketed Risperdal. In November 2013, the company admitted criminal misconduct and agreed to pay $2.2 billion to settle whistleblower allegations that it gave kickbacks to doctors and engaged in illegal off-label marketing for Risperdal and two other drugs.
The company resolved similar off-label marketing allegations in August 2012 by agreeing to pay $181 million to 36 states.