A Philadelphia jury has slapped Johnson & Johnson with a $70 million verdict after finding that its antipsychotic drug Risperdal caused an adolescent boy to develop female breasts, leading some to speculate whether the pharmaceutical giant may be ready to settle the more than 1,700 Risperdal side effects lawsuits pending in Philadelphia.
The staggering verdict in the fifth Risperdal case to go to trial is the fourth win for plaintiffs but it vastly overshadows the other jury awards, which total $4.75 million. The lawsuits allege that Johnson & Johnson and its subsidiary Janssen Pharmaceuticals withheld side effects data with Risperdal, in particular the risk of breast growth in boys and young men, a condition known as gynecomastia.
The condition is both physically and emotionally painful. Breasts can grow as large as DDs, become tender and painful, and lactate. Treatment often involves liposuction or mastectomy to remove the breast tissue.
Risperdal, known generically as risperidone, is approved by the Food and Drug Administration (FDA) to treat adults and children with schizophrenia, bipolar disorder and irritability with autism. It is often prescribed off-label to treat other conditions including ADHD. Plaintiff Andrew Yount was prescribed Risperdal in 2003 at the age of 5 to treat severe psychosis. A November 2005 medical report noted he had gained weight and developed breasts.
At the time Yount began taking Risperdal and developed gynecomastia, the medication was not approved for pediatric patients. A warning label on the drug indicated that breast growth was a rare side effect that occurred in less than one in 1,000 patients. However, Yount’s attorneys argued that Janssen knew at the time that Risperdal could cause an increase in the hormone prolactin, which could trigger gynecomastia. Yet, they failed to adequately warn doctors or the public as a whole, the complaint alleged.
Johnson & Johnson said it will contest the verdict, which the company argued was “clearly excessive.”