Johnson & Johnson’s Janssen Pharmaceuticals was hit with a $1.75 million verdict in Pennsylvania state court this week for withholding side effects involving abnormal breast growth in boys with its antipsychotic drug Risperdal. The lawsuit was the fourth to go to trial.
The latest lawsuit involved the case of Nicholas Murray, a Maryland boy who was prescribed Risperdal in 2003 when he was 9 to treat symptoms of autism. At the time, Risperdal, known generically as risperidone, was only approved for treating schizophrenia in adults. However, it was often prescribed off-label to treat children and adolescents.
In 2006, the Food and Drug Administration (FDA) expanded the indication of Risperdal to include pediatric patients. At that time, the drug’s safety label was also updated to include a risk for a side effect known as gynecomastia, a condition in which boys grow female-like breasts. The label said the risk of boys developing gynecomastia while taking Risperdal was just 2.3 percent.
However, Murray’s lawsuit claimed that studies conducted by Johnson & Johnson showed the risk was as high as 12.5 percent. Yet, the drug company failed to properly disclose just how prevalent the gynecomastia risk was to boys and young men.
Murray’s lawsuit was the fourth in a pile of lawsuits claiming gynecomastia risk with Risperidal to go to trial in the past year. The first lawsuit resulted in a $2.5 million verdict against the drug company. The jury in a second lawsuit found that Johnson & Johnson and Janssen did not adequately warn consumers of the gynecomastia risk with Risperdal. However, the company was not ordered to pay damages. The third trial is currently underway. More than 1,500 other Risperdal lawsuits have settled during litigation or just before the lawsuits were to be heard.
Risperdal is currently approved to treat both adults and children with schizophrenia, bipolar disorder and irritability with autism. It is often prescribed off-label to treat behavioral problems such as ADHD.
Gynecomastia is both emotionally and physically painful for adolescent boys, causing breast tenderness and even lactation. Treatment generally involves surgery including liposuction or mastectomy.