- After a month-long trial centered on Janssen's Risperdal in Philadelphia, jurors have contended that Janssen should have provided more warnings about the gynecomastia (abnormal breast enlargement in males) risk associated with Risperdal (risperidone). But the company will not be forced to pay out damages.
- This lawsuit, which involved a 19-year-old plaintiff who claimed he developed gynecomastia from taking Risperdal, is one of almost 1,300 such lawsuits, which have been consolidated in Philadelphia Court of Common Pleas.
- Although Risperdal was approved in 2002, it wasn't approved for pediatric use until 2006; however, many children, including William Cirba, the plaintiff in this case, were using it before 2006.
Cirba's suit contends that Risperdal caused gynecomastia, a hormonal imbalance, which leads to breast growth in boys and men. However, the jurors did not unanimously see the link.
Nonetheless, the widespread sentiment is that Janssen has been marketing Risperal off-label, especially among pediatric patients. This is the second time in the space of a month that Janssen has been found guilty of failure to disclose this risk (and the first case also came with a $2.5 million damages decision). There are more trials coming up, and it seems unlikely that Janssen will emerge unscathed.
Just two years ago, Janssen paid more than $2.2 billion to resolve civil and criminal investigations, which were related to the marketing of Risperdal and other drugs, by the Department of Justice.