July 5, 2016 — A boy from Tennessee who grew female breasts after taking Risperdal has been awarded $70 million by a jury in Philadelphia.
Lawyers accused Janssen Pharmaceuticals of downplaying the risk of gynecomastia. The label on Risperdal reassured patients that it was a “rare” side effect that occurred in fewer than one in 1,000 boys.
Investigators say the actual risk was about 4.5% of boys. They say the company also knew that Risperdal could spike levels of the hormone prolactin, which can cause female breasts to develop on boys. Lawyers representing the plaintiff told Law360:
“It’s about time they put an end to their games. In my view, it’s outrageous that they continue to defend these cases.”
The plaintiff started taking Risperdal in 2003. Within one year, he developed a lot of weight-gain and female breasts. Janssen is facing over 1,700 Risperdal lawsuits in the Philadelphia Court of Common Pleas. Four other cases have already gone to trial, with payouts ranging from $500,000 to $2.5 million.
In 2013, Janssen agreed to pay $2.2 billion to the U.S. Department of Justice for illegally marketing Risperdal “off-label” when it was only approved for adults with schizophrenia. Risperdal was not approved for any uses in children until 2006. The label now has a “Black Box” warning that Risperdal increases the risk of death for older adults with dementia.