July 5, 2016 — A jury in Philadelphia has awarded $70 million to a teenage boy from Tennessee who grew female breasts after taking the anti-psychotic drug Risperdal as a child.
The manufacturer, Janssen Pharmaceuticals, was accused of downplaying the risk of gynecomastia. The label claimed it was a “rare” side effect that occurred in 0.8% of boys.
Lawyers say Janssen knew the actual risk was about 4.5%, and that Risperdal was associated with spikes in a hormone known as prolactin that could cause breasts to develop on boys. An attorney representing the boy 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.”
It was the fifth Risperdal lawsuit to reach trial in the Philadelphia Court of Common Pleas, where over 1,700 lawsuits have been centralized. It was by far the largest award — others range from $500,000 to $2.5 million.
The plaintiff, Andrew Yount, was prescribed Risperdal in 2003. He developed serious weight-gain and breasts the following year. At the time, Risperdal was only approved for adults with schizophrenia.
In 2013, Janssen agreed to pay $2.2 billion to resolve civil and criminal investigations alleging that it illegally marketed Risperdal to children and elderly adults with dementia.
The FDA specifically warned Janssen against marketing Risperdal “off-label.” The label now has a “Black Box” warning that it increases the risk of death for adults with dementia. The first pediatric uses were not approved until 2006.
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