Autistic Man Wins $2.5M In Damages After Antipsychotic Drug Gives Him 46DD Breasts
A 20-year-old Alabama man won a lawsuit against Janssen Pharmaceuticals (a Johnson & Johnson subsidiary) after an antipsychotic drug caused him to develop size 46DD breasts. He was awarded $2.5 million in damages on Tuesday in a Philadelphia court, the Philadelphia Daily News reported.
Austin Pledger reportedly took an antipsychotic drug known as Risperdal as a child and wasn’t “adequately warned” he would grow breasts as a side effect, his lawyer Thomas Kilne stated. Pledger, who has autism, was first prescribed the drug in 2002, back when Risperdal was not yet approved by the U.S. Food and Drug Administration (FDA) to be used in children. He was 8 years old at the time.
The drug’s label said that the risk of gynecomastia — the condition of men growing female breasts — was low. But by 2006, after the FDA had approved the drug for use in children with both schizophrenia and bipolar disorder problems, the label changed to report high levels of prolactin, a hormone that aids in breast growth, Kline said.
When the FDA revised the label, Pledger was 12 and already starting to develop breasts. And the only way they could be removed was through a mastectomy.
Janssen was "disappointed" in the court's decision, however, claiming that the drug's side effects were clear for Pledger's family and physician, according to a spokeswoman. Pledger's "quality of life was significantly improved during the time he was taking Risperdal," she argued in a statement. But the judge didn't seem to pay heed to the company's plea.
"There was a grave mistreatment of children," Stephen Sheller, another attorney for Pledger, told The Wall Street Journal. The company "hid data from the FDA, prescribing doctors and parents. Documents showed they knew there was much higher percentage of children getting gynecomastia than they admitted," which is unfortunately common practice.
Risperdal has a spotty record: in 2013, the FDA announced that Janssen Pharmaceuticals pled guilty to a charge of misbranding the drug as a treatment for dementia without it being approved by the FDA to do so. The company had to pay a $400 million criminal fine for introducing a misbranded drug, as well as $1.25 billion for another civil settlement. In addition, there are over 1,200 cases filed in Philadelphia over Risperdal waiting to be settled, Kline said.
“[Pledger's] trial is important publicly,” Kline told the Daily News, “because it provided for the first time a public window into the real risks of this drug.”