Legal Medicine

Austin Pledger, of Thorsby, Alabama, who is now 20-years old, was prescribed the drug Risperdal when he was eight to help with irritability caused by his autism. A Philadelphia jury found this week that the drug caused Pledger to grow enormous breasts – size 46DD – and awarded him $2.5 million in damages.

In 2002, Austin was prescribed the drug by a family physician. Risperdal is an anti-psychotic made by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. At the time, the drug had not been approved by the FDA for use in children. Pledger was 8-years old when the first prescription was written. The jury found that Pledger, his parents and his doctor did not receive “adequate warning” about the drug’s possible side effects.

At that time, the label warning stated that the risk of gynecomastia, a condition that causes men to grow female breasts, was low. However, Pledger soon developed breasts that grew to 46DD.

In 2006, the drug was approved by the FDA for use in children as a treatment for schizophrenia. A new warning was issued with the approval that the drug contained high levels of prolactin, a hormone that promotes breast growth.

By that time, Pledger had already begun to grow breasts. Now, a mastectomy is the only way to remove the breasts. He has not yet had the surgery because of his poor health.

A spokesperson for Janssen says the firm is “disappointed” and believes the verdict should be overturned. Robyn Reed Frenze, Janssen’s director of product communication says that the boy’s family was properly warned. She also says that Pledger’s “quality of life was significantly improved while taking Risperdal.”

The jury did not agree.

Pledger’s is the first of more than 1,200 cases over Risperdal to be settled, according to his attorney, Thomas Kline.

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