A spokeswoman for Janssen, located in Titusville, N.J., said the firm is "disappointed" and "believes this verdict should be overturned," claiming that Risperdal's side effects were clearly communicated to Pledger, his family and the prescribing doctor.
Pledger, a native of Thorsby, Ala., was first prescribed the drug in 2002 by his family physician, Kline said.
At the time, Risperdal was not approved by the U.S. Food and Drug Administration for use in children - Pledger, who has autism, was 8 years old when the prescription was written - and its label reported that the risk of gynecomastia, a condition that causes men to grow female breasts, was low, according to Kline.
However, in 2006, the FDA approved Risperdal's use as a schizophrenic aid for children and issued new label information that said the drug contained high levels of prolactin, a hormone that promotes breast growth, Kline said.
By that time, Pledger already had begun to develop breasts. To this day, Pledger has female-like breasts that can only be removed through a mastectomy, Kline said.
Robyn Reed Frenze, Janssen's director of product communication, said that the firm rejects these claims and that the FDA-approved label "properly warned" the boy's family "of the medication's potential side effects."
She added that Pledger's "quality of life was significantly improved during the time he was taking Risperdal."
The jurors apparently disagreed.
Pledger's case is the first of more than 1,200 filed in Philly over Risperdal to be settled, according to Kline.
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