January 27, 2015 — Law360 reports that a doctor testified that he would have re-evaluated his decision to prescribe Risperdal if he had been warned about the risk of gynecomastia (male breast growth).
Jan Matheisen, a clinical professor with the University of Alabama, is the first witness to testify on behalf of 20 year-old Austin Pledger, a man who started taking Risperdal in July 2002, when he was just 8 years old. Lawyers claim Risperdal caused him to develop gynecomastia.
The FDA did not approve Risperdal for the treatment of irritability associated with certain intellectual disabilities until 2006. In 2013, the Justice Department accused Janssen Pharmaceuticals of illegally marketing Risperdal to children “off-label” between 1999-2005.
Prosecutors claimed Janssen instructed sales representatives to target child psychiatrists and market Risperdal as a safe and effective treatment for children.
According to Law360, Mathiesen testified that he was visited 20 times between 2002-2004 by a sales representative for Janssen who provided samples of Risperdal.
At the time, the label on Risperdal said elevated prolactin levels were seen in adults, but gynecomastia was a rare side effect that occurred in fewer than one in 1,000 patients.
The sales representatives gave Mathiesen no information that use of Risperdal could result in gynecomastia. As a result, Mathiesen never discussed the side effect with Pledger’s family. Although Mathiesen still prescribes Risperdal to treat children, he now clearly warns about the risk of gynecomastia.
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