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Risperdal: $2.5 Million Verdict for Plaintiff in Philadelphia State Court

Philadelphia Daily News reports that a Philadelphia jury has awarded a 20 year old autistic man, Austin Pledger, $2.5 million after he developed size 46 DD breasts (a condition referred to as gynecomastia) as a young teenager after using the antipsychotic drug Risperdal. In particular, the jury found that the manufacturer, Johnson & Johnson, failed to adequately warn of the potential side effects associated with the use of the drug.

The Food and Drug Administration (FDA) initially approved Risperdal in 1993 for adults with schitzophrenia. Risperdal was not approved for children or adolescents until later in 2006. Pledger began using Risperdal for the first time in 2002 at the age of eight because his mother sought something to help with his irritability associated with his autism. Pledger’s doctor testified to the jury that he was unaware of information contained in one of the clinical studies that suggested that one of the side effects associated with use of Risperdal was gynecomastia.

Although counsel for defendants stressed to the jury that the company’s label adequately conveyed the risks of Risperdal, one of the plaintiff’s expert witnesses disagreed. David Kessler, former FDA commissioner, testified that the manufacturers did not adequately warn of the risks of the drug despite the fact that one of its own studies demonstrated increased levels of the hormone prolactin, which can lead to gynecomastia. Kessler said, “If somebody is sending a sales rep into a doctor’s office, into a pediatric neurologist’s office, and doing it multiple times, you have an obligation to provide adequate direction. Tell the good. Tell the bad.”

Philadelphia Daily News reports that this was the first case that has went before a jury regarding Risperdal and the condition gynecomastia, but thousands more lawsuits are pending in other states across the nation.

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