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Adequate Warnings plus No Warnings Causation Equals Summary Judgment for Defendants in Risperdal ...

., &Mdash; F.Supp. 3d —, 2018 WL 3212422 (E.D.N.Y June 29, 2018), the plaintiff, placed in foster care in 1996 when he was six years old, began taking Risperdal the next year after displaying aggression at school. He continued to have serious psychiatric and behavioral problems and to take Risperdal in gradually increasing doses, until 2009. That year, during a visit with his psychiatrist, the plaintiff complained that his breasts were enlarged. The psychiatrist recommended that the plaintiff stop taking Risperdal, which he observed was “probably responsible for the breast enlargement,” and noted that he had been aware of the correlation between the drug and breast enlargement for several years. The plaintiff continued to see psychiatrists, and to take antipsychotic medications, until late 2012. In April 2014, he underwent bilateral mastectomies to remove his enlarged breast tissue. In March 2015, he filed suit alleging that the defendants failed adequately to wan about rate of incidence of gynecomastia (breast enlargement) in pediatric users of Risperdal. Specifically, although the label at all relevant times, had always included a Precaution about gynecomastia, the plaintiff alleged that gynecomastia should have been listed in the “Warnings” or “Adverse Reaction” section, and that gynecomastia rates were two to five times higher than the 2.3% rate listed in the label after October 2006, when Risperdal was approved for pediatric use. He alleged that his doctor would not have prescribed Risperdal if he had known about the higher incidence rate.