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Risperdal Trial Paused as Janssen Ordered to Turn Over More Evidence

Nov 20, 2015

A trial in Philadelphia state court over breast growth in an adolescent boy allegedly caused by the antipsychotic drug Risperdal (risperidone), has been paused until early December so the company can turn over more evidence for the boy's attorneys to review.

Judge Kenneth Powell of the Philadelphia Court of Common Pleas ordered Janssen Pharmaceuticals Inc., a unit of Johnson & Johnson, to provide evidence, documents, reports and other nonprivileged information relating to "reanalysis data" to the attorneys representing the boy. The 11-year-old boy took the drug to treat Tourette's syndrome, according to court documents, Law360 reports.

The trail began last month with arguments that the pharmaceutical company had worked to sell the medication to pediatric doctors despite the lack of approval for pediatric uses. Attorneys for the boy told the jury that improper marketing led a pediatric neurologist to prescribe Risperdal to treat symptoms of Tourette's syndrome without a proper understanding of the risks of breast growth associated with the drug. The attorneys said the "powerful antipsychotic drug" was promoted and marketed for children even though it was not approved for them. "[T]he drug was never ever, to this day sitting here in this courtroom, approved for children with Tourette's. But Janssen Pharmaceuticals had different ideas and that affected what they were willing to tell doctors about the drug and what its real risks were." The attorneys say Janssen failed to adequately warn consumers about the risk of gynecomastia — the growth of breasts in boys or men—associated with Risperdal.

Risperdal was approved by the Food and Drug Administration (FDA) in 1993 and reached peak sales of $4.5 billion in 2007, according to Law360. At the time the boy was prescribed Risperdal, the warning label indicated that gynecomastia was a rare side effect in adults, occurring in fewer than one in 1,000 patients. According to the attorneys, J&J had data showing that the side effect was much more common in adolescents. The Risperdal label was updated in October 2006, when Risperdal received FDA approval for use in children with autism. The revised label indicates that there is a 2.3 percent rate of gynecomastia in adolescents taking the drug.

The boy took Risperdal for about three years beginning in February 2006 to treat the twitches and tics that are symptoms of Tourette's. The boy put on weight and part of the weight gain was from permanent breast tissue he developed, Law360 reports. He ultimately underwent surgery to have the breasts removed, but before then he suffered substantial emotional distress from being teased and taunted, his lawyers said.

Juries split verdicts in two earlier Risperdal cases. In the first case, a jury hit J&J with a $2.5 million verdict after finding not only that the company had failed to provide adequate warnings but also that Risperdal was a primary cause of breast growth in the plaintiff, who was prescribed Risperdal as a 7-year-old. In the second case, the jury found that Janssen's warnings were inadequate, but also found that there was not enough evidence that the boy's gynecomastia had been caused by the drug. The jury awarded no damages in the second case.

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