Judge Pauses Philadelphia Risperdal Trial in Data Analysis Dispute

Judge Pauses Philadelphia Risperdal Trial in Data Dispute

Judge Pauses Philadelphia Risperdal Trial in Data Dispute

Judge Kenneth Powell of the Philadelphia Court of Common Pleas has paused a trial over an adolescent boy’s breast growth allegedly caused by the antipsychotic drug Risperdal (risperidone) so that the drug maker can turn over more evidence for the boy’s attorneys to review.

Janssen Pharmaceuticals Inc., a unit of Johnson & Johnson, must provide evidence, documents, reports and other nonprivileged information relating to “reanalysis data” to the attorneys representing the boy, Law360. The 11-year-old boy took Risperdal for about three years to treat Tourette’s syndrome, according to court documents.

When the trial began last month, attorneys representing the boy argued that the pharmaceutical company marketed Risperdal to pediatric doctors despite its lack of approval for pediatric uses. The attorneys 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 children. “[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.” Janssen failed to adequately warn consumers about the risk of gynecomastia — the growth of breasts in boys or men—associated with Risperdal, according to Law360.

Risperdal received approved from the Food and Drug Administration (FDA) in 1993 and sales reached $4.5 billion in 2007, according to Law360. At the time the boy was prescribed Risperdal, the warning label said gynecomastia was a rare side effect in adults, occurring in fewer than one in 1,000 patients. But the boy’s attorneys say Janssen had data showing that this 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 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. syndrome. The boy put on weight and some of the weight gain was  from permanent breast tissue he developed, Law360 reports. Ultimately, he underwent surgery to have the breasts removed, but before that, the lawyers say, he suffered substantial emotional distress from being teased and taunted.

In two earlier Risperdal cases, the verdicts were split. In the first case, the jury awarded damages of $2.5 million 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 insufficient 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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