Philadelphia Judge Pauses Risperdal Trial and Orders Janssen Ordered to Turn Over More Evidence

Judge Kenneth Powell of the Philadelphia Court of Common Pleas has temporarily paused a trial over allegations that the antipsychotic drug Risperdal caused an adolescent boy’s breast growth and ordered the manufacturer, Janssen Pharmaceuticals Inc., to turn over more evidence to the boy’s attorneys.

The judge ordered Janssen, a unit of Johnson & Johnson, to provide documents, reports and other nonprivileged information relating to “reanalysis data” to the attorneys representing the boy. The 11-year-old boy took Risperdal (risperidone) to treat Tourette’s syndrome, according to court documents, Law360 reports. 

At the start of the trial last month, the boy’s attorneys presented arguments that Janssen had worked to sell the medication to pediatric doctors although it had not received Food and Drug Administration (FDA) approval for pediatric uses. The attorneys told the jury that improper marketing influenced a pediatric neurologist to prescribe Risperdal for the boy’s Tourette’s syndrome without a proper understanding of the risks of breast growth (gynecomastia) associated with the drug, according to Law360.

Janssen marketed the “powerful antipsychotic drug” for children even though it was not approved for them. One attorney noted, “the 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.

The boy took Risperdal for about three years beginning in February 2006 to treat twitches and tics that are symptoms of Tourette’s. The boy gained 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, his lawyers say, he suffered substantial emotional distress from being taunted.

Risperdal received FDA approval in in 1993 and reached peak sales of $4.5 billion in 2007, according to Law360. At the time Risperdal was prescribed for the boy, the warning label indicated that gynecomastia was a rare side effect in adults, occurring in fewer than one in 1,000 patients. But the attorneys say J&J had data showing that the side effect was much more common in adolescent males. 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.

Two earlier Risperdal gynecomastia cases ended in opposing verdicts. In the first case, the jury ordered $2.5 million in damages after finding not only that Janssen had failed to provide adequate warnings but also that Risperdal was a primary cause of breast growth in the plaintiff, a 7-year-old boy. In the second case, the jury found that the warnings were inadequate, but did not award damages because it found there was not enough evidence that the boy’s gynecomastia had been caused by the drug, Law360 reports.

 

 

from Parker Waichman http://www.yourlawyer.com/blog/philadelphia-judge-pauses-risperdal-trial-and-orders-janssen-ordered-to-turn-over-more-evidence/