A trial over the alleged effects of Risperdal has been paused following a data analysis dispute. According to Law 360, the month long trial in Philadelphia state court has been put on hold until early December. Johnson & Johnson’s Janssen unit was ordered to submit more evidence, to be reviewed by the plaintiff’s attorneys. The lawsuit was filed on behalf of an 11-year-old boy who developed gynecomastia, abnormal male breast growth, after taking Risperdal to treat Tourette’s syndrome. Futher details were not released.
Risperdal has never been approved for children with Tourette’s syndrome. According to the lawsuit, Janssen illegally marketed the drug off-label for this purpose and hid the risks from doctors. Allegedly, use of Risperdal caused the boy to grow breasts and J&J failed to adequately warn about this side effect. Law360 reports that the plaintiff began taking the antipsychotic medication in 2006. At the time gynecomastia was mentioned on the warning label as a rare side effect in adults, occurring in less than one in 1,000 patients. According to the plaintiff’s lawsuit, however, internal data showed Risperdal was linked to much higher rates of gynecomastia in adolescents. The plaintiff underwent surgery to remove the breasts. Prior to the procedure, he suffered emotional distress from being teased.
In October 2006, the label on Risperdal was updated to reflect a 2.3 percent rate of gynecomastia in adults. The drug also gained approval for children with autism.
The FDA approved Risperdal in 1993. In 2007, sales peaked at $4.5 billion. J&J was hit with a $2.5 million jury verdict in February. The jury found the company failed to warn about the risks and that the drug was the primary cause of gynecomastia in the plaintiff, who began taking the drug at the age of seven.