Janssen Pharmaceuticals has been ordered to turn over additional evidence in a Risperdal trial now taking place in Pennsylvania state court.

The Risperdal trial, which has already been going on for about a month, is postponed until December 9 so that plaintiff’s counsel will have time to review evidence from Janssen. Judge Kenneth Powell issued an order requiring Janssen to submit evidence that addresses “reanalysis data.”

The order did not offer any more specifics about the nature of the evidence sought.

The plaintiff in this Risperdal lawsuit is 11-year-old Timothy S., who was prescribed Risperdal in 2006 as a treatment for Tourette’s syndrome. Timothy’s lawsuit alleges the Risperdal he took caused him to develop gynecomastia, or abnormal male breast growth.

The new breast tissue was allegedly permanent – Timothy says he gained weight overall while taking Risperdal, but once he lost that weight the breast tissue remained. He eventually had to resort to surgery to remove the abnormal breast tissue.

Part of Timothy’s argument is the claim that manufacturer Janssen and its parent company Johnson & Johnson failed to properly warn patients and physicians about the risk of Risperdal gynecomastia. At the time Timothy took Risperdal, its warning label stated that gynecomastia occurred in fewer than one out of every 1,000 patients.

However, Timothy says J&J knew at that time that the rate of gynecomastia was much higher in adolescent patients. The label was later updated to show that gynecomastia occurred at a rate of 2.3 percent.

Other Risperdal Lawsuits

Two other Risperdal lawsuits that have gone to trial in Philadelphia have yielded mixed results. In February 2015, a jury awarded one plaintiff $2.5 million, finding that Janssen had failed to adequately warn about Risperdal gynecomastia.

In a different trial, the jury also found the warnings were inadequate but did not find enough evidence of a causal link between Risperdal and the plaintiff’s gynecomastia to award damages.

These trials are just a few of many Risperdal lawsuits that have been brought recently over the problem of Risperdal gynecomastia. The litigation is stirred by the results of an investigation into Johnson & Johnson’s methods of promoting Risperdal.

Officials from the U.S. Department of Justice and several states’ attorneys general alleged that J&J had unlawfully promoted Risperdal for use in young patients at a time when it was FDA-approved only for use in adults. The investigation culminated in a $2.2 billion settlement agreement reached in November 2013.

In Timothy’s own Risperdal lawsuit, he argues that improper marketing led his doctor to prescribe Risperdal to him without a full understanding of the risk of Risperdal gynecomastia.

Risperdal, also known by its generic name risperidone, was initially approved by the FDA in 1993. It’s now approved as a treatment for schizophrenia, acute manic or mixed episodes associated with bipolar disorder, and irritability associated with autistic disorder. Sales of Risperdal reached as high as $4.5 billion in 2007.

Timothy’s Risperdal lawsuit is filed in the Philadelphia Court of Common Pleas under case no. 130401984.