The first Risperdal trial is well underway in the Philadelphia Common Pleas Court. The trial is focused on how Risperdal, an antipsychotic drug originally only approved for schizophrenia and bipolar disorder in adults, was used by its manufacturer, to target young children for the treatment of autism, mental illness and behavioral issues and the manufacturer’s failure to provide an adequate warning that Risperdal caused gynecomastia in these young children. Gynecomastia is the growth of excess breast tissue caused by a hormone imbalance, in which the breast tissue can only be removed through surgery.
The trial, which began on January 23, 2015, involves a 20 year old autistic Alabama man who ingested Risperdal for five years beginning in 2002. Blaming Risperdal for excessive weight gain and gynecomastia development, the plaintiffs are arguing Johnson and Johnson not only failed to warn doctors of the risks of gynecomastia, but that Johnson and Johnson manipulated the data in order to deceive prescribing physicians that the drug was safer. David Kessler, a pediatrician and former head of the FDA for six years, testified that in 2001, Johnson and Johnson became aware of the possible risk of gynecomastia, yet failed to produce a warning label stating so. Johnson and Johnson studies on Risperdal and gynecomastia showed nearly 3.8% of boys who ingested Risperdal were likely to grow excessive breast tissue. However, it wasn’t until 2006, years after plaintiff was first prescribed Risperdal, that Johnson and Johnson included any information regarding these studies on its label.
The trial is expected to continue over the next few weeks with Kessler being cross examined this afternoon,and the mother of the plaintiff taking the stand next week.