Risperdal (risperidone) was approved by the FDA in 1993 for use in treating bipolar disorder and schizophrenia. In 2006, the FDA approved Risperdal to treat irritability associated with Autism in children. Manufactured by Janssen, a subsidiary of Johnson & Johnson, Risperdal was at one time its highest selling drug, accounting for $24.2 billion in sales from 2003 to 2010.
In addition to its FDA approved uses, the drug has been prescribed off-label in an attempt to treat other mental conditions, including anxiety, obsessive-compulsive disorder (OCD), dementia and post-traumatic stress disorder (PTSD). Off-label Risperdal use has been linked to profound negative consequences.
Risperdal can stimulate prolactin, a hormone associated with milk production. As a result of hyperprolactinemia, a notable side effect for some children or men taking Risperdal is gynecomastia, or enlarged breasts. Reports have indicated that some users even experience galactorrhea or milk production. In addition to the disruption of hormones Risperdal causes, the growth of breasts in a child, adolescent or a man is likely to cause lasting psychological and mental harm. Moreover, a mastectomy, or other surgical removal of breast tissue, is the only treatment known to remove gynecomastia.
At the state and federal levels, there have been numerous claims involving Johnson & Johnson’s failure to accurately state the risks involved with Risperdal. These claims also involved Johnson & Johnson’s practice of awarding kickbacks to physicians and facilities which prescribed Risperdal for off-label uses.
As of 2015, there have been two trials, both of which were held in Philadelphia, with one victory for the plaintiffs and one for the defense.
The California litigation is in Los Angeles Superior Court and is overseen by Judge William Highberger. There have been several hundred lawsuits filed in California thus far, with more anticipated. Gregory Skikos and Mark Crawford of Skikos, Crawford, Skikos & Joseph, hold leadership positions as co-liaison counsel in the California litigation.