Risperdal is the brand name for Risperidone, an atypical or “second generation” antipsychotic drug prescribed to treat schizophrenia and other manifestations of psychotic disorders. The defendants named in the litigation are the designers, developers, manufacturers, marketers, advertisers, distributors and/or sellers of the drug, including Johnson & Johnson (“J&J”) and its subsidiary, Janssen Pharmaceutica (“Janssen”).
On December 29, 1993, the FDA approved Janssen’s New Drug Application for Risperdal as a prescription drug used for the treatment of adults suffering from schizophrenia. In 2006, the FDA approved the use of Risperdal in children, specifically for the treatment of irritability associated with autistic disorders. The product label was also changed to state that Risperdal was “associated with higher levels of prolactin elevation than other antipsychotic agents.” Then, in 2007, FDA once more expanded the approved use of Risperdal to treat schizophrenia in adolescents ages 13-17, and for the short-term treatment of manic or mixed episodes of bipolar I disorder for children ages 10 to 17.
In addition to prescribing Risperdal in accordance with FDA approval, The defendants also promoted the drug’s off-label use. From the late 1990s and early 2000s, Janssen and J&J endorsed its product as a cure for stuttering, Tourette's syndrome, obsessive-compulsive disorder, attention deficit hyperactivity disorder (ADHD), OCD, anxiety, sleep difficulties, dementia, anger management, and depression. This was done despite the lack of FDA approval for use with children or adolescents for any purpose until 2006 and generic usage not beginning until approximately 2008.
Risperdal has been linked to several serious side effects, most notably gynecomastia, the development of male breasts. This is because the drug has been found to increase a hormone called prolactin, which stimulates breast growth. Many young boys with Risperdal-associated gynecomastia undergo breast reduction and even mastectomies to correct the problem.
The plaintiffs in this litigation allege that the defendants were aware of the known health risks to children and adolescents while marketing this drug, including for off-label usage. Further, the plaintiffs claim that that the defendants knew of various studies showing that Risperdal patients had significantly elevated prolactin levels. Despite such knowledge, the plaintiffs argue that J&J/Janssen continued to actively market the drug to children and adolescents and failed to warn of the likelihood of gynecomastia as a serious side effect.
Risperdal actions have been filed in two separate state court coordinated actions—one in Philadelphia and another in Los Angeles.