November 4, 2013 — Johnson & Johnson (J&J) will pay $2.2 billion to settle criminal and civil lawsuits alleging that they improperly marketed Risperdal (risperidone), Invega, and Natrecor, according to the Department of Justice (DOJ) announced today. It is one of the largest healthcare-fraud settlements in U.S. history.
Risperdal is a powerful anti-psychotic drug that was approved in the 1990s to treat schizophrenia and other severe mental illnesses. Federal officials charged that Risperdal was marketed to doctors with elderly dementia patients as a way to treat minor ailments, such as anxiety and depression.
J&J settled civil claims alleging that they paid kickbacks to physicians and Omnicare, Inc., the largest pharmacy for nursing homes. In 2005, the FDA added a Black Box Warning after finding that Risperdal increased the risk of death among patients with dementia-related psychosis.
Risperdal and Gynecomastia in Children
The DOJ also alleged that Risperdal was promoted for unapproved uses in children. Although there were no studies regarding the effect of Risperdal in children, J&J actively promoted it for “off-label” use in children with moderate psychiatric disorders, including behavior problems and ADHD (attention-deficit hyperactivity disorder).
Many children who were prescribed Risperdal developed severe side effects, such as gynecomastia (enlarged male breasts). Studies published as early as 1999 also linked Risperdal to “medically serious weight gain,” which led some patients to develop type-2 diabetes.
J&J has already agreed to Risperdal lawsuit settlements with several young men who took Risperdal as children and developed severe gynecomastia. One young man, Aaron Banks, used Risperdal from 1999 to 2004, when he was between the ages of 9 and 14 years old. An additional 420 lawsuits are pending against J&J, including 130 involving gynecomastia claims.
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