The Cherokee Nation has filed a Risperdal lawsuit against manufacturers Johnson & Johnson and Janssen Pharmaceuticals alleging the companies misbranded and sold drugs for unapproved uses. The Nation says that J&J sold Risperdal to the Redbird Smith Health Center for several unapproved uses, including treatment of dementia in the elderly.
In 2013, J&J paid more than $2.2 billion to the Justice Department for illegally promoting the drugs for unapproved uses. The Cherokee Nation alleges that the companies also failed to disclose the increased risks of serious Risperdal side effects, including breast tissue growth in boys and male adolescents.
Risperdal, which is approved to treat schizophrenia and bipolar disorder, has been repeatedly linked to an increased risk of breast tissue growth among boys who use the drug. The condition, known as gynecomastia, is irreversible and often requires surgery to remedy. J&J and Janssen face multiple Risperdal lawsuits alleging the drug caused breast tissue growth in males.