Litigation involving the drug Risperdal is gaining traction in many states across the country. Risperdal is a drug that is intended to treat schizophrenia, bipolar disorder and symptoms of autism, and is often prescribed to children. It contains the antipsychotic drug risperidone and is considered to be an “atypical antipsychotic.” The designation “atypical” generally denotes a safer medication with fewer side effects; however, there are many known side effects associated with this drug. The most common side effects include lightheadedness, drowsiness, dizziness, tiredness, impaired cognitive functioning, nausea, and weight gain.
Unfortunately, a new and much more abnormal side effect is being seen in many of those who take the medicine. Boys and young men who take Risperdal have reported the development and growth of male breast tissue—a condition known as gynecomastia. Gynecomastia results when levels of prolactin—a hormone in the body that facilitates human reproductive health—increase significantly beyond normal. Interestingly, the potential for increased prolactin in those who took Rispedal was a known consequence of the drug. In 2006, the Journal of Clinical Psychopharmacology published a study that linked Risperdal to increases in prolactin levels and gynecomastia. The study explained: “Risperidone administered to adolescents at doses commonly used for the treatment of psychotic symptoms can strongly increase prolactin levels, with clinical consequences such as gynecomastia and/or galactorrhea. Given that the long-term effects . . . are not well documented, especially regarding osteopenia, infertility, growth, and pubertal delay, risperidone should be administered with caution to children and adolescents.”
It is this specific side effect that has prompted the onslaught of litigation over the drug. The development of breast tissue in males, especially young boys, can cause severe and lasting emotional and psychological consequences. Furthermore, surgery is often required to fix the effects that Risperdal can have on the body (procedures range from liposuction to mastectomies). Over 400 lawsuits have been filed against Johnson & Johnson, the drug’s manufacturer, regarding the development of gynecomastia in those who have taken the medication. The company has come under attack for allowing the marketing of off-label uses for Risperdal; specifically, for allowing the drug to be prescribed to young children.
Additionally, Johnson & Johnson is facing attacks from the U.S. Food and Drug Administration and the U.S. Department of Justice for its allegedly illegal marketing practices. Recently, Johnson & Johnson and one of its subsidiaries, Janssen Pharmaceuticals, settled with the Department of Justice for $2.2 million to resolve all criminal and civil charges related to their marketing of Risperdal.