On November 4, 2013, the FDA issued a news release stating that Janssen Pharmaceuticals, Inc.—manufacturers of the anti-psychotic drug, Risperdal (risperidone)—had agreed to pay over $1.6 billion to resolve allegations of misbranding and filing false claims for the drug.
A couple months before that, Bloomberg reported that parent company Johnson & Johnson (J&J) had settled a Risperdal lawsuit on the first day of the trial. The plaintiff, Aron Banks, claimed the anti-psychotic drug had caused boys to suffer gynecomastia (enlarged breasts). The lawsuit was one of over 400 filed at the time, and one of over 100 claiming this particular side effect.
What Is Risperdal?
Manufactured and distributed by Johnson & Johnson (J&J) and its Janssen Pharmaceuticals unit, Risperdal was FDA approved in 1993 to treat schizophrenia in adults. In August 2007, the agency approved it for the same use in children ages 13-17, as well as to treat bipolar disorder in children ages 10-17.
Risperdal Serious Side Effects
In 2006, a study by Duke University researchers was published in the Journal of Clinical Psychopharmacology. Results showed that adolescents who took Risperdal exhibited significantly higher levels of “prolactin,” a hormone that stimulates breast development in women.
A 2007 study found that low-to-intermediate doses of risperidone induced a 4-fold prolactin increase in children. By 2008, some doctors were raising concerns that Risperdal was causing troubling side effects in young boys. The Wall Street Journal reported incidences of Risperdal breast development in young men (called gynecomastia), with some requiring mastectomies to treat the problem.
A later study in 2009 found that after treatment with risperidone, elevated prolactin levels persisted for up to two years in children and adolescents.
Risperdal has also been linked with an increased risk of diabetes. In a 2003 study, researchers identified 131 reports of high blood sugar in patients taking the drug. A 2006 study confirmed that medications like Risperdal increased risk of new-onset diabetes in patients, and a later study published in 2013 also found that teens taking Risperdal face a three-fold risk for developing type 2 diabetes in the first year of treatment.
Risperdal And Diabetes
At least 400 Risperdal lawsuits have now been filed against Janssen and J&J. Over 300 of those are proceeding in a mass tort in the Court of Common Pleas in Philadelphia. Male plaintiffs claim the manufacturer failed to provide adequate warnings about the risk of gynecomastia, and failed to conduct adequate safety studies before releasing the product on the market.
Though most cases are still going through pre-trial proceedings, some have already been resolved through a Risperdal Settlement. In 2012, for example, J&J agreed to a settlement with plaintiff Aron Banks, who had sued the company over claims that he developed breasts as a result of taking the drug in his pre-teen and early teen years. The settlement was reached on what was supposed to be the first day of trial before a Philadelphia jury, with the terms kept confidential.