$15.5 Million Settlement in Risperdal Failure to Warn, Off-Label Marketing Lawsuit

A settlement of $15.5 million was reached between the Kentucky Attorney General and Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson) regarding the drug Risperdal, used widely to treat schizophrenia. The suit was originally filed with allegations that the drug giant failed to disclose some of the drug’s side effects to consumers while marketing it for off-label use outside the scope of FDA approval.

Among the allegations was that Janssen marketed Risperdal off-label to elderly patients to treat the symptoms of dementia. Moreover, the suit also claimed the company created an “elder sales force,” although a study found the drug could increase the risk for death in elderly patients. That risk was not disclosed until 2003, but studies show the associated risk dates as far back as 1997.

The problem? It’s illegal for manufacturers to actively promote and market a drug for purposes beyond the scope of indications formally approved by the FDA. However, doctors can prescribe medications for off-label use.

The Risperdal side effect most highlighted is gynecomastia, the development of breasts in males that is associated with a hormonal imbalance triggered by the drug.

The Kentucky lawsuit alleged Janssen knew of the potential for gynecomastia but didn’t update the warning label to keep from losing upwards of $150 million a year in sales.

The case also contended that Janssen marketed Risperdal as an anti-psychotic drug that delivered benefits such as low weight gain and low risk for diabetes. When, according to the suit, internal studies by the drug company indicated Risperdal patients presented with equal weight gain and an even greater risk of developing diabetes after one year of use.

The settlement will also restrict the way in which Johnson & Johnson and Janssen can market Risperdal in the state in the future.

Janssen was not required to admit wrongdoing.