Janssen Pharmaceutica Inc. and parent company Johnson & Johnson have agreed to one of the largest drug settlements in history of their drug Risperdal.

Risperdal (Risperidone) is an antipsychotic drug, approved by the U.S. Food and Drug Administration to treat schizophrenia and related disorders, as well as bipolar disorder and irritability and aggression associated with autism. Like many drugs, preliminary studies have suggested that Risperdal could treat disorders other than those for which the FDA has approved it. The law allows for such “off-the-label” uses under limited circumstances. The investigations, however, alleged that manufacturers crossed legal lines related to this practice.

Allegations surfaced that the drug’s manufacturers were promoting the drug for use in patients for other conditions. While such use is legal, it is illegal for companies to promote and market the drug for such purposes. The alleged promotion took place between March 2002 and December 2003. These allegations culminated in a series of criminal and civil investigations.

>>Risperdal Lawsuits

The drug was allegedly promoted for a variety of conditions, including use in children and the elderly. While Risperdal can be a godsend for schizophrenics, it has a substantial risk of side effects. For example, it has been found to increase the risk of death in elderly dementia patients. And young males who take Risperdal have an increased risk of developing a condition called gynecomastia, or the growth of female-like breasts. Additionally, side effects including weight gain and the development of diabetes are widely reported across Risperdal patients.

The criminal investigation ended with the decision that the drug’s manufacturers would pay out $2.2 billion dollars in fines and fees. This is among the largest settlements in U.S. history over pharmaceuticals. The arrangement came as part of a plea deal in the investigations against the companies.

Related to the Risperdal settlement, a class action lawsuit investigation has been launched to help patients gain compensation. Such an investigation may allege that drug manufacturers over-promoted the drug, despite risks such as gynecomastia. Since male breast growth can be socially stigmatizing, many males may be reluctant to come forward. Also, many patients may not realize that the drug was the cause of their gynecomastia. However, such individuals may still be entitled to compensation for pain and suffering, as well as surgical correction of the issue.