johnson and johnsonIn a Philadelphia court, Johnson & Johnson (J&J) just paid out its largest award yet, $70 million for their prescription drug Risperdal (Risperidone). Criminal charges are tied to allegations that the company marketed the drug for off-label use. Off-label use is when the drug is used to treat diseases not specifically studied and approved by the FDA. In the case of Risperdal, the drug was marketed prior to U.S. Food & Drug Administration (FDA) approval for use in children and adolescents. While a doctor may prescribe a drug off-label, a company cannot market the drug for off-label use.

Risperdal, also known as Risperidone, is an atypical anti-psychotic that affects brain chemicals, as well as hormones, in the body. It is widely used for the treatment of mania and schizophrenia. However, it was prescribed and marketed off-label for children suffering from irritability disorders and dementia in the elderly prior to FDA approval. While this is the most recent gynecomastia case awarded, there are others pending due to the alleged deceptive marketing practices of J&J. Here is a current list of side effects, as listed by the U.S National Library of Medicine:

  • Increased risk of stroke
  • Neuroleptic malignant syndrome (NMS)
  • Tardive dyskinesia (could be permanent, and may include involuntary facial muscle movement)
  • High blood sugar levels or high cholesterol levels (i.e. can cause diabetes)
  • Increased levels of a hormone called prolactin (i.e. can cause gynecomastia)
  • Low blood pressure


The most recent verdict seems to be setting the tone for the remaining cases with regards to Risperdal. While J&J deems the verdict ‘excessive’, many others see this as an indication of what is on the horizon. During the course of the Risperdal lifecycle as a product, it has been marketed to different groups for off-label use, namely children, adolescents and the elderly, creating a chain reaction in lawsuits for the other side effects caused by Risperdal due to deceptive marketing practices.

Public scrutiny of one of the most beloved brands has been quite severe, to the point of a well-respected publisher, Huffington Post, creating a multi-part series about what Johnson & Johnson has done to the public, named “America’s Most Admired Lawbreaker.”


The settlement is not only significant in the amount of money received, but also in that it protects citizens from being prescribed Risperdal based on the false statements J&J previously made to health care providers.

If you have cases related to Risperdal gynecomastia or cases related to other complications after taking Risperdal, contact one of our Gacovino Lake attorneys at 1-800-550-0000 to learn how we can help your law firm prosper.