Risperdal (Risperidone) is a second-generation antipsychotic, originally approved in 1993, that is used to treat schizophrenia, schizoaffective disorder, bipolar disorder, and irritability associated with childhood autism. Off-label uses (uses not approved by the US Food and Drug Administration) include but are not limited to the treatment of obsessive-compulsive disorder, severe and treatment-resistant depression, various other anxiety disorders, Tourette’s syndrome, eating disorders, and disruptive behavior disorders in children.
Gynecomastia (Male Breast Growth)
Perhaps the most distressing risk associated with the use of Risperdal is the possibility of developing an endocrine disorder known as gynecomastia when Risperdal is used off-label by children under 18. Gynecomastia is a frequently painful and always humiliating condition that may cause a teenage boy to grow breasts larger than almost any female. Furthermore, breast growth may be uneven – one breast may grow much larger than the other. Treatment options include hormone therapy and surgery to remove breast tissue.
Psychosocial Effects of Gynecomastia
The psychological and social liabilities of gynecomastia in a teenage boy frequently far exceed the medical liabilities. Indeed, research has confirmed that gynecomastia affects a teenaged boy’s self-esteem and social adjustment as well as his eating habits. It is not difficult to imagine the vicious ridicule and social ostracism that these patients typically endure during their teenage years.
Filing a Lawsuit
The U.S. Justice Department has already concluded that Janssen Pharmaceuticals and its parent company, Johnson & Johnson, improperly marketed Risperdal by using misleading data to downplay its risks, and by paying doctors to promote its use. The fraudulent behavior of these pharmaceutical companies provides grounds for patients who were harmed by Risperdal to file personal injury lawsuits for money damages.
A gynecomastia lawsuit arising out of the off-label use of Risperdal would be filed as a product liability claim based on the undisclosed side effects of the drug. In a defective drug lawsuit, it is possible to claim damages not only for medical expenses but also for the mental anguish associated with psychological and social losses.
In recent years Risperdal has become one of the most frequent subjects of civil actions, and the development of gynecomastia has become one of the most frequently litigated Risperdal-related claims.
- In February 2015, a Pennsylvania trial court awarded a 22-year old male $2.5 million for Risperdal-related gynecomastia that caused him to begin growing size 46DD breasts about the time he reached puberty (the verdict is still under appeal by the plaintiff, Janssen Pharmaceuticals).
- In November 2013, Johnson & Johnson and Janssen Pharmaceuticals reached a $2.2 billion settlement with the U.S. Department of Justice over the deceptive marketing of Risperdal (including but not limited to claims related to gynecomastia)
- A number of plaintiff personal injury law firms are involved in multidistrict litigation against Johnson & Johnson and Janssen Pharmaceuticals over Risperdal-related gynecomastia. These lawsuits will be individual lawsuits, not class action lawsuits, and they will take place in all 50 states.
- As of December 2014, over 1,000 Risperdal-related Gyecomastia-related lawsuits had already been filed in the United States.
- Johnson & Johnson has already reached private settlements with many Gynecomastia claimants.
- In August 2012, Johnson & Johnson and Janssen Pharmaceuticals agreed to pay 36 state consumer protection agencies $181 million for Risperdal claims, including gynecomastia claims.
If you or a loved one has suffered or is suffering gynecomastia arising from the use of Risperdal or risperidone, you may be entitled to compensation. Search our directory for a qualified pharmaceutical injury attorney for an evaluation of your case.