Johnson & Johnson to Pay $1.75 Million in Risperdal LawsuitMay 10, 2016
A Philadelphia jury awarded a young man $1.75 million in a suit concerning the prescription drug Risperdal. The plaintiff started taking Risperdal at the age of 9 in 2003. At that time, Risperdal had been approved by the U.S. Food and Drug Administration (FDA) for use in the treatment of schizophrenia in adults. It was not until five years later that Risperdal was approved for the use of children and adolescents. During that time, the plaintiff developed gynecomastia, an abnormal growth of breast tissue in males, caused by the increased level of the hormone Prolactin. This condition can cause pain, swelling, tenderness, and nipple discharge.
The plaintiff's complaint alleged the drug manufacturer, Janssen Pharmaceuticals Inc., a subsidiary of Johnson & Johnson (J&J), had not warned of the potential risk of developing gynecomastia when taking this medication, digital journal.com reports.
Allegations in the lawsuit involved "off-label" marketing meaning a drug that is federally approved but is being used in a manner other than that approved by the FDA. Although Risperdal was an approved drug it was not approved for pediatric or adolescent use until after 2008.
This was the fourth lawsuit involving Risperdal and its side effects that judgement was found in favor of the plaintiff. There are over 420 lawsuits filed against J&J involving the use of Risperdal.
In 2013, J&J agreed to a $2.2 billion settlement with the U.S. Department of Justice concerning off-label marketing of Risperdal. The drug company admitted to criminal conduct in settling the federal False Claims Act allegations, stating that kickbacks were used by J&J to promote Risperdal off-label.