Johnson & Johnson, manufacturers of a controversial yet widely used antipsychotic medication, Risperdal (generic: risperidone), have lost three consecutive lawsuits over a large number of serious side effects linked to the medication.

Risperdal lawsuits filed by men and parents of young boys have alleged the antipsychotic medication causes increased breast growth, or gynecomastia caused by Risperdal.

Other injuries linked to the medication in addition to gynecomastia caused by Risperdal include nipple discharge, nipple pain and painful breasts.

Overview: Risperdal/Invega Side Effects

Risperdal was approved by the U.S. Food and Drug Administration (FDA) in 1993. It is manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. The drug was approved for treatment of certain mental and mood disorders such as bipolar disorder, schizophrenia, and irritability associated with autistic disorder.

Risperdal belongs to a class of medications called atypical antipsychotics that help to allow individuals to take part in everyday life and moderate chemical activity in the brain.

Risperdal has also been prescribed in an “off-label” treatment capacity for treatment of disorders not approved by the FDA such as dementia in the elderly, attention deficit disorder (ADD) in children, anxiety and depression.

Some adverse health complications being reported with the antipsychotic medication include gynecomastia, pituitary tumors, stroke, neuroleptic malignant syndrome (NMS), diabetes and hyperglycemia, pancreatitis, bone loss, suicide or suicidal thoughts and neutropenia.

Moderate side effects linked to Risperdal includes dry mouth, diarrhea, abnormal walk, aggression, lack of coordination, involuntary movements, decreased sexual desires, dizziness, lethargic feelings and respiratory infection.

Claims of Gynecomastia Caused by Risperdal

The Risperdal lawsuits filed by the parents of young boys and men bring forth numerous allegations against the companies, including the allegation of gynecomastia being caused by Risperdal.

Plaintiffs allege that Risperdal was illegally marketed to children for the treatment of autistic disorders and without the FDA’s approval between 1993 to 2004. Other plaintiffs accuse Janssen of concealing information about the drug’s risks and misrepresenting the drug’s risks and benefits for Risperdal use in children. Plaintiffs say the warning information provided by Risperdal only stated a low risk for developing  gynecomastia caused by Risperdal.

One lawsuit was filed by a man who developed gynecomastia caused by Risperdal. He took the medication because of his diagnosis of autism as a child. Allegedly, the Alabama man grew breasts to size 46DD before filing the Risperdal lawsuit against J&J.

Thus far, J&J has been assessed millions of dollars in judgments over the allegedly false representation and marketing of Risperdal, one of which settled in March 2015.

A judgment by a Philadelphia jury ordered Janssen and J&J to pay 2.5 million in damages to a man who took Risperdal as a an eight-year-old child and suffered from gynecomastia caused by Risperdal.