On February 25, 2015, a Philadelphia jury ordered drugmaker Johnson & Johnson to pay $2.5 million to a 20-year-old autistic man from Alabama who had developed 46 DD breasts as a young teenager – a condition known as gynecomastia.
In 2013, the company paid $2.2 billion to settle federal and state charges related to illegal marketing of Risperdal, but individual lawsuits continue to be brought in various states, including Pennsylvania, California, and Missouri.
Risperdal is an anti-psychotic drug first approved by the U.S. Food and Drug Administration in 1993 to treat adults with schizophrenia. It was not until late 2006 that it was approved for any use in adolescents and children. In 2006 and 2007, the FDA approved additional uses for Risperdal, including the treatment of bipolar disorder in adults and juveniles, schizophrenia in children, and certain behavioral symptoms in children with autism.
Risperdal works as an antipsychotic to block the activity of dopamine in certain areas of the brain; however, blocking dopamine also has an effect on the pituitary gland, causing a number of metabolic disruptions and results in the release of a hormone known as prolactin. Increased prolactin levels in young males has had unfortunate permanent effects.
Prolactin is responsible for stimulating breast tissue development and causing lactation in pregnant and nursing women, and for causing gynecomastia in adolescent males and in children as young as four. Gynecomastia can occur in one or both breasts and will not usually go away, even if the drug is discontinued. In mild cases, liposuction may be used to remove the tissue, but in more extensive cases, breast reduction surgery or a mastectomy may be indicated.
Despite initial rejection for use in pediatric patients, Janssen and Johnson & Johnson allegedly have illegally marketed the medication for use in children and for unapproved uses such as ADHD, pharmaceutical restraint, and dementia in elderly people. Though drug companies cannot officially promote drugs for unapproved uses, doctors are free to prescribe them as they see fit.
The defective drug attorneys at Childers, Schlueter & Smith are currently reviewing Risperdal cases in which a patient has been diagnosed with gynecomastia. If you have questions or concerns, contact one of our Risperdal lawyers today for a free evaluation. All inquires are completely confidential.