A plaintiff who is now 22 years old has won a $2.5 million award for the serious side effects he suffered from taking the drug Risperdal. He was prescribed Risperdal (risperidone) for autism at the age of eight in 2002. This was four years before Risperdal was officially approved by the U.S. Food and Drug Administration (FDA) for use in children and adolescents.
Gynecomastia, also known as “man boobs” was highlighted in an article about the Risperdal lawsuit that appeared in People Magazine on February 26, 2015. The article brought the condition to the public’s awareness, for some people who may not have known of its existence. The Philadelphia judge refused to overturn the award granted the young man due to the serious nature and consequences of the adverse effects suffered by the plaintiff.
Extent of Risperdal Side Effects
As reported by People, the Risperdal gynecomastia plaintiff’s breasts had grown to a size 46DD, and the autistic man in his frustration, had been known to smash his breasts on a table causing bruising. The mother of the autistic man testified during the trail that her son would typically cover himself with a large towel when he stepped from the shower, so he would not be confronted by his image in the bathroom mirror.
National law firm Parker Waichman LLP has extensive experience and success in representing clients in pharmaceutical litigation. Attorneys at the firm are available to answer questions for individuals seeking legal information for a potential lawsuit.
“Off Label” Risperdal Use
Physicians have the legal, medical and ethical right to prescribe drugs off-label. This means that drugs may be prescribed for uses other than those indications approved by the FDA provided the medication would benefit the patient. Therefore, it was perfectly within the doctor’s authority to prescribe Risperdal to the then-eight-year-old autistic boy since the assumption was that the drug would be beneficial to the young patient.
Risperdal is a widely-used antipsychotic medication, and was initially prescribed to treat extreme mental disorders such as schizophrenia and bipolar disorder in adult patients. This medication was then later FDA approved for children with specific forms of autism, along with other mental disorders.
The condition gynecomastia begins with elevated levels of prolactin, a hormone associated with female breast development and lactation, or the production of milk. The increased level of prolactin has been linked to Risperdal and to the growth of female-like breasts in men and boys. Symptoms may include enlarged nipples, painful breasts, and nipple discharge. Although gynecomastia is not a life-threatening condition, it may lead to embarrassment and severe psychological stress for some individuals. The excess breast tissue growth can only be removed surgically.
Other serious risperidone side effects began to surface as early as 2006. The issues reported by patients and scientific studies included diabetes, heart problems, as well as gynecomastia. In 2003, a study published in Pharmacotherapy reported that treatment with antipsychotic drugs such as risperidone may increase the risk of high blood sugar and diabetes. The FDA required a warning placed on package inserts in 2004, alerting patients and doctors of these potential risks.
Lack of Awareness of Gynecomastia Risk with Risperdal
At the Philadelphia trial, the family physician testified that he was not aware of Risperdal side effects that potentially may lead to male breast growth. The young man’s mother testified as well, that she was unaware of the risk for Risperdal gynecomastia. Her son was now facing a possible double mastectomy, surgery being the only way at this time, to remove the unwanted growths to restore a more masculine upper torso.
Despite the manufacturer’s seeking a new trial and appealing for the verdict to be overturned, citing the countless children and adults who benefited from the use of Risperdal, the Philadelphia court denied their motions and the judge in State court in Pennsylvania upheld the original verdict of the $2.5 million award for the family from Alabama.
Risperdal litigation’s largest verdict to date is $70 million, awarded in July 2016 to a teenager who suffered excessive breast growth shortly after he began treatment with Risperdal in 2003. At the time, he was five years old – another case where Risperdal had not yet been FDA approved for pediatric use.
Legal Help and Information for Risperdal Users
If you or someone you know has been injured by adverse side effects from pharmaceuticals, such as Risperdal, you may be eligible for compensation. Parker Waichman offers free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).