Lawsuits Continue To Grow Due To Risperdal Side Effect. A recent filing with the U.S. Securities and Exchange Commission (SEC) indicates that at least 13,000 product liability claims have been filed in courts around the United States against Johnson & Johnson’s (J&J) Janssen Pharmaceuticals unit, makers of Risperdal. The number of lawsuits continues to grow due to the side effects allegedly associated with the antipsychotic medication.
According to court records, many of the product liability claims involving Risperdal were filed due to the alleged side effect of gynecomastia (excessive breast growth) in men and boys.
Risperdal (risperidone) is an atypical antipsychotic medication used to treat schizophrenia, bipolar disorder (manic depression) and other psychiatric disorders. Atypical, also called second generation antipsychotics, are newer antipsychotic agents that have a different chemical makeup than older or typical antipsychotic drugs. They can be more effective in treatment-resistant patients and may have greater efficacy to treat negative symptoms than the older typical antipsychotic drugs.
In 2006, the U.S. Food and Drug Administration (FDA) approved Risperdal for treating irritability linked to autism in children and adolescents. One year later, the FDA approved Risperdal for use in children and adolescents with bipolar disorder and schizophrenia.
Side Effects of Risperdal
The side effect of gynecomastia is due to the elevated levels of prolactin, a hormone associated with female breast development and lactation, or the production of milk. The increased level of prolactin has also been linked the use of Risperdal and to the growth of female-like breasts in men and boys. Although gynecomastia is not a life-threatening condition, it may lead to embarrassment and severe psychological stress for some individuals. The “man boobs” can only be removed by surgery.
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.
Neuroleptic Malignant Syndrome (NMS) is a potentially fatal syndrome with symptoms including irregular pulse and blood pressure, muscle rigidity, and tremor. In at least 14 cases, NMS has been associated with the use of Risperdal.
Tardive (delayed) dyskinesia (abnormal movement) is an incurable movement disorder that may result in uncontrollable muscle movements such as lip smacking, grimacing, and spasms. Several cases of the condition have been reported connected to the use of Risperdal. In 2013, a study reported a rise in the risk of ischemic (restricted blood flow to the brain) stroke with the use of risperidone in patients over 64 years of age. At least 37 reports of stroke, including 16 deaths connected with Risperdal use have been documented.
Risperdal Lawsuits and Legal Issues
Plaintiffs allege that J&J and its Janssen Pharmaceuticals unit hid data connecting Risperdal to gynecomastia and neglected to provide doctors and patients with adequate warnings concerning this risk.
The personal injury attorneys at Parker Waichman LLP are actively reviewing potential lawsuits on behalf of individuals who may have suffered injury as a result of taking Risperdal.
A number of gynecomastia cases have recently gone to trial in Pennsylvania’s Philadelphia Court of Common Pleas. Court documents show that over 2,000 of the pending Risperdal lawsuits have been filed in a mass tort litigation. A mass tort is a single tort (a civil wrong) that results in injury to many victims, and involves numerous plaintiffs suing one or several defendants who acted negligently.
The 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. At that time, Risperdal had not been approved for pediatric use.
In February 2015, the Pennsylvania litigation concluded its first gynecomastia trial. The jury awarded the plaintiff $2.5 million. In March 2015, another jury did not award a second plaintiff any damages. It was determined that there was insufficient evidence to conclude that Risperdal had caused his breast enlargement. The jury did, however, find that the safety warnings provided to doctors and patients were inadequate.
A third gynecomastia plaintiff was awarded $1.75 million in November 2015. The Court later reduced the verdict to $680,000. In December 2015, a fourth Risperdal trial concluded with a verdict awarding the plaintiff $500,000.