A Philadelphia jury recently ordered Johnson & Johnson unit Janssen Pharmaceuticals to pay $70 million to the family of a young Tennessee boy who developed female breasts after using Risperdal, an antipsychotic drug approved by the FDA in 2002 for limited use for the treatment of schizophrenia and bipolar disorder in adults. The jury’s verdict from a Pennsylvania state court was not only the most recent, but it also represented the largest setback in the drug case’s ongoing, protracted legal battle.
Risperidone, also known by the brand name Risperdal, is a medication that belongs to a class of drugs known as atypical antipsychotics. It is used to treat a variety of mental health conditions, including schizophrenia, bipolar disorder, and autism-related irritability. It works by altering the levels of certain chemicals in the brain called neurotransmitters, which can help to reduce symptoms such as hallucinations, delusions, and agitation.
Like most medications, Risperidone can cause side effects, some of which can be serious. Common side effects of Risperidone include:
Some of the less common but serious side effects can be:
Patients should consult with their doctor if they have any concerns. Your doctor may also advise you to have regular monitoring such as monitoring blood sugar level, lipid profile, and weight if you are on Risperdal for an extended period of time. It’s important to follow your doctor’s instructions and report any side effects to your doctor as soon as possible. If you experience any severe or persistent side effects, you should contact your healthcare provider immediately.
When Andrew Yount, the plaintiff, began taking Risperdal in 2003, he was only 5 years old. As a result, he began to experience gynecomastia, a disorder where males and boys acquire female breast tissue as a result of an imbalance in hormones. Since the medicine was not FDA-approved for use in children until 2006, Yount should not have been taking it at all in 2003. Yount’s lawyers argued Janssen failed to warn healthcare providers and patients of the risks of gynecomastia with Risperdal use.
Yount’s gynecomastia was not caused by Risperdal, Janssen claimed, and they asserted that Yount profited from using Risperdal despite its permanently disfiguring adverse effects. In awarding Yount $70 million, the jury determined that Janssen willfully destroyed, hid, or misrepresented scientific evidence of this risk and that Janssen neglected to inform Yount and his healthcare professionals about the risk of gynecomastia when using Risperdal.
Lest you believe that this multimillion-dollar verdict is an outlier, Janssen has previously faced financial penalties for its acts concerning Risperdal. In 2013, Janssen agreed to pay $2.2 billion to resolve criminal and civil accusations made against the company by the U.S. Department of Justice (DOJ) for selling Risperdal for unapproved off-label purposes, including as the treatment of ADHD and autism in youngsters and dementia in older persons.
Janssen acknowledged that it promoted Risperdal to kids before the FDA approved its use in kids in 2006. The DOJ discovered that Janssen promoted Risperdal for usage in elderly patients with dementia and disorientation, despite the FDA specifically refusing approval due to the elevated risk of stroke.
More than 12,000 further claims have been made against Janssen and Johnson & Johnson about Risperdal and its disfiguring adverse effects. The jury’s $70 million verdict should make it clear to Janssen and other pharmaceutical companies that they have a responsibility to create and market safe medications as well as a responsibility to inform consumers and healthcare professionals of any risks and side effects related to using their products. Failing to do either of these things could prove to be a very expensive business decision.