Risperdal Side Effects Spark Lawsuits
Risperdal (generic: risperidone) is an antipsychotic drug that is primarily used to treat bipolar disorder, schizophrenia, and irritability related to autism. A number of studies have shown the effectiveness of Risperdal in treating these conditions. However, the drug comes with the risk of a number of significant side effects, some of which have become the subject of Risperdal lawsuits. Most of the lawsuits involve a condition known as gynecomastia, which is abnormal breast tissue growth in males. Other serious side effects include stroke, Type II diabetes, and cardiac events.
More than 14,000 lawsuits have been filed against Janssen Pharmaceuticals, which is a division of Johnson & Johnson (J&J). The suits allege that J&J failed to sufficiently warn patients of the medical issues that could arise with taking the drug.
The pharmaceutical company at one time made an agreement that allowed the filing of lawsuits that fell outside the normal statute of limitations, however that agreement is no longer in effect.
Watch the YouTube video from last year reporting on an $8 billion jury verdict related to Risperdal side effects. Note that in January 2020, a judge slashed this award to $6.8 million.
Risk of Side Effects with Use of Risperdal
Here are some of the side effects associated with the use of Risperdal:
- Gynecomastia. Studies have demonstrated that Risperdal can cause the abnormal growth of breast tissue in males, including adolescents and young boys, which often requires surgery. The condition can also lead to psychological effects such as anxiety, depression, and negative body image. Gynocomastia is the subject of the vast majority of Risperdal lawsuits filed against J&J.
- Hyperprolactinemia. The use of Risperdal can lead to premature puberty in girls and cause loss of libido and lactation absent pregnancy.
- Type II Diabetes Mellitus. Several studies linked the use of Risperdal to abdominal weight gain, which can then result in insulin resistance and a greater risk of developing Type II diabetes.
- Weight Gain. The drug has also been linked to rapid weight gain in some individuals, which can be dangerous.
- Heart Attack/Stroke. This risk is present, particularly in elderly patients.
- Tardive Dyskinesia. This condition causes uncontrollable movements that may be irreversible.
According to the drug’s label, the use of the medication can also increase the risk of death in elderly patients who are taking the drug for dementia-related psychosis.
J&J Fined for Violation of the False Claims Act
The multitude of lawsuits is not the only trouble J&J has faced in connection with Risperdal. They were also investigated by the Department of Justice for off-label marketing of the drug. The DOJ investigation ended in a settlement of $2.2 billion paid by J&J that included $485 million in criminal fines for violation of the False Claims Act.
Risperdal was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult schizophrenia in 1994, but not for use in the elderly or children. J&J repeatedly attempted to gain approval for those groups but had no success. The company then engaged in illegal marketing of off-label use of Risperdal for the elderly and children. The drugmaker also enticed medical providers who prescribed the drug with perks and/or kickbacks.
J&J did not have to admit guilt as part of the $2.2 billion settlement with the DOJ. Although it was one of the biggest settlements for a matter involving healthcare-related fraud, the payment was a mere fraction of the sales that J&J made from sales of Risperdal, which was estimated to be around $30 billion at the time of the settlement.
Has the Medication been Recalled?
A small batch of Risperdal lots was recalled by J&J in 2011 due to consumer complaints of a foul odor. Aside from that, neither the manufacturer nor the FDA has issued a general Risperdal recall to date.
Sacramento Drug Products Liability Lawyer
Thanks for reading. I’m Ed Smith, a drug products liability attorney in Sacramento. Dangerous medications can lead to serious medical problems and physical injuries. If your health or that of a loved one has been affected by the use of a hazardous drug, I am happy to offer compassionate, free, and friendly advice. Call my office at (916) 921-6400, or at (800) 404-5400 if you are outside the local area code. You may also reach us online.
Photo Attribution: https://pixabay.com/photos/tablets-medicine-supplement-vitamin-5620566/
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