What Is Risperdal?
Risperdal has been responsible for a wide variety of injuries. At MGM Attorneys, in Baton Rouge, we know how to hold drug manufacturers accountable.
Issues With Risperdal
Risperdal® (risperidone) is an antipsychotic drug approved by the Food and Drug Administration (FDA) in 1993 for use in schizophrenic patients. The FDA expanded Risperdal’s indication in 2003 to include short-term treatment of patients suffering from bipolar I disorder, and again in 2007 for the treatment of irritability associated with autism. From the time of its initial approval, the Food and Drug Administration repeatedly instructed manufacturer Janssen Pharmaceutica (part of Johnson & Johnson, Inc.) that it could not promote Risperdal as being safer or more effective than any other drug on the market, and that it could not promote the use of Risperdal for uses outside of its indication. Invega® (paliperidone) is an antipsychotic drug very similar to Risperdal that was approved for use in schizophrenic patients in 2006, which Janssen also marketed.
In spite of numerous FDA warnings, Janssen engaged in an ambitious marketing campaign that overstated the benefits of Risperdal, while also downplaying the risk of serious side effects known to occur with Risperdal use. Janssen promoted Risperdal as a safer and more effective alternative to other antipsychotic drugs, and encouraged its use in patients who were more likely to experience major side effects, such as children and the elderly. Janssen also promoted Risperdal outside of its approved indication, marketing the drug for use in individuals with anxiety or depression and for use in patients who were suspicious or uncooperative. As a result of Janssen’s marketing, sales of Risperdal skyrocketed, making it the most frequently prescribed antipsychotic drug on the market, and generating billions of dollars in profit for Janssen.
Even prior to the FDA’s approval of Risperdal, Janssen was aware that the drug could be expected to cause the same dangerous side effects as the older, more well-known, antipsychotic drugs. After approval, Janssen continued to receive reports of these serious adverse events occurring in patients using Risperdal. While Janssen knew that Risperdal was causing serious injuries to people, the manufacturer not only failed to warn physicians of the dangers of Risperdal, but also actively downplayed the risks of the drug and the warnings appearing in its label.
Governmental Investigation And Prosecution Of Janssen
After approving Risperdal for marketing in the United States, the FDA repeatedly warned Janssen that its promotion of the drug was false, misleading, and lacked fair balance with respect to Risperdal’s benefits and risks. Beginning in 2004, the U.S. Department of Justice began investigating Janssen’s marketing and promotion of Risperdal, eventually filing both civil and criminal actions against the manufacturer. In November, 2013, Janssen pled guilty to criminal charges stemming from its marketing of Risperdal and Invega, and agreed to pay approximately $2.2 Billion in fines. In announcing the agreement, the U.S. Attorney General described Janssen’s marketing practices as “shameful and unacceptable,” stating also that Janssen had “recklessly put at risk the health of some of the most vulnerable members of society — including young children, the elderly and the disabled.”
Janssen has also been sued by several state governments, including Louisiana, Mississippi, Texas and Arkansas. A total of 41 states and the District of Columbia have brought suit against Janssen as a result of its deceptive marketing and promotion of Risperdal.
Risperdal Side Effects
Gynecomastia and galactorrhea in boys and men. Gynecomastia is the swelling or development of breast tissue in boys or men. Galactorrhea is the production of a milky discharge from one or both nipples that resembles breast milk. Risperdal and Invega have been shown to cause both gynecomastia and galactorrhea in boys and men. Once an individual develops gynecomastia, the condition is usually permanent, requiring surgery to remove the unwanted breast tissue. Unlike gynecomastia, galactorrhea is not typically permanent. Still, the emotional trauma resulting from these physical changes — particularly in young boys or adolescents — can be devastating.
Movement disorders (tardive dyskinesia). Tardive dyskinesia or “TD” is a disease caused by the long-term use of certain drugs, and results in the development of abnormal involuntary movements. Risperdal and Invega have been shown to cause TD when used for extended periods of time. While the abnormal movements in TD most commonly occur in the tongue, mouth or face, they can occur anywhere on the body, including the trunk, hands, arms, legs and feet. TD can be very distressing and can severely impair a person’s ability to perform such basic tasks as eating, drinking, walking or even breathing. While certain abnormal movements may occur only while a drug is being used, the symptoms of TD are much less likely to disappear, even after the drug is stopped. There are other terms that are sometimes used to describe the type of abnormal movement a patient with TD displays. These terms include:
- Torticollis or retrocollis
There is no known cure for tardive dyskinesia, and the treatments used to control the symptoms of the disease are only of limited use, and also come with substantial risks of serious side effects. Methods of treatment include Botox therapy, deep brain stimulation and treatment with the drug Xenazine® (Tetrabenazine).
Stroke Or Death In Elderly Patients
During attempts to expand Risperdal’s indication to include the treatment of patients suffering from dementia, Janssen learned that using Risperdal in elderly patients significantly increased the patient’s risk of having a stroke or dying. The FDA identified the safety risks of using Risperdal in older patients, and required the addition of multiple warnings to Risperdal’s label as a result. These warnings included a “black box warning” — the strongest warning that the FDA can issue — regarding the risk of mortality in elderly patients treated with Risperdal.
Experienced Risperdal Lawyers
MGM Attorneys has unparalleled experience in handling lawsuits involving Risperdal side effects. Our attorneys were among the first to file lawsuits against Janssen for its deceptive promotion of Risperdal, and began pursuing claims against the manufacturer even before the federal government began its formal investigation. Since that time, MGM Attorneys has successfully prosecuted numerous claims on behalf of those injured by Risperdal.
Most recently, in November, 2014, our attorneys received a $1.95 million jury trial verdict against Janssen for its negligent promotion of Risperdal to elderly nonschizophrenic patients, and its failure to warn of the dangers of using Risperdal in these older individuals. MGM Attorneys has the experience and know-how to properly handle your Risperdal lawsuit in order to achieve the best possible result.
Contact Us For A Free Consultation
MGM Attorneys is proud to represent clients throughout Louisiana, and our offices are conveniently located in downtown Baton Rouge. If you or a loved one has taken Risperdal and been injured as a result, you may be entitled to compensation for those injuries. Contact us online or call us at 225-250-1751 to discuss how we can help.