FAQs: the dangerous antipsychotic prescription medication Risperdal

On behalf of Dennis Reich at Reich & Binstock LLP

Hundreds of lawsuits have been filed seeking damages for devastating side effects.

We have frequently updated our website with new information about injuries patients have received from taking the antipsychotic drug Risperdal, manufactured by Johnson & Johnson subsidiary Janssen Pharmaceuticals. Here we answer questions about the drug and describe recent developments.

Q: What is Risperdal and why is it controversial?

Risperdal, also known by its generic name risperidone, is an antipsychotic known as atypical or second generation, referring to more recently developed medications that tend to have fewer side effects. On the contrary, however, the use of Risperdal has caused dangerous side effects in some patients.

Risperdal was approved by the Food and Drug Administration or FDA in 1993 for schizophrenia in adults. Since then, the FDA has expanded approval to schizophrenia in adolescents; bipolar disorder in adults, adolescents and children; and irritability associated with autism in children and adolescents.

However, doctors have also prescribed Risperdal for conditions not approved by FDA, called off-label use of the drug, including ADHD, obsessive-compulsive behavior, dementia and others.

Q: What is the problem with off-label prescription of Risperdal?

Prescribing a drug for unapproved uses increases the risk of dangerous side effects by 54 percent, reports The Washington Post. In 2013, Janssen Pharmaceuticals settled criminal and civil charges of health care fraud with the federal government to the tune of $1.67 billion in fines that included pleading guilty to charges related to misleading marketing and misbranding of Risperdal to doctors, according to an FDA news release.

In particular, the government alleged that Janssen had promoted the drug as safe for unapproved uses in children and the elderly. In a court filing, the government asserted that the manufacturer "downplayed" the risk of stroke in the elderly and marketed the drug to children and people with developmental disabilities, despite elevated risks of diabetes and the risk of lactation or of breast development because of hormonal changes, a devastating condition called gynecomastia, according to a news release by the U.S. Department of Justice or DOJ.

Q: What are recent headlines regarding Risperdal?

In January 2016, the U.S. Supreme Court let stand a South Carolina Supreme Court ruling that Janssen owed $124 million in a state penalty for improper marketing and concealment of the risks of Risperdal. In July, a Pennsylvania jury awarded $70 million in compensatory damages for the development of breasts in a five-year-old boy from Risperdal after the manufacturer failed to provide adequate warnings, according to Bloomberg BNA.

Q: What about other lawsuits concerning Risperdal?

Hundreds of Risperdal claims have been filed and are pending in courts across the country. Lawsuits continue to be brought seeking justice for those harmed by the drug. For example, several suits, each with multiple plaintiffs, have been filed this summer 2016 in California state court. Those complaints allege state law claims against the manufacturer and affiliated defendants like strict products liability, negligence, failure to warn, breach of various warranties, fraud and negligent misrepresentation.

Q: What should someone injured by Risperdal do?

After seeking immediate medical care, anyone injured by Risperdal or whose child or loved one has been harmed should as soon as possible seek the legal advice of an attorney with Risperdal claim experience to understand what legal options are available, including a possible personal injury lawsuit.

From their office in Houston, the lawyers at Reich & Binstock LLP represent clients in Risperdal claims throughout the state of Texas and across the country, In particular, attorney Dennis Reich was appointed to the Los Angeles, California, Risperdal Plaintiffs Steering Committee to focus on Risperdal lawsuits that seek damages for the development of gynecomastia in male patients.