When many people hear the phrase “antipsychotic drug”, they tend to think of an insane homicidal maniac who needs to be heavily sedated in order to keep society safe. But in reality, an antipsychotic drug is one that simply treats a medical condition that affects the mind. Around 7 million Americans are currently on some form of an antipsychotic, with one of the most popular being the drug Risperdal.
Risperdal has been around for decades since it was first approved by the U.S. Food & Drug Administration (FDA) in 1993. The initial approval allowed the manufacturer, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, to advertise the drug as a treatment for schizophrenia in adults only. Years later, in 2006 and 2007, the FDA granted additional approvals for the drug as a treatment for schizophrenia in children, for those suffering from bipolar disorder, and for children who had been diagnosed with autism.
It quickly became the most prescribed antipsychotic in the U.S. and yearly sales have averaged more than $3 billion a year.
However, despite being approved by the FDA, complaints about the drug began shortly after it was released onto the market.
The Problems With Risperdal
Every drug comes with side effects, however, the manufacturer is responsible for making all potential adverse reactions known to both the medical community and the patient. Researchers found that Risperdal has a long list of potential side effects.
Patients have found that the drug can cause:
- Weight Gain
- Skin Rash
- Dry Mouth
- Skin Rash
The more serious side effects of Risperdal include:
- Uncontrollable Tremors
- Stiff Muscles
- Body Aches
- Difficulty Swallowing
Today, thousands of patients have alleged that Johnson & Johnson failed to inform them of the potential side effects, in particular, gynecomastia. As a result, they have chosen to pursue personal injury lawsuits against the company, which has already faced a decade-long investigation by the Justice Department.
The first individual lawsuit alleging that the drug had caused serious harm to a patient was filed in 2010 by a man who had been given the antipsychotic drug as a child for “off-label” use between 1999 and 2004. During that time, he was diagnosed with gynecomastia.
Gynecomastia is a when men develop breasts. While occasionally this condition can go away on its own, in many cases, it takes additional medication or a mastectomy to remove the breast tissue. Not only does this lead to additional medical expenses and physical pain and suffering, but it also is emotionally traumatic for men.
A large number of the lawsuits filed against Johnson & Johnson involve plaintiffs who suffer from gynecomastia. They allege that the company never informed patients that this condition might occur and therefore caused thousands to suffer. It is also alleged that many of these men took the medication because the product was illegally marketed for “off-label” use.
Justice Department Investigation
Whenever a doctor prescribes a drug to a patient to treat a condition that the FDA did not approve the drug for, this is called an “off-label” prescription. Doctors are legally allowed to make these decisions if they feel that the drug is a good choice for their patient.
The manufacturer, however, is not allowed to advertise their product for a use other than what the FDA approved.
In the case of Risperdal, the Justice Department began an investigation into whether or not the company illegally marketed their product after numerous plaintiffs filed complaints. It was alleged that not only had the company marketed the drug as a treatment for children with schizophrenia prior to obtaining approval from the FDA, but that they had also advertised that it could be used to treat other conditions such as ADHD, depression, anxiety, and agitation in elderly patients with dementia.
In 2013, Johnson & Johnson agreed to a plea bargain and admitted to encouraging physicians to use the drug to treat elderly patients with dementia. As a result, they had to pay $2.2 billion in fines.
This isn’t the only circumstance in which the company paid out a large amount. Numerous settlements and successful verdicts have been obtained for plaintiffs and additional lawsuits are being filed every day. If your family has been affected by the adverse effects of Risperdal, our New York defective drug lawyers can help you learn more about your legal options today in a free consultation.