What is Risperdal?
Risperdal (generic: risperidone) is an antipsychotic medication that works by changing the effects of chemicals in the brain. The drug is approved to treat schizophrenia, bipolar disorder (manic depression) and symptoms of irritability in children with autism spectrum disorder. Risperdal is made by Janssen Pharmaceuticals (a Johnson & Johnson company), and was first approved by the U.S. Food & Drug Administration (FDA) in 1993.
Which side effects have been linked to Risperdal?
Serious side effects of Risperdal may include:
- Production of prolactin
- Pituitary tumors
- Tardive Dyskinesia
- Neuroleptic Malignant Syndrome (NMS)
- Increased risk of sudden death from heart attack
- Diabetes, hyperglycemia and other blood sugar side effects
- Suicide, suicidal thoughts
- Bone loss
- Increased mortality in the elderly with dementia and related psychosis
Other, less severe side effects may include:
- Uncontrolled movements
- Upset stomach
- Runny nose
- Vision changes
- Saliva increase
- Abdominal pain
- Inability to control urination
- Weight gain
Who is at the greatest risk?
Studies have found that children face the greatest risk of developing a serious injury from Risperdal. The largest study regarding side effects of the drug in adolescents and children showed hormonal changes in male patients that triggered abnormal breast tissue growth. The researchers found that 3 out of 10 adolescents studied developed gynecomastia, and concluded that Risperdal should be administered to children and adolescents with extreme caution.
How long after taking Risperdal do side effects appear?
Side effects can occur anytime after a patient begins taking a drug. In one case, a boy developed gynecomastia after taking Risperdal for 5 years. Other side effects may present sooner. One study found that elevated levels of prolactin (a hormone that stimulates breast growth) in Risperdal users could persist for up to 2 years after treatment is discontinued.
Is there evidence linking Risperdal to gynecomastia?
Numerous studies have found an increased risk of gynecomastia with Risperdal. For example, a 2006 study in the Journal of Clinical Psychopharmacology described elevated prolactin levels in adults after they were treated with risperidone. In 2009, a paper in the Journal of Child and Adolescent Psychopharmacology noted that “persistent elevation of prolactin for periods up to 2 years has been documented in maintenance treatment with [Risperdal].”
What are Lawsuits Alleging?
Risperdal lawsuits allege that consumers were not warned that side effects of the drug may include gynecomastia. Plaintiffs may qualify to file a claim if they experienced abnormal breast growth requiring surgery (liposuction or mastectomy) to remove excess fat tissues. Complaints have also been filed alleging Risperdal caused tardive dyskinesia, neuroleptic malignant syndrome, heart attack, stroke, type 2 diabetes and even death.
Can I file a lawsuit if I took a generic form of Risperdal?
Not at this time. The U.S. Supreme Court has ruled that generic drug manufacturers may not be sued under state failure-to-warn laws for adverse reactions associated with their medications.
Has a class action been filed?
In April 2012, Johnson & Johnson was ordered to pay $1.1 billion over claims by the state of Arkansas that it failed to adequately warn doctors and consumers about the health risks associated with Risperdal. The verdict was J&J’s third straight loss in complaints filed over its marketing of the drug. Arkansas accused the company of concealing the side effects of Risperdal, and of misleading the state’s Medicare program, causing it to overpay for prescriptions. Previous class action lawsuits filed by the states of Louisiana and South Carolina resulted in fines of $258 million and $327 million, respectively, as well as a $158 million settlement in Texas.
Have any cases reached a settlement?
In September 2012, a lawsuit filed on behalf of 21-year-old Aaron Banks was settled on the opening day of the trial in Philadelphia. According to the suit, Banks took Risperdal between the ages of nine and 14, and subsequently developed gynecomastia, which led to prolonged psychological trauma. The terms of the settlement have not been made public.
Johnson & Johnson in November 2013 agreed to resolve criminal and civil investigations into the marketing of Risperdal and other medications by paying over $2.2 billion, one of the largest penalties ever levied against a company for healthcare fraud. J&J’s Janssen division pleaded guilty to misbranding Risperdal for “off-label” (unapproved) uses, and for paying kickbacks to doctors and to Omnicare Inc., the largest pharmacy for nursing homes.
Has there been a recall?
No. Despite being linked to gynecomastia and other serious side effects, Risperdal is still on the U.S. market and continues to be prescribed to patients across the country.
How much time do I have to file a Risperdal lawsuit?
Each U.S. state has its own statute of limitations (SOL) specifying how long consumers have to file a lawsuit. If you’ve been injured by Risperdal, you should contact a lawyer immediately to learn more about your legal rights. Don’t wait – your time to file a claim is limited.
I don’t have health insurance. Can I still file a lawsuit?
Having or not having health insurance has no effect on whether you qualify to file a Risperdal lawsuit. In fact, if you did not have health insurance coverage during your Risperdal treatment, the out-of-pocket money you paid for the drug may figure into potential losses alleged in the complaint.
How much money can I recover by filing a Risperdal lawsuit?
Risperdal users who developed gynecomastia may be entitled to significant compensation for their losses, including pain and suffering. The severity of your injuries, the medical treatment required, and time you were unable to work as a result of your condition will determine how much you may be able to recover in a Risperdal lawsuit.