Risperdal Side Effects and Litigation
By Christie Nicholson, J.D. | Legally reviewed by Oni Harton, J.D. | Last reviewed February 08, 2024
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Risperdal (risperidone tablets) is an atypical antipsychotic medication for patients with schizophrenia. Johnson & Johnson's subsidiary, Janssen, manufactures and sells Risperdal. The U.S. Food and Drug Administration (FDA) approved Risperdal in 1994. This medication helps relieve schizophrenia symptoms.
Some of these symptoms include:
- Hallucinations
- Hearing voices
- Sensing things that are not there
- Unusual suspiciousness
- Paranoia
This medication also helps patients with bipolar I. Bipolar disorder is a mental illness that causes extreme mood episodes.
Thousands of patients take Risperdal to treat their mental health disorders. Many doctors have also prescribed Risperdal to young patients with autism spectrum disorder. The drug seems to help with many symptoms of the condition.
Like most drugs, Risperdal has serious side effects. Some of these adverse effects are severe enough to cause patients to sue the drug manufacturer.
Risperdal Side Effects
Most psychotropic medications carry adverse side effects. Common side effects of Risperidone include:
- Low blood pressure
- Dizziness and lightheadedness
- Trouble breathing
- Chest pain
- Muscle spasms
- Increased heartbeat
- Possible fainting
- Seizures
- Drowsiness
- Muscle stiffness
- Drooling
- Dry mouth and sore throat
- Persistent erection
- Thrombotic thrombocytopenic purpura (seen as fever and bruising)
- Increase or decrease in body temperature
- Difficulty swallowing
- Constipation
- Uncontrolled urination
- Weight gain
This list is long, but it isn't exhaustive. In addition to these side effects, there are other, more severe health risks for patients taking Risperdal.
Risperdal Health Risks
Before you take Risperdal and other antipsychotic medications, you must consider the potential health risks. These risks are higher for elderly patients and people suffering from:
- Hypotension
- Parkinson's disease
- Hyperglycemia
Some of the severe health risks caused by Risperdal include:
- Neuroleptic malignant syndrome (NMS): A life-threatening nervous system problem that can cause high fever, stiff muscles, sweating, fast or irregular heartbeat, change in blood pressure, and confusion. NMS can also affect your kidneys. Call your healthcare professional right away if you experience these symptoms.
- Tardive dyskinesia (TD): This condition involves involuntary bodily movements. Call your healthcare professional immediately if you get muscle movements that don't stop.
- High blood sugar and diabetes: Patients with diabetes or who have a higher chance of diabetes should have their blood sugar checked often.
- Stroke: Strokes have occurred in elderly patients with mental illness from dementia-related psychosis. The FDA did not approve this medication for this use.
- Gynecomastia: Young men who take Risperdal have reported symptoms of this disorder. Gynecomastia is an increase in breast tissue that can occur in men and boys. This side effect has spawned numerous lawsuits against Johnson & Johnson.
If you suspect you're experiencing any of these issues, talk to your doctor. Don't stop taking your medication until you speak with a healthcare professional. You could suffer withdrawal symptoms after a missed dose. Just take your next dose until you can meet with your prescribing physician.
What Should I Tell My Healthcare Professional?
Talk to your doctor before you begin a new drug regimen. Do the same for Risperidone.
Before you start taking Risperdal, tell your healthcare professional if you have any of the following:
- Heart problems
- Seizures
- Diabetes or increased blood sugar
- Liver disease
- Obstruction of your intestines
- Reye's syndrome
- Brain tumor
- Phenylketonuria
- Breast cancer
- Are pregnant, trying to become pregnant, or breastfeeding
- Drink alcohol
Even a low dose of Risperdal can cause problems if you suffer from any of these conditions. You must talk to your doctor if you're breastfeeding. Risperdal can appear in your breast milk.
Interactions With Other Drugs and Foods
Because certain medications can interact with Risperdal, talk to your healthcare professional about all prescription and non-prescription medicines you're taking. This includes supplements and vitamins.
Your healthcare professional may have to adjust your dose or watch you more closely if you take the following medications:
- Blood pressure medicines
- Levodopa and medicines called dopamine agonists
- Clozapine
- Carbamazepine
- Phenytoin
- Rifampin
- Phenobarbital
- Fluoxetine and paroxetine
In addition, you should avoid drinking alcohol while taking Risperdal. Your doctor will ensure there isn't a risk of an adverse drug interaction or allergic reaction before they prescribe this drug.
Is There Anything Else I Need To Know About Taking Risperdal?
You may experience dizziness and fainting while taking Risperdal. This is because Risperdal can cause a drop in blood pressure. This is especially true when you first start taking the drug or when your doctor increases your dosage.
Risperdal may also impair your:
- Judgment
- Thinking
- Motor skills
Be careful when operating machinery, including your car, until you know how Risperdal affects you. Avoid overheating and dehydration while taking Risperdal—the drug makes it harder to lower your body temperature.
Risperdal Lawsuits and Settlements
Numerous patients taking Risperdal filed suit against Johnson & Johnson (and other drugmakers) as a result of developing gynecomastia. Almost all the plaintiffs were young men who developed unusual breast tissue after long-term use of the drug.
Most plaintiffs sued in the Philadelphia County Court of Common Pleas and state courts in Missouri and California. As of November 2022, the defendants have resolved all the gynecomastia lawsuits.
The defendants in these cases included the following drug manufacturers and their subsidiaries:
- Johnson & Johnson
- Janssen Pharmaceuticals Inc.
- Patriot Pharmaceuticals Inc.
- Janssen Research and Development
The drugs that were the subject of these cases included the following:
- Risperdal
- Risperidone
- Invega
- Risperdal Consta
We will discuss some of the significant lawsuits regarding Risperdal in detail below.
Major Risperdal Litigation
In total, 13,400 plaintiffs sued the drug manufacturers for adverse side effects—specifically, gynecomastia. The defendants named above have resolved or settled most, if not all, of the Risperdal lawsuits. Some of the more remarkable cases occurred in the following jurisdictions.
Alabama State Court
This was the first victory for a Risperdal plaintiff. The plaintiff filed suit in February 2015. He took the drug for several years. By the time he sued, he had developed 40-DD breasts. He sued the manufacturers for failure to warn and for hiding information about the drug's risks. The jury awarded Pledger $2.5 million. But the defendants are currently appealing this case.
Philadelphia County Court of Common Pleas
The plaintiff was five years old when he first started taking Risperdal for a psychiatric disorder. The drugmaker never informed the plaintiff, his parents, or his doctor that gynecomastia was a potential side effect of the drug.
The young man developed full-sized breasts by the time he was a teen. The jury found in his favor and issued the largest verdict in the litigation, awarding him $70 million. The next largest award was just $2.5 million.
Damages for emotional distress caused by the plaintiff's gynecomastia was a large part of the jury award. The defendant, Johnson & Johnson, is currently appealing the damages portion of this case.
New York Federal Court
The plaintiff started taking Risperdal in 2002 when he was just nine years old. Like many other plaintiffs, he developed large breasts after taking the drug for years. His attorney argued that the drug manufacturers hid the fact that their drug caused gynecomastia. The jury agreed and awarded him $1 million.
Wisconsin State Court
This plaintiff didn't take Risperdal until after the FDA approved the drug for use in children and adolescents. He argued that the defendant didn't warn him or his doctor about the possibility of developing gynecomastia. The jury sided with the plaintiff and awarded him $500,000 in damages.
Johnson & Johnson Faces Criminal and Civil Penalties
Individual plaintiffs weren't the only ones who sued the makers of Risperdal and related drugs. The government pursued the drug company both civilly and criminally. The charges stemmed from what the government alleged was healthcare fraud and deceptive marketing for off-label uses of the drug.
In November 2013, Johnson & Johnson agreed to pay $2.2 billion to resolve the charges. This was one of the largest government penalties ever levied against a company for healthcare fraud.
According to the agreement, Johnson & Johnson pled guilty to misbranding Risperdal for unapproved uses. It also pled guilty to paying kickbacks to physicians and Omnicare Inc., the largest pharmacy for nursing homes.
Why Was Johnson & Johnson Liable?
Defendants Johnson & Johnson were liable for damages under product liability law. The law demands that consumer products be safe and meet consumers' expectations. As a result of its deceptive marketing practices, the courts held Johnson & Johnson liable for patient injuries. In some cases, the courts found the company responsible for emotional distress as well.
If you or a loved one experiences any unusual or painful medical conditions after taking Risperdal, you should first contact your doctor or other healthcare professional. Then, you should contact a product liability attorney.
Is the Drug Manufacturer Liable for Your Injuries?
Most medications have specific anticipated side effects. Drug manufacturers must make their products as reasonably safe as possible. They may be liable for damages if it fails to do so or markets the drug for off-label uses. The same is true if they hide information or don't warn consumers (patients) of adverse side effects.
Gynecomastia and other Risperdal side effects can seriously impact both your physical and mental health. They can also saddle you with significant medical bills. You may receive substantial compensation if you file a product liability lawsuit against the drug makers.
Considering a Risperdal Claim? Contact an Attorney Today
Treating Risperdal complications, including gynecomastia, can require expensive surgeries and medical care. A product liability suit can allow you to receive compensation for these expenses. Product liability law is complex. Consulting with an experienced attorney near you today is in your best interests.
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