Risperdal: Research and Litigation

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.

Risperdal has serious side effects, including gynecomastia, the enlargement of male breast tissue. These adverse effects have prompted thousands of patients to sue the drug manufacturer.

This article shares important legal and lawsuit information regarding Risperdal. You’ll also learn about the drug’s off-label uses and side effects. Towards the end of the article, you’ll find a timeline of research and legal updates.

Drug manufacturers have a legal responsibility to ensure their medications carry adequate warnings and are safe to use. If you or a loved one has been harmed by Risperdal, you have legal options. Contact a product liability attorney near you to share your story and learn your rights. An attorney can determine if you have a valid claim and advocate for fair compensation.

What Does Risperdal Treat?

Risperdal helps relieve schizophrenia symptoms, including:

• 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.

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 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 experiencing:

• 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.

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 below.

Major Risperdal Litigation

To date, more than 13,000 Americans have sued the drug companies over their antipsychotic drug Risperdal. Many of the cases involved men who developed breasts while taking the medication. Studies confirm that male breast growth is a side effect of taking Risperdal.

The plaintiffs in the Risperdal gynecomastia lawsuits filed claims in federal district courts. They also filed cases in state courts. Some significant cases occurred in:

• Alabama
• Philadelphia
• New York
• Wisconsin

The U.S. Department of Justice also charged the defendants with deceptive marketing of Risperdal and healthcare fraud. In 2013, the federal government sued Johnson & Johnson for failing to warn patients about the growth of breast tissue. The parties settled the case for more than $2.2 billion.

Johnson & Johnson also faced charges in Texas. The Texas attorney general filed charges against the drug company for making misleading statements about Risperdal’s safety and effectiveness. The pharmaceutical company settled the matter for $158 million.

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 for Risperdal Injuries?

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.

Timeline of Risperdal News and Research Updates

Keep reading for significant updates regarding Risperdal research and scientific studies.

Oct. 20, 2006: Group Urges Caution on Use of Risperdal to Treat Autism

The U.S. Food and Drug Administration (FDA) approved Risperdal for the symptomatic treatment of irritability in autistic children and adolescents. In response, the National Autism Association (NAA) urged parents and health care providers to carefully research the potential side effects of Risperdal use by autistic children.

According to the NAA, documented side effects include:

• Lactation (in boys and girls)
• Weight gain
• Tardive dyskinesia, an often irreversible movement disorder

May 2020: Use of Risperdal to Treat Dementia Patients

The FDA has not approved Risperdal for the treatment of age-related dementia. The FDA hasn’t approved any antipsychotics for this purpose. But studies suggest that these drugs may help treat patients with “Behavioral and Psychological Symptoms of Dementia” (BPSD).

In a May 2020 study appearing in Frontiers in Pharmacology, researchers found that, of all the antipsychotics, risperidone may be the most effective at treating dementia. Other countries have approved Risperdal for this use. These countries include:

• Canada
• UK
• Australia

Other prescription medications the study considered include:

• Olanzapine
• Clozapine
• Quetiapine
• Aripiprazole

Of all these drugs, the study found Risperdal to benefit older patients who have dementia the best. But researchers warn that using antipsychotics to treat dementia and Alzheimer’s is a last resort.

November 2020: Study on Risperdal and Treatment of Generalized Anxiety Disorder

Mental Health Clinical published a study in November 2020 about the use of Risperdal to treat generalized anxiety disorder (GAD). According to the study, more than half the patients suffering from GAD fail to respond to initial treatment. So, researchers are often looking for alternative therapies and treatment options.

This 2020 study found that Risperdal can be effective at treating GAD. But, the study warned that these patients should take much lower doses of Risperdal than patients who have schizophrenia or bipolar disorder.

The reason experts believe Risperdal helps with GAD is that patients with an anxiety disorder usually have the same symptoms as those with schizophrenia and bipolar disorder. These symptoms include:

• Insomnia
• Fatigue
• Sleep disturbances
• Excessive fear and anxiety
• Inability to concentrate
• Irritability
• Muscle tension

Risperdal has sedation and calming effects. Researchers believe it may be suitable for the long-term treatment of GAD.

February 2021: Effectiveness of Using Risperidone to Treat Stuttering

In February 2021, Frontiers in Neuroscience published a study on using risperidone to treat stuttering. The study found that patients who took Risperdal had higher glucose uptake levels. They also showed an increased metabolism in the left striatum.

There is ample evidence that people with a stutter have higher metabolisms in the striatal and Broca areas. Risperdal works to slow down this activity. This, in turn, reduces a patient’s stuttering.

August 2021: Study Shows Harms May Outweigh Benefits for Patients Taking Risperdal

A study in BMC Medicine found that the risks of risperidone may outweigh the benefits in patients who have schizophrenia and bipolar disorder. This August 2021 study used the Positive and Negative Syndrome Scale (PANSS) to measure the pros and cons of taking this medication.

Researchers found that patients taking Risperdal were up to eight times more likely to suffer an adverse event compared with patients taking a placebo.

Specifically, the study found that Risperdal caused the following adverse side effects:

• Weight gain
• Tardive dyskinesia
• Gynecomastia

The study suggested that Risperdal was less harmful than benzodiazepines for the long-term treatment of schizophrenia and bipolar disorder. But, the health risks are still high. Researchers urge doctors to consider these adverse events before prescribing the drug.

Injured by Risperdal? Get Legal Help

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. It doesn’t matter if you took Risperdal or a generic version of the drug.

Over the years, plaintiffs have filed individual and class action lawsuits against various pharmaceutical companies. Specifically, plaintiffs have filed personal injury suits against the following drugmakers:

• Johnson & Johnson
• Janssen Pharmaceuticals
• Janssen Research and Development
• Elsevier Inc.
• Excerpta Medica Inc.

An experienced attorney can review your claim and guide you through the legal process. FindLaw’s directory of product liability attorneys can connect you with qualified legal help in your area. Select your state or city to review contact and ratings information for local experts. Your search results will also link you to additional details about the attorneys’ experience with dangerous drug litigation.