When antipsychotic drug Risperdal was released in the 1990s, pharmaceutical company Johnson & Johnson touted it as a step up from anything else on the market. Their claim is why it has since been used by millions of Americans to treat schizophrenia, bipolar disorder, and irritability related to autism.
What the public didn’t realize until much later was that the drug carried unexpected and life-altering side effects. Thousands of men have claimed that taking Risperdal caused them to develop gynecomastia, a disorder resulting in the enlargement of male breasts. They accuse drugmaker Johnson & Johnson and its subsidiary Janssen Pharmaceuticals of hiding the risks and failing to warn the public about side effects.
On top of all that, Johnson & Johnson was slapped with more than $2 billion in government fines for marketing its drug to vulnerable populations - against the recommendation of the U.S. Food and Drug Administration.
Thousands of lawsuits are currently pending in court and moving toward a possible settlement.
What is Risperdal?
Risperdal is in a class of drugs called atypical antipsychotics, also known as second-generation antipsychotics (SGAs). The generic ingredient of Risperdal is risperidone. It is used to treat schizophrenia, bipolar disorder, and autism-related irritability.
Although the exact way Risperdal works is not entirely known, it is believed Risperdal affects different neurotransmitters in the brain, particularly dopamine and serotonin. These two neurotransmitters are naturally occurring chemicals1 that help the body and mind stay calm. By rebalancing the two through reduction or blockage, Risperdal could improve mood, behavior, and thinking.
The drug is typically taken once or twice a day with or without food. Doses start low before being slowly increased over the course of several weeks, and can be administered orally or intravenously.
Common Risperdal Side Effects
Like nearly all medications, side effects can occur in patients taking Risperdal. Some of the most common adverse reactions found in clinical trials include:
- Upper respiratory tract infection
- Urinary incontinence
- Increased saliva production
- Abdominal pain
- Increased appetite
- Dry mouth
Serious Risperdal Side Effects
In some cases, rare but serious side effects can also occurwhile taking Risperdal. They include:
- Metabolic syndrome
- Transient ischemic attacks
- Heart attack
- Neuroleptic malignant syndrome
- Extrapyramidal effects
- Weight gain
History of Risperdal
Studies on Risperdal safety and efficacy started in the late 1980s. Janssen Pharmaceuticals, a division of Johnson & Johnson, eventually submitted a new drug application to the FDA where it was officially approved2 for use in the treatment of adults with schizophrenia in late 1993.
In the following years, Janssen worked to expand the use of the drug for other treatments. In 2003, it was approved for adult bipolar disorder. Then, in 2006, Risperdal was approved for use in treating irritability in autistic children between ages 5 and 16. Finally, in 2007, the FDA approved Risperdal for treatment of schizophrenia in children between 13 and 17.
In 2008 Johnson & Johnson lost the patent on Risperdal but up until that point the drug was a huge seller for the company. In the years it was available, some estimates say the drug brought in $18 billion in profits. In 2007 alone, Risperdal’s global sales reached around $4.5 billion.
Studies Link Risperdal to Gynecomastia
After Risperdal was approved, there was an increase in reports of a disorder called gynecomastia — a condition marked by the swelling of the breast tissue in males.
Risperdal is believed to cause gynecomastia because the drug increases levels of prolactin in the user. High levels of prolactin in males can stimulate breast development and even lactation, known as galactorrhea.
A 2006 study in the Journal of Clinical Psychopharmacology3 found a connection between adult males taking risperidone and gynecomastia. The authors concluded, “Risperidone administered to adolescents at doses commonly used for the treatment of psychotic symptoms can strongly increase prolactin levels, with clinical consequences such as gynecomastia and/or galactorrhea.”
In 2015, a separate study chronicled in the Journal of Child and Adolescent Psychopharmacology4 stated that “risperidone is associated with an increase with the risk of gynecomastia in adolescent and young adult males.” Researchers looked at more than 400,000 males and found that those taking risperidone had around four times the risk of developing gynecomastia than males not taking the drug.
Clinical trials also revealed that 2.3% of 1,885 children and adolescents taking Risperdal developed gynecomastia.
In some of the cases of gynecomastia, males have developed breasts up to cup size DD.
Dangers of Gynecomastia
Although mild cases will sometimes resolve themselves after stopping treatment with Risperdal, more severe cases of gynecomastia will require intervention.
Some males who developed gynecomastia after taking Risperdal had to undergo liposuction or male breast reduction surgery. Several boys even had to undergo a mastectomy to address the disorder.
Although some cases of gynecomastia are not harmful physically, they can be detrimental to the mental health of males. Men who develop the disorder often score lower on surveys measuring quality of life.
One report in the medical journal of the American Society of Plastic Surgeons5 revealed that even mild gynecomastia could have a negative psychological effect on boys. Patients not only had lower scores for physical health but also had lower scores for social functioning and mental health.
Thousands File Risperdal Lawsuits
As a result of the unexpected side effects that negatively affected countless boys taking Risperdal, thousands of lawsuits have been filed against Janssen Pharmaceuticals and Johnson & Johnson.
One of the first gynecomastia lawsuits6 against the companies was filed in 2008 in Philadelphia. Two of the six boys filing the suit required mastectomies to remedy the problem. At the time, Johnson & Johnson argued that there was a warning of gynecomastia on the label. However, a researcher agreed with the plaintiffs, saying that changes in hormones aren’t harmless.
Shortly after, several more lawsuits were filed with similar stories.
In 2010, for example, Aron Banks sued Janssen7 over claims that he experienced rapid weight gain and problems with his endocrine system after taking Risperdal starting at age 9 from 2000 to 2004. He blamed Risperdal for causing the development of breasts he said would likely require a mastectomy to remove. He settled the case with Janssen for an undisclosed amount in 2012.
Allegations Made in Risperdal Lawsuits
Thousands of men have filed lawsuits, and the allegations against the companies making Risperdal and other risperidone-containing drugs are varied.
Many of the lawsuits accuse Johnson & Johnson of engaging in illegal marketing practices, leading to increased doctor recommendations. They also claim that manufacturers knew Risperdal had dangerous side effects but did not properly warn patients of the elevated risks.
Risperdal was often touted as safer and more effective than competing antipsychotics, but evidence suggests it was not.
Johnson & Johnson Pays $2.2 Billion in Risperdal Settlement
There is a precedent for Johnson & Johnson failing to warn the public about dangers and putting profits over safety.
In November 2013, the pharmaceutical giant agreed to pay more than $2.2 billion to settle a lawsuit8 brought by the U.S. Department of Justice over a variety of criminal and civil charges. The settlement was one of the largest in history against a drugmaker.
According to the Justice Department, the FDA repeatedly told Janssen not to market Risperdal to the elderly because it could be dangerous, especially to those with dementia. Despite knowing the risks, they continued off-label marketing to the elderly.
Along with those claims, the government also accused the company of promoting the drug to children and adolescents, even though it knew about the increased risk of gynecomastia.
“When companies put profit over patients’ health and misuse taxpayer dollars, we demand accountability,” then-Associate Attorney General Tony West said in a statement at the time. “In addition to significant monetary sanctions, we will ensure that non-monetary measures are in place to facilitate change in corporate behavior and help ensure the playing field is level for all market participants.”
Risperdal Verdicts & Settlements
Although there are still thousands of cases pending, some have already gone to trial or reached settlements.
Here is a partial list of some of the verdicts and settlements so far:
September, 2012 - Aron Banks was one of the first to reach a settlement over claims that Risperdal caused his gynecomastia. The two sides reached a settlement7 two years after the lawsuit was filed for an undisclosed amount. The settlement was reached the morning the trial was set to begin.
October, 2012 - Five more settlements were reached9 with those claiming Risperdal caused their gynecomastia.
February, 2015 - A jury awarded a $2.5 million verdict in favor of a boy named Austin Pledger, who developed gynecomastia after taking Risperdal. It was the first bellwether trial, and Janssen was later denied a request10 for a new trial.
March, 2015 - The jury in the second trial found Janssen had failed to warn patients adequately about the risk of gynecomastia but did not award any damages to the plaintiff.
May, 2015 - Another case was settled for an undisclosed amount before going to trial.
November, 2015 - A jury found in favor of the plaintiff and awarded a man who developed breasts after taking Risperdal $1.75 million.
December, 2015 - The fourth jury to return a verdict in gynecomastia cases found Janssen failed to warn about the risks of Risperdal. A young boy was awarded11 $500,000 in compensatory damages.
July, 2016 - Johnson & Johnson was hit with the highest verdict12 so far after a teenager blamed Risperdal for giving him large breasts. He was awarded $76 million.
January, 2017 - Another case filed in 2013 by the family of a boy from New York who grew large breasts following treatment with Risperdal was settled for an undisclosed amount.
In the first half of 2017, thousands of additional cases related to gynecomastia were filed against Janssen and Johnson & Johnson. More cases are expected to be filed in the coming months. Anyone who has been harmed by Risperdal should contact an attorney immediately.