Risperdal (risperidone) is an antipsychotic drug that has been linked to severe side effects in children, including growth of female breasts on boys (gynecomastia). Some children have suffered through surgery and long-term medical care for these potentially permanent side effects.
Risperdal Lawsuit Ends in $8 Billion Verdict
In October 2019, a jury in Philadelphia ordered Johnson & Johnson to pay $8 billion in punitive damages for failing to warn about the risk of breast-growth side effects from Risperdal. Click here to read more.
Over 5,000 Risperdal Lawsuits in Philadelphia
There are now over 5,800 Risperdal lawsuits pending in the Philadelphia Court of Common Pleas accusing Johnson & Johnson of failing to warn about the risk of gynecomastia. Click here to read more.
J&J Facing Over 18,500 Risperdal Lawsuits
As of January 2017, over 18,500 Risperdal lawsuits have been filed by young men who developed female breasts (gynecomastia). Johnson & Johnson has paid several confidential settlements to avoid jury trials. The biggest trial verdict was $70 million in 2016. Four other trials ended in payouts ranging from $500,000 to $2.5 million.
Jury Awards $70 Million in 5th Risperdal Trial
In July 2016, a 16 year-old boy from Tennessee who grew female breasts after taking Risperdal was awarded $70 million by a jury in Philadelphia. He started growing breasts when he was 5 years old. Click here to read more.
What is Risperdal?
Risperdal (generic: risperidone) is an oral antipsychotic medication that controls severe mood disorders, including schizophrenia and manic bipolar disorder. It is also sometimes used in combination with antidepressants to control depression. Risperdal is made by the Janssen Pharmaceuticals unit of Johnson & Johnson. It was approved by the FDA in 1993. Since then, it has been approved to treat several other psychiatric disorders.
What is Gynecomastia?
Gynecomastia is the growth of female breasts on boys. The tissue is not cancerous, but it can be painful and embarrassing, especially for teenage males. For this reason, many doctors recommend surgery. Severe gynecomastia may require a surgical procedure called a mastectomy, which involves the removal of breast tissue and excess skin. Because it involves glandular tissue, liposuction alone is usually not an effective treatment.
Risperdal and Gynecomastia
Risperdal may increase levels of prolactin, a hormone that causes the enlargement of breast tissue. In females, this can cause spontaneous production of milk (galactorrhea). In males, it can cause the breast tissue to enlarge (gynecomastia).
Studies first linked Risperdal to gynecomastia in 1999. Since then, many more studies have found evidence of this risk. According to one study published in Journal of Clinical Psychopharmacology in 2006:
“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 … risperidone should be administered with caution to children and adolescents.”
Other studies have found that young men on Risperdal may be 5-times as likely to develop gynecomastia. The risk also increases for older men, who may be 69% more likely to develop gynecomastia compared to men who do not take antipsychotic drugs.
Juries Award Millions to Risperdal Gynecomastia Victims
In November 2015, J&J was ordered to pay $1.75 million to the family of a boy from Maryland who was diagnosed with gynecomastia after taking Risperdal. Earlier that year, a confidential settlement was reached with a boy from California with gynecomastia. J&J has also paid $5.6 million to the family of a man who died after taking Risperdal during a clinical trials.
In December 2015, a jury in Philadelphia ordered Janssen to pay $500,000 to a boy from Wisconsin who was diagnosed with gynecomastia after taking Risperdal as a teenager from 2006-2009. It was the 4th case to go to trial in Philadelphia and the third to end in favor of the plaintiffs.
$2.5 Million Awarded to Boy With 46DD Breasts
In March 2015, a jury in Philadelphia has ordered J&J to pay $2.5 million to a 22 year-old autistic man who developed size 46DD breasts after taking Risperdal “off-label” as a child. Dr. David Kessler, a pediatrician and former commissioner of the FDA, testified that J&J failed to warn about gynecomastia. The boy’s doctor also said he would have reconsidered prescribing Risperdal.
Over 1,000 Risperdal Lawsuits Filed in Philadelphia
Over 1,100 lawsuits involving Risperdal have been centralized in Philadelphia. Many of these lawsuits allege that Johnson & Johnson engaged in illegal off-label marketing of Risperdal, created a pay-off system to motivate nursing homes to prescribe Risperdal, and defrauded the state Medicare system of millions of dollars.
One lawsuit was filed by a 27 year-old man who took Risperdal and developed severely enlarged breasts that had to be treated with a double mastectomy. Another lawsuit was filed by a boy who was given Risperdal “off-label” for ADHD and developed gynecomastia.
$2.2 Billion Settlement With Justice Dept. for Risperdal Marketing
In November 2013, J&J agreed to pay $2.2 billion in civil and criminal fines to the Justice Department. The drug-maker was accused of illegally marketing Risperdal to dementia patients and children while paying kickbacks to doctors.
Several states sued J&J for fraud, but in March 2014 the Arkansas Supreme Court tossed a $1.2 billion judgement against J&J, reducing it to $7.75 million. The drug-maker also cut a deal to pay less than $5 million to each of 36 states, Law360 reports. In South Carolina, J&J was ordered to pay $124 million for marketing violations.
J&J: America’s Most Admired Law Breaker
In September 2015, investigative journalist Stephen Brill published named Johnson & Johnson America’s Most Admired Law Breaker, a 15-part exposé published by the Huffington Post. The in-depth report showed how J&J used illegal marketing tactics in Texas to convince doctors around the world to prescribe Risperdal “off-label” for children and the elderly.
J&J also “massaged the data” to downplay serious side effects. It takes only a third-grader’s math level to understand how Johnson & Johnson fudged the numbers to make it seem like Risperdal had only a 0.8% risk of causing gynecomastia, when in fact the number was closer to 4.5% of boys.
Risperdal and Diabetes
Risperdal is associated with an increased risk of type-2 diabetes and hyperglycemia (high blood-sugar) in children and adults. Risperdal can lead to the development of “medically serious” weight gain, which predisposes patients to diabetes. Studies linking Risperdal and diabetes:
- Pharmacotherapy (2003) — 131 cases of high blood-sugar (hyperglycemia) linked to the use of Risperdal.
- American Journal of Epidemiology (2006) — Study links Risperdal and weight-gain that “may contribute to the increased risk of diabetes.”
- Child & Adolescent Psychiatry (2014) — Study found that 0.72% of children on antipsychotic drugs like Risperdal develop diabetes, compared to just 0.27% of children who did not take the drugs.
Risperdal Side Effects
- Blood sugar disorders (hyperglycemia)
- Transient ischemic attack (mini-stroke)
- Weight gain
- Pituitary tumors
- Neuroleptic Malignant Syndrome (NMS)
- Tardive dyskinesia (involuntary movement disorder)
- Heart problems
- Bone loss
- Increased risk of stroke among the elderly with dementia
- Click here for a list of side effects