Risperdal Lawsuit

Like nearly all medications, side effects can occur in patients taking Risperdal. Some of the most common adverse reactions found in clinical trials include:

• Drowsiness
• Fatigue
• Upper respiratory tract infection
• Vomiting
• Coughing
• Urinary incontinence
• Increased saliva production
• Abdominal pain
• Anxiety
• Increased appetite

• Dizziness
• Dry mouth
• Rash
• Tremor
• Nausea
• Dystonia
• Akathisia
• Dyspepsia
• Rhinitis
• Parkinsonism

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 approved²for 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.

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.

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.”

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 request¹⁰for 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.