Risperdal lawsuits allege patients were not properly warned of severe side effects like gynecomastia (abnormal breast tissue growth in males), type 2 diabetes, stroke and cardiac events. Patients have filed more than 14,000 Risperdal lawsuits against Janssen Pharmaceuticals (a division of Johnson & Johnson), about half of which have been filed in Philadelphia.
In addition to thousands of civil lawsuits from consumers, the drugmaker was investigated by the U.S. Department of Justice for off-label Risperdal marketing. The investigation resulted in a $2.2 billion settlement, which included payment of $485 million in criminal fines for violating the False Claims Act.
Why People Are Filing Risperdal Lawsuits
Risperdal (risperidone) is an atypical antipsychotic drug used primarily to treat schizophrenia, bipolar disorder, and irritability associated with autism. While many studies have demonstrated Risperdal's effectiveness at treating these conditions, the drug can also cause a number of serious side effects. Most of the legal claims in Risperdal lawsuits have focused on these adverse effects, particularly gynecomastia, blaming J&J for failing to adequately warn patients of the problems that could develop if they took the drug.
Gynecomastia (Male Breast Development)
Several studies have shown that Risperdal can cause growth of breast tissue in males, including young boys and adolescents. The condition often requires surgical treatment in cases of long duration. It can also lead to psychological consequences including depression, anxiety and negative body image.
The vast majority of legal claims against J&J are related to gynecomastia. Most of these claims are filed by young men or the parents of boys who required surgery to remove breast tissue. In addition to medical costs of treatment for gynecomastia, plaintiffs also claim that their abnormal male breast tissue growth led to humiliation, emotional suffering and a lower quality of life.
Other Risperdal Side Effects
Some lawsuits have also named other serious side effects of Risperdal as the basis for a legal complaint. These include:
- Hyperprolactinemia: Risperdal can trigger premature puberty in girls and young women, leading to lactation (without being pregnant) and loss of libido.
- Type II Diabetes Mellitus: Studies have linked Risperdal use to abdominal weight gain, which can lead to insulin resistance and an increased chance of developing type II diabetes.
- Rapid Weight Gain: Risperdal has been linked to dangerously fast weight gain in some individuals.
- Tardive Dyskinesia: Risperdal may increase the risk of developing tardive dyskinesia, a sometimes irreversible condition characterized by uncontrollable movement.
- Heart Attack and Stroke: Elderly patients in particular who take Risperdal may be at a higher risk of a heart attack or stroke.
- Death: According to a black box warning on the drug label, Risperdal increases the risk of death in elderly patients with dementia-related psychosis.
Fewer lawsuits have been filed in relation to these adverse effects, and many of these conditions are now listed on the drug label warning. If you are a loved one are taking Risperdal, you, should talk to your doctor to see how to reduce the risk of severe complications.
Johnson & Johnson Marketing Claims
Risperdal was first approved for the treatment of schizophrenia in adults in 1994. At that time, it was not approved by the U.S. Food and Drug Administration (FDA) for use in children or the elderly. Johnson & Johnson tried multiple times in the 1990s to gain approval for these age groups without success. Nonetheless, J&J ran illegal marketing campaigns targeting both young and old individuals for off-label uses.
As part of its efforts, the pharmaceutical company provided various perks ("kickbacks") to physicians and medical facilities that prescribed the drug. For example, J&J developed a shady profit-sharing scheme with Omnicare, one of the largest nursing home pharmacy systems in the U.S. Separately, in 2003 a marketing manager proposed including lollipops and small children's toys with Risperdal samples as part of a "back to school" campaign.
After a lengthy investigation, in 2012 the U.S. Department of Justice and J&J agreed to settle a large number of civil and criminal charges related to illegal marketing of unapproved uses of Risperdal. The $2.2 billion settlement amount included approximately $485 million in fines specifically tied to False Claims Act allegations, although the drug manufacturer did not have to admit guilt as part of the settlement. As one of the largest healthcare-related fraud settlements ever in the U.S., it still represents only a fraction of the $30 billion J&J had made from sales of Risperdal at the time of the settlement.
Current Risperdal Litigation
According to Johnson & Johnson's most recent annual report, the company is still facing about 13,400 Risperdal lawsuits. Approximately half of these are filed in the Philadelphia Complex Litigation Center, with the rest being filed in various other state and federal district courts around the country. Unlike many other drug lawsuits, there is no multidistrict litigation for Risperdal.
Philadelphia Risperdal Lawsuits
As of March 2019, more than 6,700 Risperdal lawsuits had been filed in the Philadelphia Complex Litigation Center (CLC), a special Pennsylvania State court designed to handle large-scale civil trials (also known as mass torts). The earliest CLC cases were filed in 2010, and a large group of older cases were settled in 2013.
In early 2017, an influx of about 3,000 Risperdal lawsuits were filed in the CLC after J&J canceled its "tolling" agreement with plaintiffs, drastically shortening the statute of limitations deadline by which new lawsuits could be filed. In early 2018, a Superior Court of Pennsylvania ruling paved the way for thousands of Risperdal cases in the Philadelphia court to seek punitive damages from Johnson & Johnson. Punitive damages had previously been barred by a 2014 trial court judge.
The most recent case management order indicates that the first group of the recent Risperdal trials will begin in June 2019, with additional trials beginning each month after that through 2020. Depending on how early trials go, Johnson & Johnson may be persuaded to settle claims with the remaining plaintiffs. On the other hand, if J&J wins some early verdicts, the company could be persuaded to keep dragging out the trials in the hopes that many more plaintiffs will lose or withdraw their lawsuits.
Risperdal Settlements and Verdicts
While there are many Risperdal lawsuits still working their way through various courts, some cases have already been settled or received a verdict. Here are a few stories from those who have undergone the process.
Nicholas Murray - $680,000
In November 2015, the jury in this case took only 2.5 hours to award damages in the amount of $1.75 million to the plaintiff. Murray had been prescribed Risperdal in an off-label fashion for symptoms associated with his autism and developed "female-like breasts" as a result of the prescription. Even after stopping the medication and losing weight from exercise and nutrition, the breasts remained.
The initial award was later reduced by the trial judge to $680,000, based on the maximum amount of compensation allowed by the plaintiff's home state (Maryland). However, in February 2018, a three-judge panel of the Superior Court of Pennsylvania ruled that the case should go back to trial to determine eligibility for punitive damages, based on a previous decision preventing such damages according to New Jersey state law (where Johnson & Johnson is headquartered).
This "choice of law" principle gives plaintiffs more options for seeking damages in personal injury cases. Regardless of whether Murray receives any punitive damages, his $680,000 verdict will stand, based on the Superior Court's unanimous ruling.
Andrew Yount - $76.7 million
This record-breaking verdict in June 2016 dwarfed its predecessors when the jury awarded $70 million in damages to Andrew Yount, an adolescent boy with autism, and his parents. In addition to finding that J&J had failed to warn the plaintiff, his parents, and his doctors about the gynecomastia risk, the jury also determined that J&J had purposely concealed and falsified information about the risks.
After the initial award, a Pennsylvania state judge added $6.7 million in "delay damages" to Yount's total amount of compensation. Delay damages are a type of compensation given to some plaintiffs who have had to wait an especially long time to resolve their case, in many cases due to unnecessary or prolonged delays caused by the defendant. In this case, the Yount family had to wait for well over two years filing their complaint before the matter was resolved.
Austin Pledger - $2.5 million
The second-largest Risperdal verdict to date is $2.5 million, awarded to Austin Pledger in February 2015. Pledger took Risperdal for five years as a child to help decrease behavioral issues connected to his autism. His parents claimed that the exposure made Pledger develop size 46DD breasts. They also alleged that Johnson & Johnson had knowingly withheld information about the side effect from both his parents and his physician.
A key witness in the case was Pledger's doctor, who testified he was not aware that gynecomastia was a potential side effect of Risperdal, indicating that J&J had not done enough to make physicians aware of the issue. The drug company appealed the trial verdict, but in May 2016, a Philadelphia judge denied the appeal, leaving the $2.5 million award in place.
Timothy Stange - $500,000
In December 2015, Timothy Stange won $500,000 in his trial against Johnson & Johnson over Risperdal. The suit was originally filed in 2013 due to Stange's breast growth related to his taking Risperdal since 2006.
While Stange won half a million dollars in compensatory damages, he was initially prohibited from pursuing punitive damages as well, due to a decision by the trial judge and complications in the interactions of various state laws. Shortly after the verdict, Stange appealed to be allowed to file punitive damages claims. In February 2018, the Superior Court of Pennsylvania ruled in Stange's favor, ordering the case to go back to trial to determine whether punitive damages should be awarded and, if so, how much they should be.
Did Johnson & Johnson issue a Risperdal recall?
No Risperdal recalls have been issued recently.
In 2011, J&J recalled a small number of Risperdal lots due to users complaining about a foul odor. After an investigation by the company and the FDA, the pills were found to be contaminated with trace amounts of TBA (2,4,6 tribromoanisole), a chemical used to treat the wooden pallets that transported the drugs. However, there is no evidence that the contamination led to any serious adverse events, though a few users reported gastrointestinal issues.
Can I file a Risperdal Lawsuit?
Because Johnson & Johnson canceled its tolling agreement in early 2017, many people may no longer be able to file Risperdal lawsuits if their statute of limitations has expired. Our lawyers are not currently accepting new Risperdal lawsuits.