Risperdal lawsuits allege patients weren’t warned of severe side effects like gynecomastia (abnormal breast tissue growth in males), type 2 diabetes, stroke and cardiac events. Patients have filed 14,000+ Risperdal lawsuits against Johnson & Johnson, but none have been settled yet. J&J was also fined $2.2 billion for off-label Risperdal marketing.
Johnson & Johnson Marketing Issues
Despite not having approval, Janssen Pharmaceuticals (a division of J&J) specifically marketed Risperdal to elderly patients and kids.
Risperdal was first approved for use by adults with schizophrenia in 1994. At that time, it was not approved by the FDA for use by children or the elderly. Through its subsidiary, Janssen Pharmaceuticals, Johnson & Johnson tried multiple times in the 90’s to gain approval for these age groups, without success. But despite this, marketing efforts by J&J specifically targeted these groups for off-label usage.
J&J encouraged the use of Risperdal in children with autism, ADHD and other behavioral disorders, as well as use by geriatric dementia patients, who are known to exhibit behavioral issues. They provided kickbacks to physicians who prescribed the drug, held golf tournaments, and provided other benefits to expand their market. Targeting seniors, J&J engaged in profit sharing with Omnicare, one of the largest nursing home pharmacy systems in the U.S. In 2003, a marketing manager even proposed including lollipops and small children’s toys in with samples as part of a “back to school” campaign.
By 2000, more than one-fifth of users were children and adolescents. The FDA repeatedly warned J&J about marketing Risperdal to children, until finally approving the drug for use in children and adolescents, especially those with autism in 2006. There is a suspicion that J&J knew evidence showing a link between Risperdal and gynecomastia, and manipulated the findings in order to get this approval. The FDA did also eventually approve the drug for elderly patients.
Black Box Warning
In 2005, the FDA issued a black box warning for Risperdal, the harshest label they can require. The warning specifically addressed elderly patients with dementia-related psychosis, citing a high risk for death, including from cardiovascular events. The warning also noted that Risperdal was not approved for use in these cases at the time.
Risperdal Black Box Warning
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
See full prescribing information for complete boxed warning.
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. RISPERDAL® is not approved for use in patients with dementia-related psychosis.
Source: FDA-required Risperdal Label
In 2011, J&J and the FDA recalled the following medications: Risperdal tablets 3mg, Bottles of 60 Tablets (Lot #0GG904, expiration 5/2012) and risperidone tablets 2mg, Bottles of 60 Tablets (Lot #OlG175, expiration 8/2012). The drugs were recalled originally because of complaints about a foul odor. After the investigation, these products were found to be contaminated with TBA, a byproduct of a chemical preservative used on wood pallets.
$2.2 Billion Fine for Risperdal Off-Label Marketing
After a lengthy investigation, in 2012 the U.S. Department of Justice levied a $2.2 billion fine against Johnson & Johnson and its subsidiary Janssen Pharmaceuticals. The core reason for the fine was Janssen’s marketing and sale of Risperdal and other drugs (Invega and Natrecor) for unapproved uses, including the treatment of:
According to the DOJ’s public statement, the drug maker also had entered into an illegal kickback scheme with Omnicare Inc., a pharmacy that specializes in providing drugs to elderly care and assisted-living facilities. The $2.2 billion fine constitutes one of the largest healthcare-related fraud settlements in the history of the U.S. Even so, it is only a fraction of the $30 billion J&J had made from sales of Risperdal at the time of the settlement.
Why File a Risperdal Lawsuit?
Since its creation, Johnson & Johnson has made billions of dollars in profits from Risperdal. They have repeatedly acted against FDA regulations and warnings and prescribed Risperdal for off-label uses. Additionally, they have allegedly hidden evidence from the FDA and consumers regarding Risperdal side effects. Some evidence suggests that they knew about risks of stroke, cardiac events and gynecomastia long before the links were publicized in research.
If you or a loved one has been injured by Risperdal, it’s important to talk with a lawyer about your options. If your suit goes to trial, you may be compensated in one of a few ways:
- Past medical expenses: Risperdal side effect may lead to hospitalization or necessitate surgery, which can be incredibly expensive.
- Loss of income: Frequent medical visits or an inability to work can result in lost wages.
- Pain and suffering: You may receive damages to cover pain and suffering after being subjected to the adverse effects of Risperdal. This specifically would cover issues of humiliation, which might result from a side effect like gynecomastia.
- Punitive action: Johnson & Johnson has profited from their deliberately deceitful marketing techniques. Punitive damages punish them financially, which may make them think twice before acting the same way again.
- Funeral expenses: For elderly patients, an adverse side effect from Risperdal may lead to death. If you’ve lost a loved one, a jury may provide awards to help cover burial and funeral costs.
Common Risperdal Lawsuit Claims
While every Risperdal case is different, most of the legal claims have focused around a few specific side effects and complications of taking the antipsychotic drug. Brief descriptions of these assertions are provided below.
Gynecomastia (Male Breast Development)
Hundreds of men, adolescents, and young boys have claimed that Risperdal usage caused them to grow breasts. This claim is most often filed by young men because gynecomastia is, in many cases, only fixed by surgery. These plaintiffs also posit that their abnormal breast tissue growth was a source of humiliation and suffering.
Hyperprolactinemia (Premature Puberty)
Young women who took Risperdal have experienced premature puberty, and hyperprolactinemia, which can cause lactation in women who are not pregnant or breastfeeding. In both men and women, hyperprolactinemia can cause a loss of libido, and men can become impotent. Prolonged hyperprolactinemia can even affect fertility.
Type II Diabetes Mellitus
Risperdal has been alleged to have caused insulin resistance, greatly increasing the chance of type II diabetes. Other cases have claimed that Risperdal use led to above average weight gain, which is a risk factor for Type II diabetes. In severe cases, diabetes can cause nerve problems and vision issues, and even death.
Tardive Dyskinesia (Uncontrollable Movement)
A number of patients who take Risperdal have developed a condition known as tardive dyskinesia, which causes uncontrollable movements. The disorder is often irreversible, and risk of developing it increases the longer that an individual takes risperidone.
This claim has come mostly from elderly patients, for whom Risperdal was not originally approved. In some cases, Risperdal has been connected with strokes or heart attacks, which can be deadly, even if treated immediately.
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.
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.
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.
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.
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 award and, if so, how much they should be.
Current Risperdal Lawsuits
As of October 2018, there are at least 13,000 Risperdal lawsuits pending in state and federal courts (down slightly from a high of 14,000 in April 2018), according to Johnson & Johnson’s SEC filings. The company says lawsuits have primarily been filed in Pennsylvania, California, and Missouri.
Nearly half of the Risperdal lawsuits (more than 6,600) are situated in Philadelphia’s Complex Litigation Center, the court that handles mass tort litigation for the Commonwealth of Pennsylvania. 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.
If you or a loved one has experienced gynecomastia, hyperprolactinemia, or another severe side effect after taking Risperdal, talk to a lawyer today to see if you may be eligible for compensation.