Risperdal has been the focus of hundreds of lawsuits against pharmaceutical giant Johnson & Johnson. An antipsychotic developed for schizophrenics, Risperdal has a long history of being marketed for off-label uses by every age group and demographic. If you or a loved one has been injured by Risperdal, it’s important to know the facts and your options for legal recourse.
Johnson & Johnson Marketing Issues
Despite not having approval, Johnson & Johnson specifically marketed Risperdal to elderly patients and kids.
Risperdal was first approved for use by schizophrenic adults in 1994. At that time, it was not approved by the FDA for use by children or the elderly. 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, ADD and other behavioral disorders, as well as use by geriatric patients with dementia, 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 a 5th of Risperdal users were children and adolescents. The FDA repeatedly warned J&J about marketing the drug to children, until finally approving Risperdal 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.
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.
FDA Fines J&J
After a long investigation, the FDA hit J&J with a $2.2 Billion fine in 2012. The fine was meant to punish the corporation for criminally marketing Risperdal, both in marketing the drug for unapproved uses & age groups, and for their kickback agreement with Omnicare. However, by this point, J&J had made around $30 Billion from Risperdal already.
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 Claims
Hundreds of young men 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.
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.
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.
Current Risperdal Litigation
As of June 2017, there are over 5,000 Risperdal Lawsuits filed in Philadelphia’s mass tort program alone. Thousands have come forward with claims regarding Risperdal’s side effects and J&J’s deceitful marketing techniques. If you or a loved one has been injured by Risperdal, you can talk with a lawyer to establish your case and determine the right court system for you.
Major Verdicts in Risperdal Trials
Andrew Yount — $70 million — July 1, 2016 — This record-breaking verdict dwarfed its predecessors when the jury awarded the plaintiff $70 million in compensatory damages. Not only did the jury find that J&J had failed to warn the plaintiff, his parents, and his doctors, about the gynecomastia risk, but they also determined that J&J had purposely concealed and falsified information about the risks.
Timothy Stange — $500,000 — December 11, 2015 — Just like William Cirba’s case, the jury found that J&J had been negligent in warning physicians and patients about the risk of gynecomastia. However, in this case, the jury also found evidence that J&J’s actions had directly caused Stange’s condition.
Nicholas Murray — $1.75 million — November 11, 2015 — The jury in this case took only 2 ½ hours to award the verdict to the plaintiff. Murray had been prescribed Risperdal in an off-label fashion for symptoms associated with his autism, and developed “female-like breasts.” Even after stopping the medication, and weight loss from exercise and nutrition, the breasts remained.
William Cirba — No Damages Awarded — March 20, 2015 — Cirba had also taken Risperdal for a number of years, and also developed gynecomastia. However, although the jury agreed that J&J had failed to warn the plaintiff of this side effect, they could not establish a confident link between the Risperdal use and the gynecomastia in this case. Therefore, the jury found in favor of J&J.
Austin Pledger — $2.5 million — February 24, 2015 — Pledger took Risperdal for 5 years as a child, to help assuage behavioral issues connected to his autism. His parents claimed that the exposure made Pledger develop size 46DD breasts. The plaintiff also alleged that Johnson & Johnson had knowingly withheld information about the side effect from both his parents and his physician.