The History of Risperdal
Risperdal has been on the market for more than 20 years. In that time, many people have been devastated by the unfortunate side effects of the drug. If you intend to seek compensation from Johnson & Johnson because you developed gynecomastia or another serious condition, you need to talk to a Risperdal attorney at Arnold & Itkin. With our award-winning counsel and record of success, you can be confident trusting your case to our team.
Arnold & Itkin’s representation of a Risperdal case became a significant part of this drug’s history. We secured a $76.6 million verdict against Janssen Pharmaceuticals and Johnson & Johnson. This award was the largest of its kind to date—more than 20 times larger than the previous 4 verdicts added together. In addition, as one of the first law firms to try a Risperdal case in the Philadelphia Court of Common Pleas multi-district litigation, we uncovered compelling evidence (known as “Tab 4”) that proved the link between gynecomastia and the drug’s use. We also discovered through cross-examination that Janssen knew of the relationship well before doctors or families were informed of the risk.
Review a brief history of the drug below so you can be informed about your case.
- 1993 – The U.S. Food and Drug Administration approved the use of Johnson & Johnson's Janssen Pharmaceuticals Inc. drug, Risperdal. The drug was only approved to treat schizophrenia in adults.
- April 2005 – A Black Box Warning was added to the drug's label after the FDA learned that the use of the drug among elderly patients with dementia could heighten the possibility of death.
- June 2006 – A study conducted by Duke University revealed that Risperdal could cause male breast growth. The study also showed that the possibility for gynecomastia was stronger with Risperdal than with other antipsychotic medications. In addition, it revealed that some female children taking the medication lactated before puberty.
- August 2007 – The FDA approved for children between 13 and 17 to take Risperdal to treat schizophrenia. The FDA also determined that children 10-17 could take the medication to treat bipolar disorder. This year, J&J made over $2.2 billion in sales before the company lost the patent protection for Risperdal.
- November 2008 – The Wall Street Journal issued a report claiming Risperdal stimulated the production of prolactin in boys. Prolactin is the hormone that causes lactation in women. About 70% of all cases of gynecomastia in children analyzed were due to Risperdal. Also, the FDA hosted a meeting where doctors discussed their concerns about the side effects of Risperdal in children, but they do not strengthen the warnings on the drugs.
- July 2010 – A man who took Risperdal between 1999 and 2004 filed a gynecomastia lawsuit against J&J after he suffered emotional trauma from breast growth. The 21-year-old said that he was taking the drug before it was approved for use by children and wanted compensation for the emotional and physical pain of the incident.
- June 2011 – A recall of Risperdal 3mg tablets and Risperidone 2mg tablets is issued after consumers reported concerns of an uncharacteristic odor coming from the pills. It was likely because the drug had trace amounts of TBA on it. This is a byproduct of a chemical preservative used on the wood pallets that the pharmacy uses to transport and store the drugs. Some patients claim that they suffered gastrointestinal problems.
- 2012 – The Department of Justice begins probing Johnson & Johnson's practices. The company offered the Department of Justice $2.2 billion to halt the investigation. Johnson & Johnson says that they want to avoid admitting conduct that may affect the outcome of the many personal injury lawsuits pending against them.
- August 2012 – Johnson & Johnson arrives at a $181 million settlement with 36 states and the District of Columbia regarding the marketing of Risperdal. The prosecutors claimed that Johnson & Johnson promoted their drug for uses that it did not have approval for, such as treatment in children. In addition, plaintiffs claimed that the company minimized the seriousness of side effects that can be experienced when taking the drug.
- September 2012 – Reports indicate that 420 Risperdal side effect lawsuits were filed in courts throughout America. 130 of these lawsuits involved plaintiffs suffering from gynecomastia. All of the lawsuits claim that J&J did not provide adequate warning labels of the side effects. The plaintiffs claim that the company downplayed the danger of breast growth in children. Also this month, Forbes reported that one plaintiff settled with Johnson & Johnson, but the company's CEO would not need to testify.
- October 2012 – Johnson & Johnson agreed to an additional five Risperdal gynecomastia settlements. The company may have decided to settle so the former FDA Commissioner would not be called to the stand as a witness.
- May 2013 – The Department of Justice begins to inspect Johnson & Johnson to determine whether or not they had adequate labeling on their product and if they were careful and cautious with the medication. The Department has not yet decided if they will adhere to the company's request to stop the investigation where it stands.
- November 2013 – Johnson & Johnson pleads guilty to aggressively marketing Risperdal for off-label uses and paying kickbacks to physicians and one of the largest long-term care pharmacy providers. As a result, the company agreed to pay more than $2.2 billion in criminal and civil fines.
- 2015 - After continual exposure of Risperdal's side effects and J&J’s actions, the company is facing 1,300+ gynecomastia and product liability suits, with an estimated ten thousand unfiled claims waiting to be heard.
- February 2015 – A young man who developed 46 DD breasts after taking Risperdal at age eight wins his case against Johnson & Johnson. The jury found J&J guilty of failing to adequately warn users of the side effects—mainly that it carried the risk of developing breast tissue. The case ended with a $2.5 million verdict.
- October 2015 – A California jury ruled in favor of a victim of Risperdal, awarding them a $5.6 million wrongful death verdict against Johnson & Johnson’s Janssen Pharmaceuticals. The man died during a clinical study of the drug.
- June 2016 – Arnold & Itkin secured a $76.6 million verdict against Johnson & Johnson, the largest verdict to date by more than 2000 percent. Judge Paula Patrick later upholds the verdict despite post-trial motions from the defendant.
What’s the Problem with Risperdal?
Multiple investigations have revealed that producers of Risperdal continued to market the anti-psychotic to children despite knowing that it can cause young boys to develop female breasts. Our team has been successful with holding Johnson & Johnson accountable with marketing this drug to children despite knowing its risks.
What Is Gynecomastia?
Gynecomastia described the enlargement or swelling of breast tissue in males. It’s most typically associated with an imbalance of hormone levels. In some instances, Gynecomastia is accompanied by galactorrhea, a condition that triggers a milky white discharge from the nipples.
How Does Risperdal Cause Gynecomastia?
Researchers have linked prolonged usage of Risperdal to an increase in prolactin levels in young boys. This elevated prolactin level is associated with Risperdal-induced gynecomastia. Studies have shown that 3 out of 10 adolescents might develop gynecomastia after taking Risperdal.Researchers have linked prolonged usage of Risperdal to an increase in prolactin levels in young boys. This elevated prolactin level is associated with Risperdal-induced gynecomastia. Studies have shown that 3 out of 10 adolescents might develop gynecomastia after taking Risperdal.
Are You Suffering from the Side Effects of Risperdal?
If you want more information about Risperdal lawsuits or if you or a loved one developed gynecomastia after using this drug, talk to an attorney at Arnold & Itkin. Our seasoned lawyers keep your case confidential and preserve the client-attorney relationship while assisting you in seeking compensation for your pain and suffering. With billions of dollars recovered, we have a strong reputation for recovering maximum compensation for our clients. That is the representation you need behind your Risperdal claim.
Ready to discuss your case? Reach out to us today to set up a consultation with our caring attorneys.