Hundreds of plaintiffs who filed a Risperdal lawsuit received good news several months ago when Johnson & Johnson was ordered to pay more than $2.2 billion for illegally marketing their antipsychotic drug for off-label use. The FDA first approved Johnson & Johnson’s Risperdal for the treatment of schizophrenia in 1993. A decade later, the FDA approved the drug for the treatment of bipolar disorder. In 2006, autism-related irritability was added to the conditions treated with Risperdal.
However, the U.S. Department of Justice says that Risperdal had been prescribed to elderly patients and adolescents before gaining FDA approval. By 2005, it had become the most popular antipsychotic drug — prescribed to over a million patients.
The product liability lawyers at The Sanders Firm are here to help victims of male breast growth tied to Risperdone and those who suffered other serious side effects of J&J’s controversial drug.
Risperdal side effects
Like most antipsychotic drugs, the risk of serious side effects from Risperdal should always be weighed against the intended benefits. Common complaints include:
- Weight gain: In 2011, an FDA advisory panel recommended monitoring Risperdal side effects after a study published in the Archives of General Psychiatry found that patients gained 11 to 13 pounds in less than two months after taking antipsychotics. According to the NY Times, a three-year-old boy taking the drug reached 49 pounds – nearly 20 pounds overweight for a child that age. Along with obesity, come the risks of high cholesterol, heart disease and diabetes. A University of Massachusetts study found that kids on antipsychotic drugs were four times more likely to develop diabetes. In 2004, Risperdal packaging was updated to include the risk of diabetes for all patients.
- Gynecomastia: Male breast growth is one of the most life-altering side effects associated with Risperdal. In addition to experiencing abnormal tissue growth, other symptoms include inflamed and enlarged nipples, pain and discharge. In some instances, boys have developed breasts up to a 38D cup in size. A 2012 study published in the Journal of Child and Adolescent Psychiatry concluded that risperidone-using males ages 10-20 were 72 times more likely to have elevated prolactin levels than those who were not taking the drug.
- Stroke: At least 31 children have died and more than 1,200 children suffered serious health problems after taking Risperdal. Cardiac arrest and stroke were the most common causes of death. A 2003 study published in the British Medical Journal found that antipsychotics cause a higher risk of stroke in all patients. A 2013 study linked risperidone to strokes in patients over the age of 64.
- Neuroleptic Malignant Syndrome: There have been at least 14 reported cases of Risperdal patients experiencing a fatal syndrome marked by muscle rigidity, fever, altered consciousness, irregular pulse, and blood pressure fluctuations.
Other less serious side effects include: tremors, dizziness, sedation, insomnia, restlessness, dry mouth, congestion, abdominal pain, diarrhea, nausea, vomiting and fatigue.
Recent Risperdal litigation & settlements
According to Bloomberg News, more than 420 Risperdal lawsuits have been filed against Johnson & Johnson alleging injuries. Of those, at least 130 cases are related to gynecomastia. “The billions J&J made had a terrible human cost,” said a lawyer working on the case. “The drug caused female breasts to grow on little boys around the country. Their childhoods were stolen, but billions were made.”
The first Risperdal gynecomastia lawsuit went to trial in September 2012. The 21-year-old plaintiff said he began taking the drug when he was just nine years old and continued taking it for several years. His lawyers noted that Risperdal was not FDA-approved for use in adolescents at the time. The boy said he suffered “psychological trauma” after growing breasts.
Forbes reports that Johnson & Johnson settled for an undisclosed sum on the first day of trial proceedings, without much fight or comment – other than to say that “Risperdal has and continues to improve the lives of countless people throughout the world who suffer from debilitating mental illnesses.”
That same year, three more bellwether cases were settled for undisclosed amounts when former FDA chief Dr. David Kessler M.D. agreed to testify as a medical expert in the mass tort filed in the Philadelphia Common Pleas Court. “The promotion of non-approved uses in the most vulnerable children of powerful drugs is most concerning,” he wrote in a 92-page report.
Johnson & Johnson agrees to $2.2 billion for illegal marketing practices
Then, in November 2013, Johnson & Johnson agreed to pay over $2.2 billion in criminal and civil fines to settle charges that they illegally promoted Risperdal to elderly patients with dementia and children with behavioral disabilities from 1999 through 2005. Bloomberg News reports that this agreement marks the third-largest pharmaceutical settlement in U.S. history. Federal officials have been looking into the company’s marketing practices for a decade and say that the manufacturer knew children were susceptible to certain health risks due to the elevation of prolactin hormone caused by the antipsychotic drug.
Despite all the health risk allegations, there were no Risperdal recalls issued – except for one lot of 70,000 doses in September 2013, which was recalled due to mold contamination concerns. The recalled lots involved the long-acting, injected form of the drug, rather than the basic Risperdal pills. The company conducted a voluntary recall after discovering the problem and stated that “there have been no trends of adverse events of infection associated with this lot.”
Seeking damages in a Risperdal lawsuit
Boasting a highly-credentialed team of personal injury attorneys, The Sanders Firm offers more than 45 years of trial experience. We have gone up against major pharmaceutical companies like Merck and pursue justice for those injured by reckless, profit-seeking corporations that negligently fail to warn consumers of risks and side effects associated with their products. Over the years, we have won over $100 million in settlements and successful jury awards for our clients.
Compensation available to victims
Big pharmaceutical cases can lead to compensation for victims that may cover:
- Past and future medical expenses
- Loss of income or productivity
- Emotional pain and suffering
- Punitive damages
To recover compensation, an attorney must prove that your specific injuries were associated with the use of the product and that the manufacturer was somehow negligent in promoting the prescription to your demographic without adequate warning of the risks involved.
One of our experienced product liability attorneys will assemble your medical records, conduct discovery, obtain medical expert witnesses, prepare paperwork and litigate your case – seeking the maximum damages for your injuries.
The Sanders Firm: experience you can trust
If you or someone you love has been affected by Risperdal side effects like male breast growth, take comfort in knowing The Sanders Firm is here to help. Our proven track record of success in similar cases combined with our sympathetic ear can assist you in getting through the most difficult times.
We take all dangerous drug cases on a contingency basis only – meaning that you only pay us if we win a settlement or jury award on your behalf. To speak with one of our lawyers about your eligibility for filing a Risperdal lawsuit, call 1-800-FAIR-PLAY any time 24 hours a day, 7 days a week.
- Bloomberg News – J&J Settles Risperdal Lawsuit on Opening Day of Trial http://www.bloomberg.com/news/2012-09-10/j-j-settles-risperdal-lawsuit-on-opening-day-of-trial.html
- Forbes - J&J Sees Male Breasts And Quickly Settles Risperdal Suit http://www.forbes.com/sites/edsilverman/2012/09/11/jj-sees-male-breasts-and-quickly-settles-risperdal-suit
- Philly.com - Former FDA chief David Kessler says J&J broke the law in promoting Risperdalhttp://www.philly.com/philly/blogs/phillypharma/Ex-FDA-chief-David-Kessler-says-JJ-broke-the-law-in-promoting-Risperdal.html#dWVp8LIR1zhF5aXC.99
- BMJ, Exposure to antipsychotics and risk of stroke: self controlled case series study http://www.bmj.com/content/337/bmj.a1227
- JAMA, Certain Antipsychotic Drugs Pose Greater Death Risk for Elderly http://newsatjama.jama.com/2012/02/24/certain-antipsychotic-drugs-pose-greater-death-risk-for-elderly