Risperdal lawsuits have been filed, alleging that the medication was used off-label and that it causes enlarged breast growth (gynecomastia) in boys and male adolescents. You may be entitled to compensation. We are currently working with some of the more experienced Risperdal lawyers in the country, who charge no legal fees until you receive a settlement or award. Contact us 24/7 toll free or online for a free (no obligation) consultation.
Have You Suffered Enlargement Of The Breasts After Taking Risperdal?
Read Below Why You May Have a Claim.
Why Are There Lawsuits Against Risperdal?
Risperdal is a drug that is approved for treatment of bipolar disorder and schizophrenia. Originally, Risperdal was given to adults and teenagers 13 years or older. Eventually, the drug began to be used for treatment of behavioral disorders in adolescents with autism. Risperdal works by affecting the way that your body creates hormones. Because adolescent bodies are still growing, they are especially vulnerable to hormonal changes.
Medical studies have shown that Risperdal leads to gynecomastia – an enlargement of the breasts – in boys and male adolescents. Because Risperdal is primarily prescribed to teenagers with social disorders, gynecomastia can cause severe psychological problems. If you or a loved one were prescribed Risperdal and suffered from gynecomastia, call an experienced Risperdal lawyer right away.
Why Does Risperdal Cause Gynecomastia?
Studies have shown that an increase in hormones related to breast tissue production is a very real consequence for some patients. In particular, the risks of the raised hormone levels may disproportionately affect young men and male adolescents, who are still developing physically and undergoing hormonal changes.
- November 2003 — The Journal of Clinical Psychiatry published a medical study titled “Prolactin levels during long-term risperidone treatment in children and adolescents.” The doctors conducting this study found that with “long-term risperidone treatment in children and adolescents, serum prolactin levels tended to rise and peak within the first 1 to 2 months and then steadily decline to values within or very close to the normal range by 3 to 5 months.”
- March 2005 — Psychiatry published a study which documented the response of sixteen teenagers to this antipsychotic drug. Of the sixteen patients four experienced lactation.
- April 2006 — The Journal of Clinical Psychopharmacology published the results of a study which found that “risperidone administered to adolescents at doses commonly used for the treatment of psychotic symptoms can strongly increase prolactin levels, with clinical consequences such as gynecomastia and/or galactorrhea.”
- March 2014 — A team of doctors from the University of British Columbia conducted an independent drug safety review of Risperdal and its link to breast enlargement in men. The data revealed that patients using the drug faced a 69% increased risk of developing gynecomastia.
Who Manufacturers Risperdal?
Janssen, a company owned by Johnson & Johnson, introduced Risperdal to the market in the 1994 as a treatment for bipolar disorder and schizophrenia. Risperdal lawsuits allege that the FDA originally only approved this medication for a limited number of uses including Schizophrenia, and not for treatment of behavioral disorders related to autism.
The FDA never approved the use of this medication in younger patients, or elderly patients. Studies show that Risperdal posed serious health risks to elderly patients, including stroke, and it was also proven to not be safe for children. The FDA continued to warn the manufacturer of the increased health risks in elderly and young patients, however Janssen continued to aggressively market Risperdal.
What is the Government Doing About Risperdal?
As early as 2004, Janssen and Johnson & Johnson were being investigated for improperly marketing Risperdal to developmentally disabled children, as well as paying kickbacks to doctors and pharmacists. According to Bloomberg, these legal issues were resolved with a $2.2 billion settlement with the U.S. Justice Department and a $181 million settlement with 36 states.
Janssen promoted Risperdal for uses that were not deemed safe and effective by the Food and Drug Administration. The Attorney General made a statement saying that “[t]he conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust.”
While the law allows doctors to prescribe medication for off-label use, it prohibits companies from marketing and actively promoting drugs for unapproved uses. When Janssen division released Risperdal, it was marketed under an unapproved use, rendering it misbranded. The sales representatives at Johnson & Johnson promoted it for uses such as anxiety, agitation, and depression while minimizing its use to treat schizophrenia.
Not only did Janssen market Risperdal for off-label and unapproved use, they also made false and misleading statements about its safety. The government’s complaint against the company alleged that Janssen was aware of the risks involved with the use of this medication, but they downplayed them. They also allege that the manufacturer tampered with the results of their studies to give the appearance that there was a low overall risk of adverse events.
Have You Suffered From Gynecomastia While Taking Risperdal?
You May Have a Risperdal Lawsuit Claim. Call 800-992-6878 Today!
Timeline of Risperdal Lawsuits and Events:
- November 4, 2013 — Johnson & Johnson, Risperdal’s manufacturer, paid $2.2 billion in criminal and civil fines with the Department of Justice because they improperly marketed Risperdal to elderly dementia patients and children. The elderly dementia patients and children then developed severe side effects, including gynecomastia and type-2 diabetes.
- March 11, 2014 — Johnson & Johnson paid $5.9 million to settle a Risperdal lawsuit. The case was filed in 2008 by Attorney General Tim Fox, who alleged that the makers used “misleading and illegal marketing tactics” to market Risperdal.
- March 18, 2014 — Medscape reported that researchers have found data from a study linking the use of Risperdal to a 69% increased risk of gynecomastia (male breast growth) in older men. There have been several studies that link this risk to children, but now this study is suggesting that risk may also extend to older men.
- June 24, 2014 — A Risperdal lawsuit was filed by a man who took the drug then developed enlarged breasts. He was treated with a double mastectomy.
- August 22, 2014 — The Journal of Clinical Psychopharmacology published a study that linked Risperdal to a 69% increased risk of gynecomastia compared to men who do not take anti-psychotic drugs.
- December 18, 2014 — Over 1,000 lawsuits involving Risperdal have been filed so far.
- January 26, 2015 — In one of the first Risperdal lawsuits to go to trial, lawyers representing an autistic boy who developed enlarged breast tissue after taking Risperdal presented opening arguments to a jury in Philadelphia.
- January 27, 2015 — A doctor testified that he would have re-reconsidered his prescriptions if Janssen Pharmaceuticals had adequately warned about the side effect.
- January 30, 2015 — Dr. David Kessler, former commissioner of the FDA, testified and accused Johnson & Johnson of failing to warn that Risperdal could cause gynecomastia in young boys.
Why Contact Us?
If you or a loved one have suffered from gynecomastia after taking Risperdal, you may be entitled to damages for medical bills, lost income, emotional anguish, and pain and suffering, among other losses. Our firm is currently working with some of the more experienced Risperdal lawyers in the country, who don’t charge a fee unless you receive an award or settlement. Please contact our toll free number 24/7 at 1-800-992-6878, or fill out a contact form for a free (no obligation) case evaluation.