Lawsuits are now being filed against Johnson & Johnson and its Janssen unit alleging that the antipsychotic drug Risperdal can cause breast tissue enlargement, or gynecomastia, in boys and young men.
Free Risperdal Lawsuit Evaluation: If you or a loved one has been injured by Risperdal, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
Update: Punitive Damages Allowed in Risperdal Gynecomastia Lawsuit
January 17, 2018 – A Pennsylvania Superior Court has cleared the way for punitive damages in a lawsuit filed on behalf of a boy who grew breasts after taking Risperdal to treat his Tourette’s syndrome. Plaintiff Timothy Stange was awarded more than $500,000 in compensatory damages in 2015, and then on Jan. 10, a three-member judicial panel ruled that Stange could also be awarded punitive damages for his injuries.
What is Risperdal?
Manufactured by Janssen, a division of Ortho-McNeil-Janssen Pharmaceuticals, Risperdal (generic: risperidone) belongs to a class of drugs known as atypical antipsychotic medications. First approved by the U.S. Food & Drug Administration (FDA) in 1993, Risperdal was originally strictly intended for use in adult schizophrenic patients, but later gained approval for the treatment of acute mania or mixed episodes associated with bipolar disorder in adults over the age of 18. The generic version of Risperdal, risperidone, is manufactured and marketed by a number of different pharmaceutical companies.
Risperdal Side Effects
- Production of prolactin
- Pituitary tumors
- Tardive Dyskinesia
- Neuroleptic Malignant Syndrome (NMS)
- Increased risk of sudden death from heart attack
- Diabetes, hyperglycemia and other blood sugar side effects
- Weight gain, potentially rapid and extreme
- Suicide, suicidal thoughts
- Bone loss
- Increased mortality in the elderly with dementia and related psychosis
While anyone taking Risperdal may develop one or more of these serious side effects, children and the elderly seem to be at a particularly increased risk. Additionally, minors under the age of 18 are at an increased risk of side effects such as weight gain, extreme rapid onset of diabetes, blood disorders, and more pronounced movement disorders such as tardive dyskinesia.
Janssen Settles Risperdal Gynecomastia Lawsuit
In September 2012, Janssen settled a lawsuit with a Texas man who claimed that he grew breasts as a child after being treated with Risperdal. The plaintiff, 21-year-old Aaron Banks, told the judge that he agreed to the deal, but offered no further comment. According to allegations raised in the complaint, Banks was prescribed Risperdal from 1999 to 2004 – between the ages of nine and 13 – when it was not approved for use in pediatric patients. Banks claimed that his breasts grew so large from Risperdal that he required surgery to remove an excessive amount of fatty material from around the area.
Boys may be at particular risk of developing gynecomastia after being treated with Risperdal. Due to an increase in the amount of prolactin in the blood, male pediatric patients may experience growth of breasts, possibly with pain and nipple discharge. A mastectomy may be required to remove the breast(s).
Janssen Granted Non-Suit Motion in Philadelphia Risperdal Lawsuit
April 25, 2017 – The latest Risperdal lawsuit to go to trial in the Philadelphia Court of Common Pleas has been dismissed by a state court judge for a piece of photographic evidence allegedly lacking authentication, according to PennRecord. On April 17, Judge Kenneth Powell ruled to grant a motion for non-suit for Pennsylvania plaintiff Dean Hibbs’s case against Janssen Pharmaceuticals. It was the ninth case to proceed against the company in Philadelphia’s Risperdal mass tort program, and the second time a case has been thrown out mid-trial.
Settlement Reached in Risperdal Gynecomastia Lawsuit
January 11, 2017 – Janssen Pharmaceuticals has settled another products liability lawsuit alleging gynecomastia from Risperdal days before what would have been the seventh such case to go to trial. Plaintiff Zachary Sabol filed his complaint in the Philadelphia Court of Common Pleas in April 2013, alleging that he developed boy boobs after taking Risperdal for about a decade.
Plaintiff Awarded $2.5 Million in First Risperdal Bellwether Trial
Feb. 25, 2015 – A jury has awarded Austin Pledger $2.5 million after deciding that Johnson & Johnson failed to warn about the risk of gynecomastia associated with Risperdal, a drug the plaintiff took for autism between the ages of 7 and 11. According to the lawsuit, Pledger grew size 44 DD breasts as a result of using the drug. Click here to learn more.
Questions Raised About Adherence to Pediatric Antipsychotic Dosing Guidelines
In September 2014, a hearing held in Vermont raised questions about whether doctors were following dosing guidelines when prescribing antipsychotic drugs like Risperdal to children. A recent survey found that doctors in that state followed the American Academy of Child and Adolescent Psychiatry’s guidelines for antipsychotic use about 51% of the time. The same survey found that Vermont’s physicians only followed the FDA’s recommendations on prescribing antipsychotics to pediatric patients about 27% of the time. Click here to learn more.
J&J under investigation for questionable marketing tactics relating to Risperdal
Over the past few years, Johnson & Johnson has been fighting legal battles on several fronts over its marketing practices related to Risperdal. The healthcare giant has suffered defeats in state cases in Texas, Arkansas, South Carolina and Louisiana. In the Texas case, J&J stopped the trial, opting instead to settle for $158 million. In all of these cases, the company was accused of inappropriately marketing Risperdal through state Medicaid programs. Meanwhile, J&J is currently in the process of negotiating with the federal government over allegations related to off-label marketing and payoffs to a nursing home pharmacy company. Industry insiders have estimated that the total penalty could exceed $2 billion.
Was J&J “Too Big to Care” About Breaking the Law?
Johnson & Johnson urged its salesforce to market Risperdal illegally to children and the elderly, according to Steve Brill’s new “DocuSerial” titled America’s Most Admired Lawbreaker. According to Brill, the company’s misconduct might have gone undetected had it not been for lawsuits filed by consumers who were injured or made sick. This article highlights the importance of public disclosure in civil lawsuits.
Is prescribing Risperdal ‘off-label’ illegal?
If doctors believe that a medication has the potential to be effective for a particular indication for which it was neither tested nor approved by the FDA, he or she has the authority to prescribe it in a so-called ‘off-label’ capacity. Since it hit the market in 2007, Risperdal has been widely prescribed off-label to children for autism, irritability, aggression, and other behavior disorders including attention deficit disorder / hyperactivity disorder (ADHD). Risperdal has also been commonly prescribed to treat irritability, aggression and other behavior disorders in elderly patients.
Considering the large number of serious side effects that have been linked to Risperdal, many in the medical community feel that it should only be considered as a drug of last resort. The adverse event profile is so significant that you should not consider being treated with Risperdal unless it is absolutely necessary. It is important to understand that there are many alternatives to these kinds of drugs that carry fewer potential side effects, and to always carefully weigh the risks versus benefits of taking a prescription medication with your doctor before beginning a regimen.
Risperdal May Be Ineffective at Treating Symptoms of Autism: Study
A study published in the Nov. 2014 edition of the Journal of Child and Adolescent Psychopharmacology found that Risperdal may not be effective at treating certain symptoms of autism. The study’s authors recommended that autistic children treated with Risperdal should be periodically re-evaluated, especially considering the potential side effects associated with the drug. Click here to learn more.
Risperdal May Cause Gynecomastia in Older Men: Study
New research indicates that Risperdal can cause gynecomastia in older men as well as younger men, according to Mahyar Etminan, a drug safety scientist at the University of British Columbia. Etminan told WebMD’s Medscape Medical News that men between the ages of 45 and 80 who took the antipsychotic were 69% more likely to see abnormal breast enlargement, the primary symptom of gynecomastia. Click here to learn more.
Janssen Knew About Gynecomastia Risk with Risperdal: Ex-FDA Chief
Former FDA Commissioner David Kessler testified on Jan. 28, 2015 that Janssen was aware of Risperdal’s ability to cause gynecomastia as early as 6 years before the company changed the drug’s label to include the injury. Kessler made the comments during a trial over a lawsuit filed by the family of a 20-year-old autistic man who allegedly developed gynecomastia after taking Risperdal. Click here to learn more.
Study Confirms Link Between Risperdal and Gynecomastia in Boys and Young Men
A study published in the August 2015 online edition of the Journal of Child and Adolescent Psychopharmacology found that Risperdal users were 4 times more likely to develop gynecomastia than non-users, and that children and adolescents who took the drug were 5 times more likely to have the condition. “Risperidone is associated with an increase with the risk of gynecomastia in adolescent and young adult males,” the researchers concluded. Click here to learn more.
Risperdal Gynecomastia Lawsuit Dismissed; Plaintiffs Will Appeal
March 28, 2017 – A products liability lawsuit alleging gynecomastia from Risperdal was tossed by the presiding judge after he found that testimony from the plaintiff’s prescribing physician did not satisfy the learned intermediary doctrine, which requires proof that a different warning would have changed the treatment regimen. The doctor reportedly testified that he would’ve never considered Risperdal had he known of its potential to cause gynecomastia. However, another doctor testified that she would have continued to prescribe the drug because the potential benefits outweighed the risks.
Plaintiff Awarded $70M in Risperdal Gynecomastia Lawsuit
July 5, 2016 – J&J has been slapped with a $70 million verdict in a lawsuit alleging that Risperdal caused an adolescent boy to grow prominent breasts. The drugmaker is currently facing more than 1,500 similar cases in courts across the U.S., and has lost several that have already gone to trial. However, the $70 million award is many times larger than the damages awarded in previous cases.
Additional Resources & Information
- Plaintiffs Respond to Defense’s Motion to Dismiss Risperdal Gynecomastia Lawsuits
- Risperdal Gynecomastia Statute of Limitations
- J&J Files Motion to Dismiss Risperdal Gynecomastia Lawsuits Over Statute of Limitations Dispute
- Johnson & Johnson Risperdal Settlement
Do I Have a Risperdal Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Risperdal lawsuits. We are handling individual litigation nationwide and currently accepting new injury cases in all 50 states.
Free Confidential Case Evaluation: Again, if you were injured by Risperdal side effects, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.