St. Louis, MO
Home ► Personal Injury Lawsuit | Personal Injury Lawyer | Personal Injury Law Firm ► Do I Qualify to Participate in a Bad Drug Lawsuit? ► Risperdal Lawsuit | Risperdal Lawyer | Risperdal Gynecomastia Lawsuit
Appellate Court Issues Decision, May Reinstate Hundreds of Risperdal Lawsuits
May 8, 2020 – The Second District Court of Appeals in California came to a decision this week that could reinstate hundreds of Risperdal lawsuits against Johnson & Johnson subsidiary Janssen Pharmaceutical.
Plaintiffs in the Risperdal lawsuit allege that the prescription antipsychotic caused male users to develop gynecomastia unknowingly and without warning.
Johnson & Johnson had been granted a summary judgement, based on federal preemption grounds, that halted California Risperdal lawsuits from moving forward. The summary judgement concluded that the Food and Drug Administration (FDA) would have rejected a revised warning label on Risperdal, in accordance with Wyeth v Levine United States Supreme Court decision.
The appellate court’s reversal of the summary judgement concluded that there was “no clear evidence” that the FDA would have rejected a revised warning label. “Impossibility preemption requires the drug manufacturer to show that it fully informed the FDA,” Justice Halim Dhanidina wrote in the decision, continuing, “Janssen did not.”
The Court of Appeals emphasized in its conclusion datasets in Table 21 – data that Janssen failed to disclose to the FDA which showed a “statistically significant association” between the drug and elevated blood prolactin levels (associated with gynecomastia).
“Specifically, table 21 tended to show that children who had elevated prolactin after taking risperidone [the generic form of Risperdal] for eight to 12 weeks were 2.8 times more likely to develop prolactin-related side effects, including gynecomastia,” the opinion says. “As the risperidone label made no mention of the likelihood of developing side effects related to elevated prolactin levels for different time periods, this information demonstrated a risk of greater frequency then reported on the label.”
This appellate decision could create an opportunity for more than 300 Risperdal users who took the drug as minors prior to the 2006 label change.
If you or a loved one took Risperdal and subsequently developed Gynecomastia, you may be entitled to compensation for your injuries. Contact a Risperdal lawyer from TorHoerman Law for a free, no-obligation Risperdal lawsuit case consultation today.
A Risperdal lawsuit has been filed on behalf of individuals who used Risperdal to treat symptoms of mental disorders as children and as a result developed gynecomastia.
Thousands of people have filed lawsuits alleging that the drug manufacturer Johnson & Johnson’s popular antipsychotic drug Risperdal led to gynecomastia — the development of female breast tissue in males — in those who took the medication during childhood. The lawsuit notes that J&J marketed the drug for young people years before the U.S. Food and Drug Administration approved its use for non-adults.
Risperdal is a powerful, antipsychotic drug used to restore the balance of the brain’s natural chemicals. The FDA approved Risperdal in 1993 to treat adult schizophrenia, acute mania, and mixed episodes associated with Bipolar I Disorder.
Manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, Risperdal was marketed and prescribed to adolescents — even though the drug was not approved for that particular use until 2006. In 2006 and 2007, the FDA approved Risperdal for additional uses, including the treatment of bipolar disorder in adults and juveniles, schizophrenia in children, and certain behavioral symptoms in children with autism.
However, the marketing of Risperdal prompted doctors to prescribe Risperdal for “off-label” usage, meaning it was not properly tested through trials or approved for that specific use by the FDA.
There have been more than 13,000 adverse reactions reported to the FDA in connection with Risperdal, and the agency estimates that less than one percent of all serious events are ever reported. This indicates that the actual number of side effects occurring is likely much higher. A black box warning, the strictest warning put on prescription drug labels by the FDA, has been placed on the drug.
More than 18,000 people nationwide have filed lawsuits against Johnson & Johnson, alleging that the company knew of the gynecomastia risks associated with adolescent Risperdal use without warning consumers. After risks became known, Johnson & Johnson did not strengthen labels with gynecomastia warnings, and lawsuits claim that J&J manipulated data and withheld key evidence from the FDA.
Risperdal can increase levels of the hormone prolactin. Increased prolactin levels can lead to side effects in females such as loss of periods, increased or irregular production of breast milk, and excessive acne and body hair. Males might experience symptoms such as erectile dysfunction, decreases in body and facial hair, and in some cases gynecomastia — the development of female breast tissue.
In November 2008, the Wall Street Journal reported that Risperdal use was linked to the increased production of prolactin, a hormone that stimulates breast development and milk production in women.
In women, excess prolactin levels can cause spontaneous milk production, but in men, excess levels can lead to gynecomastia, the abnormal growth of male breast tissue.
Studies conducted by a psychiatrist at Duke University found strong links between Risperdal use in childhood and adolescence with the development of gynecomastia. The study concluded that the drug can increase levels of prolactin, leading to hormonal imbalances and gynecomastia. A study published in the Journal of Child and Adolescent Psychopharmacology found that young Risperdal users have a risk for gynecomastia up to five times higher, noting the explicit psychological burden associated with the disorder.
According to a study conducted by Boston Children’s Hospital and Harvard Medical School, gynecomastia has a negative impact on adolescent males both not only physically, but also emotionally. Specifically, the condition was found to affect “social functioning, mental health, and self-esteem.”
TorHoerman Law is currently accepting cases for young males injured by Risperdal. If you took Risperdal as a minor and have a documented diagnosis of gynecomastia, contact us for a free, no-obligation consultation.
Risperdal is an antipsychotic drug first approved by the U.S. Food and Drug Administration in 1993 to treat adults with schizophrenia. During 2006-2007, the FDA approved additional uses for Risperdal, including treatment for:
Risperdal is an antipsychotic drug that works by blocking the activity of dopamine in certain areas of the brain. However, blocking dopamine also has an effect on the pituitary gland, causing a number of metabolic disruptions and resulting in the release of a hormone known as prolactin.
Prolactin is responsible for stimulating breast tissue development and causing lactation in pregnant and nursing women, and for causing gynecomastia in adolescent males and in children as young as four. Gynecomastia can occur in one or both breasts and will not usually resolve, even if Risperdal use is discontinued. In mild cases, liposuction may be used to remove the tissue but in more extensive cases, breast reduction surgery or a mastectomy may be necessary.
As a result of the link to developing breasts after taking Risperdal, lawsuits were filed on behalf of the children and adolescents who suffered from the abnormal growth of male breast tissue and the increased production of prolactin.
The first Risperdal lawsuit ended in a $2.5 million loss for Johnson & Johnson. The jury found the drug maker negligent for failing to warn consumers about the risks of gynecomastia. The second lawsuit was a partial victory for plaintiffs, as the jury found that J&J was negligent for failing to warn the public about the risk of gynecomastia, but the jury found that Risperdal was likely not the cause of this plaintiff’s gynecomastia.
On May 27, 2015, lawyers filed a lawsuit on behalf of a California boy who developed gynecomastia after taking the anti-psychotic drug Risperdal. Johnson and Johnson settled the case just hours into opening arguments.
In the first three months of 2017, more than 3,000 additional Risperdal lawsuits were filed in Philadelphia Common Court of Pleas. The total number of cases filed in Philadelphia courts totals to more than 5,500, which are currently pending.
If you took Risperdal as a minor and have a documented diagnosis of gynecomastia, or developed physical or mental adverse symptoms from increased prolactin, contact us for a free, no-obligation consultation.
If you have any questions about a Risperdal lawsuit, please contact the personal injury lawyers at TorHoerman Law today. Before filing a Risperdal lawsuit, familiarize yourself with the steps of the civil litigation process.
The first step in a Risperdal lawsuit is choosing a personal injury attorney who has experience handling Risperdal litigation. Your Risperdal lawyer will help you to identify who holds liability for your injuries. You will need to begin gathering evidence as soon as possible to support your claim against the liable party. This evidence will help to prove the total cost of losses that you endured as a result of your injury, also known as your damages. In many personal injury lawsuits, the injured party will choose to file for both compensatory damages and punitive damages. After assessing all damages that you incurred, your Risperdal attorney will file a complaint demanding compensation to repay your damages.
If you or a loved one was prescribed Risperdal and subsequently developed gynecomastia, you should contact a Risperdal lawyer to discuss your legal options and potential compensation. TorHoerman Law offers team of experienced Risperdal lawyers that are available for a free, no-obligation case consultation anytime.
Our team is currently involved in the ongoing Risperdal lawsuit against Janssen Pharmaceutical.
If you have any questions or concerns, contact a Risperdal lawyer from TorHoerman Law and we will answer to the best of our abilities.
Your Risperdal lawyer will gather evidence to prove liability, assess damages, calculate an appropriate compensation amount, and guide your case through the legal process of a Risperdal lawsuit, representing your best interests the entire way through the process.
We fight for you so that you can focus on recovery. As your Risperdal lawyer, we will be next to you every step of the way, working as a team to help you get the compensation that you deserve for your injuries.
Worried about the costs associated with hiring a Risperdal lawyer? No need to be – TorHoerman Law operates on a contingency fee basis, so you do not pay unless we win you compensation for your injuries and losses first. This ensures that we are as committed as you are to getting a winning verdict for your case.
Contact TorHoerman Law today and learn how we can serve you.
Dec. 3, 2019 - A Pennsylvania Superior Court last week upheld a $70 million verdict awarded to a man who developed breasts as a result of J&J’s antipsychotic drug Risperdal.
Upon upholding the $70 million compensatory verdict, the plaintiff sent back the issue of punitive damages to the judge. The three-judge appeals court granted punitive damages as a possibility in the Risperdal lawsuit.
Last month, J&J faced an $8 billion punitive verdict in a similar Philadelphia Risperdal lawsuit.
The plaintiff, Andrew Yount, is a Tennessee resident who began taking Risperdal as a toddler. Yount developed breasts as a result of his Risperdal prescription, which eventually left him with “severe and permanent disfigurement” that made him the target of harassment.
There are currently more than 13,000 Risperdal lawsuits against J&J, all claiming that Risperdal caused male breast development.
According to court documents, the plaintiffs in these Risperdal lawsuits claim that J&J made efforts to hide these potential adverse effects in order to profit from Risperdal’s popularity as a go-to anti-psychotic drug.
J&J contends that it properly disclosed known risks associated with Risperdal on the product’s safety label. According to a company spokesperson, J&J plans to evaluate options to further appeal Yount’s case.
Previously in 2014, Court of Common Pleas Judge Arnold New ruled that no Risperdal plaintiffs could file for punitive damages. In January 2019, a Superior Court appeals panel overruled Judge New’s decision.
October 31, 2018 - A $2.5 million jury verdict against Johnson & Johnson was upheld by the Pennsylvania Superior Court over allegations Risperdal caused a boy to grow breasts. The case was returned to a lower court to determine whether the family was entitled to punitive damages as well.
January 2018 - A Pennsylvania appeals court threw out an order that prevented Johnson & Johnson from facing punitive damages.
October 2017 – A jury awarded $1 million to a young man who began taking Risperdal at age 9 to treat mood disorders. He developed breasts and began lactating at the age of 10 as a result of the drug.
February 2017 - Again, Judge New granted a motion for summary judgment in favor of Janssen.
January 2017 – An undiagnosed settlement was reached by Johnson & Johnson and the plaintiff, subsequently avoiding trial.
December 2016 – The seventh Risperdal trial was dismissed 11 days into the trial due to the judge's decision that the plaintiff expert witness did not provide sufficient testimony.
October 2016 – Judge Arnold L. New granted a motion for summary judgment in favor of Janssen Pharmaceuticals.
July 2016 – $70 million in damages was awarded to a young man who developed gynecomastia at the age of five due to Risperdal. The jury found that Janssen Pharmaceuticals "intentionally falsified, destroyed, or concealed records."
December 2015 – The fourth Risperdal case found in favor of the plaintiff, awarding $500,000 in damages.
November 2015 - More than 1,500 cases that alleged Johnson & Johnson did not warn of the risks associated with Risperdal were consolidated in the Philadelphia Court of Common Pleas.
November 2015 - $1.75 million was awarded to a young man who developed Gynecomastia after taking Risperdal for schizophrenia.
March 2015 – A Philadelphia jury found in favor of Janssen Pharmaceuticals stating that the man's condition was not caused by Risperdal. However, the jury did find that Janssen provided inadequate safety warnings.
February 2015 – South Carolina's Supreme Court upheld an earlier decision finding Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, improperly marketed Risperdal and hid the risks. The company was ordered to pay a penalty of $136 million.
Jan 5, 2016 - On December 22, 2015, Janssen Pharmaceuticals and its parent company, Johnson & Johnson, entered into a settlement with the Commonwealth of Kentucky, agreeing to pay $15.5 million to the state, sufficiently disclose the associated risks of the drug, and cease the company’s promotion of Risperdal for non-FDA approved uses.
The lawsuit, filed in 2013, made allegations that Janssen had misled doctors and patients about the adverse side effects of Risperdal, deliberately concealing the fact that the drug was especially dangerous for children and elderly patients.
According to court documents, Janssen allegedly marketed Risperdal to children before the U.S. Food and Drug Administration (FDA) gave the company its approval to do so, and also failed to disclose to parents and medical professionals that the medication could cause several serious conditions, including:
April 2015 - A young man was awarded $2.5 million in damages after developing size 44D breasts from taking Risperdal.
2012 - Johnson & Johnson settled a Justice Department investigation into whether the company unethically marketed and promoted Risperdal to consumers by agreeing to pay a $2.2 billion fine, the largest at the time.
2006 - A study is released by a Duke psychiatrist that suggests a strong correlation between Risperdal and Gynecomastia.
2006 - The FDA approves Risperdal to treat children, specifically those with autism.
2005 – The FDA issued a black box warning for Risperdal stating "elderly patients with dementia-related psychosis who are treated with these drugs face an increased risk of death."
1995 - Johnson & Johnson co-founded the Texas Medical Algorithm Project (TMAP). The organization's intent was to persuade doctors to prescribe the medication to off-label patients such as children and the elderly.
1994 - Risperdal is approved to treat schizophrenia in adults.
“Bipolar Disorder.” National Institute of Mental Health, U.S. Department of Health and Human Services, www.nimh.nih.gov/health/topics/bipolar-disorder/index.shtml.
“Breast Enlargement in Males: MedlinePlus Medical Encyclopedia.” MedlinePlus, U.S. National Library of Medicine, medlineplus.gov/ency/article/003165.htm.
Bronstad, Amanda. “Calif. Appeals Court Partially Reverses Federal Preemption in Risperdal Lawsuits.” The Recorder, 11 May 2020, www.law.com/therecorder/2020/05/11/ca-appeals-court-partially-reverses-federal-preemption-in-risperdal-lawsuits/.
Fair, Matt. "Pa. Appeals Court Upholds Risperdal Time Bar." Law360 - The Newswire for Business Lawyers, 13 Nov. 2017, www.law360.com/articles/984654/pa-appeals-court-upholds-risperdal-time-bar.
Legal Newsline. "Philadelphia Flooded With New Risperdal Lawsuits; Trials Split But Include Massive Verdict." Forbes, Forbes Magazine, 13 Apr. 2017, www.forbes.com/sites/legalnewsline/2017/04/10/philadelphia-flooded-with-new-risperdal-lawsuits-trials-split-but-include-massive-verdict/#2236a5db6318.
O'Shea, Timothy. "10 Black Box Warnings Every Pharmacist Should Know." Pharmacy Times, Pharmacy & Healthcare Communications, LLC, 14 Mar. 2016, www.pharmacytimes.com/contributor/timothy-o-shea/2016/03/10-black-box-warnings-every-pharmacist-should-know?p=5.
Nuzzi, Laura C. B.A.; Cerrato, Felecia E. M.P.H.; Erikson, Cameron R. B.S.; Webb, Michelle L. B.A.; Rosen, Heather M.D., M.P.H.; Walsh, Erika M. M.D.; DiVasta, Amy D. M.D., M.M.Sc.; Greene, Arin K. M.D., M.M.Sc.; Labow, Brian I. M.D. "Psychosocial Impact of Adolescent Gynecomastia: Plastic and Reconstructive Surgery." Plastic and Reconstructive Surgery, Journal of the American Society of Plastic Surgeons, journals.lww.com/plasreconsurg/Abstract/2013/04000/Psychosocial_Impact_of_Adolescent_Gynecomastia___A.44.aspx.
Reuters Staff. "South Carolina Court Orders Johnson & Johnson to Pay $136 Million..." Reuters, Thomson Reuters, 26 Feb. 2015, www.reuters.com/article/us-johnson-johnson-risperdal-lawsuit/south-carolina-court-orders-johnson-johnson-to-pay-136-million-in-risperdal-case-idUSKBN0LU0YM20150226.
"Risperdal Lawsuits." ConsumerSafety.org, www.consumersafety.org/legal/risperdal-lawsuit/.
"Risperdal Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing." WebMD, www.webmd.com/drugs/2/drug-9846/risperdal-oral/details.
Sullivan, Thomas. “California Risperdal Suits to Be Renewed?” Policy & Medicine, www.policymed.com/2020/05/california-risperdal-suits-to-be-renewed.html.
Last Modified: August 13th, 2020 @ 03:34 pm
Risperdal is an anti-psychotic drug that can cause users to develop breast tissue, a condition known as gynecomastia. Risperdal lawsuits across the country have been filed against the manufacturer, Johnson & Johnson, for knowledge of the risks, but failing to adequately warn consumers.
© 2019 TorHoerman Law LLC.
The contents of this webpage have been prepared by TorHoerman Law, LLC for informational purposes only. None of this information is intended as either legal or medical advice or opinions. No attorney/client relationship is established with use of this website. Sending or receiving information through this site, posting to our blogs/news site does not establish an attorney/client relationship. An attorney/client relationship with TorHoerman Law is established only by an express and written agreement by TorHoerman Law to represent you. Our attorneys make a case-by-case assessment of any claims and results may vary depending on the facts concerning any case. The attorneys at TorHoerman Law are licensed to practice in Illinois, Missouri, and California. In some circumstances, cases may be sent to other qualified lawyers. In those circumstances, TorHoerman Law maintains joint responsibility.