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Risperdal Lawsuit Alleges Drug Causes Gynecomastia

Risperdal Lawsuit Alleges Drug Causes Gynecomastia

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.

Litigation Updates

Appeals Court Throws Out Order Preventing J&J From Facing Punitive Damages

January 2018 - A Pennsylvania appeals court threw out an order that prevented Johnson & Johnson from facing punitive damages.

$1 Million Awarded to a Young Man

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.

Summary Judgment Granted Again

February 2017 - Again, Judge New granted a motion for summary judgment in favor of Janssen.

Undiagnosed Settlement Reached

January 2017 – An undiagnosed settlement was reached by Johnson & Johnson and the plaintiff, subsequently avoiding trial.

Seventh Trial Dismissed

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.

Summary Judgment Granted

October 2016 – Judge Arnold L. New granted a motion for summary judgment in favor of Janssen Pharmaceuticals.

$70 Million in Damages Awarded to Plaintiff

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."

$500,000 Awarded to Plaintiff

December 2015 – The fourth Risperdal case found in favor of the plaintiff, awarding $500,000 in damages.

Cases Consolidated in Philadelphia Court of Common Pleas

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.

$1.75 Million Awarded to Young Man

November 2015 - $1.75 million was awarded to a young man who developed Gynecomastia after taking Risperdal for schizophrenia.

Jury Found in Favor of Manufacturer

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.

Man Awarded $2.5 Million in Damages

April 2015 - A young man was awarded $2.5 million in damages after developing size 44D breasts from taking Risperdal.

Court Upholds Decision Ordering Manufacturer to Pay $136M Penalty

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.

J&J Settled Justice Department Investigation

2012 - Johnson & Johnson settled a Justice Department investigation into whether the company unethically marketed and promoted Risperdal to consumers by agreeding to pay a $2.2 billion fine, the largest at the time.

Study Released Suggesting Link Between Drug and Condition

2006 - A study is released by a Duke psychiatrist that suggests a strong correlation between Risperdal and Gynecomastia.

FDA Approves Risperdal for Youth Use

2006 - The FDA approves Risperdal to treat children, specifically those with autism.

FDA Issued Black Box Warning

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."

Project Created to Persuade Doctors

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.

Risperdal Approved for Use

1994 - Risperdal is approved to treat schizophrenia in adults.

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What is Risperdal?

Risperdal, a powerful anti-psychotic drug used to restore the balance of the brain’s natural chemicals, was approved by the FDA in 1993 to treat schizophrenia, as well as acute mania and mixed episodes associated with Bipolar I Disorder, in adults.

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, indicating that the actual number of side effects occurring is likely much higher.

A black box warning has been placed on the drug, specifically relating to the increased risk of death in elderly patients taking Risperdal for dementia-related issues.

 

Risperdal and Gynecomastia

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.

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 emotionally. Specifically, the condition was found to effect “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 Lawsuit

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 J&J, the jury finding the drug maker negligent for failing to warn consumers about the risk 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 have any questions about a Risperdal lawsuit, please contact the personal injury lawyers at TorHoerman Law today.

 

+ - References

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.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020272s056,020588s044,021346s033,021444s03lbl.pdf

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.

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