Risperdal | Risperdal Gynecomastia Lawsuits

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September 9, 2017

Risperdal

SAN DIEGO, Calif., September 18, 2017  –  Risperdal is a best-selling antipsychotic drug used to treat mental health conditions in adults and children. Risperdal works by targetinag dopamine in the brain to improve mood, thinking and behavior. The potent drug is FDA-approved to treat kids and teens with schizophrenia, Bipolar disorder and autism, but it is also known to cause health problems in these very same patients. Boys and men who took Risperdal when they were young say they now suffer from a condition known as gynecomastia, in which the male breast tissue swells to an unusually large size. They are suing the makers of Risperdal for negligence and fraud and have already won substantial awards in court.

Risperdal Gynecomastia Lawsuits

Did you develop gynecomastia after taking Risperdal as a child? Boys and men are now filing lawsuits against the manufacturer of Risperdal, Johnson & Johnson subsidiary Janssen Pharmaceuticals. If you took Risperdal as a child and were injured as a result, you may be entitled to financial compensation. There may be significant cash settlements or payouts to those harmed by the drug.

Over 10 thousand lawsuits have been filed by teens and young adults who took Risperdal as children and developed gynecomastia, a condition in which the male breast tissue swells to an unusually large size.

Risperdal lawsuits accuse Janssen Pharmaceuticals of designing a defective product and failing to warn about its risks. The drug maker has begun to settle some of these cases and large jury verdicts have been handed down in others — the time to file your claim is now!

Risperdal lawsuits accuse Janssen of several legal claims, including:

  • Negligence
  • Negligently designing a defective product
  • Fraud
  • Failing to warn about Risperdal’s risks
  • Strict liability for designing a defective product
  • Breach of express and implied warranties
  • Conspiracy

Risperdal Mass Tort Litigation

There are about 18,500 Risperdal cases currently pending in state and federal courts nationwide. A large majority of these lawsuits are consolidated in mass tort programs in state courts in California, Pennsylvania and Missouri.

Philadelphia’s Court of Common Pleas is home to over 5,500 Risperdal lawsuits, which were consolidated into a mass tort in 2010. A number of cases in Philadelphia’s Risperdal litigation have already gone to trial and large jury verdicts have been handed down in favor of boys and men who developed gynecomastia. This includes a $70 million verdict awarded in July 2016, which was later increased to over $76 million.

Other verdicts in this mass tort include a $2.5 million award in February 2015, a $1.75 million award (later reduced to $680,000) in November 2015, and a $500,000 award in December 2015.

Janssen also agreed to settle a number of Risperdal lawsuits for undisclosed amounts, many of were settled in the days leading up to their trials.

The Risperdal mass tort litigation is not a class action lawsuit. Risperdal lawsuits are filed individually, unlike class action lawsuits which are filed by one or more individuals on behalf of many. Settlements and verdicts reached in mass tort litigation are awarded on an individual basis, not divided equally among plaintiffs like in a class action suit.

Risperdal Gynecomastia Free Evaluation

Parents of male children affected by the drug Risperdal may be entitled to a cash award for the development of a condition called Gynecomastia. Fill out this compensation evaluation to see if you qualify.

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Risperdal Lawsuit Injuries

The main injury surrounding the Risperdal litigation is gynecomastia — a condition in which males grow unusually large breasts. Other side effects are possible and have been included in the growing number of Risperdal claims.

Lawyers and attorneys working with Risperdal claimants have documented a number of injuries associated with the drug. These injuries include:

 

  • Rapid weight gain
  • Elevated prolactin levels
  • Gynecomastia
  • Lactation
  • Pituitary tumors
  • Breast cancer
  • Osteoporosis
  • Decreased bone mineral density
  • Metabolic syndrome
  • Elevated fat levels in blood
  • High blood pressure
  • Complications of type II diabetes
  • Movement disorders

Risperdal Lawsuit Updates

The Risperdal gynecomastia litigation has been moving through the court system for a number of years and cases continue to be filed across the country each week. There were more than 18,500 Risperdal lawsuits filed against Janssen as of March 15, 2017 and that number is expected to grow.

Settlements & Verdicts

Several jury verdicts have been awarded to plaintiffs since Risperdal cases began heading to trial in 2015. These verdicts range from $500,000 to $70 million. Numerous settlements have also been reached between Janssen and plaintiffs for undisclosed amounts.

  • 1st Risperdal trial — $2.5 million verdict
  • 2nd Risperdal trial — No damages awarded
  • 3rd Risperdal trial — $1.75 million verdict, reduced to $680,000
  • 4th Risperdal trial — $500,000 verdict
  • 5th Risperdal trial — $70 million verdict, increased to $76 million
  • 6th Risperdal trial — Dismissed mid-trial

Settlements & Verdicts Timeline

Feb. 24, 2015 — A jury handed down the 1st verdict in Philadelphia’s Risperdal mass tort litigation, finding in favor of plaintiff Austin Pledger and awarding him $2.5 million. Pledger first starting taking Risperdal in 2002 when the drug was not approved for children.

March 20, 2015 — A Philadelphia jury found in favor of plaintiff William Cirba but did not award any damages. The jury found that Janssen did fail to warn about Risperdal’s risks but said there was no established link between Risperdal and gynecomastia.

Nov. 9, 2015 — Plaintiff Nicholas Murray was awarded $1.75 million by a Philadelphia jury in the 3rd Risperdal case to head to trial. Murray was prescribed Risperdal “off-label” as a teenager to treat ADHD. His award war later reduced to $680,000 after Janssen appealed the verdict.

Dec. 11, 2015 — The 4th Risperdal trial in Philadelphia’s mass tort ended in a $500,000 jury verdict in favor of plaintiff Timothy Stange. The Wisconsin resident took Risperdal to treat Tourette’s syndrome in 2006 and developed gynecomastia as a result.

July 1, 2016 — A Philadelphia jury handed down the largest Risperdal settlement to date — a whopping $70 million — to plaintiff Andrew Yount, a Tennessee teen who began taking Risperdal in 2003 when he was just 5 years old. It was the 5th Risperdal lawsuit to go to trial in the Philadelphia mass tort litigation.

March 10, 2016 — A Philadelphia judge reduced the $1.75 million verdict handed down to plaintiff Nicholas Murray to $680,000. Janssen appealed the verdict after it was handed down in November 2015.

August 2016 — A Philadelphia court added $6.6 million in delayed damages to Andrew Yount, increasing his total award from $70 million to $76.6. million.

October 2016 — Janssen settled 2 Risperdal lawsuits pending in Philadelphia court for undisclosed amounts. Both cases were slated for trial in the coming days or weeks. (N.F. et al v. Janssen Pharmaceuticals Inc. et al and Gunter v. Janssen Pharmaceuticals et al.)

Jan. 6, 2017 — Janssen settled a Risperdal lawsuit  for an undisclosed amount just 3 days before its scheduled trial. The case involved a New York boy who was prescribed Risperdal “off-label” between 2002 and 2011. It would have been the 7th case to go to trial in the Philadelphia mass tort. (Z.S. et al v. Janssen Pharmaceuticals Inc. et al., case no. 130402100)

Feb. 14, 2017 — Janssen agreed to settle another Risperdal lawsuit for an undisclosed amount just days before it was scheduled for trial. The case involved a Missouri boy who developed gynecomastia after taking Risperdal and would have been the 7th Risperdal lawsuit to go to trial in the Philadelphia mass tort litigation. (N. et al vs. Janssen Pharmaceuticals, Inc. et al, case no. 130600734.)

Lawsuit News & Updates

Oct. 22, 2015 — Judge Arnold New issued an opinion barring plaintiffs from seeking punitive damages in Risperdal litigation under New Jersey law. This dramatically decreased the amount of damages plaintiffs could be awarded and is waiting a final decision from the Superior Court of Pennsylvania.

Sept. 9, 2016 — Janssen appealed the $70 million verdict handed down to plaintiff Andrew Yount in July 2016, calling the award “excessive.”

Oct. 21, 2016 — Judge Arnold New granted Janssen’s motion for summary judgment, ending a  Risperdal gynecomastia lawsuit then-pending in the Philadelphia mass tort program. (C.W. et al v. Janssen Pharmaceuticals Inc. et al.)

Dec. 13, 2016 — A Philadelphia judge tossed the 6th Risperdal case to go before a jury mid-trial, citing the expert witness’ testimony was not sufficient to prove that Risperdal caused gynecomastia. The lawsuit was dismissed in the 11th day of trial.

Feb. 28, 2017 — Judge Arnold New dismissed a Risperdal case that was heading for trial, granting Janssen’s motion for summary judgment. The boy in the case began taking Risperdal at just 8 years old to treat ADHD. (P.D. et al v. Janssen Pharmaceuticals Inc., case no. 130600738).

March 20, 2017 — The 7th Risperdal trial was scheduled in Philadelphia’s Court of Common Pleas. The case involved plaintiff Dean Hibbs, now 23, who began taking Risperdal 15 years ago to treat Asperger’s syndrome. He filed his lawsuit against Janssen in June 2013.

What is Risperdal?

Risperdal is an atypical antipsychotic approved to treat multiple mental health disorders. Risperdal is approved for both adults and children as young as 5. It is indicated to treat schizophrenia, symptoms of Bipolar I disorder and irritability associated with autism.

Risperdal works by blocking a specific dopamine receptor in the brain to improve thinking, mood and behavior — although it is not known exactly how the drug does this.

Risperdal is manufactured by Johnson & Johnson subsidiary Janssen Pharmaceuticals Inc. The U.S. Food and Drug Administration first approved the drug in 1993 to treat schizophrenia in adults. Since its approval, Risperdal’s use has been expanded to include the treatment of other mental health disorders in both adults and children.

Risperdal was not approved for use in children until 2006, but was often prescribed “off-label” to kids and teens before the FDA expanded its use. Doctors can prescribe medications for uses that are not approved by the FDA, but drug manufacturers are not supposed to market their drugs for any reason other than those cleared by the regulatory agency.

In 2013, Johnson & Johnson and Janssen agreed to pay $2.2 billion to resolve criminal and civil allegations lodged by the U.S. Department of Justice. The company was accused of promoting Risperdal for off-label uses, including in children and the elderly, and paying illegal kickbacks to doctors and pharmacists to prescribe the antipsychotic drug.

Individual lawsuits are now being filed by boys and men who took Risperdal as children and developed gynecomastia as a result. Risperdal lawsuits accuse Janssen not only of developing a defective drug and failing to warn about its risks, but also of hiding pertinent data about the drug’s link to gynecomastia from the FDA, medical literature and the public.

Approved Uses

The FDA approved Risperdal to treat a number of different mental health conditions over the years, in both adults and children as young as 5.

Risperdal is indicated to treat:

  • Schizophrenia in adults (1993)
  • Acute manic or mixed episodes of Bipolar disorder in adults (2003)
  • Irritability associated with autistic disorder in children and adolescents, aged 5-16 (2006)
  • Schizophrenia in adolescents, aged 13-17 (2007)
  • Bipolar I disorder in children and adolescents, aged 13-17 (2007)

 

Risperdal Side Effects

Clinical studies on Risperdal showed the drug could cause numerous side effects in some patients. Gynecomastia is one such side effect, which is thought to affect a larger percentage of patients than originally reported.

Gynecomastia

A number of boys and men who took Risperdal say they developed enlarged breasts that were swollen and tender to the touch — this condition is called gynecomastia.

Gynecomastia is caused by a hormone imbalance and can be the result of natural changes in hormone levels, especially in newborns or boys going through puberty.

Some medications, like Risperdal, have been known to cause gynecomastia as well. That is because Risperdal can raise prolactin levels, a hormone whose primary function is to help women produce milk after childbirth.

Elevated prolactin levels in boys and men can lead to gynecomastia, tender, painful breasts, nipple discharge, and even tumors on the pituitary gland, where the hormone is produced.

Doctors diagnose gynecomastia using blood tests and mammograms. Gynecomastia may go away on its own, but oftentimes, surgery is necessary to remove excess breast tissue.

Other Side Effects

Risperdal has been associated with a number of other side effects apart from gynecomastia. These include movement disorders, complications with type II diabetes, metabolic changes and more.

Risperdal side effects can be serious. The Risperdal label warns of the following complications associated with the drug:

  • Movement disorders
    • Tardive dyskinesia — involuntary movements of the tongue, lips, face, trunk and extremities
    • Parkinsonism — tremors, slow movement, stiffness
    • Akathisia — feeling of restlessness and the need to be in motion
    • Dystonia — uncontrollable muscle contractions
  • Metabolic changes
    • High blood sugar and type II diabetes
    • High levels of fats in the blood
    • Significant weight gain
  • Cognitive and motor impairment
  • Seizures

Some of the most common adverse events reported during clinical trials included:

 

  • Tremor
  • Sedation
  • Dizziness
  • Anxiety
  • Blurred vision
  • Nausea
  • Vomiting
  • Upper abdominal pain
  • Stomach discomfort
  • Diarrhea
  • Increased saliva
  • Constipation
  • Dry mouth
  • Increased appetite
  • Weight gain
  • Fatigue
  • Rash
  • Nasal congestion
  • Upper respiratory tract infection
  • Cold-like symptoms

 

Black Box Warning

The FDA required Janssen to put a black box warning on the Risperdal label in 2005, highlighting the drug’s risk to elderly patients with dementia. The warning indicated Risperdal and other atypical antipsychotics could double the risk of death in elderly patients with dementia-related psychosis and was was placed on the label of all atypical antipsychotics, not just Risperdal’s.

Black box warnings are the FDA’s strictest warnings and indicate there is a risk of serious injury or death associated with the drug.

Janssen got into trouble after it was caught promoting Risperdal “off-label” to physicians who treated elderly dementia patients. Janssen paid more than $2 billion to settle allegations  it promoted Risperdal as a treatment of anxiety, agitation, depression, hostility and confusion in elderly patients with dementia.

Risperdal has never been approved for use in patients with dementia-related psychosis and can actually increase the risk of death and stroke in this population.

Other FDA Actions & Warnings

FDA released a safety announcement in 2011 highlighting the risks of Risperdal when taken during the 3rd trimester of pregnancy. The communication said newborns were at risk of abnormal muscle movements (called extrapyramidal signs or EPS) and withdrawal symptoms when mothers took Risperdal during their 3rd trimester.

The warning was issued for all antipsychotic drug, but the FDA said expecting mothers should not stop taking their medication without speaking with their doctors first.

Signs and symptoms of EPS and Risperdal withdrawal in newborns include:

  • Agitation
  • Abnormally increased or decreased muscle tone
  • Tremor
  • Sleepiness
  • Severe difficulty breathing
  • Difficulty feeding

Taking Risperdal

Risperdal is available as an oral tablet and an oral solution. The type of medication used will depend on a doctor’s recommendation and what is best for each patient.

Risperdal comes in traditional tablets and orally disintegrating tablets. Risperdal tablets come in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg strengths. Orally disintegrating tablets are available in 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg strengths. Risperdal oral solution is only available in 1 mg/mL doses.

Recommended Doses

The recommended dose of Risperdal differs for each indication and the age and weight of the patient. A doctor will help determine which dosage is right for each individual patient or whether Risperdal is right for a patient at all.

  • Schizophrenia in adults — 2 mg to start, increase to 4 mg -16 mg.
  • Schizophrenia in adolescents — 0.5 mg to start, increase to 1 mg – 6 mg.
  • Bipolar mania in adults — 2 mg – 3 mg to start, increase up to 6 mg
  • Bipolar mania in children and adolescents — 0.5 mg to start, increase to 1 mg – 6 mg
  • Irritability associated with autistic disorder — 0.25 mg – 0.5 mg to start, increase up to 3 mg

Generic Risperidone

Risperdal is available as a generic, sold under its chemical name risperidone. Generic drugs work the same as their brand-name counterparts but are generally much less costly to patients. A prescription of generic risperidone can cost about $10 per month, compared to brand-name Risperdal which can cost almost $90 per month.

Other Atypical Antipsychotics

The FDA has approved 10 other atypical antipsychotic medications (also called second generation antipsychotics) besides Risperdal. These include Abilify, Zyprexa and Symbyax.

Janssen Pharmaceuticals manufactures a second atypical antipsychotic in addition to Risperdal, as well, called Invega.

Invega

Invega was approved by the FDA in 2006 to treat schizophrenia. It was later approved to treat schizophrenia in adolescents aged 12-17 and schizoaffective disorder.

Invega is an extended release tablet similar to Risperdal. The active ingredient in Invega is paliperidone, which is processed by the body differently than Risperdal.

Patients who took Invega and developed gynecomastia and other side effects have also filed lawsuits against Janssen. These lawsuits are included in Risperdal litigation.

Risperdal Contsa

Risperdal Consta is a long-acting intramuscular injection of risperidone, the active ingredient in  Risperdal. The FDA approved Risperdal Consta in 2003 as a bi-monthly treatment for schizophrenia and Bipolar I disorder.

Patients get the Risperdal Consta injection every 2 weeks instead of a taking a once-daily pill like Risperdal.

Risperdal Consta has also been associated with a number of adverse side effects, including gynecomastia. Patients who were injured by the drug are also filing lawsuits against Janssen and their cases are included in the Risperdal litigation.

Risperdal ‘Off-label’ Marketing & Illegal Kickbacks

In 2013, Johnson & Johnson and its subsidiary were accused of illegally promoting Risperdal to treat children and elderly dementia patients and paid the U.S. Justice Department the largest health care fraud settlement at the time — $2.2 billion. The historic settlement resolved civil and criminal allegations that the company had promoted Risperdal and Invega for “off-label” uses and dished out illegal kickbacks to doctors and pharmacists to prescribe the drugs.

As part of the settlement, Johnson & Johnson and its subsidiary Janssen Pharmaceuticals admitted to criminal charges that the companies promoted Risperdal to treat behavioral symptoms in elderly dementia patients. The Justice Department said Janssen sales representatives promoted Risperdal to treat dementia symptoms like anxiety, agitation, depression, hostility and confusion even though the company knew Risperdal could cause serious health problems in these elderly patients. Risperdal now carries a black box warning because of its risk to elderly dementia patients, who are at an increased risk of stroke and death when taking Risperdal.

The company also pled guilty to charges that it provided incentives to its sales team, dubbed “ElderCare,” by basing those sales reps’ salaries on total Risperdal sales, not just sales of Risperdal for FDA-approved uses.

The FDA reportedly warned Janssen about its sales practices, cautioning that behavioral disturbances in elderly dementia patients do not necessarily mean the patient is experiencing a psychotic disorder. The FDA said the anxiety, agitation and hostility experienced by dementia patients may be an appropriate response to the deplorable conditions these patients are sometimes subjected to. The FDA said Janssen’s sales practices raised ethical questions about using antipsychotic medications like Risperdal to control “inappropriate” behavior.

The ElderCare sales force was active from about 1999 to 2005, the same time other Janssen sales reps were working to grow and maintain the company’s market share of children and adolescent patients.

Sales reps apparently called on child psychiatrists and pediatric mental health care facilities to promote Risperdal as a treatment for symptoms of various mental health disorders. Janssen reps told physicians Risperdal could safely treat symptoms of attention deficit hyperactivity disorder (ADHD), obsessive compulsive disorder, oppositional defiant disorder and autism. Janssen also paid speaker fees to doctors in exchange for more Risperdal prescriptions for children and teens.

At the time, Risperdal was not approved to treat children or adolescents for any indication; it was only approved to treat schizophrenia in adults. The Justice Department also said Janssen knew Risperdal could cause unwanted health problems in young patients, including elevated levels of prolactin which can lead to gynecomastia.

Johnson & Johnson and its subsidiary settled similar accusations involving its antipsychotic drug Invega and its heart failure medication Natrecor, and allegations it paid illegal kickbacks to Omnicare Inc., the nation’s largest pharmacy specializing in nursing home patient care.

Sources

In Re: Risperdal Litigation Master Long-form Complaint in the Philadelphia Court of Common Pleas (2010). Retrieved from https://fjdefile.phila.gov/efs/temp/48wJfJcG.pdf

Johnson & Johnson 2016 Annual Report. Retrieved from
https://jnj.brightspotcdn.com/88/3f/b666368546bcab9fd520594a6016/2017-0310-ar-bookmarked.pdf

Judicial Panel on Multidistrict Litigation, Pending MDLs by District. (March 15, 2017). Retrieved from
http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-March-15-2017.pdf

National Alliance on Mental Illness. Risperidone (Risperdal). “What is Risperidone and What Does it Treat?” (June 2016). Retrieved from
http://www.nami.org/Learn-More/Treatment/Mental-Health-Medications/Risperidone-(Risperdal)

FDA. Risperdal label (2017). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020272s078,020588s066,021444s052lbl.pdf

FDA. Press release, “November 4, 2013: Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigations.” (Nov. 4, 2013). Retrieved from
https://www.fda.gov/iceci/criminalinvestigations/ucm375816.htm

FDA. Drugs@FDA: FDA Approved Drug Products – Risperdal (NDA 020272). Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&applno=020272

Mayo Clinic. “Enlarged breasts in men (gynecomastia).” (November 2016). Retrieved from http://www.mayoclinic.org/diseases-conditions/gynecomastia/home/ovc-20257576

Healthline. Prolactin Level Test. “Understanding prolactin and the prolactin test.” (July 2016).  Retrieved from http://www.healthline.com/health/prolactin

FDA. “FDA Drug Safety Communication: Antipsychotic drug labels updated on use during pregnancy and risk of abnormal muscle movements and withdrawal symptoms in newborns.” (Feb. 22, 2011). Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm243903.htm

FDA. Invega label. (February 2017). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021999s032lbl.pdf

FDA. Risperdal Consta label. (February 2017). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021346s056lbl.pdf

 

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Risperdal lawsuit claims and settlements page updated on September 18, 2017

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