Antipsychotic linked to abnormal male breast growth.

Risperdal Injury; Lawsuits and Settlements

risperdal-free-brochure-banner-170x250Medical research has found a connection between Risperdal and adolescent male breast enlargement (gynecomastia). If you or someone you know has taken Risperdal and developed gynecomastia, you need a sympathetic advocate who will represent only your interests—and who will make the process of obtaining compensation for your injuries as painless as possible. The Rottenstein Law Group knows this, and we want you to believe it. We might be the Risperdal law firm you are looking for.

What Is Risperdal and What Is Prescribed For?

Risperdal is the brand name for the drug risperidone. Made and sold by the Johnson & Johnson subsidiary Ortho-McNeil-Janssen, this prescription medication is used to treat schizophrenia in teenagers and adults, Bipolar I Disorder in those aged 10 and older, and irritability associated with autistic disorder in children aged 5-16 years. The U.S. Food and Drug Administration (FDA) approved it in late 1993.

Ortho-McNeil-Janssen’s risperidone patent expired in 2004, and in 2008, Teva Pharmaceuticals began selling a generic equivalent in the U.S.

According to the drug’s label, scientists do not understand Risperdal’s mechanism of action, though this is not uncommon for drugs designed to treat schizophrenia. Medical experts speculate that Risperdal blocks dopamine Type 2 receptors and serotonin Type 2 receptors in the brain. It’s less likely than some antipsychotic drugs to cause involuntary body movements at low doses. Risperdal is sold in various forms including tablets, orally disintegrating tablets, oral solutions, and intramuscular injections.

Controversy Has Surrounded Risperidone

The manufacturers of risperidone are not strangers to controversy. In January 2010, whistleblowers, state attorneys general, and the Department of Justice filed a Risperdal lawsuit against Johnson & Johnson based on the False Claims Act. The government claims that between 1999 and 2004 Johnson & Johnson paid $50 million in kickbacks to a pharmaceutical supply company, Omnicare, to sell Risperdal to nursing homes. The kickbacks appeared as payments to Omnicare for sham services, and Omnicare used the money to initiate programs aimed at convincing doctors to prescribe Risperdal to nursing home residents. Omnicare settled its own lawsuit against the government for $112 million.

In 2010, investors became so angry over the Risperdal controversies that they filed a derivative lawsuit against the Johnson & Johnson’s executives in New Jersey federal court. In July 2012, that case settled for $2.2 billion.

In August 2011, Massachusetts filed suit against J&J claiming the drug company promoted Risperdal for off-label uses and failed to disclose serious Risperdal side effects including diabetes and an increased risk of death in elderly patients. Several other states have filed similar suits against J&J, with mixed results. A Risperdal-related suit brought by the State of West Virginia was dismissed, but South Carolina secured a judgment against J&J for $347 million—an amount that included $4,000 for each of 7,142 letters the drug company sent to South Carolina doctors for marketing purposes. J&J has reportedly earmarked significant funds for Risperdal-related liability. In January 2012, Bloomberg Businessweek reported that J&J settled a Risperdal fraud lawsuit brought by Texas on behalf of its Medicaid program for $158 million.

Due to the alleged marketing tactics Johnson & Johnson used, U.S. Securities and Exchange Commission filings indicate that the government has been investigating the company’s sales practices. In August 2012, per a settlement agreement, it entered a guilty plea for a misdemeanor.

In November 2013, the New York Times reported that J&J settled with the Justice Department for $2.2 billion in civil and criminal fines because J&J improperly marketed Risperdal to children, the elderly, and people with disabilities between 1999 and 2005. It is the third-largest pharmaceutical settlement in U.S. history. In January 2014, the Louisiana Supreme Court reversed a $257.7 million jury verdict in favor of the state because the attorney general failed to show that J&J and Janssen had misrepresented the drugs efficacy to recover money from a state medical program.

In June 2011, Ortho-McNeil-Janssen recalled roughly 16,000 bottles of Risperdal due to a musty odor emanating from a pesticide contained in the wooden pallets used to transport the drug. Around the same time, the FDA issued a drug safety communication alerting the public and physicians that some doctors and pharmacists had mistaken Risperdal for Requip, a drug for treating Parkinson’s disease.

Risperdal Might Cause Life-Threatening Side Effects in the Elderly

The FDA does not approve Risperdal for the treatment of dementia in the elderly, and it requires a black box Risperdal warning on the product’s label informing users that the drug carries an increased risk of death in elderly users. The FDA determined that elderly people with dementia who used Risperdal were 1.6—to—1.7 times more likely to die of various ailments, including heart disease and pneumonia.

Risperdal Might Cause Neuroleptic Malignant Syndrome and Tardive Dyskinesia

Medical resources on the Web report that Risperdal is a potential cause of Neuroleptic Malignant Syndrome (NMS). NMS is a potentially fatal disorder with the following symptoms:

  • Hyperpyrexia;
  • Muscle rigidity;
  • Altered mental status; and
  • Autonomic instability (irregular heartbeat or blood pressure, excessive sweating).

Medical resources on the Web report that Risperdal is also a potential cause of Tardive Dyskinesia, a potentially irreversible condition characterized by involuntary facial movements such as:

  • Puckering and pursing of the lips;
  • Tongue protrusion;
  • Grimacing;
  • Lip smacking; and
  • Rapid eye blinking.

Risperdal Might Cause Male Breast Growth

Although Risperdal wasn’t approved for treating children between 2000 and 2004, some doctors prescribed it to boys, some of whom developed gynecomastia. Doctors simply attributed the breasts to weight gain and not a unique side effect of the drug. In April 2013, the medical journal Plastic and Reconstructive Surgery published an article finding that gynecomastia has “a significant negative impact on primarily the psychosocial well-being of affected adolescent patients, specifically in regard to social functioning, mental health, and self-esteem.” In September 2012, one 21-year-old plaintiff’s case settled on the first day of trial for an undisclosed amount. Five more Risperdal breast growth lawsuits settled in October 2012, leaving more than 100 lawsuits that have not been resolved.

Risperidone Might Cause Other Harmful Side Effects

Like many antipsychotics, Risperdal carries a suicide warning in its “Warnings and Precautions” section.

The “Pregnancy” section of Risperdal’s label now informs doctors and women who are about to become pregnant that Risperdal causes withdrawal symptoms in infants in the form of abnormal muscle movements (called extrapyramidal signs (EPS)). In February 2011, the FDA required Ortho-McNeil-Janssen to include information about risperdone’s potential to cause EPS on the drug’s label.

Symptoms of EPS include:

  • Agitation;
  • Hypertonia (excessive muscle rigidity);
  • Hypotonia (excessive muscle elasticity);
  • Tremors;
  • Somnolence (sleep disturbances);
  • Respiratory distress; and
  • Feeding disorder.

Most EPS withdrawal symptoms pass after a few days.

There is also concern that Risperdal, like other atypical antipsychotic drugs, has the potential to cause metabolic disorders, particularly hyperglycemia (excess sugar) and diabetes. Atypical antipsychotics cause the body to metabolize fat instead of carbohydrates, leading to insulin resistance to the excess carbohydrates. At the same time they promote fat accumulation.

RLG’s Lawyers Will Make Things Easier

The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that getting satisfaction from the company that harmed you shouldn’t be just more hardship. That’s why we do everything we can to streamline the process, and we will file a Risperdal lawsuit on your behalf if necessary.

If you believe you have experienced adverse side effects as a result of taking Risperdal, submit this simple secure form for a free and confidential evaluation of your eligibility to file a Risperdal lawsuit.

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rlg Previous Comments

  1. Guest
    on September 29, 2012 at 2:05 pm

    Risperdal has lost the use of language of my child of 6 years after my 3 and 5 months, plus tard the child. Also developed an inguinal hernia and hydrocele surgery was performed. The psychiatrist of 83 years of continuous St. Justine Hospital and gave aufmenté dose by force, the child is the subject of repeated intoxication, and its rate of glucose and cholesterol is very high, the child has developed disruptive behavior, excluded from school not school age.

  2. Guest
    on September 19, 2012 at 4:36 pm

    I have been diagnosed with bipolar schizo affective disorder for over 9yrs plus. I have been taking risperidal, cogentin, paxil and depakote. Several months ago I became very sick, nausea, vomiting, weight loss and headaches. Finally after several emergency visits my doctor decided to take me off of the paxil and the depakote. I was recently diagnosed with periodontal disease and told that my bone density is weak and that all of my teeth have to be removed. I spoke with a close relative and I was told that some valproic medicines and certain psychotropic meds decrease vitamins D and K.

  3. Guest
    on August 31, 2012 at 5:14 am

    I took risperdal in 2000 and again in 2008. In 2008 there were side effects. I just stared at people talking to me and mentally wasn't able to think or respond like I normally did. I would like to know if I can receive any compensation for taking that drug and suffering through the side effects.

  4. Guest
    on August 24, 2012 at 7:42 pm

    I have taken risperidsone and was diagnosed with an atrial septal defect ostium secundum type. I also gained 60 lbs in a matter of weeks to months (under 90 days) and now have an enlarged heart. I believe the doctor that prescribed it should have screened me cardiovascular problems. My doctor does not know if he can fix it.

  5. Guest
    on August 23, 2012 at 2:19 pm

    My mother is 75, diagnosed with dementia and agitation. Was being treated with Risperdal. She would be completely out of it one day and the next red faced and could at least move a little then the next day a pasty white face and couldn't move or talk. I believe the doctor prescribed the wrong drug for her and now, in just 2 weeks, we have noticed a marked decline in her overall health.

  6. Guest
    on August 12, 2012 at 1:10 pm

    Our mother, who is now 86, is in hospital from a fall of unknown reasons. She has been dizzy for sometime given a walking frame and an ugly useless bed which drops to the floor especially when someone heavy sits on it. Mum was taken in shock to ED and admitted to a rehab ward immediately. She was taken off respiridone cold turkey and developed worse shakes like severe Parkinson's disease. She cant feed herself nor think for herself, she sweats and sweats all day and night, her skin is constantly cold and clammy. Over the past few months she developed a trembling lip, slight trembles in her hands, and her face has turned up ward on one side. The hospital staff have supplied adequate prevention to stop further falls however they won't believe Mum has only been this useless since her fall. We have tried to say she is experiencing withdrawal symptoms but aren't getting any help as they don't believe Respiridone does these terrible things. Mums walking has improved since being off the Respiridone for 5 days but the trembling and sweating remains the same. She is very frightened especially when her belly starts actively rolling around and spasming visibly. Should the nursing homes be made aware of the side effects of this drug Respiridone? My mother wouldn't have fallen and diminished her capacity to remain independent. A couple of months ago, mother was helping to wash dishes in the nursing, today she can barely feed herself. A couple of months ago my mother was independently toileting herself, today she requires strict supervision and help to prevent her from falling again. A week ago she had good skin, then her skin remained dry and smooth for the last few days. she is constantly cool and moist causing her bed clothes and gowns to be damp. The doctors don't want to know and the nurses are in denial. Why do our elderly parents have to be drugged to the point of becoming vegetables.

  7. Guest
    on August 7, 2012 at 6:35 pm

    One of my 12 year old twins was given this for a 'mental disorder'. While taking this drug, he was ALWAYS hungry and gained a lot of weight. He also developed breasts...which I have heard has happened to others. He became MORE violent while on this medication and had occasional 'tics' that happened off and on. There is so much going on with him, it is hard to tell what to do anymore. But at least since he is off of Risperidone he is not eating all the time and sneaking away and eating full cartons of ice cream or bags of food. I feel Johnson and Johnson needs to pay for the pain and suffering of this young man...which will continue for a long time, unless he miraculously loses a huge amount of weight. And how does a male get rid of breasts? Not talking about the kind of 'breasts' you get from being over weight, but breasts. Has anyone else had this problem or heard of it? He was on two medications. I want to make sure I am getting the right medication for the right things.

  8. Guest
    on August 1, 2012 at 3:28 am

    I experienced very bad symptoms after being involuntarily put on risperidone. I was spewing every day, etc. I live in Australia and am keen to be involved in a class action.

  9. Guest
    on July 15, 2012 at 10:49 pm

    I took risperdal for at least 5 years. Since taking it, I was again given it, and then experienced somnolence. I was placed on many sedatives, and I took Lunesta for a whole year.

  10. Guest
    on July 11, 2012 at 5:29 pm

    I took risperdal after my first pregnancy for post partum depression. I believe it caused me to develop a fatty liver. I had never been overweight, except when pregnant, and was amazed when a fatty liver was discovered on an abdominal ultrasound. Since then I have developed hypothyroidism and other metabolic issues.

  11. Guest
    on July 9, 2012 at 9:56 pm

    I'm a 16 year old guy. I've been taking Risperdal/Risperidone for around 3 years, mostly without my consent or knowledge. I quit 'cold turkey' on December 2011.

    I can say for certain the medication has caused these unwanted conditions: developed sensitive breasts that discharge liquid; excess body fat and obesity; inappropriately excessive appetite; trembling; increased thirst; increased sweat; sleep paralysis and lucid dreams; muscle sprains and spasms; high heart rate and blood sugar; frequent urination; suicidal thoughts; bad posture; loss of reflexes strength and grip; frequent zoning-out, drowsiness and episodes of confusion in the middle of the day; loss of interests and hobbies; inability to process simple lessons in class; hindrance of comprehension and writing skills; inability to remember names; over-sensitivity to light and sound; partial physical paralysis; loss of sensation in hand and body; bad balance; trembling of limbs; large acne outbreaks; blurring vision; itching sensation all over my body; pains; physical inability to get up from bed in the morning; seeing stars after standing (headrush); I'd make unintentional body movements: twitching lips, twitching limbs, blinking, frowning, tapping fingers, funny faces and gestures; bad core strength; and feelings of falling.

  12. Guest
    on June 27, 2012 at 12:14 pm

    My son is 12 and has been on this med for about 2 yrs because of autism. He recently started to have a decline in his white blood cell count. His pcp has told us to stop giving him this med while we wait to see if his white blood cell count will return to normal.

  13. Guest
    on June 22, 2012 at 7:40 pm

    My son has developed breasts. We thought they would go away as he got older and taller. But, they have not. And he is always complaining of a rapid heartbeat. While on this medication, he blew up and was swollen his whole body. The doctor would not take him off the medicine. His temperament changed. We had him put in the hospital to get him off the medicines he was on.

  14. Guest
    on June 20, 2012 at 4:29 am

    I've been on this medicine for some time now. I suffer everyday. I shake so bad that I can hold onto small objects and it's getting worse. I'm at the point where I hate having to interact with other people because a complete stranger asks me why I shake so bad. Now I've had suicidal tendency even that has gotten worse also since being placed on this stuff. I feel as though I'm being turned into a woman. Mental and physically I have become extremely emotional and I have some white discharge coming out of my chest.

  15. Guest
    on June 2, 2012 at 7:22 pm

    I am a Vietnam veteran and around 1970, I was injured and fell about 30 feet was partially paralyzed on the left side including left arm, chest, deaf in left ear had to sleep with left eye open had to use tape to keep left eye shut, left arm and skull fractures. When I was able to go home, I had some mobility back and was suffering from 100% psychotic schizophrenic. With all my medication, I have to take risperidone 3mg, and the one mg. they have had me on this for a very long time. About 2 and 1/2 years ago, I got bad pneumonia and my wife will tell you I also have these symptoms -- the puckering and pursing of lips and tongue protrusion, grimacing lip smacking and rapid eye blinking. This has started in the last 3 or 4 years and is gradually getting worse. My wife has brought this up a lot but we did not think if this was due to my medication.

  16. Guest
    on April 18, 2012 at 9:54 pm

    I was prescribed Risperdal in 2001 and had a severe reaction to it. My heart rate raced out of control, I was extremely anxious and insomniac. It traumatized me. Yes, I am in probably the .1% of patients who cannot take the drug. In fact, to go out on a limb, I think the psychiatrist who ordered it already knew before he ordered it that I was in that .1%. I'd like to hear more about what lawyers are doing about Risperdal. Have new prescriptions for the drug fallen off recently? I'd like to hear about that too.

  17. Guest
    on April 14, 2012 at 10:08 pm

    My son was prescribed risperdal soon after he was diagnosed with autism in or round about 2000, he was about 5 and had speech delays and disabilities with speech; so he was irritable. His psychiatrist here in Texas prescribed him the drug. He was on it till he was 14 years old. I took him off when I realized, from various websites that the drug caused a host of reactionary symptoms. My son who now suffers with his Autism now copes also with Tardive and EPS. A condition I determined was due to excessive and continuous doses over a decade of use. His doctor never prescribed any other more, and never tested him for side effects. I, a couple years back complained to the medical boar and Cigna. He dropped us as patient after I complained and asked for his medical records. I admonished him for his "assembly line," approach seeing patients. My son didn't have all these terrible afflictions before this horrid drug was used on him.

  18. Guest
    on April 11, 2012 at 7:08 pm

    My mother developed a movement disorder and stopped walking while taking Risperdal in a nursing home. I finally was able to get the doctor to discontinue the drug, but, she is now bed bound due to contractures on her feet from not walking. She didn't speak for nearly two years and developed Parkinsonism and TD. Since the withdrawal of Risperdal, the Parkinsonism has resolved but she is bed bound and crippled due to five years of inactivity arising from the Parkinsonism. I believe that Omnicare was the pharmacy that the nursing home used when she first developed the movement disorder. My mother might be still walking if she had not been given Risperdal. This "medicine" is dangerous and should *never* be given to elderly patients. It has ruined her life.

  19. Guest
    on April 10, 2012 at 5:29 pm

    My daughter has schizophrenia and has taken this medicine like 8 or more years and I still have the medicine to prove it and I believe she has side effects from this medicine.

  20. Guest
    on February 12, 2012 at 1:12 am

    My brother was prescribed with that medicine in April 2011, not sure how long he took it, but he died January 17th 2012 of a stroke at 31 years old.

  21. Guest
    on February 2, 2012 at 1:51 pm

    I have a 7 year old son who is taking risperidone 2mg twice a day, ritalin la 20mg capsules twice a day, and clonidine 0.1mg tablet at 7pm. He has ADD, ADHD, Aspergers, OCD, and now in the last 6 months he was told he is prediabetic. Do you think it was called from the meds he takes?

  22. Guest
    on October 24, 2011 at 12:43 pm

    After my father spending several hours a day each day we have finally achieved a horrible diagnosis for my brother. He has been diagnosed with Tardive Dyskenisa and it is very severe. He has been on Risperdal for over 10 years and for the past 5 years my father has been telling the doctors that something is wrong. We have been asking if it could be related to his medications and we are told NO its related to his special needs. Wrong!!! He has been having symptoms that mock a stroke. He has been through many CT scans, MRI's blood tests. The doctors just say that its because of his special needs. He has a diagnosis of Autism, and Mental Retardation. This condition has now put him in a wheelchair for safety and has caused my father to become emotionally distressed. My father can't bear to see this continue to debilitate my brother. What can we do? It is tearing all of us up to see my brothers condition worsening and watching how scared he is. When your gut tells you it could be medication and Dr's tell you different so you listen to the professionals, now you feel guilty and helpless in a situation where the individual has no communication to tell you whats happening. Instead you watch them suffer. My brother was a smiling, happy, loving kid who is now, sad, angry, aggressive and hard to be around. This is worse knowing we can't reverse this condition.

  23. Guest
    on August 7, 2011 at 12:04 am

    I have been diagnosed with schizophrenia & suffered panic attacks for the past 17 years & with bipolar disorders over the last year. My symptoms seems to mimics having the condition of Fibromyalgia. Because of the progression of side the affects, I have been undergoing a series of tests to rule out initiating factors, which may have caused the progressive injury to the neurologically dysfunctional and uncontrollable tremors & movements in many areas of my body; inclusive, yet not limited to, the loss of coordination, weight gain, diabetes, increasingly unstable blood pressure, dizziness, headaches, sideways gait, with episodes of chronic events of falling down, which appears potentially to increase as a negative individual or combined effect when wearing the new Sketchers Shape-ups; although, inconclusively noted, as the primary, contributory factor of falling down, but in combination with the taking of prescribed psych medications. Consequently, the causing agent(s), shows an adverse affect, medically documented, of a supporting ,subtle onset of side affects dated initially, five years ago, with severely marked progression over the past year of NMS/Tardive dyskinesia; primarily, observed in regular medical examinations and psychotherapy sessions.

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