$76.6 Million Won by Arnold & Itkin LLP in a Risperdal Case
Arnold & Itkin won a $76.6 million verdict against Johnson & Johnson for a client who took Risperdal as a child and developed gynecomastia. Our verdict was more than 20x larger than the prior 4 verdicts combined and is the largest result of a Risperdal trial to date nationwide. We were thrilled to help our client get justice after years of bullying and emotional distress. We hope to help other clients accomplish the same.
Information Regarding the Risperdal Drug
Risperdal, otherwise known as risperidone, is an anti-psychotic drug that was initially approved by the FDA and released in 1994 to treat people who have schizophrenia and bipolar disorders. This product was established by Janssen-Cilag, a subsidiary company of Johnson & Johnson. This drug was initially approved for use in cases of schizophrenia, but this was limited to use in adults. In 2003, the drug was also approved for short-term treatment of mixed and manic states that were associated with bipolar disorder. Three years later, children and adults who had autism could use the drug to reduce irritability. It wasn't until August 2007 that the FDA determined risperidone could be used in youths between the ages of 13-17 as it was the only drug that was on the market for this purpose. Later, it was approved for children 10-17.
Off-label versions of risperidone are used to treat a variety of conditions such as:
- Obsessive-compulsive disorder
- Treatment-resistant depression
- Tourette syndrome
- Eating disorders
- Behavior disorders in children
- Acute intoxication
The patent given to Janssen for risperidone expired in December 2003 and the exclusive marking rights were terminated the following June, allowing for generic companies to begin marking the same product for a lower price. Today, risperidone can be found in tablet forms, oral solutions, and through biweekly injections. This includes Risperdal M-Tab (disintegrating tablets) and Risperdal Consta (injectable).
Call (888) 493-1629 to discuss your Risperdal injuries with our attorneys. Let us determine if you have a case.
Risperdal Causes Breast Development in Boys
While this treatment has shown success for patients suffering from varying conditions, it has also proved to have devastating side effects. One of the most disheartening is the fact that it severely elevates the patient's prolactin hormone levels, which can lead to numerous health concerns. For a female, having too high prolactin in the body can lead to difficulties in becoming pregnant, the ending of the menstruation cycle, or unwanted breast milk. If a male suffers from increased prolactin levels, he too may begin experiencing female-like side effects. Gynecomastia is a condition in which a male experiences benign breast tissue growth—in some cases up to the equivalent of a size D-cup in a female bra. Rather than having increased fat cell growth, the hormone itself causes these breast tissues to evolve and form. It is also common that due to the increased levels of prolactin, the male patient may develop galactorrhea, which is a condition where he produces a milky white discharge.
Possible Side Effects of Risperdal
Along with the possible side effects of male breasts and milky discharge, there are many other side effects that patients may experience. Because these side effects may be severe, if you find that you are experiencing any of the following, be sure to contact your doctor.
Other side effects may include, but are not limited to:
- Fast or uneven heartbeats, confusion
- Stiff muscles or restless muscle movements
- Flu, fevers, chills, body aches, headaches
- Drooling or uncontrollable shaking (tremors)
- High blood sugar (hyperglycemia)
- Changes in cholesterol
- Weight gain
Johnson & Johnson also writes that the medication can make patients more sensitive to heat, can cause extrapyramidal symptoms like muscle disturbances and tremors, or can heighten the risk of seizures. Also, the medicine can affect a person's driving ability and may deal with sleepiness, headaches, aching limbs, dizziness, and restlessness. The most common side effects of Risperdal are weight gain and tremors.
Neuroleptic Malignant Syndrome (NMS)
One of the most dangerous side effects of risperidone-based medications is Neuroleptic Malignant Syndrome (NMS).
NMS is a rare but potentially fatal side effect that comes with the following symptoms:
- Stiff muscles
- Uncontrollable shaking
- Change in pulse or heart rate
- Muscle pain
Tardive Dyskinesia (TD)
Risperidone-based medications can also result in Tardive Dyskinesia (TD). This is a serious and permanent side effect that causes uncontrollable movements of the face, tongue, and other parts of the body. Often, the condition can develop after a brief period of treatment and will persist permanently. There is no treatment for TD, so those that develop the condition will always struggle with their facial expression control.
Risperdal & Low White Blood Cell Count
The FDA has stated that the taking of antipsychotic agents, such as Risperdal, have been linked to events involving leukopenia and neutropenia. Leukopenia is an occurrence where the number of white blood cells decreases, increasing the risk of infection. It is tied very closely to neutropenia, which is the decrease of neutrophil granulocytes (a specific type of white blood cell). The FDA noted that individuals who have a history of low white blood cell count are more susceptible to leukopenia/neutropenia when taking Risperdal.
Risperidone & HPG Axis Dysfunction
Reports have proven that risperidone comes with some serious risks and can create embarrassing and devastating side effects. The medicine has been linked with HPG Axis Dysfunction, which stands for hypothalamic-pituitary-gonadal axis dysfunction. In this condition, the pituitary gland, gonads, or hypothalamus in the body are tampered with in a way that causes them to stop working correctly. Together, the three endocrine glands that make up the HPG axis operate to develop and regulate the reproductive systems and the immune system.
In some cases, risperidone can cause the body to release serum prolactin from the pituitary gland. While adults usually don't suffer side effects from this process, children with developing bodies are at more of a risk to an illness or injury. When the prolactin levels remain elevated after taking risperidone, this can result in delayed sexual maturation and reduced bone growth.
When prolactin keeps the HGP Axis from working, it can cause a variety of symptoms. As a result, many children do not have a natural maturation during puberty or may have an increased risk of benign breast tumors. HPG axis dysfunction has also been known to cause reduced bone density.
Risperdal & Gynecomastia Studies
While the drug has been used in many adolescent children over the years, researchers have discovered a disturbing link between the use of this drug in males and the development of gynecomastia and galactorrhea. The study titled "Galactorrhea and Gynecomastia in a Hypothyroid Male Being Treated with Risperidone" in the 1999 publication of Psychopharmacology, discusses this very concern. From this study, researchers were able to find a strong connection with the use of Risperdal and the development of both milk supply and breast tissues in a male.
Risperdal usage over an extended period caused many to experience elevated prolactin levels.
Doctors in this study looked closely at one 38-year-old Hispanic male who was suffering from bipolar disorder after a motor vehicle accident two decades earlier, which caused a brain injury. While the doctors were able to restore his ability to walk, the patient displayed behavioral symptoms, which negatively affected his moods and impulsivity, also dealing with inappropriate social behaviors. To treat these symptoms, he was given a prescription of Risperidone and was told to take 2.5 mg twice daily. The patient reported to be showing symptoms in just 12 days.
The doctors conducted tests and found that his prolactin levels were significantly higher, and his breasts both increased in size and discharged a milky white liquid. A normal prolactin level would have been between 1.4ng/mL to 24.2 ng/mL, and the patient on day 13 was at 48.2 ng/mL, clearly over the natural levels. The doctors pulled him off of the drug the next day and, over 10 days, his levels returned to normal.
By day 87, his breast sized had gone down by 75%, and he stopped producing the milky discharge. Seven years later, the same type of study was done explicitly geared toward children; they came to find similar and devastating results. Also published by Psychopharmacology, the study titled "Risperidone-induced symptomatic hyperprolactinemia in adolescents" found that 3 out of 10 cases of adolescents developed the same symptoms as the adult in their first study. They concluded that the clinical consequences might lead to both gynecomastia and galactorrhea.
Risperdal Lawsuits Regarding Male Breast Development
In September 2012, Johnson & Johnson came to a quick settlement on the first day of a case involving gynecomastia, which had a jury picked and was set to begin trial in a Philadelphia courthouse. According to the plaintiff's lawyer, the effects suffered from his client were severe—with breast growth reaching into "D" sized cups. Many believe that this confidential settlement could be the start of justice for victims.
The argument of the plaintiff rested on the fact that Johnson & Johnson were marketing Risperdal for treatment with children in the 1990s—before it ever received FDA approval for that usage. This marketing tactic is being targeted as being illegal and for concealing the fact that the ingestion of the drug could result in hormones which could increase the chance of male breast development.
Over the last few years, several trials have resulted in Johnson & Johnson having to pay up for their marketing tactics. In fact, since 2004, the U.S. Justice Department has been investigating into the marketing for Risperdal based on accusations that the drug was being marketed for unapproved purposes. In 2012, the company agreed to pay more than $2 billion to resolve the issue.
In February 2012, Johnson & Johnson reported that they are currently facing more than 400 product liability cases related to Risperdal. Of these, more than 100 are believed to be linked to the allegations that the taking of the drug caused male breast growth. Former FDA Commissioner David Kessler, M.D. has also opened up about the allegations, claiming that the company broke the law in the ways they marketed.
In a report submitted for trial, Kessler said the following:
"The promotion of non-approved uses by a manufacturer, because it undercuts the system and safeguards of drug regulation, is concerning. The promotion of non-approved uses in the most vulnerable children of powerful drugs is most concerning. Janssen's promotion of Risperdal, a powerful drug, for non-approved uses in the most vulnerable children is deeply troubling."
Justice Department Investigates J&J After Lawsuits
The Justice Department has dispatched agents to look into allegations that Johnson & Johnson illegally promoted their drugs. J&J claims they don't want to admit any conduct that could affect the outcome of multiple lawsuits that they are dealing with at present. They also say they are already settling many lawsuits against the company, and that they do not need the Justice Department to conduct an investigation that could alter the outcome. The Department of Justice's research is centered on the way that J&J labeled and promoted Risperdal for youths.
J&J submitted side-effect data to U.S. regulators for approval before adding this information to containers of the medication for children and adolescents, and the language was approved. Now, authorities are not sure whether the language on the bottles sufficiently indicated the seriousness of the side effect. Prosecutors want J&J to admit they downplayed the risks that adolescents were taking when they consumed the medication. J&J says that they don't want to deal with this case and would prefer that the Department of Justice dropped the case altogether. This is because the wording of any confession could impact dozens of lawsuits against J&J regarding Risperdal.
J&J maintains the position that they adequately warned consumers of the potential side effects of their medicine. A spokeswoman says the FDA accepted the language for the side-effect warnings and the packaging clearly states the drug increases levels of prolactin. J&J also says the information for Risperdal says that the side effects have caused a small number of males to develop breasts. The label also says breast development was reported in 2.3% of all boys in a clinical trial with 1,885 children. In addition to these allegations, the Justice Department is looking into claims that J&J promoted the use of Risperdal in children even before it was approved for this purpose by the FDA.
Taking Legal Action for Risperdal Injuries. Call (888) 493-1629 Now!
Since September 2012, lawsuits against Johnson & Johnson have been occurring as victims and their families seek to hold the company accountable for the devastating, and embarrassing effects that this drug has had on their male loved ones. Federal investigators with the U.S. Justice Department have been fighting to prove that J&J is responsible for not only creating a product with these side effects but also for not adequately warning users of the potential risks. Due to their actions, many males who were taking Risperdal for their schizophrenia and bipolar disorders have suffered from male breasts and milky discharge, among many other side effects. If you or a loved one have taken Risperdal and experienced any of these many side effects, do not hesitate in taking legal action against those responsible for your suffering. By contacting an experienced drug injury lawyer at Arnold & Itkin, you will receive the aggressive legal representation you deserve on your side. Together, we will fight to prove that your illness has been directly caused by exposure to this drug, and pursue the financial compensation you deserve.
Call us today at (888) 493-1629 to learn more about how our skilled attorneys can fight on your behalf!