Information Regarding the Risperdal Drug
Arnold & Itkin secured 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.
Risperdal, otherwise known as risperidone, is an antipsychotic drug that was originally approved by the FDA and released in 1994 to treat people suffering with schizophrenia and bipolar disorders. This product was established by Janssen-Cilag, a subsidiary company of Johnson & Johnson. The drug's primary focus is to treat those suffering from varying degrees of schizophrenia, although its original approval by the FDA was only for adults until 2006 when they agreed to its usage for both young and old. Once J&J received the second approval, adolescents between the ages of 13 and 17 were able to take the prescription; adolescents between 10 and 17 were also later approved to use the drug.
The patent given to Janssen for risperidone expired in December of 2003, and the exclusive marking rights were terminated the following June, allowing for generic companies to begin marking the same product for a cheaper price. Today, risperidone can be found in tablet forms, oral solutions, and through biweekly injections.
Call (888) 493-1629 to discuss your Risperdal injuries with our attorneys. Let us determine if you have a case.
Risperdal and Gynecomastia Studies
While the drug has been used in many adolescent children over the years to treat symptoms of schizophrenia, bipolar disorders, and other medical concerns, 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 time period caused many patients 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. In order 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 a 10 day period, 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 geared specifically toward children; they came to find the similar and devastating results. Also published by Psychopharmacology, the study titled "Risperidone-induced symptomatic hyperprolactinaemia in adolescents" found that three out of ten cases of adolescents developed the same symptoms as the adult in their first study. Their conclusion was that the clinical consequences may lead to both gynecomastia and galactorrhea.
Possible Side Effects of Risperidone
Along with the possible side effects of male breasts and milky discharge, there are a number of other side effects that patients may experience as a result of this drug. Because these side effects may lead to severe health concerns, if you find that you are experiencing any of the flowing while using this drug, 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 in your jaw, tongue, eyes, or neck;
- Flu, fevers, chills, body aches, headaches; and
- Drooling or uncontrollable shaking (tremors).
Risperidone & 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 decrease, resulting in an increase in the risk of infection. It is linked 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.
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 court house. 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 rests 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 came to an agreement 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, he 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 investigation 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 certain whether the language on the bottles fully 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 drop 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 language for the side-effect warnings was accepted by the FDA 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
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 properly 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 LLP 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 to learn more about how our skilled attorneys can fight on your behalf!