Arnold & Itkin is no longer accepting new Risperdal clients.
Arnold & Itkin won an $8 billion verdict against Johnson & Johnson for a client who took Risperdal as a child and developed gynecomastia. We were thrilled to help our client get justice after years of bullying and distress.
Risperdal, otherwise known as risperidone, is an anti-psychotic drug initially approved by the FDA and released in 1994 to treat people who have schizophrenia and bipolar disorders. This product was established by Janssen, 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 associated with bipolar disorder. Three years later, children and adults who had autism could use the drug to reduce irritability. It wasn't until October 2006 that the FDA determined risperidone could be used in children and adolescents.
Off-label versions of risperidone are used to treat a variety of conditions such as:
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).
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.
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.
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."
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.
Contact us at (888) 493-1629 to learn how our skilled attorneys can fight on your behalf.