Risperdal is an antipsychotic drug produced by Johnson & Johnson subsidiary Janssen Pharmaceuticals. It’s used to treat symptoms of several mental health conditions, including schizophrenia, mood disorders, manic episodes associated with bipolar disorder, and irritability in autistic patients.
In 2007, the FDA approved Risperdal for limited pediatric uses. Some children had already been prescribed the drug prior to its approval or were prescribed Risperdal for uses not approved by the FDA. Federal regulations allow doctors to prescribe medication for “off-label” uses not approved by the FDA, but they don’t allow manufacturers to market toward these uses.
Unfortunately, later litigation revealed that Johnson & Johnson had aggressively marketed Risperdal to child and teen psychiatrists, making more than 100,000 calls to these practitioners starting in 1994. Doctors were also paid to attend pediatric advisory board meetings for Johnson & Johnson, often traveling to expensive resorts on the company’s dime. By 2010, Risperdal sales had reached $1.5 billion, and the drug had hit a 50 percent share of the pediatric antipsychotic category. However, Johnson & Johnson’s lengthy history of flouting the FDA’s marketing rules was about to catch up to them.
Both civil and criminal charges were filed by the US government, including False Claims Act allegations that the company’s marketing of Risperdal for “off-label” use in children and elderly patients resulted in numerous Medicaid/Medicare bills for unapproved treatment. In 2013, Johnson & Johnson agreed to a $2.2 billion dollar settlement regarding the marketing of Risperdal and two other medications for off-label uses. Most of the settlement money, in this case, went to reimburse state and federal governmental agencies for these false Medicaid claims. However, many individuals also suffered harm from the company’s marketing tactics, especially those who never received any warning about Risperdal’s potential side effects.
Pharmaceutical companies are responsible for warning potential patients about the risk of side effects when they advertise a drug. In the criminal complaint associated with the 2013 case against Janssen/Johnson & Johnson, the FDA noted that it had repeatedly warned the company to discontinue “misleading marketing messages” promoting Risperdal for use in children and teens. They also alleged that Janssen knew the drug could increase levels of prolactin, a hormone that promotes the growth of breast tissue in both male and female patients.
Risperdal works in the brain, affecting dopamine and serotonin receptors. Because dopamine affects the pituitary gland, which controls levels of a hormone called prolactin, patients taking Risperdal may develop higher levels of prolactin. In males, high prolactin levels can lead to breast development, called gynecomastia.
Research supports allegations that Risperdal use can lead to breast development in young males. One 2006 study friom the Journal of Clinical Psychopharmacology stated that Risperidone, or generic Risperdal, “administered to adolescents at doses commonly used for the treatment of psychotic symptoms can strongly increase prolactin levels, with clinical consequences such as gynecomastia.”
This study further noted that because the long-term effects of Risperdal and its relationship to growth and delay in puberty are not well-documented, the drug should be prescribed only cautiously to children and adolescents.
Often one of the earliest symptoms of this condition is a small lump on the chest, typically under the nipple. This area usually becomes tender and may continue to grow. Gynecomastia can affect breast tissue on one or both sides and may do so evenly or unevenly (one side may have more breast tissue growth than the other). Nipple sensitivity and nipple discharge are also common symptoms. In some cases, prolactin levels may be high enough to cause lactation, or the production of breast milk.
If you notice these symptoms after beginning treatment with Risperdal, contact your doctor right away as they could get worse. You should not stop taking your medication without speaking to your doctor, as doing so could affect mental health symptoms, but you and your doctor should discuss your options. In some situations, they may be able to switch you to a different medication that doesn’t affect prolactin in the same way.
In many cases, symptoms of gynecomastia go away when the patient stops taking Risperdal. However, for some patients, the enlarged breast tissue remains, causing the patient distress. This can be especially difficult for boys and teens, who may suffer from embarrassment or teasing from peers. Some patients have reported developing serious psychological trauma as a result of these physical changes.
If the enlarged breast tissue remains for more than a year, doctors may consider surgical options to remove it, including liposuction, breast reduction surgery, or mastectomy. These surgeries have risks, including pain, scarring, and infection. In some circumstances, these procedures are considered cosmetic or elective, and the patient’s health insurance will not pay for them. This only adds to the patient’s psychological distress if they can’t afford the surgery on their own.
By the end of 2018, more than 13,000 lawsuits had been filed by Risperdal patients or their families, citing allegations that the drug caused gynecomastia, which in some cases led to intense emotional distress or required surgery to reduce breast tissue. Many of these product liability cases have been resolved successfully for the plaintiffs. In late 2021, Johnson & Johnson announced they’d settled a number of these claims that had been filed by thousands of claimants.
In one 2016 case in Philadelphia, a teenager who had first been prescribed the drug at age 5 sued Johnson & Johnson on the grounds of failure to warn. Because drug manufacturers are legally required to inform potential customers of a medication’s risks and side effects, failure to warn is a common legal precedent used in product liability cases of this type. The teenager reported that he and his family were never warned that Risperdal could cause him to develop breast tissue. His legal team presented evidence that Johnson & Johnson knew of a study linking Risperdal with breast development in males, but concealed this information from doctors so they would continue writing prescriptions for the drug. The jury found in the teenager’s favor and awarded him a $70 million verdict.
It’s important to understand that verdicts in Risperdal product liability cases can vary widely depending on a variety of factors, including the severity of the plaintiff’s injuries, the evidence in the case, and the jury itself. Most verdicts will not be as high as $70 million, but you should expect an adequate amount for your situation. You and your St. Louis dangerous drugs lawyer should discuss what amount of compensation would be appropriate in your case. Typically, plaintiffs deserve full compensation for any medical bills they accrued as the result of their injuries – such as the cost of a surgery their insurance didn’t cover – as well as additional damages for their pain and suffering.
It’s also helpful to know that only a small percentage of dangerous drug lawsuits go to trial at all. The majority of these cases settle out of court. It can still take months to reach a resolution, as there may be several rounds of offers and counter-offers before both parties can reach an agreement. We will discuss every offer received with you, and answer any questions that you have. If we see that the offer may not cover all your damages, we will let you know. In the end, it is your decision if you want to accept a settlement offer. If you do, we’ll go over the paperwork for the final agreement with you to ensure all the terms are clear.
We always work to reach the quickest resolution that meets our client’s needs for compensation, and often we’re able to avoid a lengthy trial that could be stressful for the client. However, in some situations, the other party simply won’t agree on a fair settlement and it becomes necessary to proceed to trial. When that occurs, we’re ready to fight for our clients’ rights in court, and we will be by your side every step of the way.
Because these cases could take months to complete, we encourage you to contact a St. Louis personal injury lawyer today. If you’re not sure if you have a valid claim, please call us at Goldblatt + Singer, the St. Louis Injury Law Firm, for a free consultation. We’re happy to answer your questions and explain the options available to you.
Young boys or men who have developed breasts after using Risperdal may suffer from severe psychological trauma as well as extensive medical costs. If you or someone you know have suffered from gynecomastia you believe was caused by Risperdal, contact us today to begin your Risperdal lawsuit.
Since 1949, Goldblatt + Singer, the St. Louis Injury Law Firm, has been representing St. Louisans like you. You never have to worry about any up-front charges – we work on a contingency fee basis, so you will only be charged a fee if we are successful in recovering compensation for you.