Risperdal is often used to treat behavior problems associated with Attention Deficit/Hyperactivity Disorder (ADHD) in children, even though it has never been approved for this purpose. While its manufacturers have settled allegations with state and federal prosecutors involving the improper marketing of the drug for off-label uses, they still face hundreds of product liability lawsuits in which they are accused of wrongly promoting Risperdal for ADHD and other unapproved indications.
The off-label use of Risperdal in children is extremely concerning, as the medication is associated with some very serious side-effects, including the development of gynecomastia (male breast growth) in men and boys. Individuals with ADHD who took Risperdal may be entitled to compensation for medical bills and other damages if they developed gynecomastia as a result of their treatment.
Off-label use occurs when a drug is prescribed for an indication not approved by the U.S. Food & Drug Administration (FDA). Doctors are permitted to prescribe approved medications in any way they see fit, but pharmaceutical companies are barred by law from marketing their products based on any off-label use. While Risperdal is now approved for a few pediatric uses, that was not the case until 2006. Risperdal for ADHD is not an approved use of the drug in any age group.
In August 2014, a study conducted by researchers at Columbia University and published in the Archives of General Psychiatry reported that the number of pediatric patients who were prescribed antipsychotics like Risperdal for ADHD had grown significantly between 1999 and 2009. The authors of the report pointed out that while there is evidence to suggest that this class of medications might help children who exhibit severe behavioral problems, it is less clear that they will benefit the majority of those with ADHD. They also noted that the drugs’ long-term effect on children’s developing brains require further investigation. Among the antipsychotics included in the study, Risperdal was the medication most often prescribed to children and adolescents with ADHD.
Johnson & Johnson and Janssen Pharmaceuticals, the manufacturers of Risperdal, have settled a number of state and federal lawsuits that accused the companies of promoting the drug for off-label use. In 2012, they agreed to pay $181 million in order to resolve charges over improper marketing brought by 36 state attorneys general, as well as the District of Columbia. In November 2013, both companies reached a settlement with the U.S. Department of Justice that resolved similar claims over Risperdal and other drugs.
Among other things, federal prosecutors had charged that Johnson & Johnson and Janssen promoted Risperdal for obsessive compulsive disorder and ADHD in children, even though they were aware that this patient population was susceptible to gynecomastia and other disorders associated with its use. The $2.2 billion agreement was one of the largest ever in a federal case involving healthcare fraud.
The manufacturers of Risperdal have also been accused of promoting off-label pediatric uses in hundreds of gynecomastia lawsuits that are currently moving forward in U.S. courts. A fair number of these cases were filed on behalf of plaintiffs who were prescribed Risperdal for ADHD.
If a man or child you know developed gynecomastia while taking Risperdal to treat ADHD, it is important to act now to ensure your legal rights are protected. For a free, no-obligation review of your case, please fill out our online form, or call to contact an Risperdal attorney with Bernstein Liebhard LLP today.