When a product manufacturer fails to provide consumers with sufficient information to use their product safely, and injuries occur as a result, the basis for a strict product liability case exists. In 2013, Johnson & Johnson agreed to pay $2.2 billion to settle claims involving their role in injuries due to the use of Risperdal by consumers who were unaware of the risks involved with using the drug. In fact, Johnson & Johnson and Janssen Pharmaceuticals allegedly not only failed to warn consumers of potential danger, they knowingly concealed findings of dangerous side effects and illegally marketed the drug to children and geriatric consumers. Because the company didn’t wait for FDA approval before promoting Risperdal for use in children, Johnson & Johnson’s marketing of Risperdal to older adults, children, and individuals with developmental disabilities was improper and constitutes a marketing defect product liability lawsuit.
The U.S. Department of Justice found that Johnson & Johnson’s illegal marketing practices included: training its sales force to promote Risperdal to pediatricians as early as 2003 (it was not approved for use in children until 2006); issuing this directive despite lack of approval for any use in children; and compensating doctors with money and incentives to recommend the drug specifically for use in children.
Despite eventual FDA approval, however, Risperdal has been shown to cause severe side effects, including gynecomastia (enlargement of breast tissue in males), type 2 diabetes due to excessive weight gain, and movement disorders, such as tardive dyskinesia and neuroleptic malignant syndrome. Hundreds of lawsuits involving gynecomastia in young males due to Risperdal use have been filed against Johnson & Johnson and Janssen Pharmaceuticals, and overall, the company’s marketing activities have been called out by consumer protection regulators in 36 states.
Risperdal—the trade name for the antipsychotic drug risperidone—was approved in 1993 to treat severe adult schizophrenia. In 2007, the FDA approved broader use of the drug for short-term treatment of bipolar disorder (manic depression) for children ages 10-17, as well as treatment of schizophrenia patients in the 13-17 age group. Risperdal is also approved for children between the ages of 5-16 who suffer from irritability associated with autism. Off-label prescribing for ADHD, as promoted by Johnson & Johnson, has increased at a rate of three times higher than in the 1990s despite the fact that Risperdal side effects in children may be life-altering and severe, including the risk of stroke and cardiac arrest.
Several studies have shown that Risperdal causes significant adverse side effects. Risperdal use increases levels of prolactin, a hormone that stimulates breast development, resulting in male breast tissue enlargement (gynecomastia), as well as lactation in female consumers. Gynecomastia often results in physical damage and emotional anguish that may require therapy or psychiatric treatment. Severe cases of gynecomastia may require a mastectomy. There have been documented cases of boys who developed breasts as large as a 38D cup size due to the use of Risperdal.
Risperdal has also been shown to substantially increase the risk of type 2 diabetes due to excessive weight gain while taking the drug. One of the most commonly reported side effects in children who use Risperdal, weight gain can be dramatic, increasing the risk of diabetes. One study discovered that young patients gained up to 13 pounds in only six to eight weeks of treatment. Some children were found to have gained weight at a rate of five pounds per week. In addition to predisposing children to diabetes, other obesity-related conditions may occur, such as high cholesterol and insulin resistance. However, the risk of developing diabetes is tripled within the first year of Risperdal use, according to another study.
In another study, twelve other side effects were found to be common to Risperdal use (involving more than five percent of users in clinical trials), including tremors, sedation, insomnia, anxiety, abdominal pain, nausea, diarrhea, fatigue, and dizziness.
Risperdal was marketed and sold by Johnson & Johnson without any warning to young males of the risk of developing breasts, and the company has been accused of concealing information from studies that showed an increase in prolactin, which is what causes gynecomastia in males. This information provides the basis for a strict product liability claim.
A product liability marketing defect lawsuit may be initiated by proving that Johnson & Johnson had knowledge or foreseeability of a risk at the time the product was marketed; that Johnson & Johnson failed to provide warning or instruction, making the product unreasonably dangerous to the user; and a link between Johnson & Johnson’s failure to provide warnings and the product user’s injury.
Macaluso & Fafinski are experienced in representing clients who have been victims of marketing defect and product liability. If you or your loved one took Risperdal and suffered with gynecomastia, and you were not warned of these severe side effects prior to use, we will review your case at no cost to determine if you or your loved one may be eligible for compensation for injuries, medical bills, lost income, pain, and suffering. Many who have suffered severe side effects from Risperdal are coming forward to seek justice and appropriate compensation.
To arrange a free evaluation of your case and explore your legal options, call Macaluso & Fafinski today at 718.364.4000 (in the Bronx) or 212.480.9000 (from elsewhere in New York), or simply fill out our convenient online form, and we will respond as soon as possible. The offices of Macaluso & Fafinski are conveniently located to serve the five-borough area and its residents.