Ileus, or an intestinal blockage, has been added this spring to the list of numerous adverse reactions that have been voluntarily reported by patients taking the antipsychotic Risperdal (risperidone). The FDA approved Risperdal for the treatment of schizophrenia, acute manic or mixed episodes associated with Bipolar I, and irritability associated with autistic disorder.
This is practically a footnote to one side effect; for ileus is not the reason Risperdal's manufacturer, Janssen Pharmaceuticals, a Johnson & Johnson corporation, is defending itself from product liability lawsuits. Those actions primarily pertain to the drug's alleged relationship to the development of breasts in male youth who use the drug.
Plaintiffs in Risperdal lawsuits allege that the drug was inappropriately marketed to male adolescents and that the drug lacked warnings about the risk of abnormal breast development, or gynecomastia, in such young patients. Today, gynecomastia is listed in Risperdal's prescribing information as an adverse reaction observed in clinical trials.
Johnson & Johnson has only itself to blame for the emergence of these civil suits. One need not believe this space; believe the U.S. Attorney General's office. Federal prosecutors announced Nov. 4, 2013, that, under a plea agreement, J&J would pay $2.2 billion in criminal and civil penalties arising from its marketing practices. Allegedly, J&J marketed Risperdal to children from 1999 through 2005. The FDA, which originally approved Risperdal in 1993, had not cleared the drug for use in adolescents until 2007, according to FDA documents.
One wonders how a pharmaceutical company could overlook the side effect. It's not as if there was no evidence. For instance, in a Swiss study of adolescent risperidone patients published back in 2006 in the Journal of Clinical Psychopharmacology, the drug batted three-for-three in inducing the side effect that is at the heart of product liability lawsuits. Researchers wrote, "Among the 10 psychotic adolescents treated with risperidone in our unit, we had 3 cases of gynecomastia in 3 male patients..."
Male children and youth who developed gynecomastia after taking Risperdal may be entitled to compensation. The product liability attorneys at Reich & Binstock are ready and able to leverage their 30 years of experience for the pursuit of justice for these victims. Call toll-free or send a message through the website for a free consultation.