Also known by the generic name risperidone, Risperdal is a powerful, anti-psychotic medication prescribed to treat schizophrenia, autism and bipolar disorders in adults. Its manufacturer, Johnson & Johnson (J&J), has recently been making headlines, especially in the Huffington Post, where its story has been the subject of a 57,000-word series by Steven Brill. The series discusses the tumultuous journey of Risperdal and J&J, which paid more than $2 billion in government penalties due to marketing several drugs, including Risperdal, for off label uses.
The investigative news series shows that $2 billion in penalties, for J&J, is a small price to pay for a profit of about $30 billion in Risperdal sales since 1994.
The problem comes from the fact that J&J earned a majority of its profit from wrongfully marketing the drug to a target audience that was not approved by the U.S. Food & Drug Administration: children.
Multiple studies had shown the risk of gynecomastia (male breasts) among children taking the drug. One study found that Risperdal led 5.5 percent of boys to develop large breasts – but the company covered up this information and continued to market Risperdal off-label to adolescents and children.
While the drug was approved for adolescent use in 2007, Risperdal was allegedly marketed before it was approved for adolescent use by the FDA. The drug was promoted off-label to treat the following childhood disorders:
- Attention deficit hyperactivity disorder
- Oppositional defiant disorder
- Obsessive-compulsive disorder
- Autism
The pharmaceutical manufacturers knew Risperdal posed certain health risks to children. Regardless of this knowledge and repeated warnings from the FDA, the company continued to market the drug for off-label uses. And even though J&J agreed to pay the $2 billion in settlement costs, it still made a massive profit from the sales of the drug that amounted to almost $30 billion.
File a Risperdal Lawsuit
If you or someone you love has experienced negative side effects including the development of male breasts from use of Risperdal, the experienced Risperdal lawyers, led by Named Partners Paul Hanly and Jayne Conroy, at Simmons Hanly Conroy are here to help. We are currently investigating claims from people who have been harmed by Risperdal.