Jury Awards $2.5 million to Autistic Man Injured by Risperdal Side Effects

The maker of the drug Risperdal recently lost its first jury trial and was ordered to pay compensation for harm caused by the company’s failure to adequately warn of the side effects of the antipsychotic drug.

A Pennsylvania jury said the drug manufacturer Johnson & Johnson should pay $2.5 million to a 20-year-old autistic man in Alabama who developed size 46 DD breasts as a young teenager after taking the drug. It was the first Risperdal case taken to trial involving the condition known as gynecomastia, according to the Philadelphia Inquirer. Many other patients have lawsuits pending.

In 2013, Johnson & Johnson agreed to pay $2.2 billion in criminal and civil fines to resolve accusations that from 1999 to 2005, it improperly promoted the prescribing of Risperdal to older adults, children, and people with development disabilities, according to the U.S. Department of Justice. It was the third largest pharmaceutical settlement in U.S. history, the New York Times reported.

That settlement did not preclude individuals who were allegedly harmed by Risperdal from filing a product liability lawsuit.

Drug makers have a legal responsibility to make and market products that are safe and effective when used as intended and to warn consumers of any side effects. When pharmaceutical companies disregard Food and Drug Administration requirements, they put patients at risk.

The U.S. FDA approved Risperdal in 1993 for adults diagnosed with schizophrenia. It was not approved for any use in children or adolescents until 2006.

By the time the drug was approved for children and adolescents, a drug sales representative for Johnson & Johnson’s Janssen subsidiary, had made more than 20 sales trips to the pediatric doctor who was treating the autistic boy in Birmingham, Alabama.

Inadequate Warnings About Risperdal Risks

Former FDA Commissioner David Kessler testified during the trial that Janssen did not do enough to warn patients and the FDA, when one of Janssen’s own studies suggested that gynecomastia could result from elevated production of the hormone prolactin when using the drug.

According to the New York Times, Janssen had promoted the use of Risperdal to people with mental disabilities and children in the years before the company received FDA approval to market to children. The drug sales reps promoted Risperdal as a safe treatment for disorders such as obsessive compulsive disorder and attention deficit hyperactivity, although the company knew that children were vulnerable to certain side effects when taking Risperdal.

The FDA said it had repeatedly warned the company that promoting use of Risperdal for children was a problem and could be a violation of the law.

Drug companies should be held accountable when they make and market dangerous drugs that harm patients. If you or a loved one has been injured by the side effects of a prescription drug such as Risperdal, contact a unsafe drugs lawyer at Burch, George & Germany for assistance. Our personal injury attorneys are available to assist patients and their families throughout Oklahoma with product liability claims related to dangerous drugs and their side effects.