J&J Loses First Jury Trial for Risperdal

On Feb. 25, 2015, a Philadelphia court ruled that Johnson & Johnson (J&J) failed to adequately warn about the potential for the antipsychotic drug Risperdal (risperidone) to cause gynecomastia, according to The Philadelphia Inquirer. J&J will pay $2.5 million to the first plaintiff, in a long list of thousands of lawsuits that are lined up to go to jury trial alleging that gynecomastia was caused by Risperdal. The plaintiff, a 20-year old autistic man from Alabama, reportedly developed size 46 DD breasts after Risperdal was prescribed to alleviate the irritability caused by his autism.

In 2013, J&J paid $2.2 billion to settle state and federal criminal and civil charges related to illegally marketing the drug for indications not approved by FDA. Drug companies cannot officially promote drugs off-label.  However, doctors can prescribe them on an off-label basis. The doctor who treated the plaintiff claimed that a sales representative for the drug had repeatedly visited his office promoting the use of Risperdal, but did not mention the severity of side effects, and, when the doctor began prescribing it to the young plaintiff, it had not been approved for use in adolescents. At the time, there were J&J studies that suggested that Risperdal may cause gynecomastia, but this information was not relayed to healthcare providers.

An attorney for the company argued that the label listed the risks associated with the drugs, but former FDA Commissioner David Kessler testified that the company did not do enough to inform patients and healthcare providers about the risks involved with the drug. Kessler also cited that, in an FDA study of the drug, Risperdal was found to cause higher levels of the hormone prolactin, which suppresses gonadotropin release, producing secondary hypogonadism, subsequently contributing to the development of gynecomastia, according to a report on gynecomastia.

According to Drug Watch, some who testified against the defendant alleged that J&J began to promote the use of Risperdal in children, as early as 2003, three years before it was approved for that indication by FDA. While this is the first trial relating the use of Risperdal to gynecomastia that has gone to jury trial, Forbes reported in September 2012 that J&J had already settled a lawsuit for the same type of lawsuit, and was expecting hundreds more to come.

Source: The Philadelphia Inquirer