A 20 year old male from Alabama was awarded $2.5 million dollars in damages by a Philadelphia jury in February 2015. Austin Pledger, had grown size 46DD breasts and gained 100 pounds as a result of taking Risperdal, an antipsychotic drug. Pledger is autistic, and was prescribed Risperdal to him to help deal with schizophrenic episodes.
Risperdal is manufactured by Janssen Pharmaceutica, a subsidiary of Johnson and Johnson. At one time Risperdal was Johnson and Johnson’s best selling drug, generating $24.2 billion in worldwide sales between 2003 and 2010. Drug manufacturers have the duty warn users of the medication’s potential side effects. This is commonly done with a warning label on the bottle or a disclaimer that is handed out at the same time a pharmacist dispenses the prescription. Sometimes a pharmacist may even verbally warn users of the side effects when handing over the prescription. Drug commercials are notorious for listing potential side effects at the end, which sound worse than the actual illness it’s supposed to cure.
Initially, Risperdal’s label said there was a low chance that the drug would result in males growing what would be perceived as female breasts – a condition known as gynecomastia. However, after the drug was approved by the FDA in 2006, the label was changed to read that it had high levels of prolactin – the hormone responsible for breast growth. David Kessler, the former head of the U.S. Food and Drug Administration, testified at trial that Janssen was aware of the heightened chance of the gynecomastia side effects as early as 2001. Janssen had funded a study back then that showed 3.8% of boys who used Risperdal developed male breasts. This percentage is deemed to be high enough that Janssen had the responsibility to warn users of the potential side effect. Pledger began taking Risperdal in 2002.
There are currently 1,278 cases listed in the Philadelphia Court of Common Pleas. There have been six cases that have reached settlements. Furthermore 2 cases reached settlements after trials had begun.
This case is particularly noteworthy because it is the first one to go to trial on the particular issue of gynecomastia. There have been cases in other states that have reached out of court settlements. As for Pledger, his lawyer claimed the only way to reverse his enlarged breasts would be by having a mastectomy. Unfortunately Pledger is not in the best of health at the moment, so it would not be in his best interest to have the surgery in his current condition. We certainly do wish him the best.