J&J — once again in the news — lost the first case to come to court on Risperdal. A Philadelphia jury determined that J&J’s Janssen Pharmaceuticals division knew of the risk of breast growth in men and boys and failed to warn the public or even tell the FDA. J&J will likely appeal.
The case concerned a doctor who prescribed the drug an 8-year-old with autism who subsequently grew size 46DD breasts as a result of the medication. The drug was not approved (at that time) for use with children or adolescents. According to People.com, which profiled Austin Pledger, Risperdal was prescribed to “deal with the irritability associated with autism.” This isn’t even what the drug was approved for. Risperdal Consta (risperidone) is approved for the treatment of schizophrenia and for the maintenance treatment of Bipolar I Disorder.
There are more than 1,000 similar cases already filed about Risperdal. It seems to me that there is blame to share here. Without excusing J&J’s unethical and illegal behavior, why was a doctor giving an 8-year-old a drug not approved or tested for use in children?
J&J has a growing list of fines and settlements related to not warning patients about known side effects, for example $2.2 billion in fines for false marketing in Nov. 2013. BTW, that case involved sending “independent” physicians to nursing homes to review records (and presumably recommend J&J drugs) while on J&J’s payroll. I wonder if those docs faced consequences? I’ve done a Google search with no answer. If anyone knows, please tell me. For more info on that case see my blog “J&J Walk of Shame.”
