Johnson & Johnson (J&J) and its subsidiary, Janssen Pharmaceuticals, are now facing a mass tort program alleging that serious side effects resulted from the use of its antipsychotic drug, Risperdal. The fifth trial currently underway in Philadelphia began with a family telling the jury that their adolescent son developed breasts as a result of taking Risperdal. The jury was shown a picture of the boy’s swollen chest, alleging that the condition was a direct result of his taking Risperdal prescribed to treat his psychiatric issues.
In a prior Risperdal trial, the jury was convinced that the antipsychotic drug was responsible for male breast growth, or gynecomastia. The family was awarded $1.75 million as a result of their Risperdal lawsuit.
A family from Tennessee has filed the current Risperdal suit and is accusing J&J of knowingly concealing the male breast growth side effects associated with Risperdal. The boy began taking Risperdal when he was 15 years old after trying other drugs to treat his psychiatric issues, namely attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD).
Allegations include that J&J concealed data about gynecomastia side effects associated with Risperdal from the FDA. Initially, approval had been declined by the FDA in 1997 for the use of Risperdal in children, citing insufficient data on the safety of the drug. In October 2006 Risperdal was approved to treat the symptoms of autism in children.
When the boy in the current lawsuit began taking Risperdal in 2003, the drug–at that time–was only approved to treat adult schizophrenia patients, according to court documents. Also at that time, a warning label on Risperdal pointed to gynecomastia as a rare side effect that might affect fewer than one in 1,000 patients, according to lawsuit allegations.
Janssen scientists were allegedly aware that Risperdal was associated with spikes of the hormone, prolactin, which is responsible for milk production; this, according to internal emails from J&J officials, according to Court documents. Allegations also include that information on gynecomastia was apparently not shared with the FDA.