The case is TM et al v. Janssen Pharmaceuticals, Inc. et al, Case No. 130501076, originally filed May 13, 2013 at Philadelphia Court of Common Pleas.
Risperdal (risperidone) was originally approved by the US Food and Drug Administration (FDA) in 1993 for the treatment of schizophrenia in adults. Risperidone was later approved for treatment of bipolar disorder, and in 2006 was given the nod for treatment of autism-related irritability in children as young as five years of age.
The plaintiff in the aforementioned bellwether trial was 7 years old when he was prescribed Risperdal in 2004. In his lawsuit, the plaintiff asserts that like other plaintiffs, he was affected by Risperdal and growing male breasts as an adolescent. The plaintiff also claims he never would have taken, or continued on with Risperdal had the product label not been misleading, or so it is alleged. According to the Risperdal lawsuit, the product label characterized Risperdal gynecomastia as a rare side effect that occurred in less than one, in a thousand cases.
So far, Risperdal bellwether trial outcomes have been heavily weighted in the plaintiff’s favor, with the possible exception of one bellwether plaintiff who was not awarded damages given the jurists’ inability to conclusively determine that Risperdal gynecomastia was, indeed responsible for growing male breasts. That said, the jury nonetheless concluded that safety warnings on the Risperdal label were inadequate.
What would have been, originally the sixth bellwether trial was settled in November, prior to the Risperdal trial getting underway. Opening arguments for the current bellwether trial were delivered December 2.
READ MORE RISPERDAL LEGAL NEWS
While physicians have the legal, moral and medical authority to prescribe medications for indications outside the recommendations of the FDA, manufacturers are not allowed to promote pharmaceuticals to doctors for indications not otherwise sanctioned by the FDA.
Some 2,000 Risperdal lawsuits are housed in the mass tort at Philadelphia.