Risperdal and Invega CasesAnnotate this Case
Plaintiffs, two adolescents who were prescribed the antipsychotic drug risperidone after it was approved by the FDA to treat behavioral symptoms in children with autism, filed suit against Janssen for failure to adequately warn of the risk of gynecomastia on the drug's label.
In the published portion of the opinion, the Court of Appeal held that the trial court was correct to decide the issue of preemption without submitting any purported underlying factual questions to a jury. The court also held that Janssen did not meet its burden to establish its preemption defense and that plaintiffs' claims based on the information in table 21, studies 41 and 70, are not preempted. In this case, Janssen did not meet its burden to show by clear evidence that it fully informed the FDA and, in turn, the FDA rejected a proposed label change.