The US District Court of California, dismissed the case on the grounds that under state law all of the claims required showing that GSK should have included a warning in Paxil’s labeling in 1997 that there was an increased risk of suicidality. The plaintiffs’s claims created a direct conflict with the federal labeling requirements for Paxil established by the FDA, preempting the plaintiffs’s tort claims.
Importantly, the court recognized that at the relevant time, in this case 1997, there was no reasonable scientific evidence to support the plaintiffs’s proposed warning. The decision is significant and precedent setting because it is believed to be the first case in which a court has fully considered the legal issue of implied conflict preemption and rendered an opinion in a pediatric suicide case brought against an antidepressant manufacturer alleging a failure-to-warn of an increased risk of suicidality. This ruling could potentially lead to the dismissal of similar cases on preemption grounds.