A federal appeals court has decided that the drugmakers can't be held liable for a pair of suicides that were blamed on antidepressants and an alleged failure by the manufacturers to include sufficient warnings about links to suicide. The ruling comes just months before the US Supreme Court is scheduled to review preemption and whether the concept should apply to prescription drugs.
The preemption debate centers on an argument by the FDA and drugmakers that agency approval of a drug supercedes state lawsuits challenging safety, efficacy or labeling. FDA officials, who once viewed litigation as a tool for aiding oversight of safety issues, now maintain that state lawsuits could lead to an overlapping patchwork of rules that would burden drugmakers and might discourage patients from taking useful meds.
In this latest decision, two of three judges on the US Court of Appeals for the Third Circuit ruled against the family of Lois Colacicco, 55, who took a generic version of Paxil sold by Apotex in October 2003 and committed suicide less than a month later, and the family of Theodore DeAngelis, 64, who in January 2003 took Zoloft and committed suicide eight days later. In doing so, the court dismissed arguments that the drugmakers possessed undisclosed data closely linking their antidepressants to suicide and the FDA's subsequent warnings for youngsters in 2004.
"Our holding is limited to circumstances in which the FDA has publicly rejected the need for a warning that plaintiffs argue state law requires," the court wrote in its 58-page decision. "Even when it began to reevaluate its position regarding the association of antidepressants with pediatric and adolescent suicidality, the FDA continued to announce its rejection of adult suicidality warnings for SSRIs as it had for the decade before the prescriptions and deaths at issue in this litigation."
UPDATE: An attorney for the Colacicco family says that "we read this to be a narrowly tailored decision dealing with only those cases where the FDA has reviewed the issue. In this case, it was SSRIs and suicidality. It doesn't deal with all drugs."
"Just months prior to Lois Colacicco’s death, the FDA publicly stated that Paxil was not associated with a risk of suicidality in adults. Similarly, four months before DeAngelis' death, the FDA filed a public brief stating its position that scientific evidence did not support the addition of a suicide warning on Zoloft’s labeling.
"The FDA explains in the amicus brief that 'the basis for federal preemption is not the (labeling) guidelines themselves..., but rather FDA’s repeated determinations prior to October 2003 that there was insufficient scientific evidence of an association between adult use of SSRI and suicide or suicidality to permit a warning on the labeling for those drugs...
"The FDA’s view that 'the imposition of liability under state law for defendants' alleged failure to warn would interfere with FDA's accomplishment of regulatory objectives,' is in ourview entitled to at least as much deference, if not more, as the FDA’s view of its preemption authority."
In a dissenting opinion, Ambro wrote that "Allowing the plaintiffs’ cases to proceed beyond the motion-to-dismiss stage means instead that the state courts and federal district courts applying state tort law may eevaluate - provide a check on - whether the FDA struck the right balance in the precautions and warnings it required for SSRIs."