Originally published March 2, 2010
Keywords: Paxil, failure-to-warn claims, Mason, SmithKline, warnings, risk, prescription drug preemption, Wyeth, SSRIs
The US Seventh Circuit Court of Appeals has held that failure-to-warn claims against the manufacturer of the prescription antidepressant Paxil are not preempted by federal law. The court's decision in Mason v. SmithKline Beecham Corp., No. 08-2265 (7th Cir. Feb. 23, 2010) is of considerable importance, as the Seventh Circuit is one of the first federal appellate courts to address prescription drug preemption—and the first to do so in the context of a class of antidepressants called selective serotonin re-uptake inhibitors (SSRIs)—following the Supreme Court's decision in Wyeth v. Levine, 129 S. Ct. 1187 (2009).
In Mason, the plaintiffs—parents of a 23-year-old woman who committed suicide in March 2003, two days after she began taking Paxil—argued that Smithkline Beecham Corporation, doing business as GlaxoSmithKline (GSK), was negligent for not including warnings that Paxil increased the risk of suicide for young adults. GSK argued that the claim was preempted because it was impossible for the company to comply with both the state-law duties underlying such a failure-to-warn claim and its federal labeling obligations.
Reversing the decision below—which had granted summary judgment in favor of GSK—the Seventh Circuit declared that Wyeth represents a "sea change in the way courts are to consider issues of federal preemption." According to the court, Wyeth underscores the "central premise" of federal drug regulation: the principle that a "manufacturer bears responsibility for the content of its label at all times."
The court acknowledged that, even after Wyeth, a state-law claim premised on the alleged inadequacy of a prescription drug's labeling could be preempted by federal law if "the manufacturer met the stringent standard of proving that there was clear evidence the FDA would have rejected the proposed change in the drug's label." But the Seventh Circuit described the Supreme Court's "clear evidence" standard as an "exacting" one, noting that in Wyeth itself, there was an "ample administrative record that the FDA strongly considered a similar warning to the one the plaintiff proposed and the Court still did not find preemption."
The Mason court held that GSK failed to satisfy Wyeth's "clear evidence" standard with respect to the plaintiffs' proposed suicide warnings for Paxil. As an initial matter, the Seventh Circuit rejected the plaintiffs' argument that GSK had misled the FDA into approving Paxil without a warning about suicide. The court nonetheless concluded that the fact that "the FDA initially approved Paxil after considering the proper data does not provide much, if any, evidence that the FDA would have rejected the warning the plaintiffs say should have been in place." The court also gave little weight to the FDA's rejection of citizen petitions calling for a "labeling change for Prozac [another SSRI] that would have included a warning about suicide" and the FDA's "call to do more research" into the link between SSRIs and suicide. The court reasoned that these events took place several years before the March 2003 suicide and that "even though Prozac and Paxil are both SSRIs, they are different drugs made by different manufacturers."
The court also considered it significant that in October 2003, "the FDA informed health care providers of a possible increased risk of suicidality in pediatric" patients. (emphasis added) According to the Seventh Circuit, this made it "unlikely that the FDA would have refused to allow GSK to warn about a possible risk of suicide for young adults" in March 2003, when just a few months later it "warned the public that Paxil was potentially unsafe for 17-year-olds." Finally, the court concluded that events in 2006 and 2007—when first GSK and then the FDA modified the labeling for Paxil—were "not persuasive in determining whether there was clear evidence that the FDA would have rejected the proposed warning" in March 2003.
For these reasons, the Seventh Circuit held that GSK did not meet its burden of demonstrating by "clear evidence" that the FDA would have rejected a labeling change warning about an increased risk of suicide by young adults.
This case is significant because the FDA has been heavily involved in reviewing and revising SSRI labeling, and thus many argue that it should be an easy instance in which to find state-law claims preempted. Mayer Brown filed an amicus brief on behalf of the Product Liability Advisory Council, Inc., and the Chamber of Commerce of the United States in Mason. There are at least two other pending appellate cases addressing whether similar failure-to-warn claims against the manufacturers of SSRIs are preempted by federal law. See Miller v. Smithkline Beecham Corp., Nos. 08-5042, 08-5050 (10th Cir.); Dobbs v. Wyeth Pharmaceuticals, No. 08-6018 (10th Cir.). We will issue Client Alerts when those appeals are decided.
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