7th Circ. Rules Paxil Suicide Case Not Preempted
February 23rd, 2010
Law360, New York (February 23, 2010) — A federal appeals court ruled Tuesday that federal law does not preempt the state law claims of parents who sued SmithKline Beecham Corp. after their daughter committed suicide while taking Paxil, allowing the case to head to trial.
The U.S. Court of Appeals for the Seventh Circuit reversed a district court’s decision in 2008 to grant SmithKline summary judgment because the plaintiffs’ state law allegations that SmithKline failed to adequately warn about Paxil’s suicide risk on its label were preempted by federal law.
One attorney said it was the first time the Seventh Circuit ruled on whether a preemption defense was valid in a pharmaceutical product liability case since the U.S. Supreme Court issued the landmark decision in Wyeth v. Levine that limited federal preemption.
Generally, drug companies have argued that federal law preempts state law claims in failure-to-warn cases because drug labels that include the warnings need to be approved by the U.S. Food and Drug Administration, a federal agency, explained Chris Coffin, an attorney for the plaintiffs.
But the Supreme Court ruled last year in Wyeth v. Levine that federal preemption could not apply to state law claims unless the drug company could show there was “clear evidence” the FDA would not have approved the changes in the drug’s label that plaintiffs alleged were necessary.
“It’s unfortunate that many cases prior to Levine had been dismissed based on preemption,” Coffin said. “This is another victory for consumers, and it shows that what the Supreme Court did is having a major impact on the ability of consumers to pursue actions against pharmaceutical companies.”
Sarah Alspach, a spokeswoman for SmithKline, said in an e-mail that the company was disappointed and disagreed with the ruling. She did not comment further.
SmithKline was sued after Tricia Mason, 23, killed herself after taking Paxil for two days in 2003. The parties disagreed about whether Mason had a history of suicidal behavior, and the Seventh Circuit noted that would be up for a jury to decide.
Nonetheless, SmithKline argued there was “clear evidence” to show the FDA would not have approved the Paxil label change the plaintiffs requested. First, it noted the FDA approved Paxil without requiring a suicide warning after SmithKline submitted its new drug application in 1989.
Second, it argued the FDA had been thoroughly reviewing data available about selective serotonin reuptake inhibitors, the type of drug that Paxil is, and concluded there was not an increased risk of self-harm.
Third, SmithKline argued the FDA’s inaction, as in its failure to mandate a warning about the risk of suicide, around the time of Mason’s death is clear evidence the FDA would not have approved the change in the label the plaintiffs sought.
Finally, even though the FDA ordered all antidepressant manufacturers to include a warning about young adult suicides in 2007, the company said the methods used to analyze the data were not available at the time of Mason’s suicide. It also said it did not have access to the data anyway.
The Seventh Circuit, however, rejected each argument in turn.
“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 before Tricia took her life,” the Seventh Circuit said. “In Levine, the court held that FDA approval by itself does not warrant preemption.”
Issuing Tuesday’s decision were Circuit Judges Terence T. Evans and Diane S. Sykes and District Judge Philip P. Simon.
The plaintiffs were represented by Pendley Baudin & Coffin LLP and Baum Hedlund Aristei & Goldman PC.
SmithKline was represented by King & Spalding LLP.
The case is Mason et al. v. SmithKline Beecham Corp., case number 08-2265, in the U.S. Court of Appeals for the Seventh Circuit.
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