Preemption Watch: Two Wins for Pharma

Apr 16, 2008

The Third Circuit Court of Appeals found in favor of pharma last week, stating that FDA labeling preempts any liability on the part of the drug companies. According to the decisions in two cases—Colacicco v Apotex and McNellis v Pfizer—pharma can not be held accountable for adverse events caused by drugs that were being monitored by FDA.

In the two cases, plaintiffs accused the pharmaceutical manufacturers of improperly labeling the side effects of their selective serotonin reuptake inhibitors (SSRIs). Family members of suicide victims claimed that the pharma companies didn't do enough to warn patients of suicidality associated with Pfizer's Zoloft and Apotex's generic Paxil.

FDA has continuously studied SSRI and the suicidal risks and the warnings at issue, and has stated that those kinds of warnings aren't warranted because there is no scientific basis for them.

"With respect to SSRIs, FDA had publicly rejected the very type of warning that the plaintiffs had asserted should have been given," said John Q. Lewis, partner in the trial practice group in the Cleveland office of Jones Day. "That's a crucial fact for the court's decision in finding preemption. The FDA said that they do not believe that there is a scientific basis for the type of warning that, ultimately, the plaintiffs felt should have been given in this case."

Legal experts said that while this is a victory for pharmaceutical manufacturers, there were facts brought before the court that don't necessarily exist in all pharma preemption cases.

"A loss here would have been a real problem for pharmaceutical manufacturers," Lewis told Pharm Exec. "The facts were really good for preemption in this case, and if it had been rejected in the Third Circuit, it would have been a big loss for the drug companies."

Pending Preemption
The court did not address whether simple FDA approval of labeling without rejection of additional warnings is sufficient to give rise to a preemption defense. That issue might be decided in Wyeth v Levine, currently pending in the US Supreme Court.

In that case, a woman lost her arm due to the onset of gangrene that was attributed to Wyeth's Phenergan. According to Wyeth, the nausea drug was properly labeled and approved by FDA. The plaintiff won a $6.8 million in the Vermont Supreme Court. The case is scheduled to go before the US Supreme Court within the next year.

"Ultimately, the issue is going to be covered by the Levine decision, so it's really sort of a temporary win," Lewis said. "Everyone is sitting on the edge of their seats waiting for that case to play out."

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