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Court rules in favor of Pfizer, GlaxoSmithKline

Pharma Compliance Alert, April 16, 2008

Another case, another preemption win for the pharmaceutical and medical device industries.

In a 2-1 ruling, the 3rd U.S. Circuit Court of Appeals last week said Pfizer and GlaxoSmithKline (GSK) could not be blamed for the suicides of two people taking antidepressants known as selective serotonin reuptake inhibitors. The plaintiffs claimed the warning labels on Pifizer’s Zoloft and GSK’s Paxil were not strong enough.

However, the court ruled the failure-to-warn claims “conflict with, and are therefore preempted by, the FDA’s regulatory actions.” In the majority opinion, Circuit Judge Dolores Sloviter said the FDA had filed papers in the case asserting it had rejected stronger label warnings the plaintiffs’ lawyers said would have protected their clients.

The Supreme Court could decide the preemption issue in the fall when it hears Wyeth’s challenge to a judgment awarded to a Vermont woman over an anti-nausea drug. If Wyeth is successful, the court may bar any suit that questions the adequacy of an FDA-approved packaging insert to ensure drug safety. The Court ruled in favor of preemption for medical device makers earlier this year and deadlocked on a case involving a Michigan law.

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