Supreme Court Split On Second Preemption Case

         The Supreme Court issued its second opinion on preemption is as many weeks, this time in Warner Lambert v. Kent, rendering a split 4 to 4 opinion that leaves this critical issue still up for grabs. The case involved Warner-Lambert’s diabetes drug Rezulin, which was pulled from the market in 2000 when it was revealed that it caused liver damage.

        The Court considered a Michigan law that bars lawsuits over drugs approved for sale by the FDA except if the drug company committed fraud during the FDA review process. Who could argue against such an exception? Surely, if the drug company lied to the FDA during the approval process, it should not be able to use FDA approval to shield itself from lawsuits. Well, at least four Justices believed otherwise, holding that the fact that a drug company defrauded the FDA do not give rise to a private cause of action. Even worse, most Court observers believe Chief Justice Roberts would have provided the fifth vote for preemption but he recused himself because he owns stock in Pfizer which now owns Warner Lambert. The split vote leaves intact a Second Circuit decision in favor of the plaintiffs injured by the drug.

     Still another preemption case looms on the horizon, Wyeth vs. Levine, and Roberts unfortunately does not own stock in Wyeth.

Alan Milstein