The U.S. Supreme Court delivered a split decision in a closely watched case involving the degree to which the Food and Drug Administrations authority eclipses liability lawsuits against drug companies under state tort law.
The case, Warner-Lambert Co. v. Kimberly Kent, specifically asked whether a Michigan law appropriately allows plaintiffs to argue that drugmakers defrauded the FDA to win approval to market a product, raising the specter that judges and juries would be called on to second guess the federal agency charged with regulating the industry. Chief Justice John Roberts recused himself from the case, reportedly because he owns stock in Warner-Lamberts parent company, Pfizer. The split decision, which comes with no opinion, preserves contradictory opinions in the 2nd Circuit and 6th Circuit appeals courts. As an immediate consequence though, the lawsuit over Warner-Lamberts diabetes drug Rezulin will be allowed to move forward.
John Lewis, a partner in the Cleveland office of law firm Jones Day, said the case will provide a case study that drives the arguments the next time the issue reaches the Supreme Court. Were going to be able to see how this issue plays out and how burdensome a case like this will be on the FDA, Lewis said.
Meanwhile, the court also has agreed to review a case involving Wyeth that more broadly addresses federal pre-emption in drug-liability cases, and the Warner-Lambert result might indicate that the justices are split on the underlying question, though they decided in an 8-1 decision last month that such pre-emption does exist in medical-device cases. -- by Gregg Blesch
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