Supreme Court hears preemption case

The U.S. Supreme Court heard oral arguments Monday in Warner-Lambert v. Kent, a case involving FDA preemption provisions in a Michigan law. The Michigan law grants a defense to a product's liability claim if the drug and its label were in compliance with FDA "at the time the drug left the control of the manufacturer or seller." It provides an exception when a manufacturer commits fraud on FDA when obtaining approval.

The case was filed against Warner-Lambert, now part of Pfizer (NYSE:PFE), by patients alleging they were harmed by the company's diabetes drug Rezulin troglitazone, which was voluntarily withdrawn from the market in 2000. Michigan state courts ruled that the fraud-on-FDA exception is unconstitutional and dismissed the suit, but the U.S. Court of Appeals for the Second Circuit in New York reversed that decision. The patients' allegations that Warner-Lambert withheld information about Rezulin's liver toxicity were never heard by the courts. ...