The Supreme Court decided yesterday to grant cert in a pharmaceutical products liability case to determine whether federal regulation of pharmaceuticals preempts state tort claims. In the class action case, Warner-Lambert v. Kent, a group of Michigan plaintiffs allege that the manufacturer of a diabetes drug called Rezulin fraudulently persuaded the FDA to approve the drug, which was later implicated in the deaths of more than 60 patients. Product liability suits against a drug manufacturer are barred under Michigan law if the drug was approved by FDA and marketed in accordance with that approval. But that bar is lifted if the plaintiff can show that the manufacturer obtained approval fraudulently.
It’s worth noting that FDA has never indicated that its approval of Rezulin was fraudulently induced. Indeed, FDA was aware at the time it approved Rezulin that it posed a substantial liver toxicity risk. The agency nevertheless approved Rezulin since no other treatment for Type II diabetes was nearly as effective, and a warning of the risk was included in the drug’s label. The drug was only pulled from the market after FDA approved two other treatments believed to just as effective.
The trial court never reached the merits of fraud claim, however, because it dismissed the case after concluding that state tort claims of this nature are preempted by federal regulation of pharmaceutical drugs. The Second Circuit Court of Appeals reversed the trial court, finding that federal preemption does not apply in the specific circumstances of this case. The Supreme Court has already agreed to hear another drug preemption case this term, Wyeth v. Levine, and the high court could do patients a world of good of it protects innovators from this kind of tort predation.