Supreme Court takes preemption case

The U.S. Supreme Court on Tuesday agreed to hear Warner-Lambert v. Kent, a case involving FDA preemption provisions in a Michigan law. The Michigan law grants "an absolute defense to a product's liability claim if the drug and its labeling were in compliance with the FDA's approval at the time the drug left the control of the manufacturer or seller." It provides an exception for instances when a manufacturer obtains approval by committing a fraud on FDA.

Based on a 2001 U.S. Supreme Court decision in Buckman Co. v. Plaintiffs' Legal Committee, Michigan state courts ruled that the fraud-on-FDA exception is unconstitutional and dismissed a case against Warner-Lambert, now part of Pfizer (PFE). The case was filed by patients who had invoked the exception, alleging that they were harmed by Warner-Lambert's diabetes drug Rezulin troglitazone. Rezulin was withdrawn from the market at FDA's request in 2000 because of liver toxicity. ...