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ARTICLE | Company News

Pfizer endocrine news

March 10, 2008 7:00 AM UTC

An equally divided U.S. Supreme Court affirmed the U.S. Court of Appeals for the Second Circuit's decision in Warner-Lambert v. Kent, a case involving FDA preemption provisions in a Michigan law. The affirmation enables Michigan state courts and juries to determine whether a company has defrauded FDA. That decision is in direct contradiction to a ruling made by the Sixth Circuit in another preemption case involving the same statute. The Supreme Court would need to accept a third case to resolve the contradictory Circuit rulings.

The case was filed against Warner-Lambert (now part of Pfizer) by patients alleging they were harmed by the company's diabetes drug Rezulin troglitazone, which was withdrawn from the market in 2000. 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. ...