Here we go again : Drug manufacturers and Fraud

Court Allows Suit Against Drug Maker

http://www.nytimes.com/2008/03/04/washington/04scotus.html?ref=health

WASHINGTON — A 4-to-4 vote on Monday left the Supreme Court unable to decide a pharmaceutical pre-emption case that was argued a week ago.

The tie vote, with Chief Justice John G. Roberts Jr. not participating, will permit a lawsuit to proceed against the Warner-Lambert Company, the maker of a diabetes drug, Rezulin. The plaintiffs are 27 diabetes patients from Michigan who suffered liver damage while taking the drug. Rezulin was approved by the Food and Drug Administration in 1997 and withdrawn from the market three years later at the agency’s request.

A tie vote at the Supreme Court automatically affirms the lower court’s judgment. In this case, the federal appeals court in New York had rejected the company’s argument that the reasoning of a seven-year-old Supreme Court precedent barred individual damage suits that are based on the claim that a drug manufacturer obtained F.D.A. approval through fraud. Affirmance by a tie vote resolves only the particular dispute, without setting a precedent for other cases.

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This case, Warner-Lambert Co. v. Kent, presented a narrow slice of the broad pre-emption issue that the court will take up in its next term. In that new case, Wyeth v. Levine, the question is whether the Food and Drug Administration’s approval of a drug’s label precludes individual damage suits based on the claim that the label failed to include sufficient information or adequate warnings.

http://www.nytimes.com/2008/03/04/washington/04scotus.html?ref=health