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Wednesday, March 05, 2008
Courts - More on: "Supreme Court Considers Protecting Drug Makers From Lawsuits"
Updating this ILB entry from Feb. 26 about the case of Warner-Lambert v. Kent, Linda Greenhouse reported yesterday, March 4, in the NY Times:
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 Rezulin was approved by the Food and Drug Administration in 1997 and withdrawn from the market three years later at the agency’s request.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. * * *
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.
In essence, if the answer is yes, most individual lawsuits for damages caused by approved drugs would be pre-empted. Last month, in Riegel v. Medtronic Inc., the court interpreted a federal law, the Medical Device Amendments, as barring most individual lawsuits against manufacturers of approved medical devices.
The Warner-Lambert case, by contrast, specifically questioned the status of lawsuits alleging that F.D.A. approval was obtained by withholding or misrepresenting crucial information — in other words, by fraud. A 2001 Supreme Court decision, Buckman v. Plaintiffs’ Legal Committee, barred general claims of fraud.
But the lawsuit by the Rezulin patients was brought under the specific provisions of a Michigan law that, while prohibiting product liability suits against makers of approved drugs, specifically permits claims that the manufacturer withheld or misrepresented information that was important to the approval process. The question was whether the existence of the state law placed the lawsuit on a different footing for the purpose of pre-emption analysis.
Posted by Marcia Oddi on March 5, 2008 09:55 AM
Posted to Courts in general