Healthy Skepticism Library item: 12962

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Publication type: news

Greenhouse L.
Court Allows Suit Against Drug Maker
New York Times 2008 Mar 4
http://www.nytimes.com/2008/03/04/washington/04scotus.html?ref=health

Full text:

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 Rezulin was approved by the Food and Drug Administration in 1997 and withdrawn from the market three years later at the agency’s request.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.

According to his financial disclosure form, Chief Justice Roberts owns $5,001 to $50,000 in stock in Pfizer Inc., Warner-Lambert’s corporate parent. When there is a tie vote, the court issues a one-sentence order that does not identify the positions of the justices who voted.

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.

The Bush administration, which has embraced a broad theory of federal pre-emption of individual tort suits, entered the case on the manufacturer’s behalf. It argued that “permitting lay juries to second-guess” the adequacy of a drug application would interfere with the agency’s “exercise of its expert judgment.”