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Healthy Skepticism Library item: 12962

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

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 Rezulin was approved by the Food and Drug Administration in 1997 and withdrawn from the market three years later at the agency’s request.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

 

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909