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Wyeth v. Levine: Preemption and The Facts
Date:10/17/2008

n of the drug to Ms. Levine, the product labeling listed four separate warnings about risks of improper administration of IV Phenergan. The appropriate use of the product and the wording of the warnings had been reviewed multiple times over the years by FDA as well as by an expert advisory committee, and reflected FDA's careful consideration of decades of data on Phenergan use. All drugs have risks, and FDA must balance those risks against the benefits to the public health. There is no evidence, argument, or even suggestion that Wyeth concealed or failed to provide the FDA with any relevant information about the risks associated with Phenergan.

Notwithstanding the view of the FDA, a Vermont jury determined that Wyeth failed to adequately warn about the risk of IV push Phenergan. However, the FDA-approved labeling for Phenergan was mandated by federal law. Absent any new evidence, Wyeth could not change Phenergan's labeling to comply with the labeling sought by the Vermont jury without violating federal law. This is true even if the change is intended to add or strengthen a contraindication or warning.

-- Preemption Protects Everyone

The Constitutional principle of preemption is not new. Preemption arises from the U.S. Constitution, which under the Supremacy Clause invalidates all state laws that conflict or interfere with federal law. In Wyeth v. Levine, the Vermont's jury verdict was in direct conflict with the FDA's considered scientific judgment.

Patients and physicians need to be able to rely on a single federal standard and guidelines for the risks, benefits, and use of medicines -- the FDA-approved labeling. The public health is better served by having a single expert regulatory body making decisions about risks, benefits, and warnings -- rather than an ad hoc system that could produce hundreds of conflicting results that would be impossible for manufacturers, physicians, and patients to reconcile or interpret. Such a system would u
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SOURCE Wyeth
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