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

ndermine the careful balance struck by the FDA when making approval decisions.

Upholding preemption will still leave America's courthouse doors open to injured patients. The only claims that will be decided are those where the jury's verdict conflicts with the FDA's considered scientific judgment. Any consumer who is injured as a result of a manufacturing defect may still seek redress in court and manufacturers will remain subject to strict FDA-imposed penalties for concealing information from the FDA. The circumstances of this case present only the situation where Wyeth fully disclosed to the FDA information about the risk at issue, and the FDA was fully informed about the risk when it approved Phenergan's labeling. If Wyeth prevails here, it will only reinforce the principle that doctors are entitled to rely on FDA-approved professional labeling.


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SOURCE Wyeth
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