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

WASHINGTON, Oct. 17 /PRNewswire/ -- On Monday, November 3, the Supreme Court will hear opening arguments in Wyeth v. Levine. It's a case that stems from an unfortunate error that resulted in a tragic injury. The patient already has been compensated by those who improperly administered the drug to her in a separate action. The only claims currently being decided in Levine are those where the jury's verdict conflicts with the FDA's considered scientific judgment.

-- Wyeth v. Levine: The Facts

Diana Levine's tragic injury was the result of an improper administration of Wyeth's product, Phenergan. In April 2000, Ms. Levine sought treatment for severe migraine and nausea. Still experiencing symptoms later that day, Ms. Levine again sought treatment. She was again prescribed Phenergan to treat her nausea, this time via intravenous injection (or "IV push") rather than intramuscular injection, to provide relief more quickly. However, the product was improperly administered by a physician assistant at a dose twice the labeled maximum for IV use, and clear indicators of an improper administration were ignored.

As a result of this unfortunate error, Ms. Levine developed gangrene which required amputation of her forearm. She sued the health center, the supervising physician, and the physician assistant who gave the injection, and ultimately Ms. Levine received a financial settlement. Subsequently, Ms. Levine sued Wyeth. A Vermont jury awarded Ms. Levine $6.7 million, ruling that Wyeth should have changed the Phenergan labeling to prohibit physicians from administering the medicine through IV push. The ruling was in direct conflict with federal law, which required that Wyeth only use the FDA-approved labeling.

-- The FDA-Approved Phenergan Label

For decades, millions of people have benefited from Phenergan's immediate nausea relief: instances of human error in administering Phenergan have been extremely rare. At the time of administratio
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SOURCE Wyeth
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