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Wyeth v. Levine: Preemption and The Facts

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 administration 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 undermine 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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