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FDA Preemption

Wyeth v. Levine: A Triumph for Consumer’s Rights

On March 4, 2009, the United States Supreme Court announced a triumph for consumer safety in their much-anticipated decision of Wyeth v. Levine. In a 6-3 ruling affirming the Vermont Supreme Court’s decision, the Supreme Court held that state law failure-to-warn claims are not preempted by federal law. Notably, the Court stated that “[i]f Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express pre-emption provision at some point during the FDCA’s 70-year history.”

Derived from the Supremacy Clause of the United States Constitution, the doctrine of Federal Preemption basically makes all laws passed by Congress supreme over any State or local laws and ordinances, and in many cases, invalidates them. Here, the defendant argued that by complying with the FDA’s labeling requirements they were immune from being sued for a defect in their product that violated the laws of Vermont.

The case originated in a Vermont state court, when Diana Levine, a musician, commenced a personal injury claim against Wyeth Pharmaceuticals. In support of this claim, the following facts were revealed. In efforts to relieve her migraine, a physician’s assistant administered a medicinal cocktail of Demerol pain reliever and Wyeth’s nausea inhibitor, Phenergan, via an IV-push. This risky method allowed Phenergan to enter Ms. Levine’s artery and come into contact with arterial blood, causing Ms. Levine to develop gangrene. Eventually, this condition led to the amputation of her entire forearm.

Ms. Levine filed a complaint in Vermont State Court, alleging that Wyeth failed to adequately warn of Phenergan’s grave risks when administered intravenously. After a jury found Wyeth negligent and their product defective, Diana was awarded $6.7 million in damages. The Vermont Supreme Court affirmed on appeal, holding that the jury’s verdict “did not conflict with FDA’s labeling requirements for Phenergan because [Wyeth] could have warned against IV-push administration without prior FDA approval… . . .”

Thereafter, Wyeth appealed this decision to the United States Supreme Court, alleging that FDA regulations preempted Ms. Levine’s state law product liability claims. Wyeth argued that it would be impossible to comply with state law’s labeling requirements without violating federal law.

The Supreme Court rejected Wyeth’s arguments and affirmed the judgment of the Vermont Supreme Court. We applaud Ms. Levine for her continued strength, admirable determination, and for her huge part in this historic ruling.

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