Design Defect Claims Against Vaccine Manufacturers Are Preempted by Federal Law


On February 22, 2011, in Bruesewitz v. Wyeth, Inc., the U.S. Supreme Court held in a 7–2 decision that the National Childhood Vaccine Injury Act of 1986 (“Vaccine Act”) preempts all design defect claims brought against vaccine manufacturers. The case is not only a victory for supporters of federal preemption, but signals that the Court is willing to find “express preemption” in a federal statute that many criticize as not expressly preempting state law claims. This willingness, however, is not likely a harbinger of expansion of the federal preemption doctrine, but rather, evidence of the Court’s consideration of factors other than the words of the statute, such as the effect of rampant lawsuits on a particular industry, and strong public policy considerations.

Express preemption occurs when a federal statute contains a clause that expressly preempts state law, such as “this Act expressly preempts state law claims.” In such cases, the preemption is clear and the only issue may be the scope of the preemption. After the Supreme Court’s 2009 decision in Wyeth v. Levine, in which the Court ruled that approval of a drug’s label by the U.S. Food and Drug Administration (“FDA”) did not preempt state law claims for insufficient drug safety warnings, it seemed that the Court was taking a narrow view of federal preemption, at least in the pharmaceutical industry. Since there is no express preemption provision of failure to warn claims in the Federal Food, Drug and Cosmetic Act (“FDCA”), Wyeth argued in Levine that it would have been impossible for it comply with state law labeling requirements without violating FDA requirements. The Supreme Court rejected Wyeth’s “impossibility” or “conflict” preemption argument and stated that “[i]f Congress thought state-law suits posed an obstacle to its objective, it surely would have enacted an express pre-emption provision at some point during the FDCA’s 70-year history.” It seemed from this statement that in order for federal law to preempt state law, at least with regard to failure to warn claims in the pharmaceutical industry, an express statement of preemption in the federal statute was needed.

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