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Preemption of Tort Litigation

Earlier this month, the United States Supreme Court heard oral argument on an extremely important case concerning the rights of Americans.  The case is Wyeth v. Levine.  The case involves a 62-year-old woman (Levine) who was given the drug Phenergan by "intravenous push."  The intravenous push allowed the drug to enter Levine's arterial blood system, which caused injury and ultimately led to the amputation of her hand and forearm.  A jury found Wyeth (the manufacturer of Phenergan) negligent in failing to provide adequate warnings concerning this possible danger, and awarded Levine compensation for her injuries.

The Wyeth v. Levine case involves the legal doctrine of "preemption." Preemption is the concept that federal law takes precedence over state or local law.  When properly invoked, it stands for the proposition that when federal law regulates certain activity then that regulation supercedes any conflicting state law.

In the context of the Wyeth case, the Food & Drug Administration (FDA) is the federal agency that regulates the labeling of drugs.  The Food, Drug, and Cosmetic Act (FDCA) is the federal law that applies to drugs such as Phenergan.  Wyeth argues that that FDA approved the drug label for Phenergan, which permitted the administration of the drug through intravenous push, and that therefore state law should not permit a tort claim.  In contrast, Levine argues that the FDA never considered, much less rejected, a label that would have prohibited intravenous push administration, and that Wyeth should have added that prohibition to its label on its own in light of Wyeth's knowledge of its risks.  Additionally, Levine argues that the FDCA does not have any express preemption clause, which indicates congressional intent to have the FDCA trump state law.

The significance of the Wyeth v. Levine case lies less in the legal doctrine at play, but more on who is best able to protect Americans from known dangers of drugs and other products.  The United States Supreme Court's decision will have a profound effect for patients and drug safety.  If the Court decides in favor of Wyeth, then the FDA will become the sole protector of patients.  The problem is that the FDA is not equipped to evaluate the safety of drugs and its warning labels.  Moreover, given the approval process for drugs in the United States, many safety problems are never discovered until after a drug's approval, and then only if the drug manufacturers report such problems voluntarily.  The United States has a long tradition of relying upon the tort system in general, and upon the state tort system specifically, in order to protect the safety of Americans from unreasonbaly dangerous drugs and products.  The tort system has demonstrated itself to be effective in undercovering adverse drug reactions and manufacturer delay in responding.    

In support of the tort system, a recent article appeared in the Journal of the American Medical Association.  This article was written by physicians, and supported the notion that the FDA is not capable of protecting Americans on drug safety issues.  They argued that patients are best served by the tort system.  Let's hope that the United States Supreme Court listens, if not to the lawyers, than at least to the physicians.