American Journal of Law & Medicine

How the FDA can overturn Wyeth v. Levine.

ABSTRACT

In Wyeth v. Levine, the Supreme Court held that an FDA-approved drug label did not preempt state tort law. Although the Supreme Court did not defer to the FDA's position, language in the opinion, and Breyer's concurring opinion, suggest that the FDA may be able to abrogate Wyeth v. Levine using the administrative law doctrine originally announced in Chevron v. Natural Resources Defense Council. That is, the FDA may claim deference to its position in a future case involving the same legal questions. This Note explains how Wyeth impacts the Chevron doctrine and identifies how the FDA assertion that drug labels preempt state law may win in a future case.

I. INTRODUCTION

Typically, an agency cannot overturn a Supreme Court decision, yet an administrative law doctrine may permit the Food and Drug Administration (FDA) to abrogate a recent Court decision construing a federal statute without Congressional action. The Supreme Court recently decided Wyeth v. Levine, holding that an FDA-approved drug label does not preempt state tort failure-to-warn claims. (1) The 6-3 decision split on whether a state jury's verdict in favor of plaintiff Diane Levine, which requires pharmaceutical-company Wyeth to strengthen its warning on the drug Phenergan, conflicted with Congressional intent and the FDA regulatory scheme. (2) The majority concluded that the jury's verdict did not conflict with the FDA regulatory scheme or Congressional intent, and thus federal law did not preempt state failure-to-warn claims.

Justice Breyer wrote a separate (and short) concurring opinion in the case for one reason: "to emphasize the Court's statement that we have no occasion in this case to consider the preemptive effect of a specific agency regulation bearing the force of law." (3) Breyer's point may permit the FDA to preempt state tort laws, despite the court's decision in Wyeth. If the FDA specifically determines that state tort law acts as a "help or a hindrance to achieving" its mission, then "it is possible that such determinations would have pre-emptive effect." (4)

Breyer suggests that the Supreme Court would defer to the FDA if the agency establishes its position through the formal rule making process which carries the force of law. Thus, the FDA has the authority to overturn Wyeth v. Levine without Congressional action. (5) After this introduction, Part II summarizes the facts and reasoning of the court in Wyeth, including a summary of federal preemption laws. Part III discusses the court's deference to agency interpretations, especially in preemption cases. Part IV argues that Breyer's concurring opinion, as well as language in the majority opinion itself, highlights a way the agency can overturn the Court by using formal procedures and that, in fact, the FDA has already begun that process.

II. WYETH V. LEVINE AND FDA'S CLAIMED AUTHORITY TO PREEMPT

A. A TRAGIC ACCIDENT

In April 2000, patient and plaintiff Diane Levine suffered from nausea stemming from a migraine headache. (6) A nurse administered Phenergan, an anti-nausea medication, through an intramuscular injunction, but her nausea returned later that same day. (7) A different nurse administered a second injection directly into Levine's arm, in the interior crook of the elbow known as the antecubital fossa, using a technique known as "IV push" which provides faster relief. (8) According to its label, Phenergan should only be injected into a vein, never into an artery because of the risks of gangrene. (9) An IV-push into the antecubital fossa region is very dangerous because the drug may enter an artery either because the nurse accidentally injects the drug into an artery by mistake or because of perivascular extravasion--a process where the drug can transfer between an artery and vein due to their thin walls in the area. (10) Nurses generally know about the danger of perivascular extravasion, although the nurse who administered the drug later admitted that she was unaware that an IV-push in the antecubital fossa could result in intra-arterial, rather than intra-venous, injection. (11)

After the injection, Ms. Levine developed gangrene, and several weeks later a doctor amputated her arm. (12) Because Ms. Levine was a professional guitarist, she lost her livelihood as well as her arm. (13) She sued the hospital for negligence and the drug manufacturer Wyeth for a failure-to-warn tort. (14) Levine claimed that Wyeth's label did not adequately warn medical personnel of the risks of IV-push injections. A jury found in favor of Levine, and concluded that a stronger warning would have prevented the injury. (15)

B. PRINCIPLES OF PREEMPTION

The U.S. Constitution grants Congress the authority to regulate interstate commerce. (16) Thus, when Congress intends to preempt state law, the state law must give way. (17) The critical question is whether Congress intended federal law to preempt state law. (18)

The Supreme Court recognizes four types of preemption: express, field, "impossibility conflict," and "obstacle conflict" preemption. (19) Express preemption occurs when Congress includes statutory language specifically stating its intent to preempt state law. (20) Even when Congress includes an "express preemption clause," questions of scope remain. (21) Field preemption takes place when the "federal law so thoroughly occupies a legislative field as to make reasonable the inference that Congress left no room for the States to supplement it." (22) Impossibility conflict preemption arises when someone cannot obey both the state and federal laws. (23) Obstacle conflict preemption, which is the most commonly litigated, occurs when the state law "stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress." (24)

The Supreme Court presumes that federal law does not preempt state law, a presumption based on the Tenth Amendment to the U.S. Constitution. (25) Thus, the "presumption against pre-emption is rooted in the concept of federalism. (26) The Constitution assures that federal law preempts state law only "when Congress intends to preempt" (27) because otherwise, the Tenth Amendment reserves to each state the authority to create and manage its own affairs. Although the presumption against preemption is rooted in the Constitution, the question of preemption is ultimately one of statutory interpretation. (28)

When Congressional intent is implied, the Supreme Court could make one of two errors: either the Court will preempt state law when Congress did not intend to do so, or the Court will fail to preempt state law despite Congress's intent to do so. In these cases, the Court generally errs on the side of state law by using the presumption against preemption. (29) If the Court makes the latter error, then Congress will likely act swiftly to clearly re-assert its legislative goal to preempt. If the Court makes the former error, then Congress is not likely to act quickly because the error merely frustrates the states, and Congress may not notice or care to act to cede power back to the states. (30) The second error, if indeed the Court's decision was wrong, is more likely to be corrected and thus less likely to do harm to Congressional intent. (31) The Court also uses the presumption against preemption "to slow the transfer of authority from the states to the federal government." (32) The Supreme Court rarely limits Congress's power to pass laws under the broad "commerce powers" authority. (33) One scholar went so far as to say that "there exists no identifiable sphere of activities reserved to the states alone, and thus no piece of state legislation that is not at risk of being preempted by a competing federal law. (34) Thus, the Court slows the transfer of power by preempting state law only based on clear Congressional intent.

Finally, striking down state laws may "strip individuals of long-standing remedies available under state law." (35) The Vermont Supreme Court decided Levine v. Wyeth primarily on this rationale. (36) The Vermont Supreme Court stated, "Plaintiffs negligence and product-liability claims fall squarely within the scope of traditional state regulations, so it is appropriate to apply the presumption against preemption here." (37)

C. A HISTORY Or THE FDA's CLAIM TO PREEMPT

Unlike the Medical Device Amendments, which the Supreme Court found to preempt state tort law, the Food, Drug, and Cosmetics Act (FDCA) does not contain an express preemption clause. (38) Thus, the FDA must argue that Congress impliedly intended the FDA's labeling process to preempt state failure-to-warn claims. Yet since its creation, the FDA label warning system has never preempted state failure-to-warn claims, suggesting Congress did not intend to preempt these claims. On the other hand, the FDA is responsible for both the safety and efficacy of the nation's drug supply, thus permitting it to balance the risks and benefits of any particular drug, including the drug's label. (39)

On December 22, 2000, the FDA proposed a rule changing the format of labels for prescription drugs. (40) The FDA proposed adding a new "Highlights of Prescribing Information" section aimed at summarizing the most important safety and efficacy information on the drug. The purpose of the rule was to "make [the prescribing information] easier to use and read" (41) and to "highlight only the labeling information that practitioners consider to be the most important." (42)

The FDA specifically stated, "this proposed rule does not preempt State law." (43) Yet when the FDA published its final rule on January 24, 2006 (based on the 2000 proposed rule), the agency had changed its tune. In the final rule, the FDA asserted "the exercise of State authority conflicts with the exercise of Federal authority under [the Food, Drug, and Cosmetics Act]." (44) The FDA explained that "[i]f State authorities, including judges and juries applying State law, were permitted to reach conclusions about the safety and effectiveness information disseminated with respect to drugs for which FDA has already made [an informed judgment], the federal system for regulation of drugs would be disrupted." (45)

The regulation preempts six types of claims, and two are particularly important in the Wyeth case. (46) First, the regulation preempts all claims that a drug company failed to include a contraindication unsupported by evidence. …

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