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Torts - Cases, Principles, and Institutions Fifth Edition, 2016a

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Witt & Tani, TCPI 9. Liability without Fault?<br />

3. A presumption against preemption? One doctrinal answer that has emerged is that courts<br />

should generally presume that federal law does not preempt state law. Professor Roderick Hills<br />

argues that this presumption is justified as a way to jump-start democratic deliberation in the<br />

national lawmaking process:<br />

Because of the size <strong>and</strong> heterogeneity of the population that it governs, Congress<br />

has institutional tendencies to avoid politically sensitive issues, deferring them to<br />

bureaucratic resolution <strong>and</strong> instead concentrating on constituency service.<br />

Nonfederal politicians can disrupt this tendency to ignore or suppress political<br />

controversy by enacting state laws that regulate business interests, thus provoking<br />

those interests to seek federal legislation that will preempt the state legislation. In<br />

effect, state politicians place issues on Congress’s agenda by enacting state<br />

legislation. Because business groups tend to have more consistent incentives to<br />

seek preemption than anti-preemption interests have to oppose preemption,<br />

controversial regulatory issues are more likely to end up on Congress’s agenda if<br />

business groups bear the burden of seeking preemption. . . . Therefore, by adopting<br />

an anti-preemption rule of construction, the courts would tend to promote a more<br />

highly visible, vigorous style of public debate in Congress. . . .<br />

Hills contends that regulated industries favoring preemption have systematically “greater<br />

capacity” to obtain votes on preemption than do the opponents of preemption. Only the former,<br />

goes the argument, have “an interest in regulatory uniformity for its own sake” because only<br />

national business <strong>and</strong> industry groups benefit greatly from national uniformity. See Roderick M.<br />

Hills, Jr., Against Preemption: How Federalism Can Improve the National Legislative Process, 82<br />

N.Y.U. L. REV. 1 (2007).<br />

4. What did Geier mean for future preemption cases? The next case, in the prescription drug<br />

context, contains a lengthy debate about what exactly were the core principles of Geier <strong>and</strong> how<br />

far they should reach.<br />

Wyeth v. Levine, 555 U.S. 555 (2009)<br />

STEVENS, J.<br />

Directly injecting the drug Phenergan into a patient’s vein creates a significant risk of<br />

catastrophic consequences. A Vermont jury found that petitioner Wyeth, the manufacturer of the<br />

drug, had failed to provide an adequate warning of that risk <strong>and</strong> awarded damages to respondent<br />

Diana Levine to compensate her for the amputation of her arm. The warnings on Phenergan’s<br />

label had been deemed sufficient by the federal Food <strong>and</strong> Drug Administration (FDA) when it<br />

approved Wyeth’s new drug application in 1955 <strong>and</strong> when it later approved changes in the drug’s<br />

labeling. The question we must decide is whether the FDA’s approvals provide Wyeth with a<br />

complete defense to Levine’s tort claims. We conclude that they do not.<br />

Phenergan is Wyeth’s br<strong>and</strong> name for promethazine hydrochloride, an antihistamine used<br />

to treat nausea. The injectable form of Phenergan can be administered intramuscularly or<br />

intravenously, <strong>and</strong> it can be administered intravenously through either the “IV-push” method,<br />

whereby the drug is injected directly into a patient’s vein, or the “IV-drip” method, whereby the<br />

593

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