Against Categorical Preemption: Vaccines and the Compensation Piece of the Preemption Puzzle

Abstract

In tort preemption cases, when federal law ousts conflicting state tort law, two fundamental functional premises should hold true: (1) the federal standard of care is more than a minimal standard and (2) the state standard of tort liability has a significant regulatory effect (if not the regulatory purpose) by trading off risks and benefits to inhibit or to encourage risk-taking conduct that interferes with, or substantially alters, a federal regulatory scheme. The regulatory role of state tort law is front and center in this paradigm of preemption. But what about the compensatory role of tort law? Should there, in fact, be a third premise that the federal regulatory regime must provide a substitute to injured victims for tort-based compensation? Or perhaps a weaker version, such that the absence of federally provided compensation is a thumb on the scale against preemption? Conversely, should the existence of such a federal compensation scheme weigh in favor of preemption?

The National Childhood Vaccine Injury Act (Vaccine Act) is a rare example whereby Congress provides for a federally administered compensation fund alongside its newly fashioned regulatory standards. The vaccine context thus provides an opportunity to explore the relationship between preemption and compensation.

In this Article, I provide some alternative frames for analysis. Frame One is conventional statutory interpretation focused on statutory text and legislative history. Frame Two is consideration of the backdrop of tort lawsuits at the time when Congress acted and, relatedly, whether Congress provided a substitute administrative compensation scheme for tort law remedies. This frame is key to resolving disputes that amount to implied field preemption — namely, a categorical preemption claim that federal law ousts state law regardless of the precise risks considered by the underlying federal regulatory agency. My argument here is that the absence of compensation — particularly against a backdrop in which, prior to enactment of the federal scheme, tort law effectuated both regulatory and compensatory goals — renders the regulatory scheme incomplete. Conversely, the existence of a federal compensation scheme keeps categorical preemption claims on the table.

But the analysis should not end with Frame Two. Even if a categorical preemption argument fails because of the absence of a federal compensation fund, a narrower form of risk-based implied conflict preemption — in which the underlying regulatory agency has considered the risks and benefits at issue and resolved them in a way that is at odds or in tension with imposition of the asserted state-law duty — may be justified. And even where a categorical preemption argument is plausible, given the existence of a federal compensatory regime, there may nonetheless be a stronger underlying risk-based argument worth considering. Here is where Frame Three comes into play. Frame Three encapsulates the “agency reference model” I have developed in prior work, whose prime target is conflict preemption. The primary question in conflict preemption cases involving ambiguous congressional intent should be whether the federal agency considered the same risks and benefits that are the source of the competing state standard. Substantial deference should also be accorded to the underlying agency’s position on preemption, based on the thoroughness and consistency of its considered views.

Keywords: preemption, vaccines, Bruesewitz, tort

JEL Classification: K13, K23, K41