Paternalism, Self-Governance, and Public Health: The Case of E-Cigarettes

This article develops a normative framework for assessing public health laws, using the regulation of e-cigarettes as a case study. Although e-cigarettes are likely far less dangerous to individual users than traditional cigarettes, it remains uncertain whether their proliferation will lead to a reduction of smoking-related disease and deaths or to increased morbidity and mortality. This scientific uncertainty, whether and how to regulate e-cigarettes. This article presents a normative framework for analyzing such questions by offering three justifications for public health laws: impaired agency, harm to others, and self-governance. Each justification responds to the common charge that public health laws are impermissibly paternalistic. The selfgovernance rationale, which is the most robust, and most reflective of public health’s own population perspective, has been the least theorized. This article develops that theory, examining the basis for the justification as well as its limitations. The article then applies its normative framework to the regulation of e-cigarettes, focusing on the FDA’s so-called deeming regulations, which at the time the article was written were pending but have since been promulgated in a substantially similar form. The article supports the FDA’s ultimate decision to ban the sales of e-cigarettes to minors and to require the disclosure of warning labels based upon the impaired agency rationale. However, the scientific uncertainty renders the harm rationale inadequate. As a result, the regulations’ pre-market review requirement must rely on the self-governance rationale for its normative justification. Given the lack of clear legislative guidance and political engagement, the article concludes that the pre-market review provisions are normatively problematic: if public health advocates want to claim the mantle of self-governance, they must take it seriously

The COVID Cases: A Preliminary Assessment of Judicial Review of Public Health Powers During a Partisan and Polarized Pandemic

In response to the very real possibility that there will be insufficient resources to properly respond to the COVID-19 pandemic, states have been developing crisis standard of care plans, which may authorize the prioritization of patients for scarce resources based on changing circumstances and increased demands. Due to the dearth of necessary resources and trained professionals during a public health emergency, the standard of care that clinicians may be able to provide during the COVID-19 pandemic may, by necessity, depart significantly from standard nonemergency medical practice. Adhering to crisis standards of care may expose health care providers and entities to considerable costs and burdens, including the risk of both civil and criminal liability. Liability shields may be necessary when, due to the circumstances of the emergency, a state faces scarce resources and the state activates its crisis standards of care. This Article comprehensively evaluates state laws, passed both in advance of the current public health crisis and in response to COVID-19 pandemic. It concludes that liability protections are most appropriate in instances where health care providers and, in limited circumstances, health care institutions, follow—in good faith—rules, guidance, or protocols that are modified from the “norm” and necessitated by emergency circumstances or intended to respond to the circumstances of the public health crisis. Blanket immunity provisions are inappropriate. Rather, we should determine liability protections based on whether: (1) the federal government, state government, local government, professional society, or medical institution has provided rules, guidance, or crisis standards of care, elucidating the modifications to the existing standard of care required during the state of emergency; and (2) there is an identified need to extend legal protections to providers or institutions, based on perceived reluctance to follow crisis standards of care intended to save lives, due to fear of liability. Although this proposal is narrower than what many states, some policymakers, and politicians have proposed, it is more likely to ensure accountability and protect vulnerable patients

Paternalism, Self-Governance, and Public Health: The Case of E-Cigarettes

This article develops a normative framework for assessing public health laws, using the regulation of e-cigarettes as a case study. Although e-cigarettes are likely far less dangerous to individual users than traditional cigarettes, it remains uncertain whether their proliferation will lead to a reduction of smoking-related disease and deaths or to increased morbidity and mortality. This scientific uncertainty, whether and how to regulate e-cigarettes. This article presents a normative framework for analyzing such questions by offering three justifications for public health laws: impaired agency, harm to others, and self-governance. Each justification responds to the common charge that public health laws are impermissibly paternalistic. The selfgovernance rationale, which is the most robust, and most reflective of public health’s own population perspective, has been the least theorized. This article develops that theory, examining the basis for the justification as well as its limitations. The article then applies its normative framework to the regulation of e-cigarettes, focusing on the FDA’s so-called deeming regulations, which at the time the article was written were pending but have since been promulgated in a substantially similar form. The article supports the FDA’s ultimate decision to ban the sales of e-cigarettes to minors and to require the disclosure of warning labels based upon the impaired agency rationale. However, the scientific uncertainty renders the harm rationale inadequate. As a result, the regulations’ pre-market review requirement must rely on the self-governance rationale for its normative justification. Given the lack of clear legislative guidance and political engagement, the article concludes that the pre-market review provisions are normatively problematic: if public health advocates want to claim the mantle of self-governance, they must take it seriously