Pandemic Influenza: Ethics, Law, and the Public\u27s Health

Highly pathogenic Influenza (HPAI) has captured the close attention of policy makers who regard pandemic influenza as a national security threat. Although the prevalence is currently very low, recent evidence that the 1918 pandemic was caused by an avian influenza virus lends credence to the theory that current outbreaks could have pandemic potential. If the threat becomes a reality, massive loss of life and economic disruption would ensue. Therapeutic countermeasures (e.g., vaccines and antiviral medications) and public health interventions (e.g., infection control, social separation, and quarantine) form the two principal strategies for prevention and response, both of which present formidable legal and ethical challenges that have yet to receive sufficient attention. In part II, we examine the major medical countermeasures being being considered as an intervention for an influenza pandemic. In this section, we will evaluate the known effectiveness of these interventions and analyze the ethical claims relating to distributive justice in the allocation of scarce resources. In part III, we will discuss public health interventions, exploring the hard tradeoffs between population health on the one hand and personal (e.g., autonomy, privacy, and liberty) and economic (e.g., trade, tourism, and business) interests on the other. This section will focus on the ethical and human rights issues inherent in population-based interventions. Pandemics can be deeply socially divisive, and the political response to these issues not only impacts public health preparedness, but also reflects profoundly on the kind of society we aspire to be

Workplace Wellness Programs: Empirical Doubt, Legal Ambiguity, and Conceptual Confusion

Federal laws that protect workers from insurance discrimination and infringement of health privacy include exceptions for wellness programs that are “voluntary” and “reasonably designed” to improve health. Initially, these exceptions were intended to give employers the flexibility to create innovative wellness programs that would appeal to workers, increase productivity, and protect the workforce from preventable health conditions. Yet a detailed look at the scientific literature reveals that wellness program efficacy is quite disputed, and even highly touted examples of program success have been shown to be unreliable. Meanwhile, the latest administrative regulations on wellness programs were vacated by a district court in January 2019, leaving the legal scope of wellness programs in flux. The U.S. District Court of Connecticut now has a case before it that could start a national overhaul of these programs. In this Article, we give a scientific and legal overview of wellness programs and explain why wellness programs are a source of ethical controversy. Given the unsteady evidence on wellness programs’ benefits and their real potential risks, we argue that more should be done to regulate their scope and design. A robust interpretation of the relevant statutes would help protect workers in the face of indecisive evidence. To this end, we conclude with an attempt to resolve the widespread disagreement over the terms “voluntary” and “reasonable design” with the goal of providing courts and regulators with a more workable framework to apply

Prisons and Pandemics

This Article focuses on how to balance public health, public safety, and incarcerated people’s legal rights when implementing a program for early release from confinement. Ethical, epidemiological, and legal arguments all point to a need for an immediate reduction in the incarcerated population. However, this leaves open several points of reasonable disagreement about how to manage early release. These include how to set priorities for processing and releasing individuals across the country. For example, officials could prioritize screening individuals who are housed in facilities that have been hit hard by infection; or by screening individuals who have a safe place to quarantine post-release; or individuals who are being held for violations of parole, lower level and nonviolent crimes, or prior to their trials; or individuals who are most vulnerable to coronavirus; or individuals who have already served most of their sentences; and so on. This Article discusses how to set priorities for safely and quickly returning incarcerated individuals to their communities during a life-threatening outbreak. In Part II, we establish why incarcerated people are especially vulnerable during a public health emergency. For a variety of reasons, incarcerated people are more likely than the general public to acquire and to experience negative outcomes from infectious diseases, putting their health and the health of surrounding communities at risk. In Part III, we discuss the pandemic response taken by federal and state prisons and local jails and explain why it has had little success. For the most part, releases have been slow and discretionary, meaning that whether an individual is released is “like the luck of the draw” because there are “wardens in certain prisons that will get right on it, and some that won’t release a soul.” We also outline some of the recommendations proposed by bodies like the ACLU and members of Congress. Careful consideration of these different plans for releasing incarcerated people from confinement is important in order to prepare for COVID-19 in the coming months and to look toward future pandemics. In Part IV, we summarize the moral, practical, and legal arguments for making the health of incarcerated people a priority during a pandemic. These arguments rely on the ethical principle that we are morally required to protect individuals who have been deprived of the liberty to protect themselves; empirical evidence indicating that high infection rates within correctional facilities have serious public health consequences for surrounding communities; and legal precedent that suggests that incarcerated people have a right to protection from infectious diseases. Taking these arguments together, it is reasonable to support a substantial reduction in jail and prison populations, irrespective of one’s general views about the ethics and purpose of mass incarceration. In Part V, we delve into the details of how to release incarcerated people. There have been several general recommendations outlining broad guidelines for doing so. However, the ethical priorities that underlie these different recommendations have not been made explicit and have not been considered together. In this Part, we identify the various ethical considerations relevant to early release, and we argue that five factors should be given special priority. These are (1) risk of recidivism for a violent offense, (2) presumption of innocence for the accused, (3) risk of mortality from coronavirus, (4) proportion of sentence served, and (5) responsibilities to third parties

The Future of Physicians’ First Amendment Freedom: Professional Speech in an Era of Radically Expanded Prenatal Genetic Testing

This Article explores the First Amendment questions prenatal whole genome sequencing (PWGS) is likely to raise. It argues that most of the foreseeable options for state intervention in conversations between physicians and prospective parents about genetic sequencing should trigger at least heightened scrutiny. Part I provides an overview of the most recent advances in genetic testing. It assesses the ongoing impact of non-invasive prenatal testing (NIPT) for providers and patients and charts the course from NIPT to PWGS. Part II establishes a foundational background for evaluating First Amendment claims. Part II.A describes the development of First Amendment jurisprudence, focusing on the doctrinal distinctions between levels of judicial scrutiny. Part II.B explores historical Supreme Court case law addressing professional speech. Part III surveys the current legal landscape. Using a handful of recent Circuit cases, Part III.A demonstrates that the legal frameworks for assessing physician speech qua professional speech are shambolic. Part III.B provides an overview of the most recent Supreme Court ruling on professional speech in the 2018 case National Institute of Family and Life Advocates v. Becerra. Part IV uses the material in Parts I–III to predict how legislative efforts to limit reproductive decision-making are likely to manifest in the PWGS context. Based on the case analyses in Part III, Part IV identifies the Fourth and Eleventh Circuit approaches as the most defensible for future judicial interventions. This Article concludes that state-based restrictions on PWGS-related speech would be vulnerable to First Amendment challenges and unlikely to survive heightened judicial scrutiny

When Not to Ask: A Defense of Choice-Masking Nudges in Medical Research

In this article, we examine the legality and ethics of a controversial but widespread practice in clinical research: choice-masking nudges. A choicemasking nudge (CMN) exists when a research team explicitly obscures a meaningful choice from participants by presenting a default decision as the standard way forward. Even though an easy-to-use opt-out mechanism is available for participants who independently express concerns with the standard default, the fact that a default has been pre-selected is not made obvious to research participants. To opt out of the nudge, a participant must overtly request non-standard treatment. We argue that use of such nudges in medical research can be justified by their individual, collective, and social benefits, provided that they respect autonomy and satisfy four additional acceptability conditions. In Part II of this Article, we describe three controversial cases of CMNs in medical research. In Part III, we provide background on nudging and explain how our proposed CMNs fit into the existing literature on nudging and libertarian paternalism. In Part IV, we explain how the reasonable person standard as employed by United States research regulations can be used to support CMNs. In Part V, we anticipate some of the strongest objections to CMNs by explaining how CMNs are compatible with a wide range of plausible accounts of autonomy. Finally, in Part VI, we discuss four additional core considerations an acceptable CMN must meet: legitimate policy goals; benefits outweighing harms; burdens distributed fairly; and absence of ethically superior feasible alternatives. We also revisit and analyze the three existing controversies previously explored in Part II and show how each would benefit from the conceptual clarity offered by our analytic framework. Medical research is complicated and can be difficult for participants to understand. Thoughtfully designed CMNs can play an important role in gently guiding large numbers of research participants toward decision outcomes that really are best for them and their communities

Finding Fault?: Exploring Legal Duties to Return Incidental Findings in Genomic Research

The use of whole genome sequencing in biomedical research is expected to produce dramatic advances in human health. The increasing use of this powerful, data-rich new technology in research, however, will inevitably give rise to incidental findings (IFs), findings with individual health or reproductive significance that are beyond the aims of the particular research, and the related questions of whether and to what extent researchers have an ethical obligation to return IFs. Many have concluded that researchers have an ethical obligation to return some findings in some circumstances, but have provided vague or context-dependent approaches to determining which IFs must be returned and when. As a result, researchers have started returning IFs inconsistently, giving rise to concerns about legal liability in circumstances in which notification could have potentially prevented injury. While it is clear that ethical guidance should not be automatically codified as the law, and that crafting ethical obligations around legal duties can be inappropriate, the ethical debate should not proceed unaware of the potential legal ramifications of advancing and implementing an ethical obligation to return IFs. This article is the first to assess the legal claims that could be brought for a researcher’s failure to return IFs. The potential for researchers to be held liable in tort is still uncertain and turns largely on a number of factors — including customary practice and guidance documents — that are still in flux. Unlike medical care, which has a well-defined duty into which evolving scientific knowledge about genetics and genomics can readily be incorporated, a researcher’s duty to return IFs is less well defined, making it difficult to determine at the outset whether and when legal liability will attach. This article advocates for a clearer, ethically sound standard of requiring that researchers disclose in the informed consent document which approach to offering IFs will be taken. This approach enables participants to know at the outset which findings will be returned, allows researchers to ascertain when their failure to appropriately return incidental findings will give rise to liability, and enables courts to make determinations that will produce consistent legal guidance