HealthLawProf Blog

The FCTC Dilemma on Heated Tobacco Products

Lukasz Gruszczynski (Kozminski University), Margherita Melillo (European University), The FCTC Dilemma on Heated Tobacco Products, 18 Globalization and Health 1-14 (2020):

Background: In October 2018, the Conference of the Parties of the Framework Convention on Tobacco Control adopted its first decision on novel and emerging tobacco products, including heated tobacco products (HTPs). The decision remains ambiguous, e.g. by making a distinction between tobacco sticks and HTP devices. Against this background, the article seeks to answer two interrelated questions: whether and to what extent HTPs are covered by the FCTC, and whether regime provided by the Convention is suitable for their regulation. Results: HTPs need to be classified under the FCTC as tobacco products. The distinction made by the Conference of the Parties between sticks and devices leads however to unsatisfactory results as it creates loopholes in tobacco control standards existing at the international level. A better approach, as argued in this article, is to conceptualize the notion of ‘tobacco products’ in functional terms as a combination of both a device and stick. While subjecting HTPs to all FCTC disciplines is, in light of our current scientific knowledge, a rational approach, such classification can be modified in the future once a sufficient amount of new evidence on their risk profile is collected. Any decision on the optimal regulatory model for HTPs will need to take into account not only health risks and potential benefits for individual users, but also the specific systemic concerns (e.g. HTPs as a gateway product). The state of scientific research is however not the only factor that will determine the fate of HTPs under the Convention. What is equally important is a conceptualization of the FCTC’s objectives. If a complete eradication of the tobacco epidemic is the ultimate goal, reduced levels of risk may not be enough to justify the different (i.e. more lenient) regulatory regime for HTPs. Conclusions: The Conference of the Parties should clarify the definition of tobacco products in light of recent changes in the market. When designing the regulatory regime for HTPs under the FCTC in the future, one has to consider not only scientific evidence but also pay attention to the objective of the Convention (or more generally to the values that underlie the current tobacco control paradigm).

Intellectual Property as a Determinant of Health

Ana Santos Rutschman (Saint Louis University), Intellectual Property as a Determinant of Health, Vanderbilt J. Trans’l L. (2021, Forthcoming):

Public health literature has long recognized the existence of determinants of health, a set of socio-economic conditions that affect health risks and health outcomes across the world. The World Health Organization defines these determinants as “forces and systems” consisting of “factors combin[ing] together to affect the health of individuals and communities.” Frameworks relying on determinants of health have been widely adopted by countries in the global South and North alike, as well as international institutional players, several of which are direct or indirect players in transnational intellectual property (IP) policymaking. Issues raised by the implementation of IP policies, however, are seldom treated as an integral part of analyses using these frameworks, even though IP bears direct effects on the dynamics of several determinants of health, such as access to health goods and health services. This article conceptualizes post-TRIPs IP as a contributing element to the literature on the socio-economic determinants of health. IP norms and policies have long been understood as playing a role in outcomes that closely align with determinants frameworks, but interventions inspired by institutions relying on determinants frameworks routinely fail to consider the role of international IP regimes. The article explores two consequences of this dissociation: first, it argues that TRIPs-implemented IP materially affects several determinants of health, both at the social and economic levels; and second, it argues that IP should be regarded on equal footing with other canonically recognized determinants of health. While taking steps towards the development of an IP framework that can be articulated with, and incorporated by, literature on the determinants of health, the article presents three short case studies on pharmaceutical and agricultural technologies—HIV prophylactic drugs (Truvada); drugs and vaccines needed for epidemic and pandemic preparedness (Ebola vaccines and COVID-19 treatments like remdesivir); and genetically modified rice crops.

Digital Disease Surveillance

Alan Z. Rozenshtein (University of Minnesota), Digital Disease Surveillance, 70 Am. U. L. Rev. (2021, Forthcoming):

Fighting the coronavirus pandemic will require digital disease surveillance: the use of digital technology to enhance traditional public-health techniques like contact tracing, isolation, and quarantine. But legal scholarship on digital disease surveillance is still in its infancy. This Article fills that gap. Part I explains why disease surveillance will play a key role in responding to coronavirus and future infectious-disease outbreaks. Part II explains how the “special needs” exception to the Fourth Amendment’s warrant requirement permits almost any rationally designed disease surveillance program. Part III suggests safeguards beyond what Fourth Amendment doctrine currently requires that could protect rights without diminishing surveillance effectiveness, including: review for effectiveness and equality, procedural requirements, and periodic legislative authorization. Part IV proposes a mixed standard for judicial review: courts should require these safeguards under an evolving understanding of Fourth Amendment reasonableness while tempering their review with deference to the political branches. Part IV concludes by outlining how the doctrinal evolution spurred by digital disease surveillance programs—the development of a “special needs with teeth” standard—might advance a key research agenda in criminal procedure: how to apply the Fourth Amendment to modern, data-driven surveillance regimes.

Palsgraf Meets Medicine: Physician Beware! — The Unidentified Non-patient and the Duty of Care

Marc Ginsberg (UIC), Palsgraf Meets Medicine: Physician Beware! — The Unidentified Non-patient and the Duty of Care, 54(1) Suffolk U. L. Rev (2021, Forthcoming):

This paper focuses on the intersection of proximate causation and physician liability. Specifically, the issue is this: should a physician be liable to an unidentified victim of a motor vehicle accident caused by a physician’s patient who was not warned to avoid driving due to a medical condition, prescription medication or procedure which may impair the patient’s driving ability? This paper surveys the jurisprudence of various states in search of the answer.

The Patentability of Gene Related Inventions in Personalized Medicine Under European and US Patent Law

Ayben Işılay Özdoğan, The Patentability of Gene Related Inventions in Personalized Medicine Under European and US Patent Law, MIPLC Master Thesis Series (2018/19)

Personalized medicine defines an individualized healthcare system based on patients’ unique characteristics, such as genetic information. It aims to reduce the predictable risk of disease and improve response to treatment by applying a specific therapy. This particular field brings along the gene related patent applications. In recent years, ethical sides, policy considerations on patent applications in gene sequences, and gene related diagnostic and treatment methods led to many debates among biotech/pharma companies, patent stakeholders, researchers, clinicians, and patients. Although the patent system is an incentive for the dissemination of the innovation by providing recovery to the companies for their investments, it is claimed that gene related patents are violating human rights by removing the information (gene sequences are like large databases) from the public domain. Patent protection for gene related inventions is treated differently, relying on diverse grounds in different countries, and there is no consistency in different patent laws in terms of patentability for these inventions. In Europe, the boundaries are set clearly in EPC and the Biotech Directive, whilst in the US, patent protection for gene related inventions is mostly assessed under eligibility criteria. The subject matter eligibility requirements are defined under 35 U.S.C. § 101 in the US. A draft bill, planned to reform the patent eligibility in the US, was introduced on May 22, 2019, and came along with many debates. The fear is that if enacted, decisions of some prominent cases such as Mayo and Myriad may be opened to discussions again. However, there is uncertainty whether this draft bill will ease the patentability of genetic inventions or not, it will be clear only after several decisions of the CAFC or the Supreme Court. On the other hand, this draft legislation may meet the long-felt need after Mayo and Myriad cases which may contribute to the development of bioeconomy in the US. The bill questions the patent system in the US independent from its enactment. At this stage, it is hard to estimate the possible influence of this bill on Europe. Nevertheless, it is commonly accepted that this proposal will approximate the US patent law to European patent law.

The Privileged Physician and Medical Malpractice: Why a Qualified Expert Testimonial Privilege Should Not Apply to Defendant Treating Health Care Providers

Kevin Sweeney (University of Connecticut), The Privileged Physician and Medical Malpractice: Why a Qualified Expert Testimonial Privilege Should Not Apply to Defendant Treating Health Care Providers, 52(1) Conn. L. Rev. (2020):

In Redding Life Care, LLC v. Town of Redding, the Connecticut Appellate Court recognized a qualified expert testimonial privilege that precludes discovery of an unretained expert’s opinion. That decision threatens to eliminate relevant and irreplaceable testimony of defendant treating health care providers in medical malpractice cases. The Appellate Court set forth a balancing test to determine if a party can overcome the qualified privilege as applied to a particular unretained expert: (1) whether the expert reasonably should have expected to be called upon to provide opinion testimony in subsequent litigation; and (2) whether there exists a compelling need for expert opinion testimony in the case. This Note analyzes the balancing test set forth in Redding as applied to defendant health care providers who participated in the treatment relevant to malpractice litigation. First, this Note considers whether the need for defendant health care providers’ testimony should overcome the Redding qualified testimonial privilege. Second, this Note explores whether the testimonial privilege violates Connecticut’s liberal rules of discovery as applied to defendant health care providers’ deposition testimony. Part I begins by discussing the risk of losing the expert opinion testimony of defendant treating physicians in medical malpractice litigation, addressing Connecticut’s requirements for expert testimony of treating physicians and the unique role of defendant health care providers. Part II presents a compelling need for defendant health care providers’ expert testimony in medical malpractice litigation, balancing the rights of expert witnesses to be free from testifying with the needs of courts and litigants for their evidence. Part III concludes by challenging the application of a qualified expert testimonial privilege to the discovery stage of medical malpractice litigation, considering the practical difficulties imposed by the Redding privilege in light of Connecticut’s liberal rules of discovery.

Formula Feeding Can Help Illuminate Long‐Term Consequences of Full Ectogenesis

Zeljka Buturovic, Formula Feeding Can Help Illuminate Long‐Term Consequences of Full Ectogenesis, 34(4) Bioethics 331 (2020):

Breastfeeding is analogous to pregnancy as an experience, in its exclusiveness to women, and in its cost and the effects it has on equitable share of labor. Therefore, the history of formula feeding provides useful insights into the future of full ectogenesis, which could evolve into a more severe version of what formula feeding is today: simplify life for some women and provide couples with a more equitable share of work at the cost of stigma, guilt and a daily diet of studies purporting to show the benefits of natural pregnancy. Making pregnancy an optional route to motherhood would make women's life trajectory more similar to men's and thus put pressure on women to compete with men on the ground shaped by men's preferences. Despite being a treasured experience of many women today, bearing children could become the luxury of the few, the province of the very poor and a choice working women will pay a high price for as women who choose pregnancy become stigmatized as self‐indulgent or unprofessional and penalized for it in the workplace. At the same time, scarce societal resources that could be used to support pregnant women and working mothers would instead be directed toward proving to women or even forcing them to gestate children “the right way.” While not necessarily threatening on its own, when added to formula feeding, IVF, stem‐cell produced ova and sex robots, full ectogenesis could diminish men's stake in women's wellbeing and even existence.

Navigating Inequities: A Roadmap out of the Pandemic

Shainoor Ismail, Matthew Tunis, Linlu Zhao, Caroline Quach, Navigating Inequities: A Roadmap out of the Pandemic, SSRN:

The COVID-19 pandemic has exposed social inequities that rival biological inequities in disease exposure and severity. Merely identifying some inequities without understanding all of them can lead to harmful misrepresentations and deepening disparities. In order to be effective, public health actions in a pluralistic society cannot ignore diversity in disparities. We present the first validated equity framework applied to COVID-19 that sheds light on the full spectrum of health inequities, navigates their sources and intersections, and directs ethically just interventions. The Equity Matrix also provides a comprehensive map to guide surveillance and research in order to unveil epidemiological uncertainties of novel diseases like COVID-19. In the race to a COVID-19 vaccine, this urgently needed roadmap can steer global leadership towards equitable allocation with diverse strategies for diverse inequities. Such a roadmap has been absent from discussions on managing the COVID-19 pandemic, and is critical for our passage out of it.

Masking Up: A COVID-19 Face-off between Anti-Mask Laws and Mandatory Mask Orders for Black Americans

Caroline Lawrence (Yale Law School), Masking Up: A COVID-19 Face-off between Anti-Mask Laws and Mandatory Mask Orders for Black Americans, Ca. L. Rev. Online (2020, Forthcoming):

Mandatory PPE orders during COVID-19 have forced Black Americans to weigh the dangers of disease against the dangers of selective enforcement and racial profiling. In states with civil rights-era anti-mask laws, both wearing and eschewing masks could lead to police interaction. This Article argues that anti-mask laws were only superficially intended to protect Black Americans, continue to harm minorities during COVID-19, and should be repealed. It motivates this policy by empirically showing the ineffectiveness of anti-mask laws and the statistically significant relationships between PPE usage patterns and race. A revisionist legal history reveals anti-mask laws’ racist underpinnings, further motivating their repeal.

Period Poverty in a Pandemic: Harnessing Law to Achieve Menstrual Equity

Bridget J. Crawford (Pace University), Emily Gold Waldman (Pace University), Period Poverty in a Pandemic: Harnessing Law to Achieve Menstrual Equity, Wash. U. L. Rev. (2021, Forthcoming):

Period poverty is not new, but it has become more visible during the COVID-19 crisis. Worldwide, menstruation has long caused marginalization and vulnerability for some. The pandemic has amplified these conditions. This Article makes three claims. The first is descriptive, identifying four interrelated aspects of global period poverty that have gained new salience during the coronavirus pandemic: lack of access to affordable menstrual products; lack of access to other needed supplies and services for health and sanitation; lack of menstruation-related information and support from schools and health professionals; and menstrual stigma and shame. By using examples from multiple countries, the Article highlights the importance of having the ability to manage one’s menstruation in a safe and affordable way. The Article’s second claim is that law has a role to play in eliminating period poverty—both during a pandemic, and beyond. By making sure that menstruation-related concerns are taken into account in defining “essential businesses,” for example, governments can both address the material needs of approximately half the population and signal that those needs are important. Finally, the Article explores the heightened visibility of menstruation-related concerns during the COVID-19 crisis as suggestive of an emerging popular awareness of period poverty. This Article’s account has important implications for a larger world-wide menstrual equity movement that takes aim at all menstruation-related obstacles standing in the way full participation for all people in private and public life.

Public Health Emergencies and Human Rights: Problematic Jurisprudence Arising from the COVID-19 Pandemic

Stephanie Palmer (University of Cambridge), Stevie Martin (University of Cambridge), Public Health Emergencies and Human Rights: Problematic Jurisprudence Arising from the COVID-19 Pandemic, European Human Rights L. Rev. (2021, Forthcoming):

The COVID-19 pandemic has presented many issues for courts, often requiring immediate consideration and swift delivery of reasons. Nevertheless, experience has taught us that, in times of crisis, heightened vigilance must be afforded to the protection of individual rights. Two judgments delivered at the peak of the pandemic illuminate the fragility of rights in the face of wider societal concerns. Both cases contain statements of purported principle which are legally dubious and, if left unqualified, have the potential to fundamentally dilute the protections afforded by the European Convention on Human Rights.

Advancing Reproductive Rights through Legal Reform: The Example of Abortion Clinic Safe Access Zones

Ronli Sifris (Monash University), Tania Penovic (Monash University), Caroline Henckels (Monash University), Advancing Reproductive Rights through Legal Reform: The Example of Abortion Clinic Safe Access Zones, 43 (3) U. New S. Wales L. J. (2020):

The past two decades have seen significant reforms in abortion law throughout Australia. From the perspective of advancing women’s reproductive rights, the most significant abortion law reforms have been the decriminalisation of abortion, removal of impediments to accessing medical abortion, the imposition of an ‘obligation to refer’ on medical practitioners with a conscientious objection to abortion, and the introduction of safe access zones around abortion clinics. This article focuses on the introduction of safe access zones as a key legal reform that has been implemented in a number of Australian jurisdictions to support and promote women’s reproductive rights, drawing on empirical research conducted by the first and second authors and discussing this research in the context of the recent High Court decision confirming the constitutionality of safe access zones.

How Efforts to Lower Health Care Costs are Putting Patients and Providers on a Collision Course

Jessica Mantel (University of Houston), How Efforts to Lower Health Care Costs are Putting Patients and Providers on a Collision Course, 44 Oh. N.U.L.Rev. 371 (2018):

In an effort to address these causes of rising health care spending, policymakers, insurers, and employers have embraced two major strategies. The first strategy targets the demand-side of the equation. Specifically, patients are encouraged to become more price-sensitive consumers through the imposition of higher cost sharing. The second strategy targets the supply-side, offering financial rewards to physicians, hospitals, and other providers that successfully constrain health care costs while also improving the quality of care. Many third-party payors have simultaneously adopted both higher-cost sharing for patients and financial incentives for providers to lower costs and improve quality. The potential interplay between these two strategies, however, puts providers and patients on a collision course, as patients who delay or forego recommended care in response to higher cost-sharing burdens may undermine providers’ efforts to promote coordinated, high-value health care. This provider-patient conflict may be particularly acute as between providers and their lower income and sicker patients. In response, some providers may fire or refuse to treat sicker patients and those from lower socioeconomic groups who are enrolled in high-deductible cost plans.

Merger Law for Biotech and Killer Acquisitions

D. Daniel Sokol (University of Florida), Merger Law for Biotech and Killer Acquisitions, 71 Fl. L. Rev. 1 (2020):

This Essay suggests a framework of how to conceptualize “killer acquisitions” in the biotech sector. In a killer acquisition, a larger branded pharmaceutical company buys a start-up company with a pipeline product with the intention to shut the pipeline product down. The Essay offers a way to police against acquisitions that may hurt consumers and still encourage pro-competitive acquisitions that may improve innovation and consumer welfare.

Access to Substance Use Disorder Treatment During COVID-19: Implications from Reduced Local Jail Populations

Erkmen Giray Aslim (Grand Valley State University), Murat C. Mungan (George Mason University), Access to Substance Use Disorder Treatment During COVID-19: Implications from Reduced Local Jail Populations, J. Subs. Abuse Treatment (2021, Forthcoming):

Many states have responded to the spread of COVID-19 by implementing policies which have led to a dramatic reduction in jail populations. We consider benefits associated with providing the population of individuals who would, but for these policies, be incarcerated with substance use disorder (SUD) treatment. We discuss problems that may prevent this population from receiving SUD treatment as well as policies which may mitigate these problems.

The Irony of Health Care’s Public Option

Allison K. Hoffman (University of Pennsylvania), The Irony of Health Care’s Public Option, U. Penn Law School, Public Law Research Paper No. 20-34:

The idea of a public health insurance option is at least a half century old, but has not yet had its day in the limelight. This chapter explains why if that moment ever comes, health care’s public option will fall short of expectations that it will provide a differentiated, meaningful alternative to private health insurance and will spur health insurance competition. Health care’s public option bubbled up in its best-known form in California in the early 2000s and got increasing mainstream attention in the lead up to the 2010 health reform, the Patient Protection and Affordable Care Act (ACA). The idea has reemerged with vigor once again as a core tenet of Democratic presidential nominee Joe Biden’s plans to build on the ACA. When people talk about health care’s public option, they mean a public health insurance plan, typically based on Medicare that someone could select in the individual, or nongroup, health insurance market instead of a private health insurance offering. Proponents have argued that a public health insurance option could deliver better cost-control than private insurance, while also being able to offer a broad choice of providers and quality control.

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Bring the Masks and Sanitizer: The Surprising Bipartisan Consensus About Safety Measures for In-Person Voting During the Coronavirus Pandemic

Joshua A. Douglas (University of Kentucky), Michael Zilis (University of Kentucky), Bring the Masks and Sanitizer: The Surprising Bipartisan Consensus About Safety Measures for In-Person Voting During the Coronavirus Pandemic, SSRN:

Americans overwhelmingly support various safety measures at polling places for the November 2020 election. Issues like face mask requirements, social distancing, and sanitizing polling equipment after each voter have strong support, regardless of party, even if adopting them might mean longer lines or wait times to vote. For instance, 79 percent of Americans support face mask requirements at the polls, with little difference among the views between Democrats and Republicans. That surprising statistic comes from a representative, nationwide survey of Americans we conducted in August 2020 about their views of the election during a pandemic. Although beliefs about expanded vote-by-mail have significant partisan overtones, support for safety measures for in-person voting does not. As of mid-September, five states (Indiana, Louisiana, Mississippi, Tennessee, and Texas) will not allow concerns about COVID-19 to qualify as a valid excuse for absentee voting. These states will therefore likely have a high rate of in-person voting. But the states vary slightly on the safety measures they will employ, with only some requiring poll workers to wear masks and none imposing a mask mandate for voters. Although no voter should be turned away for not wearing a mask, the data in our survey suggests that states can do more to make voters feel more comfortable when voting in person. Given that Americans broadly support some modifications to in-person voting and also express safety concerns about polling places, the failure to adopt them could depress turnout, particularly in states that do not make absentee voting easy. This paper presents the survey data and offers policy recommendations regarding safety measures states should employ to make Americans more comfortable when voting this fall.

Private Liability for Public Health

Jerrold Soh, Private Liability for Public Health, SSRN:

COVID-19 continues to spread around the world. Most disease transmissions are (one hopes) unintentional. But could one nonetheless be liable for unintentionally, yet carelessly, transmitting the disease? If so, when would liability arise, and how wide may its scope be? This essay discusses how private liability might complement public regulation in the battle against COVID-19. It first examines the law and economics case for establishing private liability for public health. It then explores causes of action that victims may bring against disease transmitters, focusing on battery and negligence. Legal issues arising from such claims, particularly surrounding the vexed question of disease causation, are examined. The essay finally explores auxiliary issues surrounding transmission liability, namely secondary victim claims as well as business (employer/occupier) liability.

The Political Economy of Pandemic Policy, COVID-19 and Climate Change. Why Market Fundamentalism and the Trump Administration Fail to Protect Public Health and the Economy

Mark Cooper, The Political Economy of Pandemic Policy, COVID-19 and Climate Change. Why Market Fundamentalism and the Trump Administration Fail to Protect Public Health and the Economy, SSRN:

This paper makes a simple point about the U.S. response to the COVID-19 pandemic and its implications for many spheres of life in the 21st century. The U.S. had one of the worst policy responses in the world to the pandemic, certainly among the large, high-income democracies, including Asian (e.g. South Korea), European (e.g. Germany), and other nations (e.g. Australia). That response was driven by a view of political economy that rejects the idea that society can impose social responsibility on its members, even under the most dire of circumstances. This political economy rests on a belief that markets perform perfectly when government gets out of the way and the pursuit of individual interests is synonymous with the public good. Currently called market fundamentalism, it was known as laissez faire economics and social Darwinism for well over a century. The paper refers to the Trump administration and it supporters. Although the overwhelming majority of Trump administration supporters were Republicans, some were not. Indeed, a few were very vocal about it, like Larry Hogan, the Republican Governor of Maryland and the Chairman of the National Governors’ Association.

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Exploring College Sports in the Time of COVID-19: A Legal, Medical, and Ethical Analysis

Marc Edelman (City University of New York), Thomas Baker  (University of Georgia), John T. Holden (Oklahoma State University), Andrew G. Shuman, MD (University of Michigan), Exploring College Sports in the Time of COVID-19: A Legal, Medical, and Ethical Analysis, 2 Mich. St. L. Rev. (2021, Forthcoming):

The emergence of the COVID-19 pandemic threatens the safety of people attending large social gatherings including organized sporting events. As the number of deaths and hospitalizations from COVID-19 skyrocketed in March 2020, the National Collegiate Athletic Association (“NCAA”) suspended all member colleges’ spring sports seasons. The NCAA has since implemented new guidelines that allow for individual member colleges to make independent decisions about if, and when, to resume their intercollegiate sports programs. This Article explores the implications of resuming intercollegiate sports in the midst of a pandemic from a legal, medical and ethical perspective. The team of scholars who authored this Article include professors at four major public universities, with terminal degrees in the fields of law, medicine, education, and sports management. Adopting a true interdisciplinary approach to the question of how and when to return to sport, the authors collectively express their concerns regarding how NCAA member colleges are approaching the legal and ethical issues surrounding the offering of intercollegiate sports during a pandemic, and propose ten best practices for colleges to determine when and how to resume offering intercollegiate sports.