HealthLawProf Blog

The Choice Between Persuading and Coercing Americans to Get Vaccinated Against COVID-19

Paul J. Larkin (The Heritage Foundation), The Choice Between Persuading and Coercing Americans to Get Vaccinated Against COVID-19, Georgetown J. L. & Pub. Pol’y (forthcoming 2022):

Throughout history, organized societies have demanded that inhabitants make sacrifices—such as serving in the military or receiving a vaccine that protects against a contagious and potentially fatal disease—in a time of national emergency to help ensure the nation’s survival. President Joe Biden could and should have sought to persuade the nation that the problem of SARS-CoV-2 was not a matter fit for political debate, and that, just as politics once stopped at the water’s edge, politics should play no part in the nation’s response to the pandemic on this side of those shores. To prove his commitment to save lives, he could have demonstrated that he was willing to risk his political future and the judgment of history by embracing compromise and working with people outside his party to negotiate a nationwide vaccination mandate, even if he had to trade away policies that his party wanted to see enacted into law. He chose not to make the sacrifices necessary to take this issue out of politics. As a result, it is poetic justice to see so many people object to entreaties to make a personal sacrifice for the public benefit offered by a politician who refused to make his own.

Legal Access to Marijuana and Motor Vehicle Fatalities in the United States, 1990--2019

Gregory Leung (University of Kansas), Jessica Dutra (Secretariat Economists), Legal Access to Marijuana and Motor Vehicle Fatalities in the United States, 1990—2019, SSRN (2021):

In the past 25 years, several states and the District of Columbia have implemented statewide marijuana laws. By employing difference-in-differences model and using the data from the Fatality Analysis Reporting System (FARS), this paper focuses on the effects of policy changes that legalize the use of medical and recreational marijuana on motor vehicle fatalities. The results show that legalization of medical marijuana laws are associated with a decrease in traffic fatalities by 6.87 percent, while there is no statistically significant change in traffic fatalities rate after the legalization of recreational laws, which is consistent with the literature.

Nfib V. Sebelius, the Commerce Clause and Activity/Inactivity

David Drachsler (Independent), Nfib V. Sebelius, the Commerce Clause and Activity/Inactivity, SSRN (2021):

There has been considerable disagreement among courts and legal commentators whether Chief Justice Roberts’ Commerce Clause discussion in NFIB v. Sebelius was a holding of the Court or dicta. Some lower courts have relied on his opinion as a holding on the reach of the Commerce Clause, but others have viewed it as dictum or questioned its precedential value. The Chief Justice’s assertion that “most” members of the class of uninsured individuals are not active in the healthcare market is not consistent with numerous studies on healthcare utilization.

Biosimilar Bias: A Barrier to Addressing American Drug Costs

Cynthia M. Ho (Loyola University), Biosimilar Bias: A Barrier to Addressing American Drug Costs, 99 Denver L. Rev. 3 (2022):

Forty percent of spiraling US drug costs are based on a mere two percent of all drugs –biologic drugs (biologics) made from living cells that are administered by injection or infusion. These costs will continue to balloon as new biologics are approved; the recently approved Alzheimer’s drug is expected to result in a 50% increase in Medicare spending and cost individuals 40% of their annual income. These drugs are expensive because they cannot be mass-produced, and their cost places important treatments for conditions such as arthritis (Humira) and cancer (Herceptin) out of reach for many Americans. Fortunately, just as there are generic versions of brand name pills, there are lower cost biosimilars of original biologics allowed by an expedited regulatory approval process that lowers the costs of obtaining regulatory approval. However, US adoption of biosimilars is minimal, in stark contrast to widespread use of generic drugs, and despite a decade of safe biosimilar use in other countries.

Continue reading

The Role of CSR in Providing Employment Opportunity to Persons with Disabilities

Jay Pandya (Independent), The Role of CSR in Providing Employment Opportunity to Persons with Disabilities, SSRN (2021):

‘Societal discrimination and ‘feeling of being ignored’ are the two major concerns with the Persons with Disability (PWD) in Indian society. Limited access to healthcare services, education opportunities, and fewer employment opportunities are worsening the livelihood of a majority of the PWD population in India. The Government (Central/State/Local) has taken several initiatives in association with Corporate-Houses and NGOs to strengthen them physically and economically. However, physical accessibility to buildings, transportation, and services remains a major challenge to them. This leads to a much higher unemployment ratio for persons with disabilities. Enabling and strengthening mobility of the PWD population and giving technical education and skills would empower them to get jobs/businesses and sustain themselves financially. Further, they would support their families too. Present research work aims to analyze the impact/effectiveness of educational interventions on the PWD population in India. This research work would be analyzing the role of Corporate Social Responsibility (CSR) initiatives towards empowering the PWD population to boost their employment, improve their quality of life and self-confidence. Researchers are working with NGO Partner ‘Motivation India’. Motivation India is working towards providing mobility devices and skill development interventions for the PWD population in India. A follow-up study would be conducted in Bangalore, Kanakpura, Chamarajanagar, and Pavagada districts of Karnataka. Around 100 participants (PWD) would be studied with appropriate survey methods. This research would produce how CSR activities are important in removing the physical and mental barriers while empowering the PWD population. This will further throw light on the importance of mobility and skill development activities in the self-sustainability of the PWD population.

Food and Drug Regulation: A Statutory Approach (Chapter 1)

Adam I. Muchmore (Penn State), Food and Drug Regulation: A Statutory Approach (Chapter 1), Penn St. L. Stud. Research Paper 21 (2021):

This is the first chapter of a new casebook on food and drug regulation. This book presents food and drug regulation as a statutory subject. It is organized around the structure of the Federal Food, Drug, and Cosmetic Act, and emphasizes guided reading of statutes, regulations, and federal register documents. Cases are presented primarily when they involve major issues of statutory interpretation, are historically significant, or are in one of the areas where case law plays a major role.

Continue reading

How a New Farm Bill with a Twist on Conservation Easements Can Save the Environment and the Family Farm

Amy Blake (Texas Tech University), How a New Farm Bill with a Twist on Conservation Easements Can Save the Environment and the Family Farm, SSRN (2022):

Have you ever considered how tax law impacts the environment? It certainly does. A simple, tax-based conservation program enacted in the next farm bill can solve two major issues that are rapidly destroying the environment and the world’s food supply.

Continue reading

Balancing Public Health and Environmental Protection and Economic Stakes? Bayer CropScience and the Court’s Defence of the EU Socially Acceptable Risk Approach

Giulia Claudia Leonelli (University of London), Balancing Public Health and Environmental Protection and Economic Stakes? Bayer CropScience and the Court’s Defence of the EU Socially Acceptable Risk Approach, 58 Common Market L. Rev. 1845–1874 (2021):

This case centres on procedural questions which have profound substantive implications. Through its sophisticated appeal strategy, Bayer CropScience sought to shift the focus from questions surrounding the sufficient safety of a product or process and the acceptability of uncertain risks, to scientific proof of the unsafety of a product or process and regulatory cost-benefit effectiveness. The ECJ forcefully defended the very foundations of the EU socially acceptable risk approach to the governance of uncertain risks: adherence to a prudential approach to risk assessment, the pursuit of a high level of public health and environmental protection, the centrality of the precautionary principle, and the possibility for EU risk managers to take any other legitimate factors (OLFs) at stake into consideration.

No Wheat Crisis: Agricultural Trade Liberalization in Quebec during the 1830s and 1840s

Vincent Geloso (George Mason University), Alicia Plemmons (Southern Illinois University), Andrew Thomas (George Mason University), No Wheat Crisis: Agricultural Trade Liberalization in Quebec during the 1830s and 1840s, GMU Working Paper Econ. No. 22-05 (2022):

In the first half of the nineteenth century, the wheat oriented agrarian economy of Lower Canada (the French-speaking modern-day province of Quebec) saw a rapid collapse in wheat production dubbed the “wheat crisis.” In a single decade, Quebec went from being an exporter of wheat to an importer. Given that Quebec was an agrarian economy, this collapse of wheat exports has been used to infer falling living standards in the colony during the period. These developments have been blamed on many factors ranging from soil exhaustion to cultural conservatism among French-Canadian farmers. In this paper, we provide evidence suggesting this rapid collapse was largely the result of adjustment to the trade shock that followed the Colonial Trade Act of 1831 (a unilateral liberalization of the entry of agricultural goods from the United States) and a rapid reduction in freight costs between the Canadian colonies. We find that areas that were more exposed to external markets—as proxied by road access—shifted away from wheat production. We provide supportive evidence that this was welfare-enhancing.

Menthol Cigarette Bans in Canada and the US the Role of Legal and Market Structures

Ian Irvine (Concordia University Montreal), Menthol Cigarette Bans in Canada and the US the Role of Legal and Market Structures, SSRN (2022):

Menthol cigarettes have been viewed as a scourge on youth because they have facilitated initiation and made quitting more difficult. Many jurisdictions have banned menthol-flavored combustible cigarettes. However, while bans on menthol cigarettes are favored by public-health professionals and advocates, their efficacy may be limited. Carpenter and Nguyen (2021) found that both prevalence and sales were minimally impacted by bans imposed by federal and provincial governments in Canada. Their analysis focused upon consumer substitution. This essay analyzes the supply side of the market with a view to providing additional understanding of why the Canadian bans had such a limited impact. I show that consumer ‘success’ in evading bans in Canada was aided by the structure of the marketplace and the array of borderline-legal products introduced by tobacco companies immediately prior to the bans. The paper concludes by examining the US market, where the Food and Drug Administration has a menthol ban as a goal. I argue that both the efficiency and ethical grounds for a menthol ban have weakened since the mid two thousand teens.

Stamping out COVID-19 in New Zealand: Legal Pragmatism and Democratic Legitimacy

Dean R. Knight (Victoria University of Wellington), Stamping out COVID-19 in New Zealand: Legal Pragmatism and Democratic Legitimacy, Victoria U. Wellington L. Research Paper No. 47 (2021):

This paper recounts the New Zealand government's legal response to the COVID-19 pandemic (up to October 2020), including legal underpinnings of the lockdown (and challenges to it); the bespoke legislative framework adopted during the pandemic for health orders; the way legitimacy for public health measures was built through accountability in various forms; and what the response tells us about New Zealand's constitutional culture.

The Public Library As Health Information Resource

Venelin Terziev (Georgi Rakovski Military Academy), Silva Vasileva (Independent), The Public Library As Health Information Resource, SSRN (2022):

Due to the situation caused by the coronavirus pandemic health matters have become a very sensitive subject to the society. The existing issues motivate researchers and specialists to look through the documents and archives describing the historical development of Bulgarian healthcare and medical and social activity, focusing on the activity of Bulgarian healthcare institutions and professional medical organizations, as well as mentioning them in specialized medical publications. Even more – these issues prioritized the matters related to the implementation of rules, norms and regulation in the field of healthcare.

The New Abortion Battleground

David S. Cohen (Drexel University), Greer Donley (University of Pittsburgh), Rachel Rebouché (Temple University), The New Abortion Battleground, 123 Columbia L. Rev. (forthcoming 2023):

This Article examines the paradigm shift that will occur if (and, likely, when) the Supreme Court overturns Roe v. Wade this coming summer. While most commentators are focusing on what a post-Roe world looks like within individual states, this Article examines the challenging legal issues that will arise across state borders and between the state and federal government. We emphasize how these issues intersect with innovations in the delivery of abortion, which can now occur entirely online and transcend state boundaries. The interjurisdictional abortion wars are coming, and this Article is the first to provide the roadmap for what lies ahead.

Continue reading

Distributed Governance of Medical AI

Nicholson Price II (University of Michigan), Distributed Governance of Medical AI, 25 SMU Sci. & Tech. L. Rev. (forthcoming 2022):

Artificial intelligence (AI) promises to bring substantial benefits to medicine. In addition to pushing the frontiers of what is humanly possible, like predicting kidney failure or sepsis before any human can notice, it can democratize expertise beyond the circle of highly specialized practitioners, like letting generalists diagnose diabetic degeneration of the retina. But AI doesn’t always work, and it doesn’t always work for everyone, and it doesn’t always work in every context. AI is likely to behave differently in well-resourced hospitals where it is developed than in poorly resourced frontline health environments where it might well make the biggest difference for patient care. To make the situation even more complicated, AI is unlikely to go through the centralized review and validation process that other medical technologies undergo, like drugs and most medical devices. Even if it did go through those centralized processes, ensuring high-quality performance across a wide variety of settings, including poorly resourced settings, is especially challenging for such centralized mechanisms. What are policymakers to do? This short Essay argues that the diffusion of medical AI, with its many potential benefits, will require policy support for a process of distributed governance, where quality evaluation and oversight take place in the settings of application—but with policy assistance in developing capacities and making that oversight more straightforward to undertake. Getting governance right will not be easy (it never is), but ignoring the issue is likely to leave benefits on the table and patients at risk.

HIPAA at 25 - A Work in Progress

Anita L. Allen (University of Pennsylvania), HIPAA at 25 - A Work in Progress, New Eng. J. Med (2021):

HIPAA is best viewed as a framework of evolving regulation that has been revised periodically by Congress and DHHS rulemakers in response to demands of biomedical innovation and public health in the digital age. That capacity for adaptive modification is among the greatest strengths of HIPAA and its rules. While HIPAA is not a perfect law and continues to have critics, it represents an advance in data protection for American health care consumers, who will need additional protections moving forward.

Seeking Safety While Giving Birth During the Pandemic

Elizabeth Kukura (Drexel University), Seeking Safety While Giving Birth During the Pandemic, St. Louis U. J. Health L. & Po’y (2021):

As COVID-19 spread throughout the United States in early 2020, many pregnant people sought alternatives to delivering in a hospital. Whether due to fear of COVID-19 exposure in health care settings or out of a desire to avoid restrictive hospital policies regarding support people and newborn separation, people who had not previously considered home birth were newly drawn to midwifery care and others who had considered a midwife-attended birth redoubled their efforts to find an available provider. But many pregnant people who sought midwifery care during the pandemic discovered they lacked access to non-hospital-based alternatives, as the supply of local midwives could not meet demand or legal restrictions meant there simply were no midwives in the area.

Continue reading

Co-Parenting During Lockdown: COVID-19 and Child Custody Cases Before the Vaccine. (A Project of the New York Law School Family Law Quarterly Editors)

Lisa Grumet (New York Law School), Co-Parenting During Lockdown: COVID-19 and Child Custody Cases Before the Vaccine. (A Project of the New York Law School Family Law Quarterly Editors), NYLS L. Stud. Research Paper No. 4060447 (2022):

This Article looks back at child custody disputes from the early days of the COVID-19 pandemic in the United States, when there were no vaccines available to limit the spread or impact of the disease and much of the country was in “lockdown.” Beginning in March 2020, most state governments issued some form of “stay-at-home” orders with the goal of protecting public health by limiting the spread of the virus. Restrictions on travel as well as concerns about exposure to the disease impacted co-parenting arrangements for parents who shared custody or visitation of their children while maintaining separate households. Some parents went to court with emergency applications to enforce or modify custody and visitation arrangements based on pandemic-related disputes. Judges considered arguments that the pandemic itself warranted suspending a visitation schedule; that children should not travel or be exposed to “hotspot” jurisdictions; that COVID-19 testing or quarantine protocols should be followed; and that one parent’s noncompliance with COVID-19 protocols put a child at risk of infection.

Continue reading

Bullying, Cyberbullying and Hate Speech

Raphael Cohen-Almagor (University of Hull), Bullying, Cyberbullying and Hate Speech, 13 Int’l J. Technoethics (2022):

This paper applies the concepts of moral and social responsibility to the Internet in considering bullying and cyberbullying that result in loss of life. Specifically, I probe the moral and social responsibilities of Internet users (agents), of their immediate surroundings, and of the education system in fighting cyberbullying. Balance needs to be struck between two most important principles: freedom of expression and social responsibility. Illustrative examples in which this disturbing and harmful phenomenon of cyberbullying had cost young life are mentioned. It is argued that cyberbullying has some of the characteristics of hate speech and that many of the tools used to fight against hate may be utilised to fight against cyberbullying. It is further argued that all relevant stakeholders need to think of the consequences of their conduct, that Internet abusers should be accountable for their wrongdoing and be penalized, and that people who have the ability to stop or at least reduce the risk of cyberbullying should take proactive steps, exhibiting zero tolerance to cyberbullying. The article calls for a responsible concerted effort by responsible users of the Internet, parents, schools, governments, NGOs, and administrators of social networking sites to raise awareness of the problem, address it, and fight together to lessen and possibly eliminate it from the online information highway. Disregard for the consequences of both cyberbullying and hate speech and inactivity facing them are immoral.

Miscarriage of Justice: Early Pregnancy Loss and the Limits of U.S. Employment Law

Laura T. Kessler (University of Utah), Miscarriage of Justice: Early Pregnancy Loss and the Limits of U.S. Employment Law, 108 Cornell L. Rev. (forthcoming 2022):

This Article explores judicial responses to miscarriage under federal employment law in the United States. Miscarriage is an incredibly common experience. Of confirmed pregnancies, about fifteen to twenty-five percent will end in miscarriage. Yet this experience slips through the cracks of every major federal employment law in the United States.

Continue reading

Deferring Intellectual Property Rights in Pandemic Times

Peter K. Yu (Texas A&M University), Deferring Intellectual Property Rights in Pandemic Times, 74 Hastings L. J. (2022):

In the intellectual property arena, policymakers and commentators have advanced different proposals to combat the COVID-19 pandemic. One pathbreaking proposal that has become highly controversial calls for a waiver of more than thirty provisions in the WTO TRIPS Agreement, covering copyrights, industrial designs, patents, and the protection of undisclosed information. Even after more than a year since the release of the initial proposal in October 2020, policymakers and commentators remain deeply divided.

Continue reading