HealthLawProf Blog

Effects of Drug Policy Liberalization on Public Safety: A Review of the Literature

Maria M. Orsini (Ohio State University), Effects of Drug Policy Liberalization on Public Safety: A Review of the Literature, Drug Enforcement & Pol’y Center (2022):

After decades of criminalization, cannabis policy has liberalized rapidly throughout the U.S. in the 21st century. Following cannabis legalization in Colorado and Washington, legalization has gained momentum in many other U.S. states. While some states have fully legalized recreational cannabis for adult use, others have only decriminalized or legalized medical use. These reforms may have significant effects on public safety and public health, and therefore have become a topic of considerable academic interest. This review summarizes extant literature on the effect of drug policy liberalization on crime, traffic safety, law enforcement, and racial disparities.

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Medicaid Recovery for All?: Iowa’s Controversial Managed Care Organization and the State’s Abrogation of the Collateral Source Rule

Jenna Nelson (University of Iowa), Medicaid Recovery for All?: Iowa’s Controversial Managed Care Organization and the State’s Abrogation of the Collateral Source Rule, 108 Iowa L. Rev. 2 (2023):

While the collateral source rule has deep roots in state, common law jurisprudence—certain states have declined to uphold it. This is the case in Iowa, where the state partially abrogated the collateral source rule in medical malpractice cases. Under Iowa Code Section 147.136, if a patient is injured by a negligent health care provider and their insurance covers their medical expenses, that patient cannot personally recover those medical expenses if they are covered by a private insurer but can recover if they are covered by Medicaid. In 2016, Iowa adopted the managed care organization model—privatizing the state’s Medicaid program. Iowa Code Section 147.136 accounts for private insurers and Medicaid but fails to account for managed care organizations. This Note argues that the law should be amended to include managed care organizations.

“Long COVID,” Bodily Systems as ADAAA Major Life Activities, and the Social Model of Disability

Leslie P. Francis (University of Utah), Michael Ashley Stein (Harvard Law School), “Long COVID,” Bodily Systems as ADAAA Major Life Activities, and the Social Model of Disability, 2022 U. Chicago Legal Forum 159 (2022):

Long COVID claims for disability-related employment discrimination have been met by physical reductionism during determinations of disability. Difficult to diagnose due to an absence of agreed-upon physiologically observed biomarkers, and liable to elude ADA coverage and/or eligibility for reasonable workplace accommodations, long COVID illustrates a misunderstanding of the relationship between disability, bodily function, and disability anti-discrimination law. Although the ADAAA was intended to extend the range of people considered to be disabled for purposes of disability anti-discrimination law, including bodily system function as a major life activity in the amended statute has contributed to problematic physical reductionism in disability determinations as demonstrated in recent federal court decisions. To remedy this discordance, we suggested how social understandings of the body and disability, congruent with the ADAAA, can counter misleading reductionism about ambiguously diagnosed conditions as disabilities, including long COVID.

Normalizing Death as 'Treatment' in Canada: Whose Suicides Do We Prevent, and Whose Do We Abet?

Ramona Coelho (Adelaide Southdale Center), K. Sonu Gaind (University of Toronto), Trudo Lemmens(University of Toronto), John Maher (Independent), Normalizing Death as 'Treatment' in Canada: Whose Suicides Do We Prevent, and Whose Do We Abet?, 70 World Medical J. 3 (2022):

In 2021, within five years of the adoption of a first “Medical Assistance in Dying” law that partially legalized the practice of euthanasia and assisted suicide in Canada, the Canadian parliament removed several key safeguards in a new MAiD legislation, Bill C-7. It did so after the federal government failed to appeal a provincial (Quebec) lower court decision, which had ruled that the restriction of MAiD to natural death being ‘reasonably foreseeable’ was unconstitutional. The government then expanded de facto eligibility to include those not approaching their natural death but living with disabilities; and as of March 2023, this will also include those suffering solely from mental disorders. This article, which is the first of two World Medical Journal articles on the developments of MAiD law in Canada, reviews the Canadian experience to date and raises issues to consider as assisted dying policies or expansion are considered in the rest of the world. It documents the rapid increase of MAID in Canada in the context of serious failings in Canada's health care and social support systems. It discusses various problematic components of the practice of MAID in Canada. And it explores how the expansion outside the end-of-life context puts Canadians with disabilities at risk of premature death.

R (Gardner and Harris) v. Secretary of State for Health and Social Care and Others [2022] Ewhc 967: Scant Regard for Covid-19 Risk to Care Homes

Victoria Moore (University of Manchester), Luke D. Graham (University of Manchester), R (Gardner and Harris) v. Secretary of State for Health and Social Care and Others [2022] Ewhc 967: Scant Regard for Covid-19 Risk to Care Homes, 30 Medical L. R. 4 (2022):

During the first wave of the Covid-19 pandemic in 2020, approximately 20,000 care home residents died from the illness. In R (Gardner and Harris) v Secretary of State for Health and Social Care and others, the daughters of two of the men who died in the first wave brought a judicial review claim against (i) the Secretary of State for Health and Social Care, (ii) NHS England (NHSE), and (iii) Public Health England (PHE). The case is an example of public interest litigation; litigation in which those raising the action seek to advance a widely shared interest. This commentary presents a discussion of the heads of claim and the potential implications upon the upcoming public inquiry into the government’s pandemic response.

Case Study of Food-Related Patents Protected by the University of Brasilia, Brazil

Rafael Fança (Universidade de Brasilia), Marileusa Dosolina Chiarello (Universidade de Brasilia), Larisse Araújo Lima (Universidade de Brasilia), Grace F. Ghesti (Universidade de Brasilia), Case Study of Food-Related Patents Protected by the University of Brasilia, Brazil, Heliyon (2023):

Patents are important tools to protect innovations in the food industry. They are also indicators of the research and development of an institution. Universities play a big role in generating and developing innovative technologies. This case study analyzes the patents and patent applications related to food deposited by the University of Brasilia (UnB). The results provide data to contribute to strategic decision-making in developing new technologies related to food and nutrition and their transfer to society. Future research will be necessary to follow the evolution of these processes and investigate commercial opportunities for the University.

Tightening The Leash on Housing Provider Loopholes: Protecting Disabled Texans By Amending The Texas Property Code To Prevent Constructive Denial of Emotional Support Animals

Diana Hernandez (Texas Tech University), Tightening The Leash on Housing Provider Loopholes: Protecting Disabled Texans By Amending The Texas Property Code To Prevent Constructive Denial of Emotional Support Animals (2022):

Currently, Texas does not have any specific guidelines regarding responding to reasonable accommodation requests generally applicable to all housing providers in the state in compliance with the Fair Housing and Texas Fair Housing Acts. Because Texas lacks generally applicable guidelines regulating responses to a reasonable accommodation request under the Fair Housing and Texas Fair Housing Acts, housing providers may, inadvertently or purposely, constructively deny legitimate requests by failing to render a timely decision in direct violation of these Acts above. Without express guidance, housing providers may also make an inundation of unnecessary information requests to establish a reasonable accommodation. Constructive denial of legitimate, reasonable accommodation requests for emotional support animals not only impacts the requestor but may also leave well-meaning Housing Providers liable to discrimination complaints and civil suits. In order to protect both requestors and housing providers from the negative impacts of housing discrimination, Texas should amend the property code to create bright-line rules for response times to accommodation requests and limit the amount of information requested for an emotional support animal accommodation.

 

The Americans with Disabilities Act's Unreasonable Focus on the Individual

Ruth Colker (Ohio State Unviersity), The Americans with Disabilities Act's Unreasonable Focus on the Individual, Ohio St. Legal Studies Research Paper 742 (2022):

In this Article, I argue that the requirement to claim status as an “individual with a disability” to seek reasonable accommodations under the Americans with Disabilities Act undermines the advancement of structural reform that could promote broad conceptions of disability justice. I urge the reader to consider how the ADA could better advance disability justice if we focused on its ex ante requirements rather than the post hoc rules made possible by the statute’s reasonable accommodation requirement. It makes more sense to build a society under the expectation that people with a range of disabilities will be part of our community than make one-at-a-time retrofits after someone identifies themself as disabled. One should not need to publicly claim disability to be treated with compassion and respect.

Medical Education and Individuals with Disabilities: Revisiting Policies, Practices, and Procedures in Light of Lessons Learned from Litigation

Laura Rothstein (University of Louisville), Medical Education and Individuals with Disabilities: Revisiting Policies, Practices, and Procedures in Light of Lessons Learned from Litigation, 46 J.C. & U. L. 2 (2021):

In the thirty plus years since the Americans with Disabilities Act was passed, there have been a significant number of lengthy and costly judicial disputes involving medical school admission and enrollment of individuals with disabilities. This article reviews the history of medical education and provides a description of the evolution of the educational curriculum for medical school and how it has changed in recent years. It provides the legal framework of statutory and regulatory requirements for the application of federal disability discrimination law to medical school applicants and enrolled students. A synthesis of these cases (many lasting several years from incident to resolution) sheds light on what must be done, what can be done, and what should be done by medical school policy makers and administrators in response to the admission and enrollment of individuals with disabilities. The article suggests ways that medical schools could revise their evaluation procedures and practices both at the admissions stage and during medical school. The article stresses the importance of key top medical school leadership and medical school legal counsel in ensuring that this framework is implemented.

Stopping to Smell the 1-800-Flowers: Dignitary Harms in Accessibility Litigation

Blake E. Reid (University of Colorado), Sainab Alkebsi (Independent), Stopping to Smell the 1-800-Flowers: Dignitary Harms in Accessibility Litigation, Green Bag Almanac & Reader (2022):

On first glance, Gathers v. 1-800-Flowers.com is a garden-variety web accessibility case. But 1- 800-Flowers.com provides an opportunity to set aside the metaphysical questions about the ADA’s application that pervade the Internet accessibility literature and reflect on the indignity that web users with disabilities frequently suffer for having the audacity to enforce their civil rights.

USPTO's Lax Policy Leads to Biologic Formulation Thicket

Bernard Chao (University of Denver), USPTO's Lax Policy Leads to Biologic Formulation Thicket (2023):

Biosimilar drugs enter the United States market well after they enter the European market. That is likely due to high patent assertion rates in the U.S. and stronger patent portfolios in this country. But why are patent thickets protecting biological drugs in the United States an American phenomenon? Presumably, biological drug companies seek extensive patent coverage everywhere.

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Mifepristone, Preemption, and Public Health Federalism

Patricia J. Zettler (Ohio State University), Annamarie Beckmeyer (Ohio State University), Beatrice L. Brown (Harvard University), Ameet Sarpatwari(Harvard University), Mifepristone, Preemption, and Public Health Federalism, J. L. & Biosciences (Forthcoming):

On June 24, 2022, the Supreme Court issued an opinion in which five justices voted to overturn Roe v. Wade. Even before the final opinion issued, scholars and advocates had begun to consider legal strategies that might mitigate the decision’s anticipated harmful consequences. One such strategy involves challenging state restrictions on FDA-approved pregnancy termination drugs on preemption grounds. This Article begins by exploring how these challenges might fare—considering both drug-specific restrictions and complete bans on abortion—arguing there are compelling legal grounds on which courts should conclude that many state restrictions are preempted. Importantly, although these state restrictions have arisen within a larger debate about reproductive health care, this is far from the only area in which states seek to regulate prescription drugs. States have long regulated drugs in ways that diverge from FDA, arguably increasingly so in recent years. Accordingly, the Article investigates the implications that preemption challenges in the abortion context may have for other areas of state drug regulation, making the case that the benefits of public health federalism need not be undermined by successful preemption challenges in the abortion arena.

The Declining Appeal of Inherited Retirement Accounts

Richard Kaplan (University of Illinois), The Declining Appeal of Inherited Retirement Accounts, 42 Va. Tax Rev. 2 (2023):

As retirement accounts proliferate and grow in value, American retirees are increasingly leaving substantial balances in these accounts to their adult children, siblings, and other relatives. Until recently, these new owners were able to withdraw funds from these tax-favored accounts over their lifetimes as their personal circumstances dictated. But legislation enacted in late 2019 and regulations issued in February 2022 have sharply limited the flexibility that non-spousal beneficiaries now have regarding these assets. This article examines those changes, analyzes their impact on the new owners of inherited retirement accounts, and considers what planning strategies are now appropriate.

Impact of Food Safety and Standards Regulation on Food Business Operators

Arokiaraj David (Saint Francis Insitute of Management & Research), C. Ganesh Kumar (Indian Institute of Plantation Management), Gomathi Sankar Jeganathan (Independent), Impact of Food Safety and Standards Regulation on Food Business Operators (2022):

The main aim of the study is to understand food regulation and food safety in the Indian context and global aspects. It also explains the major health problem and recent past reports of FSSAI. The primary data were collected from food business operators (mobile food vendors, many small-scale hotels, and local restaurants). It also helps to ensure the knowledge and awareness level of the food business operators. This study is to understand the view of food-business operators in a B-grade city of India “Salem” in Tamil Nadu about the FSSAI regulations and the status of performance of the food safety department in maintaining the safety and quality of food and also to know about the level of awareness among the usage of fortified foods among food-businesses. The Study concludes that the Food and Safety Officers should regularly visit for inspection and monitor the food business operators for the betterment of public health. There should be proper awareness about the ingredients used in fortified food among food businesses to eliminate malnutrition and avoid food adulteration. The future rules and regulations of FSSAI should be strictly implemented all over India and properly monitor the activities of food business operators to fulfill the FSSAI standards.

Harvest Time: Why the UK Should Unleash the Power of Gene Editing

Cameron English (Independent), Harvest Time: Why the UK Should Unleash the Power of Gene Editing (2023):

On the one hand, gene editing is a process of modifying the existing genetic material of an organism. On the other hand, genetic modification involves the introduction of genetic material from another organism.

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Governing Conflicts between International Humanitarian Law and International Criminal Law: The Crime of Starvation in Non-International Armed Conflicts

Matthias Vanhullebusch (Shanghai Jiao Tong University), Governing Conflicts between International Humanitarian Law and International Criminal Law: The Crime of Starvation in Non-International Armed Conflicts, Khan, B.U. and Bhuiyan, J.H. (eds.), Human Rights and International Criminal Law (Leiden/Boston: Brill/Nijhoff, 2022):

The criminalisation of starvation in non-international armed conflicts in the Rome Statute in December 2019 finally addressed the plight of civilian populations at the brink of starvation. All parties to the conflict – state and non-state alike – shall be held accountable inter alia for arbitrarily denying offers of international humanitarian relief. It would complement fighting parties’ existing positive and negative obligations under international humanitarian law vis-à-vis the civilian population under their control, namely, respectively, the obligation to provide in the means necessary to their survival and the prohibition of the use of starvation against them as a method of warfare. Despite their noble humanitarian objectives, this normative criminal justice agenda establishing a symmetry of criminalised conduct across international and non-international armed conflicts, however, has overlooked the fundamental question whether or not non-state armed group actually have the right to consent to offers of international humanitarian relief – the so-called right to strategic consent – in the first place before criminalising its abusive exercise that amounts to the violation of the prohibition of starvation. This article examines these doctrinal obstacles and the impossibility for the crime of starvation, pursuant to the law on the application of conflicting norms, to trump the law of international humanitarian relief governing the right to strategic consent and offers an alternative pathway to move ahead with this normative agenda in the long-term.

UN Food Systems Summit 2021 – What Role Science and Innovation in the Summit and in Countries’ Plans and Why?

Joachim von Braun (University of Bonn), UN Food Systems Summit 2021 – What Role Science and Innovation in the Summit and in Countries’ Plans and Why?, ZEF Discussion Papers on Dev. Pol’y  325 (2023):

The UN Food Systems Summit 2021 was different from all six previous food summits held in the past eight decades. New features of this Summit included the fact that it was anchored in the Sustainable Development Goals, focused on food systems, was based on multi-stakeholder engagement, had a focus on country level strategies (so called National Pathways), and the Summit was held in New York rather than Rome, where the UN food agencies are based. Moreover, for the first time the UN called upon science to provide guidance for a food summit. In this article outcomes and political economy processes of the Summit are briefly reviewed, and then a focus is on the role of science for shaping outcomes is quantitatively assessed by reviewing the 118 country reports of National Pathways. In 62% of the countries’ strategies science, research, technology and innovation are more or less significantly mentioned. Quality of governance effectiveness is identified as a strong driver of more attention to science in countries’ strategies. The relative weight of agriculture in the national economy shows some positive correlation with attention to science too, whereas level of undernutrition does not correlate with attention to science in the strategies. Implications of these findings are drawn for the science – policy interface in food systems, and for the follow-up process to the Summit that has been put in place by the UN until 2030.

What are the Actions and Inactions of Liberia’s Banking Sector in the Employment and Accessibility of Persons with Disabilities in their Business Strategies

Sahr Nouwah (Independent), What are the Actions and Inactions of Liberia’s Banking Sector in the Employment and Accessibility of Persons with Disabilities in their Business Strategies (2023):

The main goal of this research is to investigate actions and inactions within the Liberian Banking Sector regarding the employment and social inclusion of people living with disability in Liberia and provide recommendations, ensuring that the rights of persons with disabilities to employment and to quality financial services are upheld in practice and in their policies. Actions in this sense focus on what the Banks are doing for disability Accessibility and employment while inactions focus on what they are not doing for disability accessibility and employment.

The Canada Disability Benefit: Battling Abelism in Design and Implementation

Lindsay M. Tedds (University of Calgary), Jennifer Robson (University of Calgary), The Canada Disability Benefit: Battling Abelism in Design and Implementation (2023):

The Canada Disability Benefit Act is legislation that, when passed, will establish a new statutory program intended to reduce poverty and support the financial security of working-age persons with disabilities. However, the act is what is known as framework legislation meaning it sets out the high-level context and structure of the proposed program, but it does not provide any describe specific program details. The critical details—including eligibility conditions, the benefit unit and amount, and interactions with existing disability support programs—of the proposed Canada Disability Benefit program will, instead, be set out in regulations following stakeholder engagement. We use a benefit design framework to highlight the program elements that must be defined, highlighting the importance of conducting the design process through an inclusive and intersectional lens to ensure that ableist assumptions are not embedded into benefit design. The framework outlined in this paper should serve as a useful reference for all stakeholders involved in the benefit design process.

Harm Caused by (Intelligent) Medical Devices – Looking for a Level Playing Field and Consumer Trust?

Sofia Sormunen (University of Helsinki), Katri Havu (University of Helsinki), Harm Caused by (Intelligent) Medical Devices – Looking for a Level Playing Field and Consumer Trust?, Helsinki Legal Stud. Research Paper 76 (2023):

Civil liability for defective medical devices, especially intelligent ones, is not regulated by European Union (EU) law clearly or comprehensively. The current EU product liability rules cover a significant proportion of cases that concern the liability of manufacturers, but the national laws of EU Member States remain relevant. The liability of parties other than manufacturers is largely left to national laws. Given the vagueness of the applicable EU law and the central role of national rules, case outcomes may vary, and the law is liable to be uncertain. If the exact circumstances in which harm ought to be compensated are unclear, individuals may feel that it is imprudent to rely on new technologies. This reluctance would retard the adoption of innovations among the public and the service providers that cater to them. Economic operators, too, need clear liability rules to gauge the risks of introducing innovations to the market. For some time now, EU legislators have been striving to promote the use of beneficial artificial intelligence. The EU has recently published two proposals for legislation that touch on liability for intelligent devices. In this working paper, we address the problems of contemporary EU law and analyse the implications of the proposals.