HealthLawProf Blog

Editor: Katharine Van Tassel
Case Western Reserve University School of Law

Friday, January 21, 2022

What Tobacco Control Rules Would an Ethically Responsible FDA Implement (If the White House Let It)? − Would a Nicotine-Reduction Rule Pass Muster?

Eric Lindblom (Georgetown University), What Tobacco Control Rules Would an Ethically Responsible FDA Implement (If the White House Let It)? − Would a Nicotine-Reduction Rule Pass Muster?, SSRN (2021):

The U.S. Food and Drug Administration (FDA) has not yet used its extraordinary tobacco control powers to implemented any substantive tobacco control rules that would sharply reduce the more than 400,000 deaths and other enormous harms and costs caused by smoking and other tobacco use each year. FDA’s failure is not entirely its fault. Since 2009, when FDA first received its tobacco control authorities, the agency has never received the support it needs from the White House and the Office of Management and Budget to move any major rules through the federal clearance process successfully. Instead, White House apathy or opposition, alternative priorities, or political concerns have impeded FDA’s efforts to put effective new tobacco control rules into effect.

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January 21, 2022 | Permalink | Comments (0)

Of Masks and Men: Protecting Freedom of Assembly During an Era of Mass Surveillance

Jason Buhi (Barry University), Dhillon Ramkhelawan (Independent), Of Masks and Men: Protecting Freedom of Assembly During an Era of Mass Surveillance, SSRN (2021):

Clocks are striking thirteen around the world, as 1984 arrives only modestly delayed. Surveillance cameras, facial recognition, social media, big data, acoustic footprints and even DNA databases are allowing governments to impose ever more ubiquitous and stricter surveillance of individuals and civil society organizations. As a result, masks have become more common at assemblies, processions, and demonstrations. This has not gone unnoticed by authoritarian governments, giving rise to a global wave of anti-mask legislation. With the advent of the dystopian surveillance state such laws constitute a threat to various fundamental rights, including speech, petition, assembly, and privacy. Nevertheless, roughly one-third of the United States currently possess anti mask legislation. While about half of those laws punish mask-wearing only during the commission of a crime, the rest are overbroad because they serve to thwart any form of anonymous political assembly. The U.S. Supreme Court has thus far denied certiorari on this issue, leaving the constitutionality of mask bans up to the states. The authors of this paper acknowledge the difficult historic reasons for several mask bans, where cowards have hidden their faces to engage in vandalism and violence. Still, in light of the new surveillance state, the use of anti-mask legislation by authoritarian regimes, and the many fundamental rights at stake, the United States must commit to protecting the anonymity of orderly demonstrators during peaceable assemblies. This article surveys the existing mask laws of the several states, analyzes the related jurisprudence and – recognizing the imminent new era of mass surveillance facing us all – argues for the narrow-tailoring of anti-mask laws to balance law enforcement concerns against the myriad individual rights at stake.

January 21, 2022 | Permalink | Comments (0)

Thursday, January 20, 2022

The First General Federal Vaccination Requirement: The OSHA Emergency Temporary Standard for COVID-19 Vaccinations

Paul J. Larkin (The Heritage Foundation), Doug Badger (Independent), The First General Federal Vaccination Requirement: The OSHA Emergency Temporary Standard for COVID-19 Vaccinations, Am. Univ. L. Rev. (forthcoming):

There has never been a general federal vaccination requirement, and, until recently, President Joe Biden opposed adopting one. Instead, he took numerous opportunities to encourage or incentivize the public to become vaccinated—in effect to “nudge” people toward that result, rather than order them to do so. On September 9, 2021, however, he switched gears. Expressing frustration that an insufficient number of Americans had received the vaccine, Biden directed the Occupational Safety and Health Administration (OSHA), for the first time in American history, to promulgate a federal “emergency temporary standard” (ETS) requiring all private businesses with 100 or more employees to ensure that every employee is vaccinated against the virus or presents a negative test result on a weekly basis. The OSHA standard is predicted to apply to at least 80 million people.

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January 20, 2022 | Permalink | Comments (0)

China, the TRIPS Waiver and the Global Pandemic Response

Peter K. Yu (Texas A&M University), China, the TRIPS Waiver and the Global Pandemic Response, Tex. A&M U. Sch. L. Legal Stud. (Research Paper No. 21-52, 2021):

In October 2020, India and South Africa submitted an unprecedented proposal to the Council for Trade-Related Aspects of Intellectual Property Rights of the World Trade Organization. The proposal was subsequently revised in May 2021. Although China is neither a proponent nor cosponsor of this proposal, it has provided considerable support to the ongoing effort to adopt a COVID-19 TRIPS waiver at the WTO.

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January 20, 2022 | Permalink | Comments (0)

Wednesday, January 19, 2022

The Impact of Claimant Representation Fee Schedules on the Disability Applicant Process and Recipient Outcomes

Cody Tuttle (University of Maryland), Riley Wilson (University of Maryland), The Impact of Claimant Representation Fee Schedules on the Disability Applicant Process and Recipient Outcomes, SSRN (2021):

Many applicants to Social Security Disability Insurance (SSDI) retain representation to help with the approval process. The Social Security Administration imposes strict rules on representative compensation. Representatives are paid only if claimants are awarded disability, and are paid the lesser of 25 percent of claimant’s past due benefits or a pre-specified maximum fee dollar amount ($6,000 since 2009). Because past due benefits are a function of the number of months claimants wait to be awarded, representatives face incentives to delay case resolution until past due benefits push representative fees past the maximum fee threshold. This paper uses difference-in-differences and bunching strategies to evaluate how these incentives impact SSDI applicant wait times. To do this, we use information on claimant characteristics and wait times constructed from the Disability Analysis File Public Use File (DAF PUF). Difference-in-differences estimation show that after changes in the maximum fee threshold, average wait times increase by 0.4-0.7 months among applicants for whom the fee threshold is more binding. We also observe bunching in the wait time distribution around the fee threshold kink in years after the policy change relative to the preceding years. Although both policy changes occur in years associated with economic recessions (2002 and 2009), we provide suggestive evidence that the increase in wait times is not driven by secular economic trends. Key limitations of this paper are data availability issues in the DAF PUF. In the DAF PUF, we are unable to observe who retains representations, so we can only observe the reduced form impacts of representative fee schedules on claimant outcomes. With more complete information on the claimant application and appeal process, we could more effectively probe the types of impacts that representation have on case outcomes and the sensitivity of the results to secular economic trends.

January 19, 2022 | Permalink | Comments (0)

Insights Into Due Process Reform: A Nationwide Survey of Special Education Attorneys

Bailey Sanders (United States Court of Appeals for the Eleventh Circuit), Jane Wettach (Duke University), Insights Into Due Process Reform: A Nationwide Survey of Special Education Attorneys, 20 Conn. Pub. Int. L. J. (2021):

The federal law that guarantees an appropriate and inclusive education for children with disabilities relies on private enforcement; parents concerned about the inadequacy of their children’s education can take advantage of an administrative hearing to seek resolution of disputes with the child’s school district. While conceived in the Individuals with Disabilities Education Act (IDEA) as a prompt and informal tool, evidence suggests that special education due process hearings have become overly complex, prohibitively expensive, and excessively lengthy, thus limiting their accessibility and usefulness as an enforcement mechanism.

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January 19, 2022 | Permalink | Comments (0)

Tuesday, January 18, 2022

Do Reason-Based Abortion Bans Prevent Eugenics?

Sital Kalantry (Seattle University), Do Reason-Based Abortion Bans Prevent Eugenics?, 107 Cornell L. Rev. (forthcoming):

Two judges of the U.S. Supreme Court, Amy Coney Barrett and Clarence Thomas, as well as several other U.S. Federal Court of Appeals judges have argued that reason‑based abortion bans are designed to prevent eugenics. Eleven states currently prohibit doctors from performing an abortion if they know that the reason the patient is seeking one is because of the predicted gender, race, and/or disability of the fetus. These prohibitions apply from the moment the biological sex and genetic defects of the fetus can be identified, which is well before viability.

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January 18, 2022 | Permalink | Comments (0)

Ending the Charade: The Fifth Circuit Should Expressly Adopt the Deliberate Indifference Standard for ADA Title II and RA § 504 Damages Claims

Derek Warden (Louisiana Supreme Court), Ending the Charade: The Fifth Circuit Should Expressly Adopt the Deliberate Indifference Standard for ADA Title II and RA § 504 Damages Claims, Tex. A&M L. Rev. (forthcoming):

While the Americans with Disabilities Act (“ADA”) has been law for over 30 years, the Fifth Circuit Court of Appeals has yet to adopt a definitive standard for how plaintiffs win damages under Title II of that law. Further, while the Rehabilitation Act (“RA”) has been law for almost 50 years, the Fifth Circuit has failed to announce any specific standard for how plaintiffs obtain damages under that law as well. I previously wrote an article in the pages of this journal that sought to “clarify” the Fifth Circuit’s jurisprudence on the issue. In Fifth Indifference: Clarifying the Fifth Circuit's Intent Standard for Damages Under Title II of the Americans with Disabilities Act, 7 Tex. A&M L. Rev. Arguendo 1 (2019), I argued (1) that the Fifth Circuit should adopt the “deliberate indifference” standard and (2) that no Fifth Circuit precedent should be read as explicitly forbidding the adoption of that standard. My paper has seen great success in its downloads and its recent citation in a brief to the Fifth Circuit. However, the Fifth Circuit has still failed to adopt any specific standard and continues to use phrases like “seem to have required” and “something more than deliberate indifference.” Fortunately, what the Fifth Circuit has said and what it has done have been two different things. In reality, the Fifth Circuit has been using nothing more, less, or different than a standard deliberate indifference analysis. Thus, the “seem to have required more than deliberate indifference” standard is a mere charade. This charade should now be abandoned, and the Fifth Circuit should explicitly adopt the deliberate indifference standard. That standard being (1) a defendant knew of facts that presented a substantial risk of harm to an ADA or RA right and (2) the actor or entity failed to act appropriately on that risk.

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January 18, 2022 | Permalink | Comments (0)

Monday, January 17, 2022

A Hub-and-Spoke Model of Multidistrict Litigation

Theodore Rave (University of Texas at Austin), Francis E. McGovern (Duke University), A Hub-and-Spoke Model of Multidistrict Litigation, 84 L. and Contemporary Problems 21 (2021):

Consolidating mass tort cases in federal multidistrict litigation (MDL) has been a successful strategy for efficiently managing, facilitating the maturation of, and resolving nationwide disputes. This has been particularly true for cases involving single-event mass disasters or defective products sold by a single defendant, even when thousands of plaintiffs are involved. But in "mega mass torts"--those involving multiple defendants and multiple products and activities over an extended period of time (e.g., asbestos, silicone gel breast implants, opioids)--comprehensive resolution in an MDL has proven elusive. In these mega mass torts, the MDL judge can become a bottleneck, as there are only so many motions, discovery disputes, and bellwether trials a single judge can decide. But while these types of mega mass torts may be too varied for a single simultaneous trial or global settlement, eschewing aggregation would result in massive losses of efficiency and consistency.

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January 17, 2022 | Permalink | Comments (0)

Indictability of Early Abortion c. 1868

John Finnis (University of Oxford), Robert George (Princeton University), Indictability of Early Abortion c. 1868, SSRN (2021):

Aaron Tang posted on Sep. 13, 2021 "The Originalist Case for an Abortion Middle Ground," arguing that "originalist pro-life advocates," including the present authors in our amicus curiae Brief in the Dobbs case, have made significant mistakes in assessing how many states in 1868 criminalized elective abortion at all stages of pregnancy. When the historical facts about the various statutes and cases are correctly reported and understood, the number of such states must, he argued, be reduced from 27 to 15 – from a clear majority to a minority of the then 37 states. Pro-life advocates had mischaracterized 12 states. His paper was immediately very widely circulated, and called for a response, however preliminary. So on Sep. 20 we posted on SSRN "A Preliminary Rejoinder to Aaron Tang," arguing that the first five we looked at from his list of 12 turn out not to have been mischaracterized by pro-life advocates or us, but by Professor Tang.

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January 17, 2022 | Permalink | Comments (0)

Sunday, January 16, 2022

Culture and Attitudes Towards Euthanasia: An Integrative Review

A. Karumathil (Indian Institute of Management), Ritu Tripathi (Indian Institute of Management), Culture and Attitudes Towards Euthanasia: An Integrative Review, OMEGA J. Death and Dying 1 (2021):

We examine and integrate last two decades of research on euthanasia from a cultural perspective. After an exhaustive search from Scopus and Web of Science, 40 studies matching our criteria are included in the review. We qualitatively summarize the literature country-wise and use text map of co-occurring terms in the titles, keywords, and abstracts of these articles to determine the similarities and differences among sub-themes in continental clusters. Research done in Asian, European, North American, and multi-cultural studies suggests that attributes unique to each culture are instrumental in shaping public attitudes towards euthanasia. We also find that some cultures, despite the prevalence of euthanasia, are underrepresented in empirical research. This review of literature on the cultural nuances in end-of-life decisions such as euthanasia is pertinent to social scientists, healthcare professionals and social workers in any given time, but more so during such critical events as worldwide COVID-19 pandemic.

January 16, 2022 | Permalink | Comments (0)

Adaptive Approval of Drugs for Rare Diseases

Wendy Olsder (Eindhoven University of Technology), Tugce Martagan (Eindhoven University of Technology), Jan C. Fransoo (Tilburg University), Adaptive Approval of Drugs for Rare Diseases, SSRN (2021):

Problem definition: Adaptive approval is a new concept that aims to enable earlier patient access to new drugs. The concept of adaptive approval has been specifically proposed for rare diseases with unmet clinical needs. Although some stakeholders believe that adaptive approval is a promising opportunity for patients and pharmaceutical firms, others remain skeptical about its feasibility. This paper examines various concepts of adaptive approval that will likely impact its implementation in the upcoming years.

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January 16, 2022 | Permalink | Comments (0)

Saturday, January 15, 2022

Licensed to Kill? Contextualising Medical Misconduct, Malpractice and the Law in Ghana

Joel Zutah (Ankaful General Hospital), Elijah Tukwariba Yin (University of Cape Coast), Peter Atudiwe Atupare (University of Cape Coast), Francis Kofi Korankye-Sakyi (University of Cape Coast), Licensed to Kill? Contextualising Medical Misconduct, Malpractice and the Law in Ghana, U. Cape Coast L. J., 1(2), 49-118 (2021):

Now, more than ever, the Ghanaian patient is better informed, more discerning and increasingly aware of his/her healthcare rights and options. Despite the rate of awareness, scholars have paid less attention to some medicolegal issues in the country. This paper examines the prevailing regime of healthcare delivery and regulation, and attempts to construct the context of medical misconduct and malpractice in Ghana. Using a desktop approach, the study made use of secondary data such as news articles, journal publications, and statutes, among others. The analysed data indicate that what determines professional-patient relationship outcomes are contextual issues of regulatory, institutional, political, socio-cultural, and legal. It is proposed that any prosecution or adjudication of malpractice claims, or considerations for medical law reforms, must be done with due regard to the prevailing context, if just and suitable ends are envisaged.

January 15, 2022 | Permalink | Comments (0)

State Use Provisions for Patent Law, and Expropriations: Some Comparative Law Guidelines for South Africa during the COVID-19 Crisis and Beyond

Mikhalin du Bois (University of South Africa), State Use Provisions for Patent Law, and Expropriations: Some Comparative Law Guidelines for South Africa during the COVID-19 Crisis and Beyond, SSRN (2021):

This article views section 4 of the Patents Act 57 of 1978 against section 25 of the Constitution of the Republic of South Africa, 1996 and Article 31 of the Agreement on Trade-Related Aspects of Intellectual Property Rights of 1994 (hereafter TRIPS). The purpose is to find a suitable framework for the state/government use/utilisation of patented products or processes for public purposes. A comparison is done with the Crown use provisions in United Kingdom, Australian and Canadian law to find a suitable approach to questions relating to remuneration for state use, the prior negotiations requirement set by Article 31 of TRIPS, and the public purposes and exclusive patent rights that would be included under state use. The COVID-19 international pandemic has caused a state of national disaster in South Africa, which is exactly the kind of situation of extreme urgency envisioned by the exception in Article 31 of TRIPS, which permits the state use of patents without requiring prior negotiations with the patent owner. In the battle against COVID-19 and its concomitant fallout, the South African government (and authorised private parties) would be permitted to utilise patent rights without explicit authorisation from the patent owner and without prior negotiations, but subject to the payment of reasonable remuneration by the government and other terms and conditions as agreed upon or as determined by a court. This may include making (manufacturing), using, exercising, and importing patented products (for example, personal protective equipment, pharmaceuticals, ventilators and diagnostic tests) deemed necessary in the fight against COVID-19. Foreign jurisdictions considered in this article indicate that section 4 of the Patents Act 57 of 1978 may certainly benefit from an update to provide detailed guidance on the state use of patented products or processes for public purposes. In the interest of a timeous offensive against the COVID-19 virus, the patent provisions need a speedy update to allow state use compliant with TRIPS and the Constitution of the Republic of South Africa, 1996.

January 15, 2022 | Permalink | Comments (0)

Friday, January 14, 2022

The Child’s Right to Be Vaccinated

Katherine Hunt Federle (Ohio State University), The Child’s Right to Be Vaccinated, Ohio St. U.  Sch. L. Legal Stud. (Research Paper No. 659, 2021):

Vaccine hesitancy highlights a problem within current rights constructs under U.S. law. Refusal to vaccinate is ineluctably cast as a contest between parental choice, to which the law traditionally defers, and state concerns for public safety and the individual welfare of children. But rarely is the discussion cast in terms of the child’s right to be vaccinated because our rights talk revolves around the capacity (or lack thereof) of the rights holder. If, however, we recast rights in terms of empowerment, then we can see that rights flow to the child not because she has the requisite capacity but because she is less powerful. In this sense, rights exist for children because they are children. The authority of the state to mandate immunization under U.S. law also may reconsidered because the state is acting to protect the rights of those less powerful—the children who cannot be vaccinated.

January 14, 2022 | Permalink | Comments (0)

Ageism, Race and Ethnicity

Alan Gutterman (Ageism Project), Ageism, Race and Ethnicity, SSRN (2021):

23% of the persons in the US who were age 65 and over in 2017 (11.8 million) were members of racial or ethnic minority populations—9% were African-Americans (not Hispanic), 4% were Asian (not Hispanic), 0.5% were American Indian and Alaska Native (not Hispanic), 0.1% were Native Hawaiian/Pacific Islander, (not Hispanic) and 0.8% of persons age 65 and over identified themselves as being of two or more races. Racial and ethnic minority populations are projected to increase to 27.7 million in 2040 (34% of all older adults). The UN Independent Expert on the Enjoyment of All Human Rights by Older Persons has noted that “[a]ge and race combined create aggravating forms of discrimination and can cause an increased risk of dehumanization of older persons with minority ethnic background”. She reported that “racial and ethnic minority groups are more likely to enter old age in poorer health and at greater risk of vulnerability owing to chronic inequalities and widespread racial discrimination and exclusion” and that “[o]lder members of ethnic minorities are more likely to live in poorer quality, unsafe and overcrowded accommodation in severely deprived areas that have poor access to facilities, thereby maximizing loneliness and social exclusion”. The Independent Expert argued that systematic disparities at the intersection of ageism and racism are rarely addressed in policy and practice and that racism exists in care settings and older members of ethnic minorities experience worse conditions in employment, such as lower wages, longer hours, unsafe environments and higher risk of unemployment, all of which create additional risks for health and poverty in old age. This chapter describes minority rights in international human rights law and discusses the impact of the intersection of age, race and ethnicity on the lives and experiences of African Americans, Hispanic Americans, Asian Americans and Indigenous Peoples in the US.

January 14, 2022 | Permalink | Comments (0)

Thursday, January 13, 2022

Is This the Time to Harmonize the Required Minimum Distribution Rules?

Albert Feuer (Law Offices of Albert Feuer), Is This the Time to Harmonize the Required Minimum Distribution Rules?, SSRN (2021):

In September, the House of Representatives Ways and Means Committee released proposals requiring many employers without retirement plans to establish and automatically enroll employees in IRAs with the default contributions going to Roth IRAs or in simple 401(k) plans. The proposals would also require a person whose employee benefit plans, Roth IRAs, and traditional IRAs have an aggregate balance in excess of $10 million to withdraw at least 50% of the excess balance. Broadening those proposals to require Roth IRAs to comply with the same required minimum distribution (RMD) rules that now govern employee benefit plans and traditional IRAs, would better implement the common-sense policy of using tax incentives to encourage adequate retirement savings by focusing on retirement savings.

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January 13, 2022 | Permalink | Comments (0)

Chosen Family, Care, and the Workplace

Deborah A. Widiss (Indiana University), Chosen Family, Care, and the Workplace, Ind. U. Sch. L. Legal Stud. (Research Paper No. 463, 2021):

Employees often request time off work to care for the medical needs of loved ones who are part of their extended or chosen family. Until recently, most workers would not have had any legal right to take such leave. A rapidly growing number of state laws, however, not only guarantee paid time off for family health needs, but also adopt innovative and expansive definitions of eligible family.

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January 13, 2022 | Permalink | Comments (0)

Wednesday, January 12, 2022

Allocating Scarce Medical Resources During a Pandemic: Can States and Healthcare Systems Consider Sex? Should They?

Diane E. Hoffmann (University of Maryland), Katherine E. Goodman (University of Maryland), Allocating Scarce Medical Resources During a Pandemic: Can States and Healthcare Systems Consider Sex? Should They?, U. Md. Sch. L. Legal Stud. (Research Paper No. 2021-13, 2021):

Nearly two years into the pandemic, COVID-19 has touched all U.S. states and populations. However, severe outcomes and deaths have not been borne equally. As is now well recognized, there have been significant demographic disparities by age and race: nearly 80% of all U.S. COVID-19 deaths have been among persons aged 65 or older, and hospitalization and death rates for Black and Hispanic patients with COVID-19 are two to three times higher than the rate for White patients. What has received much less attention, however, is an additional demographic disparity evident in the COVID-19 pandemic — sex. Nationally there are 20% more COVID-19 deaths among men, and men have higher COVID-19 mortality rates in every U.S. state with publicly available data. Numerous studies have established that male sex imposes an independent, approximately 30 percent higher risk of death, even when accounting for other risk factors, such as hypertension and obesity, that are more common among men.

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January 12, 2022 | Permalink | Comments (0)

Pandemic Governance

Yanbai Andrea Wang (University of Pennsylvania), Justin Weinstein-Tull (Arizona State University), Pandemic Governance, SSRN (2021):

The COVID-19 pandemic created an unprecedented need for governance by a multiplicity of authorities. The nature of the pandemic—globally communicable, uncontrolled, and initially mysterious—required a coordinated response to a common problem. But the pandemic was superimposed atop our decentralized domestic and international governance structures, and the result was devastating: the United States has a death rate that is eighteenth highest in the world, and the pandemic has had dramatically unequal impacts across the country. COVID-19’s effects have been particularly destructive for communities of color, women, and intersectional populations.

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January 12, 2022 | Permalink | Comments (0)