HealthLawProf Blog

Opioid Accountability

Daniel Aaron (Harvard Law School), Opioid Accountability, Tenn. L. Rev. (forthcoming 2022):

The opioid crisis has steadily killed Americans for twenty years. In total, we have lost 450,000 American lives since the 1990s, and countless more suffer from chronic addiction.

After years of piecemeal efforts to address this massive loss of life and health, the opioid litigation, largely centralized in Ohio federal district court, has brought significant hope for change. But there is a notable divide between the popular sense of the litigation and its reality. A full 57% of Americans believe that opioid companies should be held accountable for precipitating a public health crisis. However, the litigation has been dedicated to rapid monetary settlement, and scholars have generally been hostile to corporate accountability.

 

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Flexible Regulation for Dynamic Products? The Case of Applying Principles-Based Regulation to Medical Products Using Artificial Intelligence

Walter G. Johnson (Australian National University), Flexible Regulation for Dynamic Products? The Case of Applying Principles-Based Regulation to Medical Products Using Artificial Intelligence, 14 L., Innovation & Tech. 2 (forthcoming):

Emerging technologies including artificial intelligence (AI) enable novel products to have dynamic and even self-modifying designs, challenging approval-based products regulation. This article uses a proposed framework by the US Food and Drug Administration (FDA) to explore how flexible regulatory tools, specifically principles-based regulation, could be used to manage ‘dynamic’ products. It examines the appropriateness of principles-based approaches for managing the complexity and fragmentation found in the setting of dynamic products in terms of regulatory capacity and accountability, balancing flexibility and predictability, and the role of third parties. The article concludes that successfully deploying principles-based regulation for dynamic products will require taking serious lessons from the global financial crisis on managing complexity and fragmentation while placing equity at the centre of the framework.

Of Life and Death in Canadian Penitentiaries

Adelina Iftene (Dalhousie University), Of Life and Death in Canadian Penitentiaries, 66 Can. Fam. Physician 1 (2020):

A federal penitentiary is a prison where individuals serve long sentences, of 2 years or longer, including life sentences. Take a second to picture a person serving a sentence in such a place. Who do you see in your mind’s eye?

Did you imagine a 70-year-old in an advanced stage of multiple sclerosis? Or a 72-year-old with metastatic lung cancer? Or a 55-year-old with an above-the-knee amputation and stage 1 dementia?

The Role Advocacy in Special Needs Education Administration in Nigeria

Lazarus Udie, The Role Advocacy in Special Needs Education Administration in Nigeria, SSRN:

The role advocacy in special needs education administration in Nigeria is an issue discussed in the paper. The paper examined the role of advocacy in special education administration of people with disabilities, for possible integrations into the society; possible ways to locating advocates to help mitigates or collaborates to cushion some of the effects of disabilities was also outlines. The paper further examined various interest organizations that advocate for persons with disabilities such organizations include National Association of Special Education teachers, the Association of people with intellectual and developmental disabilities, National center for learning disabilities, individual with disability education Act, the council of exceptional children, with their defined mandate and vision to promote equal opportunity and inclusion for people with disabilities and also to legislate on behalf of the persons with disabilities for proper special education administration.

Job Posting: Assistant Professor of Law Teaching Health Law

Assistant Professor, Law

Job Summary

Full-time Assistant Professors will typically teach two courses per semester, which may include first-year and/or required courses. Our curricular needs include a variety of first-year, required, and elective courses, including Civil Procedure, Complex Litigation, and E-Discovery; Constitutional Law, Employment Discrimination, Federal Courts, Health Law, and Indian Law; Contracts, Antitrust, and other Business Law courses with an emphasis on Corporate Social Responsibility; and academic support or bar preparation courses taught in conjunction with doctrinal courses. Gonzaga Law embraces a unified faculty model, in which all faculty members are supported as scholars in all subject matter areas and have the opportunity to teach experiential, clinical, academic support, or bar preparation courses if desired. Candidates must demonstrate the ability to be an outstanding teacher, a commitment to service, and excellent scholarly potential, particularly in alignment with Gonzaga Law’s two academic Centers – the Center for Civil & Human Rights and the Center for Law, Ethics & Commerce.

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IRS Guidance About the SECURE Act's Beneficiary Provisions Requires Revision

Albert Feuer, IRS Guidance About the SECURE Act's Beneficiary Provisions Requires Revision, 49 Comp. Plan. J. 5 (2021):

The IRS has presented its first and only guidance about how the SECURE Act changed the Required Minimum Distribution (RMD) Rules. This was done in a detailed IRS guide for preparing 2020 returns, and an IRS FAQ web site that referenced the guide that had been released a day earlier. The SECURE Act limited the set of individual beneficiaries permitted to use their own life expectancy to stretch out the benefit distributions after the death of participant. Non-favored individual beneficiaries became subject to a 10-year rule similar to the 5-year rule upon which it is based. The 5-year rule does not require any benefit distributions before the end of the 5-year period, but requires distribution on or before the final day of the period. The 5-year rule is applicable to an estate or trust not treated as a pass-through entity when the participant died before attaining the participant’s required beginning date.

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What Regulators Can Learn from Global Health Governance

Cary Coglianese (University of Pennsylvania), What Regulators Can Learn from Global Health Governance, 16 Glob. Health Governance 1 (2021):

The Great Pandemic of 2020 shows how much public health around the world depends on effective global and domestic governance. Yet for too long, global health governance and domestic regulatory governance have remained largely separate fields of scholarship and practice. In her book, Global Health Justice and Governance, Jennifer Prah Ruger offers scholars and practitioners of regulatory governance an excellent opportunity to see how domestic regulation shares many of the same problems, strategies, and challenges as global health governance. These commonalities reinforce how much national and subnational regulators can learn from global health governance. Drawing on insights from Prah Ruger’s impressive book, I offer seven lessons for domestic regulators around the world to use to improve their performance, arguing that it is vital for regulators to see themselves as operating in a larger social environment in which they must remain agile, vigilant, and responsive to other actors and to changing circumstances.

Ex Tenebris Lux: Buck v. Bell and the Americans with Disabilities Act

Derek Warden, Ex Tenebris Lux: Buck v. Bell and the Americans with Disabilities Act, 51 Univ. Tol. L. Rev. 57 (2019):

Justice Holmes's opinion in Buck v. Bell allowed thousands of people with disabilities to be forcibly sterilized. Holmes's opinion was of such a nature that it was used to support the Nazis' use of sterilization at the Nuremburg Trials. Thankfully, our nation and world began viewing people with disabilities in a different light. One such change in views became manifest in the Americans with Disabilities Act. That law, as shown above, allows plaintiffs at risk of sterilization or who are victims of such a practice, to sue public entities directly either for injunctive relief or damages regardless of any claims of sovereign immunity. Thus, the ADA stands as a blockade to one of Justice Holmes's worst opinions. As such, the ADA echoes back in time to say, "ten generations of Buck v. Bell are enough."

Vulnerable Populations and Vaccine Injury Compensation: The Need for Legal Reform

Katharine A. Van Tassel (Case Western Reserve University School of Law), Sharona Hoffman (Case Western Reserve University School of Law), Vulnerable Populations and Vaccine Injury Compensation: The Need for Legal Reform, in COVID-19 and the Law: Disruption, Impact and Legacy (I. Glenn Cohen et al., eds., Cambridge University Press forthcoming 2022):

This chapter argues that the potential for vaccine-related harms raises acute concerns for vulnerable populations. These harms have a disparate impact on low-income people, who are disproportionately non-White, and who have limited financial resources to obtain medical care, weather job losses, and pursue injury compensation. When a vaccine is given as a countermeasure during a declared public health emergency (PHE), the problem is acute because of the limited availability of injury compensation.

Promoting Public Health Through State Sovereign Immunity

Sapna Kumar (University of Houston), Promoting Public Health Through State Sovereign Immunity, Univ. Pa. J. L. & Innovation (2021):

During the COVID-19 outbreak, the United States experienced widespread shortages of patented drugs and goods. But although states negotiated with foreign governments to obtain needed medical equipment, they were seemingly powerless to obtain or produce their own supply of scarce drugs. This Essay proposes an unorthodox solution to drug shortages during public health emergencies: states could disregard the Patent Act and directly produce or import needed patented drugs. The doctrine of state sovereign immunity shields states from having to pay damages when they violate federal law, including patent law. Moreover, courts and agencies are generally unwilling to award injunctions or other prospective relief if it disserves the public interest. State action is admittedly not a perfect solution to patent-related drug shortages and comes with a variety of costs and risks, including retaliation from the U.S. Food & Drug Administration. But at minimum, it could serve as a means for pressuring the federal government and pharmaceutical companies to work to provide drugs to the public.

Long-Term Care

Alan Gutterman, Long-Term Care, SSRN:

Long-term care includes activities undertaken by others to ensure that those with a significant ongoing loss of physical or mental capacity can maintain a level of ability to be and to do what they have reason to value and involves a variety of services provided in a number of places and by different groups of caregivers ranging from care in the home from unpaid family members and friends (mostly female), which is the most common form of long-term care; home-based services provided by paid caregivers, including caregivers found informally or through home health care agencies and healthcare professionals (i.e., nurses, home health care aides and therapists); and services provided by health and care professionals in institutional settings such as nursing homes or community-based adult day centers. Caregiving for older persons is an important issue, regardless of how and where the care is provided, since the data shows that the global population over age 65 will more than double over the next three decades, and steps need to be taken to determine the best means to fund and otherwise support the services that will be needed to maintain the physical and mental wellbeing of the most vulnerable members of this group. While there is no international human rights instrument specifically addressing long-term care for older persons, the human rights of older persons with respect to long-term care can be derived from a combination of several different rights explicitly recognized in international human rights. This chapter discusses the human rights law foundation for providing older persons with high quality long-term care alternatives and considers the current state of institutional care in nursing homes and assisted living centers, which is especially relevant in the aftermath of the Covid-19 pandemic. The chapter also describes the sweeping impact that caregiving provided outside of institutions by family members and friends has on all aspects of society and the steps that are being proposed to reduce economic and psychological stress on millions of older persons and their caregivers through development of an “infrastructure of care”.

The Need for a Strong and Stable Federal Public Health Agency Independent from Politicians

Jacqueline Salwa (Harvard Law School), Christopher T. Robertson (Boston University), The Need for a Strong and Stable Federal Public Health Agency Independent from Politicians, in COVID-19 Policy Playbook: Legal Recommendations for a Safer, More Equitable Future, (Scott Burris, Sarah de Guia, Lance Gable, Donna Levin, Wendy Parmet, & Nicholas Terry, eds., Boston: Public Health Law Watch 2021):

The COVID-19 pandemic has revealed the precariousness of federal public health institutions in the United States, and how disastrously things can go when those institutions are undermined by political forces. Such institutions can be disbanded, underfunded, populated with incompetent political hacks, manipulated, or sidelined. As a field, public health in particular needs some political space, given that it requires deep scientific expertise and needs to communicate to the public clearly, reliably, and with authority to engender trust. Key public health agencies, such as the Centers for Disease Control and Prevention (CDC) in particular, should be buttressed against future political encroachment, using legal mechanisms from administrative law, which are tried and true in other domains of governance. Models include the Federal Deposit Insurance Commission (FDIC) (created in 1933), the Federal Reserve System (1913), the Federal Trade Commission (FTC) (1914), and the National Labor Relations Board (NLRB) (1935). Key features of these agencies include having multi-member boards of qualified experts to lead them, enjoying independence from the president (not able to be fired without cause), and having statutory budgetary authority by not requiring congressional appropriation or allowing executive reallocation. We discuss the ways in which independence can increase deference accorded by the courts, as well as the risk that it may reduce political accountability.

The No Surprises Act Does Not Solve Air Ambulance Cost, Cost-Shifting, and Supply Problems: A Coda

Melissa Alexander (University of Wyoming), The No Surprises Act Does Not Solve Air Ambulance Cost, Cost-Shifting, and Supply Problems: A Coda, 21 Wyo. L. Rev. 1 (2021):

The No Surprises Act, which takes effect in 2022, should help resolve air ambulance balance billing and narrow network problems, but the Act leaves significant underlying structural problems in the air ambulance market. The Act does not address the cost, cost-shifting, and supply challenges plaguing air ambulances. It does not establish a benchmark payment standard for out-of-network rates or otherwise provide a mechanism to correct current market price distortion. Moreover, the No Surprises Act neither regulates supply nor frees states to do so. Further, by failing to address price discrimination, it continues to allow privately insured patients to be unfairly burdened with costs attributable to government insured and uninsured patients. Worse still, because it requires insurers to assume liability for out-of-network transports without controlling costs, it appears likely to increase health insurance premiums, unintentionally exacerbating inequities in access to care. A more comprehensive solution to air ambulance problems that addresses cost, cost-shifting, and supply remains needed.

Regulatory, Safety, and Privacy Concerns of Home Monitoring Technologies during COVID-19

Sara Gerke (Harvard University), Carmel Shachar (Harvard Law School), Peter R. Chai (Harvard University), I. Glenn Cohen (Harvard Law School), Regulatory, Safety, and Privacy Concerns of Home Monitoring Technologies during COVID-19, Nature Med. 26 (2020):

There has been increasing interest in the use of home monitoring technologies during the COVID-19 pandemic to decrease interpersonal contacts and the resultant risks of exposure for people to the coronavirus SARS-CoV-2. This Perspective explores how the accelerated development of these technologies also raises major concerns pertaining to safety and privacy. We make recommendations for needed interventions to ensure safety and review best practices and US regulatory requirements for privacy and security. We discuss, among other topics, Emergency Use Authorizations for medical devices and privacy laws of the USA and Europe.

Access to Health Care by Migrants with Precarious Status during a Health Crisis: Some Insights from Portugal

Vera Lúcia Raposo (University of Macau), Teresa Violante, Access to Health Care by Migrants with Precarious Status during a Health Crisis: Some Insights from Portugal, SSRN:

In March 2020, the Portuguese Government issued a remarkable regulation by which irregular migrants who had previously started the regularization procedure were temporarily regularized and thus allowed full access to all social benefits, including healthcare. The Portuguese constitutional and legal framework is particularly generous regarding the right to healthcare to irregular migrants. Nevertheless, until now, several practical barriers prevented full access to healthcare services provided by the national health service, even in situations in which it was legally granted. This decision is not only remarkable in light of the fulfilling of migrants’ rights to health, as imposed by international commitments assumed by, but also in view of the fight against COVID-19. The decision is grounded both on human rights and in public health reasons. The paper is divided in two main parts. In the first one, it analyzes national State obligations with regard to healthcare provision to migrants in irregular situation. In the second part, it analyzes the Portuguese solution, using this case study to discuss the possible mechanisms to comply with such obligations.

Invisible or Mainstream? Disability in Surveys and Censuses in Low- and Middle-Income Countries

Sophie Mitra (Fordham University), Wei Chen (Fordham University), Justine Herve (Fordham University), Sophia Pirozzi, Jaclyn Yap (Fordham University), Invisible or Mainstream? Disability in Surveys and Censuses in Low- and Middle-Income Countries, SSRN:

This paper examines to what extent household surveys and censuses in low- and middle-income countries include disability questions and the types of questions under use. A pool of 734 data sets and 1,297 data set-years from 133 low- and middle-income countries from 2009 to 2018 were screened for disability questions, which were classified by type of questions: Washington Group short set of questions, other functional difficulty questions, activities of daily living, broad activity limitation, general disability, and other disability questions. Only 31% of the data sets under review had at least one disability-related question and 15 % of the datasets of low- and middle-income countries have functional difficulty questions that meet international standards, whether the Washington Group short set or other functional difficulty questions. The most commonly found disability question is the general question “Do you have a disability?” which does not produce meaningful and internationally comparable data. The adoption of functional difficulty questions such as the Washington Group short set in national censuses and surveys and in international surveys is needed to monitor the implementation of the 2030 Agenda for Sustainable Development as well as the Convention on the Rights of Persons with Disabilities.

Study Paper on Inclusive Investing: Respecting the Rights of Vulnerable Investors through Supported Decision-Making

Canadian Centre for Elder Law, Study Paper on Inclusive Investing: Respecting the Rights of Vulnerable Investors through Supported Decision-Making, SSRN:

Supported decision-making allows adults to pick who may assist them in making decisions. Supported decision-making can enable people living with disabilities to make their own decisions about financial, personal, health care, legal, or other matters. For people living with dementia, supported decision-making may open a door to maintaining a degree of autonomy in making decisions regarding their investments.

The Inclusive Investing Project was born out of a desire to enhance capacity within the investment sector to work with clients who may prefer to make decisions with the support of family and friends. We are thrilled to share with you this study paper, which is the culmination of many years of research and consultation.

The work of the Canadian Centre for Elder Law (CCEL) aims to break down silos of practice to support robust conversations about law and policy reform. The Inclusive Investing study paper reflects the perspectives of stakeholders from financial, legal, and other professional sectors, and incorporates the lived experience of older people living with dementia, people living with intellectual or developmental disabilities, and family members who provide support. Like many CCEL projects, the Inclusive Investing Project was a collaboration — this time with project partners Alzheimer Society of B.C. and Inclusion BC. The collaboration amongst the project partners was integral to ensuring this research reflected diverse experiences.

Who owns tobacco stocks?

David Blitz, Laurens Swinkels (Erasmus University Rotterdam), Who owns tobacco stocks?, SSRN:

We compare the ownership characteristics of tobacco stocks with their peers in the same country and industry group. We find lower reported ownership for stocks in the tobacco industry, which suggests that anonymous investors are larger owners of these sin stocks. Compared to peer stocks, U.S. and U.K. asset managers collectively overweight tobacco stocks, while norm-constrained investors such as sovereign wealth funds and pension funds underweight tobacco stocks. Passive managers have large stakes in tobacco stocks that are in line with the weights of these stocks in broad capitalization-weighted indices, indicating that passive replication of ethically screened indices is still a niche. We also identify some prominent active investors who take large positions in tobacco stocks.

Videoconferencing and Procedural Doctrine

Scott Dodson (UC Hastings), Videoconferencing and Procedural Doctrine, Sw. Univ. L. Rev. (forthcoming):

Enduring post-pandemic reliance on, and normalization of, videoconferencing in federal civil litigation and throughout society and commerce ought to have downstream effects on legal doctrines that depend upon contacts, burdens, and conveniences. Videoconferencing facilitates interstate contacts while mitigating burdens and costs associated with litigation in distant or otherwise geographically inconvenient forums, a fact that should broaden the reach of personal jurisdiction and influence venue transfer. The use of videoconferencing also should make certain discovery, like nonparty depositions, easier, quicker, cheaper, and more convenient—and therefore less objectionable. In this symposium essay, I consider the impact of normalized videoconferencing on these procedural doctrines. I begin by setting out the pandemic lessons for the use of videoconferencing technology in commercial, social, and litigation contexts, and I forecast its persistence post-pandemic. I then turn to various legal doctrines based on burdens and conveniences—including subpoenaed depositions, personal jurisdiction, and venue transfer—and I argue that videoconferencing will change the way these doctrines should be applied to post-pandemic civil litigation.

Disability Rights and Welfare in Sri Lanka

Rasika Karunarathne, Disability Rights and Welfare in Sri Lanka, SSRN:

People who are differently-abled is one group that often gets into trouble due to the less attention from society. Providing equal opportunity for all people is a highly considered fact worldwide. In order to establish equity and equality in society, all countries in the world urge to care about people who have become marginalized from the mainstream due to many reasons. Therefore, they should be given more welfare programs to uplift their living condition in order to protect social security. Also, there should be made special attention to empower those who have become destitute. With a view to making attempts to enable people potentiality, some countries have introduced many attractive approaches. In comparisons between developed and underdeveloped countries, there can be seen various differences among developed countries which have established more attractive welfare facilities on behalf of disabled people. Accordingly, this paper is discussed the condition of differently-abled people and to identify the contribution of government and non-government agencies to empower disabled people in Sri Lankan society.