HealthLawProf Blog

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

Sunday, March 3, 2024

Patentability – Impacts of Biotechnology following Association for Molecular Pathology v Myriad Genetics and D’Arcy v Myriad Genetics

Theresa-Marie Shaw (University of Queensland), Patentability – Impacts of Biotechnology following Association for Molecular Pathology v Myriad Genetics and D’Arcy v Myriad Genetics (2024):

In Association for Molecular Pathology v Myriad Genetics Inc ‘Myriad’ and D’Arcy v Myriad Genetics Inc ‘D’Arcy’, the U.S Supreme Court ‘SC’ and High Court of Australia ‘HCA’ considered whether isolated nucleic acid sequences were patentable subject matter, with mutations being linked to diagnostic testing for breast and ovarian cancer. These findings have significant implications for the field of intellectual property law.

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March 3, 2024 | Permalink | Comments (0)

Legal Regulation of Whole Genome Sequencing of Listeria monocytogenes in the Food Industry: Challenges, Attitudes, Possibilities

Christiane Hunsbedt, Lee A. Bygrave (University of Oslo), Annette Fagerlund (Nofima), Solveig Langsrund (Nofima), Legal Regulation of Whole Genome Sequencing of Listeria monocytogenes in the Food Industry: Challenges, Attitudes, Possibilities (Univ. Oslo Fac. L. Rsch. Paper No. 2024-01) (2024):

This report presents the outcome of legal research conducted under the aegis of the project ‘Food Safety with High Precision—Pathogenomics for the Food Industry’ (short title: PathoSeq). A central objective of the PathoSeq project has been to prepare the Norwegian food industry for challenges accompanying the introduction of whole genome sequencing (WGS) of foodborne bacteria. The report elucidates the legal rules that may affect the implementation of WGS of bacterial pathogens in the food industry, using Listeria monocytogenes (Lm) as a case study. While the report focuses predominantly on the Norwegian context, account is also taken of the experiences and practices of certain other European states, particularly Austria, in light of EU food safety rules. Three key issues are canvassed: (i) the role of WGS data in assessing the safety of food; (ii) access by food safety authorities to WGS data, or to isolates on which to perform WGS, from the food industry; and (iii) food business operators’ ability to receive Lm isolates and sequences held by the authorities. A special feature of the report is that it builds on, and presents, an extensive mapping of stakeholder perspectives on these issues and, more generally, on potentials, hindrances and needs in respect of mitigating Lm-related risk through WGS technology.

March 3, 2024 | Permalink | Comments (0)

Saturday, March 2, 2024

Artificial Intelligence in Medicine: Issues when Determining Negligence

Paul Nolan (Australian Bar Association), Rita Matulionyte (Macquarie Law School), Artificial Intelligence in Medicine: Issues when Determining Negligence (2023):

The introduction of novel medical technology, such as artificial intelligence (AI), into traditional clinical practice presents legal liability challenges that need to be squarely addressed by litigants and courts when something goes wrong. Some of the most promising applications for the use of AI in medicine will lead to vexed liability questions. As AI in health care is in its relative infancy, there is a paucity of case law globally upon which to draw. The article will analyse medical malpractice where AI is involved, what problems arise when applying the tort of negligence – such as establishing the essential elements of breach of duty of care and causation – and how can these be addressed. Product liability under Australian Consumer Law is beyond the scope of this article. In order to address this question, the article will: (1) identify the general problems that black box AI causes in the health care sector; (2) identify the problems that will arise in establishing breach and causation due to the “black box” nature of AI, with reference to the Civil Liability Act 2002 (NSW) and common law through two hypothetical examples; and (3) consider selected legal solutions to the problems caused by “black box” AI.

March 2, 2024 | Permalink | Comments (0)

Is intellectual property the COVID-19 bad guy? Lessons we could learn from the pandemic

Charles Lawson (Griffith University), Is intellectual property the COVID-19 bad guy? Lessons we could learn from the pandemic (2023):

At the time the COVID-19 pandemic was declared there was no vaccine and other medical products were insufficient to meet demands. At the time intellectual property was considered a limitation to an effective pandemic response and the World Trade Organisation considered a waiver of intellectual property addressed by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The lesson from the COVID-19 pandemic and TRIPS waiver is that given enough time sufficient medical products will be delivered, albeit there remain some complicated delivery challenges and vaccine hesitancy issues. This comment addresses the moment before that medical product saturation and the inherent limitation imposed by the broader industry policies applied in the predominantly rich, democratic and developed States that are pro-trade, free market and capitalist economies. This preference is to outsource to the private sector late-stage innovation, manufacturing and delivering the medical products for responding to pandemics with consequences for intellectual property settings and pandemic responses. The comment concludes that the private sectors’ motivating factors need to be integrated into the design of global public health pandemic responses from the start.

March 2, 2024 | Permalink | Comments (0)

Friday, March 1, 2024

The Undeserving Poor and the Marketization of Medicaid

Elenore Wade (Rutgers University), The Undeserving Poor and the Marketization of Medicaid (2023):

No welfare program in the United States is available to the poor solely by virtue of their low income. Instead, programs like Medicaid require people to be the type of person who is “deserving” of aid, usually because law and policy have decided their poverty is not entirely their fault. Until the passage of the Affordable Care Act, the Medicaid program was highly restricted to people defined as the “deserving poor.” These categorical restrictions are closely linked to ideas about the discipline required to enforce participation in the “free market,” and U.S. welfare law has long been concerned that providing the poor with welfare benefits insulates them from the “true cost” of goods and services, creating risks of welfare dependency and laziness. Such conceptions of the “risk” of providing welfare have led to the replacement of robust social welfare programs with the hollow rhetoric of free-market opportunity. However unfounded and degrading, these concerns of animate all of Medicaid law, and they animate the uneven legal and political environment of Medicaid expansion in the states.

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March 1, 2024 | Permalink | Comments (0)

Force Multiplier: An Intersectional Examination of One Immigrant Woman's Journey Through Multiple Systems of Oppression

Amelia Wilson (Seton Hall University), Force Multiplier: An Intersectional Examination of One Immigrant Woman's Journey Through Multiple Systems of Oppression, 38 Berkeley J. Gender L. & Just. (2023):

The immigrants’ rights movement can assume an intersectional and cooperative approach to dismantling co-constitutive systems of oppression that conspire to punish, exclude, and exploit disfavored groups. Racial justice must be at the center of the movement, but so too must we understand the devastating role that gender, disability, and documentation status play in marginalizing immigrants and their communities. This article examines one immigrant woman’s experiences in the Southeastern United States as she passed through the mental health care system, competency proceedings, criminal justice system, and the deportation pipeline to explicitly lay bare intertwining forms of systemic subjugation.

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March 1, 2024 | Permalink | Comments (0)

Thursday, February 29, 2024

Comments of Jeffrey Lefstin, Peter Menell, and Allison Schmitt on the Patent Eligibility Restoration Act of 2023

Jeffrey A. Lefstin (University of California San Francisco), Peter S. Menell (University of California Berkeley), Allison A. Schmitt (University of California Berkeley), Comments of Jeffrey Lefstin, Peter Menell, and Allison Schmitt on the Patent Eligibility Restoration Act of 2023 (U.C. S.F. Rsch. Paper) (forthcoming 2024):

The U.S. patent system has been in disarray for more than a decade as a result of the Supreme Court’s flawed interpretation of the Patent Act. As part of the 2012 Mayo decision and its subsequent jurisprudence, the Supreme Court has imposed an extra-statutory requirement that scientific discoveries—often the most important breakthroughs in promoting progress—must be “inventively applied” to be eligible for patent protection. The Patent Act imposes no such requirement. Prior to the  Mayo decision, courts interpreted Section 101 to require only that scientific discoveries be applied in some form to be eligible for patent protection. Yet the Mayo decision has eliminated protection for applied scientific discoveries (including many diagnostic discoveries), one of the most important means of promoting scientific and technological progress in a wide variety of scientific and technical disciplines.

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February 29, 2024 | Permalink | Comments (0)

Pandemic Harms and Private Law's Limits: A Proposal for Tort Replacement

Alberto De Diego Carreras, Jill R. Horwitz (University of California Los Angeles), Daniel B. Rodriguez (Northwestern University), Pandemic Harms and Private Law's Limits: A Proposal for Tort Replacement (Nw. Pub. L. Rsch. Paper No. 24-02) (2024):

In the early days of the COVID-19 pandemic, many predicted a flood of tort litigation against commercial businesses brought by consumers alleging negligent exposure to the virus. Although these negligently-caused injuries almost certainly occurred, the predicted flood of litigation never materialized. Along with various state-imposed liability shields for businesses, the private law of tort itself also proved a formidable barrier to potential plaintiffs, particularly given the difficulty of establishing causation in this context. This absence of tort suits no doubt helped businesses, ranging from residential health care providers to restaurants, as well as the economy and social life more generally. But the dearth of claims almost certainly left a great number of negligently-injured parties without recourse or compensation to address their devastating harms. 

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February 29, 2024 | Permalink | Comments (0)

Wednesday, February 28, 2024

Expanding Access to Exchanges: a Proposal to Address Healthcare Affordability in the U.S.

Lukas J. Helikum (Swansea University), Gita Sharma (Rutgers University), Expanding Access to Exchanges: a Proposal to Address Healthcare Affordability in the U.S., 33 Midwest L.J. (2023):

Escalating health care costs are an issue faced by millions of Americans. While the Affordable Care Act expanded access to coverage, it did little to curb skyrocketing costs. Most households in the United States continue to rely on employer-provided coverage where constantly increasing out-of-pocket expenses (e.g., premiums, deductibles, co-payments) have made medical care increasingly unaffordable for many. This paper documents some of the challenges of shifting increased costs to employees and proposes expanded access to government health insurance Exchanges as an effective strategy for cost control and quality improvements.

February 28, 2024 | Permalink | Comments (0)

What Spurs Production and Innovation in the Vaccine Industry? Insights from Policy Interventions in the US

Myongjin Kim (University of Oklahoma), Firat Demir (University of Oklahoma), Ahmed El Fatmaoui (University of Oklahoma), Qi Ge (Vassar College), et al., What Spurs Production and Innovation in the Vaccine Industry? Insights from Policy Interventions in the US (2023):

This paper investigates the impact of supply- and demand-side policy interventions on firms' output and innovation. Leveraging a unique dataset on vaccine production and development, we evaluate the effectiveness of a tort reform, a supply-side policy intervention that reduces vaccine manufacturers' product liability, and a demand-side policy intervention, the expansion of Medicare coverage of select vaccine products. Our difference-in-differences analysis indicates that while both interventions result in significant increases in vaccine production, the impact of the demand-side policy can be 3-6 times greater in magnitude. There is also evidence suggesting that vaccine manufacturers are more likely to invest in R&D when facing the demand-side policy intervention, and the effect is likely driven by the underlying market structures.

February 28, 2024 | Permalink | Comments (0)

Tuesday, February 27, 2024

Pharmaceutical Industry Funding to Patient-Advocacy Organizations: A Cross-National Comparison of Disclosure Codes and Regulation

Laura Karas (Harvard Law School), Robin Feldman (UC San Francisco), Ge Bai (Johns Hopkins University), So-Yeon Kang (Johns Hopkins University), et al., Pharmaceutical Industry Funding to Patient-Advocacy Organizations: A Cross-National Comparison of Disclosure Codes and Regulation, 42 Hastings Int’l and Compar. L. Rev. (2023):

Transparency has become one of the primary themes in health care reform efforts in the United States and across the world. In the face of exorbitant drug prices, high levels of patient cost-sharing, and pharmaceutical expenditures that consume a growing proportion of public sector budgets, much attention has been drawn to the pharmaceutical industry. Congressional investigations, academic publications, and news articles have endeavored to reveal the extent of drug and device industry influence on health care actors. In response, several nations, including the United States, have passed legislation mandating disclosure of drug company payments to physicians. In the United States, there are currently no legal requirements for disclosure of pharmaceutical industry sponsorship to patient-advocacy organizations by either party to the transaction. An ongoing concern is that drug industry payments could interfere with the objectivity of patient-advocacy groups and may induce them to take public positions favorable to the drug industry but at odds with the interests of patients. This article provides a comparative analysis of industry codes of practice and regulation that govern relationships between pharmaceutical companies and patient-advocacy organizations in the United States, the United Kingdom, Germany, France, Australia and Canada, with an emphasis on disclosure policies for industry sponsorship. The article draws upon the practices of other nations and the Physician Payments Sunshine Act to make a case for an expansion of the Sunshine Act to patient-advocacy groups.

February 27, 2024 | Permalink | Comments (0)

Accessing the Safety Net: How Medicaid Affects Health and Recidivism

Analisa Packham (Vanderbilt University), David Slusky (University of Kansas), Accessing the Safety Net: How Medicaid Affects Health and Recidivism (IZA Discussion Paper No. 16665) (2023):

We estimate the causal impact of access to means-tested public health insurance coverage (Medicaid) on health outcomes and recidivism for those recently released from incarceration. To do so, we leverage a policy change in South Carolina that allowed simplified Medicaid re-enrollment for previously incarcerated eligible individuals. Using linked administrative data on criminal convictions and health insurance claims, we find that reducing barriers in access to Medicaid for vulnerable populations increases enrollment and utilization of health care services. However, we do not find that this improved health care insurance access reduces 1-year or 3-year recidivism, suggesting that effectiveness of such policies is context dependent.

February 27, 2024 | Permalink | Comments (0)

Sunday, February 25, 2024

An Appraisal of Policy for Employment of Persons With Disabilities (PWDs)

Agha Ghulam Haider (Ministry of Federal Education and Professional Training), An Appraisal of Policy for Employment of Persons With Disabilities (PWDs) (2024):

The present paper discusses the challenges faced by people with disabilities (PWDs) in Pakistan concerning employment opportunities. PWDs have diverse impairments that affect their ability to participate in society and the workforce. However, inadequate policy implementation is a major hindrance, as existing laws meant to protect the rights of PWDs are not effectively enforced. Pakistan lacked sufficient legislation and mechanisms until 2022, despite ratifying the UN Convention on the Rights of Persons with Disabilities in 2011. Various policies have been formulated to address disability-related challenges, but their limited impact results from insufficient monitoring, evaluation, and implementation, affecting PWDs' employment prospects.

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February 25, 2024 | Permalink | Comments (0)

Saturday, February 24, 2024

Quality of Life for People with Mental Illness Employed in Extended Employment Programs in two Arab Towns in Israel: An Exploratory Study

Leena Badran (University of California), Stephen A. Rosenbaum (University of California), Arik Rimmerman (University of Haifa), Quality of Life for People with Mental Illness Employed in Extended Employment Programs in two Arab Towns in Israel: An Exploratory Study, 14 Frontiers in Psychiatry (2023):

This study aims to examine the quality of life (QOL) for people with psychiatric disabilities who are engaged in extended employment programs (homogeneous versus heterogeneous) in the Arab-populated Triangle Area of Israel. The homogeneous program participants are exclusively Arab while the heterogeneous program includes both Arabs and Jews. A quantitative research study involved 104 adults with psychiatric disabilities engaged in two communal extended employment programs. Participants completed demographic (age, gender, marital status), religion (Muslim, Jewish, Christian), dichotomous nationality variable (Jewish/Arab), years of education, and employment questionnaires. 

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February 24, 2024 | Permalink | Comments (0)

Friday, February 23, 2024

When is Age Discrimination a Human Rights Violation?

Gerald L. Neuman (Harvard Law School), When is Age Discrimination a Human Rights Violation?, Harv. Hum. Rts. J. (forthcoming):

Chronological age is a social construct that reflects physical and biological regularities as well as interactions with social structures. Legal systems commonly use chronological age in the design of rules, and they increasingly regulate the use of chronological age in governmental or social practices. Age discrimination law originated in employment law, primarily for the protection of middle-aged and older workers, before expanding in three dimensions: from employment to other fields of action, from older workers to age in general, and from “direct” (or intentional) discrimination to “indirect” discrimination (with discriminatory effect). Some of these expansions have been inadvertent or unconsidered.

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February 23, 2024 | Permalink | Comments (0)

Case Western Reserve University’s Law-Medicine Center Presents The 2024 Law-Med Conference: Cognitive Decline; 8:45AM – 4:00PM on Friday, March 1st, 2024.

Case Western Reserve University’s Law-Medicine Center Presents  The 2024 Law-Med Conference: Cognitive Decline.

As the American population ages, a growing number of people will suffer cognitive decline. Cognitive decline may affect individuals’ ability to work, drive, obtain medical care, manage their finances and engage in other activities of daily living. As cognitive decline becomes more prevalent in American Society, legal experts and policy makers will need to grapple with its implications. This conference will explore a variety of legal and policy challenges associated with cognitive decline. Topics will include medical decision-making, guardianship, cognitive decline among incarcerated individuals, family caregivers, telemedicine and much more.

 

 

 

Agenda and speaker biographies.

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Register to attend virtually or in person for the March 1st, 2024 conference.

February 23, 2024 | Permalink | Comments (0)

Thursday, February 22, 2024

Transportation Policy as Hindrance and Handmaiden of the Hundred-Year Life

Gregory H. Shill (University of Iowa), Transportation Policy as Hindrance and Handmaiden of the Hundred-Year Life (U. Iowa Legal Rsch. Paper No. 2024-01) (2024):

There are two barriers to realizing the promise of the hundred-year life in the United States. The first is that few get to live it: unlike peers in other high-income countries, the life expectancy of Americans is short. Paradoxically, however, boosting American longevity would aggravate a second problem: on important dimensions, Americans enjoy less independence in old age than their peers. These problems have something perhaps unexpected in common: a built environment that requires driving as the price of first-class citizenship. That bargain, a legacy of twentieth-century transportation and land use policy, first lops years off of life expectancy by claiming lives at disproportionately young ages and then saps independence and quality of life among the small share of Americans who are fortunate to reach very old age.

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February 22, 2024 | Permalink | Comments (0)

Imperfect Insanity and Diminished Responsibility

Lea Johnston (University of Florida), Imperfect Insanity and Diminished Responsibility, Fla. L. Rev. (forthcoming 2024):

Insanity’s status as an all-or-nothing excuse results in the disproportionate punishment of individuals whose mental disorders significantly impaired, but did not obliterate, their capacities for criminal responsibility. Prohibiting the trier of fact from considering impairment that does not meet the narrow definition of insanity contradicts commonly held intuitions about mental abnormality and gradations of responsibility. It results in systemic over-punishment, juror frustration, and, at times, arbitrary verdicts as triers of fact attempt to better apportion liability to blameworthiness. 

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February 22, 2024 | Permalink | Comments (0)

Tuesday, February 20, 2024

Against Silence: Why Doctors Are Obligated to Provide Abortion Information

Michelle Oberman (Santa Clara University), Against Silence: Why Doctors Are Obligated to Provide Abortion Information, 26 J. Health Care L. & Pol’y (2023):

This essay describes some of the early findings from my ongoing study of how U.S. doctors are responding to laws criminalizing the provision of abortion. After providing an overview of the research project, I will hone in on one of the most troubling findings that emerged—specifically the reluctance of clinicians to share abortion information. Once I’ve described why abortion information matters so much, particularly to vulnerable patients, I will explain why doctors are duty bound to such information. Finally, I will discuss the various fears that are leading doctors to pull back from sharing abortion information, assessing both their merit and their implications for healthcare at an individual and profession-wide level.

February 20, 2024 | Permalink | Comments (0)

What Psychedelic Practitioners Can Learn from Eye Surgeons About 'Soft Furniture' Method Patent Reform

Laurel Kilgour, What Psychedelic Practitioners Can Learn from Eye Surgeons About 'Soft Furniture' Method Patent Reform (2023):

The article proposes targeted patent reform tailored to the emerging field of psychedelic facilitation, drawing parallels to historical patent disputes in the medical profession.

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February 20, 2024 | Permalink | Comments (0)