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9 Steps To End Covid-19 And Prevent The Next Pandemic: Essential Outcomes From The World Health Assembly, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

A year ago, the World Health Assembly (WHA) met virtually for the first time since the creation of the World Health Organization (WHO) in 1948. Last year’s WHA adopted a resolution asking states to intensify action to fight COVID-19. Yet a year on, there have been 3.7 million deaths reported, with the real number estimated as more than 7 million. From May 24-31, 2021, the 74th WHA (WHA74) was again held virtually amidst this historic pandemic. The WHA created a member states working group on strengthening WHO preparedness for and response to health emergencies to make recommendations to next year’s …

Is It Time To Adopt A No-Fault Scheme To Compensate Injured Patients?, Elaine Gibson

Articles, Book Chapters, & Popular Press

The tort system is roundly indicted for its inadequacies in providing compensation in response to injury. More egregious is its response to injuries incurred due to negligence in the provision of healthcare services specifically. Despite numerous calls for reform, tort-based compensation has persisted as the norm to date. However, recent developments regarding physician malpractice lead to consideration of the possibility of a move to “no-fault” compensation for healthcare-related injuries. In this paper, I explore these developments, examine programs in various foreign jurisdictions which have adopted no-fault compensation for medical injury, and discuss the wisdom and feasibility of adopting an administratively-based …

Guidelines For Physician-Assisted Suicide, Raphael Cohen-Almagor

raphael cohen-almagor

This paper proposes a set of guidelines for physician-assisted suicide (PAS). This set of guidelines integrates pertinent guidelines that were adopted in Oregon, where physician-assisted suicide is legal, in the Netherlands and Belgium where euthanasia is legal, in Switzerland where assisted suicide is practiced, and in the Northern Territory of Australia, where physician-assisted suicide was legal for a short period of time.

Guidelines For Physician-Assisted Suicide, Raphael Cohen-Almagor

raphael cohen-almagor

This paper proposes a set of guidelines for physician-assisted suicide (PAS). This set of guidelines integrates pertinent guidelines that were adopted in Oregon, where physician-assisted suicide is legal, in the Netherlands and Belgium where euthanasia is legal, in Switzerland where assisted suicide is practiced, and in the Northern Territory of Australia, where physician-assisted suicide was legal for a short period of time.

Co-Occurring Substance Use Disorder And Mental Illness In Criminal Offenders, Jayme M. Reisler

Jayme M Reisler

The high rate of comorbid substance use disorder and other mental illness (“dual diagnosis”) poses an enormous obstacle to public policy and sentencing in criminal cases. It is estimated that almost half of all Federal, State, and jail inmates suffer from dual diagnosis – a significantly higher prevalence than in the general population. Yet such inmates lack access to proper and effective treatments for their conditions. Several etiological theories have been put forth to explain the occurrence of dual diagnosis in general. However, virtually no studies have explored possible etiological reasons for the higher prevalence of dual diagnosis specifically in …

Addressing Prescription Opioid Abuse Concerns In Context: Synchronizing Policy Solutions To Multiple Public Health Problems, Kelly Dineen

Kelly Dineen

No abstract provided.

Probiotics: Achieving A Better Regulatory Fit, Diane E. Hoffmann, Claire M. Fraser, Francis Palumbo, Jacques Ravel, Virginia Rowthorn, Jack Schwartz

Diane Hoffmann

In 2007, the National Institutes of Health (NIH) launched the Human Microbiome Project (HMP), a $150 million initiative to characterize the microbial communities found at several different sites on the human body and to analyze the role of these microbes in human health and disease. Many lines of research have demonstrated the significant role of the microbiota in human physiology. The microbiota is involved, for example, in the healthy development of the immune system, prevention of infection from pathogenic or opportunistic microbes, and maintenance of intestinal barrier function. The HMP findings are helping us understand the role and variation of …

Compelling Product Sellers To Transmit Government Public Health Messages, Stephen D. Sugarman

Stephen D Sugarman

No abstract provided.

Are Changes To The Common Rule Necessary To Address Evolving Areas Of Research? A Case Study Focusing On The Human Microbiome Project, Diane Hoffmann, J. Fortenberry, Jacques Ravel

Diane Hoffmann

This article examines ways in which research conducted under the Human Microbiome Project, an effort to establish a “reference catalogue” of the micro-organisms present in the human body and determine how changes in those micro-organisms affect health and disease, raise challenging issues for regulation of human subject research. The article focuses on issues related to subject selection and recruitment, group stigma, and informational risks, and explores whether: (1) the Common Rule or proposed changes to the Rule adequately address these issues and (2) the Common Rule is the most appropriate vehicle to provide regulatory oversight and guidance on these topics.

Moral Gridlock: Conceptual Barriers To No-Fault Compensation For Injured Research Subjects, Leslie Henry

Leslie Meltzer Henry

The federal regulations that govern biomedical research, most notably those enshrined in the Common Rule, express a protectionist ethos aimed at safeguarding subjects of human experimentation from the potential harms of research participation. In at least one critical way, however, the regulations have always fallen short of this promise: if a subject suffers a research-related injury, then neither the investigator nor the sponsor has any legal obligation under the regulations to care for or compensate the subject. Because very few subjects with research-related injuries can meet the financial or evidentiary requirements associated with a successful legal claim to recover the …

Revising The Common Rule: Prospects And Challenges, Leslie Henry

Leslie Meltzer Henry

The annual Bioethics and Law Roundtable, jointly sponsored by the Law & Health Care Program at the University of Maryland Francis King Carey School of Law and the Johns Hopkins Berman Institute of Bioethics, convened in April 2012 to address "Human Subjects Research Regulations: Proposals for Reform." This paper serves as the introduction to the seven papers presented at the symposium that discuss the prospects and challenges of revising the Common Rule.

Respecting, Rather Than Reacting To, Race In Biomedical Research: A Response To Professors Caulfield And Mwaria, Michael J. Malinowski

Michael J. Malinowski

This Commentary is part of a colloquy on race-based genetics research.

A Discourse On The Public Nature Of Research In Contemporary Life Science: A Law-Policy Proposal To Promote The Public Nature Of Science In An Era Of Academia-Industry Integration, Michael J. Malinowski

Michael J. Malinowski

This article addresses the impact of integration of academia, industry, and government on the public nature of research. The article concludes that, while the integration has benefited science immensely, regulatory measures should be taken to restore the public nature of research in an age of integration.

United States Regulation Of Stem Cell Research: Recasting Government's Role And Questions To Be Resolved, Owen C. B. Hughes, Alan L. Jakimo, Michael J. Malinowski

Michael J. Malinowski

This article directly addresses the stem cell controversy, but also the broader history and norms regarding the roles of federal and state government in U.S. science research funding.

Could You Repeat That Please? Forty-Five Years Of Testing Pesticides On People, Barbara R. Leiterman Esq.

Barbara R. Leiterman Esq.

Little has been published in the literature about pesticide experiments conducted on human subjects. Yet there were at least twenty-two tests between 1967 and 2011 in which people were intentionally exposed to specific doses of pesticides. Almost all of these experiments violated scientific ethics and human rights. This article aims to describe those tests and their shortcomings, and explore the laws and regulations that incentivize such human experimentation. Ironically, as the public desire for pesticide safety increases, so does the industry’s motivation to test pesticides on people. Bringing these pesticide experiments to light, expanding the public discourse on the subject …

Legal Barriers To Implementing International Providers Into Medical Provider Networks For Workers' Compensation, Richard Krasner

Richard Krasner

Over the last twenty years, medical costs associated with lost time workers’ compensation claims has risen dramatically, despite efforts to reform the system. Medical tourism, a popular option for many seeking lower cost health care, is one option that has yet to catch on. Issues of quality of health care in other countries is no different for workers’ compensation patients, as it is for health care patients, and with accreditation from the Joint Commission International (JCI), hospitals that cater to medical tourists offer better care at lower cost than most U.S. hospitals offer. Certain procedures, common to workers’ compensation claims, …

Individual Mandate Is Constitutional, Leslie Henry, Maxwell Stearns

Maxwell L. Stearns

Supreme Court should find that key aspect of Obama's signature law is a legitimate exercise of Commerce Clause power.

Individual Mandate Is Constitutional, Leslie Henry, Maxwell Stearns

Leslie Meltzer Henry

Supreme Court should find that key aspect of Obama's signature law is a legitimate exercise of Commerce Clause power.

The Paradox In Madness: Vulnerability Confronts The Law, Marie Failinger

Marie A. Failinger

Using personal narrative, this article engages the durable power of attorney and the abuses that can occur when the maker of a power is mentally ill. It proposes some basic safeguards necessary to protect the dignity and autonomy of the maker.

The National Residency Exchange: A Proposal To Restore Primary Care In An Age Of Microspecialization, Glen Cheng

Glen Cheng

Healthcare deficiencies in the United States have long been perpetuated by a shortage of primary care providers. A core purpose of the Patient Protection and Affordable Care Act (PPACA) is to provide health insurance for America’s approximately fifty million uninsured. Implementation of universal health insurance, however, does not mean sufficient healthcare access for all, since the supply of physicians does not and will not meet demand. For reasons reviewed in this Article, the current physician shortage mainly impacts primary care providers. This shortage is particularly troubling because increased provision of primary care relative to specialty care has been associated with …

Consent Requirements For Pelvic Examinations Performed For Training Purposes, Elaine Gibson, Jocelyn Downie

Articles, Book Chapters, & Popular Press

In 2010, The Society of Obstetricians and Gynaecologists of Canada (SOGC) and The Association of Professors of Obstetrics and Gynaecology of Canada (APOG) released an updated policy statement regarding pelvic examinations performed on women under anesthesia. The updated statement, unlike the previous 2006 guideline that applied to “medical trainees” (explicitly including students and residents), for the most part only applies to “medical students”. Pelvic examinations conducted for training purposes presumably constitute a battery in law, subject to the defence of consent. Residents need to be covered by an SOGC and APOG policy statement regarding pelvic examinations for training purposes with …

The New First Amendment And Its Implications For Combating Obesity Through Regulation Of Advertising, Tamara R. Piety, Samantha Graff

Tamara R. Piety

This chapter reviews the recent decisions of the Supreme Court as they bear on attempts to combat childhood obesity through regulating marketing and concludes that attempts to regulate marketing will face substantial First Amendment obstacles in the courts.

Physicians Who Break The Law, Diane E. Hoffmann

Diane Hoffmann

This paper takes as its starting point a recent article by Prof. Sandra Johnson, Regulating Physician Behavior: Taking Doctors “Bad Law” Claims Seriously. In the article, Johnson focuses on doctors who comply with the law despite their belief that the law is “bad”, i.e., causes them to behave in ways that are harmful to their patients. In Physicians Who Break the Law, I explore cases where physicians break the law claiming that it is “bad”. In this exploration, I focus on two areas of physicians’ lawbreaking: (1) violations of business-related laws, in particular, insurance fraud; and (2) violations of laws …

Who Decides Whether A Patient Lives Or Dies?, Diane E. Hoffmann, Jack Schwartz

Diane Hoffmann

No abstract provided.

The Girl Who Cried Pain: A Bias Against Women In The Treatment Of Pain, Diane E. Hoffmann, Anita J. Tarzian

Diane Hoffmann

In general, women report more severe levels of pain, more frequent incidences of pain, and pain of longer duration than men, but are nonetheless treated for pain less aggressively. The authors investigate this paradox from two perspectives: Do men and women in fact experience pain differently - whether biologically, cognitively, and/or emotionally? And regardless of the answer, what accounts for the differences in the pain treatment they receive, and what can we do to correct this situation?

Testing Children For Genetic Predispositions: Is It In Their Best Interest?, Diane E. Hoffmann, Eric A. Wulfsberg

Diane Hoffmann

No abstract provided.

Fear Of Facebook: Private Ordering Of Social Media Risks Incurred By Healthcare Providers, Nicolas P. Terry

Nicolas P Terry

The last two years have seen important quantitative and qualitative shifts in social media use patterns in the healthcare environment. Reacting to present and future risks there has been a rapid deployment of private ordering: social media policies and other contractual constructs emanating from physicians, professional organizations, employers and educators. These private, often contractual attempts to regulate online interactions or social media conduct are not all benign, themselves creating ethical or legal risk. This article, a follow-up to Physicians And Patients Who ‘Friend’ Or ‘Tweet’: Constructing A Legal Framework For Social Networking In A Highly Regulated Domain, 43 IND. L. …

The Joint Action And Learning Initiative: Towards A Global Agreement On National And Global Responsibilities For Health, Lawrence O. Gostin, Eric A. Friedman, Gorik Ooms, Thomas Gebauer, Narendra Gupta, Devi Sridhar, Wang Chenguang, John-Arne Røttingen, David Sanders

O'Neill Institute Papers

A coalition of civil society organizations and academics is initiating a Joint Action and Learning Initiative on National and Global Responsibilities for Health (JALI) to research key conceptual questions involving health rights and responsibilities, with the goal of securing a global health agreement andsupporting civil society and community mobilization around the human right to health. The social mobilization is critical to creating the political space that would make such an agreement possible and to ensuring its implementation.

This agreement, such as a Framework Convention on Global Health, would inform post-Millennium Development Goal global health commitments, be grounded in the right …

Flag On The Play: The Ninth Circuit’S End-Run Around Implied Rights Of Action Runs Afoul In County Of Santa Clara V. Astra, Usa Inc., Brooke Burns

Brooke Burns

In County of Santa Clara v. Astra, USA Inc., the Ninth Circuit held that a third party was entitled to bring a private right of action for breach of contract under federal common law, even though the governing statute neither expressly nor impliedly provides for this right. Because the Supreme Court has increasingly limited the ability of a third party to bring an implied right of action claim, private parties have pursued third party beneficiary claims instead. As a result, a considerable circuit split has resulted as to whether federal common law provides a private right of action to a …

Don’T Split The Baby: How The U.S. Could Avoid Uncertainty And Unnecessary Litigation And Promote Equality By Emulating The British Surrogacy Law Regime, Austin R. Caster

Austin R Caster

This article will show that the United States can protect the rights of the intended parents, the surrogate, and the child while avoiding uncertainty and unnecessary litigation by enacting uniform legislation akin to the United Kingdom’s regime. The first section will examine the history of surrogacy law in the United States, demonstrate the inconsistency of these laws, and suggest that reform is needed. Section two will discuss the United Kingdom’s legislative response to the problem of surrogacy arrangements, which has provided more uniformity despite obstacles similar to those faced in the United States. The third section will illustrate that the …