LOMBARDIA, ITALY - FEBRUARY 26, 2020: Empty hospital field tent for the first AID, a mobile medical unit of red cross for patient with Corona Virus. Camp room for people infected with an epidemic.

Pandemic Guidelines, Not Changed Malpractice Rules, Are the Right Response to COVID-19

By Valerie Gutmann Koch, Govind Persad, and Wendy Netter Epstein

On March 17, the Washington Post published an op-ed by Dr. Jeremy Faust, titled Make This Simple Change to Free Up Hospital Beds Now. In it, he argues that cities and states should “temporarily relax the legal standard of medical malpractice,” in order to encourage hospitals to admit, and physicians to treat, the patients who need help during the COVID-19 pandemic.

In a tweet promoting the piece, Dr. Faust expresses concern that in the absence of such a legal change, “docs will keep doing ‘usual’ low yield admissions.”

And on March 23, the Governor of New York issued an executive order suspending state law to make all health care providers “immune from civil liability for any injury or death alleged to have been sustained directly as a result of an act or omission by such medical professional in the course of providing medical services in support of the State’s response to the COVID-19 outbreak, unless it is established that such injury or death was caused by the gross negligence of such medical professional.”

We agree with Dr. Faust that cities and states should work to alleviate doctors’ uncertainty about malpractice liability when providing appropriate medical care to patients during the COVID-19 pandemic.

But they should do that not by redefining malpractice, like New York State did this week, but by activating and publicizing pandemic response plans, like New York State’s 2015 Ventilator Allocation Guidelines, which authorize the prioritization of patients for scarce resources based on their capacity to benefit from treatment.

Because these protocols depart significantly from standard non-emergency medical practice, states should formalize these plans, thereby providing some degree of legal protection — perhaps immunity — for following them. Such an approach provides clearer guidance than vaguely “relaxing” the definition of medical malpractice.

Importantly, many legal experts agree that the common law legal standard of care is adaptable to changing circumstances, and therefore would adjust to the necessities of medical care in a pandemic. No proposal, including ours and Dr. Faust’s, can prevent patients from filing lawsuits.

But in public health emergencies, hospitals and physicians are ethically obligated, as the AMA recognizes, to prioritize patients who can most benefit.

Empirical research suggests doubt about the efficacy of changed malpractice definitions in affecting physician behavior.

In contrast, activating and disseminating pandemic guidelines, combined with legal protections, may effectively offer hospitals and physicians peace of mind in treating COVID-19 patients (and others) while protecting patients from substandard care. Recommendations like ours may eliminate concerns about physician and institutional reluctance to follow triage protocols and pandemic preparedness plans that could save the most lives.

 

Photograph of a doctor in blue scrubs overlaid with an illustration of a padlock

Anonymity in the Time of a Pandemic: Privacy vs. Transparency

By Cansu Canca

As coronavirus cases increase worldwide, institutions keep their communities informed with frequent updates—but only up to a point. They share minimal information such as number of cases, but omit the names of individuals and identifying information.

Many institutions are legally obligated to protect individual privacy, but is this prohibition of transparency ethically justified?

Some even go a step further and ask you, an individual in a community, to choose privacy over transparency as well. Harvard—alongside with  Yale, Chicago, and Northwestern—requests you to “Please Respect Individuals’ Privacy. Anonymity for these individuals remains paramount. Please respect their privacy—even if you believe you know who they are—so they can focus completely on their health” (emphasis in original).

But do you have an ethical obligation to do so at the time of a pandemic?

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The Week in Health Law podcast logo twihl.com

New TWIHL with Françoise Baylis

I welcome Dr. Françoise Baylis, University Research Professor at the NTE Impact Ethics interdisciplinary research team based at the Faculty of Medicine, Dalhousie University in Halifax Canada. She is a member of the Order of Canada and the Order of Nova Scotia, as well as a Fellow of the Royal Society of Canada and a Fellow of the Canadian Academy of Health Sciences. In 2017 she was awarded the Canadian Bioethics Society Lifetime Achievement Award. She is a distinguished researcher and prolific scholar with 200 or so books, refereed publications and chapters to her name. Her latest book published by Harvard University Press is Altered Inheritance: CRISPR and the Ethics of Human Genome Editing. At the time of recording we knew the book had been nominated for an Association of American Publishers Professional and Scholarly Excellence (or PROSE) award, which it subsequently won!

The Week in Health Law Podcast from Nicolas Terry is a commuting-length discussion about some of the more thorny issues in health law and policy. Subscribe at Apple Podcasts or Google Play, listen at Stitcher Radio, SpotifyTunein or Podbean.

Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find me on Twitter @nicolasterry or @WeekInHealthLaw.

corridor with hospital beds

3 Human Rights Imperatives for Rationing Care in the Time of Coronavirus

By Alicia Ely Yamin and Ole F. Norheim

Scholarly and official statements and publications regarding human rights during the current pandemic have largely reiterated the important lessons learned from HIV/AIDS, Zika and Ebola, such as: engagement with affected communities; combatting stigma and discrimination; ensuring access for the most vulnerable; accounting for gendered effects; and limiting rights restrictions in the name of public health.

But there is a notable silence as to one of the most critical decisions that almost every society will face during the COVID-19 pandemic: rationing scarce health care resources and access to care.

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Call for Submissions: Journal of Law and Biosciences, “Law and Ethics in the Time of a Global Pandemic”

The Journal of Law and the Biosciences (JLB) is soliciting essays, commentaries, or short articles for a special issue on “Law and Ethics in the Time of a Global Pandemic.” For this issue we especially encourage shorter pieces, of roughly 1500 to 5000 words. If any particular aspect of how this pandemic will affect some part of the law—from lease terms to courtroom procedures to constitutional questions about mandatory testing—intrigues you, write it up and send it in.

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pill bottle - buprenorphine / naloxone

Protecting the Vulnerable Substance Use Disorder Population During COVID-19

By Brandon George and Nicolas P. Terry

Introduction

Earlier this month, Dr. Nora Volkow, director of the National Institute on Drug Abuse identified those with substance use disorder (SUD) as a particularly vulnerable population during the COVID-19 pandemic. She highlighted the negative effects of opioid or methamphetamine use on respiratory and pulmonary health in addition to the disproportionate number of those with SUD who are homeless or incarcerated.

We detail the additional challenges faced by the SUD population and, specifically, the opioid use disorder (OUD) sub-group at this time, identify positive ameliorative steps taken by federal, state, and local governments, and recommend additional steps.

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hospital equipment, including heart rate monitor and oxygen monitor functioning at bedside.

The Ethical Allocation of Scarce Resources in the US During the COVID-19 Pandemic: The Role of Bioethics

By Beatrice Brown

Critical resources for handling the COVID-19 pandemic, including ventilators and ICU beds, are quickly becoming scarce in the US as the number and density of infections continue to rise. Leading bioethicists have crafted guidelines for the ethical rationing of these scarce resources during the pandemic. On March 16, The Hastings Center published “Ethical Framework for Health Care Institutions and Guidelines for Institutional Ethics Services Responding to the Novel Coronavirus Pandemic,” detailing three ethical duties for health care leaders: 1) duty to plan; 2) duty to safeguard; and 3) duty to guide. The report also contains a compilation of materials on resource and ventilator allocation.

More recently, on March 23, two insightful pieces were published in the New England Journal of Medicine: “The Toughest Triage — Allocating Ventilators in a Pandemic” by Truog, Mitchell, and Daley, and “Fair Allocation of Scarce Medical Resources in the Time of Covid-19” by Emanuel et al. These two pieces complement each other well and lay a crucial foundation for the inevitable resource allocation that clinicians and hospitals will be forced to practice in the coming weeks. As such, here, I summarize the central takeaways from these two articles while understanding their recommendations in tandem, as well as reflect on the importance of bioethics during these times of medical crisis and how the work of this field must adapt to changing circumstances. Read More

Stacks of books against a burgundy wall

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariCharlie LeeFrazer Tessema, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School.

Below are the abstracts/summaries for papers identified from the month of February. The selections feature topics ranging from the compliance of manufacturers with clinical trial reporting requirements, to estimation of possible savings that could be attained for diabetics purchasing insulin, to documentation of how frequently pharmaceutical industry-sponsored charity patient assistance programs cover off-label uses of a drug. A full posting of abstracts/summaries of these articles may be found on our website.

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Hand signs a contract

Meeting the Challenges of Advance Care Planning for Advanced Dementia – A Social Justice Imperative.

By Dr. Stanley Terman

It is not easy to die of advanced dementia. Yet almost everyone has this goal: a dying that is private, peaceful, and timely.

Dementia patients cannot qualify for Medical Aid in Dying (Physician-Assisted Suicide). Usually, their only legal, peaceful option is to stop ingesting food and fluid. Yet some authorities strongly oppose this way of dying. Knowing that traditional advance directives are not effective, and learning that authorities may oppose newer “dementia-specific” directives/living wills, many patients harbor the “Dementia Fear.” They have reason to worry that others will force them to endure prolonged dying, possibly with increased suffering, perhaps for years.

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a covid 19 swab test being inserted into a vile

Protecting our Most Vulnerable Populations in the COVID-19 Pandemic

By Sharona Hoffman

A recent news story focused attention on the plight of the elderly during the COVID-19 crisis.  A young woman named Rebecca Mehra heard someone calling her from a car in a grocery store parking lot.  When she approached, an elderly couple told Rebecca that they were afraid to enter the store.   Because they were in their eighties, they were very anxious about exposure to the novel coronavirus.  Rebecca won much praise for doing the couple’s shopping for them.

The elderly are not the only people with special needs during a public health emergency.  Additional vulnerable groups include individuals with disabilities, prisoners, people with language barriers, the impoverished, and others.  Years ago, I spent a sabbatical semester at the Centers for Disease Control and Prevention’s (CDC) Public Health Law Program.  We worried a lot about vulnerable populations in public health emergencies, and I wrote a long article on the topic.  It is critical to plan for the needs of all vulnerable populations while preparing emergency response strategies.

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