A Different Kind of Immunity
As a physician, when I think about immunity during a pandemic, I generally think of herd immunity – that moment when enough of us have been infected that a virus has no one else to infect. After wreaking its devastation and lacking a hospitable host, it peters out.
But as a bioethicist during the COVID-19 pandemic, I have thought about a different kind of immunity – the legal kind – that might protect clinicians when they deviate from normal practice once crisis standards of care have been declared. One only needs to recall the prosecutions of physicians who did their earnest best caring for ventilated patients during the impossible circumstances of Hurricane Katrina to appreciate that the threat is real. While their actions were complicated, their heroism was forgotten by opportunistic prosecutors who were somehow amnestic about the context of care during a Category Five hurricane that left devastation and power outages in its wake.
Working as a bioethicist at the epicenter of the COVID-19 storm, I worried about civil and criminal liability as the system was overwhelmed by surges of patients. Although the official line from the state was that there were enough ventilators to go around, the reality was that the system buckled. While there may have been enough machines in theory, they were not always accessible to patients in need. And beyond machines, there were additional challenges due to a lack of adequate staff to intubate patients and to monitor them. The pain for patients and staff was palpable, and colleagues turned to me as a bioethicist for guidance about how they might allocate scarce resources, like ventilators and ICU beds.
While I might have been able to provide an ethical analysis to address the utilitarian challenges posed by the emergent conditions of the pandemic, in good conscience I did not want to provide advice that might put my colleagues in legal jeopardy. They were already risking their lives practicing in extreme conditions without adequate personal protective equipment (PPE). It would have been an ethical breach to ask them to practice outside the law and also place their liberty at risk. Any guidance I might have provided was constrained by the limits imposed by prevailing New York law.
Two incommensurate objectives were in tension at the outset of the pandemic: How to maintain usual standards of care versus providing the best possible care during the scarcity posed by the pandemic. One could not achieve both objectives at the same time even though it was clear that once the surge began it would be impossible to practice the high standard of care which patients expected and to which we were accustomed.
As I pondered my responsibilities to my colleagues and our collective obligation to save as many lives as possible, there was a gnawing feeling in my gut that much of this could have been prevented if science and not politics had dictated policy. Although our crisis was caused by an emerging pathogen, perhaps the greater pathology was human nature. From the outset of the pandemic, the crisis was made worse by a series of abdications and a lack of moral courage.
First, there was the suppression of the brave Chinese ophthalmologist Dr. Li Wenliang who sounded the alarm about the virus only to be arrested by his country’s authoritarian regime and left to die from the disease he sought to warn the rest of us about. Then there was the dismantling of the Pandemic Desk at the National Security Council during the dawning days of the Trump Administration because it had been created by a reviled predecessor. The hollowing out of the Center for Disease Control and Prevention’s international monitoring abilities including efforts in China deprived us of a critical early warning system. One could only think that its surveillance of events in Wuhan would have provided credible intelligence and more time to prepare for COVID-19’s arrival on our shores. Finally, there was the denial and delay by the federal government, minimizing the severity of the threat and scapegoating the impeachment proceedings for the distraction. Whatever one’s political position, there is no denying that the White House’s posturing left the nation ill-prepared for what hit New York City in March. Nothing can restore precious time lost for testing and putting ventilators in place to prepare for the surge.
And the responsibility is also local. In 2015 the New York State Task Force on Life and the Law, on which I serve but do not represent here, wrote guidelines on the allocation of ventilators in the wake of the 2005 avian flu scare and the novel H1N1 pandemic in 2009. These guidelines, which I endorsed, use physiologic measures to triage ventilators in case of scarcity. The idea is to maximize survival for the greatest number utilizing sequential organ failure assessment (SOFA), an objective physiologically-based metric that seeks to achieve a fair distribution of resources without regard to other social determinants like age, race or disability.
Ventilator allocation would follow a declaration of crisis standards of care once a public health emergency is declared as defined by the 2012 Institute of Medicine Report. When ventilators were scarce, patients would be triaged into four color-coded categories based on their SOFA scores: blue, green, red, and yellow. Patients with high SOFA scores would be designated as blue and not likely to survive the acute infection despite maximal efforts. Red patients are most likely to survive if they receive a ventilator. Yellow is an intermediate class between red and blue. Green are those who are sick but do not need a ventilator.
The schema is not perfect, and it evolved over the years during which the task force adopted a more enlightened view of the needs and vulnerabilities of persons with disabilities. But even though we made progress, the report side-stepped two critical questions. First, when do these guidelines become operative? Specifically, how would we know as a society – and as clinicians entrusted to serve our community – that we were moving from an autonomy-based ethic towards utilitarianism? That is, how would we know when the goal was the greatest good for the greatest number, or more specifically when would we know that crisis standards of care had become operative?9 The second issue not addressed was legal immunity for clinicians whose practices cohered with an adopted crisis standard of care.
In our report, the Task Force on Life and the Law recommended that criteria for a declaration of a public health emergency and associated immunity be subject to legislation. The prosecution of desperate doctors during Katrina was fresh in mind and it seemed essential to address these concerns to protect clinicians and ensure compliance with whatever triage protocols might be promulgated. But our recommendations were dead on arrival. Both these issues were kicked down the road because they were politically toxic.
And then the pandemic arrived and we were clinically and epidemiologically unprepared. That lack of preparation led to the surge that brought to the fore the need to address legal contingencies in advance of a public health emergency.
Despite public declarations to the contrary, there was scarcity and resorting to crisis standards of care in New York City during the COVID-19 surge. The Society of Critical Care Medicine defines “crisis capacity” as the use of adaptive spaces, staff, and supplies not consistent with usual standards of care in support of a “sufficiency” of care defined as “the best possible care given circumstances and resources.” Activation of these standards “constitutes a significant adjustment to standards of care.” History will show that there is absolutely no doubt usual standards of care became impossible during the crisis posed by the pandemic.
COVID-19 overwhelmed the usual resources of our hospitals. Because it caused Acute Respiratory Distress Syndrome prompting a need for mechanical ventilation, ICU care capacity was severely stressed. To respond to this dire need hospitals across the city increased their ICU capacity by more than 200-300%. An inadequate number of ventilators was met with remarkable innovation. Anesthesia machines were repurposed to ventilate patients and ventilators were modified to accommodate two patients at a time. Pop-up ICUs were built in converted operating rooms, hospital lobbies, and on regular medical floors never designed for such a purpose. Field hospitals were built on Baker Field in Central Park and the U.S. Navy ship Comfort came to our assistance, docked on the Hudson.,, Necessity is the mother of invention and New Yorkers benefited immensely from the advocacy of state and local government, the generative creativity of hospital administrators who built surge capacity, and valiant clinicians who answered the call.
Although the attention was on the shortage of equipment and the built environment, the greater stressor was the lack of adequately trained personnel able to manage critically ill patients. There were simply not enough intensivists to provide care and skilled anesthesiologists and others able to intubate patients who needed artificial ventilation. This meant that physicians who were not intensivists and hadn’t been in an ICU since medical school or residency were given charge of patients who were critically ill, often working beyond the limits of their training.
In his Executive Order of March 23, Governor Andrew Cuomo mitigated some of these concerns by allowing practitioners to practice outside their usual scope of practice and permitting practitioners licensed in other states to come to New York in mutual aid during the public health emergency. This also allowed medical students to graduate early (as they did during World Wars I and II) to add to the workforce.
While helpful in increasing the available workforce, this executive order did not address the critical concern about remaining legal liability. Even if practitioners had permission to practice outside their scope of practice and do so in highly unconventional settings, would this permission also afford them protection from civil and criminal liability? With intense lobbying from medical groups and the health bar,, the governor inserted the Emergency or Disaster Treatment Protection Act (EDTPA) of 2020 into the state budget, which was signed into law on April 3.
The EDTPA extended limited civil and criminal liability in the context of the public health emergency retroactive to March 7, 2020. Its purpose is to “promote the public health, safety and welfare of all citizens by broadly protecting the health care facilities and health care professionals from liability that may result from treatment of individuals with COVID-19 under conditions resulting from circumstances associated with the public health emergency.” More specifically, the act stipulated that any health care facility or health care professional “shall have immunity from any liability, civil or criminal, for any harm or damages alleged to have been sustained as a result of an act or omission in the course of arranging care.”
This immunity was operative provided that care was given “pursuant to the COVID-19 emergency rule or otherwise in accordance with applicable law”; that care decisions or omissions were in response to the outbreak or in support of a state directive; and that health care services were being provided in good faith. Acts of “willful or intentional criminal misconduct, gross negligence, reckless misconduct, or intentional infliction of harm” were deemed to be outside the scope of immunity. Acts or omissions secondary to resource or staffing shortages, however, were not deemed outside of eligibility for immunity.
As helpful as these provisions were, they left a wave of ambiguity in their wake for the clinical community that we hoped the state Department of Health (DOH) would clarify with the promulgation of clear guidelines for decisions about resuscitation and triage decisions. For example, if during a crisis, a physician or institution were to make a decision about triage or the futility of resuscitation with the family objecting to a “do not resuscitate” (DNR) order, these decisions would be made without having clarity about an emergency rule or law. This could bring the immunity provision into question. Short of that, there is the additional concern that actions might not have been viewed as being done in “good faith.” This too could conceivably undermine the immunity provisions. These were concerns that DOH guidelines could have ameliorated with clear guidance.
Even more critically, without consistent guidelines, there was a worry that different institutions would adopt their own policies leading to regional variation and possibly hospital shopping by worried patients and families. In sum, this would lead to the differing treatment of similarly situated patients depending upon where they were hospitalized, resulting in worrisome practice variation.
There were intense discussions with DOH in late March and early April imploring them to issue guidance that would operationalize the task force guidelines in the context of the current pandemic. This included clear direction on exclusion criteria and ventilator allocation. Regrettably, no guidance was issued. Let us take these two critical issues in turn.
First, the question of resuscitation. At the peak of the surge, patients were overwhelming the city’s emergency departments. Many COVID-19 patients who were certain to die if they had a cardiac arrest were resuscitated because, absent a DNR order, that was still the prevailing norm. But in the context of the surge, resuscitation became highly problematic if we think about risks and benefits. The survivor data from Wuhan of patients who sustained a cardiac arrest was negligible. In contrast, the risk of health workers contracting COVID-19 is very real during a resuscitation, when chest compressions lead to aerosolization. This risk was compounded in the early days of the surge when PPE was in short supply. In the aggregate, this makes resuscitation disproportionate. DOH draft guidelines based on earlier task force work that were circulated would have excluded those patients who were likely to have died with or without resuscitation. The lack of guidance therefore led to ethical disproportionality: risk without associated benefit.
A second problem was one of scarce resources. Absent a pandemic policy to make a futility determination regarding resuscitation, scarce resources were consumed in futile resuscitations that might have been more effectively deployed for other patients who might survive. At the peak of the surge, multiple patients were potentially in need of intubation. Not all could be helped. Guidance on who might be excluded in a manner consistent with DOH guidance would have led to improved survival of patients who could have been saved. This would have certainly decreased the moral distress of clinicians who felt compelled to do everything for everyone when that was clearly an impossible (though valiant) aspiration.
A final point is one of practice variation. Without clear and consistent guidance from the DOH, entities, practitioners and institutions were left to determine how to proceed. For example, the Regional Emergency Medical Services Council (REMAC) of New York City instituted its own DNR policies and issued a directive on March 31, invoking Article 30 of the Public Health Law to withhold CPR in the field.
When this gained public attention in a tabloid, it was misreported as being a state directive when it had originated from REMAC, whose authority derives from a 1976 designation from the Commissioner of Health.
When the current commissioner was asked about this policy, he clarified that he had not sanctioned this practice and ordered it to be discontinued. 
Within the hospital sphere, there was variability in resuscitation policies with some hospitals adopting unilateral DNR orders during the COVID-19 emergency. Putting aside the ethical propriety of these actions, the regulatory concern was the creation of variable and perhaps idiosyncratic policies across the state. The lack of clearly articulated DOH guidance during the exigency of the surge led to this practice variation.
Turning to the question of triage and resource allocation. By both the IOM definition and that of the Society for Critical Care Medicine, New York City was unquestionably operating under crisis standards of care.1,9,11,12 From my vantage point, the state came close to articulating an allocation schema following up the SOFA methodology articulated in the 2015 Task Force Report but again, guidance was not provided.
Because of this void, hospitals went their own way preparing multiple drafts of their own guidelines following up on the last known stance of a DOH working group addressing these issues. Some set up call schedules for what the state had designated in its draft guidance, Hospital Clinical Review Teams (HCRT) that would review SOFA scores and other information in order to make triage decisions. A bioethicist from Lincoln Hospital in the resource-stressed Bronx, the borough with the highest incidence and mortality rates in the city, reported that decisions were made to unilaterally withhold and withdraw life-sustaining therapy. He reported on a national bioethics listserv – that “we have mostly stopped performing CPR (notwithstanding absence of a DNR order) in cases where there was no chance of survival even with CPR” and even more notably that decisions were also made to withdraw ventilatory support invoking guidance from the 2015 task force report, which did not have the force of law and was only an advisory document. The email was as follows:
I work at a city hospital in the South Bronx in one of the parts of town most impacted by covid. We came up to the brink 3 weeks ago with no available ventilators of any kind at which time we implemented step 1 exclusion criteria triage (NY State Ventilator Allocation Guideline, p. 57). Fortunately, the only patients withdrawn from ventilators that day (without advance directive or family permission) were those with true physiologic futility. Arguably, these withdrawals were acknowledgement of reality, not a true triage. A shipment of ventilators within hours removed the need to continue to step 2.30
A comprehensive historical analysis of this period will likely reveal additional heterogeneity of care, a situation that in my view is untenable from ethical and regulatory standpoints. Some in government have voiced concerns that triage policies could be potentially discriminatory against vulnerable groups, particularly people with disabilities. There is no doubt that they could be, and this is a grave concern.8,10, But I believe the greater threat is practice under pandemic-related stressors without clear guidance. Their absence could lead to the risk of idiosyncratic practices that could reflect unexamined biases. Indeed, immunity absent clear guidance could lead to even more abuse. So, guidance and immunity must be ligated to each other both conceptually and practically.
Finally, beyond the needs of patients and their families for a clearly articulated set of policies that save the most lives in a fair and transparent manner, are the needs of clinicians. They have been called heroes. Society has valued their contributions. Like Atlas, they have carried the weight of the world on their shoulders. But heroism is neither sustainable in a crisis nor a way forward because a disproportionate burden has been placed upon them. One of the most distressing burdens has been the ethical choices presented by resource scarcity amidst the onslaught of challenging cases during the surge. The clinical and emotional burden of clinical care was compounded by the lack of ethical and legal guidance from the State.
If society truly values what clinicians have done, their emotional and physical self-sacrifice, they should compel state leadership in the executive branch to clearly articulate guidance for care and voice on-going support for immunity so long as this crisis continues. One wise colleague of mine suggested that the duration of crisis standards of care might persist, in one form or another, until we have an effective vaccine. A failure to acknowledge these stressors upon clinicians will risk what has been described as a parallel pandemic, which would compromise clinician well-being.
Governor Cuomo has done a brilliant job in articulating the citizenry’s responsibility to each other and adherence to social isolation to mitigate the threat of contagion. He built a medical infrastructure and marshaled resources as he inspired New Yorkers. I imagine he hoped that he could avoid triage through this determined response. But now, as the storm has passed, he can do even more by asking DOH Commissioner Howard Zucker, the New York State Task Force on Life and the Law, and other stakeholders to operationalize guidelines for the challenging issues of resuscitation and triage of life-sustaining therapies. There is a normative obligation for the state to step in. This is what governments are for and it best we are better prepared.
If this pandemic has taught us anything, it is not a question of if but when we will need this guidance. We are not done with COVID-19 and it could easily return with a vengeance in the fall. We need to ready ourselves for this possibility and prepare for the difficult ethical choices we will face as a society. And we need to do so openly and with transparency. Supreme Court Justice Louis Brandeis famously said that “sunshine is the best disinfectant.” I would humbly add that this is doubly so during a pandemic.
Dr. Joseph J. Fins is the E. William Davis, Jr. M.D. professor of medical ethics and chief of the Division of Medical Ethics at Weill Cornell Medical College where he also serves as professor of medicine, professor of public health and professor of medicine in psychiatry. He is also an attending physician and the director of medical ethics at New York-Presbyterian Weill Cornell Medical Center and on the adjunct faculty of Rockefeller University, where he is a senior attending physician at The Rockefeller University Hospital. Dr. Fins acknowledges with gratitude the collaboration and insights of his colleagues in the Division of Medical Ethics at Weill Cornell Medical College and across New York Presbyterian Hospital during the course of the pandemic in New York City and the invitation of Mary Beth Morrissey, J.D., Ph.D. and Brendan Parent, J.D. to contribute to the journal of the Health Law Section of the New York State Bar Association. He also is grateful to Robert N. Swidler, J.D. for his comments. The views expressed herein are those of Dr. Fins and do not represent those of the New York State Task Force on Life and the Law or any other organization with which he may be affiliated.
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