Professor Carl Coleman, JD Academic Director of Division of Online Learning Seton Hall Law School

Seton Hall Law Expert Comments on Global and US impact of COVID-19

MedicalResearch.com Interview with:

Professor Carl Coleman, JD Academic Director of Division of Online Learning Seton Hall Law School

Prof. Coleman

Professor Carl Coleman, JD
Professor of Law
Seton Hall Law School

MedicalResearch.com: Do health care workers have an ethical and/or legal obligation to provide treatment during an infectious disease outbreak? Are there exceptions such as pregnancy, if the health care worker is her/himself immunocompromised or have young children at home?

Response: As a legal matter, health care workers can generally be required to fulfill pre-existing employment or contractual obligations during an infectious disease outbreak. For example, an emergency room nurse who refuses to come to work during a pandemic can be disciplined or fired; a physician who breaches a contractual obligation to provide on-call services during an outbreak can be held liable for damages. In addition to loss of employment and contractual damages, other potential consequences for failing to honor pre-existing commitments during a pandemic could include professional discipline for patient abandonment and, for physicians with on-call responsibilities in hospital emergency departments, civil fines under the federal Emergency Medical Treatment and Active Labor Act.

This does not mean that health care workers are obligated to show up for work during a pandemic regardless of the circumstances. For example, under the Americans with Disabilities Act, health care workers who are immunocompromised can ask for a “reasonable accommodation,” such as the right to work remotely (if possible) or to take leave. Under the Family and Medical Leave Act, employers with more than 50 employees must give workers up to 12 weeks of unpaid time off to care for a seriously ill immediate family member. In addition, federal labor laws allow employees to refuse to work under “abnormally dangerous conditions,” which might apply in situations where an employer fails to provide necessary protective equipment. However, assuming protective equipment is available, it is not clear that an outbreak itself would be considered “abnormally dangerous,” particularly in fields like emergency medicine, where exposure to contagious disease is always a foreseeable risk.

In most states, health care workers without pre-existing employment or contractual obligations cannot be compelled to treat patients during a pandemic. However, a few states have laws that authorize public health authorities to require health care professionals to work during public health emergencies. I am not aware of any state that has invoked this authority so far.

As for ethical obligations, in 2004, the American Medical Association (AMA) declared that “individual physicians have an obligation to provide urgent medical care during disasters,” and that “this ethical obligation holds even in the face of greater than usual risks to their own safety, health or life.” Some academic ethicists have expressed similar views. Common justifications for this position are that physicians “assumed the risk” of exposure to infectious diseases when they voluntarily committed themselves to the healing professions; that a “social contract” requires physicians to assume risks in exchange for their social status and privileges; and that individuals who are uniquely capable of providing life-saving care have an obligation to do so.

However, I am not persuaded that all physicians — let alone health care workers more generally — have an ethical obligation to provide treatment when doing so involves significant risk. A willingness to accept risk is not a condition of obtaining a medical license, nor is it part of the oaths that students commonly take at medical school graduation. While I agree that physicians have ethical obligations to contribute to society, there are many ways they can fulfill these obligations without assuming personal health risks. And even assuming that individuals who are in a unique position to provide life-saving care should normally do so, we generally do not expect people to rescue others from danger at significant risk to themselves.

MedicalResearch.com: What duties are owed to health care workers who assume personal risk by caring for infected patients? How should limited PPE be distributed?

Response: Rather than debating whether health care workers are subject to special ethical obligation, it would be more productive to focus our energies on making sure that health care workers who choose to provide service during a pandemic — and there are many — are adequately protected. At a minimum, this includes ensuring an adequate supply of personal protective equipment. If supplies are limited, priority should be given to those who face the greatest risk of becoming infected. In addition, health care workers who become sick should be guaranteed financial support for themselves and their families. Health care workers also should have some priority in obtaining access to limited medical resources, including ventilators and, when they become available, vaccines and antiviral medications.

MedicalResearch.com: What ethical issues arise when testing unproven medical interventions during an infectious disease outbreak? Should pharmaceutical or medical device companies receive some form of liability relief for rapid innovation?

Response: We have already seen a rush to embrace unproven treatments for COVID-19 before obtaining sufficient evidence of their safety and efficacy. Some people think that there is nothing to lose by trying new treatments for a potentially fatal disease. However, it is important to remember that medical interventions can cause significant harms. Even medications that are generally safe when used for other conditions cannot be assumed to be safe when applied to a novel disease. Moreover, unless unproven interventions are rigorously tested in clinical trials, there is no way to know whether any improvements seen in patients are actually being caused by the intervention. Clinical trials are also needed to determine the appropriate dosing and duration of treatment, as well as to compare the safety and efficacy of different treatments in different patient populations.

For these reasons, unproven interventions should be subject to rigorous testing before they are disseminated broadly. While there are mechanisms for patients to obtain access to investigational drugs outside of clinical trials, pharmaceutical companies should ensure that the use of these mechanisms does not interfere with the ability to enroll sufficient numbers of patients in clinical trials to generate reliable evidence of safety and efficacy. Similarly, before prescribing existing (approved) drugs to COVID-19 patients on an “off label” basis, physicians should take the time to educate patients about why they might want to consider participating in a clinical trial instead.

As in all medical research, individuals who enroll in studies of unproven COVID-19 treatments should be given complete and understandable information about the potential benefits and risks. Studies should be designed so that they will produce scientifically reliable information; in most cases, this means that patients who receive the experimental intervention should be compared to a control group that receives standard care or another experimental treatment. Studies should be stopped as soon as there is sufficient evidence to confirm or disprove the intervention’s safety and efficacy, and, following the study’s completion, research data should be rapidly shared with the scientific community so that others can benefit.

On March 17, 2020, the Secretary of the Department of Health and Human Services issued a declaration pursuant to the Public Readiness and Emergency Preparedness (PREP) Act, providing legal immunity to manufacturers, distributors, suppliers, and administrators of qualified products and processes used to fight COVID-19. One of the purposes of this declaration was to provide liability protection to pharmaceutical companies that develop vaccines and treatments for COVID-19.

MedicalResearch.com: Under what circumstances can governments legitimately restrict individuals’ freedom of movement in order to control an infectious disease outbreak?

Response: The rights to freedom of movement and assembly are both fundamental, but governments can limit these rights when doing so is necessary to achieve an important public health goal. Any limitations on fundamental rights must satisfy several conditions, including the following:

  • There must be a justifiable basis for imposing the restrictions; that is, the threat must be significant, and there must be a reasonable basis for believing that restrictions on freedom of movement or assembly will be effective in countering it.
  • Any limitations on freedom of movement or assembly must be the least restrictive means available for achieving the public health goal. For example, individuals should not be isolated in institutional settings if they can be safely isolated at home.
  • Individuals should not be required to isolate themselves in unsafe conditions. For example, mechanisms should be provided for persons who cannot leave their homes to obtain access to basic necessities. No one who is asked to isolate themselves at home should have to worry about their heat being turned off.
  • Restrictions on freedom of movement and assembly should be applied in a non-discriminatory manner. Individuals who believe that their freedom has been restricted should have the ability to challenge those restrictions without unreasonable delay.
  • Governments should be transparent about the reasons they are imposing restrictions on freedom of movement and assembly and the expected duration of those restrictions. Individuals should have easy access to avenues for obtaining answers to questions and for communicating any concerns to authorities.

I have no conflicts to disclose.

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May 12, 2020 @ 1:57 am

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