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What is the “Standard of Care” in a Pandemic?: Medical Malpractice Defense in Response to a Public Health Emergency

By Megan B. Kelleher, Esquire

In this unprecedented COVID-19 pandemic, healthcare providers have been forced to walk a fine line between their longstanding and well-documented professional standards of care and a new time-sensitive crisis standard of care in the face of limited resources, new and unusual practice settings, and unfamiliar and ever-changing patient care needs.

In response to these new extreme circumstances, the Hastings Center has described the changing ethical framework during a pandemic as a shift from the normal “patient-centered practice” to “public-focused” care considerations “to promote equality of person and equity in distribution of risks and benefits in society.” A 2015 American Nurses Association Code of Ethics obligated professional nurses to “respect the dignity of every person in their care while also upholding the public good and collective human rights” during a public health emergency.

This underscores a stark contrast between our old normal and our new normal.  While our healthcare system has historically taken a patient-centered approach of providing the maximum care to each patient in order to ensure the best possible outcome for each individual, the COVID-19 pandemic has brought forth a new public health-centered approach: healthcare providers have been forced to change their practices and, in some situations, have had to prioritize the community above the individual patient in the face of limited resources.

While healthcare providers continue to owe a duty of care to their patients, healthcare providers have been given several new obstacles to juggle: lack of necessary equipment (personal protective equipment, ventilators, beds, etc.), ongoing lack of testing, ever-changing understanding of the signs and symptoms of COVID-19, lack of known treatments to meet patient needs, understaffing as colleagues themselves contract COVID-19 and/or call off, competing personal priorities such as care for children and elderly family members, alternative residential arrangements in order to avoid bringing COVID-19 home to their families, inability to get accurate medical history from family members due to isolation protocols, patients lacking updated living wills indicating their wishes regarding the use of ventilators and other life-sustaining treatments, etc.

On April 10, 2020, the Commonwealth of Pennsylvania issued a second version of its “Interim Pennsylvania Crisis Standards of Care for Pandemic Guidelines,” in cooperation with the Pennsylvania Department of Health and the Hospital Healthsystem Association of Pennsylvania.  The Special Note to this second version indicates that this is intended to be a “comprehensive document developed by a multi-tiered team over an 18-month period,” and “should be viewed as a ‘work in progress’ and will likely include language or content that may change in future versions.”  The first version, dated March 22, 2020, was specifically designed to “guide the allocation of patient care resources during an overwhelming public health emergency of any kind when demand for services dramatically exceeds the supply of the resources needed,” and did not substantially touch on broader standards of care.  As such, Pennsylvania’s healthcare professionals have not been able to rely on any widely-known and commonly understood new standard of care as they had in the past.

Any medical malpractice claim resulting from care and treatment rendered during the COVID-19 pandemic must thus be cognizant of the healthcare paradigm in place at this time: the ultimate clinical goal is to do the greatest good for the greatest number of patients, rather than to do the best that could have been done for every individual under normal circumstances.  Healthcare providers’ practices have been affected by the specific conditions of this crisis, and the standard of care that they are required to provide should adapt to fit this pandemic setting.  Essential decisions about allocation of resources have been made at all levels, and when such decisions have been fair, equitable, and transparent, such decisions by healthcare providers must be protected.

For instance, while hospitals have historically issued and updated written policies and procedures for their healthcare providers to follow, the same have necessarily been upended, at least in part, due to the swift and dramatic changes in circumstances which occurred in a matter of weeks.  Plaintiffs’ counsel routinely request copies of such written policies and procedures in the course of discovery, in order to compare the language contained therein with the care and treatment provided as recorded in the patient’s medical chart.  They often then depose healthcare providers regarding any perceived discrepancies between the two.  It is unclear whether or when hospitals have been able to update their written policies and procedures and/or issue new ones in response to the COVID-19 pandemic.  Medical malpractice practitioners must remain cognizant of the number and extent of competing requirements on healthcare providers during this pandemic, and reevaluate the possible effectiveness of a medical negligence argument based on prior written policies and procedures in the face of an emerging national public health emergency.  As more is discovered about COVID-19, written policies and procedures will necessarily become important for uniformity of care and to articulate a well-known and agreed-upon standard of treatment.  Until then, however, holding healthcare providers to the old pre-pandemic standards is a disservice to the medical professionals on the frontlines and the communities they serve.

Moreover, new medical malpractice claims must also reflect the state of the healthcare providers’ knowledge of the signs and symptoms of COVID-19, and any potential complications from treatments for the same, at the time of the care and treatment rendered.  As of the writing of this article, COVID-19 is only five (5) months old.  Patients may sign informed consent forms today based on our current understanding of the risks and benefits of a certain treatment, only for a new study to be published tomorrow declaring such treatment to be ineffective and potentially harmful to that same patient.  For example, while the Food and Drug Administration issued an Emergency Use Authorization pursuant to Section 54 of the Federal Food, Drug, and Cosmetic Act in March 2020 which allowed for administration of chloroquine phosphate and hydroxychloroquine sulfate for the potential treatment of COVID-19, subsequent studies have called into question the effectiveness of such medications, and others have highlighted the potential cardiac risks to patients.  The same could become true for current studies regarding famotidine and/or remdesivir, and could become true for a number of future potential treatments under experimentation.

Keeping in mind the maxim of “doing the greatest good for the greatest number of patients,” the medical malpractice practitioner must also keep in mind our ever-changing understanding of the signs and symptoms of COVID-19.  The recent discovery that COVID-19 is causing strokes in some young and middle-aged patients with otherwise mild symptoms has certainly given the healthcare profession pause.  As of the writing of this article, this discovery is less than two (2) weeks old, while the COVID-19 state-mandated lockdown is over seven (7) weeks old.  Similarly, the CDC just added six (6) new symptoms of the virus on April 28, 2020.  We must recognize the unknown elements of COVID-19, and not forget this aspect of the unknown in the future, when they become (hopefully) well-known and expected to be widely well-known.  It will be the job of defense counsel to remind future Plaintiffs and jurors of just how much is not currently known about COVID-19, and what medical guidance healthcare professionals truly had available to them at the time of the care and treatment at issue in a given case.

The extent of the COVID-19 outbreak has certainly not been uniform across the Commonwealth, the country, or the world, and the nature of the healthcare system’s response to the same has likely varied in light of different priorities and needs in different communities.  In time, the patchwork of crisis plans is expected to consolidate, resulting in greater uniformity of patient care across regions and demographics.  Nonetheless, in the interim, healthcare providers have continued to foster and maintain patient-provider relationships and care for their patients in an ethical manner in order to help all affected by the pandemic.  The applicable professional standard of care must thus be flexible enough to recognize the number and extent of swift changes to the practice of medicine in response to an unprecedented circumstance.