COVID-19 Healthcare Heroics May Ironically Lead to Future Confrontations - Causation Issues (Part 4)May 7, 2020 | Nathan Leming
In part four of our series of blog articles delving into potential dangers for healthcare providers related to the COVID-19 global pandemic, we consider causation issues for healthcare associated COVID-19 infections.
General Infection Causation Issues
While every corner of American commerce, including food suppliers and sellers, financial institutions, childcare providers and fitness centers, may face increasing liability claims from customers and third parties claiming to have been exposed to COVID-19 during a visit to their premises, in most cases, proving that an infected person caught COVID-19 from a specific source should be a difficult task, especially considering the known virus viability outside the body and incubation time (the time between contracting the virus and onset of symptoms).
According to a study published in the New England Journal of Medicine, SARS-CoV-2, the virus that causes COVID-19, can live in the air and on surfaces between several hours and several days. The study found that the virus is viable for up to 72 hours on plastics, 48 hours on stainless steel, 24 hours on cardboard, and 4 hours on copper. It is also detectable in the air for three hours. After interaction with an infection source, most estimates of the incubation period for COVID-19 range from 1-14 days, with most infected individuals exhibiting symptoms around five days. Given the difficulty tracking all interactions of an infected person during the combined length of time between virus viability outside the body and incubation, narrowing the source of infection to one source and effectively ruling out all other possible acquisition more likely than not to a reasonable degree of certainty will likely be a difficult task.
Causation Issues for Healthcare Associated COVID-19 Infections
Nosocomial or healthcare associated infections are infections acquired during care which are not present or incubating at admission or treatment start. Nosocomial infections have been a reality since the origin of medicine and have been the object of litigation for some time. Undoubtedly, the COVID-19 pandemic will result in numerous lawsuits alleging that a healthcare provider’s negligence led to infection during treatment. However, given that most infections are asymptomatic for some time after their onset, it can be very difficult to identify with precision whether the infection was indeed contracted after admission or whether the patient was infected before admission but asymptomatic. Several agencies and authorities have attempted to identify time parameters for establishing what generally constitutes a nosocomial infection. For example, the World Health Organization (“WHO”) “usually” considers infections occurring more than 48 hours after admission to be nosocomial. However, the “usual” qualifier in the WHO’s definition allows a case-specific analysis of whether an infection can be deemed nosocomial. Thus, the WHO’s 48-hour cutoff, or any other third-party’s definition is not likely to apply to alleged COVID-19 infections given the longer incubation time discussed above.
For long-term care facilities, although a complete causation defense may be complicated by a resident’s likely admission predating the COVID-19 outbreak, providers should still attempt to establish a causation defense that a resident cannot prove virus transmission to a reasonable degree of certainty after the facility knew or should have known of the risk of COVID-19 transmission and before the recommended precautions were instituted. In support of this strategy, the Centers for Disease Control (“CDC”) has recognized that long-term care residents with COVID-19 may not report common symptoms like fever or respiratory symptoms, and some may not report any symptoms at all. The CDC acknowledges that unrecognized asymptomatic and pre-symptomatic infections likely contribute to transmission in long-term care facilities. These two CDC-recognized factors should strengthen a causation defense utilizing the above strategy.
COVID-19 Healthcare Heroics May Ironically Lead to Future Confrontations - State Executive Orders (Part 3)May 5, 2020 | Terrence O'Toole, Jr. and John Mahon, Jr.
In part three of our series of blog articles delving into potential dangers for healthcare providers related to the COVID-19 global pandemic, we consider the American Medical Association’s push for states to pursue liability protections for healthcare professionals during the COVID-19 emergency.
In the wake of the COVID-19 Nationwide Public Health Emergency, the Centers for Disease Control and other federal, state and local agencies have published guidelines and recommendations for healthcare providers dealing with patient care in the midst of this crisis and resulting limitations on available resources, equipment, and healthcare staff. Indeed, the evolving response to the national emergency raises many concerns, including concerns for the health of the courageous and dedicated providers themselves.
By mid-April 2020, more than 9,000 U.S. healthcare workers had contracted coronavirus, with 27 U.S. deaths, and data suggests healthcare providers may account for approximately 11% of all COVID-19 infections. The authors of this blog series cannot fathom what these providers are going through, especially those caring for COVID patients throughout an entire shift, day after day, observing terrible suffering and outcomes, even with the best care and with healthy patients. These providers cannot help but feel that everything around them, especially in the hospital, could be a source of infection.
In addition to very real concerns for the health and wellbeing of these front-line healthcare providers, another significant concern is the risk of potential legal liability arising out of adherence to published guidelines and recommendations while also endeavoring to provide quality care. This is especially important in those areas of the U.S. hit hardest by COVID-19 that have experienced unprecedented patient load and corresponding limitations on supplies and healthcare personnel. Of particular concern are those healthcare professionals providing direct care to COVID-19 patients, those who have shifted their practices to telemedicine, and those guided in treatment decisions by governmental directives.
Thus, while federal and state laws provide existing protections to healthcare professionals, the American Medical Association has encouraged each state to consider whether additional protections should be extended to address the potential liability of healthcare providers affording care in response to COVID-19, as well as treatment decisions based on government or healthcare facility COVID-19 directives. For example, the CDC has published crisis standard of care recommendations for decontamination and reuse of filtering facepiece respirators which are not approved for routine decontamination and reuse.
To that end, the AMA has recommended states provide healthcare providers immunity from civil liability and adverse action by state medical boards for injury or death:
- caused while providing medical services in response to the COVID-19 outbreak;
- caused by volunteer physicians acting in good faith for care provided in response to COVID-19; and
- resulting from a federal, state, or local directive, including but not limited to those to cancel, delay, or deny care as a result of the COVID-19 pandemic.
In addition to the above recommendation, the AMA has provided recommendations on the appropriate mechanisms to formalize these protections, including through new laws, the expansion of existing laws, and/or by executive order. Some states have issued executive orders or proclamations to provide protections to allow for alternative standards of care. For instance, we have thus far identified executive orders in AL, AR, AZ, CT, GA, IL, MA, MI, MS, NC, NJ, NY, RI, VT. There are pending requests/proposals in other states to issue executive orders. Many of these parallel “good Samaritan” laws existing throughout the country that have for decades afforded qualified immunity from civil liability for healthcare professionals who volunteer their services as a generous compassionate act unless they engage in willful or intentional misconduct.
Thus far, one state that has followed the AMA’s recommendation is Illinois, which extended by executive order from the governor immunity to healthcare facilities, professionals, and volunteers from civil liability for any injury or death that occurs at a time when the facility or provider was providing healthcare services in response to COVID-19, except injuries or death caused by gross negligence or willful misconduct. Likewise, the governor of New Jersey issued an executive order providing immunity from civil damages for licensed healthcare providers for damages alleged to have been sustained as a result of their acts or omissions “undertaken in good faith” in connection with the State’s COVID-19 response. That immunity does not extend to acts or omissions that “constitute a crime, actual fraud, actual malice, gross negligence or willful misconduct.” For another example, the New York State Senate and Assembly passed the Emergency Disaster Treatment Protection Act that grants immunity from civil and criminal liability to healthcare facilities, professionals, and volunteers for the purpose of, “promot[ing] the public health, safety and welfare of all citizens” during the pandemic. Though the immunity does not apply to acts or omissions caused by “willful or intentional criminal misconduct, gross negligence, reckless misconduct, or intentional infliction of harm,” the Act expressly excludes unavoidable resource or staffing shortages as evidence of such conduct.
Though the authors of this blog series believe executive orders and laws like those described above are necessary in the current climate and likely helpful in mitigating some litigation risk for healthcare professionals, they will not necessarily end all litigation. These laws have not yet had to withstand scrutiny of the courts in terms of applicability, enforceability and scope. Moreover, even if some consider healthcare professionals likely to win lawsuits or that juries are likely to be sympathetic towards them, we should remember they must still defend themselves and undergo the stress, expense, and other burdens of litigation and threatened litigation in already difficult and truly unprecedented times. See here for more information on the recommendations of the American Medical Association.
COVID-19 Healthcare Heroics May Ironically Lead to Future Confrontations – Crisis Standard of Care? (Part 2)May 1, 2020 | Brandy Simpson and Kathryn Huelsebusch
In part two of our series of blog articles delving into potential dangers for healthcare providers related to the COVID-19 global pandemic, we consider the “standard of care” for healthcare providers. Specifically, we consider whether the “standard of care” may not be so “standard” during this global pandemic. Medical negligence cases are won and lost after a determination of whether a healthcare provider met or failed to meet the standard of care. In these lawsuits, a jury decides whether the healthcare provider was negligent based upon the “standard of care.” In Missouri, the “standard of care” means to use that degree of skill and. learning ordinarily used under the same or similar circumstances by members of the defendant's profession.
During the COVID-19 pandemic, the “same or similar circumstances” portion of this definition have drastically changed considering the shortages of masks, face shields, other personal protective equipment (PPE), ventilators, swab kits, and testing capacity, all of which are critical for frontline caregivers and patients.
The Institute of Medicine Committee on Guidance for Establishing Standards of Care for Use in Disaster Situations defines “crisis standards of care” as:
“a substantial change in usual healthcare operations and the level of care it is possible to deliver, which is made necessary by a pervasive (e.g., pandemic influenza) or catastrophic (e.g., earthquake, hurricane) disaster. This change in the level of care delivered is justified by specific circumstances and is formally declared by a state government, in recognition that crisis operations will be in effect for a sustained period. The formal declaration that crisis standards of care are in operation enables specific legal/regulatory powers and protections for healthcare providers in the necessary tasks of allocating and using scarce medical resources and implementing alternate care facility operations.”
The medical community is working to establish guidelines for the “crisis standard of care.” The American Medical Association created an ethics resource page titled “Crisis Standards of Care: Guidance from the AMA Code of Medical Ethics” to offer guidance to healthcare institutions and providers on these issues during the pandemic. The Code does not offer specific clinical protocols, but instead provides foundational guidance for the development of ethically sound crisis standard of care guidelines.
“The goal is to make the decisions that happen at the bedside less ad hoc, so that they're more consistent, fairer and more objective,” said Elliott Crigger, PhD, Director of Ethics Policy at the AMA. “By having a set of standards, we’re not leaving it to somebody who, say, hasn’t slept in 48 hours or someone with a subtle bias against a patient."
The National Academies of Sciences, Engineering, and Medicine published a 200 page report in 2013 entitled “Crisis Standards of Care: A Toolkit for Indicators and Triggers” which addresses the standard of care during natural disasters, pandemics, and other catastrophic events.
At this stage, crisis measures are already being implemented in healthcare facilities across the U.S. Many of the recommendations involve the preservation and reuse of PPE due to the lack of resources. Outside the pandemic context, medical negligence cases commonly involve liability theories of medication errors, inadequate staffing, and ineffective infection prevention policies. These theories are likely to remain, but published “standard of care” guidelines in these situations during a public health crisis will likely be a moving target.
Other medical sources, committees and colleges have published on the crisis standard of care, including the American College of Emergency Physicians, the Institute of Medicine, and the Board on Health Sciences and Policy, among others. Litigators can only speculate how the standard of care for cases that arise during the COVID-19 pandemic will take shape. The only thing that is certain is that the crisis standard of care will be hotly contested and at the center of controversy in suits involving the care of patients with COVID-19 and the care of non-COVID-19 patients during the time of crisis.
Watch for our next post in this series, which considers the American Medical Association’s push for states to pursue liability protections for healthcare professionals during the COVID-19 emergency. Our prior post in this series can be found here.
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