For the duration of the Covid-19 pandemic, New York state and the federal government have issued laws granting immunity from liability for negligence to health-care providers and pharmaceutical manufacturers.
These laws facilitate speedy treatments of the virus and permit the re-organization of hospital floors and staff, as well as field stations. The federal law also protects the experimental use of medications.
Good governance requires a balance of dual concerns. On one hand, we must protect the “battlefield” health-care providers from liability while they do their best under challenging circumstances, while on the other hand, we must protect the individual rights of patients. Therefore, health-care providers should follow emergent Covid-19 guidelines and protocols, such as published by the Centers for Disease Control and Prevention or their medical centers.
Emergency Pandemic Immunity Laws
The Department of Health and Human Services declared Feb. 4 that medical countermeasures against Covid-19 will be immune from liability under both federal and state law. The immunity covers the use and prescription of medications and devices.
Similarly, for New York state, Gov. Andrew Cuomo (D) issued an executive order which was codified into the Emergency or Disaster Treatment Protection Act (EDTPA). This law grants qualified immunity to hospitals, nursing homes, administrators, and medical workers from civil and criminal liability arising from acts and omissions for the duration of the emergency.
Notably, the immunity does not apply to gross negligence and reckless misconduct. Gross negligence is defined as the “reckless indifference to the rights of others.” See Kalisch-Jarcho Inc. v. City of New York (N.Y. 1983). This is different from the federal law which withholds immunity only in situations of “willful misconduct” which requires proof of conscious awareness of the wrongdoing.
Dr. Robert Klitzman, director of the bioethics program at Columbia University, explained that “[h]ealth care providers in New York can use their clinical judgment and won’t have to worry about being sued or prosecuted for their decisions, assuming, of course, they were not the product of willful or intentional or reckless misconduct, gross negligence or the intentional infliction of harm.” He describes the present circumstances as “battlefield medicine,” with limited supplies and protective equipment and a surge of patients.
Doctors don’t want to worry about being sued under these emergency circumstances. However, families expect health-care providers to do everything reasonably possible to save their loved ones. Even in this environment, there is a humane balance between what may be a carefully considered professional decision compared to one that is arbitrary and too hasty.
The kind of activities covered by the New York EDTPA and the federal law are different. The federal law is specific to “Covered Countermeasure[s]”. It describes certain scenarios, for example, “negligence by a manufacturer in creating a vaccine” or “negligence by a health care provider in prescribing the wrong dose, absent willful misconduct.”
The federal law is directed to clinical trial vaccines and off-label medication prescriptions. In contrast, New York’s liability immunity law is directed to everyday clinical and hospital practice.
In addition to covering treatment of Covid-19 patients, the EDTPA might cover a physician who renders negligent care to a non-Covid-19 patient who, for example, has an unrelated heart condition and is prematurely discharged from the hospital to accommodate space for a Covid-19 patient.
Another example could be where a patient presents to the emergency room with stroke symptoms but the neurological consult required by the standard of care is delayed due to under-staffing, preventing the administration of a life-saving medication such as TPA; or where a patient presents with a pulmonary embolism, which is not treated because of a staff shortage, and the patient dies.
Under the federal immunity law, there is no accountability for a pharmaceutical manufacturer, dispensary or physician who is grossly negligent while overseeing experimental medications, such as failing to consider whether the dosage of hydroxychloroquine (malaria medication) is safe for that particular patient.
Medical care centers as well as the CDC have issued guidelines to treat patients and prevent transmission of the Covid-19 virus. Of course there are many pre-pandemic medical care guidelines and protocols that health-care providers would be well advised not to lose sight of.
Health and Legal Implications
In this time of crisis, medical workers must be allowed to act without “red tape” delays. Yet, how far should this immunity extend when there are important rights of patients and even medical workers who can contract Covid-19?
For example, circumstances covered by the immunity order include prematurely discharging patients, or failing to isolate a Covid-19 patient, or prescribing the wrong dose of a medicine. But there are further implications. Should a nursing home be immune from liability? Such as the nursing home in Seattle, where an outbreak occurred and the problem was ignored for many days and resulted in 37 deaths, or the one in New Jersey where 70 residents died from the virus in a situation where the residents were overcrowded in rooms, there were unsanitary conditions, and there was a lack of personal protective equipment.
Similarly, in a New York City homeless shelter, there were 23 deaths because preventative actions were not taken. Should the shelter be immune? Finally, do these laws extend immunity from liability to a prisoner who wasn’t transferred to a hospital and died from Covid-19?
The most profound decision that no one will want to face, and could be entitled to immunity, is the choice of whether to ventilate a patient. What if a physician is forced to make a Hobbesian choice between two patients, one more elderly or sickly than the other, and less likely to survive even with the ventilator? Also, what if a family member with a health proxy is unwilling to sign a do not resuscitate (DNR) order, in their loving belief that no chance of life should be taken away?
Finally, does the law provide immunity for hospital administrators for conduct that affected the health of medical care workers? Many health-care workers became seriously ill because of inadequate personal protective equipment. Many have pre-existing health problems who have been fired or furloughed, and/or denied requests for accommodation to work remotely under the Americans with Disabilities Act.
It is fortunate that health-care providers can turn to national or hospital or CDC guidelines issued to address these “battlefield conditions,” so that conduct in providing Covid-19 critical medical care follows a non-negligent, patient-concerned process regardless of immunity.
In summary, our health-care providers have been in emergency mode, practicing “battlefield medicine” and should receive limited liability immunity for their unhesitatingly brave actions. However, arbitrary unprofessional decisions insensitive to the personal rights of patients, or medical workers, are problematic. Therefore, it is important for health care providers to follow new as well as pre-existing guidelines for operating a medical center and treating Covid-19 and other patients.
This column does not necessarily reflect the opinion of The Bureau of National Affairs, Inc. or its owners.
Alan Fuchsberg is a senior partner of The Jacob Fuchsberg Law Firm. He practices plaintiffs’ litigation in the areas of medical malpractice, qui tam, pharmaceutical products, toxic tort, personal injury, civil rights and employment discrimination.
Christopher Nyberg is a partner of the Jacob Fuchsberg Law Firm. He specializes in medical malpractice and personal injury cases, including birth injury, infant and pediatric, stroke, and other cases.