In the midst of one of the worst and most far-reaching health crises in American history, extraordinary measures are being implemented across all segments of society.  The state-wide shutdown necessitated by the COVID-19 pandemic has impacted literally every New Yorker. As the health care system is under tremendous stress to diagnose and treat the unfathomable numbers of persons anticipated to become infected with the virus, the existing resources in terms of facilities, hospital beds, medical equipment and health care professionals are grossly insufficient to meet those needs. Under these unprecedented circumstances, actions have been taken at the federal and state levels to address this need for resources. Some of those measures will be consequential to persons injured by medical negligence related to this crisis. They are only a small part of what is needed, but they are needed. So be it.

At the federal level, the Department of Health and Human Services (HHS) has submitted a declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) relative to COVID-19. The PREP Act (42 U.S.C. §§247d-6d, 247d-6e), which was passed in 2005, provides for limited, temporary immunity from civil liability for "covered persons" in relation to "covered countermeasures" during epidemics and pandemics. The statute is fairly detailed, and the present discussion will address the most pertinent provisions.

A "covered countermeasure" is essentially a drug, device, product or technology intended to diagnose, treat, prevent or mitigate a pandemic or epidemic. 42 U.S.C. §§247d-6d,(i)(1), (7). A "covered person" is defined as the United States or a person who manufactures, distributes, plans, administers or dispenses a countermeasure, including health care professionals. 42 U.S.C. §§247d-6d,(i)(2), (8).

In order for the Act to come into play, the Secretary of HHS must make a determination "that a disease or other health condition or other threat to health constitutes a public health emergency," and must publish "a declaration" in the Federal Register, recommending one or more covered countermeasures. 42 U.S.C. §247d-6d(b)(1). For each covered countermeasure, the declaration must identify: the category of disease, health condition, or threat for the recommended countermeasure; the effective time period of the declaration; and, the population of individuals and geographic areas affected by the administration or use of the countermeasure. 42 U.S.C. §247d-6d(b)(2).

The immunity is set forth in 42 U.S.C. §247d-6d(a)(1), which provides that "a covered person shall be immune from suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure … ." The term "loss" includes, among other things, physical, mental or emotional injury, illness, disability, and death. 42 U.S.C. §247d-6d(a)(2)(A). The immunity "applies to any claim for loss that has a causal relationship with the administration to or use by an individual of a covered countermeasure, including a causal relationship with the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use of such countermeasure." 42 U.S.C. §247d-6d(a)(2)(B). The immunity applies only to countermeasures administered or used during the effective period, and only for the categories of specified conditions or threats. 42 U.S.C. §247d-6d(a)(3). The statute creates "a rebuttable presumption that any administration or use, during the effective period of the emergency declaration …, of a covered countermeasure shall have been for the category or categories of diseases, health conditions, or threats to health with respect to which such declaration was issued." The Act also purports to prohibit judicial review of any action by the HHS Secretary in making a declaration in any state or federal court, and it preempts state law. 42 U.S.C. §§247d-6d(b)(7), (8).

There is an exception to immunity for "willful misconduct," which is defined as an act or omission "intentionally to achieve a wrongful purpose," "knowingly without legal or factual justification," and "in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit." 42 U.S.C. §247d-6d(c). Where this exception applies, it gives rise to "an exclusive Federal cause of action against a covered person for death or serious physical injury proximately caused by willful misconduct," that may be brought by the injured person or their representative only in federal court in the District of Columbia. 42 U.S.C. §247d-6d(d). Serious physical injury is defined as an injury that is life threatening, results in permanent impairment of a body function or damage to a body structure, or necessitating medical or surgical intervention to preclude such permanent impairment or damage. 42 U.S.C. §247d-6d(i)(10).

Where the exception does not apply, persons injured by a covered measure may still obtain some compensation through the Countermeasures Injury Compensation Program (CCIP). Under 42 U.S.C. §247d-6e, a fund was established to provide compensation to persons for covered injuries directly caused by a covered countermeasure.

On March 17, 2020, the HHC Secretary issued a notice of declaration pursuant to the PREP Act to provide liability immunity for activities related to medical countermeasures against COVID-19, effective as of Feb. 4, 2020. 85 Fed. Reg. 15198, March 17, 2020. In this declaration, the Secretary "determined that the spread of SARS-CoV-2 or a virus mutating therefrom and the resulting disease COVID-19 constitutes a public health emergency," recommended "the manufacture, testing, development, distribution, administration, and use of the Covered Countermeasures," and declared liability immunity to be in effect. Id. at 15201. The declaration specified that "Covered Countermeasures are any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, or any device used in the administration of any such product, and all components and constituent materials of any such product." Id. at 15202. The population is "any individual who uses or is administered the Covered Countermeasures," the geographic area is without limitation, and the effective time period is through Oct. 1, 2024. Id. The declaration also invoked the CCIP, and specified that the "causal connection between the countermeasure and the serious physical injury must be supported by compelling, reliable, valid, medical and scientific evidence in order for the individual to be considered for compensation." Id. at 15203.

A search of all federal and state decisions revealed only one published decision addressing the PREP Act, and it is from the Appellate Division in New York. In Parker v. St. Lawrence County Pub. Health Dept., 102 A.D.3d 140 (3d Dept. 2012), the Third Department held that the Act preempted state law claims for negligence and battery stemming from the administration of the H1N1 vaccine to the plaintiff's infant daughter without parental consent.

The only other case addressing the PREP Act disclosed by our research was an unpublished federal court decision in Kehler v. Hood, 2012 WL 1945952 (E.D. Mo. 2012), which stemmed from the defendant doctor's administration of the H1N1 vaccine to a patient with myelitis. The plaintiffs alleged that the patient suffered acute myelitis after receiving a flu vaccine, that he agreed to the H1N1 vaccine three months later because the defendant doctor assured him it would not aggravate the condition, and that it caused a more severe case of myelitis. The plaintiffs claimed that the defendants failed to consult an appropriate specialist and to obtain a proper informed consent prior to administering the H1N1 vaccine. The defendants brought a third-party action against the manufacturer of the vaccine, alleging defective design and failure to warn. The manufacturer removed to federal court and moved to dismiss, arguing that it was protected by the PREP Act. The court agreed, and dismissed the third-party action. It remanded the plaintiffs' claims against the defendants to state court, finding that they arose not under federal law but under state malpractice law based upon the defendants' conduct "which occurred prior to the administration of the H1N1 vaccine." It did not decide the merits of the defendants' PREP Act argument because it was being raised as defense and did not give rise to federal question jurisdiction.

We turn now to the measures taken by the state, which may have greater consequences for persons injured by medical negligence than the federal actions, albeit over a shorter time period. On March 23, 2020, Governor Cuomo issued Executive Order 202.10, which temporarily suspends or modifies multiple statutes and regulations through April 22, 2020. This broad Executive Order has far reaching effects aimed at increasing the number and availability of health care providers to respond to the COVID-19 crisis in New York, the availability of medical facilities and the availability of ambulances. Some of the measures seeking to address the shortage of medical personnel may impact on the quality of patient care and on patients injured by negligent care.

Executive Order 202.10 affects several statutory and regulatory provisions to the extent necessary to permit a number of categories of health care professionals normally required to practice under the supervision of a physician to practice without supervision. The hospital code (10 NYCRR §§405.13 and 755.4) has been modified to permit advanced practice registered nurses with doctorate or masters degrees specializing in anesthesia to administer anesthesia in hospitals and ambulatory surgery centers without physician supervision during the period in which Executive Order 202.10 is in effect. Education Law §§6542(1) and 6549(1) have respectively been modified to permit physician assistants and specialist assistants to provide medical services appropriate to their education, training and experience without oversight from a supervising physician without civil or criminal penalty related to lack of such oversight. Education Law §6902 has been similarly modified to permit nurse practitioners to provide medical services appropriate to their education, training and experience without written practice agreements or collaborative relationships with physicians. Physician supervision of these health care professionals is obviously understood to be important to the quality of care, but the temporary suspension of this supervision is understandable in the current circumstances to make up for the shortages of medical personnel.

In a similar vein, the hospital code (10 NYCRR §405.4(g)(2)(ii)) has been modified to allow graduate students from foreign medical schools with at least one year of graduate medical education to provide care in hospitals without being licensed. Health care facilities have been authorized to allow students in programs to become licensed as health care professionals to volunteer at the facility for educational credit as if the student had secured placement under a clinical affiliation agreement without requiring such an agreement. Somewhat more ominously, but still understandable, the provision in the hospital code imposing limits on working hours for physicians and post-graduate trainees (10 NYCRR §405.4(b)(6)) has been suspended during the pendency of the crisis.

Each of the above provisions may impact upon the quality of care given to patients by health care professionals covered by the provisions, and to the extent that liability would otherwise be premised, in part, upon statutes or regulations that have been suspended or modified, that will not apply during the period in which the Executive Order is in effect.

However, there is a much more potent provision that drastically limits liability in certain circumstances based upon treatment rendered during the pendency of the Executive Order. It expands the protection of the Good Samaritan laws. Education Law §§6527(2) and 6545(1), respectively provide that physicians and physician assistants "who voluntarily and without the expectation of monetary compensation render[] first aid or emergency treatment at the scene of an accident or other emergency … shall not be liable for damages for injuries alleged to have been sustained by such person or for damages for the death of such person alleged to have occurred by reason of an act or omission in the rendering of such first aid or emergency treatment unless it is established that such injuries were or such death was caused by gross negligence…." Executive Order 202.10 expands this protection:

… to the extent necessary to provide that all physicians, physician assistants, specialist assistants, nurse practitioners, licensed registered professional nurses and licensed practical nurses shall be immune from civil liability for any injury or death alleged to have been sustained directly as a result of an act or omission by such medical professional in the course of providing medical services in support of the State's response to the COVID-19 outbreak, unless it is established that such injury or death was caused by the gross negligence of such medical professional.

This immunity from liability is profound, but limited in both scope and duration.

The Executive Order also gives health care professionals limited exoneration from their obligations with respect to record keeping. They are relieved of record keeping requirements, including maintenance of accurate medical records, "to the extent necessary for health care providers to perform tasks as may be necessary to respond to the COVID-19 outbreak … ." The Order states that "[a]ny person acting reasonably and in good faith under this provision shall be afforded absolute immunity from liability for any failure to comply with any recordkeeping requirement," and that the statutory and regulatory record keeping requirements are suspended or modified accordingly.

Ours is a health care system under siege, requiring the Executive to impose serious restrictions. It is our fervent wish that the dedication and courage of our health care workers and the cooperation of all New Yorkers will significantly contribute to the resolution of this crisis.

Thomas A. Moore is senior partner and Matthew Gaier is a partner of Kramer, Dillof, Livingston & Moore.

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