This post was co-authored by David H. Fitch and Margaret E. Somerset.
By all accounts, we are back to normal with litigation in New York. Vaccines are working, masks are off in public, and the first Covid-19 claims are getting filed. The initial cases are largely breach of contract or labor law claims, but medical malpractice claims are likely just around the corner. A few cases have already started in other states.[1] Many health care professionals are worried about liability for all the deaths that occurred in the past year from this terrible disease.
In this article, we review the state and federal laws that may offer some degree of immunity to health care professionals in New York during the Covid-19 pandemic.
New York State Emergency and Disaster Treatment Protection Act (“EDTPA”)
At the beginning of Covid-19, broad immunity from civil and criminal liability was extended to nearly all medical providers with an executive order by Governor Cuomo.[2] In April 2020 a parallel law (EDTPA) was passed that extended immunity to almost all health care providers working in New York State during the pandemic.[3] That immunity was retroactive to March 7, 2020 and covered nearly all health care providers as long as they were acting in good faith (i.e., without gross negligence or intent to harm someone). Governor Cuomo used this tool to offload the pressure on our health care system and to encourage health care providers to keep working under extraordinary circumstances that placed them and their own families at risk.
In the face of heavy political opposition, immunity under the EDTPA was narrowed in August 2020 to only cover health care providers if they were treating or diagnosing Covid-19 patients.[4] This limitation was retroactive to April 3, 2020 (when the initial EDTPA became effective). Critics argued that the statute had to be narrowed because it would unfairly insulate nursing homes where death rates were high.
On April 7, 2021, the EDTPA was repealed in its entirety. However, this does not mean that health care providers lost immunity from civil and criminal liability.
For patient deaths between March 7, 2020 and April 3, 2020, health care providers still retain broad but qualified immunity under the EDTPA so long as they were not grossly negligent or malicious. (We discuss the meaning of gross negligence in our blog of May 1, 2020[5]).
For patient deaths between April 3, 2020 and April 7, 2021, health care providers have limited immunity so long as they were treating or diagnosing a patient with Covid-19 and they were not grossly negligent or malicious.
For deaths that occur after the repeal of the EDTPA, New York State will no longer provide immunity from either civil or criminal liability. However, there is a federal law that may provide some additional protections – the Federal Public Readiness and Emergency Preparedness Act (“PREP Act”).
Immunity Under the Federal Public Readiness and Emergency Preparedness (“PREP”) Act
The PREP Act was enacted in 2005 to provide the federal government the ability to push private companies to respond, as directed by the government, to address public health emergencies such as a pandemic. Under the PREP Act, the federal government can direct the manufacture of personal protective equipment or ventilators the development of experimental therapeutic treatments or the expedited production of vaccines. 42 U.S.C. § 247d-6d(a)(1). In exchange for complying with federal authorities to help address a public emergency like Covid-19, the federal law authorizes the Secretary of the U.S. Department of Health and Human Services to provide immunity to a “covered person[6]” 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.” In other words, the companies or providers who help to carry out the government’s emergency directives are extended immunity from state and federal liability. The Act does not provide immunity when willful misconduct results in injury or death.
Last fall, the General Counsel’s Office of the Department of Health and Human Services determined that senior living communities are a “covered person” under the PREP Act. The finding is significant as the Act establishes immunity from civil liability for the use or administration of “covered countermeasures[7]” that facilities implement to prevent the spread of the virus.
Countermeasures that are covered include “drugs, biologicals, and devices, including those used to diagnose, mitigate, prevent, treat, or cure Covid-19.” Examples include the use of PPEs, screening for the virus, social distancing, and limiting visitation. Under the statute, countermeasures do not need to be perfect or 100% effective in preventing the spread of the virus.
A recent decision out of the U.S. District Court in California held that measures taken by a senior living facility in response to Covid-19 were eligible for complete liability immunity under the PREP Act. Garcia v. Welltower OpCo Grp. LLC, 2021 U.S. Dist. LEXIS 25738 at *1-26 (CD Cal 2021). The Garcia plaintiffs sued the defendants alleging elder abuse and neglect, wrongful death, and intentional infliction of emotional distress. The claims stem from resident Gilbert Garcia’s death in July 2020 from Covid-19, which the resident’s sons allege was due to the facility’s failure to “implement appropriate infection control measures or follow local or public health guidelines in preparing for and preventing” the spread of the virus. Plaintiffs further allege that the home failed to follow its own policies and procedures requiring screening and monitoring of residents and staff for symptoms, failed to have enough personal protective equipment (e.g., masks), and failed to adequately limit visitation to the home.
The court held that the PREP Act provided the home complete immunity from civil liability due to the actions it did take to protect its residents from Covid-19 and granted defendants’ motion to dismiss the case.
This is a significant ruling for the senior living and post-acute industry as it establishes that the Act provides broad immunity from civil liability when a facility employs countermeasures to prevent the spread of the virus. Furthermore, the decision indicates that the countermeasures implemented by such facilities do not need to be flawless to be covered by the immunities conveyed in the PREP Act.
Liability Protections for Other Health Care Providers
At the end of January 2020, the HHS Secretary acknowledged the proliferation of the virus around the globe by declaring a public health emergency. In March 2020, the Secretary issued a Declaration which triggered the PREP Act’s immunity from February 4, 2020 through October 1, 2024.[8] Since then, the Declaration has been amended to define “qualified persons” as licensed health care providers (e.g., physicians, nurses, technicians, pharmacists), including those who are permitted to prescribe, administer, or dispense covered countermeasures. Further amendments broadened that definition to include care providers authorized to administer Covid-19 vaccines.[9]
The scope of the retroactive immunity provided by EDTPA and the PREP Act will invariably be addressed by more courts around the country in the coming months. Therefore, it is crucial for “qualified” providers to be aware of the changing legal landscape.
If you have any questions regarding the issues discussed above or if you have any other Health Care Law concerns, please contact the Underberg & Kessler attorney who regularly handles your legal matters or David H. Fitch at (585) 258-2840 or Margaret E. Somerset at (585) 919-6080 the co-authors of this article.
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[1] Garcia v. Welltower OpCo Grp. LLC, 2021 U.S. Dist. LEXIS 25738 at *1-26 (CD Cal 2021); Townsend v. Penus, 2021 NYLJ Lexis 524 (Sup Ct, Bronx County 2021); Rachal v. Natchitoches Nursing & Rehab. Ctr. LLC, 2021 U.S. Dist. LEXIS 105847 at *1-15 (WD La 2021)
[2] https://www.underbergkessler.com/post/malpractice-immunity-for-medical-professionals-treating-patients-during-covid-19
[3] https://www.underbergkessler.com/post/how-does-the-new-immunity-law-in-ny-apply-to-health-care-providers-during-the-covid-19-emergency
[4] https://www.underbergkessler.com/post/what-does-new-york-s-amended-covid-19-immunity-law-mean-for-providers
[6] Under the Act, the Secretary can deem a “covered person” to be a manufacturer and/or distributor of a countermeasure, a “program planner” (individuals or facilities that plan, administer, or supervise programs that distribute the countermeasure), and/or a “qualified person” (individuals that prescribe, administer, or distribute countermeasures, including healthcare providers).
[7] A “covered countermeasure” is defined in the Act as a drug, device, or biological product determined by the Secretary to be a “priority for use during a public health emergency.” 42 U.S.C. § 247d-6d(i)(1).
[8] 86 Fed. Reg. 15198 (March 17, 2020)
[9] 85 Fed. Reg. 79190 (December 9, 2020)