Article by Michelle Kaminski, Esq.
This research was conducted in regard to civil immunity in professional liability actions, secondary to the COVID-19 pandemic. It includes an introductory analysis of the May 6, 2020 Executive Order (“EO”) and the PREP Act. In short, the EO signed by then–PA Governor, Tom Wolf, protected certain health care providers from civil suits relating to treatment provided between May 6, 2020 and June 10, 2021. The PREP Act, on the other hand, provides liability immunity to certain individuals and entities from suits arising out of a specified category of events. Ultimately, the EO, while applicable to health care providers, specifically excludes health care facilities. In addition, while application of the EO might largely be determined at face value, applicability of the PREP Act may require further review of a Complaint, given the fact that an analysis of the exact nature of the allegations, and thus any potential avenues for civil immunity, is likely necessary.
At this time, neither the May 6, 2020 EO nor the PREP Act appears to have been heavily explored in the context of their practical application to professional liability actions. That being said, cognizant of the approaching or past statutory deadlines, this topic will be continually revised and updated in future articles, should new developments in their application, whether retroactive or otherwise, become available.
May 6, 2020 Executive Order (State)
On March 6, 2020, a Proclamation of Disaster Emergency signed by Governor Wolf stated that Pennsylvania was under a state of disaster emergency due to the COVID-19 pandemic.[1] Thereafter, on May 6, 2020, Governor Wolf signed an Executive Order (entitled “Order of the Governor of the Commonwealth of Pennsylvania to Enhance Protections for Health Care Professionals”), which effectively protected certain health care providers from liability from civil suits, as long as their actions were not considered grossly negligent.[2] The EO was to remain in effect for “the duration of the disaster emergency.” On June 10, 2021, House Resolution No. 106 was signed by the PA Senate, terminating the March 6, 2020 disaster emergency status in PA, effective immediately.[3] As the disaster emergency was no longer in effect, the protection of the EO was presumptively terminated (note also that the PA Governor Proclamations website indicates that the March 6, 2020 Proclamation was terminated by House Resolution No. 106).[4] Therefore, the immunity granted pursuant to the EO was last effective as of June 10, 2021.
Of note, the immunity granted by the EO was extended to “emergency services activities only as related to the Commonwealth’s COVID-19 disaster emergency response,” and applies to “Any individual who holds a license, certificate, registration or certification or is otherwise authorized to practice a health care profession or occupation in this Commonwealth, and who is engaged in emergency services activities or the provision of disaster services activities related to the Commonwealth’s COVID-19 disaster emergency response… in the following types of facilities and care settings… Any health care facility… engaged in the emergency services activities or the provision of disaster services activities related to the Commonwealth’s COVID-19 disaster emergency response.”
The immunity granted by the EO was extended to “emergency services activities only as related to the Commonwealth’s COVID-19 disaster emergency response.” As drafted, it was intended to apply to “Any individual who holds a license, certificate, registration or certification or is otherwise authorized to practice a health care profession or occupation in this Commonwealth, and who is engaged in emergency services activities or the provision of disaster services activities related to the Commonwealth’s COVID-19 disaster emergency response… in the following types of facilities and care settings… Any health care facility… engaged in the emergency services activities or the provision of disaster services activities related to the Commonwealth’s COVID-19 disaster emergency response.” However, the EO then states the following: “The aforementioned classifications of individuals (and not the facilities or entities themselves) shall be immune from civil liability and shall not be liable for the death of or any injury to a person…” Accordingly, while civil immunity pursuant to the May 6, 2020 EO does extend to individuals working in health care facilities, this immunity is not shared by the actual facilities.
There are, of course, additional limitations on the practical use and application of the EO. The EO’s last effective date, June 10, 2021, would today indicate that the statutory period for injuries occurring in the context of the EO is about to expire. That being said, the ability to claim immunity under the EO would appear so-limited, as well.
PREP Act (Federal and State)
On February 4, 2020, the Secretary of the Department of Health and Human Services issued a PREP Act declaration to provide immunity for “activities related to medical countermeasures against COVID-19.” The “Public Readiness and Emergency Preparedness Act (PREP Act) authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving “willful misconduct” as defined in the PREP Act.” The PREP Act is not meant to terminate until the final day of the emergency Declaration, or until October 1, 2024 (whichever occurs first).
Under the PREP Act, the term ‘‘loss’’ can mean any of the following:
- death;
- physical, mental, or emotional injury, illness, disability, or condition;
- fear of physical, mental, or emotional injury, illness, disability, or condition, including any need for medical monitoring; and
- loss of or damage to property, including business interruption loss. Each of clauses (i) through (iv) applies without regard to the date of the occurrence, presentation, or discovery of the loss described in the clause.”[5]
A “covered person” includes “…an individual, partnership, corporation, association, entity, or public or private corporation, including a federal, state, or local government agency or department.”[6]
Pursuant to the Act, “Covered Countermeasures” must be:
(A) a qualified pandemic or epidemic product;
(B) a security countermeasure;
(C) a drug, biological product, or device that is authorized for emergency use in accordance with the FDA; or
(D) a respiratory protective device that is approved by the National Institute for Occupational Safety and Health and that the Secretary determines to be a priority for use during a public health emergency declared under section 247d of this title.
Note also that a qualified pandemic or epidemic product is a drug or device that is “(A)(i) a product manufactured, used, designed, developed, modified, licensed, or procured, (I) to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic”; or (II) to limit the harm caused; “(ii) a product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by a product described in clause (i); or (iii) a product or technology intended to enhance the use or effect of a drug, biological product, or device described in clause (i) or (ii)”; and (B)(i) approved or cleared under the FDA; (ii) the object of research for possible use as described by subparagraph (A) and is the subject of an exemption under the FDA; or (iii) authorized for emergency use in accordance with the FDA.[7] Additional information, specifically in regards to case law addressing instances wherein healthcare facilities and nursing homes failed to provide staff with personal protective equipment, failed to teach them to use the equipment, or failed to ensure they did use it has been explored in the January 8, 2021 Advisory Opinion.[8]
Generally, a security countermeasure is a drug, device, or biological product which has been authorized for emergency use by the FDA.
There have been ten Amendments since the original Act was created. Of note, The Second Amendment clarifies that drugs, biological products, and devices that “limit the harm COVID-19 might otherwise cause” are covered countermeasures, and that the HHS Declaration reaches “all qualified pandemic and epidemic products defined under the PREP Act.” The Third Amendment expands categories the categories of disease which may represent a public health emergency to “other diseases, health conditions, or threats that may have been caused COVID-19, SARS COVID-Co V-2, or a virus mutating therefrom.” The Fourth Amendment expands the scope of immunity under the Act to cover all qualified pandemic and epidemic products within the meaning of the statute and can apply to claims based on not administering a covered countermeasure. Additionally, healthcare providers using telehealth have received protection as Qualified Persons. Throughout subsequent Amendments, the definition of a “Qualified Person” has been expanded and clarified multiple times.[9]
Additional information regarding the scope of the PREP Act, in addition to multiple subsequent Advisory Opinions, is available here and here, respectively. The first, fourth, and fifth Opinions may be of special pertinence to clients in the hospital and nursing home industries.
[1] March 6, 2020 Proclamation of Disaster Emergency: https://www.governor.pa.gov/wp-content/uploads/2020/03/20200306-COVID19-Digital-Proclamation.pdf (note this webpage has been removed)
[2] May 6, 2020 Order of the Governor of the Commonwealth of Pennsylvania to Enhance Protections for Health Care Professionals: https://www.governor.pa.gov/wp-content/uploads/2020/05/20200506-GOV-health-care-professionals-protection-order-COVID-19.pdf (note this webpage has been removed)
[3] June 10, 2021 House Resolution No. 106: https://www.legis.state.pa.us/CFDOCS/Legis/PN/Public/btCheck.cfm?txtType=HTM&sessYr=2021&sessInd=0&billBody=H&billTyp=R&billNbr=0106&pn=1753
[4] PA Governor Proclamations website: https://www.pema.pa.gov/Governor-Proclamations/Pages/default.aspx
[5] https://www.govinfo.gov/content/pkg/USCODE-2020-title42/pdf/USCODE-2020-title42-chap6A-subchapII-partB-sec247d-6d.pdf
[6] https://www.govinfo.gov/content/pkg/USCODE-2020-title42/pdf/USCODE-2020-title42-chap6A-subchapII-partB-sec247d-6d.pdf
[7] https://www.govinfo.gov/content/pkg/USCODE-2020-title42/pdf/USCODE-2020-title42-chap6A-subchapII-partB-sec247d-6d.pdf
[8] https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/2101081078-jo-advisory-opinion-prep-act-complete-preemption-01-08-2021-final-hhs-web.pdf
[9] The complete list of Amendments is available at https://aspr.hhs.gov/legal/PREPact/Pages/default.aspx