HHS Advisory Opinion Asserts PREP Act Immunity Extends to Health Care Facilities

On January 8, 2021, the Department of Health and Human Services (“HHS”) issued an important Advisory Opinion regarding the liability protections under the Public Readiness and Emergency Preparedness (“PREP”) Act.  The PREP Act provides limited immunity to “covered persons” with respect to “all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure.”  The PREP Act has been applicable to the nation’s response to the COVID pandemic, and the development/use of certain PPE and vaccines are included as “covered countermeasures.”  However, to date, while the PREP Act’s protections have been applied to individual practitioners, nurses and physicians, the Act has not clearly included long term care and senior service providers, including nursing homes, personal care homes and assisted living facilities as “covered persons” entitled to immunity.

The Advisory Opinion was issued in response to litigation across the nation involving nursing homes and other healthcare facilities, in which the plaintiff patients or their estates have argued that the patient contracted COVID because the facility either failed to provide sufficient PPE to patients and staff, failed to train staff on how to properly use PPE, or failed to ensure that staff actually used the PPE that was given.  The Advisory Opinion establishes the federal government’s current opinion on two issues.

First, the Advisory Opinion states HHS’s position that the PREP Act completely preempts all state court jurisdiction, meaning that all cases/claims involving the PREP Act must be litigated exclusively in federal court.  Second, HHS states that the immunity provisions of the PREP Act are intended to cover situations where a provider has to “prioritize” or allocate countermeasures (e.g., PPE or vaccines) or make decisions on whether to utilize a particular countermeasure.  Such “program planning” is expressly governed by the language of the PREP Act, and if decisions are made in accordance with a public authority’s directive or guidance, then the liability protections would attach.  Further, to the extent that a scarcity of PPE or other countermeasures exist, and as a result, the provider fails to deliver such countermeasures to its patients, immunity under the PREP Act may still attach.

Significantly, the PREP Act does not provide immunity for “wanton or willful” conduct that results in death or serious injury.  For example, if a provider willfully failed to purchase PPE or attempt to, or its conduct in delivering the PPE or other countermeasures was wanton and caused death or injury, then liability protections would not apply, and the case would proceed in federal court.  Given this “exception,” it would be reasonable to expect plaintiffs to allege such conduct in their complaints, to avoid dismissal of the case under the PREP Act’s immunity provisions.

While this appears to be the first time that HHS has stated that PREP Act immunity can be applied to health care facilities, it is important to note that this Advisory Opinion is just that – a document that sets forth the current views of HHS.  It does not have the force of law, and is not binding on a court of law.  It is also subject to modification by HHS.  However, given that immunity protections specifically designed for health care facilities and other senior service providers have not been issued by either the federal government or Pennsylvania to date, this Advisory Opinion does offer guidance to providers and courts in connection with pending COVID litigation matters.

If you have any questions regarding this Advisory Opinion and its impact on your organization, please do not hesitate to contact us.  Thank you, and stay well.