On January 8, 2021, the U.S. Department of Health and Human Services released Advisory Opinion 22-01  entitled On The Public Readiness and Emergency Preparedness Act Scope of Preemption Provision.   The Advisory Opinion addresses the Fourth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 and Republication of the Declaration, which was published in the Federal Register on December 3, 2020.  The Health Law Pulse has previously discussed the PREP Act here and here.

First, the Advisory Opinion finds the PREP Act to be a complete preemption statute:

The sine qua non of a statute that completely preempts is that it establishes either a federal cause of action, administrative or judicial, as the only viable claim or vests exclusive jurisdiction in a federal court.  The PREP Act does both.

The Advisory Opinion provides that the PREP Act may be triggered in cases of non-use of a Covered Countermeasure when non-use results from prioritization or purposeful allocation.  Specifically, it states that “[p]rioritization or purposeful allocation of a Covered Countermeasure, particularly if done in accordance with a public health authority’s directive, can fall within the PREP Act and this Declaration’s liability protections.”  Recognizing that district courts have had difficulty determining “whether the non-use of a covered countermeasure triggers the PREP Act and its complete preemption regime” the Advisory Opinion refers to the PREP Act’s plan language.   The Act provides immunity “to anything ‘relating to’ the administration of a covered countermeasure.”

One example provided is a facility that receives a “scarce therapeutic purchased by the government”.  If the facility chose not to administer the therapeutic to an individual otherwise meeting applicable requirements, where the non-use was based on conscious decision–making, the PREP Act could still be triggered.  If the failure to administer resulted in death or serious injury and was willful and wanton, liability under the PREP Act could extend to the facility.

Next, the Advisory Opinion determines that the PREP Act also includes “program planners” within the definition of “Covered Persons”:

Program planning inherently involves the allocation of resources and when those resources are scarce, some individuals are going to be denied access to them. Therefore, decision-making that leads to the non-use of covered countermeasures by certain individuals is the grist of program planning, and is expressly covered by PREP Act.

Additionally, even where creative attempts to shield a case from federal jurisdiction, “federal courts are free to entertain discovery to ascertain, for jurisdictional purposes, the facts underlying the complaint”.  United Surgical Assistants, LLC v. Aetna Life Ins. Co., 2014 WL 4059889 at*1 (M.D. Fla. Aug. 14, 2014).   The Advisory Opinion states that “ordaining the metes and bounds of PREP Act protection in the context of a national health emergency necessarily means that the case belongs in federal court.”    The General Counsel cites to the Fourth Amendment to the Secretary of HHS’s PREP Declaration:

There are substantial federal legal and policy issues, and substantial federal legal and policy interests within the meaning of Grable & Sons Metal Products, Inc. v. Darue Eng’g. & Mf’g., 545 U.S. 308 (2005), in having a unified, whole-of-nation response to the COVID–19 pandemic among federal, state, local, and private-sector entities.

Once the Grable doctrine has been invoked, the court retains the case to determine whether the immunity and preemption provisions apply.  If the court determines they are not applicable than the court tries the case as it would a diversity case.

We will learn shortly whether the incoming Biden administration will take the same approach to interpreting PREP Act immunity.  Norton Rose Fulbright attorneys will continue to provide relevant updates on the COVID-19 PHE and the PREP Act on the Health Law Pulse.