Johnson & Johnson, Moderna, and Pfizer’s COVID-19 vaccines are not the only things capable of granting immunity within the context of the on-going pandemic. Relatively unknown prior to the 2019 COVID-19 pandemic, the Public Readiness and Emergency Preparedness Act (“PREP Act”) grants “sweeping” immunity that completely protects manufacturers, distributors, and other “covered persons” against claims of loss caused by injuries from COVID-19 vaccines and various other activities the Secretary of Health and Human Services has deemed necessary to overcoming the pandemic. The Act has emerged from bureaucratic obscurity and is viewed as the underlying engine fueling many of the great strides in treatments the United States has fielded in the struggle against COVID-19. Coming up on its seventh amendment, the Act has been expanded numerous times in recent months to cover more entities and products under its liability immunity clauses.

In recent months, a potential threat has emanated from the shadows of various federal courts throughout the country. The avalanche of litigation spurred by COVID-19 has included an increasingly familiar pattern of nursing home cases resembling the following archetypical fact pattern: the estate of a deceased nursing home victim sues the nursing home in state court for failing to take measures which would have prevented the deceased from contracting COVID-19. The nursing home then removes the case to federal court claiming federal question jurisdiction under the theory of federal preemption in the PREP Act. The plaintiff then files a motion for remand and like clockwork, the court grants it. Such has been the repetitive process that has afflicted district courts across the nation from Florida to California.

Between August 12, 2020 and March 30, 2021, thirty-eight such cases have been decided with almost all being resolved with a grant of remand to state court. In Estate of Maglioli v. Andover Subacute Rehabilitation Center I, the estates of four deceased individuals brought state claims of negligence, wrongful death, and punitive damages against a New Jersey nursing home for inter alia, failing to provide staff with adequate amounts of face coverings, failing to monitor visitors to the nursing home, and failure to monitor food preparation as required under New Jersey law. The Court ultimately rejected defendants’ preemption argument concluding the PREP Act’s purpose had a narrower intent of emboldening caregivers to “administer certain encouraged forms of care” during an emergency response to a pandemic rather than having a purpose to “more broadly displace state-law causes of action.” The Court reasoned that the plain language of the PREP Act was “designed to protect those who employ countermeasures, not those who decline to employ them.”

Such court rulings inspired HHS’ Office of General Counsel (OGC) to release several advisory opinions rejecting the interpretation that the PREP Act did not preempt state law claims for negligence and wrongful death. In the six advisory opinions that followed, the OGC took the position that the PREP Act is a complete preemption statute which effectively trumps state law. More importantly, the OGC plugged up some confusion and articulated its view that claims involving non-use of covered countermeasures made as the result of “conscious decision-making” fell under the purview of the PREP Act. In the OGC’s view, only in instances of nonfeasance, i.e., where “defendant’s culpability is the result of its failure to make any decisions whatsoever, thereby abandoning its duty to act as a program planner or other covered person” would preemption not attach.

Despite all of this, a recent decision in the case of Gilbert Garcia et al v. Welltower OpCo Group LLC, et. al., 20-02250JVS (C.D. Ca. Feb. 10, 2021), has shaken up these recent precedents. Under facts similar to those articulated above, here the Court gave great deference to the OGC advisory opinions that the PREP Act was a complete preemption statute and while noting that such opinions are non-binding, they are not rendered irrelevant. The court also held that the defendants’ failure to use or administer covered countermeasures defined in the PREP Act fell within the purview of that Act as per the January 8, 2021 advisory opinion.

Could this be the beginning of a shift from what legal observers have seen these past several months? Could more courts begin to interpret the PREP Act in a manner more consistent with the OGC advisory opinions? The significance of such a potential shift cannot be understated. A judge-made loophole which allows state claims to be used against a defendant based on that defendants’ omission rather than administration of countermeasures threatens to undermine the PREP Act’s purpose.