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Jun 15, 2021

The PREP Act and Pre-emption in COVID-19 Lawsuits

By: Juliann Wilbar

The Public Readiness and Emergency Preparedness Act (the “PREP Act”), enacted in 2005, authorizes the Secretary of the Department of Health and Human Services (HHS) to issue a declaration providing 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 certain medical countermeasures (Covered Countermeasures), except for claims involving "willful misconduct." On March 10, 2020, the Secretary issued a declaration under the PREP Act for certain medical countermeasures used against COVID-19.

Today, plaintiff’s attorneys are filing lawsuits related to the use or non-use of Covered Countermeasures against COVID-19 in state court, and defendants then seek to remove such suits to federal court under a pre-emption clause within the Act. As a result of lower courts applying the pre-emption clause inconsistently, HHS issued an Advisory Opinion on January 8, 2021, elaborating on the pre-emption clause and its applicability in COVID-related lawsuits. According to the HHS Opinion, the PREP Act is a complete pre-emption statute, and, therefore, it:  (1) establishes that a federal cause of action, administrative or judicial, is the only viable claim, and (2) vests exclusive jurisdiction in the federal court. Though the HHS Opinion sought to clarify matters, a split remains among lower courts on whether the PREP Act applies in cases involving “failure to act”-type negligence claims.

For example, in the Garcia v. Welltower OpCo Group case, the Federal District Court for the Central District of California relied on the framework laid out by HHS in its Advisory Opinion when it denied a plaintiff’s motion to remand and held that the PREP Act governed any conduct related to Covered Countermeasures absent “instances of nonfeasance.”[1]  The case involved a plaintiff suing a nursing home for failing to “implement appropriate infection control measures or follow local or public health guidelines in preparing for and preventing COVID-19 spread.” Because the PREP Act was a complete pre-emption statute, the Court held that an adequate basis for federal question jurisdiction existed, and, further, that the nursing home was entitled to immunity from liability under the Act.

Other courts, however, have given less deference to the HHS opinion and have remanded cases back to state court under similar facts. For example, Judge Pittman in the Northern District of Texas considered a case involving a plaintiff suing a nursing home for failing to protect its resident from the spread of COVID-19 in Schuster v. Percheron Healthcare, Inc.[2]   The court focused on the plaintiff’s allegation that the defendant nursing home knew of the plaintiff’s needs and failed to properly monitor and care for her, resulting in her contracting COVID-19, entering acute hypoxic respiratory failure, and dying. Thus, the plaintiff complained of the facility’s non-action, not the negligent administration of a drug, product, or device. Accordingly, the court concluded the case did not fall within the scope of the PREP Act, despite the Garcia holding and the HHS Opinion referring to the Act as a complete pre-emption statute. 

Though there appears to be a growing consensus that state-law negligence claims on a defendant’s “failure to act” are not federal law claims under the PREP Act, the door appears to remain open to defendants seeking to remove cases under the complete pre-emption framework outlined in the HHS Advisory Opinion.

[1] Garcia v. Welltower OpCo Grp. LCC,  No. 8:20 CV-02250, 2021 WL 492581 (C.D. Cal., Feb. 10, 2021).

[2] Schuster v. Percheron Healthcare, Inc., 493 F. Supp.3d 533 (N.D. Tex. 2021).