2020 was unprecedented.  The COVID-19 pandemic brought the world to a stop.  Medical providers from community colleges through Ivy League schools banded together to treat and overcome the unparalleled devastation COVID-19 caused.  Nursing homes were among the hardest hit as the virus had a higher mortality rate for the elderly.  In order to protect those willing to risk their own lives for others, the Secretary of Health and Human Services (“Secretary”) issued a Declaration pursuant to the Public Readiness and Emergency Preparedness Act (“PREP Act”) to provide liability immunity for those protected under the Act for medical countermeasures against COVID-19.  It is now 2021.  Treatment evolved as more became known about the virus, however, in the interim, many lives were lost.  Inevitably, lawsuits followed despite the PREP Act.  A recent tentative federal court decision in the Central District of California affirms the federal jurisdiction retained over matters involving COVID-19, and reiterates the immunity rightfully deserved by those on the front lines.  

Gilbert Garcia was a resident of a nursing home since 2017.  His story was similar to those of other medical malpractice actions: allegations of negligence against the facility, intentional infliction of emotional distress and wrongful death are the backbone of the complaint.  However, Mr. Garcia’s cause of death was from the novel COVID-19 virus.  Mr. Garcia’s family filed a lawsuit against the operators of the nursing home facility in State Court in California.  The Defendants removed the matter to Federal Court pursuant to diversity and federal question jurisdiction and then filed a Motion to Dismiss pursuant to Fed.R.Civ.P. 12(b)(6).  The Garcia family then amended their complaint to add the manager of the nursing home and moved to remand the matter back to State Court.

The Federal Court analyzed two issues in Garcia, et al v. WellTower OpCo Group, LLC, et al: the Federal Court’s jurisdiction when the subject matter of the underlying suit involves COVID-19 and the immunity afforded pursuant to the Declaration of the PREP Act.  As indicated above, the Secretary invoked the PREP Act when it was declared that COVID-19 was a public health emergency.  In doing so, the PREP Act provides widespread immunity related to any claim for a loss related to a countermeasure against the disease or other health condition causing the public health emergency – in this case, COVID-19.  The PREP Act has little exclusions, with willful misconduct being the principal one.   For injuries sustained not subject to an exclusion under the Act, a “Covered Countermeasure Process Fund” will provide compensation to eligible individuals who were injured pursuant to a countermeasure against COVID-19.  Finances must be appropriated by Congress to put into the Fund and claimants have one year to file a Claim for Benefits from the time the countermeasure was received.  Medical records and other supporting documents must be provided and any benefits received will be reduced by public or third party payers. The Fund pays medical expenses and/or lost wages, however, non-economic damages are limited.

In consideration of the jurisdictional issue, the Plaintiff argued that the PREP Act was inapplicable and thus there was no jurisdiction based on a federal question.  The Plaintiff reasoned that the PREP Act only applies to vaccine administration or administration of drugs to patients, and not “policies, procedures, protocols or guidelines.”  Moreover, Plaintiff argued that the operators of the nursing home were not “covered persons” under the Act.  Plaintiff additionally argued that even if the PREP Act was applicable that Plaintiff has brought state based claims and Defendants’ argument is a defense, and not a basis for federal question jurisdiction.

In response, the Defendants offered three distinct bases for jurisdiction: complete preemption, the Grable doctrine and the PREP Act.  Defendants referred to a recent Advisory Opinion from the Office of the General Counsel (“OGC”) of the Department of Health and Human Services in support of their argument for preemption.  In the Advisory Opinion, dated January 8, 2021, the OGC reiterated that the PREP Act was a complete preemption statute, in 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 of the above scenarios therefore it is a complete preemption statute.  Plaintiff argued in response that the PREP Act is inapplicable because there were failures by the facility to provide appropriate PPE.  HHS outlined guidance that PPE should be used and the failure to do so constituted actionable conduct.  Plaintiff additionally argued that the Advisory Opinion goes beyond its scope of authority. 

The Court, however, confirmed that the PREP Act is a complete preemption statute.  There were several decisions within the District with differing results in response to the same question – whether the PREP Act was a complete preemption statute.  However, those decisions were prior to the January 8, 2021 Advisory Opinion, which clarified that the PREP Act was a complete preemption statute.  Moreover, the Court disagreed with Plaintiff’s argument that notwithstanding that it is a complete preemption statute, the PREP Act is inapplicable as the Defendants’ acts were not pursuant to the administration of a vaccine or medication and they are not “covered persons” within the Act.  The January 8, 2021 Advisory Opinion also provided guidance in response to several inquiries related to the use, or lack thereof, of personal protective equipment (“PPE”) by nursing homes during the COVID-19 pandemic.  Plaintiff argued that Defendants did not have appropriate infection control protocols in place, including the lack of appropriate PPE.  However, the use, misuse, or lack of appropriate PPE is “related” to a countermeasure.  The January 8, 2021 Advisory Opinion, and the Court, found allegations related to said claims, short of total inaction, are covered by the PREP Act.  

The Court then turned to the question of whether the Defendants, operators of the nursing home facility, were covered persons under the Act.  The PREP Act includes “program planners” as covered persons.  Program planners include those who supervised or administered programs concerning countermeasures.  The PREP Act is not limited to those who are involved in vaccine manufacture and administration, nor is it limited to licensed health facilities and those who provide medical services.  Through the clear words of the statute, it includes those who maintain policies and procedures related to countermeasures, in this case infection control.  The Court additionally referred to the Advisory Opinion from August 14, 2020 in which it confirms that senior living communities are covered persons under the PREP Act.

Concluding that the PREP Act is a complete preemption statute, and, therefore, the District Court maintained jurisdiction, and the operator Defendants were covered persons pursuant to the Act and their actions fall within the purview of the Act, the Court next considered their Motion to Dismiss.  The Defendants claimed they were immune from liability pursuant to the Act.  The Court held that Plaintiff’s bare allegations found within the complaint, including Mr. Garcia’s death from COVID-19 and a failure of the Defendants to allocate appropriate resources and implement appropriate policies which allegedly would have prevented Mr. Garcia from contracting and dying from COVID-19, implicated the PREP Act and the immunity attached to covered persons pursuant to it.  Plaintiff attempted to argue immunity only applies to a small class of persons, however, the Court again referred to the January 8, 2021 Advisory opinion which indicates otherwise. 

This decision is a tentative one.  That being said it has confirmed that the PREP Act is a complete preemption statute and covered persons under the Act, with few exceptions, are subject to immunity.  As lawsuits predictably will grow in response to COVID-19, this decision, and any subsequent rulings and/or appeal that emanate from it, will inevitably be at the heart of the arguments.

Update: On February 10, 2021, the Court’s decision became a final order of the Court.