As if experiencing the unspeakable tragedy of the unstoppable spread of COVID-19 among nursing center residents was not punishment enough, some of these same centers are now facing the realities of litigation arising from these unfortunate events. Despite the uncontrollable nature of the virus across all elements of society, the erroneous direction from the Centers for Disease Control and Prevention (CDC) as to how the virus was spread and the profound shortages of personal protective equipment (PPE), trial lawyers seem to have convinced grieving families that nursing centers and their caregivers were somehow at fault for the spread of COVID-19. With liability insurers creatively inserting COVID-19 exclusions into renewal policies, there could be no greater vulnerability than facing litigation without a backstop.

What is to be done now? Simply put, nursing centers need to fight these cases with a defense that features all that they did to protect residents and one another during these darkest hours. This account includes what they were being told at the time by CDC “experts” about the spread of the virus as well as how they used the scarce PPE in their possession to protect residents and staff. These centers should also take advantage of any and all civil liability protections available under state and federal law.

State Protections

Many states have recognized the unfairness of leaving the profession (and other health care sectors) exposed to significant litigation resulting from the relentless spread of a pandemic outside of their control and, instead, adopted reasonable and balanced protections arising from such unprecedented circumstances. Some states inexplicably pulled back those protections, and some never extended them at all.

Those protections were never absolute in nature. Rather, they recognized that only intentional, reckless, or grossly negligent conduct would suffice for liability to attach. Mere negligence was not enough. This effort reflected a reasoned approach that balanced the interests of consumers harmed by the pandemic with those of the health care provider community that did all that they could under the circumstances to combat the virus.

The PREP Act

Nursing centers in states with these liability protections are clearly in the best position to defend themselves from civil actions based upon COVID-19 infections. Those without these protections will need to increasingly rely on the protections of the Public Readiness and Emergency Preparedness Act (PREP Act), a law passed by Congress and signed into law in 2012.

This Act authorizes the Secretary of the Department of Health and Human Services (HHS) to issue a PREP Act declaration. Such a declaration provides immunity for civil liability (except in the instance of willful misconduct) regarding claims:
(1) Of losses caused, arising out of, relating to, or resulting from the administration or use of countermeasures to diseases, threats, and conditions;
(2) Determined by HHS to constitute a present, or credible risk of a future public health emergency; and
(3) Brought against persons or entities involved in the development, manufacturing, testing, distribution, administration, and use of such countermeasures.

The PREP Act balances consumer rights to pursue claims for injuries related to the use of countermeasures employed by covered persons and covered entities during a public health emergency such as a pandemic. While these countermeasures can be as sophisticated as the development of protective vaccines or monoclonal antibodies, they also can be as basic as testing and PPE. The organizations receiving protection from such countermeasures can be as large as an international pharmaceutical company and as small as an independently operated nursing center.

PREP Act Amendments

HHS issued a PREP Act declaration based upon the COVID-19 pandemic in March 2020. This declaration was followed by a handful of amendments to that declaration in 2020 reflecting the dynamics and nuances of the COVID-19 pandemic and has continued to issue new amendments in 2021 and 2022. These amendments were accompanied at times with opinions issued by the Justice Department as to legal determinations related to those amendments.

One of the most important amendments to the declaration involved the situation where a countermeasure in scarce supply was selectively deployed by a covered entity to address the most pressing circumstances. That amendment expressly provided that the selective use of a scarce countermeasure for some patients and non-use for others implicated the protections of the PREP Act just as much as when the countermeasures were fully utilized.

Two Directions for Claims

Under the PREP Act, claims for personal injuries or death related to the use (or non-use) of countermeasures are channeled into one of two directions. Claims alleging conduct rising to the level of “willful misconduct” are required to be filed and adjudicated in the United States District Court for the District of Columbia. All other claims would be subject to resolution through an administrative claims process. As a result, any claims falling under the protections of the PREP Act are to be processed in this fashion. As such, the PREP Act is designed to “completely preempt” all claims falling within its coverage.

Of course, trial lawyers have not honored the provisions of the PREP Act. Instead, they have proceeded to file actions in state courts across the United States regardless of whether they relate to countermeasures or allege willful misconduct. Many providers have sought to have those cases “removed” (i.e., transferred) to the federal courts in order for these cases to be handled consistent with the PREP Act. Not surprisingly, the trial lawyers have resisted these efforts and sought to “remand” (i.e., send back) these cases to state courts.

However, the federal courts deciding whether they should exercise jurisdiction over these cases have largely found that state courts should decide them instead. To date, three different Circuit Courts of Appeal have all determined that federal courts should not decide these cases. However, each of those courts has nevertheless recognized that the PREP Act may well preempt some or all of the claims but that is for state courts to decide.

These decisions are difficult to accept as the entire purpose of the PREP Act was for national uniformity of the handling of claims under its coverage. This purpose will not be fulfilled by hundreds, if not thousands, of state court judges rendering decisions regarding the application of this federal law. That cannot be what Congress expected when it passed the PREP Act.

How to Defend

For now, nursing centers across the nation are defending these cases along with using any state-based civil liability protections and the PREP Act. However, these are not the only tools that can be used in the defense of these facilities. Liability is measured by applying performance against a “standard of care” that was in place at the time of the events in question for determination as to whether the injuries were “caused” by the alleged conduct. These requirements will be difficult to meet for those suing nursing centers for COVID-19 infections. However, it is essential that defense counsel retain knowledgeable and effective experts from the epidemiological and medical communities. Nursing centers will have strong defenses to these cases if they prepare now. AHCA/NCAL and its Legal Committee have been engaged on the likely civil liability ramifications of the COVID-19 pandemic throughout this difficult period. It has partnered with State Affiliates in reviewing cases filed in numerous jurisdictions and co-authored two amicus briefs with the California Affiliate in two PREP Act cases in the 9th Circuit Court of Appeals. AHCA/NCAL will continue to support members experiencing the burdens of unjustified COVID-19 litigation.

Mark ReaganAt some point, it is fair to expect that the scope of the PREP Act may well come before the United States Supreme Court. If and when that occurs, AHCA/NCAL will be there to express the voice of the profession.

Mark Reagan, J.D., is the managing shareholder of Hooper, Lundy & Bookman. He counsels trade associations, including serving as the General Counsel for the California Association of Health Facilities and the Massachusetts Senior Care Association.​