Bill of Health -man in glasses sitting in office holds yellow book labeled "PREP Act," PREP act pandemics, nursing home lawsuits

Elderly Plaintiffs Caught in the Fray of PREP Act Immunity

By Jordan Isern, J.D.

As of February 2, 2021, over one-third of U.S. COVID-19 deaths and five-percent of all U.S. COVID-19 cases are linked nursing homes. Unsurprisingly, over fifty-five negligence and wrongful death claims related to COVID-19 have been filed against assisted living facilities in state courts across the country in recent months. The claims are as repetitive as they are tragic. For example:

  • Garnice Robertson, the daughter of a patient at a Kansas nursing home, seeks justice for her mother’s death from COVID-19. Her lawsuit alleges the nursing home was negligent for failing to have adequate staff, prevent infected employees to enter the home, and adopt social distancing.
  • The family of Vincent Martin seeks justice for Vincent, an army veteran, after he died of COVID-19 in his California nursing home. Their lawsuit alleges the nursing home was negligent for failing to have adequate staff.
  • Marc Dupervil, the son of a patient at a Brooklyn nursing home, seeks justice for his father’s death from COVID-19. The lawsuit alleges the nursing home failed to take measures to prevent the spread of the virus, including social distancing, visitor-screening, and wearing masks.
  • Vanessa Sherod, the daughter of a patient at a West Virginia nursing home, seeks justice for her mother’s death from COVID-19. The lawsuit alleges the nursing home failed to take protective measures to prevent the spread of the virus, provide masks, prevent infected workers from working, and failed to close the facility after it was contaminated with COVID-19.

All of these plaintiffs face an uphill battle to even get into court. Their claims are ensnared in the ill-defined purview of new federal immunity under the Public Readiness and Emergency Preparedness Act (“PREP Act”).

The PREP Act authorizes the Health and Human Services Secretary to shield certain healthcare workers from tort liability.[1] Accordingly, in March 2020, then-Secretary Alex Azar exercised this authority and extended tort immunity to the treatment, diagnosis, cure, prevention, or mitigation of COVID-19, in light of the breaking pandemic. However, the scope of this immunity is unclear and state tort claims, especially those alleging failure to “disclose timely, truthful information about COVID-19,” fall directly in its ambiguity. If the Act’s immunity does not apply, these plaintiffs would be able to pursue their claims in state court. But if the Act’s immunity does apply, the plaintiffs would be denied access to justice in any court and would have to file a claim with the federal Countermeasures Injury Compensation Program.

This article discusses: (1) the PREP Act; (2) the central legal issues surrounding its applicability to assisted living facilities; and (3) the impact this legal uncertainty has on plaintiffs.

The PREP Act

The PREP Act was meant for health epidemics. It first passed in 2005, in response to the Avian Flu, and it grants the Secretary of Health and Human Services special authorities only for public health emergencies. One such authority is the power to shield certain healthcare work from tort liability. The immunity provision’s purpose was to incentivize manufacturers to produce vaccines by limiting liability and close a then-existing gap in common law, which placed tort liability on manufacturers for “mass vaccinations.”

According to its text, the Secretary may provide immunity to “covered persons” for liability for loss that has a “causal relationship” with a “covered countermeasure.”

  • “Covered persons” are “qualified persons” who prescribe, dispense, or administer covered countermeasures. This includes assisted living facilities.
  • “causal relationship” is established when the loss relates to the “design, development, clinical testing or investigation, manufacture, labeling, distribution . . . dispensing, prescribing, administration . . . or use” of a “covered countermeasure.”
  • “Covered countermeasures” include vaccines, drugs, biological products, therapeutics, and devices approved or otherwise authorized by the FDA.

The Legal Issues

Prior to the COVID-19 pandemic, PREP Act immunity rarely came up in litigation. In fact, PREP Act immunity was only litigated three times before 2020. But now, courts have decided twelve cases involving PREP Act immunity, and most of these cases involve tort claims against assisted living facilities. Therefore, with scarce case law, plaintiffs face substantial uncertainty in claims against assisted living facilities and must bear the brunt of the work to shape the case law around PREP Act immunity. Right now, there are two legal issues surrounding the application of the PREP Act to “failure to disclose” claims against assisted living facilities.

Preemption

The first legal issue is whether the PREP Act preempts all state tort law claims related to COVID-19. Most plaintiffs file state tort claims in state court, but if the PREP Act preempts state tort law claims, defendants could remove the cases to federal court.

So far, all but one federal district court have rejected preemption defenses and attempts to remove. Most recently, in February 2021, a New York district court found that the PREP Act does not preempt state law tort claims in Dupervil v. All. Health Operations.  The case involved a slew of state law tort claims against an assisted living facility, including wrongful death, negligence, and medical malpractice. The district court rejected preemption, reasoning that the PREP Act does not expressly require the removal of COVID-19 related tort cases from state court to a federal court or so completely preempt or substitute a federal cause of action for the case to require removal.

However, though most district courts have thus far ruled against preemption and removal, there is reason to believe this might change. On January 8, 2021, the Department of Health and Human Services (“HHS”) issued an advisory opinion directly targeting the “spate of recent lawsuits” that have found the PREP Act does not preempt all state tort law claims. It insisted that the PREP Act is a “complete preemption” statute and that the courts interpret the PREP Act in accordance with its advisory opinion.

But so far, most courts have not acquiesced. In fact, in Dupervil v. All. Health Operations, the court expressly refused to heed HHS’s advisory opinion. The court reasoned because the agency did not issue the advisory opinion with the “force or effect of law,” it did not issue the opinion under its rulemaking authority. Thus, the opinion was not entitled to the court’s deference.

At bottom, although the advisory opinion has yet to have a persuasive effect on the courts, it gave fuel to the fire — by giving credence to defendants’ preemption defense claims. Therefore, it is likely the issue of preemption will remain a live issue in the months to come.

Failure to Act

The second legal issue is whether the PREP Act immunity applies to inaction or failure to act. This is most at issue in failure to disclose or other non-feasance negligence or malpractice cases. In these cases, federal district courts often hear and consider preemption and failure to act issues at the same time.

So far, most federal district courts have ruled that PREP Act immunity does not apply to failures to act in most situations. However, courts recognize that PREP Act immunity does apply when the failure to act is causally connected to the administration of a covered countermeasure. In other words, the failure to act must be caused by the administration of a scarce covered countermeasure to another individual. For example, the PREP Act would immunize a doctor from a claim that a plaintiff was harmed because a vaccine was administered to another individual instead of the plaintiff.

However, like preemption, HHS and the courts disagree on this issue. In its January 8, 2021 advisory opinion, HHS addressed the courts’ interpretation that the Act’s immunity does not apply to failures to act. Indeed, HHS repudiated the courts’ narrow interpretation and opined that “[w]here a facility has been allotted a scarce therapeutic purchase by the federal government and the facility fails to administer that therapeutic to an individual . . . the facility’s refusal to administer that therapeutic could still trigger the PREP Act assuming the non-use of the therapeutic was the result of conscious decision-making.” While this was also not entitled to deference, HHS’s insistence on the matter means that the Act’s application to failure to act will remain an ongoing issue.

The Impact on Plaintiffs

Though only one court has found PREP Act immunity applies, these legal issues still present hurdles to plaintiffs’ access to justice even in a friendly court.

First, the question of preemption and removal creates delays in cases against nursing home facilities. In fact, one claimant, Garnice Robertson called the assisted living care facility’s tactics and preemption argument “unfair.” Because the nursing home asserted preemption, Robertson’s case has been subject to “months of delays,” and her lawyers have been prevented from “getting records and interviewing witnesses critical to her case[.]” A District Court Judge also commented on this argument in Vincent Martin’s case, stating such arguments raised “a serious possibility of such removals being used in a cynical, strategic way to stall cases and to extract concessions . . . from opposing plaintiffs.”

Furthermore, just raising the PREP Act complicates the legal issues in these cases. As University of Wyoming Law Professor Mike Duff told Reuters, “Time is money and complexity is time and the more complexity in a case means the less likely the wrongful death claimants will find lawyers to represent them[.]”

In sum, the amorphous scope of PREP Act immunity has subjected plaintiffs to uncertainty and expense in COVID-19-related state tort cases against assisted living facilities. And, in many cases, this uncertainty and expense erect barriers to these plaintiffs’ access to justice.

Conclusion

At bottom, plaintiffs in COVID-19-related state tort cases against assisted living facilities have been swept up into the ill-defined scope of the PREP Act. Though these plaintiffs bear the burden and expense of clarifying the PREP Act’s boundaries, hopefully future litigants will benefit from the development in PREP Act case law during the COVID-19 pandemic.

[1] Notably, the law cannot be invoked to shield workers from liability for “willful misconduct.”

 

This post was originally published on the COVID-19 and the Law blog.

Jordan Isern graduated from Harvard Law School in May 2021.

The Petrie-Flom Center Staff

The Petrie-Flom Center staff often posts updates, announcements, and guests posts on behalf of others.

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