The PREP Act and Vaccines Immunize, But Equally Well?

The executive and judicial branches do not see eye-to-eye on the scope of PREP Act immunity. The U.S. Department of Health and Human Services (HHS), under the current administration, has taken umbrage at how lower courts have interpreted the Public Readiness and Emergency Preparedness Act, Public Law 109-148, Div. C, § 2 (2005) (PREP Act), as amended. By means of its Fourth Amendment to the Declaration under the Act, HHS insists that its Secretary's Declaration must be construed in accordance with HHS advisory opinions.

Days ago, HHS reiterated its concern at a "spate of recent lawsuits, most involving nursing homes and other healthcare facilities, where patients or their estates alleged that patients contracted COVID-19, because the facility, among other things, failed to provide its staff with personal protective equipment ("PPE"), failed to teach the staff how to properly use that equipment, or failed to ensure that its staff used the PPE that it had been given." In light of these cases, HHS has received questions as to whether the PREP Act applies where a covered person declines to use a covered countermeasure when it arguably ought to have been used.

There is no debate that a couple of types of conduct are not immunized. Death or serious physical injury proximately caused by willful misconduct of a covered person is a statutory exception to immunity under the PREP Act.¹ The action must be filed in or transferred under the Act to the U.S. District Court for the District of Columbia.² HHS also agrees that failing to act purposefully or failing to make any decision whatsoever in connection with failing to provide a covered countermeasure is not necessarily protected by the PREP Act.

But disagreement is sharp over whether purposefully failing to inoculate is protected.

Differences of Opinion

The Fourth Amendment states that, if done in accordance with a public health authority's directive, a decision not to inoculate should fall within the PREP Act and Declaration's liability protections. "The court was wrong" in Casabianca v. Mt. Sinai Med. Ctr., HHS insists, when it decided the PREP Act did not immunize the treating physicians' decision not to vaccinate the patient.³ "The plain meaning of 'management and operation of programs for providing countermeasures' includes following CDC vaccine-prioritization guidelines. And if there were any doubt, the plain meaning of 'activities related to' such management and operation is even broader."

Taking on another court, HHS reiterated, the " 'black and white' view" in Lutz v. Big Blue Healthcare, Inc.,⁴ that the Act is not " 'equally applicable to the non-administration or non-use of a covered countermeasure' … clashes with the plain language of the PREP Act."

It is not just when covered persons follow public directives that HHS believes there may be immunity. HHS states, "There can potentially be other situations where a conscious decision not to use a covered countermeasure could relate to the administration of the countermeasure" subject to the willful misconduct boundary. In contrast, the court in Estate of Maglioli v. Andover Subacute Rehab. Ctr. I, postulated that if a physician "made a decision to do nothing," despite a threatened outbreak of COVID-19, and that decision "lay outside the realm of reasonable medical judgment, it could give rise to a malpractice claim" that the PREP Act would not preempt.⁵ Driving home the point, the court concluded that the Act "still leaves room for ordinary claims of negligent or substandard care."⁶

The Fourth Amendment and HHS advisory opinions support federal preemption under the PREP Act that would remove these kinds of cases from state court in accordance with the complete preemption doctrine. Even when a plaintiff pleads nonfeasance, HHS encourages federal courts to allow jurisdictional discovery to determine the facts. The HHS Secretary added in the Fourth Amendment and the advisory opinion reiterated that the response to the COVID-19 pandemic requires a "unified, whole-of-nation response," so federal courts ought to hear claims recognized under state law that turn on substantial questions of federal law and policy.

Even more recent than the Jan. 8, 2021, guidance from HHS, a district court in Estate of Olive B. Smith v. The Bristol at Tampa Rehab. and Nursing Ctr., LLC still remanded a case that the defendant removed to federal court under the PREP Act, ruling that the complete preemption doctrine was inapplicable and that it is well established that a defendant may not remove a case to federal court based on the existence of a federal defense. ⁷ The court observed that it was ruling in line with the preceding decisions such as Lutz that HHS disapproves. Two of these decisions are being appealed.⁸

Takeaways and Considerations

Plenty more scenarios will test the limits of PREP Act immunity. Some will turn on categories of "covered persons." For example, a "program planner" includes a person who supervises or administers the administration, dispensing, distribution, provision or use of a vaccine. ⁹ The Fourth Amendment states that administration of covered countermeasures includes operation of locations for the purpose of distributing and dispensing countermeasures. This will include a wide variety of non-healthcare providers assisting with the distribution of the vaccine, but the scope of this protection is unchartered in the courts. Treatment might vary, for example, if a serum recipient trips and falls in a program planner's vaccination tent versus the other end of the mall.

More commonly, PREP Act immunity will turn on whether there was a causal relationship with the administration or use of a covered countermeasure. Therefore, the court in Lutz declared it was "not convinced that a facility using covered countermeasures somewhere in the facility is sufficient to invoke the PREP Act as to all claims that arise in that facility."¹⁰ Beyond this, the PREP Act naturally applies only to covered countermeasures. In Estate of Maglioli, the court observed that "many of the measures with which Defendants allegedly failed to comply" were not in this category; e.g., " 'social distancing, quarantining, lockdowns and others.' "¹¹ Some states have adopted immunities of their own by executive order or legislation that could fill some of these immunity gaps. This requires a state-by-state evaluation.

Congress intended to provide broad immunity under the PREP Act to a covered person with respect to claims for loss relating to the administration of the vaccine. The protection and willingness of healthcare providers, businesses, schools and others to assist is critical to ensure rapid dissemination of the vaccine. But whether the PREP Act will inoculate as well as the vaccines depends a great deal on whether the incoming Biden Administration's HHS will concur with the current HHS and, more importantly, whether federal courts of appeal will concur with HHS' current views or affirm the district courts. Until then, covered persons should proceed cautiously.

Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your Holland & Knight representative or other competent legal counsel.