By Nathan Adams

Law360 (January 26, 2021, 5:43 PM EST )

Nathan Adams

The executive and judicial branches do not see eye to eye on the scope of Public Readiness and Emergency Preparedness Act immunity.

The U.S. Department of Health and Human Services, in recent months, has taken umbrage at how lower courts have interpreted the 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.

Recently, HHS reiterated its concern that:

[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, 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.

HHS insists that the New York Supreme Court for the County of New York was wrong in Casabianca v. Mt. Sinai Medical Center, in 2014, when it decided that the PREP Act did not immunize the treating physicians' decision not to vaccinate the patient.[3]

According to HHS:

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.

HHS also reiterated that the U.S. District Court for the District of Kansas' 2020 decision in Lutz v. Big Blue Healthcare Inc.,[4] that the act is not equally applicable to the nonadministration or nonuse 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 that 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, in Estate of Maglioli v. Andover Subacute Rehabilitation Center I, the U.S. District Court for the District of New Jersey postulated in August 2020 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," potentially giving 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 guidance from HHS, in Estate of Olive B. Smith v. The Bristol at Tampa Rehabilitation and Nursing Center LLC, the U.S. District Court for the Middle District of Florida 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, the Maglioli case and Sherod v. Comprehensive Healthcare Management Services LLC,  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-health-care 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 health care 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 Biden administration's HHS will concur with the previous 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.

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Nathan A. Adams IV is a partner at Holland & Knight LLP.

The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.

[1] 42 U.S.C. s. 247d-6d(d)-(e).

[2] 42 U.S.C. s. 247d-6d(e).

[3] No. 112790/10, 2014 WL 10413521 (N.Y. Sup. 2014).

[4] No. 2:20-cv-2316, 2020 WL 4815100 (D. Kan. Aug. 19, 2020).

[5]Nos. 20-6605 & 20-6985, 2020 WL 4671091, *9 (D. N.J. Aug. 12, 2020).

[6] Id.

[7] No. 8:20-cv-2798-T-60SPF, 2021 WL 100376 (M.D. Fla. Jan. 12, 2021).

[8] Estate of Maglioli v. Andover Subacute Rehab Ctr. I , Nos. 20-6605 & 20-6985, 2020 WL 4671091 (D.N.J. Aug. 12, 2020); Sherod v. Comprehensive Healthcare Mgmt. Servs., LLC , No. 20cv1198, 2020 WL 6140474 (W.D. Pa. Oct. 16, 2020).

[9] 42 U.S.C. § 247d-6d(i)(6).

[10] Lutz, 2020 WL 4815100, at *7.

[11] 2020 WL 4671091 at *10.

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