COVID-19 Vaccinations Are Coming, But What Will the PREP Act Immunize?

The Public Readiness and Emergency Preparedness Act, Public Law 109-148, Div. C, § 2 (2005) (PREP Act), as amended, authorizes the Secretary of Health and Human Services (HHS) to limit legal liability for losses relating to the administration of medical countermeasures. (See Holland & Knight's previous alert, "PREP Act: Liability Protection Is Available During COVID-19 Pandemic," May 18, 2020.) Due to the recent announcements of successful trials for a COVID-19 vaccine, healthcare providers are asking about the extent to which the PREP Act will protect them against liability under state and federal law.

The bottom line of the few cases that have examined the question is that the PREP Act is likely to preempt state claims relating to the administration of a vaccine but unlikely to cover the failure to administer the vaccine or, more generally, the care received by patients at healthcare facilities.

PREP Act Immunity Requirements

As background, the requirements for PREP Act immunity break down as follows: 1) the individual or entity must be a "covered person"; 2) the legal claim must be for a "loss"; 3) the loss must have a "causal relationship" with the administration or use of a covered countermeasure; and 4) the medical product that caused the loss must be a "covered countermeasure."

Individuals who die or suffer serious injuries caused by the administration of covered countermeasures are eligible to receive compensation through the Countermeasures Injury Compensation Program.

"Covered persons" include, inter alia, "qualified persons" who prescribe, administer or dispense covered countermeasures. 42 U.S.C. § 247d-6d(i)(2)-(4), (6), (8)(A) and (B). "All claims for loss" under federal and state law include death; physical, mental or emotional injury; illness; disability or condition; fear of such injury including medical monitoring costs; and loss of or damage to property, including business interruption loss. Id. (a)(2)

A loss has a "causal relationship" if pertaining to the "design, development, clinical testing or investigation, manufacture, labeling, distribution, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing or use" of a "covered countermeasure," which includes vaccines against COVID-19. 42 U.S.C. § 247d-6d(i)(1) and (7).

Secretary of HHS Alex Azar invoked the PREP Act, effective Feb. 4, 2020, and declared COVID-19 to be a public health emergency warranting liability protections for covered countermeasures. The Secretary has said that the PREP Act precludes liability claims 1) alleging "negligence by a health care provider in prescribing the wrong dose, absent willful misconduct" and 2) "relating to the management and operation of a countermeasure distribution program or site, such as a slip-and-fall injury or vehicle collision by a recipient receiving a countermeasure … ." But "an injury occurring at the site that was not directly related to the countermeasure activities is not covered … ."

Limited Case Law

There is limited case law addressing the applicability of the PREP Act. In Estate of Maglioli v. Andover SubAcute Rehab Ctr. I, Nos. 20-6605 & 20-6985, 2020 WL 4671091 (D.N.J. Aug. 12, 2020), the estates of nursing home residents who died allegedly due to the nursing homes' failure to take precautions against COVID-19 sued for negligence, wrongful death and medical malpractice. The defendants removed the case on the theory that field preemption by the PREP Act barred the claims.

The court disagreed that the PREP Act occupies the field of negligence or malpractice claims and disagreed that removal on this basis would be proper anyway. According to the court, "Nothing in the language of the [PREP] Act suggests that it was intended to more broadly displace state-law causes of action for, e.g., malpractice or substandard care – even if proper care possibly would have entailed administration of such countermeasures."

The court added that the Act "covers the administration and distribution of products meant to curb the spread of COVID-19," but "does not, by its plain terms, cover more generally the care received by patients in healthcare facilities," such as a facility decision to do nothing in the face of an outbreak of COVID-19 at the facility.

Importantly, the Maglioli court distinguished Parker v. St. Lawrence Cnty. Pub. Health Dep't, 102 A.D. 3d 140, 954 N.Y.S.2d 259 (3d Dep't App. Div. 2012), relied on by the defendants. In St. Lawrence, parents of a minor sued a school district that administered H1N1 influenza vaccination to their child without their permission. The court determined that the PREP Act preempted their negligence and battery claims. The Maglioli court decided this was because administering the vaccine was explicitly defined in the PREP Act as a covered countermeasure, whereas the estates claimed that their injuries arose from the nursing homes' failure to take countermeasures.

Courts in several more cases have followed this approach. For example, in a series of cases against Big Blue Healthcare (see, e.g., Lutz v. Big Blue Healthcare, Inc., No. 2:20-cv-2316, 2020 WL 4815100 (D. Kan. Aug. 19, 2020)), a surviving relative sued an assisted care facility for wrongful death. Defendants removed the case and the court remanded because the PREP Act did not preempt claims for failure to take preventative measures. The court observed, "[A] facility using covered countermeasures somewhere in the facility" is not "sufficient to invoke the PREP Act as to all claims that arise in that facility."

In Sherod v. Comprehensive Healthcare Mgmt. Servs., LLC, the court ruled likewise on behalf of the administrator of a deceased employee of a rehabilitation facility exposed to COVID-19 while working and infected. The Sherod and Lutz courts relied in part on Casabianca v. Mt. Sinai Med. Ctr., 2014 WL 1043521 (N.Y. Sup. 2014), where a hospital was not immunized against liability by the PREP Act when it decided against administering a vaccine for the H1N1 flu to a patient hospitalized for a medical procedure who later contracted and died from it.

According to Casabianca, Sherod and Lutz, immunity under the PREP Act is limited to claims resulting from the administration or use of a covered countermeasure, whereas "[n]othing is spoken of regarding a decision not to use the vaccine or of a failure to use it." The holdings of the few cases to consider the issue are clear: Failure to immunize medically will result in a failure to immunize legally, whereas medical immunization may lead to legal immunization of the administration of the vaccine.

DISCLAIMER: Please note that the situation surrounding COVID-19 is evolving and that the subject matter discussed in these publications may change on a daily basis. Please contact your responsible Holland & Knight lawyer or the author of this alert for timely advice.

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.