Public Readiness and Emergency Preparedness Act

The Public Readiness and Emergency Preparedness Act (PREP Act) added new powers to the federal government under the Public Health Service (PHS) Act, and provides immunity from liability for the use of covered medical countermeasures against chemical, biological, radiological and nuclear agents of terrorism, epidemics, and pandemics. First enacted in 2005 and amended since then, the PREP Act further conferred authority for establishing a program to compensate eligible individuals who suffer injuries from administration or use of products which are immunized against liability by the immunity provisions in the PREP Act.

At least two decisions have upheld immunity for the administration of vaccines, under the PREP Act.

Conditions

The Secretary of HHS may declare a medical countermeasure based on one or more of the following:

• A qualified pandemic or epidemic product;
• A security countermeasure;
• An unapproved drug, biological product, or device used under an Emergency Use Authorization (EUA) issued by FDA;
• An approved drug, biological product, or device used pursuant to Federal law in conditions that are in consistent with its approval ; or
• An unapproved drug, biological product, or device, or an approved drug, biological product, or device intended for an unapproved use, that is intended for emergency use and shipped and held by a government agency or someone working on that agency’s behalf for use only when that use is authorized.

Declaration

The Declaration is by the Secretary of Health and Human Services. It is published in the Federal Register, but is effective upon signature rather than upon publication.

Litigation

As a Federal District Court held on August 19, 2020, in connection with COVID-19:

“

Plaintiffs' complaint is admittedly broadly written, as most complaints are. But drilled down, Plaintiffs allege that the decedent died of COVID-19 because Defendants failed to take preventative measures to stop the entry and spread of COVID-19 within the facility. Plaintiffs contend that Defendants' failure to take those precautions led to the decedent contracting and dying of COVID-19. But nowhere in the complaint do Plaintiffs suggest that the decedent's death was causally connected to the administration or use of any drug, biological product, or device (i.e. a covered countermeasures). The claim seems to be precisely the opposite: that inaction rather than action caused the death. There is very limited caselaw on the applicability of the PREP Act. Very recently, the District of New Jersey remanded a similar group of cases to state court. Like here, those cases involved allegations that residents at a care facility contracted COVID-19 because of the defendants' failure to exercise due care. The allegations included the failure to observe a variety of safety and infection-prevention protocols. Estate of Maglioli, et al. v. Andover Subacute Rehabilitation Ctr., 2020 WL 4671091, at *1-*2 (D.N.J. 2020). The plaintiffs sued in state court for negligence, and the defendants removed the case to federal court. Id. The court, on the plaintiffs' motions to remand, compared the allegations to the PREP Act and found the PREP Act inapplicable. Id. at *9-*10. Specifically, the court concluded that a malpractice claim about countermeasures that were not used "would not be preempted by the PREP Act, which is designed to protect those who employ countermeasures, not those who decline to employ them." Id. at *9. In an earlier case evaluating the PREP Act in the context of the H1N1 influenza pandemic, a New York state court likewise concluded that the PREP Act does not apply to inaction. In Casabianca v. Mount Sinai Medical Center, the decedent had been hospitalized for a medical procedure but was not given the H1N1 influenza vaccine. He was later exposed to H1N1 and died. His family sued the hospital for medical malpractice and wrongful death. Casabianca v. Mount Sinai Med. Ctr., 2014 WL 10413521, at *1 (N.Y. Sup. 2014). The defendants sought protection under the PREP Act. The court noted that immunity under the PREP Act is limited to claims "resulting from the administration . . . or use" of a covered countermeasure, and that non-administration is not addressed, noting that "[n]othing is spoken of regarding a decision not to use the vaccine or of a failure to use it." Id. at *3-*4. Parker v. St. Lawrence County Public Health Department involved the administration of a vaccine to a child without parental consent. Parker v. St. Lawrence Cty. Pub. Health Dept., 102 A.D.3d 140, 141, 954 N.Y.S.2d 259 (N.Y. App. Div. 2012). The court applied the PREP Act and conclude the plaintiff's claim was preempted. Id. at 143-44. Defendants argue that Parker necessarily involved a claim of inaction because it centered on the failure to obtain consent before a vaccine was administered. But in Parker, it was undisputed that the vaccine was administered to the child. There was no question that the claim of loss—administration of a vaccine without consent—was "caused by, [arose] out of, relat[ed] to, or result[ed] from the administration to . . . an individual of a covered countermeasure." See id. at 143; see also 42 U.S.C. § 247d-6d(a)(1). The same cannot be said here. Read together, Maglioli, Casabianca, and Parker support the conclusion that the PREP Act applies to action, not inaction. Defendants generally argue that Plaintiffs' allegations fall within the scope of the PREP Act. But in doing so, they generally just re-write Plaintiffs' allegations using the language of the PREP Act—language never actually used in Plaintiffs' complaint. They also argue that allegations that the facility failed to provide adequate protections invokes all devices and other interventions that the facility did use. But the complaint says almost nothing about any interventions—drugs, devices, etc.—that were used, and there are no allegations that the administration or use of any of those things caused the death of the decedent. Again, the allegations are the opposite—that Defendants' failure to act caused the decedent's death. To the extent Defendants want to argue that the PREP Act applies, they must do so based on the complaint as it is—not as Defendants would prefer it to be. Caterpillar, 482 U.S. at 396-97 (noting that a defendant cannot ignore the allegations in the complaint and argue "that there are different facts [a plaintiff] might have alleged that would have constituted a federal claim" so that it can "justify removal on the basis of facts not alleged in the complaint"). Defendants also argue that Plaintiffs interpret the PREP Act too narrowly in several ways. First, they argue that the PREP Act does not only apply to injuries "caused" by the administration or use of a covered countermeasure, but also to injuries "arising out of, relating to, or resulting from" their administration or use. See 42 U.S.C. § 247d-6d(a)(1). That is a correct statement of the PREP Act. But Defendants fail to meaningfully connect this to any allegation in Plaintiffs' complaint. Again, Plaintiffs' case is premised on inaction. There is no clear allegation that any injury or claim of loss was caused by the administration or use of any covered countermeasure, let alone that the loss arose out of, related to, or resulted from the same. Second, Defendants argue that "administration or use" is not only defined as the "physical provision" of countermeasures. Defendants are correct that "administration" also covers "activities and decisions directly relating to public and private delivery, distribution and dispensing of the countermeasures to recipients" and the "management and operation of countermeasure programs, or management and operation of locations for purpose of distributing and dispensing countermeasures." Declaration, 85 Fed. Reg. at 15,202. Relying on this definition, Defendant claims that Plaintiffs' allegations are "inextricably intertwined" with Defendants' management and operation of its facility, which must have involved the use of covered countermeasures. But Defendants' parsing of Plaintiffs' allegations on this point is not persuasive. Suffice it to say that the Court is 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. The PREP Act still requires a causal connection between the injury and the use or administration of covered countermeasures, and that link is not present under Defendants' interpretation. Third Defendants argue that the immunity provision of the PREP Act covers "the administration to or use by an individual of a covered countermeasure," which means that it need not be the decedent who received the countermeasure, so long as there was administration of a countermeasure to someone. Again, Defendants correctly recite the language of the PREP Act but ignore the causation language. Plaintiffs' complaint does not allege that the administration or use of a countermeasure to someone else somehow caused the decedent's death. Fourth, Defendants argue that Plaintiffs interpret the definition of "covered countermeasures" too narrowly, and that it extends beyond drugs to biological products, devices, and respiratory protective devices. Again, this is correct. See 42 U.S.C. § 247d-6d(i)(1). But again, Defendants fail to point to any claim in the complaint where Plaintiffs allege that the administration or use of any of these things caused the decedent's death. Fifth, Defendants argue that Plaintiffs' interpretation of the PREP Act does not comport with Congress's intent to provide broad immunity. But Congress's intent to provide broad immunity for the claims covered by the PREP Act does not mean that the PREP Act covers the claims here. Indeed, if Congress intended the PREP Act to apply as broadly as Defendants advocate, it certainly [*21] could have written it to clearly apply to inaction as much as action. Instead, the PREP Act addresses the administration or use of covered countermeasures. There is simply no room to read it as equally applicable to the non-administration or non-use of covered countermeasures. See Estate of Maglioli, 2020 WL 4671091, at *9 (finding that "the PREP Act . . . is designed to protect those who employ countermeasures, not those who decline to employ them"). Accordingly, the Court finds the PREP Act inapplicable. Because the PREP Act does not apply, it cannot be used to establish federal question jurisdiction under the doctrine of complete preemption. Remand is appropriate.

”

Baskin v. Big Blue Healthcare, No. 2:20-cv-2267-HLT-JPO, 2020 U.S. Dist. LEXIS 150012, at *14-21 (D. Kan. Aug. 19, 2020).