Sometimes The PREP Act Does NOT Apply (Part 2)
Based upon their rulings in the cases below, the 2nd, 3rd, 5th, 6th, 7th and 9th Circuit Courts and a number of district and state courts seem to properly understand the limits of the PREP Act.
In my humble opinion, the PREP Act violates the Constitution in at least three ways and it also violates at least 5 (and maybe even 6) of the Amendments to the Constitution.
I also believe that the manner in which the PREP Act has been administered by the Executive branch has violated both the letter and the spirit of the PREP Act itself and has also violated the Administrative Procedure Act.
However, this article is not about any of the above issues.
This article provides a summary of court cases that have successfully threaded the needle (to varying degrees) in the search for justice for those who have been harmed and killed by the Pharmaceutical Hospital Emergency Industrial Complex.
As horrible as the PREP Act is, it does NOT protect anyone from criminal prosecution.
The PREP Act also does NOT protect those who infringe upon Constitutionally protected rights or violate state laws governing the general practice of medicine.
There are some situations where the PREP Act does NOT apply:
Insufficient link to countermeasures: Some claims are not directly related to the administration of countermeasures but rather to general issues like staffing or infection control.
Negligence claims: The PREP Act does not automatically preempt all state law negligence claims. Lawsuits claiming negligence other than the administration of a covered countermeasure are NOT prevented by the PREP Act.
Failure to use countermeasures: The PREP Act typically DOES provide immunity for the use or administration of countermeasures, not for failing to use Many courts have held that the PREP Act provides no immunity for a healthcare provider's failure to use countermeasures, such as not implementing social distancing or providing proper PPE.
For example, lawsuits brought in state courts involving nursing homes where patients were injured or harmed by something other than a “covered countermeasure” (such as poor or negligent care, malpractice, failure to receive proper consent, etc.) should NOT have been dismissed based on the protections provided by the PREP Act.
IN PLAIN ENGLISH:
Some civil court cases (very few) have been presented and argued in a clear and specific way by lawyers who have successfully interpreted the PREP Act and properly addressed the very specific and unique circumstances faced by their clients. In general, the harms suffered by their clients were caused by something other than a “covered countermeasure.”
Other than the few cases listed below, the vast majority of harm and death that has been caused by the Pharmaceutical Hospital Emergency Industrial Complex has gone unpunished due to the protection from lawsuits and liability provided by the PREP Act.
THE PREP ACT MUST BE REPEALED
DETAILS: REPEALThePREPAct.com
SIGN THE PETITION: REPEALThePREPAct.ORG
Washington DC District Court
Estate of George Watts, Jr., v. Lloyd J. Austin III, Secretary of Defense
[This case is still active.]
In the ONLY case alleging willful misconduct in the administration of a “covered countermeasure” that has been properly filed in Washington DC District Court under the PREP Act, attorney Ray Flores is still awaiting his day in court in the lawsuit that was filed against the DOD by the family of George Watts Jr., a 24-year-old college student who died from complications of COVID-19 vaccine-induced myocarditis.
Circuit court cases that ruled that the PREP Act did NOT provide protection from lawsuit or liability:
The United States Courts of Appeals are the intermediate appellate courts that review decisions made by the district courts within their specific geographic regions. There are 12 regional circuit courts, plus the Federal Circuit, which has nationwide jurisdiction over specific types of appeals, making a total of 13 circuit courts.
Based upon their rulings in the cases below, the 2nd, 3rd, 5th, 6th, 7th and 9th Circuit Courts seem to properly understand the limits of the PREP Act.
Second Circuit
Solomon v. St. Joseph Hospital, 62 F.4th 54 (2nd Cir. 2023)
Plaintiff sued Defendants St. Joseph Hospital and Catholic Health System of Long Island, Inc. for injuries he sustained at St. Joseph Hospital, where he was admitted in March 2020 with COVID-19. Plaintiff brought claims for malpractice, negligence, and gross negligence in New York state court. Defendants removed the case to the New York district court and moved to dismiss for lack of subject-matter jurisdiction. Defendants asserted state and federal immunities under the Emergency or Disaster Treatment Protection Act (“EDTPA”) and the Public Readiness and Emergency Preparedness Act (“PREP Act”). The district court denied Defendants’ motion to dismiss.
The Second Circuit vacated the district court’s order and remanded with directions to remand the case to state court. The court concluded that removal to federal court was improper because the district court lacked jurisdiction to hear the case.First, Plaintiff’s state-law claims are not completely preempted by the PREP Act.
Second, there is no jurisdiction under the federal-officer removal statute because Defendants did not “act under” a federal officer.
Finally, Plaintiff’s claims do not “arise under” federal law.
https://law.justia.com/cases/federal/appellate-courts/ca2/21-2729/21-2729-2023-03-07.html
Rivera-Zayas v. Our Lady of Consolation Geriatric, 2023 U.S. App. LEXIS 8827 (2d Cir. 2023)
Ana Martinez was one of 39 residents of Our Lady of Consolation Geriatric Care Center (OLOC), a nursing home in West Islip, New York, who died of COVID-19 in the Spring of 2020. Her daughter, Vivian Rivera-Zayas, filed a lawsuit against OLOC in June 2020, in New York state court, arguing that her mother’s death was the result of OLOC’s inadequate infection control policies and procedures—inadequacies that it had been cited for even before the COVID-19 pandemic.
OLOC removed the case from state court to federal court in reliance on 28 U.S.C. § 1442(a), the federal-officer removal statute. OLOC claimed that it was “acting under” the direction of a federal officer when operating its nursing homes because it was subject to heavy regulation as part of its participation in the Medicare and Medicaid programs and because the federal government had issued guidance on infection control in nursing homes.
It also argued that the Public Readiness and Emergency Preparedness (PREP) Act, a statute enacted in 2005 to encourage the production and distribution of vaccines, “completely preempted” the Ms. Rivera-Zayas’s claims and thus provided a basis for federal-court jurisdiction.
In August 2021, the district court rejected OLOC’s arguments and remanded the case to state court.
OLOC appealed the remand order to the Second Circuit.
Public Citizen represents Ms. Rivera-Zayas on appeal. The appellate brief explains that regulation and non-binding guidance do not create a relationship that satisfies the “acting under” requirement of § 1442(a). the brief also explains that the PREP Act has no application to the claims in this case, which do not arise from OLOC’s “use or administration” of any “covered countermeasures,” as those terms are used in the PREP Act, but from OLOC’s policies of non-use and negligent failure to provide a safe environment for its residents.
Moreover, the brief explains, Congress did not confer federal-court jurisdiction over every case that involves the question whether the immunity defense provided by the PREP Act applies to a state-law claim. After the Second Circuit decided the related case of Solomon v. St. Joseph Hospital, we filed a supplemental brief arguing that that decision required affirmance of the district court’s remand order.
In April 2023, the court issued an opinion agreeing with our arguments and affirming the district court’s decision.
https://www.citizen.org/litigation/rivera-zayas-v-our-lady-of-consolation-geriatric-care-center/
Third Circuit
Maglioli v. Alliance HC Holdings LLC, 16 F.4th 393, 400 n.2 (3rd Cir. 2021)
The estates of New Jersey nursing home residents, who died from COVID-19, alleged that the nursing homes acted negligently in handling the COVID-19 pandemic. The nursing homes removed the case to federal court.
The district court dismissed the cases for lack of subject-matter jurisdiction.
The Third Circuit affirmed rejecting three arguments for federal jurisdiction: federal-officer removal, complete preemption of state law, and the presence of a substantial federal issue.
The 2005 Public Readiness and Emergency Preparedness Act (PREP Act), 42 U.S.C. 247d-6d, 247d6e, which protects certain individuals—such as pharmacies and drug manufacturers—from lawsuits during a public-health emergency, was invoked in March 2020 but does not apply because the nursing homes did not assist or help carry out the duties of a federal superior.
The PREP Act creates an exclusive cause of action for willful misconduct but the estates allege only negligence, not willful misconduct; those claims do not fall within the scope of the exclusive federal cause of action and are not preempted. The PREP Act’s compensation fund is not an exclusive federal cause of action.
https://law.justia.com/cases/federal/appellate-courts/ca3/20-2833/20-2833-2021-10-20.html
Fifth Circuit
Mitchell v. Advanced HCS, L.L.C., 28 F.4th 580 (5th Cir. 2022)
Plaintiff filed suit against Wedgewood in Texas state court after his mother, Emma Mitchell, died in a nursing home. Plaintiff alleged state-law causes of action for medical negligence, corporate negligence, and gross negligence.
After removal to federal court, the district court granted plaintiff's motion to remand to state court.
The Fifth Circuit affirmed the district court's judgment, concluding that the Public Readiness and Emergency Preparedness (PREP) Act does not completely preempt plaintiff's state-law negligence claims.The court explained that, because the compensation fund created by the Act does not satisfy this Circuit's test for complete preemption, and because plaintiff could not have brought his claims under the willful-misconduct cause of action, those claims are not completely preempted.
The court also rejected Wedgewood's claim that plaintiff's claims raise a significant federal issue that creates federal jurisdiction under the Grable doctrine. The court concluded that Wedgewood cannot avail itself of the federal officer removal statute because it failed to satisfy the third prong of the test where it was not acting pursuant to a federal officer's directions.
Accordingly, the court remanded with directions to further remand to the appropriate state court.
https://law.justia.com/cases/federal/appellate-courts/ca5/21-10477/21-10477-2022-03-10.html
Manyweather v. Woodlawn Manor, No. 21-30718 (5th Cir. 2022)
Plaintiffs sued a nursing home and its insurer in state court after their mother contracted COVID-19 at the facility and died. The home, Woodlawn Manor, removed the action to federal court. After dismissing Plaintiffs’ federal claims, the district court remanded to state court, declining supplemental jurisdiction over the state-law claims that remained.
Woodlawn contested that remand arguing that the state-law claims pose federal questions that the district court could and should have heard. Further, Woodlawn argued that even if those claims did not pose federal questions the court should have exercised supplemental jurisdiction over them despite having dismissed all federal claims.
The Fifth Circuit affirmed holding the Public Readiness and Emergency Preparedness Act (“PREP” or “Act”) does not preempt state-law negligence claims.Second, Plaintiffs did not plead willful-misconduct claims. But even if they had, they could not have brought them under the Act.
Further, Plaintiffs asserted state-law claims for negligence. Under Mitchell, the PREP Act does not preempt those claims, so they cannot support original federal jurisdiction. Thus, because Plaintiffs’ factual allegations, taken as true, do not state and could not support a willful-misconduct claim under the Act, there is no federal question here.
https://law.justia.com/cases/federal/appellate-courts/ca5/21-30718/21-30718-2022-07-07.html
Sixth Circuit
Hudak v. Elmcroft of Sagamore Hills, 58 F.4th 845, 853 (6th Cir. 2023)
In May 2020, Koballa died of COVID-19. Hudak, the executrix of Koballa’s estate, sued, asserting negligence and related state-law claims against Elmcroft, an assisted-living facility. Elmcroft removed the case to federal court under the general removal statute, 28 U.S.C. 1441(a), and the federal-officer removal statute, 28 U.S.C. 1442(a)(1), based on arguments it made under the Public Readiness and Emergency Preparedness Act (PREP), 42 U.S.C. 247d-6d.
The district court found that the PREP Act did not provide grounds for removal under either removal statute and remanded the case to state court for lack of subject-matter jurisdiction. The Sixth Circuit affirmed.Hudak does not allege that Elmcroft engaged in willful misconduct in the administration or use of a covered COVID-19 countermeasure, so the PREP Act does not “provide[] the exclusive cause of action for the claims” and does not completely preempt Hudak’s state-law claims. Hudak’s state-law claims do not arise under federal law and could not be removed.
Elmcroft is not a "federal officer"; it operated a facility that came under significant federal regulation as part of the federal government’s COVID-19 response but did not have an agreement with the federal government, did not produce a good or perform a service on behalf of the government, and has not shown that the federal government exercised control over its operations to such a degree that the government acted as Elmcroft’s superior.
https://law.justia.com/cases/federal/appellate-courts/ca6/21-3836/21-3836-2023-01-23.html
Lisa Kay Goins v. St. Elizabeth Med. Ctr., No. 22-6070 (6th Cir. 2024)
In this case, a patient brought claims alleging negligent medical care against a physician and the hospital where she was treated, as well as claims against two other defendants. As relevant here, the physician and hospital moved to dismiss on the theory that they were immune from liability under the Public Readiness and Emergency Preparedness (PREP) Act because the patient had received a COVID-19 vaccine.
The district court denied the motion, concluding that PREP Act immunity did not apply because the patient’s allegations against them did not concern “administration or use” of a covered countermeasure, as is required for immunity under the PREP Act.
The physician and hospital appealed, making a new argument: that the PREP Act’s immunity provision applied to the injuries allegedly incurred during a diagnostic procedure performed by the physician, because unspecified doctors had remarked that the patient’s condition “could” have been a side effect of the COVID-19 vaccine. Public Citizen filed an amicus brief addressing that argument and explaining that such remarks were not enough to establish the applicability of the PREP Act defense.
In January 2024, the Sixth Circuit affirmed the district court’s denial of immunity, adopting our reasoning and rejecting the immunity defense because the complaint did not allege a connection between the vaccine and the plaintiff’s injury.
https://www.citizen.org/litigation/goins-v-st-elizabeth-medical-center/
Seventh Circuit
Martin v. Petersen Health Operations, LLC, 37 F.4th 1210 (7th Cir. 2022)
While residing in a nursing home, Hill died of COVID-19. Her estate sued in state court under the Illinois Nursing Home Care Act, The defendant removed the suit to federal court, asserting that Martin’s suit necessarily rests on federal law, 28 U.S.C.1441(a), and that it was “acting under” a federal officer under 28 U.S.C.1442(a)(1).
The district judge remanded to state court. The Seventh Circuit affirmed.
The nursing home is subject to extensive federal regulation (especially for Medicare or Medicaid reimbursement), and CDC orders during the pandemic have increased that regulatory burden but regulation does not turn a private entity into a public actor.
The Public Readiness and Emergency Preparedness Act, 42 U.S.C. 247d, forbids liability under state law for injuries caused by use of a “covered countermeasure”, and creates a federal claim for injuries caused by “willful misconduct” in connection with covered countermeasures (payable from a federal fund), but does not preempt any other kind of claim nor occupy the field of health safety. The estate’s claims are not even arguably preempted. The principal disputes in this suit are likely to be whether the nursing home allowed members of the staff to work while ill or failed to isolate residents who contracted COVID-19, which are unrelated to federal law.
https://law.justia.com/cases/federal/appellate-courts/ca7/21-2959/21-2959-2022-06-15.html
Ninth Circuit
Saldana v. Glenhaven Healthcare LLC, 27 F.4th 679 (9th Cir. 2022)
Relatives of Saldana, who died from COVID-19 at Glenhaven nursing home, sued Glenhaven in California state court, alleging state-law causes of action. Glenhaven removed the case to federal court. The Ninth Circuit affirmed a remand to state court.
The district court lacked jurisdiction under the federal officer removal statute, 28 U.S.C. 1442, because Glenhaven did not act under a federal officer or agency’s directions when it complied with mandatory directives from the Centers for Medicare and Medicaid Services, the Centers for Disease Control and Prevention, and the Department of Health and Human Services.
The claims were not completely preempted by the Public Readiness and Emergency Preparedness Act, which provides immunity from suit when the HHS Secretary determines that a threat to health constitutes a public health emergency, but provides an exception for an exclusive federal cause of action for willful misconduct. A March 2020 declaration under the Act provided "liability immunity for activities related to medical countermeasures against COVID-19.” The Act does not displace non-willful misconduct claims related to the public health emergency, nor did it provide substitute causes of action. The federal scheme was not so comprehensive that it entirely supplanted state law claims.
The district court did not have jurisdiction under the embedded federal question doctrine, which applies if a federal issue is necessarily raised, actually disputed, substantial, and capable of resolution in federal court without disrupting the federal-state balance approved by Congress.https://law.justia.com/cases/federal/appellate-courts/ca9/20-56194/20-56194-2022-02-22.html
State courts to resolve claims:
Following the U.S. Supreme Court's denial of certiorari in Saldana v. Glenhaven Healthcare LLC, the issue of whether PREP Act immunity applies to state-law claims continues to be decided on a case-by-case basis by state courts.
Michael Hampton, et al v. State of California, et al, No. 22-15481 (9th Cir. 2023)
Early in the COVID-19 pandemic, the California Institution for Men (“CIM”) suffered a severe COVID-19 outbreak. In an attempt to protect CIM inmates, high-level officials in the California prison system transferred 122 inmates from CIM to San Quentin State Prison, where there were no known cases of the virus. The transfer sparked an outbreak of COVID-19 at San Quentin that infected over two-thousand inmates and ultimately killed over twenty-five inmates and one prison guard. The wife of one of the deceased inmates sued, claiming that the prison officials had violated her husband’s constitutional and statutory rights. The officials moved to dismiss, asserting that the claims were barred by various federal and state immunities, including immunity under the Public Readiness and Emergency Preparedness Act and qualified immunity.
The district court held that the officials were not entitled to immunity at this stage of the proceedings, and the officials filed this interlocutory appeal.
The Ninth Circuit affirmed in part and reversed in part the district court’s order denying Defendants’ motion to dismiss on the basis of immunity under the PREP Act and qualified immunity in an action brought against California prison officials arising from the death of a San Quentin inmate from COVID-19;and (2) dismissed for lack of jurisdiction Defendants’ claims asserting immunity under state law.
The panel held that Defendants were not entitled to qualified immunity on plaintiff’s Eighth Amendment claim, which adequately alleged that Defendants acted with deliberate indifference to the health and safety of San Quentin inmates, including Hampton.
https://law.justia.com/cases/federal/appellate-courts/ca9/22-15481/22-15481-2023-10-03.html
Emma Martin, et al v. Serrano Post Acute LLC, et al, No. 21-55400 (9th Cir. 2023)
The court affirmed the remand to state court, finding that the defendants were precluded from relitigating federal jurisdiction claims that had already been decided in an earlier appeal.
https://law.justia.com/cases/federal/appellate-courts/ca9/21-55400/21-55400-2023-06-21.html
Federal district court decisions that ruled the PREP Act did NOT provide protection from lawsuit or liability:
Dupervil v. Alliance Health Operations, 516 F. Supp. 3d 238 (E.D.N.Y. 2021): The court ruled that the PREP Act was not a complete preemption statute and remanded the case to state court.
Grohmann v. HCP Prairie Village KS OpCo LLC, 516 F. Supp. 3d 1267 (D. Kan. 2021): “In enacting the PREP Act, Congress created federal remedial rights. But plaintiff’s claims do not fall within the scope of those remedies.” The court refused to preempt state claims, finding that a care facility's failure to use a countermeasure was not protected by PREP Act immunity.
Estate of Winfred Cowan v. LP Columbia KY, LLC, No. 1:20-CV-00118-GNS (W.D. Ky. March 31, 2021): Remanded the case back to state court, determining that the PREP Act did not completely preempt the state law claims.
Brown v. Big Blue Healthcare, Inc., No. 20-2443, 2021 WL 1196445 (D. Kan. Mar. 30, 2021): “The Court agrees that the PREP Act's provisions regarding the administration or use of covered countermeasures are not applicable to the allegations in this case, which allege negligence stemming from a failure to follow certain policies, procedures, and guidelines regarding COVID-19. Accordingly, this Court lacks subject-matter jurisdiction and remands this case to state court.” Originally a federal case, it, along with a dozen related COVID-19 death cases from the same facility, was remanded to state court after the district court found the PREP Act inapplicable to the alleged failure to take preventive measures.
Maltbia v. Big Blue Healthcare, Inc., No. 20-2607-DDC-KGG, 2021 WL 1196445 (D. Kan. Mar. 30, 2021): The court determined the PREP Act was not triggered because the alleged negligence—failure to use covered countermeasures—did not fall within the use or administration of those countermeasures.
State court decisions that ruled that the PREP Act did NOT provide protection from lawsuit or liability:
Gunter v. CCRC OPCO-Freedom Square, LLC (M.D. Fla. 2020): The court determined the PREP Act did not apply to claims that a nursing home failed to provide adequate medical supplies and maintain cleaning standards, reducing the cleaning practices in the facility and failing to effectively communicate with defendants’ residents and families had nothing to do with “the administration of a qualified pandemic or epidemic product, drug, biological product, or device for which the PREP Act provides immunity” as these were not related to administering a qualified product.
Emma Martin v. Serrano Post Acute LLC (C.D. Cal. 2020): The court determined the PREP Act was inapplicable to allegations that a nursing facility failed to properly staff, prevent spread, or react to COVID-19 infections.
Sherod v. Comprehensive Healthcare Management Services, LLC, 2020 WL 6140474 (W.D. Pa. Oct. 16, 2020): Plaintiff’s claim were outside the PREP Act because the complaint alleges defendant failed to provide decedent with any protection/countermeasures.
Happel v. Guilford County Board of Education, 913 S.E.2d 174 (N.C. 2025): An appeals court in North Carolina found that state constitutional claims regarding forced vaccination were not preempted by the PREP Act. The court also clarified that immunity applied only where countermeasures were obtained voluntarily.
A fourteen-year-old boy, Tanner Smith, was vaccinated against COVID-19 at his school clinic without his or his mother Emily Happel's consent. The school clinic, operated in partnership with Old North State Medical Society (ONSMS), administered the vaccine despite lacking the required parental consent. Plaintiffs, Smith and Happel, sued the Guilford County Board of Education and ONSMS for battery and violations of their state constitutional rights.
The Superior Court of Guilford County dismissed the case, agreeing with the defendants that the federal Public Readiness and Emergency Preparedness (PREP) Act preempted the plaintiffs' state law claims, granting them immunity.The Court of Appeals affirmed this decision, holding that the PREP Act's broad immunity shielded the defendants from liability for all of the plaintiffs' claims.
The Supreme Court of North Carolina reviewed the case and held that the PREP Act's immunity only covers tort injuries and does not bar state constitutional claims. The court concluded that the PREP Act does not preempt claims brought under the state constitution, specifically those related to the right to control a child's upbringing and the right to bodily integrity. The court reversed the dismissal of the state constitutional claims and remanded the case for further proceedings.
The unconstitutional PREP Act DOES preempt state court cases that DO involve an injury caused by the use of a covered countermeasure administered by a covered person during a declared emergency. This is why the PREP Act must be repealed.
DOUBLE NEGATIVE:
HOWEVER, even the unconstitutional PREP Act DOES NOT preempt state court cases that DO NOT involve an injury caused by the use of a covered countermeasure administered by a covered person during a declared emergency.
SUMMARY:
The following 11 Circuit Court cases, 5 Federal District Court Cases and 4 State Court cases determined that the PREP Act did NOT provide protection from lawsuit or liability.
Circuit Courts:
Rivera-Zayas v. Our Lady of Consolation Geriatric, 2023 U.S. App. LEXIS 8827 (2d Cir. 2023)
Maglioli v. Alliance HC Holdings LLC, 16 F.4th 393, 400 n.2 (3rd Cir. 2021)
Mitchell v. Advanced HCS, L.L.C., 28 F.4th 580 (5th Cir. 2022)
Hudak v. Elmcroft of Sagamore Hills, 58 F.4th 845, 853 (6th Cir. 2023)
Lisa Kay Goins v. St. Elizabeth Med. Ctr., No. 22-6070 (6th Cir. 2024)
Martin v. Petersen Health Operations, LLC, 37 F.4th 1210 (7th Cir. 2022)
Saldana v. Glenhaven Healthcare LLC, 27 F.4th 679 (9th Cir. 2022)
Michael Hampton, et al v. State of California, et al, No. 22-15481 (9th Cir. 2023)
Emma Martin, et al v. Serrano Post Acute LLC, et al, No. 21-55400 (9th Cir. 2023)
Federal District Courts:
Dupervil v. Alliance Health Operations, 516 F. Supp. 3d 238 (E.D.N.Y. 2021)
Grohmann v. HCP Prairie Village KS OpCo LLC, 516 F. Supp. 3d 1267 (D. Kan. 2021)
Estate of Winfred Cowan v. LP Columbia KY, LLC, No. 1:20-CV-00118-GNS (W.D. Ky. March 31, 2021)
Brown v. Big Blue Healthcare, Inc., No. 20-2443, 2021 WL 1196445 (D. Kan. Mar. 30, 2021)
Maltbia v. Big Blue Healthcare, Inc., No. 20-2607-DDC-KGG, 2021 WL 1196445 (D. Kan. Mar. 30, 2021)
State Courts:
Emma Martin v. Serrano Post Acute LLC (C.D. Cal. 2020) (9th Circuit agreed)
Happel v. Guilford County Board of Education, 913 S.E.2d 174 (N.C. 2025)
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