Trial Magazine

As we slowly emerge from the COVID-19 pandemic as vaccination rates increase, a question remains about what recourse people may have if they are injured by drugs or medical devices developed to respond to the pandemic. The effort to prepare medical research, development, and manufacturing at an unprecedented pace raises concerns about potential defects and the hurdle of fully informing consumers of the associated risks.

Plaintiff lawyers approached by potential clients adversely affected by COVID-19 medical treatments must be aware of the 2005 United States Public Readiness and Emergency Preparedness Act (PREP Act). The PREP Act provides comprehensive tort immunity for manufacturers, distributors, and administrators of drugs and medical devices intended to thwart an epidemic or pandemic, among other events.¹ Immunity applies to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of medical countermeasures described in a federal “declaration” issued by the secretary of the U.S. Department of Health and Human Services (HHS).² The HHS secretary has sole authorization to make the determination of whether there is a public health emergency or the credible risk of one.³

For each “covered countermeasure” in a declaration, the secretary must identify, among other things, the category of the disease or health condition, the time period during which the disease or health condition is in effect, the individuals for whom liability immunity is in effect, and the applicable geographic areas.⁴

Countermeasures can include vaccines, drugs, or medical devices to be used against chemical, biological, radiological, and nuclear agents of terrorism; epidemics; and pandemics.⁵ Before the COVID-19 pandemic, there were seven PREP Act declarations since the act’s passage.⁶ The declarations have covered H5N1 and H1N1 pandemic influenza vaccines and antivirals, and countermeasures for the following diseases: anthrax, botulism, pandemic influenza, smallpox, and acute radiation syndrome.⁷ The losses covered include claims for death; physical, mental, or emotional injury, illness, disability, or condition; fear of physical, mental, or emotional injury, illness, disability, or condition (including any need for medical monitoring); and loss of or damage to property (including business interruption loss, among others).⁸

COVID-19 PREP Act Declarations

On March 10, 2020, then-serving HHS Secretary Alex Azar declared a public health emergency for the entire United States to aid the nation’s health care community in responding to the novel coronavirus.⁹ Azar issued a PREP Act declaration, effective Feb. 4, 2020, through Oct. 1, 2025, to provide broad immunity for activities related to medical countermeasures against COVID-19.¹⁰ This immunity protects individuals and entities engaged in efforts to control the COVID-19 pandemic, as well as those involved in the administration of the countermeasures.¹¹ Pursuant to that declaration, the covered countermeasures are

any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, used to treat, diagnose, cure, prevent, or mitigate COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, or any device used in the administration of any such product, and all components and constituent materials of any such product.¹²

The declaration has since been amended nine times, most recently on Sept. 14, 2021, at the time of publication.¹³ The subsequent declarations, for instance, expanded what types of countermeasures related to COVID-19 were covered and added “qualified persons” covered by the act.¹⁴ The secretary also issued a separate declaration on May 1, 2020, to authorize the FDA to issue Emergency Use Authorizations (EUAs) permitting the unapproved use of a drug, biologic, device, or diagnostic, among other public health measures.¹⁵ An EUA allows for the use of a drug that has not been proven safe and effective for distribution in the United States by health care providers to treat suspected or confirmed COVID-19 cases.¹⁶

‘Willful Misconduct’ Exception

The only exception to the act’s broad grant of statutory immunity applies when the plaintiff can prove by clear and convincing evidence that “death or serious physical injury” by a covered person was caused by “willful misconduct.”¹⁷ Unfortunately, the exception presents a high bar, and it is unlikely that most claims could meet it.

Notably, under the PREP Act, willful misconduct cannot be found against a manufacturer or distributor for actions regulated under the Public Health Service Act or the Federal Food, Drug, and Cosmetic Act if the secretary or U.S. attorney general fails to initiate an enforcement action, or if an enforcement action is initiated and resolved without imposing a criminal, civil, or administrative penalty.¹⁸ Ultimately, the PREP Act allots the federal government a remarkable amount of discretion.

The burden to prove willful misconduct under the PREP Act is difficult to meet, requiring evidence of “an act or omission that is taken intentionally to achieve a wrongful purpose, knowingly without legal or factual justification, and in disregard of a known or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.”¹⁹ A plaintiff must establish, by clear and convincing evidence, that the willful misconduct proximately caused death or serious injury.²⁰ One of the only courts to consider the willfulness requirement in this context found that the burden was not met.²¹

The Case Law Landscape

So long as the manufacturer is a covered entity that provides a covered countermeasure, the immunity provision will broadly preempt traditional state law tort claims.²² During the effective period of the declaration, no state or political subdivision of a state may establish or enforce any law or legal requirement that is different from, or is in conflict with, the act.²³ Case law established before the current pandemic and the cases that have generated rulings during it so far shed light on how courts are interpreting the PREP Act’s scope.

Pre-COVID-19 cases. Until the COVID-19 pandemic, the only declaration to generate meaningful litigation was the 2009 H1N1 (swine flu) declaration.²⁴ For example, in a case against a county health department in New York alleging absence of parental informed consent for an H1N1 vaccination, the appellate court broadly construed the preemption clause found within the PREP Act.²⁵ It dismissed the plaintiff’s claims, finding that the PREP Act preempted state law claims and that the act’s immunity provision precluded the plaintiff’s claims of negligence and battery.²⁶

In a case in Missouri, the parties did not dispute that the manufacturer had immunity under the PREP Act, nor did they allege that the manufacturer had engaged in willful misconduct.²⁷ Instead, a plaintiff sued his physician and employer in Missouri for being vaccinated for the H1N1 influenza without his informed consent.²⁸ The physician and employer filed a third-party complaint against the vaccine manufacturer, who removed the case to federal court.²⁹ The federal court in Missouri held that the immunity provision of the PREP Act barred the claims against the flu vaccine manufacturer.³⁰

Prior case law also demonstrates that PREP Act immunity attaches only to “claims based on activities that fall within the scope of the applicable Declaration,”³¹ or those that have a “causal relationship” with the “administration or use” of an identified countermeasure.³² For example, a New York court held that immunity under the act would be available only if the plaintiff had received the flu vaccine at issue.³³ In 2014, a wrongful death action was brought on behalf of a decedent who contracted the H1N1 influenza in the hospital while recovering from a transplant but was not given the flu vaccine by the hospital due to a supply shortage.³⁴ The court denied the defendant’s assertion of immunity, finding that the act “consistently speaks of administering or using the countermeasure,” and therefore “the vaccine must be administered to or used by a patient.”35 The court concluded that “such a cause of action is in no way covered by PREP, and the immunity from suit claimed by the defendants here simply does not exist.”³⁶

Recent COVID-19 rulings. Since the start of the pandemic, PREP Act litigation has largely focused on outbreaks in skilled nursing facilities. Generally, a suit is filed in state court against a skilled nursing facility, and the facility removes the case to federal court, arguing that the PREP Act completely preempts the state court claims and confers federal question jurisdiction. The facility further claims it has immunity from suit because it qualifies as a program planner administering covered countermeasures under the PREP Act. The federal district courts have largely rejected these attempts at immunity.³⁷

Plaintiffs have successfully argued that the PREP Act does not apply to such COVID-19 outbreak claims because there must be a causal connection between the administration of a covered countermeasure and the injury complained of in the petition.³⁸ This is supported by the PREP Act’s Covered Countermeasure Process Fund, under which a person is eligible to file a claim only if he or she was injured by a covered countermeasure.³⁹

Plaintiffs have also been successful in arguing that if the PREP Act does not apply, the inquiry ends, and complete preemption need not be analyzed. Regardless, courts have rejected that the PREP Act preempts state court COVID-19 nursing home claims. For instance, the court in Estate of Maglioli v. Andover Subacute Rehabilitation Center rejected the skilled nursing facility’s claims that the PREP Act provided express, field, and conflict preemption.⁴⁰

Garcia v. Welltower OpCo Group LLC is an outlier case that found the PREP Act applied and preempted a COVID-19 claim against a skilled nursing facility.⁴¹ However, courts in the same district have found the opposite.⁴² Another judge in the same district noted in a later opinion that Garcia “deferred to the HHS Secretary’s opinion of PREP Act complete preemption but did not consider the Ninth Circuit’s two-part complete preemption test. Therefore, the Court does not find the Garcia decision persuasive, as the HHS Secretary’s opinion of PREP Act preemption is . . . neither persuasive nor entitled to deference.”⁴³ Other courts throughout the country have similarly rejected Garcia.⁴⁴ At the time of writing, no other district courts have found Garcia to be persuasive, and Garcia is currently on appeal to the Ninth Circuit.

So far, it is largely unknown how the PREP Act’s immunity provisions will be interpreted by courts in products cases based on the vast array of countermeasures that have been used to fight the coronavirus—vaccines, medicines being used “off label” to treat patients, tests developed to detect the presence of or immunity to the virus, and more. However, the PREP Act’s immunity provision is something you must be aware of when evaluating potential cases.

Catelyn McDonough is an attorney at Anapol Weiss in Philadelphia and can be reached at cmcdonough@anapolweiss.com.

Notes

1. 42 U.S.C. §§247d-6d, 6e (2005).
2. 42 U.S.C. §§247d-6d(a)(2)(B), 6d(b).
3. 42 U.S.C. §247d-6d(b)(1).
4. 42 U.S.C. §§247d-6d(b)(2)(A–D).
5. Ass’n of State & Territorial Health Officials, Public Readiness and Emergency Preparedness Act Fact Sheet, https://tinyurl.com/yv5fpc2e.
6. U.S. Dep’t of Health & Human Servs., Public Readiness and Emergency Preparedness Act, www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx.
7. Id.
8. 42 U.S.C. §§247-6d(a)(2)(A)(i–iv).
9. U.S. Dep’t of Health & Human Servs., Determination That a Public Health Emergency Exists, Jan. 31, 2020, https://tinyurl.com/82xm3cx9.
10. Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15198 (Mar. 17, 2020).
11. Id.
12. Id.
13. U.S. Dep’t of Health & Human Servs., supra note 6; see also Kevin Hickey, Cong. Research Serv., LSB10443, The PREP Act and COVID-19: Limiting Liability for Medical Countermeasures, at 6 (2021).
14. Hickey, supra note 13 at 4–6.
15. News Release, Food & Drug Administration, Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization for Potential COVID-19 Treatment, May 1, 2020, https://tinyurl.com/pabkpbtn.
16. Cf. id.
17. 42 U.S.C. §247d-6d(c)(3).
18. 42 U.S.C. §§247-6d(c)(5)(A)(i–ii).
19. 42 U.S.C. §§247-6d(c)(1)(A)(i–iii).
20. 42 U.S.C. §§247d-6d(e)(1), (5), 6d(c)(3); see also U.S. Dep’t of Health & Human Servs., Advisory Opinion on the Public Readiness and Emergency Preparedness Act and the March 10, 2020 Declaration Under the Act April 17, 2020, as Modified on May 19, 2020, https://www.hhs.gov/sites/default/files/prep-act-advisory-opinion-hhs-ogc.pdf. For more on what the regulations require, see 42 U.S.C. §247d-6d(d)(1).
21. See Parker v. St. Lawrence Cty. Pub. Health Dep’t, 102 A.D.3d 140, 144 (N.Y. Sup. Ct. 2012).
22. Rodney M. Hudson & Emmanuel L. Brown, Preparing for the COVID-19 Immunity Preemption Defense, Faegre Drinker on Products, Apr. 24, 2020, https://tinyurl.com/2ezydcs7.
23. 42 U.S.C. §247d-6d(b)(8)(A).
24. See Determination and Declaration Regarding Emergency Use of the Antiviral Product Peramivir Accompanied by Emergency Use Information, 74 Fed. Reg. 56640 (Nov. 2, 2009).
25. Parker, 102 A.D.3d 140, 142–44.
26. Id. at 144–45.
27. Kehler v. Hood, 2012 WL 1945952 (E.D. Mo. May 30, 2012).
28. Id. at *1.
29. Id.
30. Id. at *3.
31. U.S. Dep’t of Health & Human Servs., PREP ACT Q&A, https://www.phe.gov/Preparedness/legal/prepact/Pages/prepqa.aspx.
32. 42 U.S.C. §247-6d(a)(B).
33. Casabianca v. Mount Sinai Med. Ctr., 2014 WL 10413521 (N.Y. Sup. Ct. Dec. 2, 2014).
34. Id. at *1.
35. Id. at *4.
36. Id. at *5.
37. See, e.g., Lollie v. Colonnades Health Care Ctr. Ltd., 2021 WL 4155805 (S.D. Tex. Sept. 13, 2021); Schleider v. GVDB Operations, LLC, 2021 WL 2143910 (S.D. Fla. May 24, 2021) (the defendants have appealed the denial of removal to the Eleventh Circuit); Estate of Jones v. St. Judge Operating Co., LLC, 2021 WL 886217, at *8 (D. Or. Mar. 8, 2021); Estate of McCalebb v. AG Lynwood, LLC, 2021 WL 911951, at *4 (C.D. Cal. Mar. 1, 2021); Lyon v. Cucumber Holdings, LLC, 2021 WL 364640, at *2 (C.D. Cal. Feb. 3, 2021); Dupervil v. All. Health Operations, LCC, 2021 WL 355137, at *13 (E.D.N.Y. Feb. 2, 2021); Anson v. HCP Prairie Vill. KS OPCO, LLC, 2021 WL 308156, at *14 (D. Kan. Jan. 29, 2021); Estate of Smith v. Bristol at Tampa Bay Rehab. & Nursing Ctr., 2021 WL 100376, at *1–2 (M.D. Fla. Jan. 12, 2021); Sherod v. Comprehensive Healthcare Mgmt. Servs., LLC, 2020 WL 6140474, at *7–8 (W.D. Pa. Oct. 16, 2020); Baskin v. Big Blue Healthcare, Inc., 2020 WL 4815074, at *8 (D. Kan. Aug. 19, 2020); Estate of Maglioli v. Andover Subacute Rehab. Ctr. I., 478 F. Supp. 3d 518, 533 (D.N.J. 2020).
38. See, e.g., Lutz v. Big Blue Healthcare, Inc., 480 F. Supp. 3d 1207, 1215 (D. Kan. 2020).
39. 42 U.S.C. §247d-6e(b)(4).
40. 478 F. Supp. 3d at 530–32. HHS under the prior presidential administration issued a series of advisory opinions that aim to encourage immunity in nursing homes. Advisory Opinion 21-01, issued in January 2021, reinforced that the PREP Act is a complete preemption statute.
41. 2021 WL 492581, at *7 (C.D. Cal. Feb. 10, 2021).
42. Estate of McCalebb, 2021 WL 911951, at *4; Lyon, 2021 WL 364640, at *4–5; Saldana v. Glenhaven Healthcare LLC, 2020 WL 6713995, at *2 (C.D. Cal. Oct. 14, 2020); Martin v. Serrano Post Acute LLC, 2020 WL 5422949, at *2 (C.D. Cal. Sept. 10, 2020) (remanding and stating the PREP Act is a defense).
43. Golbad v. GHC of Canoga Park, 2021 WL 1753624, at *3 (C.D. Cal. May 4, 2021).
44. Anson, 2021 WL 308156, at *9; see also Golbad, 2021 WL 1753624, at *3; Schuster v. Percheron Healthcare, Inc., 493 F. Supp. 3d 533, 537 (N.D. Tex. 2021); Maltbia v. Big Blue Healthcare, Inc., 2021 WL 1196445, at *10 (D. Kan. Mar. 30, 2021).