On whether the PREP Act confers immunity on government officials and others from state-level criminal prosecution for COVID-19-era wrongdoing or preempts such prosecutions - Part One

Introduction

Seventeen state attorneys general recently sent a letter[i] to Congressional Leadership requesting the House Select Subcommittee on the Coronavirus Pandemic (Coronavirus Subcommittee) share information and expressing their willingness to use such information to initiate “state-level investigations or legal proceedings” pertaining to any possible "violations of state law" committed by federal officials during the COVID-19 response, if factually supported.

While the letter specifically identifies only Dr. Anthony Fauci, in context of President Biden’s eponymous pardon,[ii] the letter’s signers would consider “potential courses of action under state law” “to hold all [such] actors accountable for their misconduct.” I’ve impliedly encouraged my state attorney general to explore doing exactly that.[iii]

When I wrote about the prospects for county- and state-level investigation and prosecution of CDC personnel and others for wrongdoing in the COVID-19 vaccination era,[iv] I didn’t discuss whether the Public Readiness and Emergency Preparedness Act[v] (PREPA) confers immunity on government officials and others from criminal prosecution, as opposed to PREPA’s broad civil immunity reach. I do so below and conclude PREPA does not confer such immunity, which I hope will remove PREPA as a putative obstacle to state-level criminal investigations and proceedings or at least provide grounds for that legal argument.

Part Two will address whether PREPA’s preemption provision poses an obstacle to such investigations and proceedings. For readers interested in that, a good starting place is the Congressional Research Service’s primer on federal preemption,[vi] which provides citations to authorities which could be used for arguing PREPA’s preemption provision does not pose that obstacle.

For example, the primer states with citation “the Supreme Court has held that—in certain contexts—generally applicable state laws are more likely to fall outside a federally preempted field than state laws that “target” entities or issues within the field[,]”[vii] also stating in a parenthetical for a separate citation that “generally applicable criminal laws are not likely to fall within the preempted field of nuclear safety regulation[,]”[viii] which could support an analogous argument that generally applicable state criminal laws don’t fall within PREPA’s putative preemptive field.

It’s okay with me if somebody gets there first, “there” being posting about PREPA and preemption using those ideas and others. What’s important is the information get posted, so it can be discussed, and sent to any aligned state attorneys general or others interested in pursuing such cases, so they’re not easily dissuaded by PREPA-based immunity or preemption arguments against undertaking such state-level criminal investigations and proceedings when there’s support for good faith legal arguments to the contrary.

To the subject at hand.

PREPA’s plain text supports that it confers broad civil immunity, not immunity from criminal prosecution.

PREPA neither expressly confers immunity from a criminal action nor contains a specific defense to a criminal action. When Congress intends to preempt state criminal sanctions or provide a statutory specific defense, Congress expressly says so. See, e.g., 8 U.S.C. § 1324a(h)(2)[ix] (Unlawful employment of aliens) (“The provisions of this section preempt any State or local law imposing civil or criminal sanctions other than through licensing and similar laws[.]”) (internal parenthesis omitted); 50 U.S.C. § 4558(j)[x] (Defense Production Act of 1950) (providing a specific defense “to any civil or criminal action brought under the antitrust laws or any similar law of any State”) (internal parenthesis omitted).

PREPA’s use of civil law terminology supports that it’s intended to confer broad civil immunity, not immunity from criminal prosecution.

PREPA’s rife use of civil law terminology, plus the absence of criminal law terminology therein, supports it confers broad immunity from civil actions, but not from criminal prosecution: “suit and liability[,]” “claims for loss[,]” 247d-6d(a)(1); “design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing, or use of such countermeasure[,]” 247d-6d(a)(2)(B); “shall consider the need to define the scope of permissible civil actions under subsection (d)[,]” 247d-6d(c)(2)(B); “each covered person sued[,]” 247d-6d(c)(3) (“sued” not “prosecuted”); “the sole exception to the immunity from suit and liability covered persons set forth in subsection (a) shall be for an exclusive Federal cause of action against a covered person[,]” 247d-6d(d)(1) (“cause of action” not “indictment” or “prosecution”); “An action under this subsection may be brought for wrongful death or serious physical injury by any person who suffer such injury or by any representative of such person[,]” 247d-6d(d)(2) (civil actions are brought by “person[s]” or their “representatives[,]” prosecutions are brought by governments) to be “prov[en] by clear and convincing evidence of willful misconduct[,]” 247d-6(c)(3) (“clear and convincing” being a civil standard of proof, as opposed to proving elements of a crime beyond reasonable doubt, the criminal law standard); “the complaint shall plead each element of the plaintiff’s claim[,]” 247d-6d(e)(3) (civil actions are brought by plaintiffs, in a complaint, criminal actions are brought by governments, in an information or indictment), “the plaintiff shall verify the complaint[,]” 247d-6d(e)(4)(A); “the complaint shall include a verification, made by affidavit under oath, stating the pleading is true to the knowledge of the deponent[,]” 247d-6d(e)(4)(B); “Any action…shall be assigned initially to a panel of three judges[,]” 247d-6d(e)(5) (criminal actions are tried in front of a judge or jury, not a three judge panel); discovery governed by “Rule 37, Federal Rules of Civil Procedure[,]” 247d-6d(e)(6)(B); “award of damages[,]” 247d-6d(e)(7)(A) (an award of damages, not a criminal sentence imposed or order of restitution imposed as part of a criminal sentence); “No provider of collateral source benefits shall recovery any amount against the plaintiff or receive any lien or credit or credit against the plaintiff’s recovery or be equitably or legally subrogated to the right of the plaintiff in an action under subsection (d)[,]” 247d-6d(e)(7)(B) (civil action terminology); “noneconomic damages may be awarded[,]” “proportional to the percentage of responsibility[,]” 247d-6d(e)(8) (same).

PREPA’s legislative history supports that it was intended to confer broad civil immunity, not immunity from criminal prosecution.

During the Senate discussion of PREPA Senator Hatch acknowledged its “bold proposals[,]” one of which was “to make a fundamental change in our” “civil liability systems toward” “increasing our Nation's public/private sector capacity to” “counter the effects for the dozens of known biological, chemical or nuclear threat agents[;]” discussed the effect of the “the last several decades of product liability exposure[;]” and the “pervasive climate of apprehension about product liability and litigation exposure” among “many pharmaceutical and biotechnology firms” “chilling the necessary private sector activity[,]”[xi] all of which suggest PREPA was intended at conferring broad civil immunity, not immunity from criminal prosecution.

Senator Biden stated PREPA does not immunize from criminal behavior, albeit in a qualified way, stating “the only way a victim could still recover compensation from a drug maker for a dangerous drug or vaccine would be to prove “willful misconduct,” and then only by “clear and convincing evidence.”[xii] What this means is that, for a victim to be able to be compensated by the company that harmed him, he must prove that they committed a crime. And even if he can do that, the company can still avoid liability simply by notifying the authorities within 7 days that someone was harmed by their product. In other words, so as long as you “confess” to your bad behavior, you can get away with it!”[xiii]

Though, Senator Leahy stated that “[e]ven if the drug company with the intent to harm people, it would nevertheless be immune from criminal conduct unless the Attorney General or Secretary of Health and Human Services initiates an enforcement action against a drug company that is still pending at the time a personal claim is filed.”[xiv]

Senator Leahy entered into the Congressional Record Professor Erwin Chemerinsky’s[xv] letter[xvi] addressing “serious constitutional issues raised by” PREPA. That letter referred to, among other things, the “scope of permissible lawsuits[,]” “cause[s] of action[,]” “plaintiff’s claim[s][,]”[xvii] all of which imply PREPA’s civil nature.

Representative Conyers, who also entered that letter into the Congressional Record, criticized PREPA’s corporate liability protections, the result being “no out of pocket payments by reckless corporations and no real recovery for injured citizens[,]”[xviii] a “massive tort reform” that “would severely limit any compensation[,]” all of which imply PREPA’s civil nature.

No appellate decision I know of has held PREPA confers immunity from criminal prosecution.

In addition to knowing of no such decision, recently, in Happel v. Guilford Cnty. Bd. of Educ.,[xix] a civil case where a “medical provider injected” “a fourteen-year-old boy[]” “against his and his mother’s wishes[,]” the Supreme Court of North Carolina decided PREPA immunity covers “tort injuries” but not “constitutional claims[,]” the latter meaning “infringing on their fundamental rights under the [North Carolina] state constitution[,]” the fundamental rights at issue in Happel being “a parent’s right to control her child’s upbringing, including” “mak[ing] medical decisions on her child’s behalf[,]” and “the right to bodily integrity,” “define[d] as the right of a competent person to refuse forced, nonmandatory medical treatment[,]” introductorily putting it this way: “The PREP Act’s plain text leads us to conclude that its immunity only cover tort injuries.”

Happel’s dissent asserted “the PREP Act neither promotes wrongdoing nor does it completely insulate bad actors from punishment[,]” stating “PREP Act immunity is one from civil suits and liability. A person who violates a penal statute may still be charged and punished criminally because a prosecution is not in any sense a “claim for loss,” and our statutes already criminalize the unlawful administration and dispensation of medication, including to children.” (emphasis in original).

The U. S. Dept. of Health and Human Services (HHS) advisory opinions about PREPA immunity discuss immunity from civil liability, not criminal prosecution.

HHS’s General Counsel issued six PREPA advisory opinions between May 2020 and January 2021.[xx] None claim PREPA confers immunity from criminal prosecution. The fourth one, Advisory Opinion 20-04 on the Public Readiness and Emergency Preparedness Act and the Secretary's Declaration under the Act October 22, 2020, as Modified on October 23, 2020,[xxi] which “re-emphasizes the breath of PREP Act immunity[,]” discusses only civil actions in the hypothetical examples therein.

Relatedly, the Congressional Research Service Legal Sidebars about PREPA do not claim it confers immunity from criminal prosecution.[xxii]

Conclusion regarding PREPA conferring immunity from criminal prosecution

The sources and cursory discussion above lead me to conclude PREPA does not confer immunity from criminal prosecution. I’m open to challenge based on quoted language from cited sources.

*I thank in alphabetical order Karlo Berkovich, Risa Evans, Sasha Latypova, Mimi Miller, and Katherine Watt for related dialog, ideas, and materials. Thanking them doesn’t imply they agree with or endorse any of this. I don’t know if they do or not. Any mistakes are mine.

---

[i] https://drive.google.com/file/d/1LbNbjrePFXlfz47ouR7ZdRpR62Vm14xM/view?usp=sharing Note, regarding this link and other links provided, this is neither a law review article nor a legal brief, so I don’t pin cite or Blue Book cite herein. So, if you open a linked document, you’ll need to Control-F search for the word or phrase you’re looking for.

[ii] https://drive.google.com/file/d/1Hh1rTrhKKC8Lfz-0gSzQsoNc8Hl0QswG/view?usp=sharing

[iii] https://drive.google.com/file/d/1nMxqyz22geoOQ5LTiPRUKayYkG9v1_E3/view?usp=sharing. The state attorneys general don’t necessarily need to wait for the Coronavirus Subcommittee to share information, because there may already be enough extant information in Freedom of Information Act (FOIA) productions, like the two cited in FOIA'd CDC Emails Reveal Disturbing Myocarditis Timeline Warranting Investigation: Different Messaging Internally Vs. Publicly About COVID-19 Vaccines and Myocarditis. - DailyClout, combined with the analytical and statistical work done by aligned professionals, like, for example Dr. Karl Jablonowski’s and Dr. Brian Hooker’s work, see, e.g., Lock the Doors: The Myocarditis Disaster and a call for the broad examination of the CDC and FDA | Medical Research Archives, to support reasonable suspicion to investigate, as discussed in On the Prospects for County- and State-Level Investigation and Prosecution of CDC Personnel and Others for Wrongdoing in the COVID-19 Vaccination Era - DailyClout; https://open.substack.com/pub/edberkovich/p/on-the-prospects-for-county-and-state-576?r=cld73&utm_campaign=post&utm_medium=web. Hopefully, more FOIA productions will be forthcoming. I asked Secretary Kennedy to take executive action on that in this letter: https://drive.google.com/file/d/14xrWKZOwsAdvho4U1nxa7CW7K7nlptZB/view?usp=sharing

[iv] On the Prospects for County- and State-Level Investigation and Prosecution of CDC Personnel and Others for Wrongdoing in the COVID-19 Vaccination Era - DailyClout; https://open.substack.com/pub/edberkovich/p/on-the-prospects-for-county-and-state-576?r=cld73&utm_campaign=post&utm_medium=web

[v] 42 U.S. Code § 247d–6d - Targeted liability protections for pandemic and epidemic products and security countermeasures | U.S. Code | US Law | LII / Legal Information Institute

[vi] CRS_R45323.4.pdf - Google Drive

[vii] Id., at p. 22 and citation therein.

[viii] Id., at p. 23, n. 187.

[ix] 8 U.S. Code § 1324a - Unlawful employment of aliens | U.S. Code | US Law | LII / Legal Information Institute

[x] 50 U.S. Code § 4558 - Voluntary agreements and plans of action for preparedness programs and expansion of production capacity and supply | U.S. Code | US Law | LII / Legal Information Institute

[xi] Congressional Record | Congress.gov | Library of Congress; https://tinyurl.com/y6puw5ej

[xii] Congressional Record | Congress.gov | Library of Congress; https://tinyurl.com/3mdw5hd6

[xiii] Congressional Record | Congress.gov | Library of Congress; https://tinyurl.com/3mdw5hd6

[xiv] Congressional Record | Congress.gov | Library of Congress; https://tinyurl.com/3mdw5hd6

[xv] Erwin Chemerinsky - UC Berkeley Law

[xvi] Congressional Record | Congress.gov | Library of Congress; https://tinyurl.com/3mdw5hd6 (That letter was ordered printed in the Congressional Record. To read it there, open the one of the links in this footnote, then do a Control-F search for “Chemerinsky”.)

[xvii] Congressional Record | Congress.gov | Library of Congress; https://tinyurl.com/3mdw5hd6

[xviii] Congressional Record | Congress.gov | Library of Congress; https://tinyurl.com/yvn6nrah

[xix] https://drive.google.com/file/d/1fL8Rd7aFJ9OfJkHKD45AxJSIjVF8J-z2/view?usp=sharing

[xx] PREP Act | Public Readiness and Emergency Preparedness Act; https://tinyurl.com/mwdferuj

[xxi] | Guidance Portal; https://tinyurl.com/bdfcn7rh

[xxii] LSB10443.18.pdf; https://tinyurl.com/4zwmkw3b; The PREP Act and COVID-19, Part 2: The PREP Act Declaration for COVID-19 Countermeasures | Congress.gov | Library of Congress; https://tinyurl.com/37hsvfxr