Ed Berkovich

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 Two

Readers short on time can Control-F for “Construing PREPA’s preemption clause at subsection (8) as it reads” and read the two paragraphs there for the gist.

Ed Berkovich
Nov 15, 2025
Cross-posted by Ed Berkovich
"Attorney Ed Berkovich: "There’s not a word, phrase, or sentence in [the Public Readiness and Emergency Preparedness Act]’s preemption clause to support that Congress intended [it] to supersede the states’ sovereign and historic police powers of state-level criminal law enforcement and prosecution. That’s the threshold legal standard: what Congress intended.""
- Presented by DailyClout

Introduction

Part One argued the Public Readiness and Emergency Preparedness Act (PREPA) does not confer immunity on government officials and others from state-level criminal prosecution for COVID-19-era wrongdoing. (PREPA Part One).[1]

This PREPA Part Two argues PREPA’s preemption clause does not preempt such prosecutions. There’s not a word, phrase, or sentence in PREPA’s preemption clause to support that Congress intended PREPA to supersede the states’ sovereign and historic police powers of state-level criminal law enforcement and prosecution. That’s the threshold legal standard: what Congress intended.[2] I support those assertions below and will buttress them in a later post.

Limitation

Herein, I focus specifically on the text of PREPA’s preemption clause, an admittedly fractional approach, since part of a court’s preemption clause interpretation considers the statutory framework surrounding the preemption clause, including the statute’s structure and purpose as a whole. I’ll address those considerations in a later post (though I’ve previously touched on some of them).[3] I’m posting this now to contribute to the reckoning discussion mentioned under the “About state-level action” heading below.

Why this is still relevant

First, to assist in reckoning efforts for COVID-19-era wrongdoing. Time is passing and state statutes of limitation are running, though not fatally so for all circumstances.[4] PREPA Part One and this PREPA Part Two go toward removing PREPA as a supposed obstacle (if claimed as such) to the 17 state attorneys general interested in potentially pursuing “state-level investigations or legal proceedings”[5] for “holding malign actors accountable for their actions arising out of the Pandemic,”[6] (something I’ve argued county attorneys could do too[7]).

Second, to prepare in advance to counter PREPA-based immunity and preemption defenses for wrongdoing committed under future public health emergencies declared by the Secretary of Health and Human Services (HHS Secretary), if any, including any such emergencies possibly being predicted.

Reminiscent of Dr. Anthony Fauci’s January 2017 statement that “there is no question that there will be a challenge [in] the coming [presidential] administration in the arena of infectious diseases, both chronic infectious diseases” “but also there will be a surprise outbreak[,]”[8] former Google CEO Eric Schmidt, when discussing artificial intelligence (AI) risks, has expressed an industry concern about whether “were going to have to have” “a modest death event, something the equivalent of Chernobyl, which will scare everybody, incredibly, to understand this stuff[,]”[9] meaning AI-associated risks. See also, Sam Altman’s recent agreement with the assertion there could be a world-shaking cyber attack in 2026. https://tinyurl.com/bdhafrfv.

About state-level action

Recently, Children’s Health Defense CEO Mary Holland said: “There needs to be a reckoning for COVID. The government lied to people from start to finish. Everything they told the American people . . . was wrong: about the shots, about the masks, about the tests, about the lockdowns. And there needs to be a reckoning for that. If we just sweep that under the rug and just move forward as if nothing happened, it will happen again. If we have a true reckoning, we can change the laws, we change the policies so that it never happens again. And I do worry about that. And I’ve worried about that since this administration took office. It’s still a big, big issue.”[10]

While I agree and Ms. Holland’s statement energized a Twitter/X-sphere reckoning discussion, I wonder about the merits of relying on the federal administration to initiate such a reckoning, and whether citizen efforts to make a reckoning happen would be more effective at the state level. It was some state attorneys general who brought important COVID-related lawsuits during the previous administration, after all. (I realize Ms. Holland neither suggested solely relying on the federal administration nor discounted state-level efforts.)

I hope posting this now will motivate (more) state-level reckoning discussion and efforts directed toward state attorneys general, state legislators/state legislative investigative bodies, state grand jury panels, and county prosecutors. South Africa’s Truth and Reconciliation Commission is a model for reckoning efforts alternative to retributive justice, which I’ve discussed in a past post. See infra n.34 (the first link in that footnote, then Control-F for “South Africa”).

So long as PREPA remains in effect, malign actors who commit wrongdoing during a public health emergency response could try claiming protection from criminal accountability under it, which is why I address PREPA on its own terms.

To the subject at hand.

Preemption generally

PREPA is a federal law. “Under the [U. S. Constitution’s] Supremacy Clause, from which [the] pre-emption doctrine is derived, any state law, however clearly within a State’s acknowledged power, which interferes with or is contrary to federal law, must yield.” Gade v. Nat’l. Solid Wastes Mgmt. Ass’n. 505 U.S. 88, 108 (1992) (brackets in original omitted). See also, Zyla Life Sciences v. Wells Pharma of Houston, 134 F.4th 326, 328 (5th Cir. 2025) (“Under the Supremacy Clause, any state law that contradicts federal law is preempted.”); Murphy v. Nat’l Collegiate Athletic Ass’n, 138 S. Ct. 1469, 1476 (2018) (“This means that when federal and state law conflict, federal law prevails and state law is preempted.”)

PREPA’s preemption clause

PREPA’s preemption clause can stultify at first reading, given the obscurantist way it’s drafted, including using terms defined in other parts of PREPA—some of which refer in turn to definitions in other laws—and given its use of case-law defined terms. To simply it, I’ll provide it as it reads, then provide it with its terms replaced by their definitions (but without citations or signals, for easier reading), then show how I got there by providing that version with citations and signals. Then, I’ll provide and apply relevant interpretive principles, showing why PREPA’s preemption clause would not preempt state-level criminal prosecution. Spelling it out this way, while wordy, shows what PREPA really says—readers disinclined to some initial repetitive reading can skip down a bold heading or two.

Here’s PREPA’s preemption clause as reads:

(8) Preemption of State Law

During the effective period of a declaration under subsection (b), or at any time with respect to conduct undertaken in accordance with such declaration, no State or political subdivision of a State may establish, enforce, or continue in effect with respect to a covered countermeasure any provision of law or legal requirement that—

(A) is different from, or is in conflict with, any requirement applicable under this section; and

(B) relates to the design, development, clinical testing or investigation, formulation, manufacture, distribution, sale, donation, purchase, marketing, promotion, packaging, labeling, licensing, use, any other aspect of safety or efficacy, or the prescribing, dispensing, or administration by qualified persons of the covered countermeasure, or to any matter included in a requirement applicable to the covered countermeasure under this section or any other section of this chapter, or under the Federal Food, Drug, and Cosmetic Act[.][[11]]

Here’s PREPA’s preemption clause with its terms replaced by their definitions, without citations and signals, and with some interpretive additions (the italicized language is interpretive):

(8) Preemption of State Law

During a public health emergency declared by the HHS Secretary, or after a public health emergency for actions undertaken during such an emergency, no State or county or municipality or regulatory body may establish, enact, promulgate, enforce, or continue in effect with respect to a biological product (which includes a vaccine), device, drug, product, respiratory protective device, or technology, any provision of law or a statute, regulation, common law duty, or other rule of law that must be obeyed that—

(A) goes beyond, or is in conflict with, any statute, regulation, common law duty, or other rule of law that must be obeyed applicable under PREPA; and

(B) has a connection with, or contains a reference to PREPA about, the design, development, clinical testing or investigation, formulation, manufacture, distribution, sale, donation, purchase, marketing, promotion, packaging, labeling, licensing, use, any other aspect of safety or efficacy, or the prescribing, dispensing, or administration by—a licensed health professional, other individual, or person in an HHS Secretary declaration, authorized to prescribe, administer, or dispense such biological products (which includes vaccines), devices, drugs, products, respiratory protective devices, or technologies under the law of the State in which the biological product (which includes a vaccine), device, drug, product, respiratory protective device, or technology was prescribed, administered, or dispensed—of the biological product (which includes a vaccine), device, drug, product, respiratory protective device, or technology, or to any matter included in a statute, regulation, common law duty, or other rule of law that must be obeyed applicable to a biological product (which includes a vaccine), device, drug, product, respiratory protective device, or technology, under PREPA or any other section of this chapter, or under the Federal Food, Drug, and Cosmetic Act.[[12]]

(Here and below, I have not replaced terms with definitions for “this chapter” or for any applicable under “the Federal Food, Drug, and Cosmetic Act[,]” or discussed them, something I’ll do later post if I think it worthwhile.)

And here’s PREPA’s preemption clause with its terms replaced by their definitions, with citations and signals, and with the same interpretive additions as above (the italicized language is interpretive):

(8) Preemption of State Law

During [a public health emergency declared by the HHS Secretary[13]], or after a public health emergency for actions undertaken during such an emergency], no State or [county or municipality or other regulatory body] may establish, [enact,] [promulgate,] enforce, or continue in effect with respect to a [biological product (which includes a vaccine),[14] device, drug, product, respiratory protective device, or technology[15],[16]] any provision of law or [a statute, regulation, common-law duty, or other rule of law that must be obeyed”[17]] that—

(A) [goes “beyond”[18]], or is in conflict with, any [“statute, regulation, common-law duty, or other rule of law that must be obeyed”[19]] applicable under [PREPA]; and

(B) [has a “connection with[,]”[20]] or contains a reference to[[21]] [PREPA about,] the design, development, clinical testing or investigation, formulation, manufacture, distribution, sale, donation, purchase, marketing, promotion, packaging, labeling, licensing, use, any other aspect of safety or efficacy, or the prescribing, dispensing, or administration by [—a licensed health professional, other individual, or person in an HHS Secretary declaration, authorized to prescribe, administer, or dispense such biological products (which includes vaccines), devices, drugs, products, respiratory protective devices, or technologies under the law of the State in which the biological product (which includes a vaccine), device, drug, product, respiratory protective device, or technology was prescribed, administered, or dispensed[22]—] of the [biological product (which includes a vaccine),[23] device, drug, product, respiratory protective device, or technology[24],[25]], or to any matter included in a [“statute, regulation, common-law duty, or other rule of law that must be obeyed”[26]] applicable to [a biological product (which includes a vaccine),[27] device, drug, product, respiratory protective device, or technology[28],[29]] under [PREPA] or any other section of this chapter, or under the Federal Food, Drug, and Cosmetic Act[.][30]

For just how limiting the term “connection with” is on the preemptive scope of a preemption clause containing that phrase, see Preemption Primer, supra n.20, at 8-10.

Relevant interpretive principles

PREPA’s preemption clause is express, meaning PREPA explicitly says it preempts state law. When a court is “presented with the task of interpreting a statutory provision that expressly pre-empts state law[,]” that court “need not go beyond [the] language [of PREPA’s preemption provision] to determine whether Congress intended” “to pre-empt at least some state law[.]” Medtronic, Inc. v. Lohr, 518 U.S. 470, 484 (1996). But a court’s interpretation of PREPA’s preemption provision “must nonetheless identify the domain expressly pre-empted by that language[.]” Id. (internal quotation marks omitted). “[D]omain” means “scope” of the preemption, as in, how much state law did Congress intend to preempt? A court’s “analysis of the scope of the pre-emption must begin with [the preemption clause’s] text[.]” Id. A court’s “interpretation of that language does not occur in a contextual vacuum. Rather, that interpretation is informed by two presumptions about the nature of pre-emption.” Id. at 485.

First, “[i]n all pre-emption cases, and particularly in those in which Congress has legislated” “in a field which the states have traditionally occupied,” courts “start with the assumption that the historic police powers of the States were not [intended by Congress] to be superseded by the Federal Act [here, PREPA] unless that was the clear and manifest purpose of Congress.” Id. (internal quotation marks and citation omitted).

This “canon of [statutory] construction [is] called the “presumption against preemption,” which instructs that federal law should not be read to preempt laws involving the states’ historic police powers “unless that was the clear and manifest purpose of Congress.”” Preemption Primer, supra n.20, at 4 (citing decisions).[31]

Second, “[t]he purpose of Congress is the ultimate touchstone in every preemption case.” Medtronic, id. (brackets in original). “Congress’ intent” “primarily is discerned from the language of the pre-emption statute and the “statutory framework” surrounding it.” Id. at 486. “Also relevant” “is the structure and purpose of the statute as a whole, as revealed not only in the text, but through the reviewing court’s reasoned understanding of the way in which Congress intended the statute and its surrounding regulatory scheme to affect business, consumers, and the law.” Id. (internal quotation marks and citations omitted). See also, Cipollone v. Liggett Group, Inc., 505 U.S. 504, 545 (1992) (Scalia, J., concurring in the judgement in part and dissenting in part) (“The ultimate question in each [pre-emption] case, as we have framed the inquiry, is one of Congress’s intent, as revealed by the text, structure, purposes, and subject matter of the statutes involved.”) (citations omitted).

Applying those interpretive principles to whether PREPA’s preemption clause preempts state-level criminal prosecution

Congress obviously intended to “preempt at least some state law[,]” Medtronic, id., when it enacted PREPA, officially titled “Targeted liability protections for pandemic and epidemic products and security countermeasures[,]”[32] (a title that itself suggests limited Congressional preemptive intent).[33] A Google Scholar case law search for post-2019 decisions containing “public readiness and emergency preparedness act” returns “about 470” results, (search done 11/09/25) a number of which are decisions addressing PREPA’s preemptive scope in civil cases.

But what about PREPA’s preemptive effect on criminal cases?

In previous articles I asserted there is reasonable suspicion to investigate certain government officials and others for reckless endangerment for failing to timely warn the public about the myocarditis risks associated with COVID-19 vaccination,[34] so I’ll use that offense as an example. Relatedly, Florida-based attorney Mimi Miller has prepared a 50-state Summary of State Criminal Laws for COVID Crime Responsibility & Accountability Projects Re: Hospital Homicides.[35] Inclined readers can think about facts they know about in light of the ideas herein.

Here’s the crime of reckless endangerment:

“An actor commits reckless endangerment if, under circumstances not amounting to a felony offense, the actor recklessly engages in conduct that creates a substantial risk of death or serious bodily injury to another individual.” Utah Code § 76-5-112(2). See also, Utah Code § 76-1-101.5(5) (“Conduct means an act or omission” to act.) “Thirty states” “have adopted a general reckless endangerment offense.” Paul H. Robinson & Tyler Scot Williams, Mapping American Criminal Law: Variations Across the 50 States, 203 (Praeger 2018).

Below, to illustrate why PREPA would not have preemptive effect on a state enforcing its reckless endangerment statute by prosecuting for failure to warn, I construe subsections of PREPA’s preemption clause in light of reckless endangerment’s text, informed by the above interpretive principles and other relevant authorities. I do each construal twice. First, using PREPA’s language as it reads. Second, using PREPA’s language with its terms replaced by their definitions. Going forward for readability I eschew quotation marks, citations, and signals for some quoted language for which I’ve already provided quotation marks, a citation, or a signal.

Construing PREPA’s preemption clause at subsection (8) as it reads:

Reckless endangerment is not a “law or legal requirement” of a “State or political subdivision of a State” “with respect to a covered countermeasure[.]”[36] Instead, reckless endangerment is a generally and broadly applicable state criminal law “with respect to” when somebody “recklessly engages in conduct [including failing to act] that creates a substantial risk of death or serious bodily injury to another individual.” Utah Code §§ 76-5-112(2); 76-1-101.5(5). Congress intended PREPA to preempt laws or legal requirements with respect to covered countermeasures.

Since enforcing state criminal laws is a historic police power of the states, see e.g., United States v. Lopez, 514 U.S. 549, 564 (1995) (referring to “areas such as criminal law enforcement or education where States historically have been sovereign”) (emphasis added), and in light of the interpretive principle that courts “start with the assumption that the historic police powers of the States were not [intended by Congress] to be superseded by the Federal Act [here, PREPA] unless that was the clear and manifest purpose of Congress[,]” given the absence of such manifest Congressional purpose in PREPA’s preemption clause, a state-level criminal prosecution for reckless endangerment would not be preempted under subsection (8) alone, before even getting to subsections (8)(A) and (8)(B), even if that prosecution was brought “[d]uring the effective period of a declaration under subsection (b)[,]”[37] which means during a public health emergency declared by the HHS Secretary.[38] See also, English v. General Elec. Co., 496 U.S. 72, 83 (1990) (field preemption decision) (parenthetically summarized as “explaining in dicta that generally applicable criminal laws are not likely to fall within the preempted field” in Preemption Primer, supra n.20, at 23, n.187); cf., Oneok, Inc. v. Learjet, Inc., 135 S.Ct. 1591, 1601 (2015) (implied preemption decision) (where state antitrust laws “are not aimed at natural gas companies in particular, but rather all businesses in the marketplace[,]” “[t]his broad applicability” “supports a finding of no pre-emption[.]”); Happel v. Guilford Cnty. Bd. of. Educ., 913 S.E.2d 174, 206 (N.C. 2025) (Riggs, J., dissenting) (“[T]he PREP Act neither promotes wrongdoing nor does it completely insulate bad actors from punishment[,]” and “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).

Construing PREPA’s preemption clause at subsection (8) with its terms replaced by their definitions:

Reckless endangerment is not a state, county, or municipal provision of law or a statute, regulation, common law duty, or other rule of law that must be obeyed “with respect to” a covered countermeasure—which is a biological product (which includes a vaccine), device, drug, product, respiratory protective device, or technology—leading me to the same conclusion as above for the same reasons.

Here, with the definition of “covered countermeasure” provided immediately above (biological product, etc.), is clearer place to say the phrase “with respect to” shows Congress in subsection (8) intended to massively limit PREPA’s preemptive scope—that is, to limit PREPA’s preemptive scope to state, county, municipal, or regulatory body laws, statutes, regulations, common law duties, or other rules of law that must be obeyed which are specifically aimed at covered countermeasures, because the phrase “with respect to” in preemption law “massively limits the scope of preemption[.]” Dan’s City Used Cars, Inc. v. Pelkey, 133 S.Ct. 1769, 1778 (2013). See also, Oneok, Inc., id., at 1599 (“[U.S. Supreme Court] precedents emphasize the importance of considering the target at which the state law aims in determining whether that [state] law is preempted.”) (emphasis in original). Reckless endangerment is obviously not aimed at matters and actions described in PREPA—it is a generally and broadly applicable state criminal law aimed at conduct falling within its terms.

Thus, on subsection (8) alone, before even getting to subsections (8)(A) and (8)(B), it is clear Congress did not intend PREPA’s preemption clause to preempt generally and broadly applicable state criminal laws like reckless endangerment or others in Ms. Miller’s 50-state Summary of State Criminal Laws for COVID Crime Responsibility & Accountability Projects Re: Hospital Homicides,[39] because such generally and broadly applicable state criminal laws are not aimed at the subject matter in subsection (8), meaning covered countermeasures as defined (biological products, etc.)

I realize discussing what Congress intended with PREPA assumes all its members knew what they were voting for and why. Still, when courts interpret statutes they assume legislatures choose their language and terms advisedly. This is true generally, see e.g., State v. Martinez, 2002 UT 80, ¶ 8 (“When examining the statutory language we assume the legislature used each term advisedly and in accordance with its ordinary meaning[.]”), and is true in the preemption context: “Congress often relies on the language of existing preemption clauses in drafting new legislation. This type of reliance can have important consequences, as courts often look to the settled meaning of statutory language to discern Congress’s intent.” Preemption Primer, supra n.20, 6.

Construing PREPA’s preemption clause at subsection (8)(A) as it reads:

Since under subsection (8) reckless endangerment is not a “a provision of law or legal requirement” of a “State or political subdivision of a State” “with respect to a covered countermeasure[,]” reckless endangerment is not a “provision of law or legal requirement that[,]” under subsection (8)(A), “is different from, or is in conflict with, any requirement applicable under” PREPA. Thus, a state law prosecution for reckless endangerment would not be preempted by PREPA, even if that prosecution was brought during a public health emergency declared by the HHS Secretary.

Construing PREPA’s preemption clause at subsection (8)(A) with its terms replaced by their definitions:

Since under subsection (8) reckless endangerment is not a state, county, municipal, or regulatory body law or statute, regulation, common law duty, or other rule of law that must be obeyed aimed at biological products (which includes vaccines), devices, drugs, products, respiratory protective devices, or technologies, reckless endangerment is not a statute, regulation, common law duty, or other rule of law that must be obeyed that, under subsection (8)(A), goes beyond, or is in conflict with, any such law or statute, regulation, common law duty, or other rule of law that must be obeyed applicable under PREPA, so a state-level prosecution for reckless endangerment would not be preempted by PREPA, even if that prosecution was brought during a public health emergency declared by the HHS Secretary.

Construing PREPA’s preemption clause at subsection (8)(B) as it reads:

Since under subsection (8) reckless endangerment is not a “provision of law or legal requirement” of a “State or political subdivision of a State” “with respect to a covered countermeasure” that is, under subsection (8)(A), “different from, or in conflict with, any requirement applicable under [PREPA]; and” (cumulative standard) since reckless endangerment, under subsection (8)(B), does not “relate[] to[[40]] the design, development, clinical testing or investigation, formulation, manufacture, distribution, sale, donation, purchase, marketing, promotion, packaging, labeling, licensing, use, any other aspect of safety or efficacy, or the prescribing, dispensing, or administration by qualified persons of the covered countermeasure, or to any matter included in a requirement applicable to the covered countermeasure under [PREPA][,]” PREPA would not preempt a prosecution for reckless endangerment, even if that prosecution was brought during a public health emergency declared by the HHS Secretary.

Construing PREPA’s preemption clause at subsection (8)(B) with its terms replaced by their definitions:

Since under subsection (8) reckless endangerment is not a state, county, municipal, or regulatory body law or statute, regulation, common law duty, or other rule of law that must be obeyed aimed at a biological product (which includes a vaccine), device, drug, product, respiratory protective device, or technology, that, under subsection 8(A), goes beyond, or is in conflict with, any such law or statute, regulation, or common law duty applicable under PREPA, and since reckless endangerment, under subsection 8(B), does not have a connection with, or contain a reference to PREPA about, the design, development, clinical testing or investigation, formulation, manufacture, distribution, sale, donation, purchase, marketing, promotion, packaging, labeling, licensing, use, any other aspect of safety or efficacy, or the prescribing, dispensing, or administration by—a licensed health professional, other individual, or person in an HHS Secretary declaration, authorized to prescribe, administer, or dispense such biological products (which includes vaccines), devices, drugs, products, respiratory protective devices, or technologies under the law of the State in which the biological product (which includes a vaccine), device, drug, product, respiratory protective device, or technology was prescribed, administered, or dispensed—of the biological product (which includes a vaccine), device, drug, product, respiratory protective device, or technology, or to any matter included in a statute, regulation, or common law duty applicable to a biological product (which includes a vaccine), device, drug, product, respiratory protective device, or technology, under PREPA[,] a state law prosecution for reckless endangerment would not be preempted by PREPA, even if that prosecution was brought during a public health emergency declared by the HHS Secretary.

Preliminary conclusion

For the reasons above, I don’t think PREPA’s preemption clause would preempt a state-level criminal prosecution for state law crimes, if supported. In a later post I’ll buttress my assertions here, including discussing both the statutory framework surrounding PREPA’s preemption clause and its structure and purpose as a whole, and discuss some other notions.


[1] https://tinyurl.com/yzes2akv.

[2] Even if Congress had so intended, there’d still be a constitutional challenge to make.

[3] Here: https://tinyurl.com/aus756e2, under the heading “PREPA’s legislative history supports that it was intended to confer broad civil immunity, not immunity from criminal prosecution.”

[4] Here: https://tinyurl.com/4t4cz38t, under the heading “Statute of limitations[.]”

[5] state AG’s letter-to-congress-covid-19-response-feb-5-2025 (2).pdf - Google Drive

[6] Id.

[7] Here: https://tinyurl.com/4t4cz38t, under the heading “Precedent for county attorney prosecution of federal officials and supremacy clause immunity[.]”

[8] Pandemic Preparedness in the Next Administration | Center for Global Health Science and Security | Georgetown University, YouTube video posted there, starting @ 3:00; locatable here too: https://tinyurl.com/4pww6hdz.

[9] https://tinyurl.com/4ypd56uf (You might have to search for this clip as at least one was no longer available to me: “Eric Schmidt modest death event Chernobyl”) (https://tinyurl.com/5x4zh6y5)

[10] https://tinyurl.com/4atfardh.

[11] 42 U.S.C. § 247-6d(b)(8).

[12] 42 U.S.C. § 247-6d(b)(8).

[13] 42 U.S.C. § 247d-6d(b)(1); 42 U.S.C. § 201(c).

[14] 42 U.S.C. § 247-6d(i)(1)(C); 42 U.S.C. § 262(i)(1).

[15] 42 U.S.C. § 247d-6d(i)(1).

[16] Whether some biological products, devices, and drugs fall within the scope of PREPA’s preemption provision depends on an HHS Secretary determination. 42 U.S.C. § 247d-6d(i)(1)(B).

[17] “[T]he Supreme Court of the United States has recognized [that] the federal legislature resorts to the term “requirement” to describe “a rule of law that must be obeyed,” [citation omitted] a meaning which “reaches beyond positive enactments, such as statutes and regulations, to embrace common-law duties[.]” Happel v. Guilford Cnty. Bd. of. Educ., 913 S.E.2d 174, 200 (N.C. 2025) (Riggs, J., dissenting), citing Bates v. Dow Agrosciences LLC, 544 U.S. 431, 445 (2005).

[18] Nat’l Meat Ass’n v. Harris, 132 S.Ct. 965, 971 (2012) (for goes “beyond”). Harris interpreted an “in addition to, or different than” preemption provision. Id. at 969.

[19] See supra n.16.

[20] Derivative of discussion in Bryan L. Adkins, Alexander H. Pepper & Jay B. Sykes, Cong. Rsch. Serv., Federal Preemption: A Legal Primer, 7 (2023) (Preemption Primer) (Federal Preemption: A Legal Primer | Congress.gov | Library of Congress, downloadable there as a more reader friendly PDF, also linked here: https://drive.google.com/file/d/1dOgDZnFRQuLGkX0AXMK7NTMX_T6LSRFu/view?usp=drive_link), regarding U.S. Supreme Court decisions interpreting “related to” preemption provisions. For example, in the Employee Retirement Income Security Act (ERISA) context, “related to” means: “(1) state laws that have a “connection with” ERISA plans, and (2) state laws that contain a “reference to” ERISA plans.” Preemption Primer, id. “The [U.S. Supreme] Court has held that state laws have an impermissible “connection with” ERISA plans if they govern “a central matter of plan administration” or interfere with “nationally uniform plan administration.” In contrast, state laws that indirectly affect ERISA plans are not preempted unless the relevant effects are particularly “acute.”” Id. (citations omitted). “Applying these standards, the Court has ruled that ERISA preempts state law governing areas of “core ERISA concern[.]” Id. Also, where a “challenged state statute expressly referenced ERISA plans, the Court held that [the challenged state statute] fell within the scope of ERISA’s preemption clause even if it was enacted to help effectuate ERISA’s underlying purposes.” Id. at 8 (citation omitted).

[21] See Preemption Primer, 8, which, in discussing an “in reference to” provision in ERISA context, states: “The [U.S. Supreme] Court has also held that ERISA preempts state laws that contain an impermissible “reference to” ERISA plans[,]” meaning “where [the “in reference to” provision] “acts immediately and exclusively upon ERISA plans,” or where the existence of an ERISA plan is “essential” to the state law’s operation.” Id. (internal citations omitted). For more discussion interpreting the meaning of “related to” and “with respect to” in preemption provisions, see Preemption Primer, 8-10, and citations there.

[22] 42 U.S.C. § 247d-6d(i)(8).

[23] 42 U.S.C. § 247-6d(i)(1)(C); 42 U.S.C. § 262(i)(1).

[24] 42 U.S.C. § 247d-6d(i)(1).

[25] See supra n.16.

[26] See supra n.17.

[27] 42 U.S.C. § 247-6d(i)(1)(C); 42 U.S.C. § 262(i)(1).

[28] 42 U.S.C. § 247d-6d(i)(1).

[29] Id.

[30] 42 U.S.C. § 247-6d(b)(8).

[31] Happel, supra n.17, discusses disagreement about whether the presumption against preemption still applies to express preemption provisions, at 189 n.8, 204 n.7.

[32] 42 U.S. Code § 247d-6d

[33] “Targeted” in the title suggests something narrowly aimed at, as opposed to something aimless or sweeping in applicability. For how titles can be used in statutory interpretation, see e.g., INS v. National Ctr. For Immigrants’ Rights, Inc., 502 U.S. 183, 189 (1991) (“[T]he title of a statute or section can aid in resolving an ambiguity in the legislation’s text.”); Salt Lake City v. Howe, 2016 UT App 219, ¶ 14 (“The title of a statute is not part of the text of a statute, and absent ambiguity, it is generally not used to determine a statute’s intent.”). See also Antonin Scalia & Bryan A. Garner, Reading Law: The Interpretation of Legal Texts 221-24 (2012), for a discussion of the title-and-headings canon of statutory interpretation.

[34] Here: https://tinyurl.com/ytecxrju; and here: https://tinyurl.com/mptfskf7.

[35] FAFO - Summary of all state criminal laws for covid prosecutions_Mimi Miller.pdf - Google Drive (version as of 06/05/25).

[36] 42 U.S.C. § 247-6d(b)(8).

[37] 42 U.S.C. § 247-6d(b)(8).

[38] 42 U.S.C. § 247d-6d(b)(1); 42 U.S.C. § 201(c).

[39] See supra n.35.

[40] While the phrase “with respect to” in preemption law “massively limits the scope of preemption[,]” Dan’s City, 133 S.Ct. at 1778, as discussed above, the phrase “related to” “expresses broad preemptive purpose.” Id. Those seemingly incongruous phrases in subsections (8) and 8(B) would be interpreted broadly and inclusively. “At the same time, the breadth of the words “related to” does not mean the sky is the limit[,]” id., to a broad and inclusive interpretation, because even if such laws were broadly and inclusively interpreted to the extent they “affect[ed]” id., the actions described in subsection (B) “in only a tenuous, remote, or peripheral manner[,]” id., such laws would not be preempted by PREPA. Id. See also, Preemption Primer, supra n.20, 6-7 (The U.S. Supreme “Court has cautioned against strictly literal interpretations of “related to” preemption clauses. Instead of reading such clauses. Instead of reading such clauses to the furthest stretch of their indeterminacy, the Court has looked to Congress’s statutory objectives to cabin the clauses’ scope”) (cleaned up).

No posts

© 2026 Ed Berkovich · Privacy ∙ Terms ∙ Collection notice
Start your SubstackGet the app
Substack is the home for great culture