Amicus Curiae Brief — Philip Morris USA Inc., Petitioner v. Armand Fontaine, Individually and as Personal Representative of the Estate of Barbara Ellen Fontaine

Supreme Court briefSep 23, 2026

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No. 26–235

In the Supreme Court of the United States

PHILIP MORRIS USA INC.,

Petitioner,

ARMAND FONTAINE, individually and as personal representative of the Estate of Barbara Ellen Fontaine,

Respondent.

ON PETITION FOR A WRIT OF CERTIORARI TO

THE MASSACHUSETTS SUPREME JUDICIAL

COURT

BRIEF OF COALITION OF U.S. MANUFACTURING COMPANIES AS AMICI CURIAE IN

SUPPORT OF PETITIONER

ERIK HAAS

ADAM S. LURIE

Counsel of Record

KATHERINE BRISSON

MAYLYNN CHEN

LINKLATERS LLP

1290 Avenue of the Americas

New York, NY 10104

(212) 903-9312

adam.lurie@linklaters.com

Counsel for Amici Curiae

TABLE OF CONTENTS

Page

INTERESTS OF THE AMICI CURIAE ..................... 1

SUMMARY OF ARGUMENT ..................................... 4

ARGUMENT ............................................................... 5

Congress Enacted Comprehensive Public

Health and Safety Regulatory Regimes .......... 5

II.

Lower Courts Disregard Congressional

Intent and This Court’s Directives .................. 9

a. Courts Permit State Law Claims that

Statutory Text Proscribes ........................... 9

b. Courts Wrongly Apply a Presumption

Against Preemption .................................. 13

III. U.S. Companies Require a Textual Standard

that Enforces Congress’s Intent to Preempt . 16

a. Uniformity Is Necessary for Interstate

Commerce .................................................. 16

b. U.S. Companies Require Certainty

to Invest ..................................................... 18

c. Preemption Furthers National Interests

in the Global Market ................................. 19

d. Science-Based Safety Standards

Must Govern .............................................. 21

e. Preemption Minimizes Abusive Claims

and Inequitable Retrospective Penalties . 23

f. Preemption Mitigates the Appearance

of Judicial Activism ................................... 24

CONCLUSION .......................................................... 26

TABLE OF AUTHORITIES

Page

Cases

Altria Grp., Inc. v. Good,

555 U.S. 70 (2008) .............................................. 9, 20

American Electric Power v. Connecticut,

564 U.S. 410 (2011) .......................................... 12, 13

Bates v. Dow Agrosciences LLC,

544 U.S. 431 (2005) ................................................ 17

Buckman Co. v. Plaintiffs’ Legal Committee,

531 U.S. 341 (2001) .................................... 12, 14, 17

Cal. Rest. Ass’n v. City of Berkeley,

89 F.4th 1094 (9th Cir. 2024) ................................ 15

Cipollone v. Liggett Group,

505 U.S. 504 (1992) ...................................... 9, 14, 15

City of New York v. Chevron Corp.,

993 F.3d 81 (2d Cir. 2021) ........................... 8, 13, 21

Cooley v. Bd. of Wardens of Port of Phila.,

53 U.S. 299 (1851) .................................................. 16

CSX Transp., Inc. v. Easterwood,

507 U.S. 658 (1993) ................................................ 14

Geier v. Am. Honda Motor Co.,

529 U.S. 861 (2000) .......................................... 16, 19

Gibbons v. Ogden,

22 U.S. 1 (1824)...................................................... 16

Gibson v. Advanced Bionics, LLC,

2025 U.S. Dist. LEXIS 170605 (C.D. Cal. Sep. 2,

2025) ....................................................................... 12

Hollenstein v. Bausch & Lomb Inc.,

2025 U.S. Dist. LEXIS 121547 (S.D.N.Y. June 27,

2025) ....................................................................... 12

International Paper Company v. Ouellette,

479 U.S. 481 (1987) .............................. 12, 13–14, 18

Landgraf v. USI Film Prods.,

511 U.S. 244 (1994) ................................................ 23

Lead Indus. Ass’n, Inc. v. EPA,

647 F.2d 1130 (D.C. Cir. 1980) .............................. 23

Mayo v. United States,

319 U.S. 441 (1943) ................................................ 16

Mayor & City Council of Baltimore v. BP P.L.C.,

353 A.3d 1142 (Md. 2026) ................................ 13, 14

Monsanto Co. v. Durnell,

146 S. Ct. 2001 (2026)................................................

.......................... 2, 6–8, 10–11, 14–15, 17, 20–21, 23

North Carolina, ex rel. Cooper v. Tennessee Valley

Auth.,

615 F.3d 291 (4th Cir. 2010).................. 7, 19, 22, 23

Oklahoma v. Castro-Huerta,

597 U.S. 629 (2022) ................................................ 14

Puerto Rico v. Franklin Cal. Tax-Free Tr.,

579 U.S. 115 (2016) ............................................ 5, 14

iii

R.J. Reynolds Tobacco Co. v. City of Edina,

60 F.4th 1170 (8th Cir. 2023) ................................ 15

Riegel v. Medtronic, Inc.,

552 U.S. 312 (2008) ...................................... 7, 12, 22

Rubin v. Monsanto Co.,

No. 4:26-CV-40079 (D. Mass. 2026) ...................... 11

Shuker v. Smith & Nephew, PLC,

885 F.3d 760 (3d Cir. 2018) ................................... 15

Stengel v. Medtronic Inc.,

704 F.3d 1232 (9th Cir. 2013)................................ 12

Statutes & Regulations

15 U.S.C. § 1334(b) ......................................................9

21 U.S.C. § 331 ............................................................8

21 U.S.C. § 360i ...........................................................7

21 U.S.C. § 360k(a) ................................................ 8, 12

42 U.S.C. § 7413 .......................................................... 8

42 U.S.C. § 7416 .......................................................... 6

5 U.S.C. § 702 ..............................................................7

5 U.S.C. § 704 ..............................................................7

7 U.S.C. § 136d(a)(2) ................................................... 7

7 U.S.C. § 136j(a)(1)(E) ............................................... 8

7 U.S.C. § 136l .............................................................8

7 U.S.C. § 136n ............................................................7

7 U.S.C. § 136v ........................................................ 6, 8

Other Authorities

American Chemistry Council, New Survey Finds

Dramatic Rise in Regulations Undercuts American

Manufacturing and National Priorities (Jan. 17,

2024) ....................................................................... 18

American Chemistry Council, Regulation (2026) .... 18

American Tort Reform Association, America’s

$367 Billion Lawsuit Epidemic (Apr. 7, 2025) ..... 24

American Tort Reform Association, The Junk Science

Playbook (Jan. 2026).............................................. 22

American Tort Reform Foundation,

Judicial Hellholes 2025/2026 (2025).................... 24

Ash Johnson, How Congress Can Foster a Digital

Single Market in America, Information Technology

& Innovation Foundation (Feb. 20, 2024) ............. 17

Glenn Lammi, Keep Federal Preemption of Railroad

Regulation on Track, WLF Legal Pulse

(Apr. 23, 2025) ....................................................... 18

Heather Mac Donald, The Climate Litigation

Swindle, City J. (Spring 2026) .............................. 21

IARC Monographs on the Evaluation of Carcinogenic

Risks to Humans, Some Organophosphate

Insecticides and Herbicides, Vol. 112 (2017) ........ 11

International Agency for Research on Cancer, IARC

Monographs on the Identification of Carcinogenic

Hazards to Humans: Questions and Answers

(Dec. 10, 2019)........................................................ 11

John Gardella, IARC PFAS Findings Will Influence

Litigation and EPA Challenges, Nat’l L. Rev.

(Dec. 4, 2023).......................................................... 22

John Kennedy, Chuck Grassley, et al., Kennedy,

Grassley, Colleagues Introduce Bill to Expose

Third-Party Funding Behind Lawsuits, Press

Release (Feb. 11, 2026) .......................................... 20

Marathon Strategies, Corporate Verdicts Go

Thermonuclear: 2026 Edition (2026) .................... 24

U.S. Department of State & U.S. Department of

Health and Human Services, Joint Statement on

the Preeminence of the U.S. Government

Regulating Health Risks for Americans (June 8,

2026) ....................................................................... 20

Constitutional Provisions

U.S. Const. art. VI, cl. 2. ........................................... 14

INTERESTS OF THE AMICI CURIAE1

Amici curiae are United States companies that,

like Petitioner, manufacture and sell products

throughout the country subject to comprehensive federal health and safety regulatory regimes.2 The plain

text, structure, purpose, and subject matter of the

statutes that create these standards clearly evince

Congress’s intent to establish exclusive federal regulatory regimes.

These federal standards are

(i) adopted through rigorous, science-based deliberative processes that afford all constituents the opportunity to participate, (ii) revised on a prospective basis

as new information or science comes to light, and

(iii) enforced by federal agencies with the authority to

impose civil or criminal penalties for non-compliance.

The standards reflect Congress’s considered judgment

that compliance therewith is necessary and sufficient

to protect the public welfare. And they provide the

regulatory uniformity companies require to develop,

market, and sell their products nationwide.

In recent years, amici have faced a deluge of litigation brought mainly by the mass tort plaintiffs’ bar

and some states, seeking to advance state law duties,

claims, and remedies that unquestionably are

1 Pursuant to Rule 37.2, ten days before this brief was due, coun-

sel for amici curiae notified counsel of record for the parties of its

intention to file this brief. Pursuant to Rule 37.6, counsel for

amici certifies that this brief was not authored in whole or in part

by counsel for any party, and that no person or entity, other than

amici or their counsel, made a monetary contribution to the preparation or submission of the brief.

2 This brief is submitted on behalf of the following coalition of

amici: Johnson & Johnson, Exxon Mobil Corporation, Ford Motor

Company, Kenvue Inc., Monsanto Company, and Textron Inc.

preempted by federal law. Certain lower courts permit these state law cases to proceed by endorsing the

“artful” re-labeling of claims to circumvent the plain

reading of the governing statute, or relying on a judicially created “presumption against preemption” to

narrow its express terms.

In doing so, these courts abrogate the social bargain underpinning the regulatory regimes. In exchange for complying with federally mandated standards, U.S. companies were to receive the regulatory

certainty they require to make the investments necessary to bring their products to market in the United

States. Instead, the courts allow opportunistic plaintiffs’ lawyers to pursue contrived state law causes of

action to recover extreme retroactive damages awards

and penalties for federally compliant sales made in

years and decades past.

Those claims are inequitable and contravene the

intended supremacy and exclusivity of federal regulations. As this Court recently held, the law should not

“retroactively penalize persons for doing what the

Government had required them to do.” Monsanto Co.

v. Durnell, 146 S. Ct. 2001, 2014 (2026). But that is

exactly what amici (and similarly situated U.S. companies across myriad industries) experience every

day.

Amici have added their names to the petition before this Court to underscore the importance of these

issues to U.S. companies endeavoring to invest, manufacture, and sell in this country. The questions presented here are the same legal issues that amici repeatedly face and that must be dispositively decided

to resolve the splits in the judiciary concerning the

preemptive force of comprehensive federal health and

safety regulatory regimes. Those legal issues are

well-framed by the record below, and can be readily

resolved by: (1) a clear endorsement from this Court

of a textual standard for interpreting the governing

federal statutes, paired with (2) an absolute renunciation of the “presumption against preemption.”

SUMMARY OF ARGUMENT

Congress intentionally created comprehensive federal health and safety regulatory regimes to govern

products across myriad industries that are sold into

interstate commerce.

These regimes—developed

through science-based processes and maintained

through federal oversight and enforcement—both protect the health and safety of the American people and

provide the uniformity and predictability that companies need to operate. These dual goals can be accomplished only when the judiciary faithfully enforces

Congress’s intent, as expressed through the plain text

of Congress’s statutes: that federal health and safety

standards should govern and state law may play a role

only where the statutory text expressly permits it to

do so.

The comprehensive federal health and safety regimes that govern amici and like companies must be

given the supremacy and exclusivity that Congress intended by its plain text. That reading is required to

(1) provide the regulatory uniformity that companies

need to participate in interstate commerce, (2) afford

U.S. companies the certainty they require to make

long-term capital investments, (3) protect national interests by ensuring that U.S. companies are governed

by U.S. standards, (4) ensure that health and safety

standards are adopted through rigorous, scientifically

grounded deliberative processes in which constituents

may participate, (5) protect against inequitable retroactive penalties imposed on companies that have complied in good faith with federal requirements, and

(6) reduce the appearance of political or parochial judicial activism in litigation.

As the decision below demonstrates, however,

lower courts are not faithfully applying Congress’s

and this Court’s directives. Respondent’s failure-towarn theory of liability was expressly preempted by

the plain terms of the Labeling Act, and yet the Massachusetts Supreme Judicial Court allowed liability to

lie on evidence of conduct it recognized would be

preempted if framed as a failure to warn. The court

also applied a “presumption against preemption” to

narrow the scope of the Labeling Act’s preemption

clause, despite this Court’s admonition that the presumption has no place when an express preemption

clause exists. See Puerto Rico v. Franklin Cal. TaxFree Tr., 579 U.S. 115, 125 (2016) (“[B]ecause the statute contains an express pre-emption clause, we do not

invoke any presumption against pre-emption but instead focus on the plain wording of the clause, which

necessarily contains the best evidence of Congress’

pre-emptive intent.”) (internal quotation marks omitted). Across diverse and important industries, lower

courts have repeated these errors, producing divergent rules, undermining Congress’s regulatory

choices, and imposing mind-boggling litigation costs

on U.S. companies (and, in turn, the American people).

This case presents an opportunity for this Court to

adopt a clear textual standard to ensure that Congress’s carefully crafted regulatory framework is respected.

ARGUMENT

Congress Enacted Comprehensive Public

Health and Safety Regulatory Regimes

Pursuant to its constitutional authority to regulate

matters affecting national public health and safety in

interstate commerce, Congress has enacted comprehensive regulatory regimes specifying the standards

that companies must meet to sell their products

throughout the country. The plain text of these statutes reflects Congress’s intent that federal health and

safety standards govern interstate commerce. Where

Congress intends to allow incremental state law duties to be imposed, it does so explicitly through express

language, through standalone “savings clauses,” see,

e.g., 42 U.S.C. § 7416 (standalone states’ rights savings clause in the Clean Air Act (“CAA”)); or “savings

clauses” paired with “preemption clauses,” see, e.g., 7

U.S.C. §§ 136v(a)–(b) (savings clause and preemption

clause pairing in the Federal Insecticide, Fungicide,

and Rodenticide Act (“FIFRA”)).

These comprehensive regimes span a range of industries, including tobacco, pesticides, medical devices, air transportation, automobiles, energy, and

certain foods—embodying Congress’s reasoned judgment that uniform national standards, rather than a

patchwork of conflicting state requirements, should

govern products implicating public welfare that are

sold nation- or worldwide. See Durnell, 146 S. Ct. at

2012. While these regulatory regimes are varied in

subject matter, they share several structural features

that evidence Congress’s intent to implement a comprehensive federal regulatory regime that (except

where explicitly stated) is both exclusive and supreme.

Rigorous Deliberative Processes. Each regime

requires a demanding, scientifically grounded deliberative process before standards are adopted. Federal

agencies must conduct thorough reviews before establishing health and safety requirements. See, e.g., Durnell, 146 S. Ct. at 2006–07 (outlining EPA’s extensive

pesticide-registration and label-approval process under FIFRA); Riegel v. Medtronic, Inc., 552 U.S. 312,

317–18 (2008) (describing FDA’s “rigorous” premarket

approval process for medical devices); North Carolina,

ex rel. Cooper v. Tennessee Valley Auth., 615 F.3d 291,

304 (4th Cir. 2010) (“The Clean Air Act’s extensive

coverage allows regulators with expertise in the relevant scientific fields to . . . create empirically-based

emissions standards.”). Interested parties have the

opportunity to participate in these deliberative processes via mandated notice and comment periods.

See, e.g., 7 U.S.C. § 136c(4) (requiring notice and comment period for new pesticide registrations under

FIFRA); Tennessee Valley Auth., 615 F.3d at 299 (explaining that, before EPA adopts emissions standards, “interested persons [may] submit written comments”). Constituents may also challenge the regulatory process and agency determinations before implementation through administrative and judicial review. See generally 5 U.S.C. §§ 702, 704 (Administrative Procedure Act); see also, e.g., 7 U.S.C. § 136n

(providing for judicial review of EPA’s registration decisions).

Ongoing Regulatory Oversight. These regimes

further require governing federal agencies to revise

standards to account for new information, data, or science—whether discovered by the agency itself, disclosed by manufacturers pursuant to mandatory reporting obligations, or submitted by the public

through mechanisms such as citizen petitions. See,

e.g., 7 U.S.C. § 136d(a)(2) (requiring pesticide manufacturers to report new information on adverse effects); 21 U.S.C. § 360i (requiring medical device manufacturers to report adverse events); Durnell, 146 S.

Ct. at 2008 (explaining that “any person can petition

EPA to modify, suspend, or cancel a pesticide’s registration based on . . . new evidence”).

Federal Enforcement. Each regime provides the

designated federal agency with the tools to enforce

compliance with its health and safety requirements,

including via civil and criminal penalties. See, e.g., 7

U.S.C. §§ 136j(a)(1)(E) (unlawful acts under FIFRA),

136l (specifying civil and criminal penalties for noncompliance); 21 U.S.C. § 331 (prohibited acts under

the Federal Food, Drug, and Cosmetic Act (“FDCA”));

42 U.S.C. § 7413 (civil, criminal, and administrative

penalties under the CAA).

Preemption of Incremental or Inconsistent

State Requirements. The clear Congressional intent

embodied in these statutes is that companies who

comply with the applicable federal regulatory requirements shall not thereafter be subjected to inconsistent

or additional obligations under state law. See, e.g., 7

U.S.C. § 136v(b) (FIFRA preemption clause); 21

U.S.C. § 360k(a) (preemption clause in the Medical

Device Amendments (“MDA”) to the FDCA). Where

Congress intended to preserve state authority, it has

said so explicitly through “savings clauses” in the governing statutes. See City of New York v. Chevron

Corp., 993 F.3d 81, 99 (2d Cir. 2021) (explaining that

the CAA “plainly permit[s] states to create and enforce their own emissions standards applicable to instate polluters”); Durnell, 146 S. Ct. at 2008 n.2 (explaining that, notwithstanding federal preemption of

labeling or packaging requirements, states “remain

free to ‘regulate the sale or use of any federally registered pesticide’”) (citing 7 U.S.C. § 136v(a)).

II.

Lower Courts Disregard Congressional

Intent and This Court’s Directives

Despite this Court’s guidance, lower courts routinely allow plaintiffs to circumvent the Congressional

intent embodied in its federal legislative schemes

through two related legal errors squarely implicated

by the questions presented in this case.

Courts Permit State Law Claims that

Statutory Text Proscribes

The plaintiffs’ bar has developed a playbook for circumventing preemption: re-label clearly preempted

claims under other state law monikers and then insist

that these restyled claims are outside the purview of

the federal regulatory regime.

The decision below is a paradigmatic example. Respondent asserted the marquee theory of liability that

Petitioner was liable under state law for failing to retain a warning in addition to those prescribed by federal law. Respondent conceded that any failure-towarn claim was barred by the express preemption

clause of the Labeling Act, which explicitly proscribed

any state-law “requirement or prohibition based on

smoking and health . . . with respect to the advertising

or promotion of any cigarettes.” 15 U.S.C. § 1334(b).

As this Court previously held, the Labeling Act

preempts state law claims where the “predicate duty”

or “gravamen” of the alleged claim was a “failure to

warn” of health risks associated with smoking. See

Altria Grp., Inc. v. Good, 555 U.S. 70, 81 (2008) (citing

Cipollone v. Liggett Grp., 505 U.S. 504, 548 (1992)).

To evade this holding, Respondent simply recast

his challenge to Petitioner’s warnings as “fraud” and

“conspiracy” claims rather than failure-to-warn—

even though the gravamen of the restyled claims still

undisputedly arose from the removed warning. Relying on the purported “presumption against preemption,” the court below narrowly construed the preemption clause in the Labeling Act and affirmed $64 million in compensatory liability and punitive damages,

expressly condoning a theory of failure-to-warn liability so long as it is pursued under the caption of a different claim. As the petition rightfully recites, the

court’s reasoning impermissibly elevates form over

substance and transforms an express preemption provision into a mere pleading requirement. That approach disregards the Congressional intent evidenced

by the clear text of the preemption clause and invites

heavy penalties and punitive awards.

But the case below is not an outlier, and the problem is not confined to tobacco. Take the Roundup litigation, for example. In 1974, EPA registered glyphosate-based pesticides and approved Roundup’s label

without a cancer warning. Starting in 1991 and for

the more than three decades since, “EPA has repeatedly re-evaluated glyphosate and has repeatedly concluded that glyphosate is not likely to cause cancer.”

Durnell, 146 S. Ct. at 2008. Notwithstanding the governing federal agency’s repeated findings that glyphosate is safe, in 2017 the mass tort plaintiffs’ bar began

filing large volumes of claims against Monsanto,

claiming injuries based on its failure to warn of purported cancer risks associated with Roundup. The

claims were mainly predicated on the classification of

glyphosate as a “probable carcinogen” by a foreign organization—the International Agency for Research on

Cancer (“IARC”), based in France. Id. at 2008–09.

Yet, IARC simultaneously conceded that it had no

evidence of any causal relationship between

Roundup’s use and cancer.3

After almost a decade of extraordinarily costly litigation, in June 2026, this Court held that state law

failure-to-warn claims are preempted by FIFRA,

which contains a preemption clause that “further underscores EPA’s comprehensive and exclusive authority in registering pesticides and approving labels.”

Durnell, 146 S. Ct. at 2008. Yet within weeks of this

Court’s decision, a Massachusetts court granted plaintiffs leave to recast their preempted failure-to-warn

claims as other state-law causes of action, effectively

inviting them to proceed with their claims against

Monsanto on the same theory, facts, and harm. See

Rubin v. Monsanto Co., No. 4:26-CV-40079, D.E. 68

(D. Mass. 2026). Similarly, just this month, a Missouri state court flouted the Durnell decision and permitted claims resting on identical conduct to go to

trial, styled as design-defect and negligence. See

Shull v. Monsanto, No. 25BA-CV4355 (Mo. Cir. Ct.

Boone Cnty. 2026). This is precisely the artful pleading dynamic that a decision for the Petitioner would

foreclose.

The same issue has presented itself in the medical

device context. Under the plain text of the MDA,

there is no private right of action to enforce FDA regulations, and no state may establish any safety

See IARC Monographs, Some Organophosphate Insecticides

and Herbicides (Vol. 112) at 398 (“There is limited evidence in

humans for carcinogenicity of glyphosate.”); IARC Monographs

on the Identification of Carcinogenic Hazards to Humans, Questions and Answers (Dec. 10, 2019) (“Limited evidence of carcinogenicity means that a positive association has been observed between exposure to the agent and cancer but that other explanations for the observations . . . could not be ruled out with reasonable confidence.”).

requirement “different from, or in addition to,” any

federal requirement applicable to a medical device. 21

U.S.C. § 360k(a)(1). This Court has consistently held

that claims asserting fraud on the FDA, or that seek

to impose safety requirements additional or contrary

to those required by the federal regime, are

preempted. See generally Riegel, 552 U.S. 312; Buckman Co v. Plaintiffs Legal Comm., 531 U.S. 341

(2001). Yet, thwarting this Court’s clear rulings,

lower courts routinely permit artfully crafted claims

asserting incremental or inconsistent state law duties

to proceed anyway. See, e.g., Hollenstein v. Bausch &

Lomb Inc., No. 24 Civ. 03843, 2025 U.S. Dist. LEXIS

121547, *45–46 (S.D.N.Y. June 27, 2025) (allowing

failure-to-warn claim to proceed under a new label,

thereby sanctioning damages not called for or allowed

by the statute); Stengel v. Medtronic Inc., 704 F.3d

1224, 1233–34 (9th Cir. 2013) (allowing plaintiffs to

replead a preempted failure-to-warn claim premised

on disclosure obligations incremental to those required by the FDA). And fraud-on-the-FDA claims

continue to be advanced as well. See, e.g., Gibson v.

Advanced Bionics, LLC, 2025 U.S. Dist. LEXIS

170605, *17 (C.D. Cal. Sep. 2, 2025).

Energy companies are seeing a similar pattern. In

International Paper Company v. Ouellette and American Electric Power v. Connecticut, this Court explained that interstate air and water pollution are a

“matter of federal, not state law.” 479 U.S. 481, 488

(1987); 564 U.S. 410, 422 (2011). The only permissible

applications of state law, this Court further explained,

are those “specifically preserved” by the savings

clauses of the Clean Water Act and Clean Air Act.

Ouellette, 479 U.S. at 492; American Electric Power,

564 U.S. at 429. Some lower courts have correctly

applied this Court’s precedent and dismissed opportunistic actions attempting to impose the costs of

global climate change on U.S. energy companies under the CAA. See generally Mayor & City Council of

Baltimore v. B.P. P.L.C., 353 A.3d 1142 (2026); City of

New York v. Chevron Corp., 993 F.3d 81 (2d Cir. 2021).

Other courts, however, have allowed these cases to

proceed by endorsing plaintiffs’ artful framing of their

claims, using labels such as nuisance, consumer deception, and civil conspiracy, to disguise their attempts to regulate interstate pollution in contravention of Ouellette and American Electric Power.4 In doing so, plaintiffs seek to use litigation to create (and

enforce) policy that properly belongs with the federal

government.

Across countless industries, the pattern is the

same: plaintiffs re-label their claims to circumvent

preemption, and lower courts endorse the evasion by

embracing the pleading label rather than the substance of the duty the claim would impose. A clearcut instruction from this Court that preemption turns

on the substance of the state-law obligation—not its

caption—would provide urgently needed clarity.

Courts Wrongly Apply a Presumption

Against Preemption

Compounding the artful pleading problem, lower

courts regularly invoke a “presumption against

preemption” when purporting to interpret federal

statutes, thereby narrowly (and incorrectly) interpreting the statutory text.

4 One example is Suncor Energy (U.S.A.) Inc., et al. v. County

Commissioners of Boulder County, et al., No. 25-170, now before

this Court on writ of certiorari to the Supreme Court of Colorado.

At its core, this issue is one of statutory interpretation. This Court has repeatedly underscored the

primacy of the text itself in that inquiry. See, e.g.,

CSX Transp., Inc. v. Easterwood, 507 U.S. 658, 664

(1993) (“[T]he task of statutory construction must in

the first instance focus on the plain wording of the

clause, which necessarily contains the best evidence

of Congress’s pre-emptive intent.”); Oklahoma v. Castro-Huerta, 597 U.S. 629, 642 (2022) (“As this Court

has repeatedly stated, the text of a law controls over

purported legislative intentions unmoored from any

statutory text.”). Plain textual interpretation is the

most faithful method of statutory interpretation, as

Justice Scalia advocated for in his dissent in Cipollone. See Cipollone, 505 U.S. at 548.

A textualist approach begets simplicity and clarity.

If a statute sets forth a comprehensive regulatory

health and safety regime with no express authorization of state law claims, then federal preemption

should apply. See Buckman, 531 U.S. at 348. If the

statute contains a “savings clause,” then the plain

reading of that clause dictates which state law claims

are allowed. Ouellette, 479 U.S. at 497; Mayor & City

Council of Baltimore, 353 A.3d at 1177–79. And if the

statute contains a “preemption clause” and a “savings

clause,” then both must be read together to discern

Congressional intent. See Durnell, 146 S. Ct. at 2008

n.2.

“Federal statutes,” after all, “shall be the supreme

Law of the Land.” U.S. Const. art. VI. Cl. 2. Neither

blind deference to state law nor a “presumption

against preemption” has any place in courts’ textual

analysis of any federal statute. See Franklin, 579 U.S.

at 125 (refusing to “invoke any presumption against

preemption,” and instead “focus[ing] on the plain

wording”) (citation omitted); Durnell, 146 S. Ct. at

2009–10 (interpreting FIFRA’s express preemption

clause based on the text itself without invoking any

presumption); Cal. Rest. Ass’n v. City of Berkeley, 89

F.4th 1094, 1101 (9th Cir. 2024) (applying “textual

analysis ‘without any presumptive thumb on the

scale’ for or against preemption”) (citation omitted).

The presumption certainly has no bearing on the interpretation of express preemption clauses.

Lower courts nonetheless continue to deploy the

presumption to narrow the reach of express preemption provisions—including the Massachusetts Supreme Judicial Court in the decision below. There, the

court invoked the Cipollone plurality’s reliance on the

“presumption against pre-emption” as part of its analytical framework. Fontaine v. Phillip Morris USA

Inc., 277 N.E.3d 585, 608 (Mass. 2026) (quoting Cippollone, 505 U.S. at 523). The result: the largest punitive jury verdict in Massachusetts history.

Other lower courts have similarly shirked this

Court’s guidance. See, e.g., Shuker v. Smith &

Nephew, PLC, 885 F.3d 760, 771 (3d Cir. 2018) (reasoning that, despite the MDA’s express preemption

provision, “‘the historic primacy of state regulation of

matters of health and safety’ re-quire[d]” the court to

“apply the presumption against pre-emption”) (citation omitted); R.J. Reynolds Tobacco v. City of Edina,

60 F.4th 1170, 1176, 1178 (8th Cir. 2023) (applying

the presumption to narrowly construe the Tobacco

Control Act’s express preemption provision).

The legal landscape resulting from lower courts’

diverging views on preemption is unworkable: it

threatens to burden U.S. industry actors and interstate commerce with inconsistent legal precedent, forum-shopping plaintiffs, and judicial activism.

III.

U.S. Companies Require a Textual Standard that Enforces Congress’s Intent to

Preempt

Congress intended to achieve and maintain national uniformity of regulation for industries that implicate public health and safety. Although the scope

of preemption may differ by statute, companies’ reliance on the certainty afforded by those statutes remains the same. This reliance is possible only if

courts enforce the statutes as written by Congress.

Uniformity Is Necessary for Interstate

Commerce

The foundational principle of the Supremacy

Clause is uniformity. Two centuries ago, this Court

recognized that the federal government “had its immediate origin in the necessities of commerce” and

was designed to provide “the relief of those necessities

. . . by establishing a uniform and steady system.”

Gibbons v. Ogden, 22 U.S. 1, 13 (1824) (emphasis in

original). Accordingly, state law incompatible with

the “uniform whole” must yield. Id. at 209–10; see also

Cooley v. Bd. of Wardens of Port of Phila., 53 U.S. 299,

319 (1851) (recognizing that Congress’s Article I commerce power “embraces a vast field” covering subjects

“imperatively demanding a single uniform rule”);

Mayo v. U.S., 319 U.S. 441, 445 (1943) (emphasizing

the “essential principle” of the Supremacy Clause that

“it is necessary for uniformity that the laws of the

United States be dominant over those of any state”).

Nowhere is this principle more critical than in setting the standards governing the nationwide sale of

products that impact the health and safety of the general public. See, e.g., Geier v. Am. Honda Motor Co.,

529 U.S. 861, 871 (2000) (recognizing Congress’s

“desire to subject the [automotive] industry to a single, uniform set of federal safety standards” to “avoid

the conflict, uncertainty, cost, and occasional risk to

safety itself that too many different safety-standard

cooks might otherwise create”) (citation omitted).

Uniformity in these markets is more important than

ever, because technological advances of staggering

scale and scope have unmoored the distribution, marketing, and sale of goods from geographic boundaries. 5

As this Court explained when evaluating the

preemptive force of disclosure requirements for interstate commerce, federal preemption embodies “Congress’ judgment that the ability to sell a product

throughout the country with a single label can be important to maintaining an efficient nationwide market.” Durnell, 146 S. Ct. at 2012. The converse is

equally true: Subjecting companies to a 50-state

patchwork of compliance obligations would significantly impair amici’s and other U.S. companies’ ability to participate in interstate commerce. See Buckman, 531 U.S. at 350 (“As a practical matter, complying with the FDA’s detailed regulatory regime in the

shadow of 50 States’ tort regimes will dramatically increase the burdens facing potential applicants—burdens not contemplated by Congress in enacting the

FDCA and the MDA.”); Bates v. Dow Agrosciences, 544

U.S. 431, 452 (2005) (noting that permitting “50 different labeling regimes prescribing the color, font size,

and wording of warnings” would “create significant inefficiencies for manufacturers”). Any additional or inconsistent requirements imposed by individual states

5 See, e.g., Ash Johnson, How Congress Can Foster a Digital Sin-

gle Market in America, Info. Tech. & Innovation Found. (Feb. 20,

2024).

“would lead to chaotic confrontation,” making compliance all but impossible. Ouellette, 479 U.S. at 496.

U.S. Companies Require Certainty to

Invest

Businesses, like markets, thrive with certainty,

and suffer without.6 Like Petitioner, amici operate in

highly regulated industries. These industries require

significant capital investment—to finance innovation,

supply chains, manufacturing, distribution, marketing, and sales—in order to bring products to market.

The regulatory regime governing the sale of these

products is a factor in any decision to invest capital in

the United States.7 A uniform federal regulatory regime provides certainty by setting defined standards

that companies must satisfy, which in turn allows for

quantification of the associated costs before investment decisions are made.

By the same reasoning, subjecting companies to

regulation through litigation, based on nebulous

state-law theories crafted by the plaintiffs’ bar after

products are already on the market, is untenable. As

the Fourth Circuit aptly put it, replacing uniform

6 Glenn Lammi, Keep Federal Preemption of Railroad Regulation

on Track, WLF Legal Pulse (Apr. 23, 2025), available at:

https://www.wlf.org/2025/04/23/wlf-legal-pulse/keep-federalpreemption-of-railroad-regulation-on-track-2/

(“Businesses

crave certainty more than anything else and navigating disparate state regulatory regimes is not only inefficient but costly.”).

7 Am. Chemistry Council, New Survey Finds Dramatic Rise in

Regulations Undercuts American Manufacturing and National

Priorities (Jan. 17, 2024) (79% of companies “would increase investment in R&D, new technologies, and new products” if compliance costs were reduced); Am. Chemistry Council, Regulation

(2026) (cumulative compliance costs on businesses “are estimated to be in the hundreds of billions of dollars annually[.]”).

federal standards with those “whose content must

await the uncertain twists and turns of litigation will

leave whole . . . industries at sea and potentially expose them to a welter of conflicting court orders across

the country.” Tennessee Valley Auth., 615 F.3d at 301;

see also Geier, 529 U.S. at 871 (noting that state tort

suits engender “uncertainty and even conflict” especially where “different juries in different States reach

different decisions on similar facts”). There is no way

to prepare for such exposure in advance, as companies

are afforded no notice of the duties that will be contrived or the remedies that will be sought. That is the

current state of play for amici and U.S. companies

across many industries. It is extraordinarily costly

and unsustainable.

Preemption Furthers National Interests in the Global Market

Congress has determined that the standards for

the manufacture and nationwide sale of products that

impact the health and safety of U.S. citizens should be

set by the U.S. government. But too often, the standards are now set through state court litigation that is

often financed by foreign entities, resulting in the

adoption of standards developed by foreign bodies.

The expertise of federal agencies should not be superseded by foreign governments and international agencies with no accountability to the American people.

Nor should private litigants invoking the findings of

foreign organizations be permitted to hold American

companies liable for selling products which the federal

government approved.

Yet that is precisely what has occurred. As discussed, plaintiffs in the Roundup litigation relied

heavily on a classification by IARC to support state19

law claims that Monsanto should have added cancer

warnings to its EPA-approved label. This Court’s decision in Durnell rejected the premise that a state tort

verdict could override EPA’s considered scientific

judgment. 146 S. Ct. at 2008–09 (noting that EPA repeatedly concluded that glyphosate is not likely to

cause cancer, a conclusion shared by numerous international regulators). That decision aligns with the recent joint statement regarding IARC issued by the Department of State and Department of Health, which

concluded that “American regulatory decisions should

be made by American institutions accountable to the

American people.”8

Likewise, growing foreign financing of U.S. litigation also allows for increasing foreign intrusion into

public health and safety determinations. As Senator

Kennedy stated in introducing bipartisan legislation

to “[m]andate disclosure of third-party litigation funding in mass tort or class action lawsuits,” “[t]he American people deserve to know when . . . foreign states

pour money into . . . lawsuits to influence outcomes.” 9

But as long as the Altria framework permits artful recharacterization of warning-based claims, the threat

of foreign-driven regulation remains.

Similarly, in the climate change litigation context,

state and municipal plaintiffs have sought to hold

8 U.S. Dep’t of State & U.S. Dep’t of Health & Hum. Servs., Joint

Statement on the Preeminence of the U.S. Government Regulating

Health Risks for Americans (June 8, 2026) (“IARC’s research provides diminishing returns on scientific enterprise, while advancing politicized narratives that are often cited for U.S. domestic

legal contexts.”).

9 John Kennedy, Chuck Grassley, et al., Kennedy, Grassley, Col-

leagues Introduce Bill to Expose Third-Party Funding Behind

Lawsuits, Press Release (Feb. 11, 2026).

American energy companies liable under state common law for worldwide greenhouse gas emissions—effectively seeking to rewrite through tort litigation the

policy choices made by Congress and the executive

branch. These suits not only implicate preemption

principles, they threaten to subject vital national defense, energy, and infrastructure assets to foreign regulatory standards or decisions by individual state

court juries. See Chevron, 993 F.3d at 86, 93–94 (state

tort suits “risk upsetting the careful balance that has

been struck between the prevention of global warming, a project that necessarily requires national standards and global participation, on the one hand, and

energy production, economic growth, foreign policy,

and national security, on the other”). The sums

sought are staggering: one Oregon county seeks

nearly $52 billion for a single 2021 heat wave; and

New York’s Climate “Superfund” statute sought to impose a $75 billion retroactive payment—all while sixteen of the twenty largest emitters globally are beyond

the reach of American courts. 10

Science-Based Safety Standards Must

Govern

U.S. expert agencies set health and safety standards through rigorous, scientifically grounded, and deliberative processes. The EPA, for example, evaluates

toxicological and epidemiological evidence before registering a pesticide and approving its label. See Durnell, 146 S. Ct. at 2006–07. The FDA conducts a “rigorous” premarket approval process for medical devices—which takes “an average of 1,200 hours” per

10 See Heather Mac Donald, The Climate Litigation Swindle, City

J. (Spring 2026).

application—reviewing clinical and laboratory data

before clearing a device and its labeling. Riegel, 552

U.S. at 317–18. It is crucial “that courts in th[ese]

highly technical arena[s] respect the strengths of the

agency processes on which Congress has placed its imprimatur.” Tennessee Valley Auth., 615 F.3d at 305–

06.

But courts are not doing that. Instead, state tort

suits, advancing theories at odds with regulations established through the sanctioned deliberative process,

task lay juries with resolving scientific disputes

armed only with junk science advanced by partisan

“expert” witnesses or outside organizations that do

not apply the same exacting methodologies as federal

agencies.11 For example, IARC’s hazard-based classifications ignore dose, duration, and route of exposure—the real-world factors that determine whether

a substance actually poses a cancer risk. The plaintiffs’ bar has exploited the resulting fear and confusion to fuel mass-tort litigation.12

In the comprehensive health and safety regulatory

regimes to which amici are subject, federal agency determinations should not be replaced by the flawed and

misleading conclusions of IARC and similar organizations. State-law claims premised on those conclusions

undermine the very regulatory framework that

11 See, e.g., Am. Tort Reform Ass’n, The Junk Science Playbook

(Jan. 2026) (“Health Canada, an outlier among regulatory bodies

and public health agencies in finding talc is a possible cause of

ovarian cancer, relied on paid plaintiffs’ expert reports in U.S.

litigation in deriving its talc Screening Assessment.”).

12 See, e.g., John Gardella, IARC PFAS Findings Will Influence

Litigation and EPA Challenges, Nat’l L. Rev. (Dec. 4, 2023)

(“IARC’s findings with respect to carcinogenicity are oftentimes

very influential on the course of litigation in the United States.”).

Congress established. See Lead Indus. Ass’n, Inc. v.

EPA, 647 F.2d 1130, 1146 (D.C. Cir. 1980) (“Congress

has entrusted the Agency with the responsibility for

making these scientific and other judgments, and we

must respect both Congress’ decision and the Agency’s

ability to rely on the expertise that it develops.”).

Preemption Minimizes Abusive Claims

and Inequitable Retrospective Penalties

“The law is not ordinarily read to retroactively penalize persons for doing what the Government had required them to do.” Durnell, 146 S. Ct. at 2014 (citing

Landgraf v. USI Film Prods., 511 U.S. 244 (1994)).

That principle is especially important where, as in the

case at hand, the challenged label was fully compliant

with federal labeling requirements. A citizen who

learns of new safety concerns “is free to bring the information to [the agency’s] attention,” but that “is

quite different from seeking to retroactively penalize a

manufacturer for doing what it was legally required

to do at the time.” Durnell, 146 S. Ct. at 2016 n.10

(emphasis in original). A clear, text-based preemption

standard prevents state common-law claims from upsetting “reliance interests and expectations on the

part of those . . . enterprises that have complied with

[the federal government’s] requirements.” Tennessee

Valley Auth., 615 F.3d at 301.

Absent such a rule, harsh retrospective penalties

have two consequences. First, they expose companies

like amici to astronomical damages awards that can

threaten their survival. In 2025, for example, corporate defendants faced nearly 200 jury awards of $10

million or more, with more than 40 exceeding $100

million; one Roundup verdict reached $2.1 billion,

with compensatory damages roughly 145 times the

plaintiff’s stipulated $450,000 in medical bills and punitive damages more than thirty times the compensatory award.13 Second, these penalties impose substantial costs on the U.S. economy and the U.S. taxpayer:

excessive litigation is estimated to cost $367.8 billion

each year, eliminate 4.8 million jobs, and cost the average American approximately $1,666 annually.14

Preemption Mitigates the Appearance

of Judicial Activism

The role of the judiciary is to enforce the law, not

rewrite it. The most faithful way to do so is through a

plain, textualist reading of the words chosen by the

legislature. A textual analysis of preemption provisions is agnostic with respect to product, industry, or

asserted claim. Any other approach risks enlisting

the judiciary to take sides in difficult policy debates

that are best left to the political branches. Textualism

asks only what the statute says, and by avoiding subjective speculation as to what it should say, removes

the appearance of judicial activism or impression that

parochial, political, or social perspectives influence

the outcome of a particular case.

The Court should grant certiorari in this case and

reaffirm the principle that, where Congress has expressed its intent to commit an area of law to comprehensive federal regulation, it is that judgment—

and not a “presumption against preemption” or any

13 See Marathon Strategies, Corporate Verdicts Go Thermonu-

clear: 2026 Edition (Aug. 18, 2026); Am. Tort Reform Found., Judicial Hellholes 2025/2026 (2025) at 61.

14 See Am. Tort Reform Ass’n, America’s $367 Billion Lawsuit

Epidemic (Apr. 7, 2025).

other conflicting principle not found in the statute’s

text—that must prevail.

CONCLUSION

The petition for a writ of certiorari should be

granted.

Respectfully submitted,