Opposition Brief — Monsanto Company, a Foreign Corporation, Petitioner v. Nancy C. Salas

No. 24-1097

IN THE

Supreme Court of the United States

__________

MONSANTO COMPANY,

Petitioner,

v.

NANCY C. SALAS,

____________

Respondent.

On Petition for a Writ of Certiorari

to the United States Court of Appeals

for the Eleventh Circuit

____________

BRIEF IN OPPOSITION FOR RESPONDENT

____________

STEPHEN F. ROSENTHAL

Counsel of Record

CHRISTINA H. MARTINEZ

PODHURST ORSECK, P.A.

2525 Ponce de Leon Boulevard

Suite 700

Coral Gables, FL 33134

(305) 358-2800

srosenthal@podhurst.com

Counsel for Respondent

June 18, 2025

QUESTIONS PRESENTED

In Bates v. Dow AgroSciences LLC, 544 U.S. 431

(2005), this Court held that the Federal Insecticide,

Fungicide, and Rodenticide Act (“FIFRA”) preempts

only state-law labeling requirements that are broader

than the statute’s “misbranding” standard.

State-law claims that target product labeling

are preempted only if they impose “requirements that

are ‘in addition to or different from’ the labeling and

packaging requirements under FIFRA.” Id. at 447

(quoting 7 U.S.C. § 136v(b)) (emphasis in Bates).

Respondent Nancy Salas sued Monsanto in

2021 after developing non-Hodgkin lymphoma; she

had used Roundup for years to kill weeds at her Florida home. Monsanto strategically settled all but one

of Salas’ claims in an effort to convert her case into a

vehicle for quick review in this Court.

The questions presented are:

1.

Whether Article III adversity is destroyed when an appellant seeks summary rejection of

its own appeal rather than relief which would redress

the harm it suffered from the adverse judgment it appealed.

2.

If this Court has jurisdiction, whether

petitioner failed to preserve the new theory it asserts

here after neglecting to raise it below and depriving

the Court of Appeals of an opportunity to address it.

3.

Assuming both hurdles are overcome,

whether the Eleventh Circuit correctly applied Bates

in holding Salas’s Florida failure-to-warn claims were

not preempted because they are narrower than

FIFRA’s misbranding standard.

ii

TABLE OF CONTENTS

Page

QUESTION PRESENTED .......................................... i

TABLE OF AUTHORITIES ...................................... iii

INTRODUCTION ............................................................. 1

STATEMENT .............................................................. 2

A. Statutory And Regulatory Background .......... 2

B. Factual Background ......................................... 6

C. Procedural History ......................................... 13

REASONS FOR DENYING THE PETITION ......... 18

I. This Case Does Not Present a Clean

Vehicle for Review ......................................... 18

II. Nor Does This Case Implicate Any

Circuit Conflict .............................................. 24

III. The Decision Below Is Correct....................... 26

A. Salas’s Failure-To-Warn Claim Is Not

Expressly Preempted ................................ 26

B. Monsanto’s Express-Preemption

Arguments Lack Merit ............................. 28

C. Salas’s Failure-To-Warn Claim Is Not

Impliedly Preempted ................................ 35

CONCLUSION.......................................................... 35

APPENDIX

Appendix A

Pretrial Order No. 285:

Order On Motions to Exclude Certain Wave

5 Experts and For Summary Judgment, In

Re: Roundup Products Liability Litigation,

No. 16-md-0271-VC .............................................. 1a

iii

TABLE OF AUTHORITIES

Page

Cases

Advance Chem. Co. v. Harter,

478 So. 2d 444 (Fla. Dist. Ct. App. 1985) ........ 27

Bates v. Dow AgroSciences LLC,

544 U.S. 431 (2005)

............................ i, 1, 4, 15, 28, 29, 30, 31, 32, 33

Carson v. Monsanto Co.,

92 F.4th 980 (11th Cir. 2024)

............................................. 15, 26, 27, 28, 33, 35

City of Springfield v. Kibbe,

480 U.S. 257 (1987) .................................... 18, 22

Durnell v. Monsanto Co.,

707 S.W.3d 828 (Mo. Ct. App. 2025) .......... 28, 35

Franklin v. Massachusetts,

505 U.S. 788 (1992) .......................................... 23

Food Marketing Inst. v. Argus Leader Media,

588 U.S. 427 (2019) ......................................... 23

Haaland v. Brackeen,

599 U.S. 255 (2023) .......................................... 23

Hardeman v. Monsanto Co.,

216 F. Supp. 3d 1037 (N.D. Cal. 2016) ...... 14, 25

iv

Hardeman v. Monsanto Co.,

997 F.3d 941 (9th Cir. 2021),

cert. denied, 142 S. Ct. 2834 (U.S. 2022)

................................................... 14, 15, 25, 32, 33

Havens Realty Corp. v. Coleman,

455 U.S. 363 (1982) .......................................... 24

High v. Westinghouse Elec. Corp.,

610 So. 2d 1259 (Fla. 1992) .............................. 27

In re: Roundup Prods. Liab. Litig.,

214 F. Supp.3d 1346 (J.P.M.L. 2016) .............. 13

Linde v. Arab Bank, PLC,

882 F.3d 314 (2d Cir. 2018).............................. 24

Medtronic, Inc. v. Lohr,

518 U.S. 470 (1996) .................................... 29, 34

National Ass’n of Wheat Growers v. Bonta,

85 F.4th 1263 (9th Cir. 2023)........................... 12

NRDC v. EPA,

38 F.4th 34 (9th Cir. 2022)......................... 12, 13

Riegel v. Medtronic, Inc.,

552 U.S. 312 (2008) .......................................... 33

Rivers v. Guerrero,

605 U.S. ___, 2025 WL 1657406

(U.S. June 12, 2025) ................................. 18, 22

Schaffner v. Monsanto Corp.,

113 F.4th 364 (3d Cir. 2024)

................. 2, 14, 19, 20, 21, 22, 25, 26, 31, 32, 33

v

Steel Co. v. Citizens for a Better Env’t,

523 U.S. 83 (1998) ............................................ 23

Tampa Drug Co. v. Wait,

103 So. 2d 603 (Fla. 1958) ................................ 27

Twin City Bank v. Nebeker,

167 U.S. 196 (1897) .......................................... 32

United States v. Aguilar-Torres,

116 F.4th 341, 342 & n.1 (5th Cir. 2024),

vacated and reh’g en banc grant-ed,

130 F.4th 450 (5th Cir. 2024)..................... 23, 24

United States v. Munoz-Flores,

495 U.S. 385 (1990) .......................................... 32

United States v. Wells,

519 U.S. 482 (1997) .................................... 18, 22

United States v. Williams,

504 U.S. 36 (1992) ............................................ 19

W. Virginia v. Env’t Prot. Agency,

597 U.S. 697 (2022) .......................................... 23

Constitutional Provisions

U.S. Const., art. III ............................ i, 1, 18, 23, 24

vi

Statutes

7 U.S.C.:

§ 136(p)(1) ..................................................... 5, 29

§ 136(p)(2) ..................................................... 5, 29

§ 136(q)(1)(A) ................................................ 3, 30

§ 136(q)(1)(E) .................................................... 29

§ 136(q)(1)(F) ................................................ 3, 30

§ 136(q)(1)(G) .......................................... 3, 27, 30

§ 136(q)(2)(D) .................................................... 30

§ 136a(a).............................................................. 2

§ 136a(c) .............................................................. 3

§ 136a(c)(2).......................................................... 2

§ 136a(c)(5)(B)-(D) .............................................. 2

§ 136a(f)(1) ...................................................... 3, 4

§ 136a(f)(2) ................................................ 3, 4, 33

§ 136a(g)(1)(A) .................................................... 3

§136d(a)(2) ...................................................... 4, 8

§ 136d(b)(1) ......................................................... 3

§ 136j(a)(1)(E) ................................................. 3, 4

§ 136k(a)-(b) ........................................................ 3

§ 136k(b)(1)(C) .................................................. 29

§ 136l................................................................... 3

§ 136v(a) ............................................................. 4

§ 136v(b)............. i, 4, 5, 14, 19, 20, 28, 31, 32, 33

21 U.S.C.:

vii

§ 360k(a) ........................................................... 34

§ 467e ................................................................ 34

§ 678 .................................................................. 34

49 U.S.C. § 30103(b) .............................................. 34

Regulations

40 C.F.R.:

§ 152.50 ............................................................... 6

§ 152.44 ....................................................... 28, 34

§ 152.44(a)

............. 5, 6, 14, 15, 17, 19, 20, 21, 22, 31, 33, 34

§ 152.46 ............................................................... 6

§ 156.10(a) ...................................................... 3, 4

§ 156.10(a)(1) ............................................... 29-30

§ 156.10(a)(5) ...................................................... 3

§ 156.64 ............................................................. 30

§ 156.66(a) ........................................................ 30

§ 156.69 ............................................................. 30

§ 159.158(a) .................................................... 4, 8

§ 159.184(a) ........................................................ 4

§ 159.184(b) ........................................................ 4

Rules

Fed. R. App. P. 40(g) ........................................ 17, 23

viii

Other Authorities

Webster’s Seventh New Collegiate Dictionary

(7th ed. 1972) .......................................................... 29

California Off. of Env’t Health Hazard Assessment, Initial Statement of Reasons: Glyphosate Proposition 65 Safe Harbors (Mar. 28,

2017), https://perma.cc/BL9Q-MPAY .................... 10

OEHHA, Glyphosate, https://perma.cc/E6VMMCAF ............................................................ 10

Off. of Pesticide Programs, EPA, Revised

Glyphosate Issue Paper: Evaluation of Carcinogenic Potential 137 (Dec. 12, 2017),

https://perma.cc/2WJM-MT7R ............................... 11

EPA, Glyphosate: Proposed Interim Registration Review Decision, No. 0178, at 10 (Apr.

2019), https://perma.cc/P84R-A93H ..................... 11

Letter from EPA to Glyphosate Registrants

(Aug. 7, 2019), https://perma.cc/6ZL4-JF8P.......... 11

Letter from EPA to Cal. Off. of Envtl. Health

Hazard

Assessment

(Apr.

8,

2022),

https://www.epa.gov/system/files/documents/2025-05/2022-epa-letter-to-ca-oehhaon-ca-prop-65_0.pdf ................................................ 12

INTRODUCTION

Monsanto has known for decades that its product, the popular weedkiller Roundup, that was sold at

hardware stores across the country, can cause cancer

through repeated exposure. Yet the company deliberately refused to alert consumers to the documented

health risks that this common household product potentially posed to unsuspecting users.

Nancy Salas sprayed Roundup for years in her

yard to control weeds, unaware that scientists both

within Monsanto and at an international body had informed Monsanto about the cancer-causing risks of

the active ingredient glyphosate. She was diagnosed

with non-Hodgkin lymphoma in 2020. Monsanto litigated her case, asserting common-law claims under

Florida law, for three years until, after notching its

first victory on federal preemption in a different

venue, the Third Circuit, quickly pivoted to enticing

Salas to settle her claims on terms structured to posture the stipulated judgment as conflicting with the

Third Circuit ruling, in order to present the appearance of conflict among federal circuits to this Court.

In Monsanto’s haste to bring this case before

this Court, the company created several collateral issues that the Court would have to confront before

reaching the merits of the FIFRA-preemption question Monsanto wants the Court to answer, despite the

existence of clear guidance from Bates v. Dow AgroSciences LLC, 544 U.S. 431 (2005). Monsanto did not preserve the express-preemption theory it urges upon the

Court, and to consider it in this case would merely reward cunning. More fundamentally, the company created an Article III defect at the Court of Appeals by

2

seeking summary affirmance of the judgment against

it.

Looking past those collateral snags, the Court

should decline to grant Monsanto’s petition for the

same reasons it should deny the petition in Monsanto

Co. v. Durnell, No. 24-1068. Monsanto’s petition in

this case adopts lock-stock-and-barrel the company’s

arguments in its petition in Durnell. Pet. i, 16. Salas

therefore adopts the applicable responses from Respondent Durnell’s brief in opposition, adding points

germane to her case and expanding on the explanation

of why Monsanto’s new express-preemption theory,

based on Schaffner v. Monsanto Corp., 113 F.4th 364

(3d Cir. 2024), is deeply flawed. This Court should reject the company’s gambit to use this case as a vehicle

for review.

STATEMENT

A. Statutory And Regulatory Background

1. FIFRA regulates the sale, distribution, and

use of pesticides, including, as relevant here, the labeling on pesticide products.

FIFRA requires pesticide manufacturers to register their products with the Environmental Protection Agency before they may sell and distribute their

product domestically. § 136a(a).1 The agency will register a pesticide if it determines—based on data the

pesticide manufacturer submits in support of its registration application, §136a(c)(2)—that the product

will not cause unreasonable harm to humans and the

environment, and that its labeling complies with

FIFRA’s requirements. § 136a(c)(5)(B)-(D). That reg-

1 Unless noted, U.S. Code citations are to Title 7.

3

istration functions as a license establishing the conditions under which the pesticide may be sold and used,

including labeling requirements. §136a(c); 40 C.F.R.

§156.10(a) (discussing, among other things, the “[c]ontents of the label,” its “[p]rominence and legibility,”

the “[l]anguage to be used,” the “[p]lacement of the label,” and “[f]alse or misleading statements”). EPA reviews a pesticide’s registration, including its effects on

human health, at least every 15 years.

§ 136a(g)(1)(A).

2. FIFRA prohibits the sale or distribution of

“any

pesticide

which

is

...

misbranded.”

§ 136j(a)(1)(E). A pesticide is “misbranded” if, among

other things, its label contains a statement that is

“false or misleading,” § 136(q)(1)(A), or omits adequate instructions for use, necessary warnings, or cautionary statements to protect health and the environment, § 136(q)(1)(F), (G). See 40 C.F.R. §156.10(a)(5).

If EPA determines a pesticide is misbranded, it

can cancel the pesticide’s registration, § 136d(b)(1); issue “stop sale, use, or removal” orders, § 136k(a); and

seize for confiscation misbranded products, § 136k(b).

Manufacturers that sell misbranded products face

civil and criminal penalties. § 136l.

Obtaining initial registration does not relieve

the registrant of liability if the pesticide is misbranded. § 136a(f )(2) (“In no event shall registration

of an article be construed as a defense for the commission of any offense under [FIFRA].”). Instead, registration merely provides “prima facie evidence that the

pesticide, its labeling and packaging comply with the

registration provisions.” Id. Because it remains unlawful to sell a registered pesticide that is misbranded, manufacturers have a continuing obligation

to adhere to FIFRA’s labeling requirements and, if

4

necessary, to update their labels. Bates, 544 U.S. at

438 (citing §136j(a)(1)(E); §136a(f)(1)-(2); 40 C.F.R.

§159.184(a), (b) (requiring manufacturers to report incidents involving a pesticide’s toxic effects that may

not be adequately reflected in warning labels));

§136d(a)(2) (duty to submit information regarding adverse effects); 40 C.F.R. §159.158(a) (same).

Monsanto has never sought permission from

EPA to warn of Roundup’s cancer risks.

3. FIFRA leaves ample room for State regulation of a pesticide within States’ respective borders.

States may, for example, ban a federally registered

pesticide, even if EPA has not determined that it is

misbranded. See §136v(a). Section 136v(a) defines

the wide contours of the States’ authority to regulate

pesticides:

(a) In general

A State may regulate the sale or

use of any federally registered pesticide

or device in the State, but only if and to

the extent the regulation does not permit any sale or use prohibited by

[FIFRA].

§ 136v(a).

The correspondingly narrow, express preemption provision provides:

(b) Uniformity

Such State shall not impose or continue in effect any requirements for labeling or packaging in addition to or different from those required under

[FIFRA].

§ 136v(b).

5

The words “labeling,” central to the scope of the

preemption provision, as well as “label,” are defined

terms:

(1) Label

The term “label” means the written, printed, or graphic matter on, or attached to, the pesticide or device or any

of its containers or wrappers.

(2) Labeling

The term “labeling” means all labels and all other written, printed, or

graphic matter-(A) accompanying the pesticide or

device at any time; or

(B) to which reference is made on

the label or in literature accompanying

the pesticide or device, except to current

official publications of the Environmental Protection Agency, the United States

Departments of Agriculture and Interior,

the Department of Health and Human

Services, State experiment stations,

State agricultural colleges, and other

similar Federal or State institutions or

agencies authorized by law to conduct research in the field of pesticides.

§136(p)(1)-(2).

4. Monsanto now contends that 40 C.F.R.

§152.44(a) affects the express-preemption analysis as

a “requirement for labeling” under §136v(b). That regulation, entitled “[a]pplication for amended registration,” states:

6

Except as provided by §152.46, any modification in the composition, labeling, or

packaging of a registered product must

be submitted with an application for

amended registration. The applicant

must submit the information required by

§ 152.50, as applicable to the change requested. If an application for amended

registration is required, the application

must be approved by the Agency before

the product, as modified, may legally be

distributed or sold.

40 C.F.R. §152.44(a).

B. Factual Background

Monsanto’s statement of the case is a verbatim

repetition of its Durnell petition (into page 13).

Salas’s counter-statement of the facts parallels and incorporates Respondent Durnell’s but cites to the record in this case.

1. Monsanto developed Roundup and introduced it on the market as a weedkiller in the 1970s.

E.g., In re: Roundup Prods. Liab. Litig., No. 3:16-md02741-VC (N.D. Cal.), MDL Dkt. 15886-4, 2.

Prior to marketing and selling the product,

Monsanto successfully registered Roundup’s active ingredient, glyphosate, with EPA based in part on studies conducted by the Industrial Bio-Test Laboratories,

which EPA later learned to be fraudulent. MDL Dkt.

15973-4, 3, 10 (summarizing findings from Food and

Drug Administration’s audits revealing “serious deficiencies” in the IBT tests). Widespread discrepancies

between the studies and the raw data prompted EPA

to order affected registrants, like Monsanto, to submit

the raw data for the IBT studies underlying the registration, and to order replacement studies in 1983. See

7

MDL Dkt. 15973-4, 10. The 1983 EPA report summarizing the IBT’s fraud stated that the IBT case “caused

serious concern and uncertainty about the potential

hazards of hundreds of pesticides involved, [including

glyphosate,] both for the EPA and the public,” with

some experts advocating “that all 212 pesticides tested

in whole or in part by IBT be removed from the market

pending retesting.” MDL Dkt. 15973-4, 5. That option, however, was deemed unavailable under thencurrent law. Id.

2. Monsanto submitted the first valid study assessing glyphosate’s effect on laboratory mice in 1983.

MDL Dkt. 15973-5, 2. Based on that study, EPA classified glyphosate as a possible human carcinogen. Id.

at 3. In response, Monsanto committed to “do[ing] all

that is possible in order to have the Agency reverse its

decision.” MDL Dkt. 15973-7, 3.

Through the IBT scandal, the 1983 mouse

study, and the resulting EPA “possible human carcinogen” determination, Monsanto did not inform consumers about the fraud, remove Roundup from the

market, or add warnings to its Roundup labels.

3. In the late 1990s, four peer-reviewed studies

concluded that Roundup and/or glyphosate was possibly genotoxic. MDL Dkt. 15973-9, 6-9. Genotoxic substances damage genetic information in cells, causing

mutations that may lead to cancer. See Salas v. Monsanto Co., No. 1:21-cv-21217-KMW (S.D. Fla.), D.Ct.

Dkt. 36, 8 (filed Mar. 30, 2021). Monsanto decided to

hire Dr. James Parry, a world-renowned genotoxicity

expert, to evaluate the four studies and offer his conclusions about them. See generally MDL Dkt. 159739, 10. When those conclusions proved inconvenient for

Monsanto—with Dr. Parry concluding that glyphosate

could be genotoxic and suggesting additional studies

8

would be the best way of clarifying the genotoxicity

question (MDL Dkt. 15973-9, 3, 10-11)—Monsanto unceremoniously “drop[ped]” him (MDL Dkt. 15973-10,

2).

After reading one of Dr. Parry’s reports, Monsanto’s Dr. William Heydens emailed Monsanto colleagues advising that the company “simply [wasn’t] going to do the studies [Parry] suggests.” MDL Dkt.

15973-11, 2. “[W]hat we are really trying to achieve

here,” Heydens admitted, is to “find/develop someone

who is comfortable with the genotox profile of glyphosate/Roundup and who can be influential with regulators and Scientific Outreach operations when genotox

issues arise.” Id. “[Parry] is not currently such a person,” he concluded. Id. Because Roundup is “currently very vulnerable” on genotoxicity, Heydens

wrote, Monsanto “should seriously start looking for

one or more other individuals” who could take the positions Monsanto wanted if Dr. Parry could not “become a strong advocate.” Id. (emphasis in original).

True to Heydens’ email, Monsanto did not conduct all of Dr. Parry’s suggested tests. MDL Dkt.

15973-12. The company effectively silenced Dr. Parry

from speaking to or sharing his findings with regulators since he was bound by a confidentiality agreement. MDL Dkt. 15973-12, 42. And, although FIFRA

requires manufacturers to report “factual information

regarding unreasonable adverse effects on the environment of [a] pesticide” to EPA on an ongoing basis,

§ 136d(a)(2); see 40 C.F.R. § 159.158(a), Monsanto did

not share Dr. Parry’s report or suggestions with EPA.

MDL Dkt. 15973-12, 43.

4. Consistent with Monsanto’s overall approach with Dr. Parry, it continued to downplay

glyphosate’s health and safety concerns and those of

9

formulated glyphosate products like Roundup, including by refusing to conduct testing on formulated

Roundup. Roundup contains not only glyphosate, but

other ingredients and also a surfactant that that decreases surface tension, enabling the product to penetrate the waxy surface of a leaf—or human skin. This

surfactant makes Roundup more genotoxic.

Monsanto understood this: a Monsanto employee wrote in 2015 that he believed that the other

ingredients in Roundup “played a role” in the positive

tumor results of a tumor-promotion study. D.Ct. Dkt.

36, 10. Additionally, in response to an article quoting

studies suggesting Roundup is not safe, Monsanto’s

Donna Farmer internally acknowledged that the company “cannot say that Roundup does not cause cancer”

because they had “not done carcinogenicity studies

with ‘Roundup.’” MDL Dkt. 15973-13, 2.

Monsanto also flooded scientific literature with

ghostwritten articles to bolster the safety profile of

glyphosate-based herbicides. For instance, the company retained Dr. Gary Williams, a pathologist, to

publish a 2000 article concluding that Roundup does

not pose a health risk to humans. Dr. Williams did

not write that article; Monsanto’s Dr. Heydens ghostwrote it. MDL Dkt. 15973, 9 n.3 (link to Williams article); MDL Dkt. 15973-6, 58-62; see also MDL Dkt.

15973-14 (Monsanto manuscript clearance form for another ghostwritten article in 2013 entitled “Review of

genotoxicity studies of glyphosate and glyphosatebased formulations”); D.Ct. Dkt. 36-41, 10 (another

ghostwritten article stating “glyphosate is not a human health risk”). EPA consistently relies on these

ghostwritten articles in assessing the safety of glyphosate-based pesticides.

10

5. In 2015, a working group at the International Agency for Research on Cancer (“IARC”), concluded that glyphosate is probably carcinogenic to humans.

Despite the lack of testing on glyphosate formulations and the IARC classification, Monsanto rushed

to ensure that EPA would not adopt the IARC determination. In 2015, for instance, Monsanto conducted

discussions with the then-Deputy Director of the Office of Pesticide Programs Health Effects Division regarding a planned review of glyphosate by the Agency

for Toxic Substances and Disease Registry, the agency

responsible for assessing chemical toxicity. See MDL

Dkt. 15973-15. The Deputy Director wanted to establish coordination with the company and stated to Monsanto’s agency lead for regulatory affairs, “If I can kill

[the glyphosate review] I should get a medal.” Id. at 3.

Monsanto obtained EPA’s word that the glyphosate review would be put “on hold,” and although Monsanto’s

chief regulatory toxicologist expressed some lingering

concerns with the review, he reflected that “at least

[EPA] know they are being watched, and hopefully that

keeps them from doing anything too stupid[.]” D.Ct.

Dkt. 36-42, 2-3.

Despite Monsanto’s efforts, in 2017, California

determined glyphosate was a chemical known to the

State to cause cancer based on the IARC’s determination. See California Off. of Env’t Health Hazard Assessment, Initial Statement of Reasons: Glyphosate

Proposition 65 Safe Harbors (Mar. 28, 2017),

https://perma.cc/BL9Q-MPAY. California’s Proposition 65 requires a warning label on glyphosate products if exposures exceed the safe harbor levels. See

OEHHA, Glyphosate, https://perma.cc/E6VM-MCAF.

11

6. For its part, EPA has not made formal findings about whether formulated Roundup causes cancer. The agency observed that the data linking

glyphosate exposure and the risk of non-Hodgkin lymphoma were uncertain, partly because “farmers and

other applicators apply formulations, not the active

ingredient alone.” Off. of Pesticide Programs, EPA,

Revised Glyphosate Issue Paper: Evaluation of Carcinogenic

Potential

137

(Dec.

12,

2017),

https://perma.cc/2WJM-MT7R. EPA has acknowledged the need for further research “to determine

whether formulation components, such as surfactants, influence the toxicity of glyphosate formulations.” Id. at 144.

EPA has noted that “[m]any commenters [have]

expressed concerns that glyphosate formulations are

more toxic than glyphosate alone and [have] questioned the toxicity of inert ingredients[.]” EPA,

Glyphosate: Proposed Interim Registration Review

Decision,

No.

0178,

at

10

(Apr.

2019),

https://perma.cc/P84R-A93H.

EPA acknowledged

that “few research projects” had tried to compare

“technical grade glyphosate” to glyphosate-based formulations like Roundup for purposes of assessing human health risk. Id. at 11. EPA stated in 2019 that,

if “at any time, information becomes available that indicates adverse human health effects of concern for exposure to glyphosate or its formulations, EPA intends

to review it and determine the appropriate regulatory

action.” Id.

In August 2019, the Director of the Registration

Division within EPA’s Office of Pesticide Programs issued a letter to all glyphosate-based product registrants. Letter from EPA to Glyphosate Registrants

12

(Aug. 7, 2019), https://perma.cc/6ZL4-JF8P. The letter stated EPA would no longer approve Proposition

65 labeling that warned consumers glyphosate was a

chemical known to California to cause cancer, and

that manufacturers must remove such a warning. Id.

This letter did not address whether Roundup or

glyphosate formulations cause cancer.

In April 2022, a different, higher-ranking EPA

official, the Assistant Administrator for the Office of

Chemical Safety and Pollution Prevention, wrote that

“EPA could approve” California’s newly proposed

glyphosate-specific cancer warning “if pesticide registrants” like Monsanto “requested it for inclusion on

glyphosate product labels.” Letter from EPA to Cal.

Off. of Envtl. Health Hazard Assessment (Apr. 8,

2022).2

7.

The Ninth Circuit recently vacated

EPA’s conclusion that glyphosate is not likely to cause

cancer. NRDC v. EPA, 38 F.4th 34, 40 (9th Cir. 2022).

Earlier, in January 2020, the agency, having completed its re-registration review of glyphosate under

FIFRA, “determined that there are no risks to human

2

See

https://www.epa.gov/system/files/documents/202505/2022-epa-letter-to-ca-oehha-on-ca-prop-65_0.pdf. EPA has

since withdrawn this letter based on National Association of

Wheat Growers v. Bonta, 85 F.4th 1263, 1266-67, 1283 (9th Cir.

2023), which held that compelling use of California’s warning label violated the First Amendment rights of a coalition of agricultural-sector businesses. The Ninth Circuit acknowledged that its

previous decision vacating EPA’s January 2020 interim decision

on glyphosate, NRDC v. EPA, 38 F.4th 34 (9th Cir. 2022), “has

little bearing on the First Amendment analysis.” Bonta, 85 F.4th

at 1280 n.14. Bonta addresses only compelled warning labels and

does not speak to, much less prohibit, a situation where a glyphosate registrant like Monsanto voluntarily requests the revised label for inclusion on glyphosate product labels.

13

health from the current registered uses of glyphosate

and that glyphosate is not likely to be carcinogenic to

humans.” Id. at 43. The Ninth Circuit, however, vacated EPA’s “not likely to be carcinogenic” conclusion,

calling EPA’s reasoning “the hallmark of arbitrary action.” Id. at 51. The agency’s determination, the

Ninth Circuit concluded, was “in tension with parts of

the agency’s own analysis and with the guidelines it

purports to follow,” and thus not supported by “substantial evidence.” Id. at 46, 51. For example, “most

studies EPA examined indicated that human exposure to glyphosate is associated with an at least somewhat increased risk of developing [non-Hodgkin lymphoma].” Id. at 46.

C. Procedural History

1.

This case was filed in Florida state court

in 2021, and Monsanto removed it to the United

States District Court for the Southern District of Florida. D.Ct. Dkt. 1. Salas alleged that she was diagnosed with non-Hodgkin lymphoma in 2020 after using Roundup products year-round between 2004

through 2014 to control weeds at her Florida residences. D.Ct. Dkt. 1-1, ¶¶134-41. The complaint advanced five claims against Monsanto: strict products

liability, negligence, breach of express warranties,

fraudulent misrepresentation, and negligent misrepresentation. Id. ¶¶142-97.

Shortly after it was filed, the case was tagged

and transferred to the multi-district litigation, which

had been proceeding before Judge Vince Chhabria in

the Northern District of California for over four years.

See In re: Roundup Prods. Liab. Litig., 214 F. Supp.3d

1346 (J.P.M.L. 2016); D.Ct. Dkt. 14. In the MDL,

14

Salas’ case became one of the “Wave 5” group of cases.

See MDL Dkt. 51.

Prior to Salas’s inclusion in the MDL, Monsanto had already presented its express-preemption

theories to the District Court. In what became the

lead case in the MDL, Hardeman, Monsanto had filed

motions to dismiss and for summary judgment arguing FIFRA preemption. In those proceedings, the

company’s express-preemption arguments never

raised the theory which now occupies a central place

in its petition: that 40 C.F.R. §152.44(a) constitutes a

requirement for labeling under §136v(b) and Bates because it “‘specifically identif[ies] the contents required

to be included on’ Roundup’s label,” Durnell Pet. 20

(quoting Schaffner, 113 F.4th at 390); Pet. i, 16 (adopting Durnell petition). See Mot. to Dismiss 6-8, Dkt.

18, Hardeman v. Monsanto Co., No. 3:16-cv-00525-VC

(N.D. Cal.) (filed Mar. 1, 2016); S.J. Mot. 5, MDL Dkt.

2419 (filed Jan. 3, 2019).3

The MDL court denied Monsanto’s motions to

dismiss and for summary judgment on expresspreemption grounds—naturally without addressing

that unpresented theory. See Hardeman v. Monsanto

Co., 216 F. Supp. 3d 1037, 1038-39 (N.D. Cal. 2016);

Order No. 101, 1-2, MDL Dkt. 2937. When Monsanto

appealed Hardeman, it did not advocate that theory

either. The regulation (40 C.F.R. §152.44(a)) thus

does not even appear in the Ninth Circuit’s decision

rejecting Monsanto’s express-preemption defense. See

Hardeman v. Monsanto Co., 997 F.3d 941, 954-58 (9th

Cir. 2021), cert. denied, 142 S. Ct. 2834 (U.S. 2022).4

3 Monsanto referenced the regulation only as part of its separate argument on implied preemption. S.J. Mot 7, 9-10.

4 The question Monsanto presented in its petition for writ of

certiorari in Hardeman was: “Whether FIFRA preempts a state-

15

When Salas’s case was transferred to the MDL,

Monsanto moved for summary judgment on FIFRApreemption grounds, incorporating by reference its

briefing from prior motions against earlier tranches of

plaintiffs. S.J. Mot. 2, In re Roundup Prods. Liab.

Litig., No. 3:21-cv-06173 (N.D. Cal.), Salas MDL Dkt.

38 (filed June 15, 2023). Monsanto therefore did not

raise in the District Court the theory that 40 C.F.R.

§152.44(a) supplies a labeling-content requirement.

That court denied the motion based on “the Ninth Circuit’s decision in Hardeman.” Respondent’s Appendix

(“R.App.”) 5a (citing Hardeman, 997 F.3d at 955-56,

970-74); D.Ct. Dkt. 72-3 (same).

2. At the end of 2023, the Judicial Panel on

Multidistrict Litigation remanded this case back to

the Southern District of Florida. In Monsanto’s rendition of the procedural history, only two events merit

mention at this point:

After the case returned to Florida, the

Eleventh Circuit issued its decision in

Carson v. Monsanto Co., 92 F.4th 980

(11th Cir. 2024). The parties here then

reached a settlement agreement.

Pet. 13 (emphasis added). This matter-of-fact juxtaposition of events casts the issuance of Carson, which

law failure-to-warn claim where the warning cannot be added to

a product without EPA approval and EPA has repeatedly concluded that the warning is not appropriate.” Pet. I, Hardeman,

No. 21-241 (Aug. 16, 2021). This Court requested the views of

the Solicitor General. The United States said, “EPA’s approval

of pesticide labeling … is not naturally characterized as a FIFRA

‘requirement’ that no such warning appear,” since a “ ‘requirement is a rule of law that must be obeyed.’ ” U.S. Amicus Brief,

Monsanto Co. v. Hardeman, No. 21-241 (U.S., filed May 10, 2022)

(“SG Hardeman Br.”) 11-12 (quoting Bates, 544 U.S. at 445).

16

rejected Monsanto’s FIFRA-preemption defenses, as

the impetus for Monsanto’s settlement. That suggestion obscures Monsanto’s maneuverings that betray

its opportunistic strategy to position this case as a vehicle to reach this Court.

Carson was decided in February 2024. By the

summer, as the litigation continued in this case, Monsanto contemplated seeking certiorari in Carson. It

filed an application in this Court for an extension of

time for that purpose. Monsanto Co. v. Carson, No.

24A-89, 3 (filed July 23, 2024). The Court gave Monsanto until September 5, 2024.

Tellingly, during that interval, mediation was

held in this case, on August 7, 2024. Carson did not

impel settlement, for the mediation ended in impasse.

D.Ct. Dkt. 51. One week later, however, the Third Circuit decided Schaffner, giving Monsanto its first victory on express-FIFRA preemption of a state-law negligent-failure-to-warn claim.

Monsanto then abandoned its plan to seek a

writ of certiorari in Carson and, instead, adopted the

strategy of using this case to position a federal case

before this Court. The day after its deadline to file a

petition for a writ of certiorari in Carson, and only a

month after failing to resolve this case at mediation,

the parties in this case announced a settlement. D.Ct.

Dkt. 55. “[I]n connection with the parties’ settlement,”

Salas agreed to move to amend her complaint to abandon all of her claims other than the negligent failureto-warn claim and to “enter into a final and appealable, stipulated judgment on that sole claim.” D.Ct.

Dkt. 57. Salas received an initial payment from Monsanto, and if Monsanto is unsuccessful in its reversing

the entry of judgment on appeal, Salas “will receive

17

and additional, substantial, monetary payment.” Id.

at 2.

Pursuant to the deal, the parties entered a joint

stipulation for entry of judgment through which “Monsanto reserve[d] the right to appeal the Entry of Judgment … based on the portions of the MDL Court’s August 21, 2023 order … addressing federal preemption.”

D.Ct. Dkt. 74. Presented with the parties’ settlement,

the District Court granted Salas leave to amend her

complaint down to a single, narrowed negligent failure-to-warn count under Florida law and entered final

judgment “[p]ursuant to the Parties’ Joint Stipulation

for Entry of Judgment[.]” D.Ct. Dkt. 67, 75.

On appeal to the Eleventh Circuit, facing Carson as binding panel precedent on the expresspreemption issue, Monsanto chose not to petition that

court initially en banc, Fed. R. App. P. 40(g), a procedure that could have allowed it to circumvent Carson

and, arguably, ventilate before the full Eleventh Circuit the theory that 40 C.F.R. §152.44(a) constitutes a

labeling-content requirement. Instead, Monsanto

sought a fast track to this Court by falling on its

sword, filing a motion for summary affirmance against

its own appeal, conceding that “Carson controls the

outcome[.]” Pet’r CA11 Mot. 8 (capitalization altered).

While seeking to “preserve its arguments that Salas’s

claim is preempted,” Monsanto urged the Court of Appeals to follow its law on prior-panel precedent and

rule against it. Id. at 10, 12-13. Having secured

Salas’s consent to pretermitting the appeal through a

self-defeating motion for summary affirmance, Monsanto’s motion was filed as unopposed.

The Eleventh Circuit obliged, giving Monsanto

the quick loss it requested in a short, unpublished

18

opinion which recognized that “Carson controls here”

under the circuit’s prior-panel rule. Pet.App. 1-3.

REASONS FOR DENYING THE PETITION

I. This Case Does Not Present a Clean Vehicle

for Review

Monsanto calls this case “a clean vehicle” for review. Pet. 15. That may be the outward appearance

Monsanto presents, but a look under the hood reveals

a different picture. This case harbors a preservation

defect on an essential theory of the express-preemption argument Monsanto seeks to advance. Further,

Monsanto’s machinations in procuring the settlement

in this case betray the kind of “cunning” this Court has

hesitated to “reward” by granting review, United

States v. Wells, 519 U.S. 482, 489 (1997). And in the

company’s haste to position this case before the Court,

by way of the expedient of a motion for summary affirmance against its own position in the Court of Appeals, Monsanto generated an Article III concern.

This case does not offer a clean opportunity to address

the express-preemption theory Monsanto wants the

Cout to adopt, and there is no Circuit conflict over implied-FIFRA preemption.

1. Monsanto predicates the propriety of certiorari on an asserted circuit split over a theory for express preemption adopted in the Third Circuit but

which Monsanto never presented for consideration to

the courts below. This Court “ordinarily will not decide questions not raised or litigated in the lower

courts.” City of Springfield v. Kibbe, 480 U.S. 257, 259

(1987); see Rivers v. Guerrero, 605 U.S. ___, 2025 WL

19

1657406, *8 (U.S. June 12, 2025); United States v. Williams, 504 U.S. 36, 41 (1992).

Specifically, the analytic point of departure between the Third Circuit and other courts involves the

too-clever-by-half theory that an EPA procedural regulation which precludes the applicant for a registered

pesticide from changing the product’s pre-approved labeling without obtaining EPA approval, 40 C.F.R.

§152.44(a), constitutes a labeling-content requirement

under FIFRA’s preemption provision, 7 U.S.C.

§136v(b). Monsanto’s petition invokes the Third Circuit’s interpretation of the effect of that regulation

(Pet. 2; Durnell Pet. 20-21), which that court dubbed

the “Preapproval Regulation,” Schaffner, 113 F.4th at

371. The Preapproval Regulation lies at the core of

the Third Circuit’s decision and, hence, Monsanto’s

claim to a circuit split.

The Third Circuit’s opinion highlights the narrowness of its point of departure from other courts,

though Monsanto’s petition suppresses that detail.

The petition states: “As the Third Circuit recognized,

… its ‘analysis differs from’ that of its ‘colleagues in

other courts.’” Pet. 2 (quoting Schaffner, 113 F.4th at

399). What the Third Circuit actually said is that its

analysis differs “chiefly in how we define the Federal

Comparator that must be employed in applying the

parallel-requirements test” from Bates. Schaffner,

113 F.4th at 399. By “Federal Comparator,” the Third

Circuit means “the federal requirement that must be

compared with the [state law requirement]” for purposes of the “parallel-requirements test” for express

preemption under FIFRA. Schaffner, 113 F.4th at

380. The Third Circuit reasoned that because 40

C.F.R. §152.44(a) prohibits the modification of health

20

warnings on a pesticide’s EPA-approved label, it “constitutes a ‘requirement’ for the purposes of section

136v(b).” Id. at 399.

Despite the truncated nature of Monsanto’s petition in this case, there is no question the company

intends to make this regulation a central feature of its

express-preemption argument before this Court. The

petition (at 16) incorporates the arguments from Monsanto’s petition in Durnell, No. 24-1068, where the

company elaborates its theory. Durnell Pet.20, 22.

However, in this case, Monsanto has never before raised the theory that this regulation gives rise to

express preemption, except insofar as it slipped a

veiled reference to it into its unilateral, unopposed

presentation to an Eleventh Circuit panel bound to affirm based on prior circuit precedent. In the district

court, Monsanto argued express preemption but did

not raise the theory that 40 C.F.R. § 152.44(a) imposed

a labeling-content requirement. See Pet’r Mot. 3-6,

MDL Dkt. 2419. The MDL court’s disposition of that

motion for summary judgment, not surprisingly, did

not consider that issue. R.App. 5a.

Nor was the new theory that 40 C.F.R.

§152.44(a) imposes a labeling-content requirement

supporting express preemption fairly raised or passed

upon by the Court of Appeals. Given that Monsanto’s

appeal of the express-preemption ruling bound up in

the stipulated judgment would be foreclosed by Carson, Monsanto had three options: (1) fully ventilate its

arguments, including its new theory, before a panel of

the Eleventh Circuit, await the obligatory affirmance,

and then seek rehearing en banc to ask the full Court

of Appeals to revisit Carson; (2) try to accomplish the

same thing through a petition for initial hearing en

21

banc; or (3) minimize the chance of any consideration

of the new theory at the Eleventh Circuit by filing a

motion for summary affirmance against its own appeal, based on Carson. Monsanto chose the last

course. Prior to filing a motion for summary affirmance its counsel contacted Salas’ counsel to secure

Salas’s non-opposition. See Pet’r CA11 Mot. 1. Monsanto then filed, unopposed, a motion to reject its own

appeal. Id.

Taking advantage of the lack of opposition and

the Eleventh Circuit panel’s lack of power to consider

the Third Circuit’s reasoning, Monsanto obliquely

sought to inject, for the very first time, the seeds of the

new express-preemption theory it advocates here. Under the guise of “preserv[ing] its arguments that

Salas’s claim is preempted,” Monsanto instead slipped

into its (supposed) “summar[y]” of arguments it had

made in the district court the brand-new theory it now

advocates, by means of this vague reference:

Once EPA preapproved Roundup’s label,

regulations prohibited Monsanto from

deviating from the approved label. See

40 C.F.R. §152.44(a).

The Third Circuit has explained in

detail why, under these circumstances, a

claim such as Salas’s is preempted.

Schaffner, 113 F.4th at 379-393.

Pet’r CA11 Mot. 10-11 (footnote omitted; emphasis

added). The panel, bound by Carson, predictably gave

Monsanto the quick adverse ruling it wanted, by summary disposition. Pet.App. 1-3.

Monsanto’s stealth approach to bringing its

new theory of express preemption before this Court

through this case should founder because it was not

22

preserved and lacks the benefit of scrutiny by the

Court of Appeals. Rivers, 2025 WL 1657406, at *8;

Kibbe, 480 U.S. at 259. Monsanto did not raise the

theory that 40 C.F.R. §152.44(a) constitutes a labeling-content requirement in the District Court. Nor

did it do so in the Court of Appeals, where the oblique

reference in an unopposed motion for summary affirmance predictably went unaddressed. Where a petitioner failed to direct lower courts to “the source of authority upon which [it] relies” for its “new theory” in

this Court, the issue has not been properly presented.

Rivers, 2025 WL 1657406, at *8. To be sure, the courts

below passed on the broader issue of express preemption under FIFRA. And the Court of course has discretion to overlook Monsanto’s failure to have litigated

this theory and thereby engaged opposing counsel and

the courts in subjecting it to scrutiny.

2. But the Court should not exercise that discretion here. Doing so would merely “reward cunning.” Wells, 519 U.S. at 489. The present posture of

this case, as well as the asserted conflict Monsanto

asks the Court to resolve, is purely a construct of the

company’s strategic behavior. Monsanto was unwilling to settle this case in early August 2024, on its own

terms, through mediation. D.Ct. Dkt. 51. But when

Monsanto learned, a week later, that another one of

its engineered settlements to narrow issues for appeal

had paid off in Schaffner, 113 F.4th at 375, the company abruptly changed gears. It abandoned its opportunity to seek certiorari in Carson and pivoted to

striking a strategic deal to settle this case to present

a different vehicle for review to this Court. D.Ct. Dkt.

55. Upon that prefab foundation in the District Court,

Monsanto sought a “fast pass to the Supreme Court,”

23

by way of securing an unopposed “summary affirmance against [it]s own interest” in the Eleventh Circuit. United States v. Aguilar-Torres, 116 F.4th 341,

342 & n.1 (5th Cir. 2024), vacated and reh’g en banc

granted, 130 F.4th 450 (5th Cir. 2024).

3. In its rush to this Court, Monsanto may have

planted this case in jurisdictional quicksand, creating

an Article III issue the Court must consider before it

could reach the merits. By employing the expedient of

seeking an adverse judgment against itself below, rather than fully ventilating its arguments and using

the procedures available in the Court of Appeals to

vindicate its position, see Fed. R. App. P. 40(g), Monsanto created an Article III standing problem.

This Court “has a special obligation to ‘satisfy

itself not only of its own jurisdiction, but also that of

the lower courts in a case under review.’” Steel Co. v.

Citizens for a Better Env’t, 523 U.S. 83, 95 (1998) (citation omitted). Standing must “‘persist throughout

all stages of litigation.’” W. Virginia v. Env’t Prot.

Agency, 597 U.S. 697, 718 (2022) (citation omitted).

While Monsanto’s injury (the obligation to pay money)

was no doubt fairly traceable to the stipulated judgment, for the company to maintain a “cognizable Article III stake” in the appeal, it was also necessary that

“a ‘favorable ruling’ from the appellate court ‘would

redress [that] injury.’” Id. (quoting Food Marketing

Inst. v. Argus Leader Media, 588 U.S. 427, 433 (2019)).

“‘Redressability requires that the court be able to afford relief through the exercise of its power[.]’” Haaland v. Brackeen, 599 U.S. 255, 294 (2023) (quoting

Franklin v. Massachusetts, 505 U.S. 788, 825 (1992)

(Scalia, J., concurring in part and concurring in the

judgment; emphasis in original)). But Monsanto

elected to request relief from the Eleventh Circuit that

24

would not redress its injury. The exercise of judicial

power it requested was to “summarily affirm the judgment of the district court.” Pet’r CA11 Mot. 14 (emphasis added). By asking the Eleventh Circuit not to

redress its injury, but instead to prolong it in the

hopes the company can get before this Court, Monsanto took a “shortcut” that at least one court has

flagged as an Article III defect. Aguilar-Torres, 116

F.4th at 342 & n.1.

Neither of the cases Monsanto cites grappled

with this particular “jurisdictional obstacle,” Pet. 15.

The settlement agreement in Havens Realty Corporation v. Coleman merely liquidated potential damages.

455 U.S. 363, 371 (1982). The parties reached that

deal in the shadow of a petition for writ of certiorari,

apparently after both the district court and court of

appeals had ruled. Id. at 370-71. The defendant-petitioner in Havens did not do what Monsanto did here:

seek relief against its own interests in the Court of Appeals. (Nor did it orchestrate a settlement to try to

tailor the substantive contours of the remaining claim

for purposes of presentation of a conflict to this Court.)

The other case Monsanto cites, Linde v. Arab Bank,

PLC, 882 F.3d 314, 324 (2d Cir. 2018), is distinguishable on the same basis.

For all of the above reasons, this case does not

present the “clean vehicle” Monsanto contends.

II. Nor Does This Case Implicate Any Circuit

Conflict

The decision below does not conflict with the

Third Circuit because it falls within the circumstances

that court expressly declined to address. As Respondent Durnell points out, Schaffner involved a “unique

quirk”: “[t]he plaintiff there had not argued that

25

‘FIFRA required Monsanto’ to seek ‘EPA approval for

a modified Roundup label that included’ a cancer

warning.” Durnell BIO 21 (quoting Schaffner, 113

F.4th at 386 n.13). But Salas did assert such a claim.

So the aspect of the Third Circuit’s analytic path that

diverged from that of the Eleventh Circuit (in Carson

at least) does not traverse this case.

Salas’s complaint alleged that both FIFRA and

Florida law imposed a duty upon Monsanto to register

Roundup and furnish EPA with information concerning its toxicity to humans. D.Ct. Dkt. 1-1, ¶¶35-37,

39, 154-155, 156(k). Her complaint was patterned after that of the lead plaintiff in the MDL, which likewise asserted a state-law failure-to-warn claim

“base[d] … on Monsanto’s alleged violation of FIFRA.”

Hardeman, 216 F. Supp. 3d at 1038. When Monsanto

sought summary judgment on FIFRA-preemption

grounds against Salas’s claims, the MDL Court denied

the motion based “the Ninth Circuit’s decision in Hardeman.” R.App. 5a. The Ninth Circuit viewed the

claim as asserting “a state cause of action that seeks

to enforce a federal requirement” under FIFRA. Hardeman, 997 F.3d at 955 (quotation omitted).

To be sure, Monsanto purchased an amendment to Salas’s complaint as part of its settlement.

But the resulting pleading did not cleanly excise

Salas’s reliance on FIFRA as a parallel source of duty

for Monsanto to present EPA with updated data. See

D.Ct. Dkt. 73, ¶¶ 18-20, 22, 118-119, 120(c). Even if it

did, Monsanto represented to the District Court in the

stipulation for entry of judgment that its appeal would

be “based on the portions of the MDL Court’s August

21, 2023 order” rejecting its preemption defense.

26

D.Ct. Dkt. 74 1.5 That order from the MDL court

(R.App. 5a) addressed the earlier version of Salas’s

complaint, before it was sanitized to Monsanto’s liking. See D.Ct. Dkt. 57. If Monsanto were to quibble

that the operative complaint is the only relevant

pleading, and that the Court should ignore the history

of the case, that contention would only underscore the

wholly contrived nature of the asserted Circuit split

Monsanto seeks to leverage here.

Further, there is no Circuit split on the issue of

impossibility preemption. The Third Circuit did not

reach that issue. Schaffner, 113 F.4th at 379 n.8.

III. The Decision Below Is Correct

A. Salas’s Failure-to-Warn Claim Is Not

Expressly Preempted

The Eleventh Circuit correctly held that Salas’s

failure-to-warn claim was not expressly preempted,

based upon Carson, because Florida’s common law on

negligent failure to warn “parallels FIFRA.” Pet.App.2. Since “Carson’s analysis govern[ed]” in Salas, id.,

the Eleventh Circuit did not have to elaborate to grant

Monsanto’s motion for summary affirmance. So that

court’s reasoning resides almost exclusively in Carson.

The Carson court properly applied the Bates

“two-step framework” to a state-law failure-to-warn

claim concerning Roundup. Carson, 92 F.4th at 990.

The plaintiff in Carson asserted a failure-to-warn

claim under Georgia common law, id. at 991, whereas

Salas’s is a Florida law failure-to-warn claim. See

5 Monsanto claims it “expressly retained the right to appeal the

judgment on FIFRA preemption grounds” (Pet. 14), but its reservation of rights in the filed stipulation was narrower.

27

D.Ct. Dkt. 73. “Florida law, like Georgia law, ‘require[s] pesticide manufacturers to warn users of potential risks to health and safety[.]’” Pet.App.-2 (quoting Carson, 92 F.4th at 992). As Monsanto told the

Eleventh Circuit, “Florida law, like Georgia law, requires manufacturers who know or reasonably should

know ‘of the potential danger in the use of the product’

to warn users when it is foreseeable that those users

may sustain ‘damage or injury.’” Pet’r CA11 Mot. 9

(quoting Advance Chem. Co. v. Harter, 478 So. 2d 444,

447 (Fla. Dist. Ct. App. 1985)); see High v. Westinghouse Elec. Corp., 610 So. 2d 1259, 1262 n.4 (Fla.

1992) (citing Advance Chem. and Tampa Drug Co. v.

Wait, 103 So. 2d 603, 607-08 (Fla. 1958)).

“If anything, [Florida] common law about failureto-warn claims imposes less of a duty on pesticide

manufacturers than FIFRA.” Carson, 92 F.4th at 992.

Florida common law requires manufacturers to warn

of “foresee[able]” “potential danger in the use of the

product” that they “knew, or by the exercise of reasonable care, should have known, of.” Advance Chem.,

478 So. 2d at 447. “By contrast, FIFRA imposes a

blanket duty on pesticide manufacturers, regardless

of knowledge or foreseeability.” Carson, 92 F.4th at

992. “FIFRA’s prohibition on misbranding effectively

imposes a strict-liability standard, as it contains no element of knowledge or intent.” Id. at 991. “So long as

the pesticide’s label omits a ‘necessary’ warning ‘to

protect health and the environment,’ the manufacturer is liable under FIFRA.” Id. at 991-92 (quoting

§136(q)(1)(G)). Therefore, Salas’s Florida common

law, failure-to-warn claim is “‘fully consistent with’ or

even narrower than federal requirements,” such that

FIFRA does not expressly preempt it. Id. (quoting

Bates, 544 U.S. at 447).

28

B. Monsanto’s Express Preemption Arguments Lack Merit

Because Monsanto’s petition simply adopts its

merits arguments from its petition in Durnell, this

brief will not compound the Court’s labor with a pointby-point response and, instead, adopts Respondent

Durnell’s persuasive rejoinder. See Durnell BIO 2130. Durnell’s arguments apply with equal force in this

case because the Missouri Court of Appeals relied on

the Eleventh Circuit’s decision in Carson. See Durnell

v. Monsanto Co., 707 S.W.3d 828, 832-33 (Mo. Ct. App.

2025).

One of Durnell’s points, regarding 40 C.F.R.

§152.44, warrants elaboration given the starring role

that regulation plays in Third Circuit’s analysis and,

hence, Monsanto’s position now. That regulation

“does not forbid [Monsanto] from warning of

Roundup’s cancer risks” but “just establishes procedures for manufacturers to update their labels.” Durnell BIO 22 (emphasis added). The distinction between substance and procedure is material to FIFRA’s

preemption regime.

1. The distinction originates in the key text of

the preemption provision, “requirements for labeling.”

§136v(b).6 That phrase concerns mandatory content

on labels, not procedures which affect them. Both “labeling” and “label” are defined terms in the statute,

and both concern informational substance. A “label”

6 The phrase “requirements for labeling” is the referent of the

pronoun “those” in “in addition to or different from those required

under this subchapter.” §136v(b).

29

is “the written, printed, or graphic matter on, or attached to, the pesticide … or any of its containers or

wrappers.” §136(p)(1). “Labeling,” in turn, is a noun

that encompasses broader territory: the label, plus

“other written, printed, or graphic matter” “accompanying the pesticide” or “reference[d] … on the label or

in literature accompanying the pesticide[.]”

§136(p)(2). The preposition “for” in this context is

“used as a function word to indicate purpose.” For,

Webster’s Seventh New Collegiate Dictionary (7th ed.

1972). A “requirement” is “a rule of law that must be

obeyed.” Bates, 544 U.S. at 445. So, “requirements for

labeling” are most naturally read as mandatory rules

for the informational content that must go on or with

the pesticide.

The statutory context supports this understanding. See Medtronic, Inc. v. Lohr, 518 U.S. 470,

486 (1996) (looking to the “statutory framework surrounding” the preemption provision to assess its

scope) (quotation marks omitted). A chief purpose of

the statute is to ensure true and reliable labeling on

pesticides. See Bates, 544 U.S. at 451. The statutory

enforcement scheme therefore presumes the existence

of established informational labeling content. EPA

may seize pesticides whose “labeling fails to bear the

information required by [FIFRA].” §136k(b)(1)(C).

The prohibition on misbranding includes not “prominently plac[ing]” “any word, statement, or other information required by or under the authority of [FIFRA]

to appear on the label or labeling.” §136(q)(1)(E). EPA

therefore promulgated “requirements” for the “[c]ontents of the label,” whereby “[e]very pesticide product

shall bear a label containing the information specified

by [FIFRA] and the regulations in this part.” 40

C.F.R. §156.10(a)(1). That regulation alone details

30

pages of requirements governing information that

must appear on pesticide labels, their language, format, and appearance.

In view of this content-based understanding of

the meaning of “requirements for labeling,” a statutory provision or regulation directly mandating labeling content carries preemptive force, whereas one

merely governing procedures that may indirectly affect labeling content does not. As the Court has recognized, FIFRA’s misbranding standards contain

broadly framed substantive requirements for labeling:

“that a pesticide label not contain ‘false or misleading’

statements, § 136(q)(1)(A), or inadequate instructions

or warnings, §§ 136(q)(1)(F), (G).” Bates, 544 U.S. at

447. See also § 136(q)(2)(D) (requiring labels on highly

toxic pesticides to bear “the skull and crossbones” and

“the word ‘poison’ prominently in red on a background

of distinctly contrasting color”). In addition, some

“EPA regulations … give content to FIFRA’s misbranding standards.” Bates, 544 U.S. at 453 (citing 40

C.F.R. §156.64, which requires “each pesticide product

to bear on the front panel a signal word,” such as

“DANGER” depending on its toxicity category). See,

e.g., id. §156.10(a)(1) (specifying the information

which every pesticide shall bear); id. §156.66(a) (requiring the child hazard warning, “Keep Out of Reach

of Children”); id. §156.69 (requiring a first aid statement). As evidenced by the Court’s references in Bates

to the statutory misbranding standards and a regulation prescribing the content of a warning, it is clear

that the Court understood “requirements for labeling”

to mean laws and regulations prescribing labeling

content, including “the color, font size, and wording of

warnings.” 544 U.S. at 452.

31

2. The Third Circuit acknowledged that Bates

interpreted “requirements for labeling” in this substantive fashion. Schaffner, 113 F.4th at 386 (“In

Bates, the Court’s analysis suggested that a ‘requirement’ under section 136v(b) must substantively restrict the content of pesticide labels.”). Nevertheless,

even though the Third Circuit recognized that 40

C.F.R. §152.44(a) “itself does not directly identify any

particular label contents as permitted, prohibited, or

required”—giving rise to the concern that it “fails to

substantively restrict the content of pesticide labels,”

113 F.4th at 386 (emphasis added)—the court still

concluded that it qualifies as a “requirement for labeling.” It held that 40 C.F.R. §152.44(a) “requires pesticide labels to conform to the EPA’s opinion as to

whether specific labels would constitute misbranding,” 113 F.4th at 391, so that the regulation “specifically require[s] a pesticide’s label to bear the particular precautionary statements on its Preapproved Label,” id. at 393. See id. at 387 (“[B]ecause the EPA will

approve only labels that it deems compliant with federal law, the prohibition on modifying a pesticide’s

Preapproved Label does ‘require the manufacturer …

to say [some]thing in particular’ on the pesticide label—namely, to include only the content that the EPA

deems compliant with federal law.”) (quoting Bates,

544 U.S. at 445).

3. If that analysis seems to have strayed from

the textual meaning of “requirements for labeling” in

§136v(b), that’s because it does. Schaffner equates a

regulation governing the process for changing a label,

but which does not itself mandate any informational

content, with one that actually prescribes labeling

content. 113 F.4th at 397 (maintaining that “the registration process” “play[s] a[] role in determining the

32

content” of a labeling requirement). That loose approach expands the scope of FIFRA’s preemption provision from substantive requirements that “directly

identify any particular label contents,” id. at 386, to

procedural requirements that only do so indirectly, if

at all. The tight syntax of §136v(b) does not lend itself

naturally to such an expansive reading. Nothing in

the unmodified adjectival phrase “for labeling”—

meaning, most concisely, for the purpose of information on a label—denotes content deriving incidentally from a chain of non-substantive requirements that do not even themselves supply that information. Cf. United States v. Munoz-Flores, 495 U.S.

385, 397 (1990) (construing phrase “Bills for raising

Revenue” in the Origination Clause of the Constitution as excluding bills “‘for other purposes which may

incidentally create revenue’”) (quoting Twin City

Bank v. Nebeker, 167 U.S. 196, 202 (1897)) (emphasis

added).

The Third Circuit’s broadening of the scope of

the preemption provision to give preemptive force to

labeling text imposed solely as a result of EPA preapproval and not mandated by any content requirement

in FIFRA (e.g., the absence of a cancer warning on

Roundup’s label) also elevates the force of EPA preapproval in a manner inconsistent with EPA practice

and the statute. EPA does not typically use the registration process to impose “chronic-risk warnings on a

pesticide’s labeling”; it “primarily seeks to control

such risks through use limitations or … cancellation

proceedings.” SG Hardeman Br. 11. It is by “promulgat[ing] … regulations” “that refine or elaborate upon

FIFRA’s broadly phrased misbranding standards”

that EPA can “affect the scope of pre-emption under §

136v(b).” Bates, 544 U.S. at 453 n.28. Further, FIFRA

33

precludes treating EPA approval of a label as a substantive requirement of the misbranding standards.

“Agency approvals provide only ‘prima facie evidence,’

not conclusive proof, that a pesticide is not misbranded.”

Carson, 92 F.4th at 993 (quoting

§136a(f)(2)); Hardeman, 997 F.3d at 956 (same). “In

no event shall registration … be construed as a defense for the commission of any offense” under FIFRA.

§ 136a(f)(2). The Third Circuit acknowledged that registration is not “dispositive[]” of non-misbranding,

Schaffner, 13 F.4th at 397, but failed to appreciate

how reliant its view is on an implausible and attenuated connection to the text of §136v(b).

It makes sense for Congress to have sought uniformity with respect to the informational labeling content specifically prescribed by federal law for pesticides. Hence this Court’s point about “50 different labeling regimes prescribing the color, font size, and

wording of warnings.” Bates, 544 U.S. at 452; id. at

n.26. But it makes little sense to think Congress

would be concerned with states intruding in rogue

fashion into the procedures a federal agency uses to

regulate those products, such as 40 C.F.R. §152.44(a).

For that reason too, it makes little sense to read the

federal “requirements for labeling” to include such

procedural regulations.

Central to Monsanto and the Third Circuit’s

analysis is the view that the Court’s interpretation of

the preemptive scope of the Medical Device Amendments of 1976 (“MDA”) in Riegel v. Medtronic, Inc.,

552 U.S. 312 (2008), is instructive because the MDA’s

preemption provision is, they say, “so similar” to

FIFRA’s. Schaffner, 113 F.4th at 388; see Durnell Pet.

25. But that similarity lies only in both statutes’ use

of the “different from, or in addition to” formula, not

34

in their language identifying the scope of the federal

comparator that preempts. The MDA uses a modifier

with copious scope: “requirement applicable under

[the MDA] to the device, and which relates to [its]

safety or effectiveness[.]” 21 U.S.C. § 360k(a) (emphasis added). See Lohr, 518 U.S. at 514 (O’Connor, J.,

concurring in part and dissenting in part) (opining

that the Food and Drug Administration’s “labeling requirements are certainly applicable to the device” at

issue) (emphasis added). FIFRA’s preemption provision—“requirements for labeling”—is much narrower,

using a defined term as its limiter. This textual distinction renders Riegel uninstructive as to the scope of

the federal comparator.7

FIFRA’s preemption provision is limited to federal requirements that supply the content for pesticide labels, not requirements governing the procedures or circumstances of when labeling can be

changed. Monsanto and the Third Circuit are wrong

to treat 40 C.F.R. §152.44 as preemptive of state-law

failure-to-warn claims.

7 Such broader language likewise differentiates other statutes

Monsanto claims to be similar to FIFRA. Durnell Pet. 35. Like

the MDA, 49 U.S.C. §30103(b) extends to federal standards “applicable to” motor vehicle performance or equipment. The

preemptive scope of 21 U.S.C. §678 extends to federal “requirements … with respect to” slaughterhouse facilities or operations.

The same is true for 21 U.S.C. §467e, giving preemptive force to

federal requirements “with respect to” poultry facilities and operations.

35

C. Salas’s Failure-To-Warn Claim Is Not Impliedly Preempted

The Eleventh Circuit correctly ruled, based on

Carson, that Salas’s failure-to-warn claims are not

barred by impossibility preemption. See Pet.App-2

(stating “Carson controls here”); see Carson, 92 F.4th

at 996-99. Monsanto’s petition adopts its petition in

Durnell, where it challenges the rejection of its implied preemption defense. Pet. 16; Durnell Pet. 28-32.

The Missouri Court of Appeals, like the Eleventh Circuit below, based its implied-preemption ruling on

Carson. Durnell, 707 S.W.3d at 833-35 (repeatedly invoking the analysis in Carson). Therefore, Durnell’s

thorough response to Monsanto covers the same

ground Salas would and is adopted by reference. See

Durnell BIO 30-33.

CONCLUSION

The petition for a writ of certiorari should be

denied.

Respectfully submitted,

STEPHEN F. ROSENTHAL

Counsel of Record

CHRISTINA H. MARTINEZ

PODHURST ORSECK, P.A.

2525 Ponce de Leon Blvd.

Suite 700

Coral Gables, FL 33134

(305) 358-2800

srosenthal@podhurst.com

Counsel for Respondent

June 18, 2025

Appendix

i

APPENDICES

Appendix A

Pretrial Order No. 285:

Order On Motions to Exclude Certain Wave

5 Experts and For Summary Judgment, In

Re: Roundup Products Liability Litigation,

No. 16-md-0271-VC .............................................. 1a

1a

Appendix A

UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF CALIFORNIA

__________________________

IN RE: ROUNDUP PRODUCTS

LIABILITY LITIGATION

____________________

Case No. 16-md-02741-VC

_________________________

This document relates to:

Salas v. Monsanto Co.,

Case No. 21-cv-6173-VC

Murdock v. Monsanto Co.,

Case No. 20-cv-1363-VC

Glavanovits v. Monsanto Co.,

Case No. 20-cv-1016-VC

Delorme-Barton v. Monsanto Co.,

Case No. 18-cv-1427-VC

__________________________

Filed: Aug. 21, 2023

__________________________

PRETRIAL ORDER NO. 285:

ORDER ON MOTIONS TO EXCLUDE CERTAIN

WAVE 5 EXPERTS AND FOR SUMMARY

JUDGMENT

Re: Dkt. Nos. 16848, 16849, 16850, 16851,

16852, 16853, 16854, 16856, 16857,

16863, 16868, 16940, 16942, 16944,

16945, 16946, 16947, 16978

____________________________

2a

The parties have filed evidentiary and summary judgment motions in Wave 5 cases.

1.

Monsanto’s motions to exclude Drs.

Knopf (Salas), Schiff (Murdock and Glavanovits), and

Conry (Delorme-Barton) are denied for reasons stated

in Pretrial Order No. 85. Accord, e.g., Pretrial Order

No. 262 (denying motion to exclude Dr. Schiff, noting

“[w]hile the experts’ opinions may be shaky in some

regards, all are admissible, and Monsanto’s challenges are best addressed through cross-examination

rather than exclusion.”).

2.

Monsanto’s renewed motions to exclude

the testimony of Drs. Portier, Ritz, Weisenburger,

Jameson and Sawyer are denied, subject to the limitations imposed on these experts in earlier rulings.

3.

The plaintiffs’ motions to exclude Drs.

Smeda (Salas), Butts (Murdock), and Johnson (Delorme-Barton) are denied without prejudice. These

witnesses generally are experts in the field of weeds

and weeds management. They were not designated to

opine on whether Roundup caused the plaintiffs’ cancer. See Pretrial Order No. 202 at 2. Similarly, Salas’s

motion to exclude Dr. Schaeffer, an industrial hygienist, is denied without prejudice. See Opp. at 1 (“Dr.

Schaeffer will not opine on causation in this case….”).

4.

The plaintiff in Delorme-Barton seeks to

exclude Dr. Tarone from testifying because he was not

disclosed as a retained expert under Rule 26(a)(2).

But Dr. Tarone wasn’t “retained” by Monsanto for litigation. Dr. Tarone grew critical of IARC’s research

methodology on his own and published two articles

3a

critiquing Monograph 112 and how IARC supposedly

ignored exculpatory data that would have eliminated

the basis to conclude glyphosate is a probable human

carcinogen. The plaintiff argues that in 2015, Monsanto’s attorney contacted Dr. Tarone’s employer, the

International Epidemiology Institute (IEI), to learn

more about IARC’s policies and procedures. And for a

three-hour meeting with IEI’s then-CEO and Dr. Tarone, Monsanto paid $1,500 to IEI. It does not appear

that Dr. Tarone received any cut of that payment.

Other courts presiding over Roundup cases have recognized that Dr. Tarone is a non-retained expert. E.g.,

Order at 3, Alesi v. Monsanto, Case No. 19SLCC03617 (Mo. Cir. Ct. Aug. 21, 2022); Order at 34–35,

Cabllero v. Monsanto, Case No. MSC19-01821 (Cal.

Super. Ct. Jan. 24, 2020). The motion is denied.

5.

Also in Delorme-Barton, the plaintiff

moves to exclude the testimony of Dr. Murphy, a hygienist and epidemiologist. The plaintiff mainly seeks

to exclude Dr. Murphy from opining that her use of

the Dial N’ Spray did not produce “driftable droplets”

because Dr. Murphy reached that conclusion simply

by using a Dial N’ Spray outdoors once and eyeballing

for any droplets. Id. The plaintiff is correct that this

method is not very scientific or reliable, so Dr. Murphy is precluded from presenting this observation to

the jury.

Nonetheless, Dr. Murphy did do an analysis

that assumed the Dial N’ Spray hose attachment produced driftable droplets. And even under this assumption in the plaintiff’s favor, Dr. Murphy said his opinion remains unchanged—that the plaintiff’s exposure

to glyphosate was a small fraction of the regulatory

limits for exposure set by California and the EPA.

4a

Opp. at 5–6. This analysis may be presented to the

jury.

The plaintiff also criticizes Dr. Murphy for using, in part, Google Earth images of the plaintiff’s four

properties to calculate the square footage that she

would have sprayed Roundup. The plaintiff argues

that the landscaping on some of the properties might

have been different than when she was living at those

locations. Perhaps that’s true, but whether the landscapes are materially different from when the plaintiff

resided there and whether Dr. Murphy underestimated the volume of Roundup used by the plaintiff

goes to the weight of his testimony, not its admissibility. The plaintiff may attempt to discredit Dr. Murphy’s property footage calculations at trial by explaining, if true, that the landscapes are now different. Relatedly, the plaintiff’s assertion that Dr. Murphy is improperly challenging her credibility by providing footage estimates inconsistent with her recollection is unfounded.

Accordingly, the motion is granted in part

and denied in part. Dr. Murphy may testify about

the matters stated in his report, save for his observation that the Dial N’ Spray does not produce

driftable droplets.

6.

The Court is considering holding a

Daubert hearing in Delorme-Barton for Dr. Tomasetti. The outcome of that hearing could affect the

admissibility of the testimony of Drs. Navarro and

Slack. The Court will update the parties on its views

5a

regarding these experts around the time of the Daubert hearings in the Engilis case.

7.

In light of the foregoing and the Ninth

Circuit’s decision in Hardeman, Monsanto’s motions

and renewed motions for summary judgment on causation and non-causation grounds are denied in

Salas, Murdock and Glavanovits. See Hardeman v.

Monsanto, 997 F.3d 941, 955-56 (9th Cir. 2021); id. at

970–74. Suggestions of remand will be issued in these

cases on or around August 30. The summary judgment motions in Delorme-Barton are also denied, and

a suggestion of remand will be issued after the Daubert motions are resolved.

IT IS SO ORDERED.

[handwritten: signature]

VINCE CHHABRIA

United States District

Judge