Petition for Writ of Certiorari — Monsanto Company, Petitioner v. Edwin Hardeman

No. 21IN THE

Supreme Court of the United States

MONSANTO COMPANY,

Petitioner,

v.

EDWIN HARDEMAN,

Respondent.

ON PETITION FOR A WRIT OF CERTIORARI TO THE

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

PETITION FOR A WRIT OF CERTIORARI

SETH P. WAXMAN

THOMAS G. SPRANKLING

Counsel of Record

WILMER CUTLER PICKERING

CLAIRE H. CHUNG

HALE AND DORR LLP

JAMES D. BARTON

2600 El Camino Real

SAMUEL M. STRONGIN

Suite 400

ALLISON M. SCHULTZ

Palo Alto, CA 94306

MEDHA GARGEYA

WILMER CUTLER PICKERING

HALE AND DORR LLP

1875 Pennsylvania Ave., NW

Washington, DC 20006

(202) 663-6000

seth.waxman@wilmerhale.com

QUESTIONS PRESENTED

Petitioner manufactures the herbicide Roundup. For

decades, the Environmental Protection Agency (EPA)

has exercised its delegated authority under the Federal

Insecticide, Fungicide, and Rodenticide Act (FIFRA) to

find that Roundup and its active ingredient, glyphosate,

do not cause cancer in humans. EPA has authorized

Roundup for sale, repeatedly approved Roundup’s labeling without a cancer warning, and recently informed pesticide registrants that including a cancer warning on the

labeling of a glyphosate-based pesticide would render it

“misbranded” in violation of federal law. And in a provision of FIFRA entitled “Uniformity,” Congress explicitly barred States from “impos[ing] … any requirements

for labeling … in addition to or different from those required under [FIFRA].” 7 U.S.C. §§136v(a)-(b).

This case is one of thousands across the country in

which individuals have nonetheless alleged that petitioner violated a state-law duty to warn that exposure

to Roundup could cause cancer. The Ninth Circuit concluded that respondent’s claims were not preempted by

FIFRA and upheld the admission of expert testimony

on causation that relied on little more than subjective

intuitions rather than the reliable application of scientific principles.

The questions presented are:

1. Whether FIFRA preempts a state-law failureto-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.

2. Whether the Ninth Circuit’s standard for admitting expert testimony—which departs from other

circuits’ standards—is inconsistent with this Court’s

precedent and Federal Rule of Evidence 702.

(i)

CORPORATE DISCLOSURE STATEMENT

Petitioner Monsanto Company is an indirect, wholly owned subsidiary of Bayer AG, a publicly held corporation. No other publicly held corporation owns 10% or

more of Monsanto’s stock.

(ii)

RELATED PROCEEDINGS

Hardeman v. Monsanto Company, Nos. 19-16636,

19-16708 (9th Cir.) (opinion and judgment issued May

14, 2021).

Hardeman v. Monsanto Company, Nos. 3:16-cv00525 & 3:16-md-02741 (N.D. Cal.) (final judgment issued May 3, 2019 and amended July 17, 2019).

(iii)

TABLE OF CONTENTS

Page

QUESTIONS PRESENTED ............................................ i

CORPORATE DISCLOSURE STATEMENT ............. ii

RELATED PROCEEDINGS.......................................... iii

TABLE OF AUTHORITIES ........................................viii

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

OPINIONS BELOW .......................................................... 4

JURISDICTION ................................................................. 4

CONSTITUTIONAL AND STATUTORY

PROVISIONS AND RULE INVOLVED ..................... 4

STATEMENT ..................................................................... 4

A. FIFRA’s Regulatory Scheme ............................. 4

B. Glyphosate’s Regulatory History ....................... 6

C. Proceedings Below ................................................ 9

REASONS FOR GRANTING THE PETITION ........... 12

I.

THE NINTH CIRCUIT’S RULING DEPARTS

FROM

THIS

COURT’S

PREEMPTION

DECISIONS AND CREATES SIGNIFICANT

CONFUSION .................................................................. 12

A. Express Preemption ........................................... 12

1.

The Decision Below Conflicts With

Bates .............................................................. 13

2.

The Decision Below Deepens

Uncertainty Over How To Apply

Similarly

Worded

ExpressPreemption Provisions ................................ 18

(v)

vi

TABLE OF CONTENTS—Continued

Page

B. Conflict Preemption ............................................ 20

C. The Scope Of FIFRA Preemption Is

An Issue Of National Importance .................... 24

II. THE

NINTH

CIRCUIT’S

DECISION

SUBVERTS TRIAL COURTS’ GATEKEEPING

ROLE IN ADMITTING EXPERT TESTIMONY ............. 26

A. The Decision Below Departs From The

Rigorous Daubert Scrutiny Other

Circuits Require .................................................. 28

B. The Decision Below Contravenes

Daubert And Federal Rule Of

Evidence 702 ........................................................ 32

C. The Proper Admissibility Standard Is

A Recurring And Important Question ............ 35

CONCLUSION ................................................................. 36

APPENDIX A: Opinion of the United States

Court of Appeals for the Ninth Circuit,

dated May 14, 2021 ..................................................... 1a

APPENDIX B: Order of the United States

District Court for the Northern District of

California, dated March 7, 2019 .............................. 71a

APPENDIX C: Order of the United States

District Court for the Northern District of

California, dated February 24, 2019 ...................... 79a

APPENDIX D: Order of the United States

District Court for the Northern District of

California, dated July 10, 2018 ................................ 91a

vii

TABLE OF CONTENTS—Continued

Page

APPENDIX E: Order of the United States

District Court for the Northern District of

California, dated April 8, 2016 .............................. 181a

APPENDIX F: Order of the United States

District Court for the Northern District of

California, dated July 17, 2019 .............................. 189a

APPENDIX G: Relevant Statutory Provisions

U.S. Const. art VI, cl. 2 ......................................... 191a

7 U.S.C. §136v ......................................................... 192a

Fed. R. Evid. 702 .................................................... 194a

APPENDIX H: EPA Letter to Glyphosate

Registrants, dated August 7, 2019....................... 195a

viii

TABLE OF AUTHORITIES

CASES

Page(s)

Bass v. Stryker Corp., 669 F.3d 501 (5th Cir.

2012) ............................................................................. 19

Bates v. Dow Agrosciences LLC, 544 U.S. 431

(2005) ................................................................... passim

Bland v. Verizon Wireless (VAW) L.L.C., 538

F.3d 893 (8th Cir. 2008) ............................................. 32

Brooks v. Mentor Worldwide LLC, 985 F.3d

1272 (10th Cir. 2021), petition for cert. filed,

No. 20-1822 (June 25, 2021) ...................................... 19

Caplinger v. Medtronic, Inc., 784 F.3d 1335

(10th Cir. 2015)............................................................ 19

Daubert v. Merrell Dow Pharmaceuticals, Inc.,

509 U.S. 579 (1993) ............................................ passim

Engine Manufacturers Association v. EPA,

88 F.3d 1075 (D.C. Cir. 1996) .................................... 25

Frye v. United States, 293 F. 1013 (D.C. Cir.

1923) ............................................................................. 34

General Electric Co. v. Joiner, 522 U.S. 136

(1997) .......................................................... 27, 33, 34, 36

Gomez-Perez v. Potter, 553 U.S. 474 (2008) ................... 18

Hall v. Conoco, 886 F.3d 1308 (10th Cir. 2018) ............. 31

In re Medtronic, Inc., Sprint Fidelis Leads

Products Liability Litigation, 623 F.3d

1200 (8th Cir. 2010)..................................................... 19

Kumho Tire Co. v. Carmichael, 526 U.S. 137

(1999) ............................................................................ 27

ix

TABLE OF AUTHORITIES—Continued

Page(s)

MacDonald v. Monsanto Co., 27 F.3d 1021 (5th

Cir. 1994) ...................................................................... 17

McMullen v. Medtronic, Inc., 421 F.3d 482 (7th

Cir. 2005) ...................................................................... 18

Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) ................. 18

Merck Sharp & Dohme Corp. v. Albrecht,

139 S. Ct. 1668 (2019) ..................................... 13, 21, 22

Moss v. Parks Corp., 985 F.2d 736 (4th Cir.

1993) ............................................................................. 25

Mutual Pharmaceutical Co. v. Bartlett,

570 U.S. 472 (2013) ............................................... 20, 21

National Association of Wheat Growers v.

Becerra, 468 F.Supp.3d 1247 (E.D. Cal.

2020) ............................................................................. 25

National Meat Association v. Harris, 565 U.S.

452 (2012) ..................................................................... 18

Norris v. Baxter Healthcare Corp., 397 F.3d

878 (10th Cir. 2005)..................................................... 32

Pilliod v. Monsanto Co., -- Cal. Rptr. 3d --,

2021 WL 3486893 (Cal. Ct. App. Aug. 9,

2021) ............................................................................. 12

PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) ... 21, 23, 24

Reckitt

Benckiser,

Inc.

v.

Jackson,

762 F.Supp.2d 34 (D.D.C. 2011) ................................ 17

Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)......... 16, 17

Rowe v. New Hampshire Motor Transport

Association, 552 U.S. 364 (2008) .............................. 19

x

TABLE OF AUTHORITIES—Continued

Page(s)

Ruckelshaus v. Monsanto Co., 467 U.S. 986

(1984) ............................................................................ 24

Shuker v. Smith & Nephew, PLC, 885 F.3d 760

(3d Cir. 2018) ............................................................... 19

Tamraz v. Lincoln Electric Co., 620 F.3d 665

(6th Cir. 2010)........................................................ 31, 36

Turek v. General Mills, Inc., 662 F.3d 423 (7th

Cir. 2011) ...................................................................... 26

United Airlines, Inc. v. Mesa Airlines, Inc.,

219 F.3d 605 (7th Cir. 2000) ...................................... 25

Wolicki-Gables v. Arros International, Inc.,

634 F.3d 1296 (11th Cir. 2011) .................................. 19

Wyeth v. Levine, 555 U.S. 555 (2009) ........................ 13, 21

DOCKETED CASES

In re Roundup Products Liability Litigation,

No. 3:16-md-02741 (N.D. Cal.) ............................ 22, 35

NRDC v. EPA, Nos. 20-70787, 20-70801

(9th Cir.)......................................................................... 9

STATUTES AND RULES

7 U.S.C.

§136 ................................................................................. 5

§136a ................................................... 4, 5, 11, 13, 17, 23

§136j ................................................................... 5, 14, 23

§136v....................................... 4, 6, 10, 12, 13, 15, 16, 18

xi

TABLE OF AUTHORITIES—Continued

Page(s)

21 U.S.C.

§352 ............................................................................... 16

§355 ............................................................................... 22

§360k............................................................................. 18

§467e ............................................................................. 18

§678 ............................................................................... 18

28 U.S.C.

§1254 ............................................................................... 4

§1407 ............................................................................. 20

49 U.S.C. §30103 ................................................................ 18

Fed. R. Evid. 702 ...................................................... passim

S. Ct. R. 10 ...................................................................... 2, 13

REGULATIONS

40 C.F.R.

§152.44 ................................................................ 5, 23, 24

§152.46 ...................................................................... 5, 23

§152.50 .......................................................................... 24

§152.122 .......................................................................... 5

§155.40 ............................................................................ 5

§155.58 ...................................................................... 5, 23

§156.10 ............................................................................ 4

§156.60 ............................................................................ 4

§156.62 .......................................................................... 15

§156.64 .......................................................................... 15

§158.500 .......................................................................... 4

62 Fed. Reg. 17,723 (Apr. 11, 1997) ................................... 7

69 Fed. Reg. 65,081 (Nov. 10, 2004) .................................. 7

xii

TABLE OF AUTHORITIES—Continued

Page(s)

OTHER AUTHORITIES

Coenen, Michael & Seth Davis, Percolation’s

Value, 73 Stan. L. Rev. 363 (2021) ........................... 20

EPA, Glyphosate: Interim Registration Review

Decision (Jan. 2020), https://tinyurl.com/

5b7c8awa ............................................................ 8, 13, 23

EPA,

Glyphosate:

Proposed

Interim

Registration Review Decision (Apr. 2019),

http://tinyurl.com/y6h2u8w6 ....................................... 6

EPA, Glyphosate: Response to Comments on

the Proposed Interim Decision Regarding

the Human Health Risk Assessment

(Jan. 13, 2019), https://tinyurl.com/EPA

CommentResponse .................................................... 22

EPA, Registration Eligibility Decision:

Thiodicarb (Dec. 1998), https://tinyurl.com/

5dmctukx ..................................................................... 24

EPA, Response from the Pesticide Reevaluation Division to Comments on the

Glyphosate Proposed Interim Decision

(Jan. 16, 2020), https://tinyurl.com/426uuejz ............ 6

EPA, Revised Glyphosate Issue Paper (Dec.

12, 2017), http://tinyurl.com/eparevdgly

phosate ....................................................................... 7, 8

EPA, Office of Pesticide Programs, Pesticide

Registration Notice 98-10 (Oct. 22, 1998),

https://tinyurl.com/yejwzhkt ................................ 6, 24

xiii

TABLE OF AUTHORITIES—Continued

Page(s)

Fitzpatrick, Brian T., Many Minds, Many

MDL Judges, 84 J. L. & Contemporary

Prob. 107 (2021) .......................................................... 20

Restatement (Third) of Torts: Physical &

Emotional Harm §18 (2010) ..................................... 15

Schroeder, Thomas D., Toward A More

Apparent Approach to Considering the

Admission

of

Expert

Testimony,

95 Notre Dame L. Rev. 2039 (2020) ......................... 30

IN THE

Supreme Court of the United States

No. 21MONSANTO COMPANY,

Petitioner,

v.

EDWIN HARDEMAN,

Respondent.

ON PETITION FOR A WRIT OF CERTIORARI TO THE

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

PETITION FOR A WRIT OF CERTIORARI

Monsanto Company respectfully petitions for a writ

of certiorari to review the judgment of the United

States Court of Appeals for the Ninth Circuit in this

case.

INTRODUCTION

Monsanto manufactures Roundup, the world’s most

widely used herbicide. Roundup’s active ingredient is

glyphosate. Like any herbicide, glyphosate is subject

to extensive regulatory scrutiny by the Environmental

Protection Agency (EPA) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA’s

scrutiny includes reviewing whether glyphosate poses

risks to humans and ensuring any risks are communicated to the public.

2

For decades, EPA has studied the enormous body

of science on glyphosate and repeatedly concluded that

glyphosate does not cause cancer in humans. As EPA

explained below, it has approved 44 versions of Roundup labeling since 1991—all without a cancer warning.

And in 2019 it instructed glyphosate manufacturers

that no request to add a cancer warning would be approved because that warning would be false and misleading.

Despite EPA’s repeated findings—confirmed by

national regulators around the world, including in Australia, the E.U., Canada, and New Zealand—a working

group at the International Agency for Research on

Cancer (IARC) classified glyphosate in 2015 as “probably carcinogenic to humans.” EPA and other regulators reviewed and rejected IARC’s conclusion, which

did not identify either the circumstances under which

glyphosate might cause cancer or the amount of exposure required. Still, based on that slender reed, many

thousands of litigants (including respondent Edwin

Hardeman) sued Monsanto asserting that it failed to

warn them about the cancer risks of using Roundup.

The Ninth Circuit’s decision here—affirming a $25

million damages award—merits review because it conflicts with this Court’s and other circuits’ decisions on

two important federal questions. See S. Ct. R. 10(a),

(c).

First, the Ninth Circuit held that FIFRA did not

preempt respondent’s state-law failure-to-warn claim

despite EPA’s conclusion that such a cancer warning

would be false and therefore prohibited by FIFRA.

That contravenes this Court’s holding that any state

labeling requirement not “genuinely equivalent” to a

FIFRA labeling requirement is preempted. Bates v.

3

Dow Agrosciences LLC, 544 U.S. 431, 454 (2005). The

ruling below also splits with how this Court and others

have understood a nearly identical preemption provision in another federal statute.

Second, the Ninth Circuit affirmed the admission of

expert opinions that glyphosate can cause nonHodgkin’s lymphoma and caused respondent’s cancer

specifically, even though those opinions rested on little

more than subjective intuitions. That conflicts with

Daubert v. Merrell Dow Pharmaceuticals, Inc., 509

U.S. 579, 597 (1993), which requires trial courts to play

“a gatekeeping role” to ensure that expert opinions are

reliable, and with Federal Rule of Evidence 702, which

requires expert opinions to be the product of “reliable

principles and methods,” “reliably applied … to the

facts of the case,” Fed. R. Evid. 702(c)-(d). The admissibility ruling also departs from other circuits’ precedent, which would have likely rejected the testimony at

issue.

These deviations merit review, particularly because this case is a “bellwether trial for the [Roundup]

cases consolidated in a multidistrict litigation,”

App.2a—meaning that the decision below will control

thousands of other federal suits, and undoubtedly influence still others pending across the country. Together,

the Ninth Circuit’s errors mean that a company can be

severely punished for marketing a product without a

cancer warning when the near-universal scientific and

regulatory consensus is that the product does not cause

cancer, and the responsible federal agency has forbidden such a warning. That is not, and should not be, the

law.

4

OPINIONS BELOW

The Ninth Circuit’s decision (App.1a-69a) is reported at 997 F.3d 941. The district court’s rulings are reported as follows: on preemption (App.181a-187a, 71a77a) at 216 F.Supp.3d 1037 and 364 F.Supp.3d 1085 and

on expert testimony (App.79a-89a, 91a-180a) at 390

F.Supp.3d 1102 and 358 F.Supp.3d 956.

JURISDICTION

The Ninth Circuit entered judgment on May 14,

2021. This Court has jurisdiction under 28 U.S.C.

§1254(1).

CONSTITUTIONAL AND STATUTORY

PROVISIONS AND RULE INVOLVED

Reprinted in the appendix are the Supremacy

Clause of the U.S. Constitution, 7 U.S.C. §136v, and

Federal Rule of Evidence 702. App.191a-194a.

STATEMENT

A. FIFRA’s Regulatory Scheme

FIFRA is a “comprehensive regulatory statute”

governing “the use, as well as the sale and labeling, of

pesticides.” Bates, 544 U.S. at 437. No pesticide may

be sold or distributed domestically without EPA registration. 7 U.S.C. §136a(a). The registration process

requires manufacturers to submit voluminous scientific

and safety data (including carcinogenicity studies), as

well as proposed labeling that includes any precautionary statements regarding potential effects on human

health. E.g., id. §136a(c); 40 C.F.R. §§156.10(a)(1)(vii),

156.60, 158.500.

5

To register a pesticide, EPA must determine both

that the pesticide poses no unreasonable risk of adverse

effects on human health, see 7 U.S.C. §§136a(c)(5)(C),

136(bb); 40 C.F.R. §152.122(e), and that its labeling

complies with FIFRA’s misbranding prohibition, see 7

U.S.C. §136a(c)(5)(B). “A pesticide is ‘misbranded’ if its

label contains a statement that is ‘false or misleading in

any particular,’” Bates, 544 U.S. at 438, or “does not

contain a warning or caution statement which may be

necessary and if complied with … is adequate to protect

health and the environment,” 7 U.S.C. §136j. Distributing a misbranded pesticide is unlawful.

Id.

§136j(a)(1)(E).

To “ensure that each pesticide’s registration is

based on current scientific and other knowledge,” 40

C.F.R. §155.40(a)(1), EPA must review a pesticide’s

registration every 15 years, 7 U.S.C. §136a(g). This

process requires EPA to consider whether any “labeling changes” are necessary given new information and

whether the product still meets FIFRA’s requirements, including not being misbranded. 40 C.F.R.

§155.58(b).

Pesticide registrants have a continuing obligation

to comply with FIFRA’s labeling requirements. It is

illegal to distribute a pesticide with labeling substantially different than the EPA-approved labeling. 7

U.S.C. §§136a(c)(1), 136j(a)(1)(B). As the United States

explained below, “[t]he label is the law.” U.S. C.A.

Amicus Br. 1. Once EPA approves a pesticide’s labeling, the manufacturer must seek approval for virtually

any substantive change thereto. 40 C.F.R. §§152.44,

152.46; 7 U.S.C. §136a(c)(9)(C). Some minor changes

may be made through a streamlined “notification” process, 40 C.F.R. §152.46, but any changes to “precautionary statements” require prior EPA approval, see

6

EPA, Office of Pesticide Programs, Pesticide Registration Notice 98-10 at 8 (Oct. 22, 1998), https://tinyurl.

com/yejwzhkt.

Recognizing that divergent state laws could impair

interstate commerce in pesticides, FIFRA limits the

“[a]uthority of States” to regulate pesticides. 7 U.S.C.

§136v. Specifically, FIFRA provides—in a subsection

entitled “Uniformity”—that States may not impose

“any requirements for labeling or packaging in addition

to or different from those required under [FIFRA].”

Id. §136v(a)-(b) (emphasis added). Congress sought

thereby to ensure manufacturers would not have to

comply with “50 different labeling regimes.” Bates, 544

U.S. at 452.

B. Glyphosate’s Regulatory History

Glyphosate, Roundup’s active ingredient, “is the

most important herbicide of [the post-war] era.”

C.A.E.R.1835. Decades of research have found it to be

highly effective, “environmentally benign,” and “one of

the least toxic pesticides to animals,” making it “a precious herbicide resource for world agriculture.”

C.A.E.R.1835-1836. EPA has registered pesticides

containing glyphosate since 1974. See EPA, Glyphosate: Proposed Interim Registration Review Decision 4

(Apr. 2019), http://tinyurl.com/y6h2u8w6.1

1

This petition uses “Roundup” and “glyphosate” (Roundup’s

principal ingredient) interchangeably. Although respondent tried

on appeal to draw a distinction between the two—suggesting inert

ingredients in Roundup called surfactants made it especially hazardous—nothing in the Ninth Circuit’s ruling turned on any such

distinction, and the district court expressly rejected it.

C.A.E.R.15 n.3, 128. EPA’s evaluation of glyphosate-based products, moreover, has encompassed both glyphosate and “any inert

ingredients.” EPA, Response from the Pesticide Re-evaluation

7

EPA has repeatedly evaluated whether glyphosate

is carcinogenic. See EPA, Revised Glyphosate Issue

Paper 12 (Dec. 12, 2017), http://tinyurl.com/

eparevdglyphosate. For example, in response to a 1983

study raising concerns about potential carcinogenicity,

EPA re-evaluated glyphosate’s effects on human

health. C.A.E.R.1844; C.A.F.E.R.23-25. EPA considered numerous studies in rodents, none of which

showed “convincing evidence” that glyphosate was carcinogenic. C.A.E.R.1845. EPA therefore “classified

glyphosate as a Group E carcinogen”—signifying “evidence

of

non-carcinogenicity

in

humans.”

C.A.E.R.1844. EPA has repeatedly reaffirmed that

classification, concluding in a 2004 Final Rule, for instance, that “[g]lyphosate has no carcinogenic potential.” 69 Fed. Reg. 65,081, 65,086 (Nov. 10, 2004); accord 62 Fed. Reg. 17,723, 17,728 (Apr. 11, 1997) (“Data

indicate … evidence of noncarcinogenicity for studies in

humans.”). Regulators worldwide have similarly found

that glyphosate does not cause cancer in humans.

C.A.E.R.1732, 1739, 1863-1870.

Against this global consensus, a working group of

the International Agency for Research on Cancer classified glyphosate in 2015 as “probably carcinogenic to

humans.” C.A.E.R.1819. IARC’s classification is merely a “hazard identification,” the first step in a publichealth assessment designed to “identify cancer hazards

even when risks are very low at current exposure levels.” C.A.E.R.58. IARC did not determine that

glyphosate poses a risk of cancer at real-world exposure levels. Id.; C.A.E.R.50.

Division to Comments on the Glyphosate Proposed Interim Decision 6 (Jan. 16, 2020), https://tinyurl.com/426uuejz.

8

Following IARC’s classification, EPA conducted

another “systematic review” of the scientific literature

on glyphosate, including all studies IARC considered.

See Revised Glyphosate Issue Paper 13,144. EPA concluded again that glyphosate is “not likely to be carcinogenic to humans.” Id. at 144. EPA reaffirmed that

determination yet again in 2020 when, in connection

with its formal glyphosate-registration review, it

“thoroughly assessed risks to humans from exposure to

glyphosate from all registered uses and all routes of

exposure and did not identify any risks of concern,” including of “cancer effects.” EPA, Glyphosate: Interim

Registration Review Decision 5, 9 (Jan. 2020),

https://tinyurl.com/5b7c8awa. EPA again authorized

labeling for glyphosate without any cancer warning.

Id. at 23-27.

EPA re-confirmed its rejection of IARC’s findings

in a 2019 letter informing glyphosate registrants that

EPA would not approve labels of glyphosate-based

products that included a cancer warning.

See

App.195a-197a.

“Given EPA’s determination that

glyphosate is ‘not likely to be carcinogenic to humans,’”

the letter stated, EPA considers a warning that

glyphosate is carcinogenic “to constitute a false and

misleading statement” that violates FIFRA’s misbranding prohibition. Id. The letter was consistent

with the fact that EPA has approved 44 versions of

Roundup’s label without a cancer warning. U.S. C.A.

Amicus Br. 26.

EPA has maintained its conclusion that glyphosate

is not carcinogenic to this day, explaining to the Ninth

Circuit again this Spring that “glyphosate is not likely

to be a human carcinogen and poses no human-health

risks of concern,” stressing that “[t]he record underlying these conclusions is robust, reflecting more than a

9

decade of analysis and thorough review of the scientific

literature.” EPA Br. 1, NRDC v. EPA, Nos. 20-70787,

20-70801 (9th Cir. May 18, 2021).

C. Proceedings Below

1. Respondent used Roundup between 1980 and

2012. App.7a. In 2015, he was diagnosed with nonHodgkin’s lymphoma, a common cancer. Id. “Approximately 70% or more of” non-Hodgkin’s lymphoma cases “are idiopathic, meaning they develop for unknown

reasons.” Id. Respondent also had hepatitis C—an “established” cause of non-Hodgkin’s lymphoma—for 25 to

40 years before developing cancer. Id.

Respondent sued Monsanto under diversity jurisdiction alleging that Roundup caused his cancer and

that Monsanto had violated its purported California duty to warn him of the cancer risks from exposure to

Roundup. C.A.E.R.2279-2308. Monsanto unsuccessfully moved to dismiss and for summary judgment on the

ground that respondent’s claims were preempted by

FIFRA. App.7a.

At trial, the district court admitted expert testimony that exposure to glyphosate can cause nonHodgkin’s lymphoma generally and caused respondent’s illness specifically, even though it acknowledged

that both questions were close even under the Ninth

Circuit’s lenient admissibility standard. For example,

the court noted that there is no “biomarker or genetic

signature” to distinguish glyphosate-caused nonHodgkin’s lymphoma from other cases, nor evidence

that non-Hodgkin’s lymphoma “presents differently

when caused by exposure to glyphosate” rather than by

something else. App.83a. The court recognized that

expert testimony that nonetheless identified glypho-

10

sate as the cause was “borderline” and probably inadmissible “[u]nder a strict interpretation of Daubert” absent “much stronger epidemiological evidence” that did

not exist here. App.83a-84a. The court explained,

however, that the Ninth Circuit requires courts to

“typically admit” opinions that “lean strongly toward

the ‘art’ side of the spectrum,” as opposed to science,

and permits “a wider range of expert opinions (arguably much wider)” than other circuits. Id.

The jury awarded Hardeman $5.27 million in compensatory damages and $75 million in punitive damages. App.10a. The district court reduced the latter, explaining that Monsanto’s culpability was “diminish[ed]”

because (1) glyphosate had been “repeated[ly] approv[ed]” by EPA and other regulators, and (2) there

was “credible evidence” that glyphosate does not cause

non-Hodgkin’s lymphoma.2

2.

The Ninth Circuit affirmed. App.1a-69a.

a. The court first held that FIFRA neither expressly nor impliedly preempts respondent’s failure-towarn claims. App.11a. As to express preemption, the

court recognized that FIFRA preempts state labeling

requirements that are “in addition to or different” from

those FIFRA requires, 7 U.S.C. §136v(b), but it held

that, at a general level, “FIFRA’s requirement that a

pesticide not be misbranded is consistent with, if not

2

Respondent’s suit is one of thousands pending in a multidistrict litigation as well as in other federal and state courts across

the country. Although some Roundup cases have settled, this one

has not, and there remain tens of thousands of filed and unfiled

claims that have not settled. Moreover, the district court recently

rejected a broad proposed settlement of potential future claimants.

Accordingly, the issues here remain live and important for thousands of pending cases, as well as any cases filed in the future.

11

broader than, California’s common law duty to warn.”

App.11a. The court acknowledged that EPA, applying

FIFRA, had concluded no cancer warning was necessary for glyphosate, including by “repeatedly register[ing] Roundup for sale without a cancer warning on

the label” and by notifying manufacturers in 2019 that

EPA would consider any glyphosate product including

a cancer warning to be misbranded. App.6a-7a, 14a.

But the court deemed those facts insufficient for express preemption, reasoning that, because registration

is not “‘a defense for the commission of any [FIFRA]

offense,’” EPA’s approval of a label “is not conclusive of

FIFRA compliance.” App.14a-15a (quoting 7 U.S.C.

§136a(f)(2)). The court also believed that neither EPA’s

approval of Roundup nor its 2019 letter “carr[ied] the

force of law.” App.15a-17a.

As to implied preemption, the Ninth Circuit saw no

“irreconcilabl[e] conflict” making it “impossible” for

Monsanto to comply with both state and federal requirements.

App.18a-22a.

Specifically, the court

thought Monsanto could have unilaterally modified

Roundup’s label to include a cancer warning through a

process for “mak[ing] minor modifications to labeling

without prior EPA approval” as long as it subsequently

notified EPA. App.20a; but see supra pp.5-6 (explaining that regulations prohibit substantive labeling

changes without prior EPA approval). The court, however, identified no example of EPA’s “‘allow[ing] a registrant to use the notification process’ where EPA previously ‘found the relevant chemical was not carcinogenic, much less where [EPA] determined a cancer

warning would render a label false and misleading.’”

App.21a. The court also rejected Monsanto’s argument

that, even if Roundup’s label could unilaterally be

changed, EPA would ultimately reject such a change.

12

And the court again deemed EPA’s repeated finding

that glyphosate is non-carcinogenic, its registration of

Roundup, and its 2019 letter indicating that a label like

the one Hardeman seeks would constitute misbranding

all irrelevant because they “do not carry the force of

law.” App.21a.

b. The Ninth Circuit also affirmed the district

court’s Daubert ruling, acknowledging that the ruling

“followed [Ninth Circuit] precedent” under which

“slight ‘deference to experts’ with ‘borderline … opinions’ was proper.” App.23a, 26a. The court asserted

that that precedent was not an “outlier,” but it distinguished just a few decisions of other circuits largely

based on the facts of each case, ignoring the more rigorous legal standards those courts apply. App.23a-26a.3

REASONS FOR GRANTING THE PETITION

I.

THE NINTH CIRCUIT’S RULING DEPARTS FROM THIS

COURT’S PREEMPTION DECISIONS AND CREATES SIGNIFICANT CONFUSION

A. Express Preemption

Respondent’s claims rest on the theory that Monsanto violated a state-law duty to warn consumers that

glyphosate is a potential carcinogen. See App.7a. But

under this Court’s precedent, that duty imposes a requirement “‘in addition to or different from’” what EPA

requires in administering FIFRA. Bates, 544 U.S. at

439 (quoting 7 U.S.C. §136v(b)). It is therefore

preempted because States may not require a warning

3

Last week, the California Court of Appeal issued Pilliod v.

Monsanto Co., -- Cal.Rptr.3d --, 2021 WL 3486893 (Aug. 9, 2021).

Although Pilliod raises similar issues, its preemption ruling relied

heavily on the Ninth Circuit’s flawed reasoning and its causation

ruling was decided under state law.

13

label where EPA has decided none is appropriate. Id.

at 453. That is the case here. EPA—exercising authority delegated under FIFRA—has repeatedly concluded

that glyphosate poses no cancer risk in humans and

warrants no cancer warning. The Ninth Circuit’s decision allowing California juries nonetheless to require a

cancer warning on Roundup merits review because it

conflicts with Bates and other relevant decisions of this

Court. See S. Ct. R. 10(c). At a minimum, it creates

uncertainties regarding how to apply this Court’s

preemption precedent more broadly. See Merck Sharp

& Dohme Corp. v. Albrecht, 139 S. Ct. 1668, 1676 (2019)

(certiorari granted to resolve “uncertainties” regarding

“the application of [implied preemption under] Wyeth”

v. Levine, 555 U.S. 555, 571 (2009)).

1. The Decision Below Conflicts With Bates

a. Bates held that a state-law claim is expressly

preempted by §136v(b) if the law (1) imposes a “requirement for labeling or packaging” that is (2) “‘in addition to or different from’” a requirement under

FIFRA. 544 U.S. at 444. There is no dispute that respondent’s claims satisfy the first requirement. They

also satisfy the second.

Pursuant to its statutory authority, see 7 U.S.C.

§136a(c), and based on its repeated conclusion that

glyphosate is not carcinogenic, see supra pp.7-9, EPA

has for decades registered Roundup for sale without a

cancer warning.

And in 2020 EPA reiterated—

following a notice-and-comment process that “thoroughly assess[ed] risks to humans from exposure to

glyphosate”—that glyphosate presents no “risks of

concern” and requires no cancer warning. Interim Registration Review Decision 9. Indeed, EPA has concluded that a cancer warning like the one respondent

14

sought would be “false and misleading,” making the

product “misbranded pursuant to” 7 U.S.C.

§136j(a)(1)(E). App.196a.

Bates compels the conclusion that any divergent

state-law labeling requirement—including the one

sought here, imposing a cancer warning EPA has rejected—is expressly preempted. In explaining the contours of express FIFRA preemption, Bates “emphasize[d] that a state-law labeling requirement must in

fact be equivalent to a requirement under FIFRA in

order to survive pre-emption.” 544 U.S. at 453 (emphasis added). In other words, “nominal[] equivalen[ce]” is

not enough. Id. at 454. Only state-law claims that truly

parallel a federal requirement survive—a category

Bates concluded might encompass challenges to warnings about the effectiveness of a product, since EPA had

not taken a position on efficacy. Id at 440, 453-454.

Bates was clear, however, that where EPA determines

that a pesticide should be accompanied by one warning

(such as “CAUTION”) but a jury concludes under state

law that the label should include a more aggressive one

(such as “DANGER”), state law is preempted. Id. at

453. That is the situation here: California would require a cancer warning on Roundup’s labeling, yet EPA

has determined no such warning is appropriate.

b. The Ninth Circuit held otherwise because it

improperly assessed FIFRA’s requirements at too high

a level of generality—an error that, if uncorrected,

could render FIFRA’s preemption provision nearly

meaningless, and undermine the uniformity in pesticide

labeling Congress sought to ensure. The court considered FIFRA and California law “parallel” because both

generally “require[] a warning” under certain circumstances: FIFRA when a warning is “necessary” and

“adequate” to protect public health, and California

15

when there is “any health risk that is known or knowable.” App.12a-13a.

Bates forecloses that reasoning. As this Court explained, that both FIFRA and state law require warning about risks is not enough; rather, preemption turns

on whether state law requires specific warnings that

EPA, in administering FIFRA, does not. 544 U.S. at

453. The crucial question is thus not whether state and

federal law have generally similar labeling standards,

but whether the labeling requirements that a State applies to a particular pesticide—including those “prescribing the … wording of warnings” (like DANGER)—are different from what EPA requires for that

pesticide (like CAUTION). Id. at 452. The Ninth Circuit’s contrary ruling directly impedes the uniformity

Congress sought to accomplish in §136v(b). Because

the basic common-law duty to warn is roughly “parallel” to the misbranding prohibition in FIFRA, under

the court of appeals’ reasoning a jury is free in applying

the common law to impose warning requirements on

pesticides dramatically different than those required by

EPA. See Restatement (Third) of Torts: Phys. & Emot.

Harm §18(a)(1) (2010) (duty to warn if defendant

“knows or has reason to know … of that risk”).

The Ninth Circuit distinguished Bates’s “‘DANGER’”-versus-“‘CAUTION’” example on the mistaken

belief that the EPA warning discussed in that example

sprang from a regulation. App.16a n.7. That misunderstands the process for determining what warnings appear on a pesticide’s label. While EPA regulations define toxicity categories (and associated warnings, see 40

C.F.R. §§156.62, 156.64), they do not assign toxicity

categories (or any warning) to particular pesticides.

Rather, EPA determines which warnings to apply by

making pesticide-by-pesticide determinations through

16

the registration process. See supra pp.4-5. Accordingly, Bates’s example necessarily addressed a situation

like this case, where (1) EPA determined the appropriate warnings for the labeling of a “given pesticide,” 544

U.S. at 543, through the registration process and (2)

state law deviated from that judgment.

The Ninth Circuit also suggested—relying solely

on implied-preemption precedent—that “the EPA actions that Monsanto alleges preempt Hardeman’s

claims do not carry the force of law.” App.15a. But the

proper focus for express-preemption purposes is the

body of statutory and regulatory provisions that prohibit manufacturers from adding safety warnings EPA

has not approved (and indeed here has determined

would be false). Those provisions impose the federal

labeling “requirements” that preempt divergent state

law. 7 U.S.C. §136v(b). And as explained, for specific

pesticides, requirements imposed “under” FIFRA (id.)

necessarily include EPA’s pesticide-specific determinations, supra pp.15-16.

In fact, this Court has held that an agency’s product-specific approval constitutes a federal “requirement” for purposes of a nearly identical expresspreemption provision. In Riegel v. Medtronic, Inc., 552

U.S. 312 (2008), the Court addressed whether state-law

claims regarding a medical device’s design and labeling

are preempted under the Food Drug and Cosmetic

Act’s Medical Device Amendments (MDA), id. at 320322. Although the MDA, like FIFRA, generally requires warnings necessary to protect health, see 21

U.S.C. §352(f), Riegel held the state-law claims

preempted to the extent they imposed specific requirements “different from or in addition to” those imposed through the Food and Drug Administration’s

(FDA) pre-market approval process. 552 U.S. at 323,

17

330. As the Court explained, “FDA has determined

that the approved form provides a reasonable assurance of safety and effectiveness.” Id. at 323. The same

reasoning applies here. When EPA registers a product

and approves the labeling, it determines that that labeling, not labeling more (or less) aggressive, provides appropriate warning. That is precisely why manufacturers cannot substantively change a registered pesticide’s

labeling unilaterally. See supra pp.5-6.

The Ninth Circuit distinguished Riegel based on an

erroneous interpretation of 7 U.S.C. §136a(f)(2), which

states that “registration” of a pesticide under FIFRA

is not “a defense for the commission of any offense under this subchapter” but is “prima facie evidence” that

a pesticide’s labeling “compl[ies] with the registration

provisions of the subchapter.” App.14a & n.6. The

court reasoned that, because “labeling determinations

are not dispositive of compliance” with FIFRA, they

are not dispositive as to preemption. App.15a. But

§136a(f)(2) has “no bearing on” preemption. MacDonald v. Monsanto Co., 27 F.3d 1021, 1025 n.4 (5th Cir.

1994). It simply “stands for the unremarkable proposition that a registration is not a defense against an allegation that a product violates the terms of that registration.” Reckitt Benckiser, Inc. v. Jackson, 762

F.Supp.2d 34, 45 (D.D.C. 2011). Monsanto, moreover,

has not been charged with an “offense” under FIFRA,

and its preemption argument turns not on the mere fact

that EPA registered Roundup but on EPA’s consistent

determinations that no cancer warning is necessary or

appropriate.

If the Ninth Circuit’s reading of

§136a(f)(2) were right, then EPA’s determination that a

warning label is unnecessary (or, as here, false and misleading) would never be preemptive. The result would

be the very proliferation of divergent state and federal

18

labeling requirements Congress sought to avoid. See

infra pp.24-25.

2. The Decision Below Deepens Uncertainty

Over How To Apply Similarly Worded

Express-Preemption Provisions

The panel’s construction of FIFRA’s key preemptive language—“in addition to or different from,” 7

U.S.C. §136v(b)—conflicts with this Court’s and other

circuits’ interpretation of virtually identical preemption

provisions in other federal laws.

Similar language appears in a wide range of statutes, including those regulating medical devices, meat,

poultry, and motor vehicles. See 21 U.S.C. §360k(a)

(MDA); 21 U.S.C. §467e (Poultry Products Inspection

Act); 21 U.S.C. §678 (Federal Meat Inspection Act); 49

U.S.C. §30103(b) (National Traffic and Motor Vehicle

Safety Act). And this Court has noted that such

preemptive language “sweeps widely.” National Meat

Ass’n v. Harris, 565 U.S. 452, 459 (2012). The Ninth

Circuit, however, has adopted a restrictive reading,

under which state requirements are preempted only if

inconsistent with federal requirements at a high level

of generality. This reading creates divergence among

the courts of appeals, threatening considerable confusion because courts routinely look to decisions interpreting similar statutory language when determining

the scope of express preemption provisions. See Bates,

544 U.S. at 447-448 (relying on the interpretation of the

MDA’s similar preemption provision in Medtronic, Inc.

v. Lohr, 518 U.S. 470 (1996)); McMullen v. Medtronic,

Inc., 421 F.3d 482, 488-489 (7th Cir. 2005) (relying on

Bates in applying the MDA’s preemption provision); see

also Gomez-Perez v. Potter, 553 U.S. 474, 479 (2008)

19

(this Court is “guided by [its] prior decisions interpreting similar language in” similar statutes).

Lower courts have diverged regarding whether, to

survive preemption, a state-law claim must merely be

consistent with federal law at the highest level of generality, or instead must be consistent with how federal

law is actually applied by the responsible agency. The

Ninth Circuit here embraced the first approach, deeming it sufficient that both state and federal law generally require warnings about pesticides’ health risks.

App.12a-13a. But other courts applying the MDA’s virtually identical preemption provision have rejected that

approach, holding instead that a state-law claim must

establish a violation of an existing federal requirement

to survive preemption. See Brooks v. Mentor Worldwide LLC, 985 F.3d 1272, 1279-1280 & n.2 (10th Cir.

2021); Shuker v. Smith & Nephew PLC, 885 F.3d 760,

776 (3d Cir. 2018); Bass v. Stryker Corp., 669 F.3d 501,

509-510 (5th Cir. 2012); Wolicki-Gables v. Arros Int’l,

Inc., 634 F.3d 1296, 1301-1302 (11th Cir. 2011). This inconsistency reflects confusion among the circuits over

what it means for state requirements to “parallel” federal requirements. See Caplinger v. Medtronic, Inc.,

784 F.3d 1335, 1338 (10th Cir. 2015) (Gorsuch, J.)

(“Lower courts have struggled … when it comes to trying to decide whether particular state claims do or don’t

‘parallel’ putative federal counterparts.”); In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig.,

623 F.3d 1200, 1204 (8th Cir. 2010) (“The contours of the

parallel claim exception … are as-yet ill-defined.”).

This Court’s review is needed to ensure consistent interpretation of language that Congress has adopted to

effectuate preemption in numerous federal statutes.

See Rowe v. New Hampshire Motor Transport Ass’n,

552 U.S. 364, 369-370 (2008) (“similar [preemption] lan-

20

guage” should be applied consistently across federal

statutes).

Notably, the unique nature of the multidistrict litigation process makes a more direct split regarding

FIFRA less likely than if this and similar cases were

adjudicated separately in different courts. This case,

for example, is one of thousands consolidated in an

MDL in the Northern District of California. See supra

n.2. That is because the MDL statute authorizes the

transfer of civil actions involving “common questions of

fact” to “any district for coordinated or consolidated

pretrial proceedings” before a single judge. 28 U.S.C.

§1407(a). In practical terms, this means that the

threshold legal issues in all current and future federal

Roundup cases alleging that Monsanto failed to warn of

the risk of non-Hodgkin’s lymphoma will be decided by

the same district court, governed by a single circuit

standard. See Fitzpatrick, Many Minds, Many MDL

Judges, 84 J. L. & Contemporary Prob. 107, 107-109

(2021). This consolidated resolution of pretrial issues

can interfere—and, in this case, has interfered—with

the “percolation” through lower courts of important legal issues. See Coenen & Davis, Percolation’s Value,

73 Stan. L. Rev. 363, 385 (2021). Because important

federal questions related to Roundup and nonHodgkin’s lymphoma that would otherwise be tested in

different courts nationwide are instead being resolved

solely in a single district, this Court should not wait to

grant review.

B. Conflict Preemption

The decision below is also inconsistent with this

Court’s holding that state law is impliedly preempted

to the extent it “conflict[s] with federal law.” Mutual

Pharm. Co. v. Bartlett, 570 U.S. 472, 479-480 (2013).

21

Such a conflict exists where it is “impossible for a private party to comply with both state and federal requirements.” Id. at 480. In the context of labeling requirements, that impossibility arises (1) where there is

“clear evidence” that the relevant federal agency would

not approve a warning required under state law, see

Wyeth, 555 U.S. at 571; Merck, 139 S. Ct. at 1678-1679,

or (2) where the warning could not have been added

without prior federal approval, see PLIVA, Inc. v.

Mensing, 564 U.S. 604, 617-619 (2011). Both situations

are present here.

1. EPA would unquestionably reject a cancer

warning for Roundup’s labeling. The state-law warning

the jury verdict in this case requires is therefore

preempted.

For decades, EPA has (based on repeated reviews

of the scientific literature) consistently approved

glyphosate, and Roundup’s labeling, without a cancer

warning. See supra pp.6-9. Even after the IARC

working group’s “hazard identification,” EPA—

following a “systematic review,” including of all studies

IARC considered—confirmed the conclusion it has

reached for years: Glyphosate is “not likely to be carcinogenic to humans.” Supra pp.8-9. Any remaining

doubt about whether EPA might approve a cancer

warning for glyphosate dissipated in 2019 when EPA

informed all glyphosate registrants that, “[g]iven

EPA’s determination that glyphosate is ‘not likely to be

carcinogenic to humans,’” EPA considers any warning

that glyphosate is carcinogenic “to constitute a false

and misleading statement” that violates FIFRA’s prohibition against “misbranded” substances. App.196a.

Even the district court—which is intimately familiar

with all relevant facts—agreed recently that EPA

would not approve the cancer warning California law

22

imposes. See Dkt. 13115, at 3 n.2, In re Roundup

Prods. Liab. Litig., No. 3:16-md-02741 (N.D. Cal. May

26, 2021).

The Ninth Circuit rejected all this on the ground

that none of EPA’s actions carried “the force of law.”

App.18a-19a, 21a-22a. That is unavailing. EPA’s actions approving Roundup’s labeling without a cancer

warning are comparable to the examples of agency action Merck identified as sufficient to “answer the preemption question.” Merck, 139 S. Ct. at 1679. This

Court explained in Merck that “agency actions taken

pursuant to the [agency’s] congressionally delegated

authority” can establish that the agency would not have

taken a particular action for conflict-preemption purposes. Id. The Court listed three ways FDA is authorized to “communicate its disapproval of a warning” and

thus “answer the pre-emption question”: (1) “noticeand-comment rulemaking setting forth labeling standards,” (2) “formally rejecting a warning label that

would have been adequate under state law,” and (3)

“other agency action carrying the force of law.” Id.4

EPA has taken analogous actions in approving

Roundup’s labeling. First, in conducting its statutorily

required registration review, EPA engaged in formal

notice-and-comment procedures before reaffirming its

conclusion that glyphosate is unlikely to be carcinogenic. See EPA, Glyphosate: Response to Comments on

the Proposed Interim Decision Regarding the Human

Health Risk Assessment (Jan. 13, 2019), https://

4

As an example of the kind of action satisfying the final category, the Court pointed to a provision requiring the FDA to notify

the manufacturer if it “becomes aware of new information … that

[it] determines should be included in the labeling of [a] drug.” 21

U.S.C. §355(o)(4)(A).

23

tinyurl.com/EPACommentResponse; Interim Registration Review Decision 5. Second, EPA has notified

glyphosate registrants in a letter that it would not approve glyphosate labeling containing a cancer warning

required under state law. App.195a-197a. And EPA

has declined to require a cancer warning through its

registration review process—a process that (like the

FDA notification requirement discussed in Merck) requires EPA to propose “labeling changes” when necessary, 40 C.F.R. §155.58(b)(4).

2. The Ninth Circuit independently erred in concluding that Monsanto could have unilaterally amended

its labeling to include a cancer warning.

In PLIVA, this Court held that a state-law failureto-warn claim is preempted where federal law bars a

manufacturer from adopting, without prior federal approval, a labeling change that state law requires. 564

U.S. at 617-618. It is irrelevant, PLIVA held, whether

the manufacturer might have persuaded the relevant

agency to approve that change after the fact. Id. at

619.

Because “[t]he question for ‘impossibility’

[preemption] is whether the private party could independently do … what state law requires,” state law is

preempted wherever the manufacturer’s ability to

comply with state law depends upon prior agency approval. Id. at 620-621 (emphasis added).

That is the case here. Selling a pesticide with labeling that makes “any claims” “substantially differ[ent]”

from the EPA-approved labeling is unlawful. 7 U.S.C.

§136j(a)(1)(B), (2)(G); see also id. §136a(c). And pesticide manufacturers may not change substantive aspects

of their products’ labeling without EPA’s prior approval. See 40 C.F.R. §§152.44, 152.46. To change labeling,

a manufacturer must submit an amended registration

24

application—a request that EPA re-register the pesticide—including submitting all data relevant to the

change. See id. §§152.44(a), 152.50. “[T]he application

must be approved by [EPA] before the product, as

modified, may legally be distributed or sold.” Id.

§152.44(a). Like the manufacturer in PLIVA, therefore, Monsanto could not have “independently do[ne] …

what state law require[d].” 564 U.S. at 620.

The Ninth Circuit speculated, however, that Monsanto could have added a cancer warning to Roundup’s

label via EPA’s “notification” procedure (an argument

respondent never raised). App.21a. But EPA disagrees: Changes to “precautionary statements” may not

be made without prior agency approval. Pesticide Registration Notice 98-10, at 8.5

C. The Scope Of FIFRA Preemption Is An Issue

Of National Importance

FIFRA is a “comprehensive regulatory statute”

that grants EPA significant power to ensure uniformity

in pesticide labeling requirements. Ruckelshaus v.

Monsanto Co., 467 U.S. 986, 991-992 (1984); see also

Bates, 544 U.S. at 452 n.26. The Ninth Circuit’s decision

undermines that uniformity.

5

The Ninth Circuit noted EPA allowed the addition of a cancer warning to the labeling of a different pesticide, Larvin, via notification. App.21a n.10. But for decades prior, EPA had classified

Larvin’s active ingredient, thiodicarb, as a “probable human carcinogen.” EPA, Registration Eligibility Decision: Thiodicarb 13

(Dec. 1998), https://tinyurl.com/5dmctukx.

And before the

amendment, EPA had already required thiodicarb’s labeling to

include extensive warnings, including that thiodicarb is “toxic.”

Id. at 100-109. The panel identified no example of EPA permitting

a registrant to use notification procedures to add a cancer warning

where, as here, EPA had previously found that the relevant chemical was not carcinogenic. App.21a.

25

Indeed, the decision is antithetical to both FIFRA’s

bedrock uniformity goal and Congress’s choice to empower EPA to enforce it. Rather, the decision permits

precisely what Bates feared: “50 different labeling regimes prescribing the … wording of warnings,” creating “significant inefficiencies for manufacturers,” 544

U.S. at 452. Other courts have similarly observed that

failure to apply preemption principles properly can lead

to “an anarchic patchwork of federal and state regulatory programs.” Engine Mfrs. Ass’n v. EPA, 88 F.3d

1075, 1079 (D.C. Cir. 1996); accord United Airlines, Inc.

v. Mesa Airlines, Inc., 219 F.3d 605, 611 (7th Cir. 2000)

(“applying the conflicting tort principles of 50 different

states to … interstate and international” agreements

“would make a mess of things”); Moss v. Parks Corp.,

985 F.2d 736, 739 (4th Cir. 1993) (preemption alleviates

“the impracticality of having the states [require] potentially fifty different labels”).

Under the regime the Ninth Circuit endorsed, each

State could—based on the tiniest sliver of scientific

support—mandate warnings carefully considered and

rejected by EPA simply because they were generally

consistent with a duty to warn of possible health risks.

A single study, even one found unreliable by EPA,

could thus spur countless divergent labeling requirements. And even if there was agreement that some

kind of warning was necessary, there might not be a

single warning a company could adopt to fulfill its statelaw obligations. For example, a California district

court has held that several potential warnings the State

proposed for glyphosate are inaccurate. See National

Ass’n of Wheat Growers v. Becerra, 468 F.Supp.3d

1247, 1259 (E.D. Cal. 2020). Under the decision below,

these difficulties could be multiplied by litigation

26

brought in different States, each potentially requiring a

different warning.

Differences in labeling also risk consumer confusion. Following the Ninth Circuit’s decision, a Nevadan

who visits California may be misled to believe that a

pesticide sold in California is more dangerous than the

formulation sold in Nevada (or vice versa). And if Nevada itself requires manufacturers to add a glyphosate

warning, even a slight difference in wording (for example: “CAUTION: this product contains glyphosate” as

opposed to “WARNING: Cancer”) could cause consumer confusion about the product’s safety. Few things are

more likely to cast doubt on the reliability of warnings

than state-by-state variances reflecting the vagaries of

juries’ divergent resolution of duty-to-warn claims. Cf.

Turek v. General Mills, Inc., 662 F.3d 423, 426 (7th Cir.

2011) (“Manufacturers might have to print 50 different

labels, driving consumers who buy [pesticides] in more

than one state crazy.”).

II. THE NINTH CIRCUIT’S DECISION SUBVERTS TRIAL

COURTS’ GATEKEEPING ROLE IN ADMITTING EXPERT

TESTIMONY

Nearly three decades ago, Daubert held that to be

admissible, expert testimony must be “not only relevant, but reliable”—i.e., it must impart “‘scientific

knowledge’” “derived by [a] scientific method” and

“supported by appropriate validation.” 509 U.S. at 589590. To ensure that only reliable expert testimony

reaches factfinders, this Court directed trial courts to

play a “gatekeeping role,” screening out expert opinions that are merely “subjective belief or unsupported

speculation.” Id. at 590, 597. For example, a court may

find an expert opinion unreliable when “there is simply

too great an analytical gap between the data and the

27

opinion proffered.” General Elec. Co. v. Joiner, 522

U.S. 136, 146 (1997); see also Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999) (reiterating “the importance of Daubert’s gatekeeping requirement”).

Federal Rule of Evidence 702, which was amended following Daubert, Joiner, and Kumho, thus requires

courts to determine not only that expert testimony is

“the product of reliable principles and methods,” but

also that the expert has “reliably applied” those principles and methods to the facts of the case before admitting testimony.

While applying Daubert and Rule 702 inherently

involves judgment, the Ninth Circuit has distorted the

requirements of Rule 702 beyond recognition in ways

that diverge from the standards applied by other circuits. Here, the court affirmed the admission of expert

testimony that glyphosate could cause non-Hodgkin’s

lymphoma in the general population and that it caused

respondent’s lymphoma, even though the experts failed

to reliably apply scientific principles and EPA (like

regulators worldwide) has consistently found that

glyphosate does not cause cancer. As the district court

acknowledged, the testimony likely would have been

inadmissible under other circuits’ Daubert standards.

E.g., App.83a-84a. The Ninth Circuit blurs the boundaries between science and speculation with a third category called “art,” which allows experts to testify based

on what are, in effect, unsupported intuitions, as long as

they are purportedly rooted in “clinical experience.”

See App.26a-27a. The Ninth Circuit’s uniquely lenient

admissibility standard has enormous consequences for

tens of thousands of pending Roundup cases and for

mass-tort and product-liability litigation more generally. Certiorari is warranted to resolve the disagreement

28

among the circuits and reaffirm trial courts’ gatekeeping responsibility in enforcing Rule 702 as written.

A. The Decision Below Departs From The Rigorous Daubert Scrutiny Other Circuits Require

1. To prevail on his claims, respondent had to

show both that glyphosate can (as a general matter)

cause non-Hodgkin’s lymphoma at realistic exposure

levels, App.91a, and that it specifically caused his illness, App.79a. Both questions involved significant

challenges for respondent because the overall epidemiological evidence studying the purported link between glyphosate and non-Hodgkin’s lymphoma confirmed what regulators around the world have concluded: Glyphosate does not cause cancer in humans. E.g.,

App.93a-94a (district court observing that epidemiological studies, “viewed in [their] totality,” seem “too

equivocal to support any firm conclusion,” thereby presenting a “daunting challenge” for respondent).

Indeed, the district court acknowledged that the

testimony of respondents’ experts would not likely survive robust Daubert scrutiny. It noted, for example,

that the Ninth Circuit places “great emphasis” on

Daubert’s “‘liberal thrust’ favoring admission,” requiring courts to exclude only “‘nonsense opinions.’”

App.101a. As the court explained, that dividing line

“has resulted in slightly more room for deference to experts in close cases than might be appropriate in some

other Circuits,” id., a difference the court acknowledged repeatedly, App.83a-84a, 93a. The court also observed—more than a half-dozen times—that even under the Ninth Circuit’s heightened “toleran[ce] of borderline expert opinions,” App.84a, it was a “close” question whether any of respondent’s expert opinions constituted reliable scientific knowledge and thus would

29

assist the jury in impartial factfinding, App.79a, 91a,

94a, 148a, 154a, 158a, 179a-180a.

Nonetheless, the district court admitted those opinions—and the Ninth Circuit affirmed—because of the

Ninth Circuit’s impermissibly forgiving standard.

For example, the district court recognized that respondent “barely inched over the [admissibility] line”

with his expert testimony that glyphosate caused his

illness. App.79a. At least 70% of non-Hodgkin’s lymphoma cases are idiopathic—they occur for no known

reason—which the district court explained presented

the “biggest concern” for respondent. App.82a. In attempting to establish that respondent’s case was

caused by glyphosate, respondent’s only testifying expert on that question, Dr. Dennis Weisenburger, conducted “differential diagnosis,” a technique that first

rules in all potential causes of an illness and then uses

the process of elimination to rule out all but one.

App.80a. Under that method, Weisenburger needed

scientific evidence to exclude not only the likelihood

that respondent’s illness was idiopathic, but also any

other non-glyphosate cause (such as respondent’s long

history with hepatitis C, see supra p.9).

That step was key here because although an expert

could theoretically account for idiopathy (for example,

by statistically ruling out unknown origins based on a

sufficiently strong epidemiological link between

glyphosate and non-Hodgkin’s lymphoma), Weisenburger’s testimony did not do so. Instead, the district

court rightly found that such epidemiological evidence

was lacking and thus, “[u]nder a strict interpretation of

Daubert, perhaps that would be the end of the line.”

App.83a; see also App.93a. But the court explained

that the Ninth Circuit has a unique tolerance for expert

30

opinions that rest not on science but on “art”—a standardless articulation of an expert’s intuitions based on

clinical experience or general qualifications. App.83a84a. According to the Ninth Circuit, “‘[m]edicine partakes of art as well as science,’” and so doctors in the

circuit “enjoy wide latitude in how they practice their

art when offering causation opinions.” Id.; see App.26a.

Thus, the district court believed itself required to admit

the testimony, noting “courts in the Ninth Circuit must

be more tolerant of borderline expert opinions than in

other circuits,” mindful that “a wider range of expert

opinions (arguably much wider) will be admissible in

this circuit.” App.84a. As the Ninth Circuit reiterated,

“[w]here, as here, … doctors who stand at or near the

top of their field and have extensive clinical experience

with the … class of disease at issue[] are prepared to

give expert opinions supporting causation, … Daubert

poses no bar based on their principles and methodology.” App.26a-27a; accord App.84a.

2. As the district court here recognized, the Ninth

Circuit’s lenient admissibility standard makes it an outlier among the circuits. See App.83a-84a, 101a. So has

the chair of the Advisory Rules Committee’s Subcommittee on Rule 702, who observed that “Ninth Circuit

caselaw appears to interpret Daubert” in ways that

“set it apart from most” circuits. Thomas Schroeder,

Toward A More Apparent Approach to Considering the

Admission of Expert Testimony, 95 Notre Dame L.

Rev. 2039, 2050 & n.85 (2020). And although the panel

here sought to distinguish some conflicting cases in

other circuits on their facts, it failed to account for the

different legal standards those courts apply. App.24a26a.

The Sixth Circuit, for example, views experts’ clinical experience with skepticism, not deference. In

31

Tamraz v. Lincoln Electric Co., 620 F.3d 665 (6th Cir.

2010), the Sixth Circuit held that the district court

abused its discretion in admitting speculative testimony, irrespective of an expert’s “‘extensive … experience’ with diagnosing” the relevant illness. Id. at 673.

Tamraz explained that in clinical practice, doctors may

employ a “low threshold” for identifying a potential

cause, since telling a patient to avoid a factor that

“might cause a disease” “can do little harm” but “a lot

of good.” Id. The court made clear, however, that similar “educated hunch[es]” or “‘scientific guesswork, even

of the inspired sort,’” have no place in the courtroom.

Id. at 671, 673.

The Sixth Circuit also requires experts to rigorously account for idiopathy in determining a cause, a requirement not excused by an expert’s clinical experience. Tamraz, for instance, was much like this case. It

involved a disease (Parkinsonism) “occur[ing] commonly in the general population and usually without any

known cause,” “making it hard to attribute one case to

[a particular substance] over … other possible causes.”

620 F.3d at 671. Nonetheless, the court made clear that

under Daubert, an expert must rule out “unknown (idiopathic) causation” as an alternative explanation for the

illness and faulted the expert there for not doing so. Id.

at 671, 675.

Similarly, the Tenth Circuit would likely have rejected Weisenburger’s testimony. As that court has

explained, courts generally understand idiopathy to

mean that the medical community has a poor understanding of what causes an illness. Hall v. Conoco, 886

F.3d 1308, 1315 (10th Cir. 2018). Thus, Hall explained

that differential diagnosis “could be considered inherently unreliable” where (as here) “idiopathy accounts

for more than half of the cases of” an illness. Id.; see

32

also Bland v. Verizon Wireless, (VAW) L.L.C., 538

F.3d 893, 897 (8th Cir. 2008) (doubting that an expert’s

opinion utilizing a differential diagnosis could be “based

upon a reasonable degree of medical certainty” where

“the cause of the condition is unknown in [most] cases”).

Hall’s approach contrasts starkly with the Ninth

Circuit’s admonition that district courts should liberally

allow experts to rely on clinical experience when conducting differential diagnoses, App.27a—even when (as

here) reliable epidemiological evidence contradicts the

expert’s conclusion purportedly based on that experience and the expert fails to reliably grapple with that

contradictory epidemiology. See App.93a (district court

noting that “the largest and most recent” epidemiological study “suggest[s] there is no link at all” between

glyphosate and non-Hodgkin’s lymphoma); see also

App.144a. The Tenth Circuit has also held that Daubert requires experts to address “a large body of contrary epidemiological evidence” with a “medically reliable

and scientifically valid methodology.” Norris v. Baxter

Healthcare Corp., 397 F.3d 878, 882 (10th Cir. 2005).

Weisenburger’s differential diagnosis likely would not

have satisfied that standard.

B. The Decision Below Contravenes Daubert

And Federal Rule Of Evidence 702

The Ninth Circuit’s lenient admissibility standard

clashes with Daubert and Rule 702. Despite the regulatory consensus that glyphosate is not carcinogenic, the

Ninth Circuit remarkably affirmed a ruling that (1) allowed experts to testify that glyphosate can cause nonHodgkin’s lymphoma and caused respondent’s illness

even (2) while acknowledging numerous flaws in the

experts’ opinions. See App.85a, 93a, 154a, 156a-158a,

161a-162a; App.35a. Respondent’s key expert even

33

conceded that he could not “identify any peer-reviewed

published article” characterizing glyphosate as a “generally accepted” cause of non-Hodgkin’s lymphoma, and

that he was making a “subjective decision” regarding

the level of glyphosate exposure sufficient to cause nonHodgkin’s lymphoma. C.A.E.R.1093-1095, 1099. The

Ninth Circuit’s blessing of such testimony departs from

the law in two ways.

First, the court’s approach is inconsistent with the

text of Rule 702. See Daubert, 509 U.S. at 587 (courts

construe the rules of evidence as they “would any statute”). No matter how much clinical experience an expert has, intuition without scientific validation is not

“the product of reliable principles and methods.” Fed.

R. Evid. 702(c). Nor could a court determine that an

expert “reliably applied” such intuitions. Id. 702(d).

Second, the Ninth Circuit’s deference to clinical experience or intuition distorts the inquiry. As Daubert

explained, “there are important differences between

the quest for truth in the courtroom and the quest for

truth in the laboratory.” 509 U.S. at 596-597. Science

may progress through “a multitude of hypotheses” and

even “[c]onjectures that are probably wrong,” but such

conjectures are “of little use … in the project of reaching a quick, final, and binding legal judgment—often of

great consequence—about a particular set of [past]

events.” Id. at 597. Accordingly, Daubert requires excluding unverifiable conjectures, even when they are

rooted in the experience of highly credentialed experts.

Put simply, “nothing in either Daubert or the Federal

Rules of Evidence requires a district court to admit

opinion evidence that is connected to existing data only

by the [expert’s] ipse dixit.” Joiner, 522 U.S. at 146.

34

The Ninth Circuit sought to justify its admissibility

standard on the ground that “flexibility is warranted”

under Daubert. App.34a; see App.23a, 26a. But Daubert’s observation that Rule 702 has a “liberal thrust”

was addressed to the “rigid” standard that preceded it:

the test from Frye v. United States, 293 F. 1013 (D.C.

Cir. 1923), under which expert testimony was admissible only if the technique used was “‘generally accepted’

as reliable in the relevant scientific community,” Daubert, 509 U.S. at 584, 588-589. Whatever “broader range

of scientific testimony” Daubert allows compared to

Frye, it also reaffirms trial courts’ critical gatekeeping

role in screening unreliable expert testimony. Joiner,

522 U.S. at 142. And any uncertainty in that regard

was resolved by the subsequent amendments to Rule

702, which provide that courts admit only those expert

opinions that “reliably appl[y]” principles and methods

“to the facts of” each case. Fed. R. Evid. 702(d).

The Ninth Circuit’s attempt to justify Weisenburger’s testimony on grounds beyond his clinical experience only underscores how far the court has strayed

from Daubert. To cite one example, the court suggested that his exclusion of idiopathic causes rested partly

on epidemiological evidence purportedly showing “a

strong association” between glyphosate and nonHodgkin’s lymphoma.

App.35a-36a.

The court

acknowledged, however, that the studies on which Weisenburger principally relied did not adjust for exposure

to other pesticides, App.35a, meaning those studies

could well have measured the likelihood of nonHodgkin’s lymphoma resulting from pesticides other

than glyphosate. Results of epidemiological studies

that fail to adjust for confounders (such as other pesticides) are inherently unreliable, and as the district

court noted, under a strict Daubert standard, respond-

35

ent would have needed “much stronger epidemiological

evidence” overall to reliably rule out idiopathy.

App.83a. The Ninth Circuit could not overlook that

fundamental flaw while remaining faithful to the principles of scientific rigor that Daubert and Rule 702 require.

C. The Proper Admissibility Standard Is A Recurring And Important Question

The Ninth Circuit’s distortion of Daubert will have

significant ramifications if allowed to stand. First, the

court’s ruling will govern the thousands of cases in the

MDL. Indeed, the district court has stated it will apply

the Ninth Circuit’s Daubert standard in all the MDL

cases (wherever they originated), despite that standard’s “relatively higher tolerance for questionable expert testimony.” Dkt. 4549 at 3-4, In re Roundup, 3:16md-02741-VC (N.D. Cal. July 10, 2019).

More broadly, the Ninth Circuit’s standard will improperly tilt the balance in the multitude of mass-tort

and product-liability cases that—like this case—rise or

fall on causation. Rule 702 gives trial courts a gatekeeping role precisely because scientific testimony is

often difficult to follow and experts inherently carry an

aura of authority. By requiring trial courts to admit

expert conclusions that are based on clinical experience—even when sound scientific evidence refutes

those conclusions—the Ninth Circuit has codified the

fallacy that when scientists speak, their views are necessarily rooted in reliable scientific principles.

That approach has deleterious consequences, reducing the broad social benefits that flow from ensuring

that mass-tort and product-liability cases are decided

based on reliable scientific testimony. “[M]odern life,

36

including good health as well as economic well-being,

depends upon the use of artificial or manufactured substances.” Joiner, 522 U.S. at 148 (Breyer, J., concurring). Thus, it is “particularly important to see that

judges fulfill their Daubert gatekeeping function, so

that they help assure that the powerful engine of tort

liability, which can generate strong financial incentives

to reduce, or to eliminate, production, points toward the

right substances and does not destroy the wrong ones.”

Id. at 148-149; see also Tamraz, 620 F.3d at 677-678

(“allowing the law to get ahead of science” would “destroy jobs and stifle innovation unnecessarily”).

This case is a good example of what happens when

that caution is ignored. For nearly fifty years, glyphosate has (with EPA’s consistent approval) brought extraordinary benefits to farmers and consumers.

C.A.E.R.1835-1836. But unreliable expert testimony—

especially if permitted to stand in the tens of thousands

of other pending and future cases—threaten to drive it

off the market. This Court should grant certiorari to

make clear that Daubert and Rule 702 do not permit

the abdication of trial courts’ gatekeeping responsibility that would lead to such highly undesirable results.

CONCLUSION

The petition for a writ of certiorari should be

granted.

37

Respectfully submitted.

SETH P. WAXMAN

THOMAS G. SPRANKLING

Counsel of Record

WILMER CUTLER PICKERING

CLAIRE H. CHUNG

HALE AND DORR LLP

JAMES D. BARTON

2600 El Camino Real

SAMUEL M. STRONGIN

Suite 400

ALLISON M. SCHULTZ

Palo Alto, CA 94306

MEDHA GARGEYA

WILMER CUTLER PICKERING

HALE AND DORR LLP

1875 Pennsylvania Ave., NW

Washington, DC 20006

(202) 663-6000

seth.waxman@wilmerhale.com

AUGUST 2021

APPENDICES