`
`No. 21-
`
`IN THE
`Supreme Court of the United States
`
`
`MONSANTO COMPANY,
`
`v.
`
`Petitioner,
`
`ALBERTA PILLIOD AND ALVA PILLIOD,
`Respondents.
`
`
`ON PETITION FOR A WRIT OF CERTIORARI TO THE
`COURT OF APPEAL OF CALIFORNIA
`
`PETITION FOR A WRIT OF CERTIORARI
`
`
`THOMAS G. SPRANKLING
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`2600 El Camino Real
`Suite 400
`Palo Alto, CA 94306
`
`SETH P. WAXMAN
` Counsel of Record
`DANIEL S. VOLCHOK
`SAMUEL M. STRONGIN
`WILMER CUTLER PICKERING
` HALE AND DORR LLP
`1875 Pennsylvania Ave. N.W.
`Washington, D.C. 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 neither Roundup nor its active
`ingredient, glyphosate, causes cancer in humans. EPA
`has authorized Roundup for sale, repeatedly approved
`Roundup’s labeling without a cancer warning, and in-
`formed pesticide registrants that including a cancer
`warning on the labeling of a glyphosate-based pesticide
`would render it “misbranded” in violation of federal
`law. FIFRA itself, moreover, bars States from “im-
`pos[ing] … any requirements for labeling … in addition
`to or different from those required under [FIFRA].” 7
`U.S.C. §136v(b).
` Respondents were nonetheless
`awarded over $17 million in compensatory damages and
`nearly $70 million in punitive damages after a Califor-
`nia jury found that the omission of a cancer warning
`from Roundup’s label violated state law. The questions
`presented are:
`1. Whether FIFRA preempts a state-law failure-
`to-warn claim where the warning cannot be added to a
`product without EPA approval and EPA has repeated-
`ly concluded that the warning is not appropriate.
`2. Whether a punitive-damages award that is a
`fourfold multiple of a substantial compensatory-
`damages award violates the Fourteenth Amendment’s
`Due Process Clause where the defendant acted in ac-
`cordance with the scientific and regulatory consensus
`regarding the safety of its product.
`
`(i)
`
`
`
`
`
`CORPORATE DISCLOSURE STATEMENT
`
`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.
`
`RELATED PROCEEDINGS
`Pilliod v. Monsanto Company, No. S270957 (Su-
`preme Court of California) (petition for review denied
`November 17, 2021).
`Pilliod v. Monsanto Company, No. A158228 (First
`Appellate District, Division 2) (opinion and judgment
`issued August 9, 2021; petition for rehearing denied
`August 25, 2021).
`Pilliod v. Monsanto Company, No. RG17862702
`(Alameda County Superior Court) (judgment issued
`July 26, 2019).
`
`
`(ii)
`
`
`
`
`
`TABLE OF CONTENTS
`
`Page
`QUESTIONS PRESENTED ............................................ i
`CORPORATE DISCLOSURE STATEMENT ............. ii
`RELATED PROCEEDINGS........................................... ii
`TABLE OF AUTHORITIES .......................................... vi
`INTRODUCTION .............................................................. 1
`OPINIONS BELOW .......................................................... 4
`JURISDICTION ................................................................. 4
`CONSTITUTIONAL AND STATUTORY
`PROVISIONS INVOLVED ...................................... 4
`STATEMENT ..................................................................... 5
`A. FIFRA’s Regulatory Scheme ............................. 5
`B. Glyphosate’s Regulatory History ....................... 7
`C. Proceedings Below .............................................. 10
`REASONS FOR GRANTING THE PETITION ...........14
`I. THE COURT OF APPEAL’S PREEMPTION
`HOLDING WARRANTS REVIEW ................................. 14
`A. Express Preemption ........................................... 14
`1. The decision below conflicts with
`Bates .............................................................. 14
`2. The decision below deepens
`uncertainty over how to apply
`similarly worded express-
`preemption provisions ................................. 19
`B. Conflict Preemption ............................................ 21
`
`(iii)
`
`
`
`iv
`
`TABLE OF CONTENTS—Continued
`
`Page
`
`C. The Scope Of FIFRA Preemption Is
`An Issue Of National Importance .................... 24
`D. Alternatively, This Petition Should Be
`Held Pending Resolution of Hardeman .......... 26
`II. THE COURT OF APPEAL’S PUNITIVE-
`DAMAGES HOLDING WARRANTS REVIEW ............... 26
`A. The Court of Appeal Deepened A
`Conflict Among Appellate Courts
`By Affirming A 4:1 Ratio Where
`Compensatory Damages Were High
`And Reprehensibility Was Not ......................... 27
`B. The Decision Below Is Wrong ........................... 29
`CONCLUSION ................................................................. 31
`APPENDIX A: Order of the Supreme Court
`of California denying petition for review
`and denying request for an order directing
`depublication, dated November 17, 2021 ................ 1a
`APPENDIX B: Opinion of the Court of Appeal
`of the State of California First Appellate
`District, dated August 9, 2021 .................................. 3a
`APPENDIX C: Order of the Superior Court of
`the State of California for the County of
`Alameda on Sargon motions and motion for
`summary judgment, dated March 18, 2019 ........... 93a
`
`
`
`
`
`v
`
`TABLE OF CONTENTS—Continued
`
`Page
`
`APPENDIX D: Amended Order of the
`Superior Court of the State of California
`for the County of Alameda denying
`motions of Defendant for JNOV and
`conditionally granting motions of defendant
`for new trial, dated July 26, 2019 ........................ 115a
`APPENDIX E: Order of the Court of Appeal
`for the State of California, First Appellate
`District denying petition for rehearing,
`dated August 25, 2021 ............................................ 143a
`APPENDIX F: Judgment of the Superior
`Court of the State of California for the
`County of Alameda on Jury Verdict for
`Plaintiffs, dated May 20, 2019 ............................... 145a
`APPENDIX G: EPA Letter to Glyphosate
`Registrants, dated August 7, 2019....................... 161a
`
`
`
`
`
`
`
`vi
`
`TABLE OF AUTHORITIES
`
`CASES
`
`Page(s)
`
`Bass v. Stryker Corp., 669 F.3d 501 (5th Cir.
`2012) ............................................................................. 20
`Bates v. Dow Agrosciences LLC, 544 U.S. 431
`(2005) ................................................................... passim
`BMW v. Gore, 517 U.S. 559 (1996) .................................. 30
`Boerner v. Brown & Williamson Tobacco
`Company, 394 F.3d 594 (8th Cir. 2005) ................... 28
`Brooks v. Mentor Worldwide LLC, 985 F.3d
`1272 (10th Cir. 2021) ................................................... 20
`Caplinger v. Medtronic, Inc., 784 F.3d 1335
`(10th Cir. 2015) ............................................................ 20
`Cote v. Philip Morris USA, Inc., 985 F.3d 840
`(11th Cir. 2021) ............................................................ 28
`Crosby v. National Foreign Trade Council,
`530 U.S. 363 (2000) ..................................................... 23
`Engine Manufacturers Association v. EPA,
`88 F.3d 1075 (D.C. Cir. 1996) .................................... 24
`Geier v. American Honda Motor Company,
`529 U.S. 861 (2000) ..................................................... 23
`Gomez-Perez v. Potter, 553 U.S. 474 (2008) ................... 16
`Hardeman v. Monsanto, 997 F.3d 941
`(9th Cir. 2021) ...................................... 12, 17, 18, 20, 26
`In re Medtronic, Inc., Sprint Fidelis Leads
`Products Liability Litigation, 623 F.3d
`1200 (8th Cir. 2010) ..................................................... 20
`
`
`
`
`
`vii
`
`TABLE OF AUTHORITIES—Continued
`
`Page(s)
`
`Johnson & Johnson v. Ingham, 141 S.Ct. 2716
`(2021) ............................................................................ 28
`Landgraf v. USI Film Products, 511 U.S. 244
`(1994) ............................................................................ 30
`Lompe v. Sunridge Partners, LLC, 818 F.3d
`1041 (10th Cir. 2016) ................................................... 28
`MacDonald v. Monsanto Company, 27 F.3d
`1021 (5th Cir. 1994) ..................................................... 18
`McMullen v. Medtronic, Inc., 421 F.3d 482
`(7th Cir. 2005) .............................................................. 20
`Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) ................. 16
`Merck Sharp & Dohme Corp. v. Albrecht,
`139 S.Ct. 1668 (2019) ...................................... 14, 21, 22
`Morgan v. New York Life Insurance Company,
`559 F.3d 425 (6th Cir. 2009) ...................................... 28
`Moss v. Parks Corp., 985 F.2d 736
`(4th Cir. 1993) ......................................................... 24
`
`Mutual Pharmaceutical Company v. Bartlett,
`570 U.S. 472 (2013) ..................................................... 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) ..................................................................... 19
`Philip Morris USA v. Williams, 549 U.S. 346
`(2007) ............................................................................ 30
`
`
`
`
`
`viii
`
`TABLE OF AUTHORITIES—Continued
`
`Page(s)
`
`Planned Parenthood of Columbia/Willamette
`Inc. v. American Coalition of Life
`Activists, 422 F.3d 949 (9th Cir. 2005) ..................... 28
`PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) ......... 21, 22
`Reckitt Benckiser, Inc. v. Jackson,
`762 F.Supp.2d 34 (D.D.C. 2011) ................................ 18
`Riegel v. Medtronic, 552 U.S. 312 (2008) .................. 15, 16
`Roth v. Farner-Bocken Company, 667 N.W.2d
`651 (S.D. 2003) ............................................................. 28
`Rowe v. New Hampshire Motor Transport
`Association, 552 U.S. 364 (2008) .............................. 21
`Ruckelshaus v. Monsanto Company, 467 U.S.
`986 (1984) ..................................................................... 24
`Saccameno v. United States Bank National
`Association, 943 F.3d 1071 (7th Cir. 2019) ............. 27
`Seltzer v. Morton, 154 P.3d 561 (Mont. 2007) ................ 28
`Shuker v. Smith & Nephew PLC, 885 F.3d 760
`(3d Cir. 2018) ............................................................... 20
`State Farm Mutual Automobile Insurance
`Company v. Campbell, 538 U.S. 408
`(2003) .................................................. 3, 26, 27, 29, 30
`Thomas v. iStar Financial, Inc., 652 F.3d 141
`(2d Cir. 2011) ............................................................... 28
`TransUnion LLC v. Ramirez, 141 S.Ct. 972
`(2020) ............................................................................ 29
`Turek v. General Mills, Inc., 662 F.3d 423
`(7th Cir. 2011) .............................................................. 25
`
`
`
`
`
`ix
`
`TABLE OF AUTHORITIES—Continued
`
`Page(s)
`
`United Airlines, Inc. v. Mesa Airlines, Inc.,
`219 F.3d 605 (7th Cir. 2000) ...................................... 24
`Wolicki-Gables v. Arros International, Inc.,
`634 F.3d 1296 (11th Cir. 2011) .................................. 20
`Wyeth v. Levine, 555 U.S. 555 (2009) .................. 14, 21, 22
`
`DOCKETED CASES
`Hardeman v. Monsanto Company,
`Nos. 19-16636, 19-16708 (9th Cir.) .......................... 6, 9
`Monsanto v. Hardeman, No. 21-241 (U.S.) ..................... 3
`NRDC v. EPA, Nos. 20-70787, 20-70801
`(9th Cir.) ......................................................................... 9
`
`CONSTITUTIONAL AND STATUTORY PROVISIONS
`U.S. Const.
`art. VI, cl. 2 ................................................................. 4-5
`amend. XIV, §1 ............................................................. 5
`7 U.S.C.
`§136 ................................................................................. 6
`§136a .................................................................... passim
`§136j ................................................................... 6, 15, 22
`§136q ............................................................................... 6
`§136v .................................................................... passim
`21 U.S.C.
`§352 ............................................................................... 16
`§360k ....................................................................... 16, 19
`§467e ............................................................................. 19
`§678 ............................................................................... 19
`28 U.S.C. §1257 .................................................................... 4
`
`
`
`
`
`x
`
`TABLE OF AUTHORITIES—Continued
`
`Page(s)
`49 U.S.C. §30103 ................................................................ 19
`
`REGULATIONS
`
`40 C.F.R.
`§152.44 ...................................................................... 7, 22
`§152.46 ...................................................................... 7, 22
`§152.50 .......................................................................... 22
`§152.112 .......................................................................... 6
`§155.40 ............................................................................ 6
`§155.58 ............................................................................ 6
`§156.10 ............................................................................ 6
`§156.60 ............................................................................ 6
`§158.500 .......................................................................... 6
`62 Fed. Reg. 17,723 (Apr. 11, 1997) ................................... 8
`
`69 Fed. Reg. 65,081 (Nov. 10, 2004) .................................. 8
`
`OTHER AUTHORITIES
`EPA, Glyphosate: Interim Registration Review
`Decision (Jan. 2020), https://tinyurl.com/
`5b7c8awa .................................................................. 9, 15
`EPA, Response from the Pesticide Re-
`evaluation Division to Comments on the
`Glyphosate Proposed Interim Decision
`(Jan. 16, 2020), https://tinyurl.com/426uuejz .......... 10
`EPA, Revised Glyphosate Issue Paper
`(Dec. 12, 2017), http://tinyurl.com/
`eparevdglyphosate ............................................. 7, 8, 22
`
`
`
`
`
`xi
`
`TABLE OF AUTHORITIES—Continued
`
`Page(s)
`
`EPA Office of Pesticide Programs, Pesticide
`Registration Notice 98-10 (Oct. 22, 1998),
`https://tinyurl.com/yejwzhkt ...................................... 7
`Feeley, Jef, Bayer Scores Another Roundup
`Trial Victory in California, Bloomberg
`(Dec. 9, 2021), https://tinyurl.com/3r2sjyz8 ............ 25
`
`
`
`
`
`
`
`
`
`IN THE
`Supreme Court of the United States
`
`No. 21-
`
`
`MONSANTO COMPANY,
`
`v.
`
`Petitioner,
`
`ALBERTA PILLIOD AND ALVA PILLIOD,
`Respondents.
`
`
`ON PETITION FOR A WRIT OF CERTIORARI TO THE
`COURT OF APPEAL OF CALIFORNIA
`
`PETITION FOR A WRIT OF CERTIORARI
`
`
`Monsanto Company respectfully petitions for a writ
`of certiorari to review the judgment in this case of the
`Court of Appeal of California.
`
`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 Insecti-
`cide, Fungicide, and Rodenticide Act (FIFRA). EPA’s
`scrutiny includes reviewing whether glyphosate poses
`risks to humans and ensuring any risks are communi-
`cated 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. Indeed, as
`EPA explained in a case raising claims similar to this
`one, it has approved 44 versions of Roundup labeling
`since 1991—each without a cancer warning. And in
`2019, it instructed glyphosate manufacturers that no
`request to add a cancer warning would be approved be-
`cause such a warning would be false and misleading.
`Despite EPA’s repeated findings—confirmed by
`national regulators around the world, including in Aus-
`tralia, the European Union, Canada, and New Zea-
`land—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 conclu-
`sion, which did not identify either the circumstances
`under which glyphosate might cause cancer or the
`amount of exposure required. Nonetheless, based on
`the slender IARC reed, thousands of litigants (includ-
`ing respondents Alberta and Alva Pilliod) have sued
`Monsanto, asserting that it failed to warn them about
`alleged cancer risks associated with Roundup.
`The Court of Appeal’s decision here—affirming
`combined awards that total nearly $87 million, includ-
`ing approximately $70 million in punitive damages—
`merits review because it conflicts with this Court’s and
`other appellate courts’ decisions on two important fed-
`eral questions.
`First, the Court of Appeal held that FIFRA did not
`preempt respondents’ state-law claims regarding Mon-
`santo’s omission of a cancer warning from Roundup’s
`label, even though EPA had repeatedly concluded that
`such a warning would be false and thus prohibited by
`
`
`
`
`
`3
`
`FIFRA, and even though FIFRA bars States from
`“impos[ing] … any requirements for labeling … in addi-
`tion to or different from those required under
`[FIFRA],” 7 U.S.C. §136v(b). That contravenes this
`Court’s holding that any state labeling requirement not
`“genuinely equivalent” to a FIFRA labeling require-
`ment is preempted. Bates v. Dow Agrosciences LLC,
`544 U.S. 431, 454 (2005). The decision below also de-
`parts from how this Court and others have understood
`a nearly identical preemption provision in another fed-
`eral statute. This Court recently called for the views of
`the Solicitor General on this precise question in Mon-
`santo v. Hardeman, No. 21-241.
`Second, the Court of Appeal upheld a massive puni-
`tive-damages award—roughly four times the substan-
`tial compensatory damages respondents received—
`even though Monsanto’s labeling followed the near-
`unanimous scientific and regulatory consensus that
`glyphosate does not cause cancer. That holding cannot
`be squared with State Farm Mutual Automobile In-
`surance Co. v. Campbell, 538 U.S. 408 (2003), which
`states both (1) that the “absence” of evidence of repre-
`hensibility “renders any [punitive-damages] award
`suspect,” and (2) that a 1:1 punitive-compensatory ratio
`“reach[es] the outermost limit of the due process guar-
`antee” when the defendant’s conduct is not particularly
`reprehensible and a plaintiff has already been awarded
`significant compensatory damages, id. at 419, 425. The
`decision below also deepens an existing divide between
`courts that adhere to State Farm’s 1:1 ratio and those
`that allow larger punitive damages in similar circum-
`stances.
`Because these two recurring and important ques-
`tions merit the Court’s review, the petition should be
`
`
`
`
`
`4
`
`granted or else held pending the Court’s disposition of
`the petition in Hardeman.
`
`OPINIONS BELOW
`The California Supreme Court’s order denying
`Monsanto’s petition for review, App.1a, is unreported,
`as is the order of the California Court of Appeal deny-
`ing Monsanto’s petition for rehearing, App.143a-144a.
`The California Court of Appeal’s opinion, App.3a-91a, is
`reported at 282 Cal. Rptr. 3d 679. The trial court’s
`amended decision denying Monsanto’s motion for
`judgment notwithstanding the verdict and conditionally
`granting Monsanto’s motion for a new trial, App.115a-
`142a, is unreported but available at 2019 WL 3540107.
`The trial court’s decision denying Monsanto’s motion
`for summary judgment, App.93a-114a, is unreported
`but available at 2019 WL 2158266.1
`
`JURISDICTION
`The California Supreme Court denied Monsanto’s
`petition for review on November 17, 2021. On January
`27, 2022, Justice Kagan extended the time for filing this
`petition through March 17, 2022. This Court has juris-
`diction under 28 U.S.C. §1257(a).
`
`CONSTITUTIONAL AND STATUTORY
`PROVISIONS INVOLVED
`Article VI, clause 2 of the United States Constitu-
`tion provides:
`
`
`1 The trial court’s amended decision on Monsanto’s post-trial
`motions “expand[ed] on and clarifie[d] some of the court’s think-
`ing.” App.115a n.1. Because all relevant parts of the court’s origi-
`nal decision appear in the amended decision, this petition cites to
`the latter.
`
`
`
`
`
`5
`
`This Constitution, and the Laws of the United
`States which shall be made in Pursuance thereof …
`shall be the supreme Law of the Land; and the
`Judges in every State shall be bound thereby, any
`Thing in the Constitution or Laws of any State to
`the Contrary notwithstanding.
`Section 136v(b) of Title 7 of the United States Code
`provides:
`Such State shall not impose or continue in effect
`any requirements for labeling or packaging in addi-
`tion to or different from those required under this
`subchapter.
`Section 1 of the Fourteenth Amendment to the
`United States Constitution provides in relevant part:
`No state shall … deprive any person of life, liberty,
`or property, without due process of law[.]
`
`STATEMENT2
`
`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 regis-
`tration. 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 precaution-
`ary statements regarding potential effects on human
`
`2 Citations to “AA” refer to the Appellant’s Appendix, and ci-
`tations to “RT” refer to the Reporter’s Transcript. These two sets
`of documents comprise the appellate record filed with the Court of
`Appeal.
`
`
`
`
`
`6
`
`health. E.g., id. §136a(c); 40 C.F.R. §§156.10(a)(1)(vii),
`156.60, 158.500.
`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. §152.112(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. §136(q)(1)(G).
`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 registration
`every 15 years, 7 U.S.C. §136a(g)(1)(A)(iv). This pro-
`cess requires EPA to consider both whether any “label-
`ing changes” are necessary given new information and
`whether the product still meets FIFRA’s require-
`ments, 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 substan-
`tially different than the EPA-approved labeling. 7
`U.S.C. §§136a(c)(1), 136j(a)(1)(B). As the United States
`explained in Hardeman, “[t]he label is the law.” U.S.
`Br. 1, Hardeman v. Monsanto Co., Nos. 19-16636, 19-
`16708 (9th Cir. Dec. 20, 2019) (U.S. Hardeman Br.).3
`
`
`3 The Court of Appeal took judicial notice of “the legal argu-
`ments asserted by the United States” in the Hardeman amicus
`brief. App.23a n.11.
`
`
`
`
`
`7
`
`Once EPA approves a pesticide’s labeling, the
`manufacturer must seek approval for virtually any sub-
`stantive change to the labeling or composition of the
`pesticide.
` 40 C.F.R. §§152.44, 152.46; 7 U.S.C.
`§136a(c)(9)(C). Certain 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 EPA, Office of Pesti-
`cide 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 thus
`sought 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 one of
`the “most commonly used herbicide[s] around the
`world,” having been approved for use by over 100 coun-
`tries due to its “low toxicity” on humans and the envi-
`ronment. 6 AA7257. EPA has registered pesticides
`containing glyphosate since 1974. App.4a. In doing so,
`the agency has repeatedly evaluated whether glypho-
`sate is carcinogenic. See EPA, Revised Glyphosate Is-
`sue 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
`
`
`
`
`
`8
`
`health. App.5a. EPA considered numerous studies in
`rodents, none of which showed “convincing evidence”
`that glyphosate was carcinogenic. 9 AA10136. EPA
`therefore “classified glyphosate as a Group E carcino-
`gen”—signifying “evidence of non-carcinogenicity in
`humans.” 9 AA10121; see also App.5a. EPA has re-
`peatedly 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 noncar-
`cinogenicity for studies in humans.”). Regulators
`worldwide have similarly found that glyphosate does
`not cause cancer in humans. App.7a; 9 AA9924-9925,
`10092-10102, 10213-10214; 13 RT1927:1-1928:3.
`Against this global consensus, a working group at
`IARC classified glyphosate in 2015 as “probably car-
`cinogenic to humans.” App.6a. IARC’s classification is
`merely a “hazard assessment,” 14 RT2214:6, the “first
`step” in a public-health assessment designed to “identi-
`fy cancer hazards even when risks are very low at cur-
`rent exposure levels,” 9 AA10234-10235. IARC did not
`determine that glyphosate poses a risk of cancer to hu-
`mans at real-world exposure levels. 9 AA10231.
`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. At the
`end of that review, EPA concluded again that glypho-
`sate 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 regis-
`tered uses and all routes of exposure and did not
`
`
`
`
`
`9
`
`identify any risks of concern,” including risks of “cancer
`effects.” EPA, Glyphosate: Interim Registration Re-
`view Decision 9
`(Jan. 2020), https://tinyurl.com/
`5b7c8awa. EPA again authorized labeling for glypho-
`sate without any cancer warning. See id. at 23-27.
`EPA also confirmed its rejection of IARC’s find-
`ings in a 2019 letter informing glyphosate registrants
`that it would not approve modifying the labels of
`glyphosate-based products to include a cancer warning.
`See App.161a-163a. “Given EPA’s determination that
`glyphosate is ‘not likely to be carcinogenic to humans,’”
`the agency stated, EPA considers a warning that
`glyphosate is carcinogenic “to constitute a false and
`misleading statement” that violates FIFRA’s prohibi-
`tion against misbranding. App.162a (quotation marks
`omitted). The letter was consistent with the fact that
`EPA has approved 44 versions of Roundup’s label
`without a cancer warning. U.S. Hardeman Br. 26.
`EPA has maintained its conclusion that glyphosate
`is not carcinogenic to this day. Last spring, the agency
`explained to the Ninth Circuit that “glyphosate is not
`likely to be a human carcinogen and poses no human-
`health risks of concern,” stressing that “the record un-
`derlying these conclusions is robust, reflecting more
`than a 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).4
`
`
`4 Because glyphosate is Roundup’s principal ingredient, this
`petition treats “Roundup” and “glyphosate” as synonymous. Alt-
`hough the Court of Appeal noted that “[g]lyphosate is not the only
`ingredient in Roundup,” App.8a, neither the court’s preemption
`analysis nor its punitive-damages analysis turned on the presence
`of non-glyphosate ingredients in Roundup. Moreover, because
`EPA has registered over 500 glyphosate products, “the agency has
`
`
`
`
`
`10
`C. Proceedings Below
`1. Respondents used Roundup on their residential
`properties for roughly three decades, starting in 1982.
`App.10a. In 2011, Mr. Pilliod was diagnosed with non-
`Hodgkin’s lymphoma, a form of cancer. App.9a. Mrs.
`Pilliod was diagnosed with non-Hodgkin’s lymphoma in
`2015. App.9a-10a.
`Respondents sued Monsanto in June 2017, alleging
`that their exposure to Roundup caused them each to
`develop non-Hodgkin’s lymphoma. App. 13a-14a. Their
`complaint raised claims of design defect and failure to
`warn. App.14a. Respondents pleaded (and ultimately
`tried) their design-defect claim solely on the basis of a
`“consumer expectations” theory. See id. Under this
`California-law doctrine, respondents’ “claims were
`based on Monsanto’s labeling, marketing, and promo-
`tion of Roundup.” Id.
`Monsanto moved for summary judgment on the
`ground that respondents’ claims were both expressly
`and implicitly preempted by FIFRA. App.111a. The
`trial court denied the motion, summarily rejecting the
`express-preemption defense by “adopt[ing]” the rea-
`soning of two trial courts in similar Roundup cases. Id.
`And it rejected implied preemption both “as a matter of
`law,” because “FIFRA allows states to regulate or ban
`
`
`assessed new inert ingredients at multiple points over the years
`for different formulations of glyphosate” and “incorporate[s] into
`[its] risk assessment[s]” “[a]ll studies of adequate scientific cali-
`ber” on different formulations containing glyphosate. 6 AA6501.
`In other words, EPA’s evaluation of glyphosate-based products
`has encompassed both glyphosate and “any inert ingredients.”
`EPA, Response from the Pesticide Re-evaluation Division to
`Comments on the Glyphosate Proposed Interim Decision 6 (Jan.
`16, 2020), https://tinyurl.com/426uuejz.
`
`
`
`
`
`11
`
`pesticides that have been federally approved,” and due
`to the existence of “triable issues of material fact” as to
`whether EPA would bar Monsanto from adding a can-
`cer warning to Roundup’s label. App.112a.
`After trial, a jury returned a verdict in respond-
`ents’ favor. App.22a. Mrs. Pilliod was awarded approx-
`imately $37 million in compensatory damages (approx-
`imately $34 million of which was for non-economic loss)
`and $1 billion in punitive damages. Id. Mr. Pilliod was
`awarded over $17 million in compensatory damages (all
`but $47,000 of which was for non-economic loss) and $1
`billion in punitive damages. Id.5
`After trial, Monsanto moved for judgment notwith-
`standing the verdict or a new trial. App.22a. Among
`other arguments, Monsanto renewed its preemption
`defense, which the trial court denied again. App.119a-
`120a. Monsanto also argued that the damages awards
`were excessive. App.22a. The trial court agreed and
`granted Monsanto a new trial unless each respondent
`accepted a reduced award—roughly $56 million for
`Mrs. Pilliod, including roughly $45 million in punitive
`damages, and roughly $31 million for Mr. Pilliod, includ-
`ing roughly $24 million in punitive damages. App.141a-
`142a. On punitive damages, the court concluded that
`Monsanto’s conduct was “repr
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