`
`
`
`
`
`No. 21-1272
`
`IN THE
`Supreme Court of the United States
`__________
`
`MONSANTO COMPANY,
`Petitioner,
`
`
`
`v.
`
`
`
`ALBERTA PILLIOD AND ALVA PILLIOD,
`Respondents.
`__________
`
`On Petition for a Writ of Certiorari
`to the Court of Appeal of California
`__________
`
`BRIEF IN OPPOSITION FOR RESPONDENTS
`__________
`
`DAVID C. FREDERICK
` Counsel of Record
`DEREK C. REINBOLD
`KELLOGG, HANSEN, TODD,
` FIGEL & FREDERICK,
` P.L.L.C.
`1615 M Street, N.W.
`Suite 400
`Washington, D.C. 20036
`(202) 326-7900
`(dfrederick@kellogghansen.com)
`
`
`
`JEFFREY A. TRAVERS
`THE MILLER FIRM, LLC
`108 Railroad Avenue
`Orange, Virginia 22960
`(540) 672-4224
`
`
`
`
`
`May 20, 2022
`
`
`
`
`
`
`QUESTIONS PRESENTED
`In Bates v. Dow AgroSciences LLC, 544 U.S. 431
`(2005), this Court held that the Federal Insecticide,
`Fungicide, and Rodenticide Act preempts only state-
`law labeling requirements that are broader than the
`statute’s misbranding standard. State-law claims
`“that require manufacturers to design reasonably
`safe products” are not preempted because they impose
`no labeling requirements. Id. at 444. The same is
`true of claims that target product marketing, because
`they do not “require[] that manufacturers label or
`package their products in any particular way.” Id.
`Respondents developed non-Hodgkin lymphoma
`after long exposure to petitioner Monsanto Company’s
`weedkiller, Roundup. A jury found that Roundup
`caused respondents’ cancer and held Monsanto liable
`in strict liability and negligence for designing a
`defective product and failing to warn of its danger in
`off-label marketing. Because Monsanto knew, but
`concealed, that Roundup was carcinogenic, the jury
`awarded punitive damages. Based on that reprehen-
`sible conduct, the California Court of Appeal held
`that reduced punitive damages of four times compen-
`satory damages were within constitutional limits.
`The questions presented are:
`1. Whether the California Court of Appeal cor-
`rectly applied Bates in holding respondents’ failure-
`to-warn claims were not preempted when they were
`equivalent to the statute’s misbranding standard.
`2. Whether this Court should adopt a new consti-
`tutional rule limiting the ratio between compensatory
`and punitive damages to 1:1 when compensatory
`damages are substantial, no matter how reprehensi-
`ble the defendant’s conduct.
`
`
`
`
`
`
`
`ii
`
`TABLE OF CONTENTS
`
`Page
`QUESTIONS PRESENTED ........................................ i
`TABLE OF AUTHORITIES ...................................... iv
`INTRODUCTION ....................................................... 1
`STATEMENT .............................................................. 3
`A. Statutory and Regulatory Background ................ 3
`B. Factual Background .............................................. 4
`C. Procedural History .............................................. 11
`REASONS FOR DENYING THE PETITION ......... 15
`I. The Preemption
`Issue Does Not
`Warrant Review ............................................. 15
`A. The Pilliods’ Claims Are Not
`Expressly Preempted ................................ 15
`1. The Pilliods’ design-defect and
`off-label
`failure-to-warn claims
`imposed no labeling or packaging
`requirements ....................................... 15
`2. The Pilliods’ label-based failure-
`to-warn claims track FIFRA ............... 18
`3. Monsanto’s
`express-preemption
`arguments lack merit .......................... 20
`B. The Pilliods’ Claims Are Not
`Impliedly Preempted ................................ 24
`C. The Petition Does Not Meet The
`Traditional Criteria For Certiorari .......... 27
`II. The Punitive-Damages Awards Do Not
`Warrant Review ............................................. 30
`
`
`
`
`
`
`
`iii
`A. The Court Of Appeal’s Decision Was
`Correct ....................................................... 30
`B. Monsanto’s Proposed Rule Lacks
`Merit, And Its Purported Circuit
`Split Is Illusory ......................................... 33
`CONCLUSION .......................................................... 36
`APPENDIX ............................................................... 1a
`
`
`
`
`
`
`
`
`iv
`
`TABLE OF AUTHORITIES
`
`Page
`
`CASES
`Arnold v. Dow Chem. Co., 110 Cal. Rptr. 2d
`722 (Cal. Ct. App. 2001) ...................................... 16
`Bates v. Dow AgroSciences LLC, 544 U.S. 431
`(2005) ................................................. 2, 3, 4, 15, 16,
`17, 18, 19, 20, 21,
`22, 23, 24, 25, 26, 29, 29
`BMW of N. Am., Inc. v. Gore, 517 U.S. 559
`(1996) .............................................................30, 31,
`32, 33, 34, 35
`Boerner v. Brown & Williamson Tobacco Co.,
`394 F.3d 594 (8th Cir. 2005) ..........................34, 35
`Brooke Grp. Ltd. v. Brown & Williamson
`Tobacco Corp., 509 U.S. 209 (1993) .................. 4, 9
`Cote v. Philip Morris USA, Inc., 985 F.3d 840
`(11th Cir. 2021) ............................................... 35-36
`Ferebee v. Chevron Chem. Co., 736 F.2d 1529
`(D.C. Cir. 1984) .................................................... 24
`Hardeman v. Monsanto Co., 997 F.3d 941
`(9th Cir. 2021), petition for cert. pending,
`No. 21-241 (U.S. Aug. 18, 2021) ................. 1, 20, 27
`Hubbard v. United States, 514 U.S. 695 (1995) ....... 28
`Huber v. New Jersey Dep’t of Env’t Prot.,
`562 U.S. 1302 (2011) ........................................... 30
`Johnson & Johnson v. Ingham, 141 S. Ct. 2716
`(2021) ................................................................... 33
`Lompe v. Sunridge Partners, LLC, 818 F.3d
`1041 (10th Cir. 2016) ......................................34, 35
`
`
`
`
`
`
`
`v
`MacDonald v. Monsanto Co., 27 F.3d 1021
`(5th Cir. 1994) ...................................................... 21
`Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) ......19, 23
`Merck Sharp & Dohme Corp. v. Albrecht,
`139 S. Ct. 1668 (2019) ....................................23, 27
`Morgan v. New York Life Ins. Co., 559 F.3d
`425 (6th Cir. 2009) ..........................................34, 35
`National Meat Ass’n v. Harris, 565 U.S. 452
`(2012) ................................................................... 28
`Pacific Mut. Life Ins. Co. v. Haslip, 499 U.S. 1
`(1991) ..............................................................32, 33
`Planned Parenthood of Columbia/Willamette
`Inc. v. American Coal. of Life Activists,
`422 F.3d 949 (9th Cir. 2005) ............................... 35
`PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) ......... 23,
`25, 26
`Reckitt Benckiser, Inc. v. Jackson, 762 F. Supp.
`2d 34 (D.D.C. 2011) ............................................. 21
`Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) ....22, 23
`Roth v. Farner-Bocken Co., 667 N.W.2d 651
`(S.D. 2003) ......................................................34, 35
`Saccameno v. U.S. Bank Nat’l Ass’n, 943 F.3d
`1071 (7th Cir. 2019) ........................................34, 35
`Seltzer v. Morton, 154 P.3d 561 (Mont. 2007) .......... 36
`State Farm Mut. Auto. Ins. Co. v. Campbell,
`538 U.S. 408 (2003) ............................ 14, 31, 32, 33
`Thomas v. iStar Fin., Inc., 652 F.3d 141
`(2d Cir. 2011) ....................................................... 34
`TransUnion LLC v. Ramirez, 141 S. Ct. 972
`(2020) ................................................................... 33
`
`
`
`
`
`
`
`vi
`TXO Prod. Corp. v. Alliance Res. Corp., 509 U.S.
`443 (1993) .......................................................32, 33
`United States v. Mendoza, 464 U.S. 154 (1984) ....... 27
`Williams v. ConAgra Poultry Co., 378 F.3d 790
`(8th Cir. 2004) .................................................34, 35
`Wyeth v. Levine, 555 U.S. 555 (2009) ..................25, 26
`
`
`STATUTES, REGULATIONS, AND RULES
`Federal Food, Drug, and Cosmetic Act, 21 U.S.C.
`§ 301 et seq. ....................................................25, 26
`Federal Insecticide, Fungicide, and Rodenticide
`Act, 7 U.S.C. §§ 136-136y ............................. passim
`7 U.S.C. § 136(p)(2) .............................................. 17
`7 U.S.C. § 136(q)(1)(A) ........................................... 3
`7 U.S.C. § 136(q)(1)(F) ..................................... 3, 22
`7 U.S.C. § 136(q)(1)(G) ................................ 3, 19, 20
`7 U.S.C. § 136a(a) .................................................. 3
`7 U.S.C. § 136a(c)(5)(B) ......................................... 3
`7 U.S.C. § 136a(c)(5)(C) ......................................... 3
`7 U.S.C. § 136a(c)(5)(D) ......................................... 3
`7 U.S.C. § 136a(d)(1) ............................................ 19
`7 U.S.C. § 136a(f)(1) ............................................ 26
`7 U.S.C. § 136a(f)(2) ....................... 4, 20, 21, 22, 28
`7 U.S.C. § 136a(g)(1)(A) ......................................... 3
`7 U.S.C. § 136d(a)(2) .............................................. 6
`7 U.S.C. § 136d(b) .................................................. 3
`
`
`
`
`
`
`
`vii
`7 U.S.C. § 136j(a)(1)(E) .................................... 3, 20
`7 U.S.C. § 136k(a) .................................................. 3
`7 U.S.C. § 136k(b) .................................................. 3
`7 U.S.C. § 136l ....................................................... 3
`7 U.S.C. § 136v(a) ................................................ 23
`7 U.S.C. § 136v(b) ........................... 4, 15, 18, 24, 29
`Federal Meat Inspection Act, 21 U.S.C. § 601
`et seq. ................................................................... 28
`Medical Device Amendments Act of 1976, Pub.
`L. 94-295, 90 Stat. 539 ........................................ 22
`21 U.S.C. § 360k(a) .............................................. 22
`Cal. Civ. Proc. Code § 3295(d) .................................. 34
`40 C.F.R.
`§ 152.50(e) ............................................................ 26
`§ 156.62 ................................................................ 29
`§ 156.64 ................................................................ 29
`§ 159.158(a) ............................................................ 6
`Sup. Ct. R. 10 ............................................................ 30
`
`
`ADMINISTRATIVE MATERIALS
`U.S. Env’t Prot. Agency:
` Glyphosate: Proposed Interim Registration
`Review Decision (Apr. 2019), http://tinyurl.
`com/y6h2u8w6 ................................................. 8, 23
` Organizational Chart, https://www.epa.gov/
`aboutepa/epa-organization-chart ........................ 12
`
`
`
`
`
`
`
`viii
`
` Revised Glyphosate Issue Paper: Evaluation
`of Carcinogenic Potential (Dec. 12, 2017),
`http://tinyurl.com/eparevdglyphosate ................... 8
`
`
`
`OTHER MATERIALS
`Brief for the United States as Amicus Curiae,
`Monsanto Co. v. Hardeman, No. 21-241
`(U.S. May 10, 2020) ............................ 17, 20, 22, 26
`Resp. Br., Bates v. Dow AgroSciences LLC, 544
`U.S. 431 (2005) (No. 03-388) (U.S. Nov. 24,
`2004) ..................................................................... 25
`
`
`
`
`
`
`
`
`
`INTRODUCTION
`Monsanto has known for decades that its popular
`weedkiller, Roundup, can cause cancer. But the
`company has refused to make its product safer or to
`inform consumers in off-label marketing they should
`exercise caution when using it. Instead, Monsanto
`has attacked those who questioned Roundup’s safety.
`Respondents Alva and Alberta Pilliod are among
`Monsanto’s victims. Unaware of the dangers, they
`used Roundup for decades before being diagnosed
`with non-Hodgkin lymphoma, a deadly blood cancer.
`The jury found that Roundup caused that cancer and
`that Monsanto’s reprehensible conduct warranted
`significant punitive damages. A remarkably thorough
`appellate decision affirmed that judgment.
`In this Court, Monsanto reprises its lead argument
`from Monsanto Co. v. Hardeman, No. 21-241 (pet.
`docketed Aug. 18, 2021), arguing the Pilliods’ failure-
`to-warn
`claims
`impose
`labeling
`requirements
`preempted under the Federal Insecticide, Fungicide,
`and Rodenticide Act, 7 U.S.C. §§ 136-136y, or FIFRA.
`This Court called for the views of the Solicitor
`General in Hardeman on December 13, 2021. On
`May 10, 2022, the Solicitor General recommended
`that this Court deny certiorari there because the
`court of appeals correctly rejected Monsanto’s
`preemption arguments and created no split in
`authority in doing so. Monsanto’s petition here is
`even less worthy of review: alternative bases exist to
`affirm the Pilliods’ verdict whatever the answer to
`Monsanto’s question presented. And the decision
`below tracks Hardeman, so it too is correct and
`presents no split. The Court should deny certiorari
`no matter its disposition of Hardeman.
`This Court’s review of Monsanto’s preemption
`argument here would be purely advisory. First,
`
`
`
`
`
`
`
`2
`Monsanto’s petition addresses only the Pilliods’ failure-
`to-warn claims, but the Pilliods brought, and won,
`design-defect claims challenging Roundup’s safety,
`not labeling. In Bates v. Dow AgroSciences LLC, 544
`U.S. 431 (2005), the leading case on FIFRA preemp-
`tion, this Court held it was “perfectly clear” that
`FIFRA does not preempt “claims for defective design”
`because they “require manufacturers to design
`reasonably safe products,” not “label or package their
`products in any particular way.” Id. at 444. Second,
`the Pilliods’ failure-to-warn claims were not limited
`to Roundup’s labeling. They also challenged off-label
`conduct like Monsanto’s failure to warn of Roundup’s
`dangers in advertisements the Pilliods saw and on
`which they relied. Nothing in FIFRA prevented
`those advertisements from warning consumers that
`Roundup may be carcinogenic or that they should
`wear protective gear when spraying the weedkiller.
`This Court’s review of the labeling issue would not
`affect these alternative bases for affirmance, which
`Monsanto ignores in its petition.
`Even if this Court views the labeling issues as cen-
`tral, there is no need for review because the decision
`below is correct and there is no split in authority.
`The California Court of Appeal – like every other ap-
`pellate court to consider the issue – rightly concluded
`that neither express nor implied preemption bars
`failure-to-warn claims based on Roundup’s labeling.
`The U.S. Environmental Protection Agency (“EPA”)
`recently confirmed that FIFRA permits Monsanto
`to warn consumers that the leading international
`authority has concluded Roundup is carcinogenic,
`which makes this petition even less worthy of review.
`Finally, Monsanto asks the Court to decree, as
`a matter of substantive due process, an arbitrary
`mathematical limit on state punitive damages that
`
`
`
`
`
`
`
`3
`would require courts and juries to ignore the compa-
`ny’s reprehensible, decades-long wrongdoing. Yet the
`company cites no case that restricts punitive damages
`for comparably reprehensible conduct exposing un-
`witting consumers to deathly harm. Further review
`is unwarranted.
`
`STATEMENT
`A. Statutory and Regulatory Background
`1. FIFRA regulates “the use, as well as the sale
`and labeling, of pesticides.” Bates v. Dow Agro-
`Sciences LLC, 544 U.S. 431, 437 (2005). As relevant
`here, the statute proscribes marketing “any pesticide
`which is . . . misbranded.” 7 U.S.C. § 136j(a)(1)(E).1
`A pesticide is “misbranded” if its label contains a
`statement that is “false or misleading in any particu-
`lar,” § 136(q)(1)(A), or if its label omits adequate in-
`structions for use, necessary warnings, or cautionary
`statements, § 136(q)(1)(F), (G).
`If EPA determines a pesticide is misbranded, it
`may cancel the pesticide’s registration, § 136d(b),
`issue “stop sale, use, or removal” orders, § 136k(a),
`and seize misbranded products, § 136k(b). Manufac-
`turers that sell misbranded products face civil and
`criminal penalties. § 136l.
`2. FIFRA requires pesticide manufacturers to
`register their products with EPA. § 136a(a). The
`agency will register a pesticide if it determines that
`(1) the product will not cause unreasonable harm to
`humans and the environment, § 136a(c)(5)(C), (D),
`and (2) the product’s label is not misbranded,
`§ 136a(c)(5)(B). EPA re-reviews a pesticide’s regis-
`tration, including its effects on human health, every
`fifteen years. § 136a(g)(1)(A).
`
`1 Except where otherwise noted, citations to provisions of the
`U.S. Code are to Title 7.
`
`
`
`
`
`
`
`4
`FIFRA confirms that obtaining registration does
`not relieve the registrant of liability if the pesticide is
`misbranded. “In no event shall registration of an
`article be construed as a defense for the commission of
`any offense under [FIFRA],” including misbranding.
`§ 136a(f)(2). Instead, registration is merely “prima
`facie evidence that the pesticide, its labeling and
`packaging comply with the registration provisions
`of [FIFRA].” Id. Manufacturers with registered
`pesticides therefore “have a continuing obligation to
`adhere to FIFRA’s labeling requirements.” Bates,
`544 U.S. at 438.
`3. FIFRA “authorizes a relatively decentralized
`scheme that preserves a broad role for state regula-
`tion.” Bates, 544 U.S. at 450. The statute’s only
`limit on state authority is its “narrow” preemption
`provision, id. at 452, which “prohibits only state-law
`labeling and packaging requirements that are ‘in
`addition to or different from’ the labeling and packag-
`ing requirements under FIFRA,” id. at 447 (quoting
`§ 136v(b)).
`B. Factual Background2
`1. The active ingredient in Roundup is glypho-
`sate, an herbicide that kills plants at their roots.
`Roundup’s label states, “Roundup formulas target an
`enzyme in plants, but not in people or pets.”
`AA8879.
`Monsanto has had EPA’s approval to sell glyphosate-
`based herbicides since 1974. To get that approval,
`Monsanto submitted studies testing whether glypho-
`sate caused cancer or cell mutations in animals.
`
`2 This Court “view[s] the evidence in the light most favorable”
`to the jury’s verdict. Brooke Grp. Ltd. v. Brown & Williamson
`Tobacco Corp., 509 U.S. 209, 213 (1993).
`
`
`
`
`
`
`
`5
`Tr.3516:15-3529:18. The company contracted Indus-
`trial Bio-Test Laboratories (“IBT”), a commercial
`laboratory, to conduct the studies. Tr.3519:4-22.
`IBT’s studies were invalid. The lab had created
`“fraudulent data in support of the registration of
`a bunch of pesticides,”
`including glyphosate.
`Tr.3520:7-8. Monsanto and regulators learned about
`the fraud in 1976. Tr.3527:13-3530:22. But the
`company continued to sell Roundup. Tr.3529:15-18.
`At the time, EPA lacked authority to remove fraudu-
`lently approved pesticides from the market. AA8990;
`Tr.3532:18-23.
`Seven years passed before there was “a valid
`mouse study assessing the carcinogenicity” of
`glyphosate. Tr.3530:3-16. That 1983 study showed
`that mice exposed to glyphosate had higher rates
`of kidney
`tumors and malignant
`lymphomas.
`Tr.1670:5-24, 2106:9-23. Based on that result, in
`1985, an EPA panel classified glyphosate as a possi-
`ble human carcinogen. AA8762. EPA requested that
`Monsanto repeat the mouse study with more mice,
`AA7200-7201, but the company never did, Tr.3560:6-
`3561:3.
`2.
`In the 1990s, several published studies con-
`cluded that glyphosate and Roundup are genotoxic.
`AA8394-8397. Genotoxic substances damage genetic
`information in cells, causing mutations that may
`lead to cancer. Monsanto retained Dr. James Parry,
`an expert in genotoxicity, to review the studies.
`AA8499. He concluded that “[g]lyphosate is capable
`of producing genotoxicity both in vivo and in vitro,”
`AA8398, and recommended the company conduct
`eight tests to learn more, AA8399, 8432-8434.
`Monsanto still has not conducted most of those tests.
`Tr.3587:14-3591:22.
`
`
`
`
`
`
`
`6
`After reading one of Dr. Parry’s reports, Dr. William
`Heydens, Monsanto’s Product Safety Assessment
`Strategy Lead, wrote to colleagues:
`We want to find/develop someone who is comfort-
`able with the genetox profile of glyphosate/
`Roundup and who can be influential with regula-
`tors and Scientific Outreach operations when
`genetox issues arise. My read is that Parry is not
`currently such a person, and it would take quite
`some time and $$$/studies to get him there.
`We simply aren’t going to do the studies Parry
`suggests. Mark, do you think Parry can become
`a strong advocate without doing this work[?] If
`not, we should seriously start looking for one or
`more other individuals to work with.
`AA8387.3
`Monsanto found another individual to work with.
`AA8499. In 2000, Dr. Gary Williams was listed as
`the lead author on an article that concluded Roundup
`was neither genotoxic nor carcinogenic. Tr.4939:13-
`4940:23. He did not write the article; Monsanto
`did. Before publication, Dr. Heydens commented that
`he “ha[d] sprouted several new gray hairs during
`the writing of this thing.” AA8591. He later
`“[r]ecall[ed]” how the company “handled” the writing
`process: “[W]e ghost-write the Exposure Tox &
`Genetox sections” while outside experts like Dr.
`Williams “would just edit & sign their names.”
`AA8314.
`
`3 Monsanto did not provide Dr. Parry’s reports to EPA. That
`failure to disclose itself violated FIFRA, Tr.3592:22-3594:8,
`which requires manufacturers to report “factual information
`regarding unreasonable adverse effects on the environment
`of [a] pesticide” to EPA on an ongoing basis, § 136d(a)(2); see
`40 C.F.R. § 159.158(a).
`
`
`
`
`
`
`
`7
`3. Glyphosate is not the only ingredient in
`Roundup; the product also contains a surfactant.
`Tr.3124:8-3133:17. In the United States, the surfac-
`tant is polyoxyethylated tallow amine (“POEA”).
`Tr.3124:10-14, 3128:2-13.
`POEA is meant to help Roundup penetrate the
`waxy surface of a leaf, but it has the same penetra-
`tive effect on human skin.
` Tr.3143:6-3147:9.
`Roundup enters the body through sweat glands, hair
`follicles, and cells. Once under the skin, Roundup
`reaches lymphatic vessels and then can circulate
`within the lymphatic system. Tr.3145:8-16.
`POEA makes Roundup more genotoxic. One study
`showed that POEA and other contaminants made
`formulated Roundup ten times more genotoxic
`than glyphosate alone. AA8393. As a result, POEA
`is banned in Europe, Tr.3103:10-20, 3162:15-17,
`where Monsanto now sells Roundup with a less toxic
`surfactant, Tr.3250:21-3251:11. This prompted one
`Monsanto scientist to ask, “there are non-hazardous
`formulations so why sell a hazardous one?” AA8659.
`Internally, Monsanto instructs employees handling
`Roundup to wear chemical-resistant gloves and cloth-
`ing and a face shield. A8770. The company gives no
`similar instruction to residential users. Tr.3608:17-
`3609:22.
`4. Monsanto never has tested whether Roundup
`causes cancer. In an internal email, Dr. Donna
`Farmer, a senior toxicologist at Monsanto, told her
`colleagues, “you cannot say Roundup is not a carcin-
`ogen. We have not done the necessary testing on the
`formulation to make that statement.” AA6906.
`Nor has EPA made any formal findings about
`Roundup’s carcinogenicity. In 2017, as part of its
`re-registration review of glyphosate, EPA determined
`
`
`
`
`
`
`
`8
`that it could not reach “a conclusion regarding the
`association between glyphosate exposure and risk of
`[non-Hodgkin lymphoma].” EPA, Revised Glyphosate
`Issue Paper: Evaluation of Carcinogenic Potential 68
`(Dec. 12, 2017), http://tinyurl.com/eparevdglyphosate.
`The agency also noted that “farmers and other appli-
`cators apply formulations, not the active ingredient
`alone,” id. at 137, and acknowledged a need for more
`research “to determine whether formulation compo-
`nents, such as surfactants, influence the toxicity of
`glyphosate formulations,” id. at 144. In its 2019
`Interim Glyphosate Review, EPA again acknowl-
`edged that it had not determined whether glyphosate
`“formulations,” like Roundup, pose any risks to human
`health. See EPA, Glyphosate: Proposed Interim
`Registration Review Decision 11 (Apr. 2019) (“EPA,
`Glyphosate”), http://tinyurl.com/y6h2u8w6.
`5. Monsanto learned in 2014 that the Interna-
`tional Agency for Research on Cancer (“IARC”) would
`evaluate whether glyphosate and glyphosate-based
`products like Roundup are carcinogenic. AA8562.
`IARC is “the worldwide authority on establishing
`whether an agent is a carcinogen.” Tr.2455:13-15.
`Monsanto expected that IARC would classify its
`product as probably or possibly carcinogenic,
`AA8681, so it planned to “Orchestrate Outcry” with
`IARC’s coming decision, AA8669.
`After a year-long evaluation, IARC convened a
`“working group” of seventeen scientists in 2015.
`Tr.2117:17-23; AA6628-6629. The scientists reviewed
`studies of real-world exposure to glyphosate-based
`products in humans and experimental exposure to
`pure glyphosate in animals. These studies provided
`“limited” evidence of cancer in humans and “suffi-
`cient” evidence of cancer in experimental animals.
`AA6631; Tr.2153:16-22. The studies linked glypho-
`
`
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`9
`sate exposure to non-Hodgkin lymphoma. Based on
`that link, the panel unanimously determined that
`glyphosate is “probably carcinogenic to humans.”
`AA6628.4
`In response, Monsanto ghostwrote articles attack-
`ing IARC’s conclusions. AA8693-8694, 8698. This
`was not the first time the company had attacked
`independent researchers studying Roundup: Monsanto
`scientists long had joked about “playing Whack-a-
`Mole” with researchers who raised safety concerns.
`AA6689, 8305.
`6. Alva and Alberta Pilliod began spraying
`Roundup in 1982. Tr.3695:16-3697:5, 3782:4-16.
`Over the next thirty years, the couple sprayed
`Roundup on approximately 1,500 days at four prop-
`erties. Tr.3246:4-3249:12. Alva did 75% of the
`spraying; Alberta 25%. Tr.2765:20-2766:2. Neither
`wore protective gear. Tr.2766:17-19.
`Alberta thought Roundup was “really safe to use.”
`Tr.3726:7-17. In television commercials she saw,
`people sprayed Roundup in shorts with no gloves or
`other protective clothing on. Tr.3731:16-19. Based
`on those commercials, Alberta told Alva that Roundup
`“was like sugar water.” Tr.3726:7-17.
`Alberta also read Roundup’s label before using the
`product. Tr.3725:9-10. The label did not warn her of
`the risk of cancer or that she should wear protective
`
`4 Amicus Washington Legal Foundation (“WLF”) describes
`IARC’s conclusion as “an outlier” and alleges conflicts of inter-
`est in two of the seventeen panelists. WLF Br. 8, 9-11. But
`Monsanto presented evidence challenging IARC’s conclusions
`and the panelists’ interests at trial, the Pilliods rebutted that
`showing, and the jury returned a unanimous verdict for the
`Pilliods. Because this Court “view[s] the evidence in the light
`most favorable” to that verdict, Brooke Grp., 509 U.S. at 213,
`WLF’s arguments lack merit.
`
`
`
`
`
`
`
`10
`equipment while spraying. Tr.3725:11-23. Had
`Monsanto warned of a cancer risk, Alberta would not
`have used Roundup. Tr.3725:24-3726:2.
`Alva testified that when he started using Roundup
`he also
`checked
`the
`label
`for precautions.
`Tr.3782:16-18. He saw no warnings about cancer or
`wearing protective gear. Tr.3782:19-23.
`In 2011, Alva was diagnosed with diffuse large
`B-cell lymphoma, an aggressive form of non-Hodgkin
`lymphoma. Tr.3772:6-14. His cancer metastasized
`in his bones; tumors caused fractures and pain so
`severe even morphine could not help. Tr.3772:15-
`3774:2; AA7114-7118. After months of chemotherapy,
`Alva’s cancer has not recurred. Tr.3808:6-3809:9.
`But he is no longer physically active. Tr.3775:7-
`3776:25.
`In 2015, Alberta also was diagnosed with large
`B-cell lymphoma, which metastasized in her brain.
`Tr.3006:9-10, 3887:6-12, 3977:2-3978:16. She began
`chemotherapy, which required injections directly into
`her spine. AA7082-7083. Her cancer recurred in
`2016. Tr.3978:20-21. Since 2017, Alberta has taken
`experimental medication to prevent her brain tumor
`from growing large again. Tr.3979:21-25; AA7321-
`7323. She still has double vision, hearing loss, and
`falls often. Tr.3749:24-3750:25.5
`Alberta kept using Roundup until 2015, when she
`became sick. Tr.3740:3-14. Alva kept using Roundup
`until 2016 or 2017, when he read articles about
`Roundup causing non-Hodgkin lymphoma. Tr.3794:25-
`3795:25; AA2716.
`
`5 Alberta’s cancer returned in 2019. See Respondents/Cross-
`Appellants’ Combined Response and Opening Brief at 139 n.21,
`Pilliod v. Monsanto Co., No. A158228 (Cal. Ct. App. Mar. 31,
`2020).
`
`
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`
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`
`11
`
`C. Procedural History
`1. The Pilliods sued Monsanto in 2017, alleging
`that their use of Roundup products caused their
`cancer and seeking compensatory and punitive
`damages. Pet.App.13a-14a. They brought design-
`defect and failure-to-warn claims in strict liability
`and negligence. Pet.App.14a.
`At summary judgment, the trial court rejected
`Monsanto’s express- and implied-preemption argu-
`ments. Pet.App.111a-112a. The court then denied
`Monsanto’s motion on punitive damages because the
`Pilliods “ha[d] presented evidence that might support
`punitive damages.” Pet.App.113a.
`At trial, the Pilliods presented expert testimony
`proving that Roundup causes non-Hodgkin lymphoma
`and that their own exposure to Roundup was a
`substantial factor in causing their cancers. And the
`jury heard testimony about Monsanto’s reprehensible
`conduct.
`The jury awarded approximately $37 million to
`Alberta and $18 million to Alva in compensatory dam-
`ages. Pet.App.151a, 159a. The jury also concluded
`there was clear and convincing evidence that Mon-
`santo acted with malice or oppression, awarding Alva
`and Alberta $1 billion each in punitive damages. Id.
`The trial court denied Monsanto’s motion for
`judgment notwithstanding the verdict. Pet.App.141a.
`The court conditionally granted Monsanto’s motion
`for a new trial unless the Pilliods accepted reduced
`damages awards: Alberta’s compensatory damages
`would be approximately $11 million and Alva’s would
`be approximately $6 million. Pet.App.141a-142a.
`The court held that Monsanto’s conduct was “repre-
`hensible” and showed “a conscious disregard for
`public health,” but “the constitutionally permissible
`
`
`
`
`
`
`
`12
`punitive damages” award for each Pilliod was an
`amount “four times [the] . . . compensatory damages.”
`Pet.App.141a. That left Alberta with approximately
`$45 million in punitive damages and Alva approxi-
`mately $25 million in punitive damages. AA8277-
`8278. The Pilliods accepted the remittitur. AA8279.
`2. After the jury’s verdict, in August 2019, the
`Director of the Registration Division of EPA’s Office
`of Pesticide Programs issued a letter to all glyphosate-
`based product registrants. Pet.App.161a-163a. The
`Director stated that EPA would no longer approve
`labeling that warned consumers that glyphosate was
`a chemical known to California to cause cancer and
`that manufacturers must remove the warning.
`Pet.App.162a-163a. This letter was not the product
`of notice-and-comment rulemaking and took no
`position on whether Roundup causes cancer.
`In April 2022, EPA “clarif[ied]” its position in a let-
`ter to California regulators. Resp.App.2a. A higher-
`ranking official,6 the Assistant Administrator for the
`Office of Chemical Safety and Pollution Prevention,
`wrote that “EPA could approve” (Resp.App.1a) Cali-
`fornia’s newly proposed glyphosate-specific warning:
`CALIFORNIA PROPOSITION 65 WARNING:
`Using this product can expose you to glyphosate.
`The International Agency for Research on Cancer
`classified glyphosate as probably carcinogenic to
`humans. US EPA has determined that glypho-
`
`6 The Assistant Administrator reports directly to the EPA
`Administrator. The Director of the Registration Division reports
`to the Director of the Office of Pesticide Programs, who reports
`to the Deputy Assistant Administrator for Pesticide Programs
`in EPA’s Office of Chemical Safety and Pollution Prevention,
`who reports to the Assistant Administrator. EPA Organiza-
`tional Chart, https://www.epa.gov/aboutepa/epa-organization-
`chart.
`
`
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`
`
`
`
`13
`sate is not likely to be carcinogenic to humans;
`other authorities have made similar determina-
`tions. A wide variety of factors affect your poten-
`tial risk, including the level and duration of
`exposure to the chemical. For more information,
`including ways to reduce your exposure, g