Case: 19-16636, 03/16/2020, ID: 11631822, DktEntry: 58, Page 1 of 133
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`Nos. 19-16636, 19-16708
`
`
`UNITED STATES COURT OF APPEALS
`FOR THE NINTH CIRCUIT
`
`EDWIN HARDEMAN
`Plaintiff-Appellee/Cross-Appellant,
`
`v.
`
`MONSANTO COMPANY,
`Defendant-Appellant/Cross-Appellee
`
`On Appeal from the United States District Court
`for the Northern District of California,
`Nos. 16-cv-00525 & 16-md-02741 (Chhabria, J.)
`
`
`EDWIN HARDEMAN’S PRINCIPAL AND RESPONSE BRIEF
`
`
`Leslie A. Brueckner
`Public Justice
`475 14th St. Suite 610
`Oakland, CA 94612
`(510) 622-8205
`lbrueckner@publicjustice.net
`
`Aimee H. Wagstaff, Esq.
`David J. Wool, Esq.
`Andrus Wagstaff, PC
`7171 W. Alaska Dr.
`Lakewood, CO 80226
`(866) 795-9529
`aimee.wagstaff@andruswagstaff.com
`david.wool@andruswagstaff.com
`
`Jennifer A. Moore, Esq.
`Moore Law Group, PLLC
`1473 South 4th St.
`Louisville, KY 40208
`(502) 717-4080
`jennifer@moorelawgroup.com
`
`
`
`
`
`
`

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`TABLE OF CONTENTS
`
`6.
`
`TABLE OF AUTHORITIES ........................................................................................................... i
`INTRODUCTION .......................................................................................................................... 1
`JURISDICTION ............................................................................................................................. 4
`COUNTERSTATEMENT OF ISSUES FOR MONSANTO’S APPEAL ..................................... 5
`STATEMENT OF ISSUE FOR HARDEMAN’S CROSS APPEAL ............................................ 6
`STATEMENT OF THE CASE ....................................................................................................... 6
`A. Statutory Background. ............................................................................................... 6
`B. Regulatory Background. ............................................................................................ 8
`1.
`EPA Has Only Made Findings Regarding Glyphosate, Not Roundup. 8
`2.
`EPA’s Mixed Conclusions Regarding Glyphosate. ............................. 9
`3.
`IARC’s 2015 Finding that Glyphosate is Carcinogenic. ................... 10
`4.
`EPA’s Registration Review for Glyphosate. ..................................... 11
`5.
`The Office of Pesticide Program’s August 2019 Letter to California.
` ........................................................................................................... 13
`EPA Has Approved Proposition 65 Warnings for Glyphosate-
`Containing Pesticides. ....................................................................... 14
`C. This Lawsuit. ........................................................................................................... 14
`7.
`Background. ....................................................................................... 14
`8.
`Pre-Trial Proceedings Related to Causation. ..................................... 15
`9.
`Evidence that Roundup is More Toxic than Glyphosate. .................. 24
`10. Evidence that Monsanto Knew that Roundup and Glyphosate Are Not
`the Same. ........................................................................................... 25
`11. Evidence that Monsanto Manipulated the Science to Hide the Risks of
`Roundup. ........................................................................................... 26
`12. Evidence that Monsanto Ghostwrote Scientific Articles to
`Misrepresent that Roundup is Safe. ................................................... 29
`13. The Verdict. ....................................................................................... 30
`14. Post Trial Proceedings. ...................................................................... 31
`STANDARD OF REVIEW .......................................................................................................... 31
`SUMMARY OF ARGUMENT .................................................................................................... 32
`ARGUMENT ................................................................................................................................ 35
`i
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`2.
`
`I. PLAINTIFF’S CLAIMS ARE NEITHER EXPRESSLY NOR IMPLIEDLY
`PREEMPTED. ................................................................................................................ 35
`A. Plaintiff’s Claims Are Not Expressly Preempted. ................................................... 35
`1.
`Plaintiff’s Claims Are Not Expressly Preempted Because they Mirror
`Federal Misbranding Standards. ........................................................ 36
`EPA’s Approval of Roundup Without a Cancer Warning and Its
`Findings Regarding Glyphosate Do Not Trigger Express Preemption.
` ........................................................................................................... 38
`B. Plaintiff’s Claims Are Not Impliedly Preempted. ................................................... 43
`1.
`Any Inquiry Into Implied Preemption Foreclosed by Bates. ............. 43
`2. Monsanto’s Implied Preemption Argument Fails on the Merits. ...... 44
`II. THE DISTRICT COURT DID NOT ERR OR ABUSE ITS DISCRETION IN
`ADMITTING THE CAUSATION OPINIONS OF HARDEMAN’S EXPERTS. ........ 56
`A. The District Court Applied the Correct Standard for Determining Admissibility
`Under Daubert. ........................................................................................................ 56
`B. The District Court Did Not Abuse Its Discretion in Admitting Hardeman’s General
`Causation Experts. ................................................................................................... 61
`1.
`Hardeman’s Experts Had a Reliable Basis to Extrapolate Results
`From the Animal and Cell Studies. ................................................... 61
`The Epidemiology Proves a Reliable Association Between GBFs and
`NHL. .................................................................................................. 65
`The District Court Did Not Abuse Its Discretion In Admitting Expert
`Opinions that Discounted the Deeply Flawed Agricultural Health
`Study. ................................................................................................. 66
`4. Monsanto’s Specific Critiques of the Epidemiology Studies Relied on
`by Plaintiff’s Experts Lack Merit. ..................................................... 68
`C. The District Court Did Not Abuse Its Discretion In Admitting Hardeman’s Experts’
`Specific-Causation Opinions. .................................................................................. 72
`1.
`Hardeman’s Experts Utilized Scientific Methods and Procedures to
`Rule Out HCV. .................................................................................. 72
`Hardeman’s Experts Reliably Ruled Out Idiopathy. ......................... 73
`2.
`III. THE DISTRICT COURT DID NOT ERR IN ADMITTING EVIDENCE ABOUT
`IARC’S CLASSIFICATION WHILE EXCLUDING CUMULATIVE EVIDENCE
`REGARDING SOME FOREIGN REGULATORY AGENCIES. ................................ 78
`A. IARC’s Classification Was Properly Admitted to Counter the Prejudice from
`Bifurcation. 80
`IV. THE CAUSATION INSTRUCTION WAS PROPER. .................................................. 84
`ii
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`2.
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`3.
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`A. The Causation Instruction Properly Encapsulated California’s Substantial-Factor
`Test for Causation. .................................................................................................. 84
`B. The Causation Instruction Did Not Lessen Hardeman’s Burden of Proof. ............. 86
`V. THE EVIDENCE ON PLAINTIFF’S FAILURE-TO-WARN CLAIM SATISFIED
`CALIFORNIA LAW. ..................................................................................................... 91
`VI. THE JURY’S PUNITIVE DAMAGE AWARD WAS PROPER UNDER
`CALIFORNIA LAW AND THE U.S. CONSTITUTION. ............................................ 92
`A. The Punitive Damage Award Comported with California Law. ............................. 92
`B. The Amount of Punitive Damages Awarded by the Jury was Constitutionally
`Sound.
`96
`C. Monsanto’s Due-Process Challenge to the Punitive Damages Award Lacks Merit.
`102
`CONCLUSION ........................................................................................................................... 104
`
`CERTIFICATE OF COMPLIANCE
`
`ADDENDUM
`
`CERTIFICATE OF SERVICE
`
`iii
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`TABLE OF AUTHORITIES
`CASES ...................................................................................................................... Page(s)
`
`Adams v. Laboratory Corp. of Am., 760 F.3d 1322
`(11th Cir. 2014) ............................................................................................................. 57
`Anderson v. Owens-Corning Fiberglas Corp.,
`810 P.2d 549 (Cal. 1991) ............................................................................................... 91
`Angie M. v. Superior Ct., 44 Cal.Rptr.2d 197 (Ct. App. 1995) ......................................... 92
`Ansagay v. Dow Agrosciences LLC, 153 F. Supp. 3d 1270
`(D. Haw. 2015) .............................................................................................................. 44
`Bates v. Dow Agrosciences, 544 U.S. 431 (2005) ..................................................... passim
`BMW of N. Am., Inc. v. Gore, 517 U.S. 559, 583 (1996) ............................ 97, 98, 102, 103
`Boeken v. Philip Morris Inc., 26 Cal.Rptr.3d 638
`(Ct. App. 2005) .......................................................................................... 93, 96, 98, 101
`Buell-Wilson v. Ford Motor Co., 46 Cal.Rptr.3d 147
`(Ct. App. 2006) ............................................................................................................ 100
`Bullock v. Philip Morris USA, Inc., 131 Cal.Rptr. 382
`(Ct. App. 2011) ............................................................................................................ 101
`Burke v. Dow Chem. Co., 797 F. Supp. 1128 (E.D.N.Y. 1992) ........................................ 55
`Caudle v. Bristow Optical Co., 224 F.3d 1014 (9th Cir. 2000) ........................................ 97
`Century Surety Co. v. Polisso, 43 Cal.Rptr.3d 468 (Ct. App. 2006) ............................... 100
`Clausen v. M/V New Carissa, 339 F.3d 1049 (9th Cir. 2003) ..................................... 60, 72
`Conte v. Wyeth, Inc., 85 Cal.Rptr.3d 299 (Ct. App. 2008) ................................................ 37
`Coursen v. A.H. Robins Co., 764 F.2d 1329 (9th Cir. 1985) ............................................ 32
`Delos v. Farmers Grp., Inc., 155 Cal. Rptr. 843 (Ct. App. 1979) ................................... 102
`Espinosa v. Little Co. of Mary Hosp., 37 Cal.Rptr.2d 541
`(Ct. App. 1995) .................................................................................................................. 86
`Estate of Barabin v. AstenJohnson, Inc., 740 F.3d 457 (9th Cir. 2014)............................ 32
`Etcheverry v. Tri-Ag Service, Inc., et al., S:072524 .................................................... 37, 56
`Fellner v. Tri-Union Seafoods, LLC, 539 F.3d 237 (3d Cir. 2008) ....................... 46, 51, 52
`In re Avandia Marketing, Sales & Products Liability Litig.,
`945 F.3d 749, 757 (3d Cir. 2019) .................................................................................. 46
`In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 758 (3d Cir. 1994) .................................. 60
`In re Silicone Gel Breast Implants Products Liab. Litig.,
`318 F. Supp. 2d 879, 893 (C.D. Cal. 2004) ................................................................... 59
`Jeffers v. Wal-Mart Stores, Inc., 171 F. Supp. 2d 617
`(S.D.W.Va. 2001) ................................................................................................................ 7
`Johnson & Johnson Talcum Powder Cases (Echeverria)
`249 Cal.Rptr.3d 642, 674 (Ct. App. 2019) ................................................................. passim
`Kennedy v. Collagen Corp, 161 F.3d 1226, 1228 (9th Cir. 1998) .................................... 64
`Kumho Tire Co., Ltd. v. Carmichael, 526 U.S. 137, 153 (1999) ...................................... 67
`
`iv
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`Lakeside-Scott v. Multnomah County, 556 F.3d 797 (9th Cir. 2009).......................... 25, 32
`Lambert v. Ackerley, 180 F.3d 997, 1008 (9th Cir. 1999) ................................................. 90
`Lane v. Hughes Aircraft Co., 993 P.2d 388, 402 (Cal. 2000) ......................................... 100
`Larabee v. MM&L Int’l Corp., 896 F.2d 1112, 1116 n.6
`(8th Cir.1990) ................................................................................................................ 57
`Logacz v. Limansky, 84 Cal.Rptr.2d 257 (Ct. App. 1999) .................................... 85, 89, 90
`Major v. R.J. Reynolds Tobacco Co., 222 Cal.Rptr.3d
`563581 (Ct. App. 2017) ........................................................................................... 86, 87
`Mathias v. Accor Economy Lodging, Inc., 347 F.3d 672
`(7th Cir. 2003) ............................................................................................................... 99
`McClellan v. I-Flow Corp., 710 F. Supp. 2d 1092 (D. Or. 2010) ..................................... 71
`Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996) .......................................................... 38
`Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct.
`1668 (2019) ........................................................................................................ 45, 48, 49
`Messick v. Novartis Pharm. Corp., 747 F.3d 1193
`(9th Cir. 2014) ............................................................................................. 21, 32, 57, 58
`Milward v. Acuity Specialty Prod. Group, Inc.,
`639 F.3d 11, 26 (1st Cir. 2011) ............................................................................... 63, 64
`Mitchell v. Gonzales, 819 P.2d 872 (Cal. 1991) .......................................................... 86, 89
`Neal v. Farmers Ins. Exchange, 582 P.2d 980 (Cal. 1978) ................................. 98, 99, 100
`Pavon v. Swift Transp. Co., 192 F.3d 902 (9th Cir. 1999) ................................................ 33
`Pfeifer v. John Crane, Inc., 1 Cal.Rptr.3d 112 (Ct. App. 2013) ................................. 92, 95
`PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) ................................................................... 53
`Reckitt Benckiser, Inc. v. Jackson, 762 F. Supp. 2d 34
`(D.D.C. 2011) ................................................................................................................ 51
`Reid v. Johnson & Johnson, 780 F.3d 952 (9th Cir. 2015) ......................................... 50, 51
`Rice v. Norman Williams Co., 458 U.S. 654 (1982) ......................................................... 45
`Rider v Sandoz Pharm. Corp., 295 F.3d 1194 (11th Cir. 2002) ........................................ 64
`Riegel v. Medtronic, Inc., 552 U.S. 312 (2008) ............................................................... .41
`Romo v. Ford Motor Co., 6 Cal.Rptr.3d 793 (Ct. App. 2003) .......................................... 95
`Rutherford v. Owens-Illinois, Inc., 941 P.2d 1203 (Cal. 1997) ......................................... 84
`S.M. v. J.K., 262 F.3d 914, 921 (9th Cir. 2001),
`as amended, 315 F.3d 1058 (9th Cir. 2003) .................................................................. 67
`Schultz v. Akzo Nobel Paints, LLC, 721 F.3d 426 (7th Cir. 2013) .................................... 68
`Silkwood v. Kerr–McGee Corp., 769 F.2d 1451 (10th Cir. 1985) .................................... 94
`Simon v. San Paolo U.S. Holding Co., 113 P.3d 63 (Cal. 2005) ................................. 97, 99
`Skidmore v. Swift & Co., 323 U.S. 134, 140 (1944) .......................................................... 52
`State Farm Mut. Auto. Ins. Co. v. Campbell, 538 U.S. 408 (2003) ...................... 33, 97, 99
`Tamraz v. Lincoln Elec. Co., 620 F.3d 665 (6th Cir. 2010) .............................................. 75
`U.S. v. W.R. Grace, 504 F.3d 745 (9th Cir. 2007)................................................. 64, 69, 71
`United States v. Joetzki, 952 F.2d 1090 (9th Cir. 1991) .................................................... 79
`United States v. Mead, 533 U.S. 218 (2001) ............................................................... 40, 50
`v
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`Uriell v. Regents of Univ. of Cal., 184 Cal.Rptr.3d 79
`(Ct. App. 2015) .............................................................................................................. 85
`Viner v. Sweet, 70 P.3d 1046, 1051 (Cal. 2003) ................................................................ 86
`Wabash Valley Power Ass’n Inc. v. Rural Electrification Admin.,
`903 F.2d 445, 454 (7th Cir. 1990) ..................................................................................... 51
`Weeks v. Baker & McKenzie, 74 Cal.Rptr.2d 510 (Ct. App. 1998) .................................. 98
`Wendell v. GlaxoSmithKline LLC, 858 F.3d 1227 (9th Cir. 2017) ............................ passim
`West v. Johnson & Johnson Products, Inc., 220 Cal.Rptr. 437
`(Ct. App. 1985) ........................................................................................................ 93, 95
`Wyeth v. Levine, 555 U.S. 555 (2009) ......................................................................... 45, 95
`
`Statutes and Regulations
`
`7 U.S.C.
`§ 136a(a) .......................................................................................................................... 6
`§136 et seq. ...................................................................................................................... 5
`§136(q)(1)(F) ........................................................................................................... 37, 38
`§136a(f)(2) ....................................................................................................... 6, 7, 42, 54
`§136v(a) ......................................................................................................................... 54
`§136v(b) ..................................................................................................................... 8, 36
`
`28 U.S.C.
`§1291 ............................................................................................................................... 4
`
`C.F.R. §§156.64 ................................................................................................................. 40
`C.F.R. §§159.152 ............................................................................................................... 48
`
`California Civil Code §3294 ......................................................................................... 6, 92
`
`Other Authorities
`
`Cal. Civ. Jury Instruction (CACI) 430 .................................................................. 84, 85, 86
`Cal. Civ. Jury Instruction (CACI) 431 .................................................................. 84, 85, 86
`
`Restatement (Third) of Torts: Phys. & Emot. Harm §28 (2010) ...................................... 64
`
`vi
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`INTRODUCTION
`This appeal involves Roundup, a weed killer containing the active ingredient
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`glyphosate. Roundup also contains a number of additional ingredients that make it
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`far more carcinogenic than glyphosate alone.
`
`Despite massive market share and millions of products sold, Monsanto has
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`never attempted to determine whether Roundup causes cancer. As recently as
`
`2009, Monsanto’s chief glyphosate spokesperson bluntly stated, “[we] cannot say
`
`that Roundup does not cause cancer [because] we have not done carcinogenicity
`
`studies with ‘Roundup’.” PSER244.1 And so Roundup remains on the market,
`
`despite overwhelming evidence that the product causes cancer in humans.
`
`Starting in 2015, thousands of cancer victims sued Monsanto in state and
`
`federal courts, alleging that Roundup caused their cancer. The federal court cases
`
`were consolidated into a multidistrict litigation (“MDL”) in the Northern District
`
`of California before Judge Vince Chhabria. ER2254-56.
`
`This appeal arises out of the first and only bellwether trial in that MDL.
`
`Edwin Hardeman regularly sprayed Roundup for over 25 years on his properties.
`
`In early 2015 he was diagnosed with diffuse large B-cell lymphoma (DLBCL), a
`
`1 Citations to PSER are to Plaintiff’s Supplementary Record Excerpts.
`Citations to ER are to Monsanto’s Record Excerpts.
`1
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`subtype of non-Hodgkin’s lymphoma (NHL). He sued Monsanto in February
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`2016, alleging his cancer was caused by his long-term exposure to Roundup.
`
`In March 2019, after a month-long trial, the jury returned a verdict in favor of
`
`Hardeman, awarding him roughly $5 million in compensatory damages and $75
`
`million in punitive damages for Monsanto’s decades of undermining the science,
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`failing to test its own product, and recklessly endangering Hardeman. ER1680-81.
`
`In ruling that punitive damages were appropriate, the district court held that
`
`“the evidence easily supported a conclusion that Monsanto was more concerned
`
`with tamping down safety inquiries and manipulating public opinion than it was
`
`with ensuring that its product was safe.” ER7. As the court put it, “the evidence at
`
`trial painted the picture of a company focused on attacking or undermining people
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`who raised concerns, to the exclusion of being an objective arbiter of Roundup’s
`
`safety.” ER8-9.
`
`* * *
`
`In this appeal, Monsanto ignores the jury’s factual findings. Instead, it retells
`
`a narrative the jury already considered and rejected. Moreover, it flouts controlling
`
`Supreme Court precedent by claiming Hardeman’s claims are expressly or
`
`impliedly preempted under FIFRA. This assertion of law rests on a two-page,
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`post-verdict letter from EPA’s Office of Pesticide Program (OPP) that tells
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`registrants such as Monsanto that—contrary to EPA decisions from a few months
`2
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`ago—they cannot change their product labels to warn of glyphosate’s risks at this
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`time. Monsanto presents precisely no evidence of the factual record OPP relied
`
`upon to issue its letter; cannot claim that the letter addresses the risks of Roundup,
`
`as opposed to glyphosate; and cannot seriously maintain that an informal letter of
`
`this nature carries the force of law.
`
`The record below is the only one before this Court. And based on that record,
`
`there is substantial evidence to support the jury’s verdict. The jury heard credible
`
`evidence that Roundup is carcinogenic and that it caused Plaintiff’s cancer. It
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`reviewed Monsanto’s own admission that it has never “done carcinogenicity
`
`studies with Roundup.” PSER244. On this record, the jury’s judgment cannot be
`
`disturbed based on Monsanto’s alternative version of the facts.
`
`Nor can Monsanto escape liability by misstating the law. Monsanto’s
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`preemption argument is not only premised on a fallacy—that Roundup is
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`“synonymous” with glyphosate (Monsanto Brief (“MB”) 5 n.1)—it is also
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`foreclosed by the U.S. Supreme Court’s decision in Bates v. Dow Agrosciences,
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`544 U.S. 431 (2005), which held that FIFRA preserves state-law warning claims
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`that parallel federal misbranding standards.
`
`Monsanto’s other main legal argument—that the district court erred by
`
`applying an incorrect standard for determining admissibility of expert testimony
`
`under Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993)—is just
`3
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`as flawed. The district court heard lengthy testimony from every expert, learned
`
`the science in minute detail, and issued well-reasoned decisions on both general
`
`and specific causation, applying Daubert with precision. There was no legal error,
`
`let alone an abuse of discretion, in admitting Hardeman’s experts.
`
`Monsanto’s kitchen-sink arguments—including that the court erred in
`
`applying an incorrect jury instruction, by excluding certain regulatory
`
`classifications as cumulative, and by allowing the jury to award punitive
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`damages—hardly bear mentioning at this juncture, except to say that the Court’s
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`determinations were as detailed, deliberate, and well-considered as its Daubert
`
`rulings. Monsanto’s appeal should be rejected and the jury’s verdict, including its
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`punitive damages award, should stand.2
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`JURISDICTION
`Plaintiff-Appellee/Cross-Appellant Edwin Hardeman agrees with
`
`Monsanto’s statement of jurisdiction as to Monsanto’s appeal. This Court has
`
`jurisdiction over Hardeman’s cross appeal under 28 U.S.C. §1291.
`
`
`2 The district court’s only error was in reducing the punitive damages award
`from $75 million to $20 million. That decision, which is the subject of Plaintiff’s
`cross appeal, is addressed infra at VI(B).
`4
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`COUNTERSTATEMENT OF ISSUES FOR MONSANTO’S APPEAL
`1. Whether Hardeman’s claims are preempted under the Federal Insecticide,
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`Fungicide, and Rodenticide Act, 7 U.S.C. §136 et seq. (FIFRA), when his claims
`
`are substantively equivalent to FIFRA’s misbranding requirements.
`
`2. Whether the district court (a) applied the correct legal standard for
`
`determining admissibility of expert testimony; and (b) acted within its discretion
`
`by admitting the testimony of Hardeman’s experts as both reliable and relevant.
`
`3. Whether the district court acted within its discretion by allowing
`
`Hardeman to introduce evidence of IARC’s classification that glyphosate is a
`
`probable carcinogen during the first phase of trial in order to mitigate the
`
`substantial prejudice Hardeman suffered from bifurcation of the trial, while at
`
`same time allowing Monsanto to admit three different regulatory agencies’
`
`opposition to IARC.
`
`4. Whether the district court properly instructed the jury it could find for
`
`Hardeman if it found that Roundup caused Hardeman’s cancer and that Monsanto
`
`cannot avoid responsibility even if it other independent factors may have been
`
`sufficient on their own to cause his cancer.
`
`5. Whether the district court properly denied Monsanto’s request for
`
`judgment as a matter of law on the ground that the risks of Roundup were “known
`
`or knowable” to Monsanto in light of the overwhelming scientific evidence that
`5
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`Monsanto willfully refused to test Roundup and spent decades impeding,
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`discouraging, and distorting the science regarding Roundup’s risks.
`
`6. Whether the jury’s punitive damages award violated California Civil
`
`Code §3294 and the Due Process Clause of the Fourteenth Amendment where the
`
`jury heard overwhelming evidence that Monsanto misled regulators and the public
`
`about Roundup’s dangers in order to protect its bottom line.
`
`STATEMENT OF ISSUE FOR HARDEMAN’S CROSS APPEAL
`Whether the district court erred as a matter of law in holding that the jury’s
`
`punitive damages award of $75 million—an amount less than 0.1% of Monsanto’s
`
`net worth—was constitutionally excessive, and reducing that award to $20 million,
`
`in light of the extreme reprehensibility of Monsanto’s decades of misconduct and
`
`the fact that its intentional deception continues to threaten the health of millions of
`
`consumers worldwide.
`
`STATEMENT OF THE CASE
`A. Statutory Background.
`FIFRA requires pesticide manufacturers to register their products with the
`
`EPA. 7 U.S.C. § 136a(a). FIFRA states, however, that “[i]n no event shall
`
`registration of an article be construed as a defense for the commission of any
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`offense under this subchapter.” 7 U.S.C. §136a(f)(2). Rather, registration of a
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`
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`6
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`pesticide is merely “prima facie evidence that the pesticide, its labeling and
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`packaging comply with the registration provisions of the subchapter.” Id.
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`EPA is entirely reliant on pesticide applicants to prove that their labels comply
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`with FIFRA. See Jeffers v. Wal-Mart Stores, Inc., 171 F. Supp. 2d 617, 623
`
`(S.D.W.Va. 2001) (“EPA does not independently test, study, or otherwise set
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`particular composition standards for the pesticides.”); EPA Pesticide Registration
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`Manual Ch. 1, Overview of Requirements for Pesticide Registration (“An
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`applicant who wishes to obtain a registration for its own pesticide product is
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`responsible for submitting or citing to all of the information and data that are
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`required to support the application.”).3
`
`EPA can bring various enforcement actions against the manufacturer of a
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`registered pesticide if it determines that the product is “misbranded,” including
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`seeking civil and criminal penalties. Bates v. Dow Agrosciences LLC, 544 U.S.
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`431, 439, 439 n.11 (2005) (citation omitted).
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`A duly registered pesticide is misbranded if, inter alia, the label “does not
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`contain adequate instructions for use, or if its label omits necessary warnings or
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`cautionary statements.” Bates, 544 U.S. at 438 (citation omitted). And, “[b]ecause
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`it is unlawful under the statute to sell a pesticide that is registered but nevertheless
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`3 Available at https://tinyurl.com/u3slhsv.
`7
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`misbranded, manufacturers have a continuing obligation to adhere to FIFRA’s
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`labeling requirements.” Id. at 438 (citations omitted). These obligations include a
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`duty to seek approval to amend a label that does not contain all “necessary
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`warnings or cautionary statements.” Id.
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`EPA’s decision to register a pesticide also does not render a manufacturer
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`immune from regulation by the States; to the contrary, a State can regulate or even
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`ban a federally registered pesticide, even if the EPA does not consider it
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`misbranded under FIFRA. Id. at 446 (citation omitted).
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`FIFRA’s only limitation on state authority is set forth in the Act’s preemption
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`clause: 7 U.S.C. §136v(b). As Bates explained, this provision is “narrow.” 544
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`U.S. at 452. Although Section 136v(b) “reaches beyond positive enactments…to
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`embrace common-law duties,” id. at 443, it “prohibits only state-law labeling and
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`packaging requirements that are ‘in addition to or different from’ the labeling and
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`packaging requirements under FIFRA.” Id. at 447 (quoting 7 U.S.C. §136v(b);
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`(emphasis in original).
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`B. Regulatory Background.
`1. EPA Has Only Made Findings Regarding Glyphosate, Not
`Roundup.
`Starting in 1974, EPA has registered various pesticide formulations containing
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`glyphosate, the active ingredient in Roundup. See EPA, Glyphosate: Proposed
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`Interim Registration Review Decision (Apr. 23, 2019), (“2019 Interim Glyphosate
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`Review”).4 A glyphosate-based formulation (GBF) is a product that contains
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`glyphosate plus other ingredients that make the product more effective and/or
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`longer lasting. PSER4895
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`Roundup is such a product: it contains glyphosate, water, and other
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`ingredients (called “surfactants”) that make it a potent weedkiller (and also, as the
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`jury found, a particularly carcinogenic herbicide).
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`Over the past 40 years, EPA has only made findings regarding the
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`carcinogenicity of glyphosate, not the formulated product Roundup. PSER489-93.
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`2. EPA’s Mixed Conclusions Regarding Glyphosate.
`Even EPA’s conclusions about glyphosate have been mixed. EPA first
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`reviewed the potential carcinogenic effects of glyphosate in 1985. In that year, an
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`EPA review of a mouse study found that “glyphosate was oncogenic in male
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`mice,” causing rare tumors. PSER264. EPA classified glyphosate as a possible
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`human carcinogen. PSER486.
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`4 Available at https://tinyurl.com/y6h2u8w6.
` See EPA, Revised Glyphosate Issue Paper: Evaluation of Carcinogenic
`Pot