Case 3:16-md-02741-VC Document 22749 Filed 10/30/26 Page 1 of 10 PageID #: 453912 1 MATTHEW V.H. NOLLER (Bar No. 325180) mnoller@kslaw.com 2 KING & SPALDING LLP 50 California St., Suite 3300 3 San Francisco, CA 94111 (415) 318-1200 4 JEFFREY S. BUCHOLTZ (pro hac vice forthcoming) 5 jbucholtz@kslaw.com KING & SPALDING LLP 6 1700 Pennsylvania Avenue NW Washington, DC 20006 7 (202) 737-0500 8 9 Attorneys for Amicus Curiae 10 UNITED STATES DISTRICT COURT 11 NORTHERN DISTRICT OF CALIFORNIA 12 SAN FRANCISCO DIVISION 13 14 IN RE: ROUNDUP PRODUCTS LIABILITY Case No. 3:16-md-02741-VC 15 LITIGATION BRIEF OF THE CHAMBER OF 16 This document relates to: COMMERCE OF THE UNITED STATES OF AMERICA AND THE WASHINGTON 17 ALL CASES LEGAL FOUNDATION AS AMICI CURIAE IN SUPPORT OF DEFENDANTS 18 19 20 21 22 23 24 25 26 27 28 BRIEF OF AMICI CURIAE Case No. 3:16-md-02741 Case 3:16-md-02741-VC Document 22749 Filed 10/30/26 Page 2 of 10 PageID #: 453913 1 TABLE OF CONTENTS 2 INTERESTS OF AMICI CURIAE ................................................................................................... 1 3 ARGUMENT ................................................................................................................................... 1 I. FIFRA preemption turns on the substance of Plaintiffs’ claims, not their labels. ......... 2 4 II. Allowing Plaintiffs to avoid preemption through artful pleading would have harmful 5 consequences. ................................................................................................................. 5 6 CONCLUSION ................................................................................................................................ 8 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 i BRIEF OF AMICI CURIAE Case No. 3:16-md-02741 Case 3:16-md-02741-VC Document 22749 Filed 10/30/26 Page 3 of 10 PageID #: 453914 1 INTERESTS OF AMICI CURIAE1 2 The Chamber of Commerce of the United States of America (“Chamber”) is the world’s 3 largest business organization. As the nation’s leading advocate for business, the Chamber 4 represents companies and professional organizations of every size, in every industry sector, and 5 from every region of the country. An important function of the Chamber is to represent the interests 6 of its members in matters before Congress, the Executive Branch, and the courts. To that end, the 7 Chamber regularly files amicus curiae briefs in cases, like this one, that raise issues of concern to 8 the nation’s business community. 9 The Washington Legal Foundation (“WLF”) is a non-profit, public-interest law firm and 10 policy center with supporters nationwide. WLF promotes free enterprise, individual rights, limited 11 government, and the rule of law. It often appears as amicus curiae in important federal preemption 12 cases, urging courts to ensure that federal law operates efficiently and uniformly—as Congress 13 intended. WLF believes that conflicting federal and state-law duties are not merely inefficient; they 14 are also unfair, making it impossible for regulated parties to comply with both state and federal law 15 without incurring enormous liability. 16 As the Court’s order inviting amicus briefs suggests, this is an important case raising many 17 issues of concern to amici and their members and supporters. In particular, this case presents a clear 18 example of the troubling phenomenon of plaintiffs using artful pleading to try to avoid federal 19 preemption. Preemption protects national uniformity in important markets and shields defendants 20 from burdensome and improper litigation of state-law claims in circumstances where federal law 21 controls. But, as here, plaintiffs often use pleading labels to avoid preemption defenses in an attempt 22 to force burdensome and expensive litigation and thereby obtain a settlement. Amici and their 23 members and supporters have a substantial interest in courts policing the pleading tactics at play in 24 this case. 25 ARGUMENT 26 In Monsanto Company v. Durnell, 609 U.S. 371 (2026), the Supreme Court held that the 27 1 No counsel for any party authored this brief in whole or in part, and no entity or person, aside 28 from amici curiae, their members, or their counsel, made any monetary contribution intended to fund the preparation or submission of this brief. 1 BRIEF OF AMICI CURIAE Case No. 3:16-md-02741 Case 3:16-md-02741-VC Document 22749 Filed 10/30/26 Page 4 of 10 PageID #: 453915 1 Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) expressly preempts state-law 2 claims that Monsanto failed to warn of alleged cancer risks associated with its pesticide Roundup. 3 Throughout this case, Plaintiffs have sought to pursue precisely such failure-to-warn claims against 4 Monsanto. After Durnell, there can be no serious dispute that FIFRA preempts those claims. To 5 avoid that result, however, Plaintiffs now argue that they are not alleging failure to warn after all. 6 Plaintiffs contend (for example) that Monsanto falsely advertised Roundup by failing to disclose 7 its cancer risks or that Monsanto defectively designed Roundup. And Plaintiffs argue that these 8 theories survive FIFRA preemption simply because Plaintiffs have rephrased them in a way that 9 does not expressly mention Roundup’s label. 10 This Court should reject Plaintiffs’ attempt to “elevate form over substance” in this way. 11 Aetna Health Inc. v. Davila, 542 U.S. 200, 214 (2004) (quotation marks omitted). Preemption turns 12 on the substance of a plaintiff’s claims, not on “the particular label affixed to them.” Id. Under 13 Durnell, therefore, FIFRA preempts any claim that would have the effect of requiring a 14 manufacturer to give a warning that does not appear on a pesticide’s EPA-approved label. 609 U.S. 15 at 390. As Monsanto explains, that is what Plaintiffs’ claims would require. FIFRA thus preempts 16 those claims—no matter what Plaintiffs tactically choose to call them. 17 Allowing such claims to survive would cause multiple undesirable outcomes. First, it would 18 destroy the nationwide uniformity that Congress enacted FIFRA’s preemption provision to protect 19 by allowing individual lay juries to override the EPA’s expert assessments as to the safety of 20 pesticides sold under an EPA-approved label. Second, it would jeopardize near-identical 21 preemption provisions in a variety of other statutes, leading to a confusing morass of different 22 warnings across several industries in which Congress has tried to ensure nationwide uniformity. 23 Third, it would expose businesses to significantly greater litigation costs, reducing the number of 24 important products available to consumers and increasing the prices of products that remain on the 25 market. The Court should avoid these harms by enforcing FIFRA’s preemption provision against 26 Plaintiffs’ claims. 27 I. FIFRA preemption turns on the substance of Plaintiffs’ claims, not their labels. 28 FIFRA expressly preempts any state law that “impose[s] or continue[s] in effect any 2 BRIEF OF AMICI CURIAE Case No. 3:16-md-02741 Case 3:16-md-02741-VC Document 22749 Filed 10/30/26 Page 5 of 10 PageID #: 453916 1 requirements for labeling or packaging in addition to or different from those required under” 2 FIFRA. 7 U.S.C. § 136v(b). Whether that provision applies to a tort claim thus depends on whether 3 it relies on an alleged state-law “requirement[] for labeling or packaging” that is “in addition to or 4 different from” requirements imposed by FIFRA and its implementing regulations. Durnell, 609 5 U.S. at 387-88 (quotation marks omitted). If so, FIFRA expressly preempts the claim. Id.; Taylor 6 AG Indus. v. Pure-Go, 54 F.3d 555, 560-61 (9th Cir. 1995).2 7 This analysis turns on the substance, not the label, of a plaintiff’s claim. To be sure, an 8 acknowledged failure-to-warn claim based on a pesticide’s label falls within section 136v(b)’s 9 preemptive scope. But that does not mean, as Plaintiffs argue, that FIFRA preemption is limited to 10 claims that plaintiffs choose to describe as “label-based failure-to-warn” claims. Dkt. No. 22682-1 11 at 1. To the contrary, the Supreme Court held in Durnell that FIFRA preempts “any state tort claim 12 that would require a pesticide manufacturer to use a label” other than “the EPA-approved label.” 13 609 U.S. at 390 (emphasis added); see also Bates v. Dow Agrosciences LLC, 544 U.S. 431, 452 14 (2005) (“The provision also pre-empts any statutory or common-law rule that would impose a 15 labeling requirement that diverges from those set out in FIFRA and its implementing regulations.” 16 (emphasis added)). So, no matter what a plaintiff chooses to call its claim—false advertising, design 17 defect, negligence, implied warranty, or anything else—FIFRA preempts the claim if, in substance, 18 it would require a pesticide manufacturer to provide a warning that does not appear on the EPA- 19 approved label. In Bates, for instance, the Court held that section 136v(b) could preempt not only 20 the plaintiffs’ “negligent failure-to-warn claims,” but also fraud claims that were not expressly 21 designated as failure-to-warn claims, because those fraud claims still sought to enforce “a standard 22 for a product’s labeling that the [defendant’s] label [was] alleged to have violated by containing 23 false statements and inadequate warnings.” 544 U.S. at 446; see also id. at 456 (Thomas, J., 24 concurring in part) (“A state-law cause of action, even if not specific to labeling, nevertheless 25 2 As Monsanto argues, FIFRA also impliedly preempts claims that conflict with FIFRA and its 26 implementing regulations, even if not related to labeling. E.g., Dkt. No. 22735 at 8-12. For 27 example, FIFRA “prohibits selling a pesticide if its ‘composition’ differs from the composition described at registration.” Durnell, 609 U.S. at 378 n.1 (quoting 7 U.S.C. § 136j(a)(1)(C)). That 28 prohibition preempts any claim that would require Monsanto to change Roundup’s composition in a manner not permitted by FIFRA. See Mutual Pharm. Co. v. Bartlett, 570 U.S. 472, 486 (2013). 3 BRIEF OF AMICI CURIAE Case No. 3:16-md-02741 Case 3:16-md-02741-VC Document 22749 Filed 10/30/26 Page 6 of 10 PageID #: 453917 1 imposes a labeling requirement ‘in addition to or different from’ FIFRA’s when it attaches liability 2 to statements on the label that do not produce liability under FIFRA.”).3 3 Outside the FIFRA context, the Supreme Court repeatedly has refused to “distinguish[] 4 between pre-empted and non-pre-empted claims based on the particular label affixed to them,” 5 which would improperly “elevate form over substance.” Davila, 542 U.S. at 214 (cleaned up); cf. 6 Chi. & N.W. Transp. Co. v. Kalo Brick & Tile Co., 450 U.S. 311, 324 (1981) (“[C]ompliance with 7 the intent of Congress cannot be avoided by mere artful pleading.”). The federal courts of appeals 8 thus have rejected attempts, like Plaintiffs’ here, to avoid preemption by relabeling what are in 9 essence failure-to-warn claims. See, e.g., Strayhorn v. Wyeth Pharms., Inc., 737 F.3d 378, 394-98 10 (6th Cir. 2013) (holding that the Food, Drug, and Cosmetic Act preempted warranty, fraud, and 11 design-defect claims that were “essentially failure to warn claims”); Papas v. Upjohn Co., 985 F.2d 12 516, 519 (11th Cir. 1993) (holding that FIFRA preempted “claims challenging the adequacy of 13 warnings on materials other than the label or package of a product,” which “necessarily imply that 14 the labeling and packaging failed to warn the user”). 15 This Court should take the same approach. Whatever state-law causes of action Plaintiffs 16 invoke, Plaintiffs may not enforce any “requirement[] for labeling or packaging” that is “in addition 17 to or different from” FIFRA’s requirements. 7 U.S.C. § 136v(b). As Monsanto explains, that is 18 what Plaintiffs are seeking to do. See, e.g., Dkt. No. 22735. For example, Plaintiffs contend that 19 Monsanto should have included cancer warnings in its advertisements, but such an advertising- 20 based claim is preempted because it “necessarily challenge[s] the adequacy of the warnings 21 provided on the product’s labeling or packaging.” Taylor, 54 F.3d at 561 (quotation marks omitted) 22 (quoting Papas v. Upjohn Co., 985 F.2d 516, 519 (11th Cir. 1993)); see also Yousefzadeh v. 23 Johnson & Johnson Consumer Inc., 184 F.4th 130, 150-51 & n.6 (2d Cir. 2026) (holding 21 U.S.C. 24 § 379r(a)(2)’s equivalent preemption provision for non-prescription drugs preempted claim based 25 on “marketing and advertising,” and citing cases holding the same under FIFRA). FIFRA thus 26 preempts Plaintiffs’ advertising-based claim, as well as any other claim that is substantively a 27 3 The Court remanded for the district court to decide in the first instance whether the plaintiffs’ 28 claims sought to enforce requirements that “diverge[d] from those set out in FIFRA and its implementing regulations.” Id. at 452-53. 4 BRIEF OF AMICI CURIAE Case No. 3:16-md-02741 Case 3:16-md-02741-VC Document 22749 Filed 10/30/26 Page 7 of 10 PageID #: 453918 1 failure-to-warn claim, no matter what Plaintiffs label those claims. 2 II. Allowing Plaintiffs to avoid preemption through artful pleading would have harmful consequences. 3 If approved, Plaintiffs’ attempt to avoid FIFRA preemption by relabeling their claims 4 “would nullify FIFRA’s preemption clause.” Durnell, 609 U.S. at 388. It is hard to imagine a 5 failure-to-warn claim that any clever lawyer could not redescribe as, for example, a false- 6 advertising or design-defect claim: Instead of openly characterizing the allegedly tortious conduct 7 as a failure to warn, a plaintiff’s lawyer easily could allege that an advertisement was “false” 8 because it did not include a given warning or that the product was defectively designed because it 9 posed an alleged risk that the company did not warn about. See Restatement (Third) of Torts: Prod. 10 Liab. § 2 (1998) (explaining that “inadequate instructions or warnings” are a category of “[p]roduct 11 [d]efect”); W. Page Keeton, Products Liability-Inadequacy of Information, 48 Tex. L. Rev. 398, 12 403 (1970) (“[T]he question whether a product was properly designed is inseparable from the 13 question whether adequate instructions are provided to [e]nsure safe usage.”). Allowing section 14 136v(b) to be so easily evaded would “expose manufacturers to potentially massive tort liability 15 for doing what EPA required them to do and eviscerate the uniformity of EPA’s labeling 16 determinations.” Id. at 392 (cleaned up). 17 That result, which is forbidden by FIFRA, would threaten nationwide markets and the 18 agricultural industry more broadly. FIFRA allows the best-equipped decisionmakers—the EPA in 19 consultation with the Department of Agriculture—to make a single nationwide judgment as to 20 whether a pesticide is safe and accompanied by appropriate warnings. Plaintiffs’ claims would 21 instead transfer that power to local juries who lack the same economic and scientific resources, 22 undermining Congress’s careful regulatory scheme. Congress recognized that removing pesticides 23 from the market can have major effects on the availability of important crops and food prices. 24 Congress therefore included layers of protections in the pesticide cancellation process to prevent 25 economic disruption. See 7 U.S.C. § 136d (requiring, among other things, consideration of 26 economic effects of cancellation, evidentiary hearings upon request, and judicial review of 27 cancellation decision). Plaintiffs here seek the same practical outcome as cancellation—removing 28 5 BRIEF OF AMICI CURIAE Case No. 3:16-md-02741 Case 3:16-md-02741-VC Document 22749 Filed 10/30/26 Page 8 of 10 PageID #: 453919 1 Roundup from shelves—without any of the same protections. Indeed, Plaintiffs’ claims would 2 allow a jury in a single jurisdiction to second-guess whether a pesticide can remain on shelves, no 3 matter its importance to the broader agricultural industry, food prices, and the national economy. 4 These consequences would not be limited to pesticides and agriculture. As the Supreme 5 Court recognized in Durnell, allowing claims like Plaintiffs’ “to overcome preemption would affect 6 more than FIFRA” because numerous other “federal statutes across a range of industries contain 7 similar or identical labeling preemption provisions.” 609 U.S. at 387.4 For example, the Medical 8 Device Amendments bar states from “establish[ing] or continu[ing] in effect … any requirement 9 … which is different from, or in addition to, any requirement” under that law. 21 U.S.C. § 360k(a). 10 Similarly, the Federal Meat Inspection Act prohibits states from imposing any “[m]arking, labeling, 11 packaging, or ingredient requirements in addition to, or different than, those made under this [Act].” 12 21 U.S.C. § 678 (emphasis added). Other examples abound. See, e.g., id. § 1052(b) (egg labeling); 13 id. § 467e (labeling poultry and poultry products); id. § 379s(a) (cosmetic labeling); id. § 379r(a)(2) 14 (non-prescription drug labeling); id. § 387p(a)(2)(A) (tobacco product labeling); id. § 343-1(a)(2)- 15 (4) (food labeling). If this Court were to hold that FIFRA’s preemption provision could be avoided 16 merely by relabeling a failure-to-warn claim, then other courts could be led to transplant the same 17 misguided reasoning into all these other provisions, disrupting “the uniformity that Congress 18 sought.” Durnell, 609 U.S. at 388. 19 That, in turn, would “work against our national marketplace, confuse consumers, raise 20 prices, undermine public confidence in our regulatory system and in products important to the 21 public health, and result in divergent public health protection throughout the country.” FDA 22 Modernization and Accountability Act, S. Rep. No. 105-43, at 64 (1997). In the context of non- 23 prescription drugs, for example, FDA has sought to ensure that warning labels are clear and 24 readable and contain “the least amount of information possible to assure proper self-selection and 25 use.” FDA, Over-the-Counter Human Drugs; Labeling Requirements, 64 Fed. Reg. 13,254, 13,269 26 4 In addition, other federal statutes use the same preemption language for state requirements outside 27 the labeling context. See, e.g., 21 U.S.C. § 379aa(h) (serious adverse event reports for non- prescription drugs); id. § 379aa-1(h) (serious adverse event reports for dietary supplements); 7 28 U.S.C. § 4817(b) (promotion and consumer education regarding pork); 15 U.S.C. § 78o(i) (regulation of brokers and dealers). 6 BRIEF OF AMICI CURIAE Case No. 3:16-md-02741 Case 3:16-md-02741-VC Document 22749 Filed 10/30/26 Page 9 of 10 PageID #: 453920 1 (Mar. 17, 1999). Jumbled warnings that change from brand to brand and state to state would 2 undermine that goal. Moreover, if labels were overloaded with disclaimers to avoid potential 3 litigation, consumers may discount all the warnings as equally unimportant. FDA has long sought 4 to prevent such “overwarning” by designing labels “so that less important information does not 5 overshadow more important information.” Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299, 6 304 (2019) (quotation marks omitted) (quoting FDA, Supplemental Applications Proposing 7 Labeling Changes for Approved Drugs, Biologics, and Medical Devices, 73 Fed. Reg. 49,603, 8 49,605-49,606 (Aug. 22, 2008)). FDA further seeks to ensure that labels “exclude exaggeration of 9 risk, or inclusion of speculative or hypothetical risks, that could discourage appropriate use of a 10 beneficial drug.” Id. (cleaned up) (quoting FDA, Supplemental Applications Proposing Labeling 11 Changes for Approved Drugs, Biologics, and Medical Devices, 73 Fed. Reg. 2848, 2851 (Jan. 16, 12 2008)). Preemption could not protect any of these important goals if plaintiffs could avoid preemption 13 through the mere contrivance of labeling their claims something other than “failure to warn.” 14 Allowing idiosyncratic labeling requirements under state law would also increase 15 regulatory compliance and litigation costs. Businesses already are subject to comprehensive 16 regulatory schemes under both federal and state law, which cost hundreds of billions of dollars 17 annually. See, e.g., U.S. Chamber of Commerce Found., The Regulatory Impact on Small Business: 18 Complex. Cumbersome. Costly. at 4 (Mar. 2017), https://perma.cc/6DVW-8MY3; Nicole V. Crain 19 & W. Mark Crain, Nat’l Ass’n of Mfrs., The Cost of Federal Regulation to the U.S. Economy, 20 Manufacturing & Small Business at 4-5 (Oct. 2023), https://perma.cc/88NS-KNAT. Allowing each 21 of the 50 states to adopt its own unique rulebook for labels and warnings across a variety of 22 industries would compound those existing burdens by subjecting businesses to a thicket of different 23 state requirements. As the Supreme Court has recognized, allowing “50 different labeling regimes 24 prescribing the color, font size, and wording of warnings … would create significant inefficiencies 25 for manufacturers” and deprive them of the “uniformity” they “need” to operate. Bates, 544 U.S. 26 at 452 & n.26. The flood of different (and perhaps conflicting) warnings would also “driv[e] 27 consumers who buy … products in more than one state crazy.” Turek v. Gen. Mills, Inc., 662 F.3d 28 423, 426 (7th Cir. 2011). 7 BRIEF OF AMICI CURIAE Case No. 3:16-md-02741 Case 3:16-md-02741-VC Document 22749 Filed 10/30/26 Page 10 of 10 PageID #: 453921 1 Opening the door to state-law litigation over requirements that Congress and federal 2 agencies chose not to impose would also force manufacturers and retailers to engage in costly legal 3 battles to defend against state-specific claims that may differ from jurisdiction to jurisdiction. This 4 is no small risk. The U.S. tort system’s commercial liability costs totaled $367 billion in 2022, an 5 increase of 13.3 percent over the year before. See U.S. Chamber of Com. Inst. for Legal Reform, 6 Tort Costs in America 7 (3d ed. Nov. 2024).5 Those costs can dissuade manufacturers from 7 investing the vast sums necessary to develop their important products in the first place. See 8 Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1346–47 (10th Cir. 2015) (Gorsuch, J.) (discussing 9 medical devices). At a minimum, increasing litigation costs lead to higher prices, as manufacturers 10 are forced to recover the costs through their sales. See Richard L. Manning, Products Liability and 11 Prescription Drug Prices in Canada and the United States, 40 J.L. & Econ. 203, 227 (1997) 12 (finding that “a substantial premium exists in U.S. pharmaceutical prices, strongly related to the 13 prospective costs of litigation, which is absent in the Canadian prices”). 14 Such an approach would increase costs for all manufacturers, large and small, as well as 15 downstream business enterprises and ordinary consumers, who would face higher prices and have 16 access to fewer valuable goods and services. Avoiding that outcome is a worthwhile goal that 17 Congress properly pursued through preemption provisions like FIFRA’s. Plaintiffs should not be 18 able to avoid those provisions—and impose the very harms Congress sought to prevent—through 19 the sort of artful pleading that Plaintiffs are attempting in this case. 20 CONCLUSION 21 The Court should hold that Plaintiffs’ claims are preempted by FIFRA. 22 23 Dated: October 30, 2026 KING & SPALDING LLP 24 By: Matthew V.H. Noller MATTHEW V.H. NOLLER 25 (Bar No. 325180) 26 JEFFREY S. BUCHOLTZ (pro hac vice forthcoming) 27 28 5 https://www.uschamber.com/assets/documents/ilr/2024_ILR_USTorts-CostStudy-FINAL.pdf 8 BRIEF OF AMICI CURIAE Case No. 3:16-md-02741