Chapman v. Monsanto Company

IN THE UNITED STATES DISTRICT COURT August 31, 2022

FOR THE SOUTHERN DISTRICT OF TEXAS Nathan Ochsner, Clerk

HOUSTON DIVISION

OTIS LINDELL CHAPMAN

AND KIM CHAPMAN, §

§

Plaintiffs, §

§

v. § CIVIL ACTION NO. H-22-738

§

MONSANTO COMPANY, §

§

Defendant. §

MEMORANDUM AND OPINION

Roundup is an herbicide used to kill weeds. Glyphosate is the active ingredient in

Roundup. In 1985, the Environmental Protection Agency briefly classified glyphosate as a

possible human carcinogen after a study found that “glyphosate was oncogenic in male mice.”

Since then, however, the EPA has repeatedly stated that glyphosate is unlikely to be carcinogenic

to humans. The EPA, which registers Roundup and periodically reviews and reregisters

glyphosate as a condition for Monsanto to distribute and market Roundup, has not required

Monsanto to include a warning on Roundup that glyphosate may cause cancer in humans.

In 2015, the International Agency for Research on Cancer classified glyphosate as

“probably carcinogenic to humans,” based on studies that found an association between glyphosate

exposure and non-Hodgkin’s lymphoma, a cancer that affects white blood cells. That classification

triggered state and federal lawsuits against Monsanto brought by tens of thousands of individuals

with non-Hodgkin’s lymphoma. Many of those cases were consolidated into a multi-district

litigation in the Northern District of California. The MDL court has handled discovery, held

Daubert hearings for expert witnesses, and decided pretrial dispositive and nondispositive

motions. The court also held a bellwether trial that resulted in a jury award to the plaintiff of

$5,066,667 in compensatory damages and $75,000,000 in punitive damages, which were later

reduced to $20,000,000. Many cases in the MDL have settled. This case has not. The MDL court

remanded this case in April 2022.

Otis Lindell Chapman used two Roundup products—Roundup® Weed & Grass Killer

Concentrate and Roundup® Ready-to-Use Weed & Grass Killer—intermittently for 20 years, from

1987 to 2018, around his home’s sidewalk, driveway, and trees. (Docket Entry No. 72-2, at 12–

13). In 2003, he was diagnosed with non-Hodgkin’s lymphoma. Chapman was successfully

treated for the cancer, but after a long period of remission, it returned. Chapman alleges that the

Roundup products, and Monsanto’s omissions or actions in designing Roundup, failing to warn

about its carcinogenic risks, and mispresenting or breaching warranties relating to safety, caused

his non-Hodgkin’s lymphoma. He asserts state-law claims of design defect, failure to warn,

negligence, and breach of express and implied warranty. His wife, Kim Chapman, has also sued

for loss of consortium.

Monsanto moved for summary judgment under a Texas statute, §82.008(c) of the Texas

Civil Practice & Remedies Code. Section 82.008(c) provides a rebuttable presumption that a

defendant is not liable for a plaintiff’s injuries related to “some aspect of the formulation, labeling,

or design of a product” that was approved or licensed for sale by a federal agency. Tex. Civ. Prac.

& Rem. Code § 82.008(c). A plaintiff can rebut the presumption of nonliability by showing that

“the standards or procedures used in a particular pre-market approval or licensing process were

inadequate to protect the public from unreasonable risks of injury or damage.” Id. § 82.008(c)(1).

A plaintiff can also rebut the presumption by showing that the defendant, “before or after pre-

market approval or licensing of the product, withheld from or misrepresented to the government

or agency information that was material and relevant to the performance of the product and was

causally related to the claimant’s injury.” Id. § 82.008(c)(2).

Monsanto argues that this Texas law, a tort-reform product, precludes its liability on the

Chapmans’ product-liability claims, because the EPA repeatedly approved and registered

Roundup and its active ingredient, glyphosate, for distribution and sale. Monsanto argues that it

is entitled to the presumption against liability under § 82.008(c), and that the Chapmans have not

come forward with record evidence rebutting the presumption. Monsanto also argues that federal

law (specifically, the Federal Insecticide, Fungicide, and Rodenticide Act) preempts the

Chapmans’ from proving under § 82.008(c)(2) that Monsanto is liable because it “withheld from

or misrepresented” material and relevant information about Roundup products to the EPA.

The Chapmans oppose the motion. The Chapmans initially argued that Monsanto was not

entitled to the presumption against liability because the EPA has never approved the composite

Roundup product, as opposed to its individual ingredients (like glyphosate). The court requested

supplemental briefing on whether the EPA has approved the specific Roundup products at issue in

this litigation, and Monsanto provided evidence that EPA had registered the products at issue. The

Chapmans have abandoned this argument. (See Docket Entry No. 74).

The Chapmans instead argue that even if Monsanto is entitled to the presumption, the

presumption is rebutted because there is evidence that the EPA’s approval process was inadequate

to protect the public from unreasonable risk of injury, and there is evidence that Monsanto

repeatedly withheld relevant information about, and misrepresented the risks of, Roundup to the

EPA. Monsanto responds by challenging the evidence of inadequate standards and procedures

used to register Roundup on which the Chapmans rely, and by arguing that federal law preempts

the Chapmans’ claim of “fraud on the EPA.”

Based on the motion, the briefs, the supplemental briefs, the record, the oral argument, and

the applicable case law, the court denies Monsanto’s motion for summary judgment. The reasons

are set out below.

I. The Summary Judgment Standard

“Summary judgment is appropriate only when ‘the movant shows that there is no genuine

dispute as to any material fact and the movant is entitled to judgment as a matter of law.’”

Shepherd ex rel. Est. of Shepherd v. City of Shreveport, 920 F.3d 278, 282–83 (5th Cir. 2019)

(quoting Fed. R. Civ. P. 56(a)). “A material fact is one that might affect the outcome of the suit

under governing law,” and “a fact issue is genuine if the evidence is such that a reasonable jury

could return a verdict for the non-moving party.” Renwick v. PNK Lake Charles, LLC, 901 F.3d

605, 611 (5th Cir. 2018) (citations and quotation marks omitted). The moving party “always bears

the initial responsibility of informing the district court of the basis for its motion,” and identifying

the record evidence “which it believes demonstrate[s] the absence of a genuine issue of material

fact.” Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986).

When the moving party has met its Rule 56(c) burden, the nonmoving party cannot survive

a summary judgment motion by resting on the mere allegations of its pleadings. The nonmovant

must identify specific evidence in the record and articulate how that evidence supports that party’s

claim. Willis v. Cleco Corp., 749 F.3d 314, 317 (5th Cir. 2014). “A party cannot defeat summary

judgment with conclusory allegations, unsubstantiated assertions, or only a scintilla of evidence.”

Lamb v. Ashford Place Apartments LLC, 914 F.3d 940, 946 (5th Cir. 2019) (citation and quotation

marks omitted). In deciding a summary judgment motion, “the evidence of the nonmovant is to

be believed, and all justifiable inferences are to be drawn in his or her favor.” Waste Mgmt. of La.,

LLC v. River Birch, Inc., 920 F.3d 958, 972 (5th Cir. 2019) (alterations omitted) (quoting Tolan v.

Cotton, 572 U.S. 650, 656 (2014)).

II. Analysis

A. Waiver

The Chapmans first argue that Monsanto’s motion for summary judgment should be

denied, because Monsanto cannot raise new arguments on summary judgment after the dispositive

motion deadline has passed. This argument is without merit, because this court already granted

Monsanto’s motion for leave to file for summary judgment. This court did not explicitly state its

reasons on the record for granting the motion, however, and so clarifies those reasons now.

In October 2016, the Judicial Panel on Multidistrict Litigation created an MDL in the

Northern District of California to coordinate for pretrial proceedings federal court cases in which

plaintiffs alleged that Roundup caused their non-Hodgkin’s lymphoma. In re Roundup Liability

Litig., 214 F. Supp. 3d 1346 (J.P.M.L. 2016). The Chapmans filed this case in the Southern District

of Texas in December 2019, and the MDL Panel transferred the case to the MDL in February 2020.

This case became part of the “third wave” of cases in the MDL.

The parties in the “Wave 3” cases completed discovery and filed dispositive motions in the

MDL court in September 2021. Monsanto moved for summary judgment based on a different

provision of the Texas Product Liability Act, § 82.008(a). Monsanto argued that it was entitled to

a presumption of no liability under § 82.008(a) on the Chapmans’ claims of strict-liability design

defect, failure to warn, negligence, breach of express and implied warranty, and loss of consortium.

In re Roundup Prods. Liab. Litig., Case No. 3:20-cv-01277-CV, Docket Entry No. 14, at 6 (N.D.

Cal. Sept. 21, 2021). Section 82.001(a) provides that:

there is a rebuttable presumption that the product manufacturer or seller is not liable

for any injury to a claimant caused by some aspect of the formulation, labeling, or

design of a product if the product manufacturer or seller establishes that the

product’s formula, labeling, or design complied with mandatory safety standards or

regulations adopted and promulgated by the federal government, or an agency of

the federal government, that were applicable at the time of manufacture and that

governed the product risk that allegedly caused harm.

Tex. Civ. Prac. & Rem. Code § 82.008(a).

Monsanto argued that “Roundup’s design, formulation, and labeling have been, at all times,

subject to mandatory standards and regulations promulgated by the U.S. Environmental Protection

Agency,” and that because “Roundup has been, and remains, fully compliant with EPA governance

in both its glyphosate formulation and labeling,” Monsanto was entitled to an rebuttable

presumption of non-liability under the Act.

The MDL court denied Monsanto’s motion for summary judgment, holding that Monsanto

had moved under the wrong provision of the Texas Product Liability Act. Instead of moving under

§ 82.001(a) of the Act, which provides a presumption of no liability for products that comply with

mandatory safety standards or regulations, Monsanto should have moved under § 82.001(c), which

provides a presumption of no liability for products that have received a federal agency’s approval

or license for sale. See In re Roundup Prods. Liab. Litig., MDL No. 2741, 2021 WL 6125536

(N.D. Cal. Dec. 28, 2021). Section (c) states that:

there is a rebuttable presumption that the product manufacturer or seller is not liable

for any injury to a claimant allegedly caused by some aspect of the formulation,

labeling, or design of a product if the product manufacturer or seller establishes that

the product was subject to pre-market licensing or approval by the federal

government, or an agency of the federal government, that the manufacturer

complied with all of the government’s or agency’s procedures and requirement with

respect to pre-market licensing or approval, and that after full consideration of the

product’s risks and benefits the product was approved or licensed for sale by the

government or agency.

Tex. Civ. Prac. & Rem. Code Ann. § 82.008(c).

After denying summary judgment, the MDL court suggested that this case be remanded to

the Southern District of Texas for trial, because discovery in this case was complete, the dispositive

motion deadline had passed, and the case had not settled following the MDL court’s denial of

summary judgment. The MDL court stated that the only remaining issue for this court to handle,

other than trial, were motions in limine that the MDL court had denied without prejudice so that

the parties could refile them before this court.

This case was transferred back to the Southern District of Texas in March 2022, and

assigned to this court. This court held a status conference on April 12, 2022. At that status

conference, Monsanto moved for leave to file another motion for summary judgment, this time

under § 82.008(c) of the Texas Product Liability Act. This court granted the motion, and ordered

Monsanto to promptly file the motion.

An MDL court’s scheduling order is the law of the case. See Charles Alan Wright & Arthur

R. Miller, Law of the Case Doctrine and the Effect of Transfer and Remand on Choice of Law, 15

Fed. Prac. & Proc. Juris. § 3867 (4th ed). If a plaintiff or defendant wishes to file a motion for

summary judgment in the transferee court after the dispositive motion deadline has passed, the

party must move for leave to file, and must show good cause. See, e.g., George v. Johnson &

Johnson, Case No. 3:12-CV-369, 2021 WL 5029471, at *3 (N.D. Ind. 2021) (denying the

defendants’ motion for leave to file a motion for summary judgment after remand from the MDL

court). To decide whether Monsanto has good cause to file this motion for summary judgment

after the dispositive motion deadline has passed, this court weighs efficiency and equity concerns.

Equity weighs in favor of the Chapmans. There is no reason why Monsanto could not have

moved in the MDL court for summary judgment under § 82.008(c), and its failure to do so was its

own. The issue that Monsanto raises now on summary judgment is precisely the type of issue—

one that could apply to all Roundup cases raising products liability claims under Texas law—that

is best handled uniformly by the MDL court.1

Efficiency, however, weighs in favor of Monsanto. This issue—whether the Texas

Product Liability Act precludes liability on the Chapmans’ claims—is one that will need to be

addressed at some point, if not now, then on a motion for judgment as a matter of law at trial under

Rule 50(a).

This court prioritizes the time and effort of the jury. This case is set for trial in February

2023. Deciding this motion for summary judgment now, as opposed to later—on a tighter

timeline—at trial, prejudices neither party. No delay in trial will occur. And even if summary

judgment is not granted, familiarity and understanding of the issues in advance of trial is helpful

to the court and the litigants. For this reason, the court granted the motion for leave to file this

motion for summary judgment, and now considers the motion on the merits.

B. The Texas Product Liability Act

Texas law includes a presumption that a manufacturer is not liable in a products-liability

action if a product at issue was

(1) subject to licensing or approval by the federal government or a federal agency;

(2) that the manufacturer complied with all of the relevant federal procedures and requirements

for licensing and approval; and

(3) that the product was approved after full consideration of the product’s risks and benefits.

Tex. Civ. Prac. & Rem Code § 82.008(c).

1 The court and the parties are aware of only one other case from the MDL involving Texas law that has

been remanded from the MDL. That is Koen v. Monsanto Company, Case No. 1:22-cv-00209-RP (W.D.

Tex.). The court also asked the parties whether they were aware of any other states that have similar statutes

to the Texas statute at issue here. The parties were not aware of other identical or similar statutes. The

parties believe that this court’s ruling on the application of the Texas statute to a Roundup case, or even to

a federally regulated and licensed product, is one of first impression.

The presumption may be rebutted if the plaintiff establishes that “the standards or

procedures used in a particular pre-market approval or licensing process were inadequate to protect

the public from unreasonable risks of injury or damage,” or that the defendant, “before or after

pre-market approval or licensing of the product, withheld from or misrepresented to the

government or agency information that was material and relevant to the performance of the product

and was causally related to the claimant’s injury.” Tex. Civ. Prac. & Rem. Code § 82.008(c)(1),

(c)(2).

Monsanto argues that it is entitled to the presumption against liability, that there is no

evidence rebutting the presumption, and that the Chapmans are preempted by federal law from

rebutting the presumption by proving that Monsanto withheld or misrepresented relevant

information regarding Roundup to the EPA. The issues are whether there are factual disputes

material to determining whether the presumption applies and, if so, whether it can be rebutted.

Both are addressed below.

i. The Presumption Against Liability

Texas law creates a rebuttable presumption against liability for a product manufacturer if

its product was “subject to licensing or approval” by a federal agency, after the agency’s “full

consideration of the product’s risks and benefits.” Glyphosate—the active ingredient in most

Roundup products—is subject to a licensing process by the EPA called “registration” and “re-

registration.” The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) requires

companies that want to sell or distribute a pesticide in the United States to go through the EPA

registration process. See 7 U.S.C. § 136a(a); 40 C.F.R. § 152.42. To register a pesticide, an

applicant must submit the name of the pesticide; a complete copy of the labeling of the pesticide;

the complete formula of the pesticide; and studies and data relating to the safety of the pesticide.

7 U.S.C. § 136a(c); 40 C.F.R. § 152.50. The EPA considers these materials “along with other

independent studies to assess the safety of the pesticide and to determine whether it should be

registered.” In re Roundup Prods. Liability Litig., 2021 WL 6125536, at *1.

The EPA must register a pesticide if it determines that the submitted labeling complies

with requirements under FIFRA and determines that the pesticide “will perform its intended

function without unreasonable adverse effects on the environment” and “when used in accordance

with widespread and commonly recognized practice . . . will not generally cause unreasonable

adverse effects on the environment.” 7 U.S.C. § 136a(c)(5). FIFRA defines “unreasonable adverse

effects on the environment” to mean “any unreasonable risk to man or the environment, taking

into account the economic, social, and environmental costs and benefits of the use of any

pesticide.” 7 U.S.C. § 136(bb). By registering the pesticide, the EPA “provide[s] a license that

establishes the terms and conditions under which a pesticide may be lawfully sold, distributed, and

used within the United States.” Nat’l Fam. Farm Coal. v. Envtl.. Prot. Agency, 966 F.3d 893, 912

(9th Cir. 2020) (citing 7 U.S.C. § 136a(c)).

It is unlawful for a manufacturer to sell a pesticide that is registered but “misbranded.” See

7 U.S.C. § 136j(a)(1)(E). A pesticide is misbranded if “its labeling bears any statement, design,

or graphic representation relative thereto or to its ingredients which is false or misleading.” Id. §

136(q)(1)(A). Manufacturers have an ongoing obligation to ensure that the pesticide’s labeling is

accurate, truthful, and compliant with FIFRA’s labeling requirements. See Bates v. Agrosciences

LLC, 554 U.S. 431, 438 (2005). Pesticide manufacturers can seek approval to amend the

pesticide’s label, see 7 U.S.C. § 136a(f)(2), and manufacturers “have a duty to report incidents

involving a pesticide’s toxic effects that may not be adequately reflected in its label’s warnings.”

Pilliod v. Monsanto Co., 67 Cal. App. 591, 614, 282 Cal. Rptr. 3d 679, 699 (2021). In 2007,

Congress added a process called “registration review,” instructing the EPA to “periodically

review[]” pesticide and herbicide registrations every fifteen years. 7 U.S.C. § 136a(g)(1)(A).

“The registration review program is intended to make sure that, as the ability to assess and reduce

risk evolves and as policies and practices change, all registered pesticides continue to meet the

statutory standard of no unreasonable adverse effects.” (Docket Entry No. 61-11, at 4).

The EPA first registered glyphosate in 1974 and has reregistered glyphosate several times

since. (See, e.g., Docket Entry No. 61-4 (concluding on reregistration in September 1993 “that the

use of glyphosate-based herbicides in accordance with label directions would ‘not pose

unreasonable risks or adverse effects to humans or the environment’”)); see also Hardeman v.

Monsanto Co., 997 F.3d 941, 951 (9th Cir. 2021) (discussing the EPA’s reevaluation of

glyphosate). The EPA’s first registration review for glyphosate is due on October 1, 2022.

EPA also reviews and registers pesticide and herbicide products, including the Roundup-

branded products.2 (See Docket Entry No. 71, at 2); Ctr. for Biological Diversity v. Envtl. Prot.

Agency, 847 F.3d 1075, 1080 (9th Cir. 2017) (“The Federal Insecticide, Fungicide, and

Rodenticide Act . . . charges the Environmental Protection Agency . . . with the obligation to

register and reregister pesticide active ingredients and pesticide products.”). A “pesticide product”

is defined as “a pesticide in the particular form (including composition, packaging, and labeling)

in which the pesticide is, or is intended to be, distributed and sold.” 40 C.F.R. § 152.3.

2 Monsanto’s motion for summary judgment did not initially explain, in detail, EPA’s process for approving

pesticide products. This court requested supplemental briefing asking for further explanation on whether

“the EPA has licensed and approved Roundup itself.” (Docket Entry No. 70, at 2). Monsanto responded

with further details about EPA’s registration process. (Docket Entry No. 71). The Chapmans responded

to the request for further briefing, but did not respond to the court’s inquiry. The Chapmans’ response

argues that the approval does not give rise to the presumption under § 82.008(c)(1), and that any

presumption that arises can be rebutted under § 82.008(c)(2). (See Docket Entry No. 74).

The same standards applicable to pesticides, such as glyphosate, apply to pesticide

products, such as the Roundup-branded products; however, the review of the pesticide product is

focused on the end-use formulation rather than just the active ingredient. The review is also

premised on EPA’s prior review and registration of the pesticide product’s active ingredient. “Any

person seeking to obtain a registration for a new pesticide product must submit an application for

registration,” which “must be approved by the [EPA] before the product may legally be distributed

or sold.” 40 C.F.R. § 152.42; see also Nat. Res. Def. Council v. Envtl. Prot. Agency, 38 F.4th 34,

40 (9th Cir. 2022) (“A pesticide product may not be distributed or sold in the United States until

EPA has issued a registration, which functions as a license setting forth the conditions under which

the pesticide may be sold, distributed, and used.”). That application requires the pesticide-product

manufacturer to submit a confidential statement of the product’s formula, including “each

component [ingredient] in [the] formulation” and the percentage amount of that ingredient

contained in the formulation. (See Docket Entry No. 72-1, at 2).

The EPA will register a pesticide product containing a new active ingredient only after

“determin[ing] that the product will perform its intended function without unreasonable adverse

effects on the environment . . . when used in accordance with widespread and commonly

recognized practice,” and “that the product is not misbranded.” 40 C.F.R. § 152.112(e), (f). The

EPA will “conditionally” register products that contain active ingredients already approved by the

EPA if the agency concludes that:

1. the pesticide and proposed use are identical or substantially similar to any

currently registered pesticide and use thereof, or differ only in ways that would

not significantly increase the risk of unreasonable adverse effects on the

environment; and

2. approving the registration or amendment in the manner proposed by the

applicant would not significantly increase the risk of any unreasonable adverse

effect on the environment.

EPA, When Can EPA Grant a Conditional Registration?, https://www.epa.gov/pesticide-

registration/conditional-pesticide-registration#epa-grant (last visited Aug. 28, 2022). “While a

conditional registration might mean the initial registration is more prompt than it otherwise would

be, . . . the ‘applicant seeking conditional registration’ must submit the same ‘data as would be

required to obtain’ unconditional registration.” (Docket Entry No. 78, at 3 (quoting 7 U.S.C. §

136a(c)(7)(A)).3

The two products that Otis Chapman allegedly used were both registered by the EPA.

Roundup Weed & Grass Killer Concentrate Plus was first conditionally registered by the EPA on

October 31, 2001. (Docket Entry No. 72-3; Docket Entry No. 78). The registration notice

instructed Monsanto to “[a]dd the phrase ‘EPA Registration No. 71995-29’ before . . . releas[ing]

the product for shipment.” (Docket Entry No. 72-3, at 2). Roundup Ready-to-Use Weed & Grass

Killer was first conditionally registered by the EPA on June 18, 1991. (Docket Entry No. 72-5).

Those registrations necessarily required the EPA to consider and conclude that registering the

product would not “significantly increase the risk of any unreasonable adverse effect on the

environment.”

Monsanto has clearly demonstrated that the Roundup products and the active ingredient,

glyphosate, have been “subject to licensing or approval by the federal government or a federal

agency.” But Monsanto has not met its burden of showing the absence of factual disputes material

to determining to whether it “complied with all of the relevant federal procedures and requirements

with respect to pre-market licensing and approval,” as necessary to be entitled to the presumption.

And the Chapmans have identified facts that might support an inference that the EPA’s application

3 At the August 25, 2022, hearing, the Chapmans agreed with Monsanto that there is no relevant distinction

between conditional and unconditional registration for the purpose of deciding whether the rebuttable

presumption applies.

of its procedures and standards to the registration and reregistration of glyphosate and Roundup-

branded products were inadequate to protect the public’s safety.

To be entitled to the presumption against liability, Monsanto must show that it “complied

with all of the relevant procedures and requirements for licensing and approval.” Monsanto argues

that “it is undisputed that Monsanto, at all relevant times, has been in compliance with the EPA’s

mandatory registration and review process,” as “evidenced by EPA’s repeated approval of the

product.” (Docket Entry No. 61, at 6). But registration does not automatically mean compliance

with relevant procedures and requirements. The Federal Insecticide, Fungicide, and Rodenticide

Act states that “registration of a pesticide shall be prima facie evidence that the pesticide, its

labeling and packaging comply with the registration provisions of [FIFRA].” 7 U.S.C. § 136a(f)(2)

(emphasis added). “Prima facie evidence is not conclusive proof.” Hardeman v. Monsanto Co.,

216 F. Supp. 3d 1037, 1038 (N.D. Cal. 2016).

The Chapmans dispute that Monsanto complied with the relevant procedures and

requirements. The Chapmans argue that Monsanto violated § 6(a)(2) of FIFRA, 40 C.F.R. §

159.158, which states:

(a) General. Information which is reportable under this part must be submitted

if the registrant possesses or receives the information, and the information

is relevant to the assessment of the risks or benefits of one or more specific

pesticide registrations currently or formerly held by the registrant.

Information relevant to the assessment of the risks or benefits also includes

conclusion(s) or opinion(s) rendered by a person who meets any of the

following:

(1) Who was employed or retained (directly or indirectly) by the

registrant, and was likely to receive such information.

(2) From whom the registrant requested the opinion(s) or

conclusion(s) in question.

(3) Who is a qualified expert as described in § 159.153(b).

Section 6(a)(2) means that “pesticide manufacturers have a perpetual duty to adhere to

FIFRA’s labeling requirements and to report any new adverse effects to the EPA.” Carson v.

Monsanto Co., 39 F.4th 1334, 1338 (11th Cir. 2022). In 1998, the EPA also issued a guidance on

Section 6(a)(2), addressing “Expert Opinion Information.” That section begins by stating:

Conclusions or opinions of experts must be submitted under FIFRA 6(a)(2)

if the registrant possesses the information and either 1) the information is

otherwise reportable under one of the substantive provisions of the rule; or

2) the registrant knows, or should reasonably know, that the information,

alone or in conjunction with other information, might raise concerns about

the continued registration of a pesticide or about the appropriate terms and

conditions of registration of a pesticide. As a general matter, the Agency

frequently relies on the “weight of evidence” in making pesticide regulatory

decisions, and it considers expert opinion that tends to confirm or validate

otherwise reportable information. In this context, expert opinions can play

an important role in Agency decision-making.

EPA, Pesticide Registration Notice 98-3, at 8 (Apr. 3, 1998),

https://www.epa.gov/sites/default/files/2014-04/documents/pr98-3.pdf.

The Chapmans argue that Monsanto had a report from a Monsanto-commissioned expert

stating that glyphosate could cause cancer but did not present this evidence to the EPA or seek to

amend its label. The Chapmans’ relevant summary judgment evidence is summarized below.

In the late 1990s, after four separate studies concluded that glyphosate was possibly

genotoxic, Monsanto hired Dr. James M. Parry, a toxicologist specializing in genetic toxicology,

to examine the potential genotoxicity of glyphosate and Roundup.4 (Docket Entry No. 66-3, at

245; id., at 436 (Q: “Monsanto agreed Dr. Parry was an expert in the area, right?” Q: “Yes.”)). Dr.

Parry was asked to do an “evaluation of the four papers [Monsanto] provided concerning the

potential genotoxicity of glyphosate and Roundup.” (Id., at 245). Dr. Parry submitted his first

4 A toxicologist is a scientist who studies the effects of chemical substances on the health of animals and

humans. (Docket Entry No. 64-3, at 437). Genotoxic substances damage genetic information in cells,

potentially leading to the development of cancers. (See Docket Entry No. 66-3, at 172–73, 186–87).

report to Mark Martens, the Toxicology Director at Monsanto Europe, in February 1999. Dr. Parry

stated that glyphosate could be genotoxic, and suggested a battery of tests that Monsanto could

conduct on Roundup’s genotoxicity. (Id., at 251–53, 262, 267–68). Dr. Parry suggested, for

example, that Monsanto conduct “an assessment of the individual components of the Roundup

mixture . . . to see if they act synergistically when they are together.” (Id., at 420). Dr. Parry

concluded his report stating, “If the genotoxic activity of glyphosate and its formulations is

confirmed it would be advisable to determine whether there are exposed individuals and groups

within the human population. If such individuals can be identified then the extent of exposure

should be determined and their lymphocytes analysed [sic] for the presence of chromosome

aberrations.” (Id., at 269).

Monsanto did not share Dr. Parry’s report or suggestions with the EPA, and Monsanto did

not conduct any of Dr. Parry’s suggested tests. (Id., at 405–06, 437). In an email discussing Dr.

Parry’s report, William Heydens—Monsanto’s toxicologist—wrote,

[L]et’s step back and look at what we are really trying to achieve here. We want to

find/develop someone who is comfortable with the genetox profile of

glyphosate/Roundup and who can be influential with regulators and Scientific

Outreach operations when genetox issues arise. My read is that Parry is not

currently such 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. . . . Even if we

think we can eventually bring Parry around closer to where we need him, we should

be currently looking for a second/back-up genetox support. We have not made

much progress and are currently very vulnerable in this area.

(Id., at 271 (emphasis added)).

Mark Martens, another toxicologist at Monsanto, emailed Heydens and Donna Farmer

(another Monsanto toxicologist) regarding Dr. Parry’s suggestions for further testing. He wrote,

in relevant part:

[I]f somebody came to me and said they wanted to test Roundup I know how I

would react—with serious concern. We have to really think about doing

formulations even if they are not on the market….glyphosate is still in there and

could get caught up in some false positive finding.

(Id, at 304). The Chapmans argue that this email suggests that Monsanto refused to conduct Dr.

Parry’s suggested tests “because it believed the tests would reveal that Roundup is genotoxic.”

(Docket Entry No. 66, at 11).

In 1999—and in parallel with Dr. Parry’s review—Monsanto retained another expert, Dr.

Gary Williams. Williams, a researcher in the Department of Pathology at New York Medical

College, published an article titled, “Safety Evaluation and Risk Assessment of the Herbicide

Roundup and Its Active Ingredient, Glyphosate, for Humans.” (Docket Entry No. 66-3, at 580).

That article stated that “under present and expected conditions of use, Roundup herbicide does not

pose a health risk to humans.” (Id.). However, neither Dr. Williams nor any other listed author

wrote the article. Monsanto ghostwrote the article. (See id., at 321 (February 2015 email from

Heydens to Farmer) (“An option would be to add Greim and Kier or Kirkland to have their names

on the publication, but we would be keeping the cost down by us doing the writing and they would

just edit & sign their names so to speak. Recall that is how we handled Williams Kroes & Munro,

2000.”)). Monsanto then used the article as “an invaluable asset” in “responses to agencies,”

“Scientific Affairs rebuttals,” and “[r]egulator reviews.” (Id., at 284). Monsanto did not disclose

to the EPA that it ghostwrote the article. The EPA relied on the Williams study in its 2017

evaluation of glyphosate’s “carcinogenic potential.” See EPA Office of Pesticide Programs,

Glyphosate Issue Paper: Evaluation of Carcinogenic Potential, at 22, 98, 120 (Sept. 12, 2016).

In 2002, Heydens suggested in an email to Farmer that Monsanto “re-visit” the

genotoxicity of Roundup. Heydens noted that “[g]lyphosate is OK but the formulated product

(and thus the surfactant) does the damage.” (Docket Entry No. 66-3, at 315). Heydens asked,

“Can we scale back a repro study to make it budgetarily palatable?” (Id., at 315). The Chapmans

argue that this email suggests that Monsanto knew that Roundup was potentially dangerous.

Despite this awareness and Heyden’s suggestion for further study, Farmer noted in a 2009 email

that Monsanto could not “say that Roundup does not cause cancer [because Monsanto had] not

done carcinogenicity studies with Roundup.” (Id., at 276). In addition, Monsanto has admitted

that it has not done “an epidemiological study to study the association between glyphosate-

containing formulations and non-Hodgkin’s lymphoma”; “has not conducted a long-term animal

carcinogenicity study on glyphosate since 1991”; and “has never conducted a 12-month or longer

term animal carcinogenicity study on any surfactants used in glyphosate-based products.” (Id., at

33).

This record shows that Monsanto hired an expert over 20 years ago to evaluate whether

glyphosate, alone or in combination with other Roundup ingredients, was genotoxic. That expert

reviewed legitimate studies showing that glyphosate could be carcinogenic and suggested follow-

up studies. Monsanto did not conduct those studies and did not submit the expert’s report to the

EPA. Monsanto looked for experts who would support its position on glyphosate and, on at least

one occasion, ghostwrote an article under the name of its hired expert. Monsanto did not reveal

that the article was ghostwritten. Monsanto’s own toxicologists considered, at various times,

conducting further testing in light of various papers and studies suggesting that glyphosate might

cause cancer in mice and humans. Monsanto never conducted any “epidemiological study to study

the association between glyphosate-containing formulations and non-Hodgkin’s lymphoma.”

This evidence creates factual disputes material to determining whether Monsanto violated

FIFRA § 6(a)(2) by failing to timely submit Dr. Parry’s report and his recommendations for further

testing to the EPA. There is some evidence that Dr. Parry’s report was relevant to the EPA’s

ability to conduct its continuing cost-benefit analysis on glyphosate. Martins, a Monsanto

toxicologist, testified during his deposition that Dr. Parry’s “conclusions were well received” by

the toxicologists, even though the stylistic “form of the report was not well received.” (Docket

Entry No. 69-3, at 437). Stephen Wratten, another Monsanto employee, stated in an email to

Farmer and Heydens, that he was “somewhat disappointed in the Parry report, not particularly

from his conclusions but just the way they’re presented. The style and rather casual lack of

completeness and preciseness would make it hard to circulate this around to anyone as supporting

information.” (Id., at 270 (emphasis added)). Emails exchanged among Monsanto’s toxicologists

also show that the toxicologists were still debating how best to “rebut[]” Dr. Parry’s report two

years later after he originally submitted it. (Id., at 272). This evidence plausibly suggests that

while Dr. Parry’s report had flaws, the flaws were primarily related to the form and presentation

of his report, as opposed to the report’s methodology, substance, and conclusions. The evidence

also suggests that Monsanto’s experts were concerned enough about the Parry report that they

debated, for at least two years, about how to deal with it. A jury could reasonably conclude that

Dr. Parry’s conclusion—that glyphosate could be genotoxic and that further testing was needed—

was, at minimum, relevant to whether Roundup products were misbranded.

The expert report of Dr. Charles M. Benbrook, which the Chapmans attached to their

response to Monsanto’s first motion for summary judgment before the MDL court, is further

suggestive of the relevance of Dr. Parry’s report. Dr. Benbrook wrote that

[t]he new scientific information in the Parry [report] . . . was directly relevant to the

EPA’s evaluation of glyphosate and Roundup risks. The core findings and

conclusions in these important reports . . . were profoundly inconsistent with the

information EPA was currently relying on in estimating Roundup applicator

exposure levels and associated risks. Monsanto was fully aware that the

information in the Parry [report] . . . would substantially raise EPA concerns over

the genotoxicity of Roundup and applicator exposure levels.

(Docket Entry No. 66-2, at 50). Dr. Benbrook then

conclude[d] that Monsanto’s failure to test formulated Roundup herbicides for

genotoxicity, as recommended by Dr. Parry, is a primary reason why the EPA and

other regulatory authorities have failed for decades to recognize the potential for

glyphosate-based herbicides to increase the risk of cancer, including risk of NHL,

via genotoxic mechanisms of action. In my opinion, Dr. Parry’s reports contained

the type of information that pesticide registrants are required to submit to the EPA

under FIFRA Section 6(a)(2).

(Id., at 98).

Monsanto argues, however, that evidence regarding its failure to submit the Parry report

cannot be reviewed by the court or a jury. That is because, Monsanto argues, Section

82.008(c)(2)—which allows a plaintiff to rebut the presumption against liability by establishing

that Monsanto “withheld from or misrepresented to the government or agency information that

was material and relevant to the performance of the product and was causally related to the

claimant’s injury”—is preempted by federal law.

Monsanto relies on Buckman Co. v. Pltf’s Legal Comm., 531 U.S. 341 (2000), Lofton v.

McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372 (5th Cir. 2012), and Nathan

Kimmel, Inc. v. DowElanco, 275 F.3d 1199 (9th Cir. 2002), for its preemption argument. In

Buckman, the plaintiffs “claim[ed] injuries resulting from the use of orthopedic bone screws in the

pedicles of their spines.” 531 U.S. at 343. The plaintiffs alleged that their injuries occurred

because the screw manufacturer, AcroMed Corporation, “made fraudulent representations to the

Food and Drug Administration . . . in the course of obtaining approval to market the screws.” Id.

The Supreme Court held that the plaintiffs’ state-law fraud claim was preempted by the Medical

Device Act. Id. The court reasoned that “[p]olicing fraud against federal agencies is hardly ‘a

field which the States have traditionally occupied,’” and the FDA had authority to “punish and

deter fraud against the [FDA],” without the additional and competing need for state-law tort

claims. Id. at 348.

In Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372 (5th Cir. 2012),

the Fifth Circuit applied the Supreme Court’s reasoning in Buckman to § 82.007(b)(1) of the Texas

Civil Practice and Remedies Code, a similar statute to the one at issue in this case. Under §

82.007(a)(1), “a drug manufacturer enjoys a rebuttable presumption that it is not liable for failure

to warn if the FDA has approved ‘the warnings or information’ accompanying the product alleged

to have harmed the plaintiff.” Tex. Civ. Prac. & Rem. Code § 82.007(a)(1).” A plaintiff can rebut

that presumption “by establishing that . . . the defendant . . . withheld from or mispresented to the

[FDA] required information that was material and relevant to the performance of the product and

was causally related to the claimant’s injury.” Id. § 82.007(b)(1).

The Fifth Circuit held that § 82.007(b)(1) was preempted by federal law because the

exception was “premised principally . . . on a drug maker’s failure to comply with federal

disclosure requirements.” 672 F.3d at 379. The court understood § 82.007(b)(1) to require a

plaintiff to prove “fraud on the FDA,” id. at 376–77 (“[The plaintiffs must show fraud-on-the-FDA

for their claims to survive . . . .”), even though the text of § 82.007(b)(1), like § 82.008(c)(2), does

not require a plaintiff to establish all elements of a traditional fraud claim, including knowledge of

falsity and intent.5 The Fifth Circuit noted the Texas statute requires a plaintiff to “establish a

violation of FDA’s required disclosures,” and “[i]n so doing, the plaintiff necessarily re-treads the

FDA’s administrative ground both to conduct discovery and to persuade a jury.” Id. at 380. The

court noted that federal law already “imposes penalties for omissions and misrepresentations” to

the FDA, and “[a]s a result, disclosures to the FDA are ‘uniquely federal’ and thus beyond the

states’ traditional police power.” Id. at 378–79. And the court further remarked that by allowing

5 Cf. Avram Blair & G. Erick Rosemond, Texas Pharmaceutical Failure-to-Warn Claims: Alive and Well,

69 Tex. Bus. J. 728, 731 (2006) (“Critically, § 82.007’s plain text does not require that a plaintiff show that

a defendant committed fraud on anybody, let alone the FDA. And it imposes no requirement that the FDA

itself determine it has been defrauded.”).

a plaintiff to make a fraud-on-the-FDA argument under § 82.007(b)(1), the FDA would “in turn

lose[] control over its ability, based on scientific expertise, to prescribe—and intelligently limit—

the scope of disclosures necessary for its work,” and “the statutory requirement of proving fraud-

on-the-FDA [could] directly invade the agency’s processes when close questions of ‘withholding’

or ‘misrepresentation’ arise.” Id. at 380. “These dangers are inherent in Buckman’s concern to

preserve the agency’s discretion to police the conduct of regulated entities.” Id.

Finally, in Nathan Kimmel, Inc. v. DowElanco, 275 F.3d 1199 (9th Cir. 2002), the Ninth

Circuit concluded that federal law preempts fraud-on-the-EPA claims, in the same way it preempts

fraud-on-the FDA claims. The court noted that:

[T]he EPA has elaborate internal hearing and appellate review procedures to

determine whether a registrant has violated any provision of FIFRA, including

violations of FIFRA’s statutory prohibition against the knowing submission of false

information to the EPA. If a violation of FIFRA or its implementing regulations is

found to have occurred, the EPA may impose substantial civil and criminal

penalties. Furthermore, the United States Attorney is statutorily authorized to

enforce such penalties on behalf of the EPA, and to otherwise prosecute any

violation of FIFRA or its implementing regulations.

275 F.3d at 1206 (internal citations omitted).

“As was the case in Buckman,” the Ninth Circuit stated, the “statutory scheme amply

empowers the [EPA] to punish and deter fraud against the [EPA], and . . . this authority is used by

the [EPA] to achieve a somewhat delicate balance of statutory objectives.” Id. (quoting Buckman,

531 U.S. at 348). In holding that fraud-on-the-EPA claims are preempted by FIFRA, the court

wrote:

[W]e are troubled that an applicant’s disclosures under FIFRA, although not

challenged by the EPA (the very agency empowered by Congress to enforce

FIFRA), may be judged illegal under state law. Such an approach would force

FIFRA applicants to ensure that their disclosures to the EPA would satisfy not only

the standards imposed by that agency under federal law, but also the potentially

heterogeneous standards propounded by each of the 50 States. Such a holding

would in turn motivate potential applicants under FIFRA to ‘submit a deluge of

information that the [EPA] neither wants nor needs, resulting in additional burdens

on the [EPA’s] evaluation of an application.’ This outcome would needlessly drain

the EPA of its limited resources, thereby detracting from its ability to efficiently

enforce FIFRA.

Id. at 1207.

Based on the cases above, Monsanto is correct that the Chapmans’ claim of fraud on the

EPA under § 82.008(c)(2) is preempted by federal law. Section 82.008(c)(2) is almost identical

to Section 82.007(b)(1), the provision at issue in Lofton. The sole difference between the two

provisions is that § 82.007(b)(1) allows a plaintiff to rebut the presumption against liability by

showing that the defendant withheld required information that was material and relevant. Section

82.008(c)(2) omits the word “required,” and states only that a plaintiff must prove “the

manufacturer, before or after pre-market approval or licensing of the product, withheld from or

misrepresented to the government or agency information that was material and relevant to the

performance of the product.” The Lofton court noted, however, that § 82.007(b)(1) was preempted,

in part, because “what is ‘material’ and ‘relevant’ must be determined by FDA itself, not by state

court juries.” 672 F.3d at 379. The omission of the word “required” in § 82.008(c)(2) would not

be material to the Fifth Circuit’s preemption analysis.

The EPA, like the FDA, moreover, is empowered to determine what it “material and

relevant” to registration under FIFRA, and the EPA can impose penalties for misrepresentations

or omissions of information that would lead EPA to conclude that Roundup was misbranded. See

Hardeman v. Monsanto Co., 997 F.3d 941, 951 (9th Cir. 2021), cert. denied, 142 S.Ct. 2834 (2022)

(“Remedies for misbranding include civil and criminal penalties.”); see also id. at 950–51 (“EPA

can also institute cancellation proceedings . . . or take other enforcement action against the

manufacturer of a registered pesticide if the agency determines the product is ‘misbranded.’”).

Because § 82.008(c)(2) requires the Chapmans to prove “fraud on the EPA,” and because a finding

that the EPA’s registration decision was invalid would interfere with the EPA’s “substantial

enforcement powers” under FIFRA, the court agrees with Monsanto that § 82.008(c)(2) is

preempted.6

But Monsanto’s preemption argument as to § 82.008(c)(2) is not relevant at this stage.

Before deciding whether the Chapmans have shown a factual dispute material to determining

whether it can rebut the presumption against liability under § 82.008(c)(2), it is first necessary to

decide whether § 82.008(c)’s presumption applies at all. To be entitled to the presumption, it is

Monsanto’s burden, at trial and at summary judgment, to show that it complied with relevant EPA

procedures and regulations for registration. See Tex. Civ. Prac. & Rem. § 82.008(c) (“[T]here is

a rebuttable presumption . . . if the product manufacturer . . . establishes . . . that the manufacturer

complied with all of the government’s or agency’s procedures and requirements with respect to

pre-market licensing or approval”). The Lofton Court stated that § 82.008(c)(2) was preempted

because it required the plaintiff to establish fraud on the EPA. 672 F.3d at 380. Here, the burden

is on Monsanto, not on the Chapmans, to establish compliance with FIFRA.

There are genuine factual disputes material to determining whether Monsanto did, in fact,

comply with relevant federal regulations related to the registration of at least one pesticide product

at issue in this case. Roundup Weed & Grass Killer Concentrate Plus was first conditionally

registered by the EPA on October 31, 2001. (Docket Entry No. 72-3; Docket Entry No. 78). This

was two years after Monsanto requested and had knowledge of the content of the Parry report.

6 Section 82.008(c)(2) may not be preempted in all circumstances. If the EPA itself finds that Monsanto

withheld material information, and institutes cancellation proceedings or other enforcement actions, the

Chapmans could rely on that evidence without undermining the jurisdiction and authority of the EPA. See

Garcia v. Wyeth-Ayest Laby’s, 385 F.3d 961, 966 (6th Cir. 2004); Ledbetter v. Merck & Co., Inc., No. 2005-

59499, 2007 WL 1181991, at *10 (157th Dist. Ct., Harris Cnty., Tex. Apr. 19, 2007) (noting that §

82.007(b)(1) is “preempted [only] to the extent that someone other than the FDA is being asked to make

the determination” that the defendant withheld material and relevant information).

Under § 6(a)(2), the Chapmans argue that Monsanto had a self-reporting duty to submit the Parry

report to EPA as part of its continuing registration obligation for glyphosate, the active ingredient

in Roundup Weed & Grass Killer Concentrate Plus. Because Monsanto did not submit the report,

despite its obligation to do so, the EPA did not have the report when it considered the conditional

registration of Roundup Weed & Grass Killer Concentrate Plus, in 2001. The EPA’s conditional

registration of pesticide products is premised on the EPA’s registration of the pesticide product’s

component ingredients and Monsanto’s duty to ensure that the glyphosate registration was

accurate, up-to-date, and complaint with § 6(a)(2). Monsanto has not pointed to record evidence

showing that it was either not required to submit the 1999 Parry report to the EPA as part of its §

6(a)(2) reporting duty for its glyphosate registration or when seeking conditional registration of

Roundup Weed & Grass Killer Concentrate Plus, or that it did, in fact, produce the Parry report.7

Because there are factual disputes material to deciding whether Monsanto has established

that it “complied with all of the government’s or agency’s procedures and requirement with respect

to pre-market licensing or approval” of Roundup Weed & Grass Killer Concentrate Plus,

Monsanto is not entitled to summary judgment on the application of the presumption against

liability under § 82.008(c)(1).

ii. Rebutting the Presumption

A plaintiff can rebut the presumption against liability—if the presumption applies—by

“establishing” that “(1) the standards or procedures used in the particular pre-market approval or

licensing process were inadequate to protect the public from unreasonable risks of injury or

damage; or (2) the manufacturer, before or after pre-market approval or licensing of the product,

7 On this latter point, the evidence appears conclusive that Monsanto did not submit the Parry report. (See

Docket Entry No. 66-3, at 437 (Q: “I assume by the same token that Monsanto never shared the Parry report

with any regulatory agencies, correct?” A: “That’s correct, yeah.”)).

withheld from or misrepresented to the government or agency information that was material and

relevant to the performance of the product and was causally related to the claimant’s injury.” Tex.

Civ. Prac. & Rem. § 82.008(c)(1), (c)(2). As discussed, federal law preempts plaintiffs from

rebutting the presumption of liability by proving that a defendant withheld from or misrepresented

material and relevant information. This means that if the presumption against liability applies, the

Chapmans can rebut the presumption only by showing that “the standards or procedures used in a

particular pre-market approval or licensing process were inadequate to protect the public from

unreasonable risks of injury or damage.” Tex. Civ. Prac. & Rem. Code § 82.008(c)(1).8 The

Chapmans argue that “there is evidence showing that EPA’s approval process has been inadequate

to protect the public from unreasonable risk of injury,” citing “[t]he Ninth Circuit’s June 17, 2022,

published Order in Nat. Res. Def. Council v. U.S. Envtl. Prot. Agency, No. 20-70787 (9th Cir. Jun.

17, 2022),” as “the most recent evidence.” (Id.).

The Ninth Circuit opinion is not summary judgment record evidence in this case. But the

opinion is relevant and suggestive of the potential inadequacy of the EPA’s testing requirements

for the registration of Roundup products. In Nat. Res. Def. Council v. Envtl. Prot. Agency, the

National Resources Defense Council argued that the EPA “shirked its duties under the Endangered

Species Act” when it determined in a 2020 Interim Registration Review Decision that glyphosate

posed “no risks to human health.” NRDC, 38 F.4th at 40–45. Congress requires “EPA to

‘periodically review[]’ pesticide registrations every fifteen years.” Id. at 40 (quoting 7 U.S.C. §

136a(g)(1)(A)). “EPA has promulgated regulations delineating an elaborate process for

8 This exception is unusual. This lawsuit is about whether Roundup-branded products more than likely

caused Chapman’s non-Hodgkin’s lymphoma, and whether Monsanto should have warned about risks of

cancer allegedly caused by Roundup usage, particularly over a long period. The adequacy of the EPA’s

registration process is not otherwise material or relevant to, and the EPA is not a party to this litigation.

Monsanto did not raise or argue that § 82.008(c)(1) is preempted by federal law.

registration review,” and “[t]he regulations . . . permit, but do not require, EPA to issue an ‘interim

registration review decision’ prior to the registration review decision.” Id. (quoting 40 C.F.R. §

155.56). The EPA issued an interim registration review decision in 2020, and the interim

registration decision was the subject of the Ninth Circuit appeal.

In 2015, during the registration review process, the “EPA’s pesticide unit made a

preliminary determination that glyphosate was not likely to be carcinogenic and shared that

determination with the agency’s Office of Research and Development.” Id. at 41. The Office of

Research and Development noted several flaws with EPA’s determination, and “[a]fter stating its

methodological concerns, . . . expressed disagreement with the pesticide unit’s determination that

glyphosate was ‘not likely to be carcinogenic.’” Id. at 42. The Office of Research and

Development’s “criticisms did not change EPA’s overall ‘not likely’ determination.” Id.

EPA then requested further feedback from an EPA-commissioned Scientific Advisory

Panel. The Panel expressed similar concerns to the Office of Research and Development and noted

that “the EPA evaluation [did] not appear to follow Cancer Guidelines” that were “intended to

guide EPA in classifying chemicals according to their carcinogenic potential.” Id. Again, EPA

did not respond to the Office of Research and Development’s concerns. “One year after receiving

the [Panel’s] feedback, EPA released a draft human-health risk assessment for glyphosate and an

updated and final paper about glyphosate’s carcinogenic potential,” which still “concluded that

glyphosate poses no serious human-health risks,” and stated that “glyphosate should be classified

as ‘not likely to be carcinogenic to humans.’” Id. In January 2020, EPA released its Interim

Registration Review Decision, which “announced that the earlier draft human-health and

ecological risk assessments were now final—with no changes from those drafts.” Id. at 43.

The National Resources Defense Council challenged EPA’s conclusions on the impact of

glyphosate on human health, among other EPA findings. Id. at 44. The Ninth Circuit “review[ed]

EPA’s Interim Decision for ‘substantial evidence when considered on the record as a whole,’” and

concluded that EPA’s conclusion that glyphosate was not likely carcinogenic to humans was not

supported by substantial evidence. The court noted that the Interim Decision “contravened the

Cancer Guidelines it purported to follow” and reached irreconcilable conclusions. Id. at 45. The

court stated that EPA improperly “discounted epidemiological studies” showing a “relationship

between glyphosate and NHL.” Id. at 46. The court noted that EPA inconsistently stated, on the

one hand, that “a conclusion regarding the association between glyphosate exposure and risk of

NHL cannot be determined based on the available evidence,” while on the other hand concluding

that glyphosate was “not likely” to cause cancer. The court concluded that these two findings were

irreconcilable, because EPA could not “reasonably treat its inability to reach a conclusion about

NHL risk as consistent with a conclusion that glyphosate is ‘not likely’ to cause cancer within the

meaning of the Cancer Guidelines.” Id. at 46–47. The court vacated the “human-health portion”

of the Interim Decision and remanded to the agency, noting that “further proceedings, including a

new public-comment process, will be needed on remand.” Id. at 52.

Two findings in the Ninth Circuit’s decision are relevant to this litigation. First, the court

found that “EPA’s choice of the ‘not likely’ [carcinogenic] descriptor conflict[ed] with a

determination EPA made earlier in [a] Cancer Paper,” in which the EPA stated that “a conclusion

regarding the association between glyphosate exposure and risk of NHL cannot be determined

based on the available evidence.” Id. at 46. The court noted that

the Cancer Paper discussed human epidemiological studies showing what

could be considered suggestive evidence that glyphosate exposure causes

[non-Hodgkins lymphoma] . . . [and] stated that “reported effect estimates

across case-control studies and the associated meta-analyses [were] greater

than 1,” meaning that most studies EPA examined indicated that human

exposure to glyphosate is associated with an at least somewhat increased

risk of developing NHL. The Cancer Paper also acknowledged that some

epidemiological studies provide evidence of an exposure-response

relationship between glyphosate and NHL. One study, for instance,

indicated that there was an increased risk of NHL for those with more than

ten years of glyphosate exposure. In addition, that same study as well as

another indicated that those who are exposed to relatively more glyphosate

in a year face a higher risk of NHL. But EPA discounted epidemiological

studies showing increased NHL risk by concluding that “chance and/or

bias” could be “an explanation for observed associations in the database.”

Id.

Second, the court noted that the EPA supported its selection of the “not likely” descriptor

by stating that the “concerning results only occurred at high doses,” and “mention[ed] that positive

results in genotoxicity studies occurred only at ‘high doses.’” Id. at 49. “Importantly, for both the

rodent studies and genotoxicity studies,” the Ninth Circuit stated, “[t]hese high doses [were] not

considered relevant to human health risk assessment based on the currently registered use pattern

for glyphosate” because “[m]aximum potential glyphosate exposure [had] been estimated at . . . 7

mg/kg/day . . . which [is] well-below the doses necessary to elicit the effects seen in these animal

carcinogenicity and genotoxicity studies.” Id.

The Ninth Circuit opinion highlights the fact that the EPA has not required or regarded as

important genotoxicity studies involving high-dosages of glyphosate. The Chapmans have raised,

throughout this litigation, other types of tests that the EPA has not required Monsanto or other

glyphosate-product manufacturers to conduct as part of the registration of glyphosate and other

Roundup-branded products. For example, the EPA requires carcinogenicity testing on the

individual ingredients in Roundup, but not for the actual composite formulation. See EPA,

Glyphosate: Response to Comments on the Human Health Draft Risk Assessment, at 8 (Apr. 23,

2018), https://www.epa.gov/sites/default/files/2019-04/documents/hed-rtc-signed.pdf (“[T]hough

the EPA evaluates the [pesticide] product components, long term testing of individual products is

not required.”). Monsanto has admitted in interrogatories that it: “has never conducted an

epidemiological study to study the association between glyphosate-containing formulations and

non-Hodgkin’s lymphoma”; “has not conducted a long-term animal carcinogenicity study on

glyphosate since 1991”; and “has never conducted a 12-month or longer term animal

carcinogenicity study on any surfactants used in glyphosate-based products.” (Docket Entry No.

66-3, at 33). A Monsanto toxicologist has stated that Monsanto could not conclusively “say that

Roundup does not cause cancer [because Monsanto had] not done carcinogenicity studies with

Roundup.” (Id., at 276). The EPA has not required Monsanto to conduct these tests.

The Ninth Circuit opinion also supports the Chapmans’ argument that the lack of any EPA

requirement for high-dosage testing or long-term carcinogenicity testing of the formulated

products has failed to protect the public from “unreasonable risks of injury,” because at least one

study has indicated that there is an increased risk of non-Hodgkin’s lymphoma for those, like

Chapman, with more than ten years of glyphosate exposure. Dr. Benbrook, the plaintiffs’ expert

on summary judgment before the MDL court, has similarly noted that Monsanto’s failure to

conduct “a long-term oncogenicity study utilizing formulated GBHs,” and “[t]he absence of a

single, well-designed chronic feeding oncogenicity study in mice or rats exposed to formulated

glyphosate-based herbicides, rather than pure glyphosate technical, is the most important single

gap in the existing scientific appraisal of the human-health risks stemming from use of, and

exposure to Roundup and other glyphosate-based herbicides.” (Docket Entry No. 66-2, at 88

(emphasis in original)).

These statements and evidence support an inference that the EPA has not required or

considered relevant long-term, high-dose carcinogenicity studies, particularly involving the

formulated Roundup products. Cf. NRDC, 38 F.4th at 50. The tens-of-thousands of defendants in

the Roundup MDL and lawsuits around the country claiming that prolonged, long-term usage of

Roundup-branded products caused their non-Hodgkin’s lymphoma at least supports an inference

that the EPA’s current testing regime for licensing and approval of Roundup-branded products is

inadequate to protect the public from unreasonable harm. Of course, at trial, the Chapmans have

the burden of proving a causal link between Roundup usage and non-Hodgkin’s lymphoma.

Because there are factual disputes material to determining whether the presumption against

liability applies, the court need not decide at this stage of the case whether the Chapmans have

presented sufficient evidence to rebut it by showing that the EPA’s decision-making process in

registering and reregistering Roundup-branded products was inadequate because the agency failed

to require Monsanto to conduct and submit studies of the carcinogenicity risks of long-term

exposure to Roundup products, including those at issue in this case. Relevant evidence on this

issue at trial may include evidence as to the types of studies the EPA requires registrants to submit

pre- and post-registration of pesticides and pesticide products, and whether specific long-term

genotoxicity or carcinogenicity studies are necessary to protect the public from “unreasonable

risk” of harm. The record shows that there are expert witnesses, some vetted by the MDL court,

who are prepared to testify on these issues, such as Dr. Benbrook. There is sufficient evidence in

the current record to create a triable issue as to whether the EPA’s procedures were so inadequate

as to rebut the presumption of nonliability created by the agency’s approval. If, at trial, Monsanto

believes that it has shown that the presumption applies under § 82.008(c) and has not been rebutted

under § 82.008(c)(1), Monsanto can move for judgment as a matter of law. The evidence at trial

will provide a much more secure footing for the court to rule on these issues of first impression.

IV. Conclusion

Monsanto’s motion for summary judgment, Docket Entry No. 61, is denied. The

arguments raised may be reurged at trial, on the basis of the fuller record the trial will provide.

The court will hold a status conference on September 26, 2022, at 10:00 A.M., by Zoom.

SIGNED on August 31, 2022, at Houston, Texas.

LW Crente

Lee H. Rosenthal

Chief United States District Judge

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