Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caed-1_16-cv-00406/USCOURTS-caed-1_16-cv-00406-1/pdf.json

Parties Involved:
Yolanda Mendoza
Plaintiff
Monsanto Company
Defendant

Document Text:

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UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF CALIFORNIA

YOLANDA MENDOZA,

Plaintiff,

v.

MONSANTO COMPANY,

Defendant.

No. 1:16-cv-00406-DAD-SMS

ORDER DENYING DEFENDANT’S 

MOTION TO DISMISS

(Doc. No. 73)

This action is proceeding on a first amended complaint (“FAC”) filed October 20, 2015. 

(Doc. No. 24.) The FAC states five causes of action related to plaintiff’s alleged development of 

non-Hodgkin lymphoma in October 2013 as a result of her use of defendant’s Roundup product

containing the active ingredient glyphosate between the years 2004 and 2012: (1) strict liabilitybased design defect; (2) strict liability-based failure to warn; (3) negligence; (4) breach of express 

warranty; and (5) breach of implied warranty. (Id. at 31–57.) 

Defendant moved to dismiss the complaint on two grounds. First, defendant argues any of 

plaintiff’s causes of action which are based on a failure to warn are preempted by the Federal 

Insecticide, Fungicide, and Rodenticide Act (“FIFRA”). (See Doc. No. 73-1 at 5–10.) Second, 

defendant asserts any of plaintiff’s causes of action based on an alleged design defect are barred 

by comments j and k to the Restatement (Second) of Torts § 402A. (Doc. No. 73-1 at 10–14.) 

Plaintiff filed an opposition to the motion on May 3, 2016, and defendant filed a reply on June 14, 

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2016. (Doc. Nos. 81, 90.) On June 21, 2016, a hearing on the motion was held. Attorneys 

Christopher Dalbey, Robin Greenwald, Hunter Lundy, Kristie Hightower, Maja Lukic, and 

Matthew Lundy appeared on behalf of plaintiff, and attorneys Martin C. Calhoun and Eric Lasker 

appeared on behalf of defendant. After considering the parties arguments, for the reasons 

discussed below, the court will deny defendant’s motion to dismiss.

I. Legal Standard

The purpose of a motion to dismiss pursuant to Rule 12(b)(6) is to test the legal 

sufficiency of the complaint. N. Star Int’l v. Ariz. Corp. Comm’n, 720 F.2d 578, 581 (9th Cir. 

1983). In determining whether dismissal is appropriate under Rule 12(b)(6), the court accepts as 

true the allegations in the complaint and construes the allegations in the light most favorable to 

the plaintiff. Hishon v. King & Spalding, 467 U.S. 69, 73 (1984); Love v. United States, 915 F.2d 

1242, 1245 (9th Cir. 1989). In ruling on such a motion, the court is permitted to consider material 

which is properly submitted as part of the complaint, documents that are not physically attached 

to the complaint if their authenticity is not contested and the plaintiff’s complaint necessarily 

relies on them, and matters of public record. Lee v. City of Los Angeles, 250 F.3d 668, 688–89 

(9th Cir. 2001). The district court may consider questions of preemption in a Rule 12(b)(6) 

motion. See, e.g., Silvas v. E*Trade Mortg. Corp., 514 F.3d 1001, 1003–04 (9th Cir. 2008); 

Nathan Kimmel, Inc. v. DowElanco, 275 F.3d 1199, 1203 (9th Cir. 2002).

II. Analysis

In large part defendant’s arguments, both in the papers and at oral argument, repeats those 

they advanced in two other cases pending before other District Courts in California: Hardeman v. 

Monsanto Co., No. 16-cv-00525 VC, 2016 WL 1749680 (N.D. Cal. Apr. 8, 2016); and Giglio v. 

Monsanto Co., No. 15cv2279 BTM(NLS), 2016 WL 1722859 (S.D. Cal. Apr. 29, 2016). In both 

of those cases, defendant’s motions to dismiss were denied. The undersigned agrees with the 

reasoning of those prior orders.

1. FIFRA Preemption

FIFRA prohibits the sale or distribution of a pesticide that is misbranded. 7 U.S.C. 

§ 136j(a)(1)(E). A pesticide is misbranded under FIFRA if the label does not contain directions 

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which “if complied with . . . are adequate to protect health,” 7 U.S.C. § 136(q)(1)(F), or if “the 

label does not contain a warning or caution statement which . . . if complied with . . . is adequate 

to protect health,” 7 U.S.C. § 136(q)(1)(G). FIFRA requires all pesticides to be registered with 

the Environmental Protection Agency (“EPA”) prior to sale or distribution. See 7 U.S.C. 

§§ 136a(a), 136(b). Under FIFRA, while the “registration of a pesticide shall be prima facie

evidence that the pesticide, its labeling and packaging comply with the registration provisions” of 

FIFRA, “[i]n no event shall registration of [the pesticide] be construed as a defense for the 

commission of any offense under this subchapter.” 7 U.S.C. § 136a(f)(2) (emphasis added). 

Therefore, a properly registered label may still be misbranded. See Giglio, 2016 WL 1722859, at 

*2 (“It is unlawful under the statute to sell a pesticide that is registered but misbranded.”); 

Hardeman, 2016 WL 1749680, at *1–2 (“[T]he mere fact that the EPA has approved a product 

label does not prevent a jury from finding that that same label violates FIFRA.”). 

FIFRA contains an express preemption provision which states:

(a) In general

A State may regulate the sale or use of any federally registered 

pesticide or device in the State, but only if and to the extent the 

regulation does not permit any sale or use prohibited by this 

subchapter.

(b) Uniformity

Such State shall not impose or continue in effect any requirements 

for labeling or packaging in addition to or different from those 

required under this subchapter.

7 U.S.C. § 136v (emphasis added). However, not all limitations the states place on pesticides run 

afoul of FIFRA’s express preemption provision. In Bates v. Dow Agrosciences LLC, 544 U.S. 

431 (2005), the Supreme Court set out the following two-part test for determining whether a state 

rule is preempted under § 136v(b): (1) it must be a requirement “for labeling or packaging”, and 

(2) it must impose a labeling or packaging requirement that is “in addition or different from those 

required under this subchapter.” Id. at 444 (emphasis omitted). Even when the state rule does 

impose a requirement for labeling or packaging, it is not preempted if the state rule is “fully 

consistent with federal requirements.” Id. at 452.

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For purposes of § 136v(b)’s express preemption provision, “the term ‘requirement’ 

reaches beyond positive enactments, such as statutes and regulations, to embrace common-law 

duties.” Bates, 554 U.S. at 443 (citing Cipollone v. Liggett Grp., Inc., 505 U.S. 504, 521 (1992)). 

A plaintiff’s “fraud and negligent-failure-to-warn claims are premised on common-law rules that 

qualify as ‘requirements for labeling or packaging,’” and thus come within the ambit of the 

preemption provision. Id. at 446. The question before this court, therefore, is whether any 

requirements to be imposed by state rules are “in addition to or different from” those required by 

FIFRA. 

“[S]tate law need not explicitly incorporate FIFRA’s standards as an element of a cause of 

action in order to survive preemption,” and a state law claim will survive as long as there is a 

substantial, not strict, parallel between it and the requirements of FIFRA. Id. at 447, 453–54. 

“To the extent state law might be construed more broadly than federal law, the solution is not to 

prohibit state law suits altogether, but to ‘instruct the jury on the relevant [federal] standards, as 

well as any regulations that add content to those standards.’” Astiana v. Hain Celestial Grp., Inc., 

783 F.3d 753, 758 (9th Cir. 2015) (quoting Bates, 544 U.S. at 454).

The definition of misbranding under FIFRA is quite expansive. See 7 U.S.C. 

§ 136(q)(1)(F)–(G) (misbranding means, in pertinent part, that the label does not contain 

sufficient directions, warnings, or cautionary statements to be “adequate to protect health”). 

Neither party points the court to properly promulgated rules or regulations from EPA further 

specifying what is meant by the term “misbranded.” Rather, defendant asks the court to take 

judicial notice of six documents: a fact sheet issued by the EPA in September 1993 concerning 

its decision to re-register glyphosate; four exhibits which were published in the Federal Register, 

dated September 27, 2002, November 10, 2004, December 3, 2008, and May 1, 2013, each of 

which reflect the EPA’s findings regarding Roundup’s carcinogenicity pursuant to its authority 

under a separate statute; and a statement of a deputy director of the EPA’s Office of Pesticide 

Programs at a hearing before the Senate Committee of Agriculture, Nutrition and Forestry. 

Judicial notice of these documents is generally appropriate. See Fed. R. Evid. 201; see also 44 

U.S.C. § 1507; Musgrave v. ICC/Marie Callender’s Gourmet Prods. Div., Case. No. 14-cvCase 1:16-cv-00406-KES-HBK Document 97 Filed 07/08/16 Page 4 of 10
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02006-JST, 2015 WL 510919, at *3 (N.D. Cal. Feb. 5, 2015) (“Documents available through 

government agency websites are often considered appropriate for judicial notice as documents in 

the public record not reasonably subject to dispute.”). However, in the undersigned’s view the 

documents do not establish what defendant claims they do.

At the heart of what defendant wishes this court to judicially notice is a fact which, if 

proven, would be dispositive of this action: Roundup is not carcinogenic. Most likely because 

that is clearly not a fact subject to judicial notice, defendant instead attempts to have the court 

judicially notice something else: that EPA has determined Roundup is not carcinogenic and 

therefore the failure to include a warning label cannot constitute misbranding under FIFRA. If 

that were the case, any state law tort claim for failure to warn of the carcinogenic nature of 

Roundup would, in effect, impose an additional requirement not imposed by FIFRA. According 

to defendant’s argument, any such claim would therefore be preempted so long as the EPA’s 

decision was not arbitrary and capricious. See Hardeman, 2016 WL 1749680, at *2 (“Of course, 

if the EPA’s approval of Roundup’s label had the force of law, it would preempt conflicting statelaw enforcement of FIFRA.”); see also Allentown Mack Sales & Serv., Inc. v. NLRB, 522 U.S. 

359, 364–65 (1998) (Courts must defer to requirements imposed by the NLRB as long as they are 

rationale and consistent with the applicable statute and the Board’s explication is not inadequate, 

irrational or arbitrary).

However, none of the documents replied upon by defendant establishes that Roundup is 

not carcinogenic or that Roundup is not misbranded under FIFRA despite its failure to include 

warnings about carcinogenicity. The first document relied upon by defendants in this regard is a 

fact sheet promulgated by the EPA in September 1993 as part of its reregistration process for 

glyphosate. It is unclear whether this fact sheet has the force and effect of law, which is 

necessary for it to have any preemptive quality. See Chrysler Corp. v. Brown, 441 U.S. 281, 

301–02 (1979) (describing substantive and procedural requirements of an agency action necessary 

for a regulation to have the “force and effect of law”). The document itself announces an

anticipated reregistration and solicits comments on the planned registration within sixty days. 

However, in order to have the force and effect of law, an agency’s action must be final. See Ass’n 

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of Flight Attendants-CWA, AFL-CIO v. Huerta, 785 F.3d 710, 713 (D.C. Cir. 2015). This 

document clearly does not reflect a final decision. In addition, the document was filed in 

September 1993 and predates the exposure alleged in this action by more than a decade. Under 

FIFRA, manufacturers have a “continuing obligation to adhere to FIFRA’s labeling requirement,” 

and a prior registration is only prima facie evidence of compliance with the registration provision 

which does not constitute a defense to any offense—such as misbranding—prohibited by the 

statute. Bates, 544 U.S. at 438. See also 7 U.S.C. § 136a(f)(2). As such, plaintiff’s challenge in 

this case can be construed, as the complaint was in Hardeman, as “implying that the EPA failed 

to enforce FIFRA correctly when it approved the label.” 2016 WL 1749680, at *2.

The second, third, fourth, and fifth documents which defendant asks the court to take 

judicial notice of are all regulations promulgated by EPA under the Food, Drug, and Cosmetic 

Act (“FDCA”), not FIFRA. They are, therefore, simply not relevant to the question of whether 

Roundup is misbranded under FIFRA. Hardeman, 2016 WL 1749680, at *2 (“FDCA regulations 

don’t ‘give content to FIFRA’s misbranding standards,’ [citation omitted] so they don’t affect the 

extent to which FIFRA preempts state law.”); see also United States v. Mead Corp., 533 U.S. 

218, 227–34 (2001). The EPA’s regulations under the FDCA would, under appropriate 

circumstances, require deference from this court concerning the interpretations of various 

statutory provisions under the FDCA. As noted, regulations under the FDCA do not speak to 

requirements under FIFRA, unless there is some specific link between the two statutes. At oral 

argument, defense counsel claimed EPA’s regulations under FDCA are expressly incorporated 

into FIFRA by force of 7 U.S.C. § 136(q)(1)(F) and 40 C.F.R. § 152.112(f). However, neither of 

these subsections references the FDCA.1 While 40 C.F.R. § 152.112(g) references the FDCA, it 

does so only in stating the EPA will not approve certain pesticide labeling for use on food, animal 

 

1

Title 7 U.S.C. § 136(q)(1)(F) also requires compliance with 7 U.S.C. § 136a(d), another section 

of FIFRA which governs classifications of pesticide. Title 40 C.F.R. § 152.112 states the EPA 

will only approve applications for registration if it determines the product is not misbranded as 

that term is defined in 7 U.S.C. § 136(q) and 40 C.F.R. §§ 156 et seq., 157 et seq., both of which 

are promulgated under the authority granted by FIFRA. Therefore, neither the statute nor the 

regulation cited by defense counsel support defendant’s argument that the court should defer to 

rulemakings under the FDCA in interpreting FIFRA.

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feed, or crops unless it also complies with the residue testing regulations EPA requires under the 

FDCA. 40 C.F.R. § 152.112(g). At most, therefore, these documents might establish that 

Roundup/glyphosate does not violate the residue testing requirements EPA has promulgated 

under the FDCA. Whether Roundup meets the FDCA’s residue testing requirements does not, 

however, answer the question of whether Roundup/glyphosate is misbranded under FIFRA, since 

this would only be one of many ways in which a pesticide could be misbranded. Compare 7 

U.S.C. § 136(q)(1)(F) (“A pesticide is misbranded if . . . the labeling accompanying it does not 

contain directions for use which are . . . adequate to protect health”) with 40 C.F.R. § 152.112(g) 

(“EPA will approve an application . . . only if . . . all necessary tolerances, exemptions . . . and 

food additive regulations have been issued.”)2Further, as plaintiff’s counsel clarified at the 

hearing on the pending motion to dismiss, the complaint in this action does not allege plaintiff 

contracted non-Hodgkin lymphoma from ingesting Roundup on food, but rather from spraying it 

around her home between at least 2004 and 2012. (See Doc. No. 29 at ¶ 71.) Therefore, the 

documents relied upon by defendant are not pertinent to their preemption argument.

The sixth document which is the subject of defendant’s request for judicial notice is a 

statement a deputy director of EPA’s Office of Pesticide Programs made to the Senate Committee 

on Agriculture, Nutrition, & Forestry. (Doc. No. 74 at 57.) This statement does not have the 

force of law, and offers neither preemptive nor persuasive force. See Perez v. Mortg. Bankers 

Ass’n, ___U.S.___, ___, 135 S. Ct. 1199, 1223–24 (2015) (“It is the text of the regulations that 

have the force and effect of law, not the agency’s intent.”); Price v. Stevedoring Servs. of Am., 

Inc., 697 F.3d 820, 830 (9th Cir. 2012) (“Without a basis in agency regulations or other binding 

agency interpretations, there is usually no justification for attributing to an agency litigating 

 

2

 At the hearing on the pending motion defense counsel essentially argued that because the EPA 

has determined under the FDCA that Roundup isn’t carcinogenic and that FDCA determination is 

incorporated into the EPA’s misbranding determination under FIFRA, when the EPA approved 

the label under FIFRA it was in effect determining Roundup was not carcinogenic. However, the

statutes and regulations defense counsel points to in this regard provide only that if a pesticide 

fails to meet the residue test under the FDCA, it will not be approved under FIFRA. While one of 

the ways a pesticide would be misbranded under FIFRA is if it fails to meet the FDCA residue 

tests, that is not the only basis upon which it could be found to be misbranded. 

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position ‘the force of law,’ essential to Chevron deference.”) (citations omitted); Appalachian 

Power Co. v. EPA, 208 F.3d 1015, 1020–22 (D.C. Cir. 2000) (recognizing various ways an 

agency decision can have binding effects).

In short, nothing presented by defendant in support of the pending motion to dismiss 

persuades this court that the failure to warn claims alleged by plaintiff in this case are subject to 

dismissal on preemption grounds under FIFRA. Defendant has not demonstrated plaintiff’s state 

law claims, if successful, will necessarily impose any additional requirements beyond FIFRA’s 

requirement that the product not be misbranded. Defendant also has not established that the EPA 

has determined Roundup is not misbranded under FIFRA. In any event, FIFRA itself does not 

deem a registration conclusive as to whether a pesticide is misbranded. See 7 U.S.C. 

§ 136a(f)(2).3 Accordingly, defendant’s motion to dismiss on preemption grounds will be denied.

2. Comments j and k of the Restatement (Second) of Torts § 402

Defendant’s second argument is that plaintiff’s design defect claims are barred by 

comments j and k to § 402A of the Restatement (Second) of Torts. (Doc. No. 73-1 at 10–15.)

Section 402A of the Restatement (Second) of Torts states:

(1) One who sells any product in a defective condition 

unreasonably dangerous to the user or consumer or to his property 

is subject to liability for physical harm thereby caused to the 

ultimate user or consumer, or to his property, if

(a) the seller is engaged in the business of selling such a 

product, and

(b) it is expected to and does reach the user or consumer 

without substantial change in the condition in which it is 

sold.

 

3 Defendant’s citation to the decision in Reckitt Benckiser, Inc. v. Jackson, 762 F. Supp. 2d 34 

(D.D.C. 2011) in its reply is inapposite. The court there considered whether the EPA itself could 

bring a misbranding action against a manufacturer under FIFRA without first canceling the 

existing registration. Reckitt Benckiser, 762 F. Supp. 2d at 41. Ultimately, the court concluded 

the EPA did not have the authority under FIFRA to pursue such an action in lieu of a cancellation 

proceeding because 7 U.S.C. § 136d “established a detailed, multi-step process that EPA must

follow when it wants to cancel or suspend a registration.” Id. at 42–43. The court concluded that 

to allow the EPA to bring a separate misbranding proceeding would render that section 

superfluous and allow the agency to avoid the cancellation process Congress had spelled out in 

the statute. Id. at 43. Here, plaintiff is a private citizen alleging failure to warn claims under state 

law rather than private action for misbranding under FIFRA. 

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(2) The rule stated in Subsection (1) applies although

(a) the seller has exercised all possible care in the 

preparation and sale of his product, and

(b) the user or consumer has not bought the product from or 

entered into any contractual relation with the seller.

Comment j provides that, “[i]n order to prevent the product from being unreasonably 

dangerous, the seller may be required to give directions or warning, on the container, as to its 

use.” Restatement (Second) of Torts § 402A cmt. j. “This means that a plaintiff can bring 

failure-to-warn claims, but it doesn’t mean that a plaintiff can bring only failure-to-warn claims.” 

Hardeman, 2016 WL 1749680, at *3.4 Indeed, that would run directly counter to § 402A, which 

states liability should be imposed for the sale of unreasonably dangerous products even when the 

seller has exercised all possible care, such as providing warnings of the product’s danger.

Comment j also says that “a product bearing such a warning, which is safe for use if it is 

followed, is not in defective condition, nor is it unreasonably dangerous.” Restatement (Second) 

of Torts § 402A, cmt. j. The crux of plaintiff’s claim in this case is that defendant failed to warn 

her about the carcinogenic effects of Roundup/glyphosate. Plaintiff may therefore also allege the 

product is in defective condition and/or unreasonably dangerous, and comment j presents no bar 

to such a claim.

In this regard, comment k states: 

There are some products which, in the present state of human 

knowledge, are quite incapable of being made safe for their 

intended and ordinary use. . . . Such a product, properly prepared, 

and accompanied by proper directions and warning, is not 

defective, nor is it unreasonably dangerous. . . . The seller of such 

products, again with the qualification that they are properly 

prepared and marketed, and proper warning is given, where the 

situation calls for it, is not to be held to strict liability for 

unfortunate consequences attending their use, merely because he 

has undertaken to supply the public with an apparently useful and 

 

4 Defendant cites the decision in Oakes v. E.I. Du Pont de Nemours & Co., 272 Cal. App. 2d 645 

(1969) as applying comment j to a pesticide. That case is not persuasive authority with respect to 

the issue before this court. There, the California Court of Appeal merely held that the rule 

embodied in comment j did not require defendant to “warn the user of unknown and unknowable 

allergies, sensitivities and idiosyncracies [sic],” which would “recast the manufacturer in the role 

of an insurer.” Id. at 650–51. This is simply not the nature of plaintiff’s claim in this action.

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desirable product, attended with a known but apparently reasonable 

risk.

Restatement (Second) of Torts § 402. “California courts have applied comment k to prescription 

drugs and medical devices only.” Giglio, 2016 WL 1722859, at *4. See also Hardeman, 2016 

WL 1749680, at *3 (“Monsanto does not cite—and the Court cannot find—a California case 

applying comment k outside the medical context, accord Garrett v. Howmedica Osteonics Corp., 

214 Cal. App. 4th 173, 153 Cal.Rptr.3d 693, 700–01 (2013). On the contrary, California courts 

appear willing to apply comment k only where a product is ‘available only through the services of 

a physician.’”). Defendant notes that decisions applying the law of other states have applied

comment k outside the narrow areas to which California courts have limited it. (See Doc. No. 73-

1 at 12–13, fns. 29–33.) However, those decisions have no relevance here since it is California 

law that controls plaintiff’s claims before this court. 

III. Conclusion

For all of the reasons set forth above, defendant’s motion to dismiss (Doc. No. 73) is 

denied. 

IT IS SO ORDERED.

Dated: July 7, 2016 

UNITED STATES DISTRICT JUDGE

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