UNITED STATES DISTRICT COURT DISTRICT OF HAWAII

Transcription

1 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 1 of 28 PageID #: 238 Michael F. O Connor, (mfoconnor@ollon.com) OGAWA, LAU, NAKAMURA & JEW Attorneys-at-Law, A Law Corporation 707 Richards Street, Suite 600 Honolulu, HI Telephone: (808) Facsimile: (808) Joe G. Hollingsworth (admitted pro hac vice) (jhollingsworth@hollingsworthllp.com) Katharine R. Latimer (admitted pro hac vice) (klatimer@hollingsworthllp.com) Eric G. Lasker (admitted pro hac vice) (elasker@hollingsworthllp.com) HOLLINGSWORTH LLP 1350 I Street, N.W. Washington, DC Telephone: (202) Facsimile: (202) Attorneys for Defendant MONSANTO COMPANY CHRISTINE SHEPPARD, KENNETH SHEPPARD, v. Plaintiffs, MONSANTO COMPANY, Defendant. UNITED STATES DISTRICT COURT DISTRICT OF HAWAII C.V. NO.: 1:16-cv JMS-RLP MONSANTO COMPANY S REPLY MEMORANDUM IN SUPPORT OF MOTION TO DISMISS PLAINTIFFS COMPLAINT Hearing Date: May 2, 2016 Time: 10:00 a.m. Judge: Hon. Michael Seabright

2 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 2 of 28 PageID #: 239 TABLE OF CONTENTS Page I. INTRODUCTION... 1 II. ARGUMENT... 2 A. Plaintiffs Claims Are Time-Barred Hawaii Law Does Not Delay Accrual Until A Defendant Concedes the Merits of Plaintiffs Claim Hawaii Law Does Not Delay Accrual Because Plaintiffs Physicians Did Not Corroborate Ms. Sheppard s Suspicion B. EPA s Repeated Rejection of Glyphosate s Alleged Cancer Risk And Approval of Roundup Labeling without Cancer Warnings Preempts All of Plaintiff s Warnings-Based Claims C. Plaintiffs Fail to Respond to Monsanto s Argument That Their Non-Warnings Based Design Defect Claims Are Barred by Comments J And K Because They Allege That Roundup Is Inherently Dangerous III. CONCLUSION i

3 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 3 of 28 PageID #: 240 TABLE OF AUTHORITIES Cases Page(s) Aana v. Pioneer Hi-Bred Int l, Inc., Civ. Nos LEK-BMK, LEK-BMK, 2014 WL (D. Haw. Feb. 27, 2014) Anderson v. Owens-Corning Fiberglas Corp., 810 P.2d 549 (Cal. 1991) In re Asbestos Cases, 829 F.2d 907 (9th Cir. 1987) Astiana v. Hain Celestial Grp., Inc., 783 F.3d 753 (9th Cir. 2015) Balog v. Ctr. Art Gallery-Hawai i, Inc., 745 F. Supp (D. Haw. 1990)... 4 Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005)...passim Bennett v. United States, No , 1992 WL (9th Cir. Sept. 2, 1992) (unpublished)... 7 Brown v. Superior Court, 751 P.2d 470 (Cal. 1988) Brown v. Superior Court (Abbott Labs.), 227 Cal. Rptr. 768 (Cal. Ct. App. 1986), review granted & opinion superseded, 723 P.2d 1248 (Cal. 1986), aff d sub nom. Brown v. Superior Court, 751 P.2d 470 (Cal. 1988) Dunlea v. Dappen, 924 P.2d 196 (Haw. 1996) abrogated by Hac v. Univ. of Hawaii, 73 P.3d 46 (Haw. 2003)... 7 Erickson v. Boston Sci. Corp., 846 F. Supp. 2d 1085 (C.D. Cal. 2011)... 5 ii

4 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 4 of 28 PageID #: 241 Euro-Pro Operating LLC v. Euroflex Americas, No. 08CV6231 (HB), 2008 WL (S.D.N.Y. Dec. 8, 2008)... 9, 10 Funke v. Sorin Grp. USA, Inc., No. SACV CJC(ASx), 2015 WL (C.D. Cal. Nov. 24, 2015) Hardeman v. Monsanto Co., Case No. 16-cv VC, Slip Op. (N.D. Cal. April 8, 2016)... 11, 14, 19 In re Incretin-Based Therapies Prods. Liab. Litig., No. 13md2452 AJB(MDD), 2015 WL (S.D. Cal. Nov. 9, 2015) Indian Brand Farms, Inc. v. Novartis Crop Protection Inc., 617 F.3d 207 (3d Cir. 2010) Johnson v. Raybestos-Manhattan, Inc., 69 Haw. 287 (Haw. 1987), (9th Cir. 1987) Jolly v. Eli Lilly & Co., 751 P.2d 923 (Cal. 1998)... 3, 5 Kersh v. Manulife Fin. Corp., 792 F. Supp. 2d 1111 (D. Haw. 2011)... 4 Knoppel v. St. Jude Med. Inc., No. SACV JVS (ANx), 2013 WL (C.D. Cal. May 7, 2013) Marshall v. I-Flow, LLC, No. 5:12-cv-721, 2012 WL (N.D.N.Y. Aug. 7, 2012)... 4 Masaki v. Gen. Motors Corp., 780 P.2d 566 (Haw. 1989) Moddha Interactive, Inc. v. Philips Elec. N. Am. Corp., 92 F. Supp. 3d 982 (D. Haw. 2015)... 3, 6 Nelson v. Indevus Pharm., Inc., 48 Cal. Rptr. 3d 668 (Cal. Ct. App. 2006)... 6 iii

5 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 5 of 28 PageID #: 242 Oakes v. E.I. Du Pont De Nemours & Co., 77 Cal. Rptr. 709 (Cal. Ct. App. 1969) Red v. Kroger Co., No. CV DMG, 2010 WL (C.D. Cal. Sept. 2, 2010) Rodenhurst v. Hawaii, No. CIV SOM-LEK, 2010 WL (D. Haw. Apr. 29, 2010)... 7 Ruiz-Guzman v. Amvac Chemical Corp., 7 P.3d 795 (Wash. 2000) Stoleson v. United States, 629 F.2d 1265 (7th Cir. 1980)... 6, 7 Strand v. Gen. Elec. Co., 945 F. Supp (D. Haw. 1996)... 6 Vaught v. Showa Denko K.K., 107 F.3d 1137 (5th Cir. 1997)... 5 Vidinha v. Miyaki, 145 P.3d 879 (Ct. App. 2006), aff d, 160 P.3d 738 (2007)... 7 E.Y. ex rel. Wallace v. United States, 758 F.3d 861 (7th Cir. 2014)... 7 Statutes 7 U.S.C. 136(p)(2)(A) U.S.C. 136(q)(1)(A) U.S.C. 136(q)(1)(F)-(G) U.S.C. 136a(f)(2) U.S.C. 346a U.S.C. 346a(b)(2)(A)(ii) Federal Tort Claims Act... 6 iv

6 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 6 of 28 PageID #: 243 Haw. Rev. Stat. 490: Haw. Rev. Stat Other Authorities 40 C.F.R (a) (1989) C.F.R (i) C.F.R (a)(1988) C.F.R (f) (2009)... 2, C.F.R (a) (1988) C.F.R (1988) C.F.R (1988) C.F.R (c) (1988) C.F.R (2007), (2007) Fed. Reg. 60,934, 60, (Sept. 27, 2002) (to be codified at 40 C.F.R. pt. 180)... 13, 14 EPA, Roundup Weed &Grass Killer Concentrate Plus, Pesticide Product Label System, NO::P8_PUID: Kat Greene, EPA Cites Pesticide Maker for Marketing Violations, Law360 (Sept. 24, 2015), 16 Kira Lerner, EPA Imposes Record FIFRA Fine For Pesticide Advertising (June 9, 2014), 16 LR 7.5(b)... 2 v

7 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 7 of 28 PageID #: 244 LR 7.5(c)... 2 Restatement (Second) Torts 402A... 2, 17 vi

8 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 8 of 28 PageID #: 245 MONSANTO COMPANY S REPLY BRIEF IN SUPPORT OF ITS MOTION TO DISMISS PLAINTIFFS COMPLAINT I. INTRODUCTION Plaintiffs Opposition to Monsanto Company s ( Monsanto ) Motion To Dismiss does not deny the key failures in their complaint that require dismissal: Plaintiffs do not deny that Ms. Sheppard authored an article in August 2009 discussing numerous scientific studies regarding Roundup, including a study that purported to link Roundup with non-hodgkin s lymphoma ( NHL ) and that she raised in that same article the possibility that her NHL was caused by Roundup. The 2-year statute of limitations for plaintiffs tort claims accordingly ended in August Haw. Rev. Stat Plaintiffs also do not deny that their last alleged purchase of Roundup was over 11 years ago, well outside the 4-year statute of limitations for her warranty claims. See Haw. Rev. Stat. 490: Plaintiffs arguments that their statute of limitations was not triggered until Ms. Sheppard had a medical diagnosis supporting her claim or Monsanto agreed with her allegation that Roundup causes cancer are contrary to Hawaii law. Plaintiffs do not deny that EPA consistently has concluded over the past twenty-five years that glyphosate does not pose a risk of cancer and that EPA repeatedly has approved Roundup labeling without warnings of the 1

9 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 9 of 28 PageID #: 246 purported risk, thereby rejecting any finding that Roundup is misbranded. Plaintiffs warnings-based claims that Monsanto should have warned of a cancer risk would impose a requirement under state law that differs from EPA s federal labeling requirements, and they are accordingly preempted. See 7 U.S.C. 136(q)(1)(A); 40 C.F.R (f) (2009). Plaintiffs do not deny that they allege that Roundup is an inherently dangerous product, an allegation that under Restatement (Second) Torts 402A, comments j and k, precludes their non-warnings based design defect claims. For each of these reasons, this case should be dismissed. 1 II. ARGUMENT A. Plaintiffs Claims Are Time-Barred. Plaintiffs do not dispute that all of their tort and warranty claims are untimely if they accrued, respectively, as of the dates of Ms. Sheppard s August 2009 article linking her NHL to Roundup and plaintiffs last alleged purchase of Roundup in Instead, plaintiffs put forth a variety of arguments to delay those accrual dates. Each of these arguments is without merit. 1 Monsanto respectfully requests that the Court consider its Reply in excess of the page limit set out in LR 7.5(c) to adequately respond to plaintiffs Opposition that exceeded the page and word limit of LR 7.5(b). 2

10 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 10 of 28 PageID #: Hawaii Law Does Not Delay Accrual Until A Defendant Concedes the Merits of Plaintiffs Claim. Plaintiffs argue that the language of the EPA-approved product labels and Monsanto s defense of Roundup s safety prevent accrual of their claims prior to March See Pl. s Opp n. To Def s Mot. To Dismiss, ( Opp. ) at 12-13, ECF No. 19. But it is well-settled that a plaintiff cannot avoid the statute of limitations until and unless a defendant concedes the merits of the plaintiff s claims. See Jolly v. Eli Lilly & Co., 751 P.2d 923, 926 (Cal. 1998) (holding that summary judgment on statute of limitations grounds was properly granted even though even today defendants allege that DES is not defective ); Moddha Interactive, Inc. v. Philips Elec. N. Am. Corp., 92 F. Supp. 3d 982, (D. Haw. 2015) (citing Jolly and finding that the statute of limitations was triggered as soon as plaintiff [had a] suspicion of wrongdoing in the summer of 2008, notwithstanding whether [plaintiff] decided to conduct a further investigation at that time ), appeal docketed, No (9th Cir. Sept. 18, 2015). All that is required to start the limitations period is plaintiffs suspicion of wrongdoing, which is established here through Ms. Sheppard s August 2009 newsletter. See id at 993. Plaintiffs related argument that Monsanto s defense of its product s safety constitutes fraudulent concealment that tolls their breach of warranty statute of limitations also is without merit. Fraudulent concealment tolling requires plaintiffs to show that Monsanto withheld information that Plaintiff needed to understand 3

11 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 11 of 28 PageID #: 248 that he had a cause of action. Kersh v. Manulife Fin. Corp., 792 F. Supp. 2d 1111, 1121 (D. Haw. 2011). Plaintiffs cannot meet this burden by alleging that a defendant concealed the risks of its product. If this were the case, there would be no statute of limitations in any failure to warn product liability case. See Marshall v. I-Flow, LLC, No. 5:12-cv-721, 2012 WL , at *3 n.1 (N.D.N.Y. Aug. 7, 2012) (rejecting fraudulent concealment tolling of breach of warranty claim in products liability context and noting [a]lthough it is claimed that Defendant told physicians and the public that its product was safe, did not disclose the FDA s rejection of use of the I-Flow in the joint, promoted the I-Flow for use in the joints, did not conduct safety studies, and was aware of problems using the pump in the joint these facts were insufficient to demonstrate fraudulent concealment of a potential cause of action ). 2 Here, Ms. Sheppard had the evidence in hand in August of 2009 to understand that she had a cause of action, but she elected to sit on her rights. 2 Plaintiffs cite to Balog v. Ctr. Art Gallery-Hawai i, Inc., 745 F. Supp. 1556, (D. Haw. 1990), but that case involved an art dealer who intentionally and directly defrauded plaintiffs about the provenance of paintings that defendant claimed had been painted by Salvador Dali. Plaintiffs do not allege any such direct communications between Monsanto and Ms. Sheppard. The related doctrine of lulling also does not apply. See Opp. at 14. Lulling is a contract exception to the statute of limitations that applies when parties enter written contractual agreements, most often in the insurance context, rather than warranty claims in products liability cases, and requires reasonable reliance by one party in foregoing its claim. See, e.g., Kersh, 792 F. Supp. 2d at

12 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 12 of 28 PageID #: Hawaii Law Does Not Delay Accrual Because Plaintiffs Physicians Did Not Corroborate Ms. Sheppard s Suspicion. In her August 2009 newsletter, Ms. Sheppard not only voiced her suspicion that her NHL was caused by exposure to Roundup ; she states that she had found a report from Sweden that linked Monsantos Roundup with increased incidence of NHL. See Monsanto s Mem. of P. & A. in Supp. of Mot. to Dismiss ( Mot. ) at 7-8, ECF No. 10-1; see also Request for Judicial Notice, Ex. A, ECF No Further, Ms. Sheppard discusses a variety of other studies that purport to make adverse findings about alleged health risks of Roundup, which she reported to have extracted from a longer article published in Scientific American. Request For Judicial Notice, Ex. A. Once Ms. Sheppard learned of scientific reports purporting to link Monsanto s Roundup to NHL, she had a duty to investigate further and to bring her claims within the limitations period. See Jolly, 751 P.2d at 929 (Cal. 1998) (finding discovery rule triggered at time when plaintiff first suspected that defendants conduct was wrongful ). The fact that her doctors did not confirm her suspicions did not allow her to sit on the information of which she was actually aware. See Vaught v. Showa Denko K.K., 107 F.3d 1137, 1141 (5th Cir. 1997) (medical diagnosis not necessary for accrual); Erickson v. Boston Sci. Corp., 846 F. Supp. 2d 1085, 1095 (C.D. Cal. 2011) (same). Plaintiff s argument is counter to an important purpose of statutes of limitations: the limiting period provides plaintiffs with a period in which to 5

13 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 13 of 28 PageID #: 250 investigate a perceived injury and investigate potential claims. Strand v. Gen. Elec. Co., 945 F. Supp. 1334, 1340 (D. Haw. 1996). If a person becomes aware of facts which would make a reasonably prudent person suspicious, he or she has a duty to investigate further and is charged with knowledge of matters which would have been revealed by such an investigation. Nelson v. Indevus Pharm., Inc., 48 Cal. Rptr. 3d 668, 673 (Cal. Ct. App. 2006) (internal quotations and citations omitted). Once the plaintiff has a suspicion of wrongdoing, and therefore an incentive to sue, she must decide whether to file suit or sit on her rights. So long as a suspicion exists, it is clear that the plaintiff must go find the facts; she cannot wait for the facts to find her. Id. at 672. A plaintiff who actually learns of the dangerous side effects of a [product to which she was exposed] ignores her knowledge at her peril.... Id. at 673; see also Moddha, 92 F. Supp. 3d at 993 ( Hawaii case law follows California precedent regarding the application of the discovery rule ) (citing cases). 3 Plaintiffs rely heavily on a factually inapposite Federal Tort Claims Act case from the Seventh Circuit in 1980, see Stoleson v. United States, 629 F.2d 1265, 1270 (7th Cir. 1980), but that case is not only irrelevant to the standard in Hawaii 3 Plaintiffs suggestion that a medical diagnosis is required for accrual also is inconsistent with her argument that her claim accrued when she learned of the March 2015 IARC report. See Opp. at 9 ( cause-of-action accrued when Ms. Sheppard learned in March of 2015 that Roundup causes NHL. ); see also Christine Sheppard Decl. at 11, Dec. 30, 2015, ECF No

14 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 14 of 28 PageID #: 251 but is no longer good law even in the Seventh Circuit. See, e.g., E.Y. ex rel. Wallace v. United States, 758 F.3d 861, 865 (7th Cir. 2014) (rejecting the actual knowledge rule and noting that accrual... is triggered instead by information sufficient to prompt a reasonable person to inquire ). 4 Plaintiffs also cite to Dunlea v. Dappen, 924 P.2d 196, 201 (Haw. 1996) abrogated by Hac v. Univ. of Hawaii, 73 P.3d 46 (Haw. 2003), but that case involves the wholly inapposite situation of alleged repressed memories of childhood sexual abuse. 5 In this case, Ms. Sheppard was fully aware of the facts necessary for her to pursue her claim. She simply failed to act on them. B. EPA s Repeated Rejection of Glyphosate s Alleged Cancer Risk And Approval of Roundup Labeling without Cancer Warnings Preempts All of Plaintiff s Warnings-Based Claims. Monsanto s opening motion provided the Court with a list of EPA s repeated regulatory findings over the past twenty-five years that glyphosate is not a carcinogen, including specific statements affirming the safety of glyphosate made 4 Contrary to plaintiffs suggestion, Bennett v. United States, No , 1992 WL , at *2 (9th Cir. Sept. 2, 1992) (unpublished) cites Stoleson for the entirely different question of whether a statute of limitations is tolled for a continuing tort. See id. at *2. That question has no bearing here because Ms. Sheppard s last exposure occurred in See, e.g., Rodenhurst v. Hawaii, No. CIV SOM-LEK, 2010 WL , at *5 (D. Haw. Apr. 29, 2010). 5 Vidinha v. Miyaki, 145 P.3d 879, 884 (Ct. App. 2006), aff d, 160 P.3d 738 (2007) is also inapposite. In that medical malpractice case, the plaintiff submitted an affidavit stating that she did not know that pancreatitis was a risk factor of [her surgical] procedure... until after she consulted with her present attorney. 7

15 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 15 of 28 PageID #: 252 by EPA as recently as October See Mot. at Plaintiffs do not dispute that these findings are relevant to the Court s preemption analysis of their state law tort claims under FIFRA. See Opp. at 26 (discussing EPA s classifications as to the carcinogenicity of Glyphosate ). Nor do plaintiffs dispute that pursuant to the Supreme Court s holding in Bates, their warnings-based claims are preempted if they impose requirements different from or in addition to those imposed by federal law. Id. at 16 (quoting Bates v. Dow Agrosciences LLC, 544 U.S. 431, 432 (2005)). In fact, plaintiffs concede that [t]here is no need to delve into a deep analysis of whether FIFRA preempts Plaintiffs claims. [As Bates] has already done so. Opp. at 16. Plaintiffs instead attempt to avoid dismissal by arguing that their warningsbased claims, which are premised entirely on glyphosate s alleged carcinogenic effects, are not preempted because they are parallel to FIFRA s misbranding requirement that products contain warnings sufficient to protect health and the environment. See Opp. at (citing 7 U.S.C. 136(q)(1)(F)-(G)). This argument misconstrues the parallel requirements exception and cannot insulate plaintiffs claims from preemption under section 136v(b). In articulating the breadth of FIFRA s preemption provision, the Supreme Court explained that [t]he provision... pre-empts any statutory or common-law rule that would impose a labeling requirement that diverges from those set out in 8

16 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 16 of 28 PageID #: 253 FIFRA and its implementing regulations. It does not, however, pre-empt any state rules that are fully consistent with federal requirements. Bates, 544 U.S. at 452 (emphasis added). Bates further established that qualifying for the parallel requirements exception from 136v(b) preemption requires more than a cursory comparison between state tort duties and FIFRA's misbranding definition. The Court not only emphasize[d] that a state-law labeling requirement must in fact be equivalent to a requirement under FIFRA in order to survive pre-emption, but also that [s]tate-law requirements must... be measured against any relevant EPA regulations that give content to FIFRA's misbranding standards. 544 U.S. at 453; see also id. at 454 ( If a case proceeds to trial.... a court should instruct the jury on the relevant FIFRA misbranding standards, as well as any regulations that add content to those standards. ). Plaintiffs argue that EPA s approval of the the initial [Roundup ] label does not prohibit a subsequent finding of misbranding under federal law, see Opp. at 22-23, 6 but that argument rests upon the fact that a manufacturer has a 6 Plaintiffs cite Euro-Pro Operating LLC v. Euroflex Americas, No. 08CV6231 (HB), 2008 WL , at *6 (S.D.N.Y. Dec. 8, 2008), an inapposite false advertising case involving competing manufacturers of portable handheld steam cleaning products, for the proposition that EPA s approval of a product s FIFRA label does not constitute a finding or an endorsement that its design is safe. Opp. at 23. In that case, the court enjoined the defendant from airing an infomercial that contained claims that its steam cleaner was EPA Tested and Approved after finding those claims false and misleading given that EPA does not test consumer 9

17 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 17 of 28 PageID #: 254 continuing obligation to adhere to FIFRA s labeling requirements as new and relevant information surfaces. See also Bates, 544 U.S. at 438. Plaintiffs do not deny that EPA s approval of a herbicide label precludes a finding of misbranding at the time of the approval. Federal law makes clear that EPA will approve a pesticide application only if [t]he Agency has determined that the product is not misbranded as that term is defined in FIFRA... and its labeling and packaging comply with the applicable requirements of the Act C.F.R (f) (1988). 7 Moreover, [a]s long as no cancellation proceedings are in effect[,] 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). Accordingly, to rebut this prima facie evidence and avoid preemption here, plaintiffs would need to show that EPA only approved the Roundup label in the past and that subsequent information had surfaced that would cause EPA to impose a new labeling requirement to include a cancer warning. Plaintiffs cannot make products.... Euro-Pro, 2008 WL , at *6. Accordingly, Euro-Pro is irrelevant to the Court s preemption analysis here. 7 As plaintiffs acknowledge, EPA will not approve a product label unless the label bear[s] precautionary statements describing the particular hazard [shown to exist through data or other information], the route(s) of exposure and the precautions to be taken to avoid accident, injury or toxic effect or to mitigate the effect. Opp. at 19 (quoting 40 C.F.R (1988)); see also 40 C.F.R (1988) ( Each product label is required to bear hazard and precautionary statements for humans and domestic animals (if applicable) as prescribed in this subpart. ). 10

18 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 18 of 28 PageID #: 255 these showings. As the public record documents establish: (1) EPA has continued to approve new labeling for dozens of different Roundup products with no cancer warnings, including as recently as this past year 8 and (2) EPA has continued to reject any purported cancer link based upon its own ongoing review of the scientific evidence, well after Ms. Sheppard s alleged exposures to Roundup. 9 Far from supporting plaintiffs non-preemption argument, the FIFRA misbranding regulations establish why plaintiffs claims must be preempted. Under the misbranding regulations, [s]pecific statements pertaining to the hazards of the product and its uses must be approved by the Agency, 40 C.F.R (c) (1988), and pesticide products may be distributed or sold only with the 8 See, e.g., EPA, Roundup Weed &Grass Killer Concentrate Plus, Pesticide Product Label System, Plaintiffs claim that [o]nce glyphosate was registered, Monsanto was able to come out with new glyphosate-containing products without going through a new registration process is a misstatement of federal law. See Opp. at 26. Any modification in the composition, labeling, or packaging of a registered product has to be submitted to the EPA with an application for amended registration. 40 C.F.R (a)(1988) (emphasis added). Thus, every new glyphosatecontaining product is subject to EPA s rigorous approval process. 9 In a recent opinion, a federal district court in the Northern District of California mistakenly rejected Monsanto s preemption argument in a similar cancer product liability case, concluding that the mere fact that the EPA has approved a product label does not prevent a jury from finding that that same label violates FIFRA. Hardeman v. Monsanto Co., Case No. 16-cv VC, Slip Op. at 2 (N.D. Cal. April 8, 2016). Bates is directly to the contrary: We emphasize that a state-law labeling requirement must in fact be equivalent to a requirement under FIFRA in order to survive pre-emption. 544 U.S. at

19 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 19 of 28 PageID #: 256 labeling currently approved by the Agency. See 40 C.F.R (a) (1988). Accordingly, the warnings that plaintiffs would require under Hawaii law not only are not equivalent to the requirements imposed on Monsanto under federal law, but they would require Monsanto to violate federal law by adding statements of alleged product hazards that EPA has directly rejected. 10 This direct conflict cannot, as plaintiffs suggest, be cured by a jury instruction. See Opp. at 20 (citing Astiana v. Hain Celestial Grp., Inc., 783 F.3d 753, (9th Cir. 2015)). In Astiana, consumers brought a putative class action under California s Sherman Act, seeking to remove natural from defendant s cosmetics labels, an allegedly misleading advertising statement that the Food and Drug Administration ( FDA ) had not specifically considered or addressed as part of its labeling determination. See 783 F.3d at 756, 758. Here, however, plaintiffs are relying on a state law requirement that squarely contradicts EPA s specific and repeated findings of non-carcinogenicity. Likewise, there is no basis for plaintiffs argument that preemption is a question for the fact finder. See Red v. Kroger Co., No. CV DMG (MANx), 2010 WL , at *7 10 See also Funke v. Sorin Grp. USA, Inc., No. SACV CJC(ASx), 2015 WL , at *4 (C.D. Cal. Nov. 24, 2015) (holding that warnings-based claims involving medical device were preempted based upon judicially noticed premarket approval of the device); In re Incretin-Based Therapies Prods. Liab. Litig., No. 13md2452 AJB(MDD), 2015 WL , at *9-13 (S.D. Cal. Nov. 9, 2015) (holding that warnings-based claims involving prescription drug were conflict preempted based upon similar FDA regulatory record rejecting plaintiffs safety allegations). 12

20 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 20 of 28 PageID #: 257 (C.D. Cal. Sept. 2, 2010) (granting motion to dismiss on preemption grounds); Knoppel v. St. Jude Med. Inc., No. SACV JVS (ANx), 2013 WL , at *3 (C.D. Cal. May 7, 2013) (same). EPA s regulatory findings regarding glyphosate and Roundup are abundantly clear in the public record, and plaintiffs do not because they cannot suggest that discovery would change the Court s preemption analysis. Plaintiffs subsequent efforts to attack the significance of EPA s findings are similarly unpersuasive. See Opp. at 25-27; see also Mot. at Plaintiffs imply that because EPA s 1991 Group E classification of glyphosate was based on animal studies it is somehow invalid. See Opp. at However, data derived from animal studies, including studies on rodents, rabbits, hens, fish, and vertebrates, is the foundation of EPA s risk assessment in deciding whether to register a product under FIFRA. See 40 C.F.R (2007), (2007). Further, EPA s post-1991 findings of non-carcinogenicity were not based solely on the lack of evidence of carcinogenicity in rodent studies. See Opp. at 26 (emphasis added). For example, in 2002, EPA specifically considered genotoxicity and epidemiology studies. See Glyphosate; Pesticide Tolerances, 67 Fed. Reg. 60,934, 60, (Sept. 27, 2002) (to be codified at 40 C.F.R. pt. 180) (rejecting advocacy group s allegations that genotoxicity and epidemiology studies support a link to cancer). And EPA s 2008 finding explicitly references its extensive 13

21 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 21 of 28 PageID #: 258 database... on glyphosate, which indicate that glyphosate is not mutagenic, not a carcinogen, and not a developmental or reproductive toxicant. See Glyphosate; Pesticide Tolerances, 73 Fed. Reg. 73,586, 73,589 (Dec. 3, 2008) (to be codified at 40 C.F.R. pt. 180). Plaintiffs then argue that the final rules of EPA, published online and in the Federal Register, establishing tolerances for residues of glyphosate pursuant to federal law are not actually regulations and contain no findings of noncarcinogenicity. See Opp. at 26-27; see also 21 U.S.C. 346a. However, as explained in Monsanto s Motion to Dismiss, [a] residue tolerance is deemed safe only if EPA determine[s] that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information. Mot. at 13 (citing 21 U.S.C. 346a(b)(2)(A)(ii) (emphasis added)). Thus, as part of its regulatory responsibility in establishing these rules, EPA was statutorily required to make a finding with respect to glyphosate s noncarcinogenicity. And EPA likewise was required to consider these regulatory findings in reviewing and approving the Roundup label under FIFRA. 40 C.F.R (i); cf. Hardeman, Slip Op. at 4 (mistakenly concluding that residual tolerance findings under FDCA don t give content to the FIFRA misbranding standards ) (internal citations and quotations omitted). 14

22 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 22 of 28 PageID #: 259 Plaintiffs fail to appreciate that preemption of their warnings-based claims here is not contingent on the alleged strength of any single EPA finding, but rather on the fact that EPA has repeatedly spoken on the same purported cancer link alleged by plaintiffs. Finally, plaintiffs argument that [n]othing in FIFRA prevents Manufacturers from warning about the dangers of its products through means [other than the label] is without merit. See Opp. at 24. Plaintiffs claims turn upon the assertion that Monsanto failed to warn of alleged cancer risks inherent in Roundup products. As plaintiffs concede, however, EPA specifically requires manufacturers to identify such potential health risks to end users through its regulatory control over the product labeling and through FIFRA s misbranding regulations. See Opp. at 19. If plaintiffs narrow reading of labeling were correct, pesticide manufacturers would be free under FIFRA to contradict EPA s requirements for safety warnings through the simple expedient of communicating with customers outside the physical label. That is not the law. Rather, FIFRA defines labeling to encompass all labels and all other written, printed, or graphic matter... accompanying the pesticide or device at any time. 7 U.S.C. 136(p)(2)(A) (emphasis added). 11 Moreover, FIFRA make[s] it unlawful for any 11 In Kordel v. United States, the Supreme Court explained in interpreting a similar labeling definition that the content of materials, not their physical proximity to a product, controls whether they accompany the product so as to be treated as 15

23 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 23 of 28 PageID #: 260 person to offer for sale any pesticide... if claims made for it as part of its distribution or sale differ substantially from any claim... required in connection with its registration under FIFRA... See 40 C.F.R (a) (1989) (provision extends to advertisements in any medium to which pesticide users or the general public have access ) (emphasis added). EPA actively pursues alleged violations of these provisions and imposes heavy civil penalties on manufacturers for unsanctioned advertising and marketing claims. 12 Accordingly, pursuant to Bates, plaintiffs warnings-based claims cannot stand. labeling. 335 U.S. 345, 350 (1948). Indian Brand Farms is not to the contrary. In that case, plaintiff s claims arose from a marketing brochure that asserted that a fungicide was more effective and would cause less crop damage than a prior product, a claim that EPA had neither considered nor addressed as part of its labeling determination. See Indian Brand Farms, Inc. v. Novartis Crop Protection Inc., 617 F.3d 207, 223 (3d Cir. 2010); see also id. at (explaining that the definition of labeling extends beyond communications physically attached to the product and covers all communications necessary to protect the integrity of [a pesticide s] uniform labeling ) (internal citations omitted). There was no claim in that case of any alleged failure to warn of a risk to human health. 12 See Kat Greene, EPA Cites Pesticide Maker for Marketing Violations, Law360 (Sept. 24, 2015), Kira Lerner, EPA Imposes Record FIFRA Fine For Pesticide Advertising, Law360 (June 9, 2014), 16

24 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 24 of 28 PageID #: 261 C. Plaintiffs Fail to Respond to Monsanto s Argument That Their Non-Warnings Based Design Defect Claims Are Barred by Comments J And K Because They Allege That Roundup Is Inherently Dangerous. In their Complaint, plaintiffs allege that glyphosate and Roundup are inherently and unavoidably dangerous. See, e.g., Compl. 77(b), ECF No. 1. Plaintiffs claims focus entirely on glyphosate s and/or Roundup s alleged carcinogenic characteristics and associated grave risk of cancer. See Compl. 77(b), 77(f), 6, 45, 96, 115. Accordingly, as explained in Monsanto s opening motion, plaintiffs design defect claims are governed by the closely related comments j and k to the Restatement (Second) of Torts 402A, and plaintiffs are limited to claims that the warnings accompanying the product are deficient. See Mot. at 19 (citing Brown v. Superior Court (Abbott Labs.), 227 Cal. Rptr. 768, (Cal. Ct. App. 1986), review granted & opinion superseded, 723 P.2d 1248 (Cal. 1986), aff d sub nom. Brown v. Superior Court, 751 P.2d 470 (Cal. 1988)). Plaintiffs argue in their Opposition that under Hawaii law, [d]esign [d]efect and [f]ailure to [w]arn claims go hand-in-hand, therefore plaintiffs can simultaneously bring claims for both... See Opp. at Plaintiffs fail, however, to explain how they can proceed under a non-warnings theory based upon the alleged facts in their Complaint. Cf. Masaki v. Gen. Motors Corp., 780 P.2d 566, 569, (Haw. 1989) (jury properly instructed on both design defect and failure to warn where plaintiff alleged product defect based on van s tendency 17

25 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 25 of 28 PageID #: 262 to self-shift[] into reverse gear and failure to install an active warning system ). Plaintiffs here are not pleading alternative causes of action. They are alleging that Monsanto can be held liable under a non-warnings design defect theory for marketing a useful but inherently dangerous product, even if the product is accompanied by adequate warnings. Plaintiffs insist that Hawaii has rejected the principles in [c]omment J, see Opp. at (citing Johnson v. Raybestos-Manhattan, Inc., 69 Haw. 287, 288 (Haw. 1987), certifying questions to 829 F.2d 907 (9th Cir. 1987). Johnson is inapposite, however, given that the case involved no non-warnings based design defect claim. See In re Asbestos Cases, 829 F.2d 907, 908 (9th Cir. 1987) ( Plaintiff's complaint... alleged that [defendant] was negligent and strictly liable for failing to warn [the decedent] of the dangers of asbestos products. ) (emphasis added). Plaintiffs therefore fail to present any Hawaii authority rejecting, or even considering, whether comment j limits plaintiffs to warnings-based claims for alleged unavoidably unsafe products, like glyphosate. Moreover, plaintiffs do not deny that Hawaii courts often look to California court decisions for guidance regarding tort law issues, see Mot. at 20 (citing Aana v. Pioneer Hi-Bred Int l, Inc., Civ. Nos LEK-BMK, LEK- BMK, 2014 WL , at *13 (D. Haw. Feb. 27, 2014)), and California courts 18

26 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 26 of 28 PageID #: 263 have specifically applied comment j to pesticides. See Oakes v. E.I. Du Pont De Nemours & Co., 77 Cal. Rptr. 709, (Cal. Ct. App. 1969). Plaintiffs argue that comment k would only apply if there was a warning. See Opp. at 32. But that simply concedes Monsanto s point that, pursuant to comments j and k, plaintiff is limited to claims that the warnings accompanying Roundup are deficient. See Mot. at And as detailed above, plaintiffs warnings-based claims are expressly preempted under FIFRA by EPA s specific findings that glyphosate is not carcinogenic. Plaintiffs maintain that comment k was intended to address only lifesaving pharmaceuticals and medical devices, see Opp. at 33 (citing Brown v. Superior Court, 751 P.2d 470, (Cal. 1988)), while ignoring the California Supreme Court s holding in Anderson v. Owens-Corning Fiberglas Corp. that Brown s logic and common sense are not limited to drugs. 810 P.2d 549, 556 (Cal. 1991) (emphasis added). And plaintiffs offer no meaningful response to the many cases in which comment k has been applied in California courts for products 13 In Hardeman, the court acknowledged under comment j 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, but it held that the plaintiff could allege that Roundup was in defective condition or unreasonably dangerous because it allegedly did not bear the warning it should have. Hardeman, Slip Op. at 5. But this misses Monsanto s point. The predicate for any claim under comment j (or comment k) is the existence of an inadequate warning. Thus, if Monsanto s Roundup warning was adequate because it met the FIFRA requirements for purposes of preemption, then all of plaintiff s claims must be dismissed. 19

27 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 27 of 28 PageID #: 264 that cannot, under any plausible scenario, be considered life-saving, including penile prostheses, breast implants, and intrauterine devices. See Mot. at 23. Finally, plaintiffs concede that the Washington Supreme Court applied comment k to herbicides in Ruiz-Guzman v. Amvac Chemical Corp., 7 P.3d 795, 807 (Wash. 2000), opinion after certified question answered, 243 F.3d 549 (9th Cir. 2000), but they argue that comment k cannot bar such claims at the motion to dismiss stage because the Washington court rejects a class-based exemption for pesticides... Opp. at 34. Plaintiffs argument ignores the fact that comment k s application here is established by the allegations set forth in their Complaint. See Compl. 3, 76 (alleging that Roundup is inherently dangerous but acknowledging that glyphosate products are registered in 130 countries and approved for use on over 100 different crops ). These allegations easily meet the standard that the Washington Supreme Court set forth for the application of comment k. See Ruiz-Guzman, 7 P.3d at ("There need not be a finding of overwhelming social utility"). Plaintiffs fail to establish why their claims should not be governed by comments j and k, and, accordingly, their non-warnings design defect claims should be dismissed. 20

28 Case 1:16-cv JMS-RLP Document 21 Filed 04/11/16 Page 28 of 28 PageID #: 265 III. CONCLUSION For the foregoing reasons, this Court should grant this motion and, pursuant to 12(b)(6) of the Federal Rules of Civil Procedure, dismiss this case in its entirety. DATED: Honolulu, Hawaii, April 11, DATED April 11, 2016 Michael F. O Connor, Richards Street, Suite 600 Honolulu, Hawaii Telephone: (808) Facsimile: (808) (mfoconnor@ollon.com) Respectfully submitted, /s/ Joe G. Hollingsworth Joe G. Hollingsworth (admitted pro hac vice) Katharine R. Latimer (admitted pro hac vice) Eric G. Lasker (admitted pro hac vice) Attorneys for Defendant MONSANTO COMPANY 21

29 Case 1:16-cv JMS-RLP Document 21-1 Filed 04/11/16 Page 1 of 2 PageID #: 266 OGAWA, LAU, NAKAMURA & JEW Attorneys-at-Law, A Law Corporation Michael F. O Connor, Richards Street, Suite 600 Honolulu, Hawaii Telephone: (808) Facsimile: (808) (mfoconnor@ollon.com) Joe G. Hollingsworth (admitted pro hac vice) (jhollingsworth@hollingsworthllp.com) Katharine R. Latimer (admitted pro hac vice) (klatimer@hollingsworthllp.com) Eric G. Lasker (admitted pro hac vice) (elasker@hollingsworthllp.com) HOLLINGSWORTH LLP 1350 I Street, N.W. Washington, DC Telephone: (202) Facsimile: (202) Attorneys for Defendant MONSANTO COMPANY CHRISTINE SHEPPARD, KENNETH SHEPPARD, v. Plaintiffs, MONSANTO COMPANY, Defendant. UNITED STATES DISTRICT COURT DISTRICT OF HAWAI I C.V. NO.: 1:16-cv JMS-RLP CERTIFICATE OF SERVICE Hearing Date: May 2, 2016 Time: 10:00 a.m. Judge: Hon. Michael Seabright

30 Case 1:16-cv JMS-RLP Document 21-1 Filed 04/11/16 Page 2 of 2 PageID #: 267 I hereby certify that, on the date and by the method of service noted below, a true and correct copy of the foregoing was served on the following at their last know addresses: Served Electronically through CM/ECF: Brian K. Mackintosh Michael J. Miller Timothy Litzenburg bmackphd@gmail.com mmiller@millerfirmllc.com tlitzenburg@millerfirmllc.com DATED April 11, 2016 Michael F. O Connor, Richards Street, Suite 600 Honolulu, Hawaii Telephone: (808) Facsimile: (808) (mfoconnor@ollon.com) Respectfully submitted, /s/ Joe G. Hollingsworth Joe G. Hollingsworth (admitted pro hac vice) Katharine R. Latimer (admitted pro hac vice) Eric G. Lasker (admitted pro hac vice) Attorneys for Defendant MONSANTO COMPANY 2