IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF HAWAI I PLAINTIFF S OPPOSITION TO DEFENDANT S MOTION TO DISMISS.

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1 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 1 of 43 PageID #: 186 LAW OFFICE OF BRIAN K. MACKINTOSH BRIAN K. MACKINTOSH Bishop Street, Suite 2201 Honolulu, Hawai i Telephone: (808) Facsimile: (808) bmackphd@gmail.com Attorney for Plaintiffs CHRISTINE SHEPPARD KENNETH SHEPPARD IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF HAWAI I CHRISTINE SHEPPARD and KENNETH SHEPPARD, Plaintiffs, vs. MONSANTO COMPANY, Defendant. C.V. NO.: 1:16-cv JMS- RLP PLAINTIFF S OPPOSITION TO MONSANTO COMPANY S MOTION TO DISMISS PLAINTIFFS COMPLAINT (Doc. No. 10) Hearing: May 2, 2016, at 10:00 a.m. PLAINTIFF S OPPOSITION TO DEFENDANT S MOTION TO DISMISS.

2 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 2 of 43 PageID #: 187 TABLE OF CONTENTS I. INTRODUCTION... 1 II. FACTUAL BACKGROUND... 4 III. LEGAL STANDARD... 8 IV. ARGUMENT... 9 a. PLAINTIFFS TORT CLAIMS ARE TIMELY FILED... 9 b. Plaintiffs Breach of Warranty Claims Are Timely Filed c. PLAINTIFF S FAILURE TO WARN CLAIMS ARE NOT PREEMPTED Hawai i Product Liability Law is Equivalent to Federal Law EPA Registration of Roundup Does Not Preempt Plaintiffs Claims21 3. Ansagay v. Dow Supports Plaintiffs Claims d. The Restatement (Second) Of Torts 402a Does Not Bar Any Of Plaintiffs Design Defect Claims As A Matter Of Law e. There is no Basis to Dismiss Plaintiff Kenneth Sheppard s Loss of Consortium Claims IV. CONCLUSION Local Rule 7.5(e) Certificate Certificate of Service i

3 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 3 of 43 PageID #: 188 Cases Table of Authorities Adams v. United States, 449 F. App'x 653, 658 (9th Cir. 2011)... 1, 18 Akhtar v. Mesa, 698 F.3d 1202, 1212 (9th Cir. 2012)... 9 Ansagay v. Dow, 2015 WL , F.Supp.3d Arias v. Dyncorp, 517 F. Supp. 2d 221, 229 (D.D.C. 2007) Ashcroft v. Iqbal, 556 U.S. 662, 663 (2009) Astiana v. Hain Celestial Grp., Inc., 783 F.3d 753, (9th Cir. 2015) Balog v. Ctr. Art Gallery-Hawaii, Inc., 745 F. Supp. 1556, 1572 (D. Haw. 1990) Bates v. Dow Agrosciences LLC, 544 U.S. 431, 432 (2005)... passim Bell Atl. Corp. v. Twombly, 550 U.S. 544, 547 (2007)... 9 Bennett v. United States, 974 F.2d 1341 (9th Cir. 1992) Brown v. Super. Ct., 751 P.2d 470, (Cal. 1988)... passim Bruesewitz v. Wyeth Inc., 561 F.3d 233, 240 (3d Cir. 2009) California Chamber of Commerce v. Brown, 196 Cal. App. 4th 233, 253, (2011)... 7 Calumet Indus., Inc. v. Brock, 807 F.2d 225, 226 (D.C. Cir. 1986)... 7 Chavez v. Blue Sky Nat. Beverage Co., 340 F. App x 359, 360 (9th Cir. 2009) 9 Chem. Specialties Mfrs. Ass'n, Inc. v. Allenby, 958 F.2d 941, 947 (9th Cir. 1992)... 24, 25 De Buono v. NYSA-ILA Med. & Clinical Servs. Fund, 520 U.S. 806, 814 (1997) Dunlea v. Dappen, 83 Haw. 28, 36 (1996)... 2, 10 Earth Island Inst. v. Hogarth, 494 F.3d 757, 769 (9th Cir. 2007)... 7 ii

4 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 4 of 43 PageID #: 189 Euro-Pro Operating LLC v. Euroflex Americas, No. 08CV6231 (HB ), 2008 WL , at *6 (S.D.N.Y. Dec. 8, 2008) Ferebee v. Chevron Chemical Co., 736 F.2d 1529, (D.C. Cir. 1984)17, 25 Forsyth v. Eli Lilly & Co., No. CIV ACK, 1998 WL , at *4 (D. Haw. Jan. 5, 1998) Freeman v. Town of Hudson, 714 F.3d 29, 36 (1st Cir. 2013)... 9 In re Hawaii Fed. Asbestos Cases, 665 F. Supp. 1454, 1456 (D. Haw. 1986) 29 In re Hawaii Fed. Asbestos Cases, 699 F. Supp. 233, 237 (D. Haw. 1988) In re Hawaii Fed. Asbestos Cases, 960 F.2d 806, 813 (9th Cir. 1992) Indian Brand Farms, Inc. v. Novartis Crop Prot. Inc., 617 F.3d 207, (3d Cir. 2010)... 18, 21, 24 Johnson v. Raybestos-Manhattan, Inc., 69 Haw. 287, 288 (1987)... 29, 31 Larsen v. Pacesetter Sys., Inc., 74 Haw. 1, 24, amended (Oct. 22, 1992) Masaki v. Gen. Motors Corp., 71 Haw. 1, 22 (1989) Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466, 2487 (2013) Navarro v. Block, 250 F.3d 729, 732 (9th Cir. 2001)... 8 Nelson v. Sandoz Pharm. Corp., 288 F.3d 954, 967 (7th Cir. 2002) New York State Conf. of Blue Cross & Blue Shld Plans v. Travrs. Ins. Co., 514 U.S. 645, 655 (1995) Ontai v. Straub Clinic & Hosp. Inc., 66 Haw. 237, (1983) Ruiz-Guzman v. Amvac Chem. Corp., 7 P.3d 795 (Wash. 2000) (en banc) 3, 34 Slaughter-House Cases, 83 U.S. 36 (1872) Stoleson v. United States, 629 F.2d 1265, 1270 (7th Cir. 1980)... 12, 13 Stoner v. Santa Clara Cty. Office of Educ., 502 F.3d 1116, 1120 (9th Cir. 2007)... 8 iii

5 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 5 of 43 PageID #: 190 Transue v. Aesthetech Corp., 341 F.3d 911, 916 (9th Cir. 2003) Vidinha v. Miyaki, 112 Haw. 336, 341 (Ct. App. 2006) Volk v. D.A. Davidson & Co., 816 F.2d 1406, 1415 (9th Cir.1987) Windward Aviation, Inc. v. Rolls-Royce Corp., No. CIV ACK, 2011 WL , at *12 (D. Haw. July 6, 2011) Wyeth v. Levine, 555 U.S. 555, (2009) Statutes Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA ), 7. U.S.C. 136 et seq Haw. Rev. Stat. Ann Other Authorities David G. Owen, The Puzzle of Comment J, 55 Hastings L.J. 1377, 1393 (2004)31 Rules F.R.C.P. 12(b)(6)... 9 Treatises Fed. Jud. Ctr., Reference Manual on Scientific Evidence, 20, 565 n. 46 (3D ED. 2011)... 6 Restatement (Second) of Torts 402A... passim Regulations 29 C.F.R (d)(4) CFR CFR CFR iv

6 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 6 of 43 PageID #: 191 I. INTRODUCTION For over forty years Monsanto has engaged in a successful campaign to conceal the fact that its weed-killer product Roundup causes cancer. In March of 2015, after a public announcement by the World Health Organization, Plaintiffs Christine and Kenneth Sheppard, first learned that Roundup was a cause of Ms. Sheppard s Non-Hodgkin s Lymphoma ( NHL ). Plaintiffs then timely filed this complaint sufficiently alleging causes of action for Strict Liability (Design Defect); Strict Liability (Failure To Warn); Negligence; Breach Of Implied Warranties; Breach of Express Warranties; and Loss Of Consortium arising from Ms. Sheppard use of Roundup, manufactured by Defendants, which caused her to develop NHL. Defendants Motion to Dismiss should be denied in its entirety. Defendant s well-worn federal preemption arguments have been rejected by decisions in the U.S. Supreme Court and the Ninth Circuit. Bates v. Dow Agrosciences LLC, 544 U.S. 431, 432 (2005); Adams v. United States, 449 F. App'x 653, 658 (9th Cir. 2011) (unpublished). Hawai i product liability warning requirements are not different from or in addition to those imposed by federal law and thus are not preempted. 544 U.S. 431, 432 (2005). States have ample authority to review pesticide labels to ensure that they comply with both federal and state labeling requirements. Id. at 442. Monsanto bears the heavy burden of proving that Plaintiff s claims are preempted, yet it fails to even state how her 1

7 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 7 of 43 PageID #: 192 complaint seeks to impose requirements other than those imposed by federal law which, like Hawai i, require Monsanto to adequately warn about the dangers of Roundup. Furthermore, this complaint was timely filed. A statement by Ms. Sheppard in 2009 indicating that she did not know and could not prove that Roundup caused her NHL is not sufficient to start the running of the statute of limitations under Hawai i law which requires actual knowledge of a causal connection. Dunlea v. Dappen, 83 Haw. 28, 36 (1996) abrogated on other grounds by Hac v. Univ. of Hawai i, 102 Haw. 92, (2003). The first time Ms. Sheppard, who has no medical training, had knowledge that Roundup caused her NHL was in March of 2015 after the public announcement by the World Health Organization. Also, had Monsanto not actively and fraudulently concealed the cancer risks of Roundup then Ms. Sheppard would have filed her breach of warranty suits within four years of her last purchase. Defendant s arguments with respect to Comment j and k under Restatement (Second) Of Torts 402A also fail. Comment j merely stands for the proposition that Defendants have a duty to warn about the risk of NHL, it does not preclude any non-warning design defect claims. Defendant acknowledges that Comment k has only been applied in California or Hawai i to the prescription drug or medical devices which are life-saving products. Even if the Court were to apply 2

8 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 8 of 43 PageID #: 193 Washington law, as urged by Defendants, then Comment k would require an intensive factual inquiry inappropriate for a 12(b)(6) motion. Ruiz-Guzman v. Amvac Chemical Corp., 7 P.3d 795, 803 ( [W]e hold that the question of whether a pesticide is governed by comment k is to be determined on a product-by-product basis... the trier of fact should determine a pesticide's value to society relative to the harm it causes. ). Monsanto s motion fails for other reasons as well. Although styled as a motion to dismiss, Monsanto fails to limit its arguments to the pleadings and assuming the truth of the allegations as the law requires for dismissal motions, instead spending pages upon pages laying out self-serving fact-based rhetoric, much of which has nothing to do with Roundup, or its active ingredient glyphosate. Indeed, in an apparent attempt to malign the World Health Organization, Monsanto suggests, without support and against prevailing evidence, that somehow world hunger would increase if Roundup were not available for food production and other similar preposterous facts. Of course, not only does Plaintiff contest those assertions, but, more importantly, they are irrelevant to her allegations against Monsanto. Thus, the Court should ignore the many extraneous statements Monsanto inserts in its motion as irrelevant to the issues and as improper for a motion to dismiss and if Monsanto thinks they are relevant to a decision on its motion, then the motion must be denied. 3

9 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 9 of 43 PageID #: 194 II. FACTUAL BACKGROUND Christine Sheppard moved to a coffee farm in Hawai i in the 1990s with the intent of living her life s dream. Complaint at 66. Ms. Sheppard had a vision of moving the farm toward organic status. However, she continued to use Monsanto s Roundup herbicide on the farm for at least four years. Id. In 2003, Ms. Sheppard was diagnosed with NHL, a sinister cancer in which the body s lymph nodes are replaced by malignancy. Id. at 67. Ms. Sheppard s disease was quickly classified as stage IV, generally accepted as end stage cancer. Somewhat miraculously, Ms. Sheppard survived the cancer for several years and is currently in remission. However, her treatment is intensive, complex and grueling, and her disease forced a move to California to have access to the recommended treatments, including chemotherapy and stem cell transplants. Id. at 68. Ms. Sheppard hoped, and attempted, to return to Hawai i but her ongoing need for cancer treatment made a permanent return impossible, and she has been forced to accept that her dream of being a Kona coffee farmer has run aground. Like millions of Americans, Ms. Sheppard purchased and used Roundup without any idea that the weedkiller could cause cancer. Id. at 80. Indeed, Monsanto has always advertised and marketed this product as safe as table salt and practically non-toxic to humans. Id. at 37. 4

10 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 10 of 43 PageID #: 195 Prior to March 2015, a lay person would be hard-pressed to find any information that Roundup was associated with NHL. Indeed, Defendants cite in their brief a number of sources prior to March 2015 which state that Roundup does not cause cancer. Def. s Mem. at pp. 2-4, This lack of public knowledge about the risks of Roundup was due to a very successful marketing and lobbying campaign by Monsanto to prevent the true risks of Roundup from being revealed. 18, In 2009, Ms. Sheppard, who has no medical training, nevertheless came across an article from Sweden on the internet linking Roundup NHL. 1 Exhibit A (Sheppard Dec. at 1). Ms. Sheppard stated she bookmarked the report, but when I had time to get back to it, it had been removed from the web... Defendants Exhibit A; Sheppard Dec. at 7-9. Ms. Sheppard speculated as to the association at the time stating [w]as this my link? We cannot prove it... Defendants Exhibit A. Ms. Sheppard followed up on this report stating I approached several of my physicians to ask about a potential link between Roundup exposure and lymphoma; these physicians informed me they were unaware of any such association. 1 Plaintiff objects to Defendants Request for Judicial Notice with respect to Ms. Sheppard s internet posting.. Under Fed. R. Evid. 201 [t]he court may judicially notice a fact that is not subject to reasonable dispute because it:(1) is generally known within the trial court's territorial jurisdiction; or (2) can be accurately and readily determined from sources whose accuracy 5

11 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 11 of 43 PageID #: 196 Sheppard Dec. at 10. Ms. Sheppard did not take further action until March 2015 when she first discovered a causal connection between Roundup and NHL and promptly retained counsel. Sheppard Dec. at It was at that time that Ms. Sheppard also learned of Monsanto s wrongdoing in this matter. Id. Ms. Sheppard did not take further action because she could not have discovered this causal link prior to March of Complaint at 18, 45, 60, 80, 100, and 138. In March of 2015, the World Health Organization, through its International Agency for Research on Cancer, declared glyphosate, the primary active ingredient of Roundup, to be a probable human carcinogen; Complaint at 45. Because of its rigorous scientific method and independence, IARC is a widely respected organization and its findings are considered authoritative. Organizations such as the American Cancer Society and Federal Judicial Center hold IARC in high esteem The Federal Judicial Center describes IARC as wellrespected and prestigious and notes that IARC s assessment of carcinogenicity is generally recognized as authoritative. Fed. Jud. Ctr., Reference Manual on Scientific Evidence, 20, 565 n. 46 (3D ED. 2011). The State of California mandates that manufactures issues warnings to the public if IARC finds a chemical to be carcinogenic because IARC is an organization of the most highly regarded national and international scientists. California Chamber of Commerce v. Brown, 196 Cal. App. 4th 233, 253, (2011). The U.S. Department of Labor s Occupational 6

12 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 12 of 43 PageID #: 197 Safety and Health Administration ( OSHA ) also relies on IARC assessments when requiring manufactures to warn of the potential carcinogenicity of chemicals. (29 C.F.R (d)(4) (2010); Calumet Indus., Inc. v. Brock, 807 F.2d 225, 226 (D.C. Cir. 1986) ( A listing in one of several authoritative sources, including the International Agency for Research on Cancer (IARC) Monographs, establishes that a chemical is carcinogenic. ) IARC is highly respected because it is free from any industry, financial or political influence. Compl. 42. IARC follows a transparent and rigorous process in evaluating all data including (a) human, experimental, and mechanistic data; (b) all pertinent epidemiological studies and cancer bioassays; and (c) representative mechanistic data. Id. at This data is reviewed for over a year by a group of 17 experts form 11 countries culminating in an intensive eight day meeting. Because IARC is not weighing policy or political considerations it focus solely on scientific evidence. See, e.g Earth Island Inst. v. Hogarth, 494 F.3d 757, 769 (9th Cir. 2007) (purely scientific analysis should not involve policy decisions). In the last two years several countries have banned the use of Roundup for private or commercial uses including Columbia, the Netherlands, France, and Bermuda. Id. at The EPA is currently in the process of re-evaluating the registration for Roundup. Id. at 25. It had conducted a preliminary assessment 7

13 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 13 of 43 PageID #: 198 in early 2015, but it delayed releasing the risk assessment pending further review in light of the WHO s health-related findings. 2 Id. at 26. In light of IARC s findings more countries will ban or add a warning to Roundup products. III. LEGAL STANDARD A Rule 12(b)(6) motion tests the legal sufficiency of a claim. Navarro v. Block, 250 F.3d 729, 732 (9th Cir. 2001). In considering a motion to dismiss, all allegations of material fact in the complaint are taken as true and construed in the light most favorable to the plaintiff. Stoner v. Santa Clara Cty. Office of Educ., 502 F.3d 1116, 1120 (9th Cir. 2007). A district court should only grant a motion to dismiss when plaintiffs have not pleaded enough facts to state a claim to relief that is plausible on its face. Bell Atl. Corp. v. Twombly, 550 U.S. 544, 547 (2007). A claim has facial plausibility when the plaintiff pleads factual content that allows 2 Defendants also ask for judicial notice of a hearsay comment by an EPA employee about an undisclosed study. Such a comment does not constitute a fact subject to judicial notice. Furthermore, the testimony cited merely suggests that EPA assessed epidemiological studies, but not animal or mechanistic studies in 2014 at the time of the October, 2015 Hearing. Dr. Jordan confirmed that we are currently reviewing the IARC report and will issue another statement after that review. See Agriculture Biotechnology: A Look at Federal Regulation and Stakeholder Perspectives: Hearing Before the S. Comm. on Agr., Nutrition, & Forestry, 114th Cong. (2015) (statement of Dr. William Jordan, Deputy Director of EPA s Office of Pesticide Programs), at time stamp 55:05 56:20 ( EPA 2015 Desk Statement ). 8

14 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 14 of 43 PageID #: 199 the court to draw the reasonable inference that the defendant is liable for the misconduct alleged. Ashcroft v. Iqbal, 556 U.S. 662, 663 (2009). It is well-established that the motion [to dismiss] is not a procedure for resolving a contest between the parties about the facts or the substantive merits of the plaintiff's case. Chavez v. Blue Sky Nat. Beverage Co., 340 F. App x 359, 360 (9th Cir. 2009). Indeed, when reviewing a motion to dismiss, a court may consider only allegations contained in the pleadings, exhibits attached to the complaint, and matters properly subject to judicial notice. Akhtar v. Mesa, 698 F.3d 1202, 1212 (9th Cir. 2012), see also, Freeman v. Town of Hudson, 714 F.3d 29, 36 (1st Cir. 2013) (judicial notice is limited to documents or facts subject Federal Rule of Evidence 201). Yet, despite this well-established standard of review, Monsanto s Motion relies on a number of documents outside the pleadings that are not matters of public record. See, e.g., Mem., pp. 1-4, 8-9, 14-15, 19. These documents are improper for purposes of a F.R.C.P. 12(b)(6) motion, and the Court must exclude Monsanto s extraneous citations in its review of this motion. See Fed. R. Civ. P. 12(d). IV. ARGUMENT a. PLAINTIFFS TORT CLAIMS ARE TIMELY FILED Plaintiffs timely filed their case within a year after the cause-of-action accrued when Ms. Sheppard learned in March of 2015 that Roundup causes NHL. 9

15 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 15 of 43 PageID #: 200 Hawai i provides a two-year statute of limitations for personal injury claims which does not start to run until the cause of action accrued. Haw. Rev. Stat. Ann (West). A cause of action does not accrue until, the moment plaintiff discovers or should have discovered the negligent act, the damage, and the causal connection between the former and the latter. Vidinha v. Miyaki, 112 Haw. 336, 341 (Ct. App. 2006) aff'd, 114 Haw. 262 (2007). With respect to medical causation, a cause of action may not accrue until a diagnosis by a medical professional. Dunlea v. Dappen, 83 Haw. 28, 33 (1996) abrogated on other grounds by Hac v. Univ. of Hawai i, 102 Haw. 92 (2003). Dunlea is instructive in this present case dealing with medical causation. In Dunlea, the plaintiff was a victim of sexual abuse as a child and had remembered the abuse throughout her life. Id. at 30. Additionally, plaintiff had been haunted by depression, thoughts of suicide, shame, disgust, and denial, which have greatly damaged every facet of [her] life, Id. at 31. Nearly thirty years after the abuse ended Plaintiff entered therapy where she allegedly discovered that these feelings were symptomatic of a psychological illness caused by her father's incestuous rape by receiving a diagnosis from a medical professional. Id. Under these facts, the Hawai i Supreme Court held that the time when Plaintiff discovered, or should have discovered, that her alleged injuries were caused by 10

16 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 16 of 43 PageID #: 201 Dappen's alleged actions is a question of fact for the jury and reversed the lower court s grant of summary judgment. Id. at 37. Medical causation is complex and not readily discernible to a lay person. A lay person s suspicion of a link between an exposure and injury does not cause a claim to accrue. As explained by the Seventh Circuit in an analogous case applying the causal connection standard: [Defendant] contends [plaintiff] s suspicion that nitroglycerin was the culprit is sufficient knowledge of causation to trigger the statute of limitations. We disagree. A layman's subjective belief, regardless of its sincerity or ultimate vindication, is patently inadequate to go to the trier of fact. Therefore, had [plaintiff] sought competent legal advice, she would have been informed quite correctly that she had no claim...[plaintiff] did have the presence of mind to seek professional advice from her physicians and BAAP's own physician. But since medical science did not then recognize the causal connection, she was powerless to pursue the matter through legal channels. To fix the time of accrual at this time would provide [plaintiff] with nothing more than a delusive remedy... For the same reasons, [plaintiff] s claim did not accrue in the spring of 1969 when she read the union newspaper article suggesting a possible link between cardiovascular problems and exposure to nitroglycerin. Nor did it accrue in the fall of that year when the state occupational safety specialist, who was neither a physician nor for that matter even a college graduate, expressed an opinion confirming [plaintiff] s suspicion. [Plaintiff] still remained a prisoner within the walls of medical science. Rather than initiate a futile suit, she diligently consulted yet another physician in a further attempt to secure medical confirmation that nitroglycerin exposure was the cause of her problems. That physician instead confirmed the opinions of the physicians she had previously consulted. Even armed with the occupational safety expert's opinion and the union newspaper article, the suggestion that [plaintiff] had a claim that she could judicially enforce is implausible 11

17 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 17 of 43 PageID #: 202 Stoleson v. United States, 629 F.2d 1265, 1270 (7th Cir. 1980). Therefore the [a]ction accrued only when physician told plaintiff of the cause and effect of nitroglycerin exposure previously unknown to medical science Bennett v. United States, 974 F.2d 1341 (9th Cir. 1992) Citing with approval Stoleson 629 F.2d at More recently, again applying a causal connection standard, the Seventh Circuit held that a question of fact was created where a doctor initially suggested to a plaintiff a link between a medication and a side effect, but then changed his mind and stated there was no link. Nelson v. Sandoz Pharm. Corp., 288 F.3d 954, 967 (7th Cir. 2002). Plaintiff followed up with a second physician who also stated there was no link. Id. Plaintiff did stop taking the medication, but the court held that [i]n making medical choices, however, an individual is free to act on mere suspicion or excessive caution; suspicions and hunches do not constitute knowledge concerning causality of injury. Nelson v. Sandoz Pharm. Corp., 288 F.3d 954, 967 (7th Cir. 2002). Likewise, Ms. Sheppard s statement in 2009 that she could not prove her suspicion of a link between Roundup and NHL is not sufficient to start the statute of limitations running. Ms. Sheppard followed up with her physicians who told her that her suspicion was wrong and that Roundup did not cause NHL. As Defendants correctly note, no governmental agency or medical association had 12

18 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 18 of 43 PageID #: 203 declared Roundup a cause of NHL prior to 2015, and there is no warning from Monsanto that Roundup causes NHL. Defendants argument is thus a bit incredulous. Throughout their motion, Monsanto vehemently denies that there is any evidence of causal link between Roundup and NHL, yet argue that Ms. Sheppard should have been aware of the causal link between Roundup and NHL in In 2009, because medical science did not then recognize the causal connection, she was powerless to pursue the matter through legal channels. Stoleson 629 F.2d at In 2009, therefore, Ms. Sheppard remained a prisoner within the walls of medical science and her cause of action had not yet accrued. Id. b. Plaintiffs Breach of Warranty Claims Are Timely Filed The statute of limitations for breach of warranty claims are equitably tolled where the Defendants actively conceal a cause of action or lull a plaintiff into not filing a claim. Windward Aviation, Inc. v. Rolls-Royce Corp., No. CIV ACK, 2011 WL , at *12 (D. Haw. July 6, 2011). There is copious case authority to support... fraudulent concealment will toll statute of limitations where affirmative conduct by one party would lead the other party to believe that he did not have a claim. Balog v. Ctr. Art Gallery-Hawai i, Inc., 745 F. Supp. 1556, 1572 (D. Haw. 1990) (citing Volk v. D.A. Davidson & Co.,

19 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 19 of 43 PageID #: 204 F.2d 1406, 1415 (9th Cir.1987)). Furthermore, [I]t is a well-settled principle that a defendant cannot avail himself of the bar of the statute of limitations, if it appears that he has done anything that would tend to lull the plaintiff into inaction, and thereby permit the limitation prescribed by the statute to run against him. Mauian Hotel, Inc. v. Maui Pineapple Co., 52 Haw. 563, (1971). In Balog, plaintiffs purchased forged artworks from defendants over a period of four years from Balog, 745 F. Supp. at Defendants continued making affirmative representations to plaintiffs that the artworks were genuine through at least Id. at In 1988 a news report and subsequent investigation revealed that the artworks were indeed forged. Id. The Court held that the affirmative representations made by defendants served to toll the statute of limitations on breach of warranty claims until the discovery of the forgery. These affirmative representations lulled [plaintiffs] into a false belief that no cause of action would lie. Id. at The Court therefore held that the four year statute of limitations did not begin to run until the affirmative representations ended. Id. Here, Plaintiffs alleged that Defendants for the last forty years have assured the public that Roundup was harmless. In order to prove this, Monsanto championed falsified data and attacked legitimate studies that revealed its dangers. Monsanto led a prolonged campaign of misinformation to convince government agencies, farmers and the general population that Roundup was safe. Complaint 14

20 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 20 of 43 PageID #: 205 at 18. This campaign, continuing today, included extensive consumer advertising telling people roundup was practically non-toxic Monsanto takes it one step further in their motion and claims Roundup is not toxic to humans or animals. Def. s Mem. at 3. Currently, Monsanto has resorted to suing the State of California in an effort to prevent California from warning its residents that Roundup causes cancer. Monsanto Company vs. Office of Environmental Health Hazard Assessment, CA Superior Ct. for Fresno County, Case No. 16CECG Monsanto s aggressive and affirmative campaign to prevent the public, including Ms. Sheppard, from finding out the truth about Roundup has tolled the running of the statute of limitations for Plaintiffs breach of warranty claims, and thus the claims are timely filed. c. PLAINTIFF S FAILURE TO WARN CLAIMS ARE NOT PREEMPTED 1. Hawai i Product Liability Law is Equivalent to Federal Law. The Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA ), 7. U.S.C. 136 et seq., does not preempt Plaintiffs claims. Monsanto bears a considerable burden of establishing that preemption applies and in this instance has failed to do so. The Court must start with the presumption that Congress does not intend to supplant state law. De Buono v. NYSA-ILA Med. & Clinical Servs. Fund, 520 U.S. 806, 814 (1997). This presumption is heightened where federal law is said to bar state action in fields of traditional state regulation. New York State 15

21 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 21 of 43 PageID #: 206 Conf. of Blue Cross & Blue Shld Plans v. Travrs. Ins. Co., 514 U.S. 645, 655 (1995). When faced with two equally plausible readings of statutory text, [courts] have a duty to accept the reading that disfavors preemption. Bruesewitz v. Wyeth Inc., 561 F.3d 233, 240 (3d Cir. 2009). This presumption is particularly strong in personal injury tort cases like this one because the states have historically enjoyed expansive powers to protect the lives, limbs, health, comfort, and quiet of all persons. Slaughter-House Cases, 83 U.S. 36 (1872). The long history of tort litigation against manufacturers of poisonous substances adds force to the basic presumption against pre-emption. Bates, 544 U.S. at 432. There is no need to delve into a deep analysis of whether FIRFRA preempts Plaintiffs claims. The United States Supreme Court has already done so. Bates, makes clear that FIFRA s preemption reach is very narrow, and that a claim is preempted only if Monsanto can show that Plaintiff s claims impose requirements different from or in addition to those imposed by federal law. 544 U.S. at 432. Bates specifically addresses common law failure to warn claims and holds that they are not preempted if they are similar to the requirements of FIFRA. Id. at 454. The Supreme Court even instructs courts how to phrase jury instructions in failure to warn claims to avoid preemption considerations holding: To survive pre-emption, the state-law requirement need not be phrased in the identical language as its corresponding FIFRA requirement; indeed, it would be surprising if a common-law requirement used the same phraseology as FIFRA. If a case proceeds to trial, the court's jury 16

22 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 22 of 43 PageID #: 207 instructions must ensure that nominally equivalent labeling requirements are genuinely equivalent. If a defendant so requests, a court should instruct the jury on the relevant FIFRA misbranding standards, as well as any regulations that add content to those standards. Id. Bates further examines and discusses the important role of common law, failure-to-warn, jury trials in furthering public policy under FIFRA: FIFRA contemplates that pesticide labels will evolve over time, as manufacturers gain more information about their products' performance in diverse settings. As one court explained, tort suits can serve as a catalyst in this process: By encouraging plaintiffs to bring suit for injuries not previously recognized as traceable to pesticides such as [the pesticide there at issue], a state tort action of the kind under review may aid in the exposure of new dangers associated with pesticides. Successful actions of this sort may lead manufacturers to petition EPA to allow more detailed labelling of their products; alternatively, EPA itself may decide that revised labels are required in light of the new information that has been brought to its attention through common law suits. In addition, the specter of damage actions may provide manufacturers with added dynamic incentives to continue to keep abreast of all possible injuries stemming from use of their product so as to forestall such actions through product improvement. Id. at 451 (quoting Ferebee v. Chevron Chemical Co., 736 F.2d 1529, (D.C. Cir. 1984)). In applying Bates, the Third Circuit further discussed the interplay between state [New Jersey] warning requirements and the warning requirements under FIFRA holding: The NJPLA imposes liability on a manufacturer where the product causing the harm was not reasonably fit, suitable or safe for its intended purpose because it... failed to contain adequate warnings or instructions. N.J. Stat. Ann. 2A:58C 2. This provision has been interpreted as consistent with Section 2 of 17

23 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 23 of 43 PageID #: 208 The Restatement (Third) of Torts: Product Liability, i.e., liability is imposed for inadequate warnings when the foreseeable risks of harm posed by the product could have been reduced or avoided by the provision of reasonable... warnings... and the omissions of the... warnings renders the product not reasonably safe. In the context of this case, this does not appear to us to impose a duty inconsistent with or in addition to the duty imposed by the text of the warning provisions of FIFRA's misbranding requirements. Moreover, Novartis does not purport to have identified any duty imposed by New Jersey law that does not come within this statutory text. Nor has Novartis identified any EPA regulations that further refine those general standards in any way that is relevant to Plaintiffs' allegations Indian Brand Farms, Inc. v. Novartis Crop Prot. Inc., 617 F.3d 207, (3d Cir. 2010); Adams v. United States, 449 F. App'x 653, 658 (9th Cir. 2011) (failure to warn claims are not preempted where jury instruction is fully consistent with FIFRA since it sufficiently tracks FIFRA's own requirements thus [t]he district court did not err in instructing the jury on Plaintiffs' failure to warn claims. ) The only question left before this Court is whether Hawai i product liability law regarding failure to warn parallels FIFRA s requirements on warnings focusing on the elements of the common-law duty at issue. Bates, 544 U.S. at 445. However, Ms. Sheppard s claims need not be phrased in the identical language as its corresponding FIFRA requirement. Adams, 449 F. App'x at Here, Plaintiffs failure to warn claims under Hawai i law parallel requirements imposed by FIFRA s misbranding prohibitions. FIFRA prohibits the sale or distribution of any pesticide that is misbranded. 7 U.S.C. 136j(a)(1)(E). It 18

24 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 24 of 43 PageID #: 209 is a matter of black letter law that when an herbicide manufacturer misbrands its product, it has violated FIFRA and EPA approval of the label is not a valid defense. 7 U.S.C.A. 136a ( In no event shall registration of an article be construed as a defense for the commission of any offense under this subchapter. ). Accordingly, FIFRA imposes a requirement upon herbicide manufacturers not to misbrand its product, consistent with those sought by Plaintiff. An herbicide is misbranded if: (F) the labeling accompanying it does not contain directions for use which are necessary for effecting the purpose for which the product is intended and if complied with, together with any requirements imposed under section 136a(d) of this title, are adequate to protect health and the environment; [or] (G) the label does not contain a warning or caution statement which may be necessary and if complied with, together with any requirements imposed under section 136a(d) of this title, is adequate to protect health and the environment[.] 7 U.S.C. 136(q)(1)(F)-(G). A product is further misbranded if its label contains a statement that is false or misleading in any particular Bates 544 U.S. at 438. Furthermore, [w]hen data or other information show that an acute hazard may exist to humans or domestic animals, the label must bear precautionary statements describing the particular hazard, the route(s) of exposure and the precautions to be taken to avoid accident, injury or toxic effect or to mitigate the effect." 40 CFR Hawai i law is equivalent in providing that Plaintiff must show that the uses to which the [defendant s product] were put were reasonably foreseeable, 19

25 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 25 of 43 PageID #: 210 that such uses involved a substantial danger that would not be readily recognized by the ordinary user of the product, and that the appellants had failed to give adequate warnings of such danger. In re Hawai i Fed. Asbestos Cases, 960 F.2d 806, 813 (9th Cir. 1992). Plaintiff s complaint tracks FIFRA and Hawai i law alleging Monsanto is liable because they failed to communicate adequate information on the dangers and safe use/exposure and failed to communicate warnings and instructions that were appropriate and adequate to render the products safe for their ordinary, intended and reasonably foreseeable uses. Complaint at 102. Plaintiff further alleges that Defendant disseminated information that was inaccurate, false, and misleading and which failed to communicate accurately or adequately the comparative severity, duration, and extent of the risk of injuries. Complaint at 103; see also 120 ( Failing to disclose to Plaintiffs, users/consumers, and the general public that use of and exposure to Roundup presented severe risks of cancer. ). Defendant fails to specify how Hawai i law is in any way different from or in addition to federal law. Indeed, it is not. To the extent it differs, the U.S. Supreme Court has instructed that a curative jury instruction can mitigate such differences. Bates supra; See also Astiana v. Hain Celestial Grp., Inc., 783 F.3d 753, (9th Cir. 2015) ( To the extent state law might be construed more broadly than federal law, the solution is not to prohibit state law suits altogether, 20

26 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 26 of 43 PageID #: 211 but to instruct the jury on the relevant [federal] standards, as well as any regulations that add content to those standards. ) Furthermore, Bates, is not limited to claims of lack of efficacy as Defendants suggest. The Plaintiffs in Bates were bringing a failure to warn suit alleging that Defendants failed to warn about the dangers of the pesticide in killing their crops. Id. at 435. The Plaintiffs did not allege the pesticide didn t work. Id. In a similar crop damage case, the Third Circuit applied Bates where the case does not involve the efficacy of [pesticide]. Plaintiffs do not allege that it fails to perform in the manner intended with respect to targeted pests; rather, they complain about plant damage, which in FIFRA terminology is damage to the environment. Indian Brand Farms, Inc., 617 F.3d at EPA Registration of Roundup Does Not Preempt Plaintiffs Claims Defendant argues that the fact the EPA registered Roundup with Monsanto s proposed label absolves them of any responsibility. This proposition is blatantly at odds with the plain language of the federal statutes, congressional intent and Supreme Court precedent interpreting the statute. In fact, the United States Supreme Court considered and rejected this in its Bates decision noting that tort suits can serve as a catalyst in this process of updating a label with new safety information. Id. at 447,

27 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 27 of 43 PageID #: 212 Under the plain language of FIFRA registration does not provide a defense to the violation of the statute. 7 U.S.C. 136a(f)(2). Therefore, an herbicide can be registered but still violate FIFRA by, among other things, failing to provide adequate warnings. 7 U.S.C. 136j(a)(1)(E), (f)(2). Because an herbicide can be registered with an approved label and nonetheless still be misbranded, FIFRA s plain language makes clear that warning requirements exist independent of EPA labeling decisions 3. If Congress wanted to make EPA s labeling decisions conclusory, Congress could have structured 136v(b) to forbid any requirements for labeling or packaging that require a different label than that approved by the EPA. Congress has taken no such action. Instead, Congress added the language in addition to or different from as evidence of its intent that state court failure to warn claims are not preempted. Under FIFRA, a manufacturer seeking to register a pesticide must submit a proposed label to EPA as well as certain supporting data. Id. (citing 7 U.S.C. 136a(c)(1)(C), (F)). However, EPA approval of a proposed label provides only a 3 Indeed, under California state law, warnings different than those of EPA are often placed on a variety of products under California s Prop 65 legislation. Here, a notice of proposed rule-making has been written which will soon require Monsanto to place a Prop 65 warning on Roundup that Roundup is known to the state of California to cause cancer, and the listing of Roundup as a known carcinogen may be completed by the time of the hearing on this matter. See, 15LCset27.html 22

28 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 28 of 43 PageID #: 213 floor of safe conduct it does not provide a ceiling on the ability of states to protect their citizens. Ferebee v. Chevron Chemical Co., 736 F.2d 1529, (D.C. Cir. 1984). The EPA does not independently test or study pesticides, but depends upon the applicant to perform the tests, assemble the studies, and provide the data upon which EPA relies in registering the product and approving the label. Id. Moreover, [t]he EPA's approval of a product's FIFRA label does not constitute a finding or an endorsement that its design is safe. Euro-Pro Operating LLC v. Euroflex Americas, No. 08CV6231 (HB ), 2008 WL , at *6 (S.D.N.Y. Dec. 8, 2008) After the EPA approves the initial label, manufacturers have a continuing obligation to adhere to FIFRA's labeling requirements. Bates. (citing 136j(a)(1)(E)). FIFRA provides that a pesticide is misbranded if the warning on the label is insufficient to protect the public health. 7 U.S.C. 136(q)(1)(G) (1988). As manufacturers uncover additional information about the health risks of their products, they must bring this information to the attention of the EPA and add this information to their product labels. Chem. Specialties Mfrs. Ass'n, Inc. v. Allenby, 958 F.2d 941, 947 (9th Cir. 1992). Further, [M]anufacturers have a duty to report incidents involving a pesticide's toxic effects that may not be adequately reflected in its label's warnings.. Id. (citing 40 CFR (a), (b) (2004)). A manufacture also may seek approval to amend its label. Bates 544 U.S

29 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 29 of 43 PageID #: 214 In a case applying analogous drug safety statutes, the U.S. Supreme Court noted that government approval of a label is not a grounds for preemption because a manufacturer bears responsibility for the content of its label at all times. It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate. Wyeth v. Levine, 555 U.S. 555, (2009) (applying analogous statutes under FDCA). Defendants here are likewise promoting an argument based on a fundamental misunderstanding that the EPA rather than the manufacturer, bears primary responsibility for drug labeling. Id. at 572. Here, it is Monsanto and not the EPA that is responsible for causing Ms. Sheppard to develop cancer. Even if the EPA did prevent Monsanto from changing the Roundup label, Monsanto can still be liable for failing to warn through means other than the label. Nothing in FIFRA prevents Manufacturers from warning about the dangers of its products through means such as advertising, press releases, pamphlets or point-of-sale banners. Indian Brand Farms, Inc., 617 F.3d at 217. (Data sheets providing further warning of pesticides presented to purchasers not contained in label is not preempted by FIFRA). Allenby, 958 F.2d at 945 (point-of-sale signs posted at retail locations warning of dangers not contained in label not preempted by FIFRA). 24

30 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 30 of 43 PageID #: 215 Monsanto s reliance upon factual assertions about EPA classifications regarding glyphosate s safety is irrelevant and improper, as the EPA itself has stated that it has made no determination of carcinogenicity and/or safety with regard to Roundup. Compl. 21, Classifications by the EPA do not constitute clear and manifest statements of Congressional intent that herbicides cannot be challenged as unsafe under state tort law. Arias v. Dyncorp, 517 F. Supp. 2d 221, 229 (D.D.C. 2007); Ferebee, 736 F.2d at (finding that a federal agency's determination that a product was safe for distribution under federal law and did not pose an unreasonable risk to the normal user, did not preempt state tort claims challenging labeling). Rather, that is a question for the fact finder to determine, especially true after Monsanto was prohibited from stating and/or advertising that Roundup was safe after a lawsuit was brought by the New York State Attorney General. See, Compl The findings, made by the EPA throughout the years in the federal registers are simply reiterations of the 1991 classification of glyphosate based on animal studies provided by Monsanto. As Plaintiffs have alleged in the complaint: Based on early studies that glyphosate could cause cancer in laboratory animals, the EPA originally classified glyphosate as possibly carcinogenic to humans (Group C) in After pressure from Monsanto, including contrary studies it provided to the EPA, the EPA changed its classification to evidence of non-carcinogenicity in humans (Group E) in In so classifying glyphosate, however, the EPA made clear that the designation did not mean the chemical does not cause cancer: It should be emphasized, however, that designation of an agent in Group E is based on the available 25

31 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 31 of 43 PageID #: 216 evidence at the time of evaluation and should not be interpreted as a definitive conclusion that the agent will not be a carcinogen under any circumstances. Compl at 28. The EPA has not made any new classifications as to the carcinogenicity of Glyphosate since The EPA s 2013 findings were [b]ased on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity 4 studies. The EPA s findings in 2008 were likewise based on the same rat studies. 5 Again in 2004, the EPA repeated its 1993 assessment stating Glyphosate is classified as a Group E chemical, negative for carcinogenicity in humans, based on the absence of carcinogenicity in male and female rats as well as male and female mice 6 Again in 2002, glyphosate was considered negative for carcinogenicity in humans, based on the absence of evidence of carcinogenicity in male and female rats as well as in male and female mice. 7 Once glyphosate was registered, Monsanto was able to come out with new glyphosate-containing products without going through a new registration process. 7 U.S.C.A. 136a(e) ( Products which have the same formulation, are manufactured by the same person, the labeling of which contains the same claims, and the labels of which bear a designation identifying the product as the same pesticide may be registered as a single pesticide. ). Finally, the 4 Glyphosate; Pesticide Tolerances, 78 Fed. Reg. 25,396, 25,399 (May 1, 2013) 5 Glyphosate; Pesticide Tolerances, 73 Fed. Reg. 73,586, 73,588 (Dec. 3, 2008). 6 Glyphosate; Pesticide Tolerance, 69 Fed. Reg. 65,081, 65,083 (Nov. 10, 2004) 7 Glyphosate; Pesticide Tolerances, 67 Fed. Reg. 60,934, 60,944 (Sept. 27, 2002) 26

32 Case 1:16-cv JMS-RLP Document 19 Filed 04/04/16 Page 32 of 43 PageID #: 217 language from Federal Register documents that Defendants cite are not actually regulations, but are rather supplementary information offered to explain changes to 40 CFR Glyphosate; tolerances for residues. There is no reference to carcinogenicity in the actual regulation. Monsanto s conclusions on rodent studies have since been debunked by the World Health Organization s International Agency for Research on Cancer ( IARC ), the authoritative source on assessing carcinogens. Compl. at Unlike the EPA s assessment based on a few, decades-old rodent studies, IARC has examined all relevant and up-to-date data which includes hundreds of studies. Furthermore, IARC makes an independent assessment free from the relentless lobbying efforts of Monsanto. 3. Ansagay v. Dow Supports Plaintiffs Claims A recent case from the U.S. District Court for Hawai i is also quite instructive on FIFRA preemption and contradict Defendants arguments that Plaintiffs can t bring a non-warning design defect claim against Pesticide manufacturers.. Following Bates, the court in Ansagay v. Dow, 2015 WL , F.Supp.3d, examined injury claims regarding a pesticide manufactured by the defendant. The court held that negligence claims were not preempted because they do not impose a labeling or packaging requirement. Instead they are based on the idea that [pesticide] itself was unsafe. Id. at *11. So 27