Case 3:16-md-02741-VC Document 331 Filed 06/08/17 Page 1 of 3 1 Aimee Wagstaff, SBN 278480 aimee.wagstaff@andruswagstaff.com 2 Andrus Wagstaff, PC 7171 West Alaska Drive 3 Lakewood, CO 80226 Telephone: (303) 376-6360 4 Facsimile: (303) 376-6361 5 Robin Greenwald rgreenwald@weitzlux.com 6 Weitz & Luxenberg 700 Broadway 7 New York, NY 10003 Telephone: (212) 558-5500 8 Facsimile: (212) 344-5461 9 Michael Miller mmiller@millerfirmllc.com 10 The Miller Firm LLC 108 Railroad Avenue 11 Orange, VA 22960 Telephone: (540) 672-4224 12 Facsimile: (540) 672-3055 13 Attorneys for Plaintiffs 14 UNITED STATES DISTRICT COURT 15 NORTHERN DISTRICT OF CALIFORNIA 16 17 IN RE: ROUNDUP PRODUCTS MDL No. 2741 LIABILITY LITIGATION 18 Case No. 16-md-02741-VC 19 20 This document relates to: 21 ALL ACTIONS 22 23 24 UNREDACTED VERSIONS OF PLAINTIFFS’ MOTION TO COMPEL THE PRODUCTION OF ALL ORIGINAL AND RECUT SLIDES OF KIDNEY TISSUE FROM 25 MICE IN STUDY BDN-77-420 AND EXHIBITS 1 AND 4 PURSUANT TO PTO #25 26 27 - 1 - 28 UNREDACTED VERSIONS OF PLAINTIFFS’ MOTION TO COMPEL AND EXHIBITS 1 AND 4 TO ECF NO. 255 AND 256 3:16-md-02741-VC
Case 3:16-md-02741-VC Document 331 Filed 06/08/17 Page 2 of 3 Pursuant to the Court’s Pretrial Order #25, entered on June 6, 2017 (ECF No. 330), attached 1 hereto are un-redacted versions of Plaintiffs’ Motion to Compel the Production of all Original and 2 Recut Slides of Kidney Tissue from Mice in Study BDN-77-420 and Exhibits 1 and 4 to said Motion 3 originally filed on April 21, 2017 (ECF No. 256-2). 4 5 Dated: June 8, 2017 Respectfully Submitted, 6 7 /s/ Aimee Wagstaff 8 Aimee Wagstaff, SBN 278480 aimee.wagstaff@andruswagstaff.com 9 7171 West Alaska Drive Lakewood, CO 80226 10 Telephone: (303) 376-6360 Facsimile: (303) 376-6361 11 Co-Lead Plaintiffs’ Counsel 12 For MDL 2741 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 - 2 - 28 UNREDACTED VERSIONS OF PLAINTIFFS’ MOTION TO COMPEL AND EXHIBITS 1 AND 4 TO ECF NO. 255 AND 256 3:16-md-02741-VC
Case 3:16-md-02741-VC Document 331 Filed 06/08/17 Page 3 of 3 1 CERTIFICATE OF SERVICE 2 I hereby certify that a true and correct copy of the foregoing document was filed with the 3 Court and electronically served through the CM-ECF system which will send a notification of 4 such filing to all counsel of record. . 5 6 DATED: June 8, 2017 /s/ Aimee Wagstaff ANDRUS WAGSTAFF, PC 7 Aimee H. Wagstaff, SBN 278480 aimee.wagstaff@andruswagstaff.com 8 7171 West Alaska Drive Lakewood, CO 80226 9 Telephone: (303) 376-6360 Facsimile: (303) 376-6361 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 - 3 - 28 UNREDACTED VERSIONS OF PLAINTIFFS’ MOTION TO COMPEL AND EXHIBITS 1 AND 4 TO ECF NO. 255 AND 256 3:16-md-02741-VC
Case 3:16-md-02741-VC Document 331-2 Filed 06/08/17 Page 1 of 13 EXHIBIT 1
Case 3:16-md-02741-VC Document 331-2 Filed 06/08/17 Page 2 of 13 Monsanto • Monsanto Company 1101 17th Street. N. W. Washington. D. C. 20036 Phone : (202 452-8860 March 13, 1985 Mr. Douglas D. Campt Director, Registration Division Office of Pesticide Programs U.S. Environmental Protection Agency 1921 Jefferson Davis Highway Arlington, Virginia 22702 Subject: Roundup@ Herbicide EPA Reg. Nos. 524-308, 524-330, 524-339, 524-332 524-343 Dear Mr. Campt: As part of a program to replace IBT toxicology studies Monsanto conducted a chronic feeding study with glyphosate in mice. Dietary levels of were used in this Even though the highest feeding level was equivalent to 3% glyphosate in the diet, no major chronic effects were observed nor were This there any treatment related oncogenic effects noted. m,_ x^ r study was Upon completion of its review, the Agency indicated concern over adenomas observed a very low incidence of microscopic renal The incidence data were 0, 0, 1, 3 in high dose male mice. for control, low-dose, mid-dose, and high dose levels, and are not statistically significant at the respectively, 99% confidence level. we in response to a request by the Agency, from tha laboratory which submitted historical control data two other major contract performed the study as well as lesion does laboratories. The data indicated that this occur occasionally and in comparable ranges. Lyle GingericI, Dr. Fred Johannsen mom Dr. We had a I met with Drs. Farber and Burnam of the EPA. -and at this meeting and appreciated the full exchange of opinions opportunity to explore the EPA position on glyphosate with them. Confidential - Produced Subject to Protective Order MONGLY00233278
Case 3:16-md-02741-VC Document 331-2 Filed 06/08/17 Page 3 of 13 Mr. Campt • March 13, 1985 Page 2 it became clear that In the course of our meeting, however, . the e s-.:the to summarize of this letter is The purpose for our position and to provide addition- the scientific basis and information for your consideration. al interpretation Inconsistency With Treatment-Related Etiology A. 1. Sex - specific Occurrence adenomas were only observed in male and not female Renal 2 years of glyphosate treatment. mice following and perhaps not considered by the EPA, Significantly, was the fact that female mice in the high - dose group • took in fully 20% more glyphosate on an mg /kg/day basis ( 4232-9859 mg/kg/day in than their male counterparts If this 3465 -7 220 mg / kg/day in males ). females vs . one would have expected lesion were treatment - related , This a dose - dependent increase in tumor development. obviously did not occur because no females on test developed a renal adenoma. No Time Course to Tumor Development 2. seen in male mice incidence of renal tumors The small possessed no normal time course to tumor development. Lesions were only observed in terminally sacrificed while none were found in animals which died animals , before the end of the 24 month study p eriod. This the observation supports ecause a decreased time-to-tumor interval would have been expected had the latter been the case. No Progression of Neoplastic Lesion 3. not malignant, a effect been treatment related, lad this formation and a multipli- progression towards carcinomas especially in :ity of sites would have been expected, senile mice. Confidential - Produced Subject to Protective Order MONGLY00233279
Case 3:16-md-02741-VC Document 331-2 Filed 06/08/17 Page 4 of 13 Mr. Campt March 13, 1985_ Page 3 No Evidence to Support a Preneoplastic Effect 4. expressed by the EPA at our In contrast to thoughts In fac no such effects_we_re observe n groups o mice fed at a dose level of 50,000 ppm for up to 3 glyphosate accession number report submitted in May 1980, months; evaluation in a broad range of 242799. Similarly, mutagenicity assays designed to assess point mutations, DNA damage or chromosomal effects in mammalian and bacterial cell systems uniformly resulted in a complete lack of geno -toxicity. Specie Specificity 5. a previously submitted 2-year rat study Results of clearly established that there were • Consistency With Spontaneous Etiology A. Lack of Statistical Significance 1. of multiple comparison of renal analysis The original and treated groups was conducted tumors between control using the chi-square test for homogeneity. The obtained from this test or p-value, significance level, The and 0.0408 (uncorrected). was 0.1241 (corrected) is essentially the same test but ;corrected chi-square a correction factor designed to improve the with the more widely More imprtantly, approximation. a p-value of 0.1249. accepted Fisher's Exact Test gives Analysis of the data by the linear dose-response trends gives a a finding of either one less tumor in the Theoretically, or one tumor in the control or low-dose high dose group at the in lack of statistical significance group results Most letter. See Table on page 4 of this level. p=0.05 importantly, • Confidential - Produced Subject to Protective Order MONGLY00233280
Case 3:16-md-02741-VC Document 331-2 Filed 06/08/17 Page 5 of 13 Mr. Campt March 13, 1985 Page 4 Cochran Armitage Test Number of Tumors at Dose p-Value 0 1000 ppm 5000 ppm 30 , 000 ppm 0 0 1 3 0.016 1 0 1 3 0.068 0 1 1 3 0.063 0 0 1 2 0.239 of Historical Values 2. Within Range (%) adenomas in large While the mean incidence of renal Monsanto has supplied groups of male mice is quite low, Since the glyphosate no contain an animal with a male control group di at the low end of the renal tumor it obviously was The incidence of renal adenomas in high dose range. albeit at the high end, of the male mice were within, • fact that historical range of 7.1% for adenomas . The no carcinomas were observed in any test group puts all of the historical at the lowest end (0.0%) four groups range for this tumor delineation. Spontaneously Occurring Tumors Appear to be Sex Specific 3. control data Based on literature surveyed and historical gathered, The fact study were also that the renal adenomas seen in this not females ( even though females seen only in males , a higher total glyphosate intake in this study), consumed is consistent with the data available on the spontaneous occurrence of this tumor type. This conclusion ha; been reached not only by Monsanto scientists but by regulatory agencies worldwide. an extremely important herbicide to As you know, Roundup is is and a:eound the world. Monsanto in the U. S. agriculture concerned that even the initiation of formal regulatory • action would have serious negative economic repercussions Confidential - Produced Subject to Protective Order MONGLY00233281
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