Case 8:22-cv-02100-GJH Document 1 Filed 08/19/22 Page 1 of 48
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MARYLAND
`Southern Division
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`
`
`Case No.:
`
`
`NICOLE SOLTYKA, individually and
`As personal representative of the Estate of
`Anthony Soltyka
`
`
`
`7007 Universal Court
`Rockville, MD 20855
`
`
`- AND –
`
`
`TO THE USE OF FELICIA SOLTYKA
`292 Main St
`East Aurora, NY 14052
`
`
`
`v.
`
`MONSANTO COMPANY
`800 Lindbergh Boulevard
`St. Louis County, Missouri
`
`
`
`Plaintiffs,
`
`Serve:
`CSC-LAWYERS INCORPORATING
`SERVICE COMPANY
`7 ST. PAUL STREET
`SUITE 820
`BALTIMORE MD 21202
`
`Defendant.
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`
`
`
`
`
`
`
`
`COMPLAINT
`COMES NOW, Plaintiff Nicole Soltyka, individually and as personal representative of the
`Estate of Anthony Soltyka, and to the use of Felicia Soltyka and states the following:
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`INTRODUCTION
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`Plaintiff brings this cause of action against Defendant. All claims in this action are a direct
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`
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`and proximate result of Defendant’s negligent, willful, and wrongful conduct in connection with the
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`design, development, manufacture, testing, packaging, promoting, marketing, distribution, and/or sale
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`Case 8:22-cv-02100-GJH Document 1 Filed 08/19/22 Page 2 of 48
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`of the products as Roundup®. Plaintiff seeks recovery for damages as a result of Anthony Soltyka (the
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`decedent”) developing Non-Hodgkin’s Lymphoma (“NHL”), which was directly and proximately
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`caused by such wrongful conduct by Defendant, the unreasonably dangerous and defective nature of
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`Roundup®, and its active ingredient, glyphosate, and the attendant effects of developing NHL.
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`Plaintiff did not know of an association between exposure to Roundup® and the increased risk of
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`developing NHL until well after July 29, 2015, when the International Agency for Research on Cancer
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`(“IARC”), an agency of the World Health Organization (“WHO”), first published its evaluation of
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`glyphosate.
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`
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`Plaintiff Nicole Soltyka brings each of her causes of action below individually pursuant to the
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`Maryland Wrongful Death Act, Md. Code, Cts. & Jud. Proc. § 3-901, et seq., and as personal
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`representative for the estate of decedent Anthony Soltyka, pursuant to the Maryland Survival Act, Md.
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`Code, Cts. & Jud. Proc. § 6-401
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`THE PARTIES
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`PLAINTIFF AND DECEDENT
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`1.
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`Plaintiff Nicole Soltyka is a citizen of State of Maryland and the personal representative
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`of the Estate of her deceased husband Anthony Soltyka. She brings this action as the surviving spouse,
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`and personal and legal representative of Mr. Soltyka.
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`2.
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`Decedent Anthony Soltyka was a citizen of the State of Maryland and is survived by
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`his wife Nicole and mother Felecia.
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`3.
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`Felecia Soltyka is the mother of the decedent and, upon information and believe a
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`citizen of the State of New York. Ms. Felecia Soltyka is a “Use Plaintiff” pursuant to Md. Rule Civ.
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`Proc. 15-1001.
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`4.
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`Decedent was first exposed to Roundup® in as early as 2010. He sprayed Roundup®
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`on his property on routine basis.
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`Case 8:22-cv-02100-GJH Document 1 Filed 08/19/22 Page 3 of 48
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`5.
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`In 2014, Anthony Soltyka was diagnosed with (Non-Hodkins Lymphoma) in and
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`suffered the effects attendant thereto ultimately succumbing to NHL and the sequalae of NHL and
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`the corresponding treatment on August 22, 2019, as a direct and proximate result of the unreasonably
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`dangerous and defective nature of Roundup® and Defendant’s wrongful and negligent conduct in the
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`research, development, testing, manufacture, production, promotion, distribution, marketing, and sale
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`of Roundup®.
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`6.
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`As a direct and proximate result of these injuries, Plaintiff has incurred medical
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`expenses and has endured and will endure pain and suffering and loss of enjoyment of life, and
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`Plaintiff has otherwise been damaged in a personal and pecuniary nature.
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`7.
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`During the entire time that Decedent was exposed to Roundup®, he did not know that
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`exposure to Roundup® was injurious to his health or the health of others.
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`DEFENDANT
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`8.
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`Defendant Monsanto is a Delaware corporation with its headquarters and principal
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`place of business in St. Louis, Missouri. At all relevant times, Monsanto also regularly conducted,
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`transacted, and solicited business in the State of Maryland. Monsanto’s world headquarters are located
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`at 800 Lindbergh Boulevard in St. Louis County, Missouri.
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`9.
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`At all times relevant to this complaint, Monsanto was the entity that discovered the
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`herbicidal properties of glyphosate and the manufacturer of Roundup®, which contains the active
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`ingredient glyphosate and the surfactant POEA, as well as adjuvants and other “inert” ingredients.
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`On information and belief, important scientific, manufacturing, marketing, sales, and other business
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`decisions regarding Roundup® were made from and in the State of Missouri.
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`10.
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`At all times relevant to this complaint, Monsanto was engaged in the business of
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`manufacturing, marketing, testing, promoting, selling, and/or distributing Roundup® in the State of
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`Missouri.
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`11.
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`At all relevant times, Monsanto had, and continues to have, regular and systematic
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`contact with and conducts business in and from the State of Maryland, such that it has purposefully
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`availed itself of the laws of the Maryland and expects to both sue and be sued in Maryland. In the
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`alternative, Monsanto’s presence in the State of Maryland satisfies the due process requirements for
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`Maryland courts to exercise jurisdiction over it.
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`JURISDICTION AND VENUE
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`12.
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`This Court has subject matter jurisdiction pursuant to 28 U.S.C. § 1332 as the parties
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`are completely diverse from each other and the amount in controversy exceeds $75,000.00.
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`13.
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`This Court has personal jurisdiction over each Defendant pursuant to Md. Code Ann.,
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`Cts. & Jud. Proc. § 6-102 and 6-103.
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`14.
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`15.
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`Venue lies in Montgomery County, Maryland as the cause of action arose therein.
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`ALLEGATIONS COMMON TO ALL COUNTS
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`In 1970, Defendant Monsanto Company, Inc. (“Monsanto”) discovered the herbicidal
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`properties of glyphosate and began marketing it in products in 1974 under the brand name Roundup®.
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`Roundup® is a non-selective herbicide used to kill weeds that commonly compete with the growing
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`of crops. In addition to the active ingredient glyphosate, Roundup® contains the surfactant
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`Polyethoxylated tallow amine (POEA) and/or adjuvants and other so-called “inert” ingredients. In
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`2001, glyphosate was the most-used pesticide active ingredient in American agriculture with 85–90
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`million pounds used annually. That number grew to 185 million pounds in 2007.1 As of 2013,
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`glyphosate was the world’s most widely used herbicide.
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`16. Monsanto is a multinational agricultural biotechnology corporation based in St.
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`Louis, Missouri, and incorporated in Delaware. It is the world's leading producer of glyphosate. As
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`1 Arthur Grube et al., U.S. Envtl. Prot. Agency, Pesticides Industry Sales and Usage, 2006–2007 Market Estimates
`14 (2011), available at http://www.epa.gov/pesticides/pestsales/07pestsales/market_estimates2007.pdf.
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`of 2009, Monsanto was the world’s leading producer of seeds, accounting for 27% of the world seed
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`market.2 The majority of these seeds are of the Roundup Ready® brand. The stated advantage of
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`Roundup Ready® crops is that they substantially improve a farmer’s ability to control weeds, because
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`glyphosate can be sprayed in the fields during the growing season without harming the crops. In
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`2010, an estimated 70% of corn and cotton and 90% of soybean fields in the United States were
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`Roundup Ready®.3
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`17. Monsanto’s glyphosate products are registered in 130 countries and approved for use
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`on over 100 different crops.4 They are ubiquitous in the environment. Numerous studies confirm
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`that glyphosate is found in rivers, streams, and groundwater in agricultural areas where Roundup® is
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`used.5 It has been found in food,6 in the urine of agricultural workers,7 and even in the urine of
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`urban dwellers who are not in direct contact with glyphosate.8
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`18.
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`On March 20, 2015, the International Agency for Research on Cancer (“IARC”), an
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`agency of the World Health Organization (“WHO”), issued an evaluation of several herbicides,
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`2 ETC Group, Who Will Control the Green Economy? 22 (2011), available at
`http://www.etcgroup.org/files/publication/pdf_file/ETC_wwctge_4web_Dec2011.pdf.
`3 William Neuman & Andrew Pollack, Farmers Cope With Roundup-Resistant Weeds, N.Y. TIMES, May 3, 2010,
`available at http://www.nytimes.com/2010/05/04/business/energy-environment/04weed.html?pagewan.
`4 Monsanto, Backgrounder-History of Monsanto’s Glyphosate Herbicides (Sep. 2, 2015),
`http://www.monsanto.com/products/documents/glyphosate-background-materials/back_history.pdf.
`5 See U.S. Geological Survey, USGS Technical Announcement: Widely Used Herbicide Commonly Found in Rain and
`Streams in the Mississippi River Basin (2011), available at http://www.usgs.gov/newsroom/article.asp?ID=2909; see also
`U.S. Envtl. Prot. Agency, Technical Factsheet on: Glyphosate, available at
`http://www.epa.gov/safewater/pdfs/factsheets/soc/tech/glyphosa.pdf.
`6 Thomas Bohn et al., Compositional Differences in Soybeans on the Market: Glyphosate Accumulates in Roundup Ready
`GM Soybeans, 153 FOOD CHEMISTRY 207 (2013), available at
`http://www.sciencedirect.com/science/article/pii/S0308814613019201.
`7 John F. Acquavella et al., Glyphosate Biomonitoring for Farmers and Their Families: Results from the Farm Family
`Exposure Study, 112(3) ENVTL. HEALTH PERSPECTIVES 321 (2004), available at
`http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1241861/; Kathryn Z. Guyton et al., Carcinogenicity of Tetrachlorvinphos,
`Parathion, Malathion, Diazinon & Glyphosate, 112 IARC Monographs 76, section 5.4 (2015), available at
`http://dx.doi.org/10.1016/S1470-2045(15)70134-8.
`8 Dirk Brändli & Sandra Reinacher, Herbicides found in Human Urine, 1 ITHAKA JOURNAL 270 (2012), available at
`http://www.ithaka-journal.net/druckversionen/e052012-herbicides-urine.pdf.
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`including glyphosate. That evaluation was based, in part, on studies of exposures to glyphosate in
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`several countries around the world, and it traces the health implications from exposure to glyphosate
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`since 2001.
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`19.
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`On July 29, 2015, IARC issued the formal monograph relating to glyphosate. In that
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`monograph, the IARC Working Group provides a thorough review of the numerous studies and
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`data relating to glyphosate exposure in humans.
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`20.
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`The IARC Working Group classified glyphosate as a Group 2A herbicide, which
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`means that it is probably carcinogenic to humans. The IARC Working Group concluded that the cancers
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`most associated with glyphosate exposure are NHL and other haematopoietic cancers, including
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`lymphocytic lymphoma / chronic lymphocytic leukemia, B-cell lymphoma, and multiple myeloma.9
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`21.
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`The IARC evaluation is significant. It confirms what has been believed for years:
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`that glyphosate is toxic to humans.
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`22.
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`Nevertheless, Monsanto, since it began selling Roundup®, has represented it as safe
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`to humans and the environment. Indeed, Monsanto has repeatedly proclaimed and continues to
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`proclaim to the world, and particularly to United States consumers, that glyphosate-based herbicides,
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`including Roundup®, create no unreasonable risks to human health or to the environment.
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`FACTS
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`23.
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`Glyphosate is a broad-spectrum, non-selective herbicide used in a wide variety of
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`herbicidal products around the world.
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`24.
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`Plants treated with glyphosate translocate the systemic herbicide to their roots, shoot
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`regions, and fruit, where it interferes with the plant’s ability to form aromatic amino acids necessary
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`for protein synthesis. Treated plants generally die within two to three days. Because plants absorb
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`9 See Guyton et al., Carcinogenicity of Tetrachlorvinphos, Parathion, Malathion, Diazinon & Glyphosate, supra.
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`glyphosate, it cannot be completely removed by washing or peeling produce or by milling, baking,
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`or brewing grains.
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`25.
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`For nearly 40 years, farms across the world have used Roundup® without knowing
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`of the dangers its use poses. That is because when Monsanto first introduced Roundup®, it touted
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`glyphosate as a technological breakthrough: it could kill almost every weed without causing harm
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`either to people or to the environment. Of course, history has shown that not to be true. According
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`to the WHO, the main chemical ingredient of Roundup®—glyphosate—is a probable cause of
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`cancer. Those most at risk are farm workers and other individuals with workplace exposure to
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`Roundup®, such as garden center workers, nursery workers, and landscapers. Agricultural workers
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`are, once again, victims of corporate greed. Monsanto assured the public that Roundup® was
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`harmless. In order to prove this, Monsanto has championed falsified data and has attacked legitimate
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`studies that revealed the dangers of Roundup®. Monsanto has led a prolonged campaign of
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`misinformation to convince government agencies, farmers and the general population that
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`Roundup® is safe.
`The Discovery of Glyphosate and Development of Roundup®
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`26.
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`The herbicidal properties of glyphosate were discovered in 1970 by Monsanto
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`chemist John Franz. The first glyphosate-based herbicide was introduced to the market in the mid-
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`1970s under the brand name Roundup®.10 From the outset, Monsanto marketed Roundup® as a
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`“safe” general-purpose herbicide for widespread commercial and consumer use. It still markets
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`Roundup® as safe today.11
`
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`10 Monsanto, Backgrounder, History of Monsanto’s Glyphosate Herbicide (Sep. 2, 2015),
`http://www.monsanto.com/products/documents/glyphosate-background-materials/back_history.pdf.
`11 Monsanto, What is Glyphosate? (Sep. 2, 2015),
`http://www.monsanto.com/sitecollectiondocuments/glyphosate-safety-health.pdf.
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`Case 8:22-cv-02100-GJH Document 1 Filed 08/19/22 Page 8 of 48
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`27.
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`In addition to the active ingredient glyphosate, Roundup® formulations also contain
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`adjuvants and other chemicals, such as the surfactant POEA, which are considered “inert” and
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`therefore protected as “trade secrets” in manufacturing. Growing evidence suggests that these
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`adjuvants and additional components of Roundup® formulations are not, in fact, inert and are toxic
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`in their own right.
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`Registration of Herbicides under Federal Law
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`28.
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`The manufacture, formulation, and distribution of herbicides, such as Roundup®, are
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`regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA” or “Act”), 7
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`U.S.C. § 136 et seq. FIFRA requires that all pesticides be registered with the Environmental
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`Protection Agency (“EPA” or “Agency”) prior to their distribution, sale, or use, except as described
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`by the Act. 7 U.S.C. § 136a(a).
`
`29.
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`Because pesticides are toxic to plants, animals, and humans, at least to some degree,
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`the EPA requires as part of the registration process, among other things, a variety of tests to evaluate
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`the potential for exposure to pesticides, toxicity to people and other potential non-target organisms,
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`and other adverse effects on the environment. Registration by the EPA, however, is not an assurance
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`or finding of safety. The determination the Agency must make in registering or re-registering a
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`product is not that the product is “safe,” but rather that use of the product in accordance with its
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`label directions “will not generally cause unreasonable adverse effects on the environment.” 7 U.S.C.
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`§ 136a(c)(5)(D).
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`30.
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`FIFRA defines “unreasonable adverse effects on the environment” to mean “any
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`unreasonable risk to man or the environment, taking into account the economic, social, and
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`environmental costs and benefits of the use of any pesticide.” 7 U.S.C. § 136(bb). FIFRA thus
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`requires EPA to make a risk/benefit analysis in determining whether a registration should be granted
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`or a pesticide allowed to continue to be sold in commerce.
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`Case 8:22-cv-02100-GJH Document 1 Filed 08/19/22 Page 9 of 48
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`31.
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`The EPA and the State of California registered Roundup® for distribution, sale, and
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`manufacture in the United States.
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`32.
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`FIFRA generally requires that the registrant, Monsanto in the case of Roundup®,
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`conducts the health and safety testing of pesticide products. The EPA has protocols governing the
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`conduct of tests required for registration and the laboratory practices that must be followed in
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`conducting these tests. The data produced by the registrant must be submitted to the EPA for review
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`and evaluation. The government is not required, nor is it able, however, to perform the product
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`tests that are required of the manufacturer.
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`33.
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`The evaluation of each pesticide product distributed, sold, or manufactured is
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`completed at the time the product is initially registered. The data necessary for registration of a
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`pesticide has changed over time. The EPA is now in the process of re-evaluating all pesticide
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`products through a Congressionally-mandated process called “re-registration.” 7 U.S.C. § 136a-1.
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`In order to re-evaluate these pesticides, the EPA is demanding the completion of additional tests
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`and the submission of data for the EPA’s recent review and evaluation.
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`34.
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`In the case of glyphosate, and therefore Roundup®, the EPA had planned on
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`releasing its preliminary risk assessment—in relation to the reregistration process—no later than July
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`2015. The EPA completed its review of glyphosate in early 2015, but it delayed releasing the risk
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`assessment pending further review in light of the WHO’s health-related findings.
`Scientific Fraud Underlying the Marketing and Sale of Glyphosate/Roundup®
`35.
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`Based on early studies showing that glyphosate could cause cancer in laboratory
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`animals, the EPA originally classified glyphosate as possibly carcinogenic to humans (Group C) in 1985.
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`After pressure from Monsanto, including contrary studies it provided to the EPA, the EPA changed
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`its classification to evidence of non-carcinogenicity in humans (Group E) in 1991. In so classifying
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`glyphosate, however, the EPA made clear that the designation did not mean the chemical does not
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`Case 8:22-cv-02100-GJH Document 1 Filed 08/19/22 Page 10 of 48
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`cause cancer: “It should be emphasized, however, that designation of an agent in Group E is based
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`on the available evidence at the time of evaluation and should not be interpreted as a definitive
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`conclusion that the agent will not be a carcinogen under any circumstances.”12
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`36.
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`On two occasions, the EPA found that the laboratories hired by Monsanto to test
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`the toxicity of its Roundup® products for registration purposes committed fraud.
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`37.
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`In the first instance, Monsanto, in seeking initial registration of Roundup® by the
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`EPA, hired Industrial Bio-Test Laboratories (“IBT”) to perform and evaluate pesticide toxicology
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`studies relating to Roundup®.13 IBT performed about 30 tests on glyphosate and glyphosate-
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`containing products, including nine of the 15 residue studies needed to register Roundup®.
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`38.
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`In 1976, the United States Food and Drug Administration (“FDA”) performed an
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`inspection of IBT that revealed discrepancies between the raw data and the final report relating to
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`the toxicological impacts of glyphosate. The EPA subsequently audited IBT; it too found the
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`toxicology studies conducted for the Roundup® herbicide to be invalid.14 An EPA reviewer stated,
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`after finding “routine falsification of data” at IBT, that it was “hard to believe the scientific integrity
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`of the studies when they said they took specimens of the uterus from male rabbits.”15
`
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`12 U.S. Envtl. Prot. Agency, Memorandum, Subject: SECOND Peer Review of Glyphosate 1 (1991), available at
`http://www.epa.gov/pesticides/chem_search/cleared_reviews/csr_PC-103601_30-Oct-91_265.pdf.
`13 Monsanto, Backgrounder, Testing Fraud: IBT and Craven Laboratories (Sep. 2, 2015),
`http://www.monsanto.com/products/documents/glyphosate-background-materials/ibt_craven_bkg.pdf.
`14 U.S. Envtl. Prot. Agency, Summary of the IBT Review Program Office of Pesticide Programs (1983), available at
`http://nepis.epa.gov/Exe/ZyNET.exe/91014ULV.TXT?ZyActionD=ZyDocument&Client=EPA&Index=1981+Th
`ru+1985&Docs=&Query=&Time=&EndTime=&SearchMethod=1&TocRestrict=n&Toc=&TocEntry=&QField=&
`QFieldYear=&QFieldMonth=&QFieldDay=&IntQFieldOp=0&ExtQFieldOp=0&XmlQuery=&File=D%3A%5Czy
`files%5CIndex%20Data%5C81thru85%5CTxt%5C00000022%5C91014ULV.txt&User=ANONYMOUS&Password=
`anonymous&SortMethod=h%7C-
`&MaximumDocuments=1&FuzzyDegree=0&ImageQuality=r75g8/r75g8/x150y150g16/i425&Display=p%7Cf&Def
`SeekPage=x&SearchBack=ZyActionL&Back=ZyActionS&BackDesc=Results%20page&MaximumPages=1&ZyEntry
`=1&SeekPage=x&ZyPURL.
`15 Marie-Monique Robin, The World According to Monsanto: Pollution, Corruption and the Control of the World’s Food
`Supply (2011) (citing U.S. Envtl. Prot. Agency, Data Validation, Memo from K. Locke, Toxicology Branch, to R. Taylor,
`Registration Branch. Washington, D.C. (August 9, 1978)).
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`39.
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`40.
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`Three top executives of IBT were convicted of fraud in 1983.
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`In the second incident of data falsification, Monsanto hired Craven Laboratories in
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`1991 to perform pesticide and herbicide studies, including for Roundup®. In that same year, the
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`owner of Craven Laboratories and three of its employees were indicted, and later convicted, of
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`fraudulent laboratory practices in the testing of pesticides and herbicides.16
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`41.
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`Despite the falsity of the tests that underlie its registration, within a few years of its
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`launch, Monsanto was marketing Roundup® in 115 countries.
`The Importance of Roundup® to Monsanto’s Market Dominance Profits
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`42.
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`The success of Roundup® was key to Monsanto’s continued reputation and
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`dominance in the marketplace. Largely due to the success of Roundup® sales, Monsanto’s agriculture
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`division was out-performing its chemicals division’s operating income, and that gap increased yearly.
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`But with its patent for glyphosate expiring in the United States in the year 2000, Monsanto needed
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`a strategy to maintain its Roundup® market dominance and to ward off impending competition.
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`43.
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`In response, Monsanto began the development and sale of genetically engineered
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`Roundup Ready® seeds in 1996. Since Roundup Ready® crops are resistant to glyphosate, farmers
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`can spray Roundup® onto their fields during the growing season without harming the crop. This
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`allowed Monsanto to expand its market for Roundup® even further; by 2000, Monsanto’s
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`biotechnology seeds were planted on more than 80 million acres worldwide and nearly 70% of
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`American soybeans were planted from Roundup Ready® seeds. It also secured Monsanto’s dominant
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`share of the glyphosate/Roundup® market through a marketing strategy that coupled proprietary
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`Roundup Ready® seeds with continued sales of its Roundup® herbicide.
`
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`16 Monsanto, Backgrounder, Testing Fraud: IBT and Craven Laboratories, supra.
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`44.
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`Through a three-pronged strategy of increasing production, decreasing prices, and
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`by coupling with Roundup Ready® seeds, Roundup® became Monsanto’s most profitable product.
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`In 2000, Roundup® accounted for almost $2.8 billion in sales, outselling other herbicides by a margin
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`of five to one, and accounting for close to half of Monsanto’s revenue.17 Today, glyphosate remains
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`one of the world’s largest herbicides by sales volume.
`Monsanto has known for decades that it falsely advertises the safety of Roundup®
`45.
`
`In 1996, the New York Attorney General (“NYAG”) filed a lawsuit against
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`Monsanto based on its false and misleading advertising of Roundup® products. Specifically, the
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`lawsuit challenged Monsanto’s general representations that its spray-on glyphosate-based herbicides,
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`including Roundup®, were “safer than table salt” and “practically non-toxic” to mammals, birds,
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`and fish. Among the representations the NYAG found deceptive and misleading about the human
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`and environmental safety of glyphosate and/or Roundup® are the following:
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`that environmentally friendly Roundup
`a) “Remember
`herbicide is biodegradable. It won’t build up in the soil so you can use
`Roundup with confidence along customers’ driveways, sidewalks and
`fences ...”
`
`b) “And remember that Roundup is biodegradable and won’t
`build up in the soil. That will give you the environmental confidence
`you need to use Roundup everywhere you've got a weed, brush, edging
`or trimming problem.”
`
`c) “Roundup biodegrades into naturally occurring elements.”
`
`d) “Remember that versatile Roundup herbicide stays where
`you put it. That means there's no washing or leaching to harm
`customers' shrubs or other desirable vegetation.”
`
`e) “This non-residual herbicide will not wash or leach in the
`soil. It ... stays where you apply it.”
`
`
`
`17 David Barboza, The Power of Roundup; A Weed Killer Is A Block for Monsanto to Build On, N.Y. TIMES, Aug. 2,
`2001, available at http://www.nytimes.com/2001/08/02/business/the-power-of-roundup-a-weed-killer-is-a-block-for-
`monsanto-to-build-on.html.
`
`
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`12
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`Case 8:22-cv-02100-GJH Document 1 Filed 08/19/22 Page 13 of 48
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`f) “You can apply Accord with ‘confidence because it will stay
`where you put it’ it bonds tightly to soil particles, preventing leaching.
`Then, soon after application, soil microorganisms biodegrade Accord
`into natural products.”
`
`g) “Glyphosate is less toxic to rats than table salt following
`acute oral ingestion.”
`
`h) “Glyphosate’s safety margin is much greater than required.
`It has over a 1,000-fold safety margin in food and over a 700-fold
`safety margin for workers who manufacture it or use it.”
`
`i) “You can feel good about using herbicides by Monsanto.
`They carry a toxicity category rating of ‘practically non-toxic’ as it
`pertains to mammals, birds and fish.”
`
`j) “Roundup can be used where kids and pets will play and
`breaks down into natural material.” This ad depicts a person with his
`head in the ground and a pet dog standing in an area which has been
`treated with Roundup.18
`
`On November 19, 1996, Monsanto entered into an Assurance of Discontinuance
`
`46.
`
`with NYAG, in which Monsanto agreed, among other things, “to cease and desist from publishing
`
`or broadcasting any advertisements [in New York] that represent, directly or by implication” that:
`
`its glyphosate-containing pesticide products or any
`a)
`component thereof are safe, non-toxic, harmless or free from risk.
`
`
`
`*
`
`*
`
` *
`
`
`its glyphosate-containing pesticide products or any
`b)
`component thereof manufactured, formulated, distributed or sold by
`Monsanto are biodegradable
`
`
`
`*
`
`*
`
` *
`
`
`its glyphosate-containing pesticide products or any
`c)
`component thereof stay where they are applied under all circumstances
`and will not move through the environment by any means.
`
`
`
`*
`
`*
`
` *
`
`
`
`
`18 Attorney General of the State of New York, In the Matter of Monsanto Company, Assurance of
`Discontinuance Pursuant to Executive Law § 63(15) (Nov. 1996).
`
`
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`Case 8:22-cv-02100-GJH Document 1 Filed 08/19/22 Page 14 of 48
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`its glyphosate-containing pesticide products or any
`d)
`component thereof are “good” for the environment or are “known for
`their environmental characteristics.”
`
`
`
`*
`
`*
`
` *
`
`
`e) glyphosate-containing pesticide products or any component
`thereof are safer or less toxic than common consumer products other
`than herbicides;
`
`f) its glyphosate-containing products or any component
`thereof might be classified as “practically non-toxic.”
`
`
`47. Monsanto did not alter its advertising in the same manner in any state other than
`
`New York, and on information and belief it still has not done so today.
`
`48.
`
`In 2009, France’s highest court ruled that Monsanto had not told the truth about the
`
`safety of Roundup®. The French court affirmed an earlier judgement that Monsanto had falsely
`
`advertised its herbicide Roundup® as “biodegradable” and that it “left the soil clean.”19
`Classifications and Assessments of Glyphosate
`
`49.
`
`The IARC process for the classification of glyphosate followed IARC’s stringent
`
`procedures for the evaluation of a chemical agent. Over time, the IARC Monograph program has
`
`reviewed 980 agents. Of those reviewed, it has determined 116 agents to be Group 1 (Known
`
`Human Carcinogens); 73 agents to be Group 2A (Probable Human Carcinogens); 287 agents to be
`
`Group 2B (Possible Human Carcinogens); 503 agents to be Group 3 (Not Classified); and one agent
`
`to be Probably Not Carcinogenic.
`
`
`19 Monsanto Guilty in ‘False Ad’ Row, BBC, Oct. 15, 2009, available at
`http://news.bbc.co.uk/2/hi/europe/8308903.stm.
`
`
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`14
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`Case 8:22-cv-02100-GJH Document 1 Filed 08/19/22 Page 15 of 48
`
`50.
`
`The established procedure for IARC Monograph evaluations is described in the
`
`IARC Programme’s Preamble.20 Evaluations are performed by panels of international experts,
`
`selected on the basis of their expertise and the absence of actual or apparent conflicts of interest.
`
`51.
`
`One year before the Monograph meeting, the meeting is announced and there is a
`
`call both for data and for experts. Eight months before the Monograph meeting, the Working Group
`
`membership is selected and the sections of the Monograph are developed by the Working Group
`
`members. One month prior to the Monograph meeting, the call for data is closed and the various
`
`draft sections are distributed among Working Group members for review and comment. Finally, at
`
`the Monograph meeting, the Working Group finalizes review of all literature, evaluates the evidence
`
`in each category, and completes the overall evaluation. Within two weeks after the Monograph
`
`meeting, the summary of the Working Group findings are published in The Lancet Oncology, and within
`
`a year after the meeting, the finalized Monograph is published.
`
`52.
`
`In assessing an agent, the IARC Working Group reviews the following information:
`
`(a) human, experimental, and mechanistic data; (b) all pertinent epidemiological studies and cancer
`
`bioassays; and (c) representative mechanistic data. The studies must be publicly available and have
`
`sufficient detail for meaningful review, and reviewers cannot be associated with the underlying study.
`
`53.
`
`In March 2015, IARC reassessed glyphosate. The summary published in The Lancet
`
`Oncology reported that glyphosate is a Group 2A agent and probably carcinogenic in humans.
`
`54.
`
` On July 29, 2015, IARC issued its Monograph for glyphosate, Monograph Volume
`
`112. For Volume 112, a Working Group of 17 experts from 11 countries met at IARC from March
`
`3–10, 2015 to assess the carcinogenicity of certain herbicides, including glyphosate. The March
`
`meeting culminated a nearly one-year review and preparation by the IARC Secretariat and the
`
`
`20 World Health Org., IARC Monographs on the Evaluation of Carcinogenic Risks to Humans: Preamble (2006),
`available at http://monographs.iarc.fr/ENG/Preamble/CurrentPreamble.pdf.
`
`
`
`15
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`Case 8:22-cv-02100-GJH Document 1 Filed 08/19/22 Page 16 of 48
`
`Working Group, including a comprehensive review of the latest available scientific evidence.
`
`According to published procedures, the Working Group considered “reports that have been
`
`published or accepted for publication in the openly available scientific literature” as well as “data
`
`from governmental reports that are publicly available.”
`
`55.
`
`The studies considered the following exposure groups: (1) occupational exposure of
`
`farmers and tree nursery workers in the United States, forestry workers in Canada and Finland and
`
`municipal weed-control workers in the United Kingdom; and (2) para-occupational exposure in
`
`farming families.
`
`56.
`
`Glyphosate was identified as the second-most used household herbicide in the
`
`United States for weed control between 2001 and 2007 and the most heavily used herbicide in the
`
`world in 2012.
`
`57.
`
`Exposure pathways