Case 3:22-cv-00403-DMS-JLB Document 1-2 Filed 03/28/22 PageID.11 Page 1 of 25
`
`,.
`
`l THE WESTON FIRM
`GREGORY S. WESTON (239944)
`2 greg@westonfirm.com
`3 1405 Morena Blvd., Suite 201
`San Diego, CA 92110
`4 Telephone:
`(619) 798-2006
`Facsimile:
`(619) 343-2789
`
`ELECTROHICALL V FILED
`Superior Court of California,
`County of San Diego
`02123/2022 at 11 :21 :3:5 JIM
`Cleric of the Superior Court
`By Bizabetl't Reyes.Deputy Clerk
`
`Counsel for Plaintiff
`
`SUPERIOR COURT FOR THE STATE OF CALIFORNIA
`
`FOR THE COUNTY OF SAN DIEGO
`
`LORETTA SCHWEINSBURG, on behalf
`of herself and all others similarly situated,
`
`Case No:
`
`37-2022-000D6951-C U-BT-CTL
`
`Plaintiff,
`
`V.
`
`CLASS ACTION COMPLAINT VIOLATIONS OF THE
`UN.FAIR COMPETITION LAW AND FOR BREACH OF
`IMPLIED W ARRA.t"ITY
`
`GENERAL MILLS, INC. and GENERAL
`MILLS SALES, INC.,
`
`No Jury Demand
`
`Defendants.
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`CLASS ACTION COMPLAINT
`
`

`

`Case 3:22-cv-00403-DMS-JLB Document 1-2 Filed 03/28/22 PageID.12 Page 2 of 25
`
`\•;··
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`TABLE OF CONTENTS
`
`I.
`II.
`III.
`IV.
`
`JURISDICTION AND VE.NTJE ....................................................................................................... 1
`
`NATURE OF THE ACTION ........................................................................................................... 1
`PARTIES .......................................................................................................................................... 2
`
`NATURE OF TRANS FAT .............................................................................................................. 2
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`There Is a Well-Established Scientific Consensus That Trans Fat Is Extremely
`Harmful. ................................................................................................................................ 3
`
`The Artificial Trans Fat General Mills Added to Hamburger Helper Caused
`Cardiovascular Disease ......................................................................................................... 5
`
`The Artificial Trans Fat General Mills Added to Hamburger Helper Caused Type-2
`Diabetes...................
`. ................................................................................................ .
`
`7
`
`The Artificial Trans Fat General Mills Added to Hamburger Helper Caused Breast,
`Prostate, and Colorectal Cancer. ........................................................................................... 7
`
`The Artificial Trans Fat General Mills Added to Hamburger Helper Caused
`Alzheimer's Disease and Cognitive De.cline ........................................................................ 8
`
`12
`
`F.
`
`The Artificial Trans Fat General Mills Added to Hamburger Helper Caused Organ
`Damage ................................................................................................................................. 9
`13
`PHO Use is Unlawful in California, the United States, and European Nations . ................ 10
`G.
`14 V.
`PLAINTIFF'S PURCHASES OF HAMBURGER HELPER ........................................................ 11
`15 VI.
`THE USE OF PHO IN HAMBURGER HELPER WAS UNFAIR. .............................................. 12
`16 VII. DEFENDANTS' PRACTICES WERE "UNLAWFUL" WITHIN THE MEANING OF
`THE CALIFORNIA UNFAIR COMPETITION LAW ................................................................. 14
`IN.TT.JR.Y ............................................................................. , ............................................................. 15
`
`17
`
`VTTT.
`
`21
`
`18
`
`19
`
`20
`
`A.
`
`B.
`
`C.
`
`Acbial, Present, Physical Tnjury .......................................................................................... 15
`
`Substantial and Measurable Increase in Risk of Disease and Early Death ......................... 16
`
`Economic Injury .................................................................................................................. 17
`
`IX.
`
`DELAYED DISCOVERY .............................................................................................................. 18
`
`ADDITIONAL TOLLING ALLEGATIONS ................................................................................. 19
`
`X.
`22 XI.
`CLASS ACTION ALLEGATIONS ............................................................................................... 19
`23 XII. PRAYER FOR RELIEF ................................................................................................................. 23
`24 XIII. NO JURY DEMAND ..................................................................................................................... 23
`
`25
`
`26
`
`27
`
`28
`
`CLASS ACTION COMPLAINT
`
`

`

`Case 3:22-cv-00403-DMS-JLB Document 1-2 Filed 03/28/22 PageID.13 Page 3 of 25
`
`1
`
`Plaintiff Loretta Schweinsburg, on behalf of herself, all others similarly situated, and the general
`
`2 public, by and through her undersigned counsel, hereby sues Defendants General Mills, Inc. and General
`
`3 Mills Sales, Inc. (collectively "General Mills" or "Defendants") and upon information and belief and
`
`4
`
`5
`
`6
`
`investigation of counsel, alleges as follows:
`
`I.
`
`JURISDICTION AND VENUE
`
`1.
`
`Jurisdiction is proper because Plaintiff is a citizen of California and because all claims are
`
`7 asserted under the laws of California and relate to a product that ic cold in California and was purchased
`
`8 by Plaintiff in California.
`
`9
`
`2.
`
`Venue is proper under Bus. & Prof. Code § 17203 because General Mills conducts
`
`10 continuous business in San Diego County and sold thousands of the product at issue in this county, and
`
`11 because thousands of class members reside in this county, who were harmed by the conduct of Defendants.
`
`12
`
`13
`
`II. NATURE OF THE ACTION
`
`3.
`
`General Mills manufactures, distributes, and sells Hamburger Helper, Tuna Helper, and
`
`l4 Chic.ken Helper (collectively "Hamburger Helper"), a line of packaged food products which contained
`
`15 partially hydrogenated oil ("PHO").
`
`16
`
`4.
`
`Artificial trans fat is a toxin and carcmogen for which there are many safe and
`
`l 7 commercially viable substitutes. During the Class Period, Defendants added artificial trans fat to
`
`18 Hamburger Helper in the form of partially hydrogenated oil ("PHO").
`
`19
`
`5.
`
`In orders ciateci November 8, 2013 and June 17, 2015, the FDA determined that PHO is
`
`20 unsafe for use in food. Tentative Determination Regarding Partially Hydrogenated Oils, 78 Fed. Reg.
`
`21 67169 (Nov. 8, 2013) and Final Determination Regarding Partially Hydrogenated Oils, 80 Fed. Reg.
`
`7.?. 146-'iO (.Tnne 17, :?.015). Yet Defendants continued to incorporate thic illegal, dangerous additive into
`
`23 Hamburger Helper, even after the FDA declared it unsafe for use in food.
`
`24
`
`6.
`
`Even before the FDA's two orders, however, PHO was an unlawful food additive under
`
`25 both California and federal law.
`
`26
`
`7.
`
`Although safe, low-cost, and commercially acceptable alternatives to PHO existed
`
`27
`
`throughout the Class Period, Defendants unfairly elected 1101 to use these safe alternatives in Hamburger
`
`28 Helper in order to increase profit at the expense of the health of consumers.
`
`CLASS ACTION COMPLAINT
`
`

`

`Case 3:22-cv-00403-DMS-JLB Document 1-2 Filed 03/28/22 PageID.14 Page 4 of 25
`
`l
`
`8.
`
`Plaintiff Loretta Schweinsburg repeatedly purchased Hamburger Helper from California
`.
`.
`
`2 grocery stores during the Class Period defined herein, for her personal and household consumption.
`
`3
`
`4
`
`9.
`
`This action is brought to remedy Defendants' unfair and unlawful conduct. On behalf of
`
`the class defined herein, Plaintiff seeks an order compelling Defendants to, inter alia: ( 1) award Plaintiff
`
`5 and the Class members restitution and (2) pay costs, expenses, and reasonable attorneys' fees.
`
`6
`
`7
`
`10.
`
`Defendants General Mills, Inc. and General Mills Sales, Inc. ("General Mills") are both
`
`III.
`
`PARTIES
`
`8 Delaware corporations headquartered in Minn·esota. Hamburger Helper is sold in stores throughout
`
`9 California.
`
`11.
`
`During the class period, General Mills owned, manufactured, distributed, and sold
`
`11 Hamburger Helper.
`
`12
`
`12.
`
`Plaintiff Loretta Schweinsburg is a citizen of California who repeatedly purchased
`
`13 Hamburger Helper from California groce1y stores during the class period for personal and household
`
`14 consumption.
`
`15
`
`16
`
`IV. NATURE OF TRANS FAT
`
`13,
`
`Artificial trans fat is manufactured via an industrial process called partial hydrogenation, in
`
`17 whid1 hydrogen atoms aJe added to nonual vegetable oil by heating the oil to temperatures above 400°F in
`
`18
`
`the presence of ion donor catalyst metals such as rhodinm, rnthenium, anci nir.ke:1. 1 The resulting prociuct
`
`19
`
`is known as partially hydrogenated oil, or PHO.
`
`20
`
`14.
`
`PHO was invented in 1901 and patented iii 1902 by German chemist Wilhelm Normann.
`
`21 PHO molecules chemically differ from the natural fat molecules in other food products.2
`
`22
`
`15.
`
`Natural fot, except the trace amount::; of natural trans fot from ruminant animal sources like
`
`23 beef, milk, and mutton, comes in two varieties: ( 1) fats that lack carbon double bonds ("saturated fat"); and
`
`24
`
`25
`
`27
`
`1 See Alice H. Lichtenstein, Trans Fatty Acids, Plasma Lipid Levels, and Risk of Developing
`26 Cardiovascular Disease, 95 CIRCULATION 2588, 2588-90 ( l 997).
`2 See Alberto Ascherio et al., Trans Fatty Acids & Corona,y Heart Disease, 340 NEW ENG. J. MED. 94, 94-
`8 (1999). See also Walter Willett, The Scientific Case/or Banning Trans Fats, SCIENTIFIC AMERICAN,
`28 available at www.scientificamerica11.com/article/the .. scientificNcase~for•banning~tra:nsufats/ (last visited
`February 18, 2022).
`
`2
`
`CLASS ACTION COMPLAINT
`
`

`

`Case 3:22-cv-00403-DMS-JLB Document 1-2 Filed 03/28/22 PageID.15 Page 5 of 25
`
`1
`
`(2) fats that have carbon double bonds. Trans fat, in contrast to cis fat, has carbon double bonds with
`
`2 hydrogen atoms on opposite sides of the carbon chain.
`
`3
`
`Sa!llratedfat
`
`: c;:i I I I I I I f I
`
`Cis fatty add
`
`Trans fatty add
`
`•
`
`•
`
`0
`l . . f COOHJ
`-
`l __
`41
`•
`e O Hydrogen atom • = Carbon atom
`
`e; Hydrogen atom e = Carbon atom
`
`e = Hyarogen alom e = Carbon atom
`
`6
`
`7
`
`16.
`
`PHO was initiaHy a "wonder product" attractive to the processed food industry because it
`
`8 combined the low cost of unsaturated cis fat with the flexibility and long shelf life of saturated fat. Like
`
`9 processed cis fat, PHO is manufactured from low-cost legumes,3 while saturated fat is derived from
`
`1 O relatively expensive animal and tropical plant sources.4
`
`11
`
`17.
`
`As detailed herein, PHO causes cardiovascular disease, diabetes, cancer, and Alzheimer's
`
`12 disease, and accelerates memory damage and cognitive decline. These risks were well known during the
`
`13
`
`14
`
`15
`
`entire Class Period, and at no point during the Class Period was there ever a consensus that PHO was safe
`
`to use, neither in general nor as an ingredient in packaged food products.
`
`18.
`
`Jn using PHO in Hamburger Helper, Defendants failed to submit a food additive petition
`
`16 and failed to undertake a GRAS self-determination.
`
`17
`
`18
`
`A. There Is a Well-Established Scientific Consensus That Trans Fat Is Extremely Harmful.
`
`19.
`
`The National Academies of Science were charted by an act of Congress, signed by President
`
`19 Lincoln in 1863. Under that charter, in 1970, the National Academy of Medicine was created. In a 2005
`
`20
`
`report, under its former name of the Institute of Medicine, it·concluded there was "no safe level" of PHO
`
`21 or artificial trans fat intake. 5 Therefore, in 2005, there was no consensus that PHO was a safe ingredient to
`
`22 use in food. To the contrary, the consensus was that it is unsafe.
`
`23
`
`24
`
`25
`
`26
`
`27
`
`28
`
`20.
`
`In addition, "trans fatty acids are not essential and provide no known benefit to human
`
`3 e.g., corn oil, cottonseed oil, soybean oil, peanut oil
`
`4 e.g., butter, cream, tallow, palm oil, coconut oil
`
`5 Food&. Nutrition Bd., Inst. of Med., Dietary Reference Intakes For Energy, Carbohydrate, Fiber, Fat,
`Fatty Acid~·, Cholesterol, Protein, and Amino Acids (2005).
`3
`
`CLASS ACTION COMPLAINT
`
`

`

`Case 3:22-cv-00403-DMS-JLB Document 1-2 Filed 03/28/22 PageID.16 Page 6 of 25
`
`health."6 Thus, while IOM provided safe maximum levels for other food elements like saturated fat, in
`
`2 could not and declined to provide one for trans fat when requested by the FDA, the reason being that "any
`
`3
`
`4
`
`incremental increase in trans fatty acid intake increases the risk of CHO." id. ( emphasis added).
`
`21.
`
`In 2006, Dariush Mozaffarian of Harvard Medical School wrote in the New England Journal
`
`5 of Medicine, "the consumption of trans fatty acids results in considerable potential harm but no apparent
`
`6 benefit. "7
`
`22.
`
`Julie Louise Gerberding, who served eight years as the head of the United States Centers
`
`for Disease Control and Prevention, wrote in 2009:
`
`The scientific rationale fbr eliminating exposure to artificial trans fatty acids in foods is rock
`solid. There is no evidence that they provide any health benefit, and they ai-e certainly harmful.
`These compounds advers~ly affect both low- and high-density lipoprotein cholesterol levels
`and increase the risk for coronary heart disease, even at relatively low levels of dietary intake.
`Gram for gram, trans fats are far more potent than saturated fats in increasing the risk for herut
`disease, perhaps because they also have pro-inflammatory properties and other adverse effects
`on vascular endothelium ... Eliminating exposure to these dru1gerous fats could have a powerful
`population impact-potentially prot~cting 30,000 to I 00,000 Americans from death related to
`heart disease each year. 8
`·
`
`23.
`
`Dr. Mozaffarian further writes:
`
`Given the adverse effects of trans fatty acids on serum lipid levels, systemic inflammation, and
`possibly other risk factors for cardiova_scular disease_ and the positive associations with the risk
`of CHD, sudden death from cardiac causes, and possibly diabetes, the potential for harm is
`clear. The evidence and the magnitude of adverse health effects of trans fatty acids are in fact
`far stronger on average than those of food contaminants or pes_ticide residues, which have in
`some cases received considerable attention. 9
`
`24.
`
`Tn ?.011, Walter Willet, also a professor at Harvard Medical School, described Defendants'
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`6 .FMd Labeling; Health Claim; Phytosterots· and Risk of Coronary Heart Disease,· Proposed Rule, 75 f.cd.
`Reg. 76526, 76542 (Dec. 8, 2010).
`·
`25
`7 Dariush Mozaffarian et al., Trans Fatty Acids and Cardio·vascular Disease, 354 N. ENGL. J. MED: 1601,
`26. 1608-1609 (2006).
`8 Julie Louise Gerberding, Safer Fats for HP.~lth;er Hearts: The Case for Eliminating Dietary Arttficial
`27 Trans Fat Intake, 151 ANN.INTERN.MED.137-138(2009).
`9 Dariush Mozaffarian et al., Trans Fatty Acids and Cardiovascular Disease, 354 N. ENGL. J. MED. 1601
`28
`(2006).
`
`4
`
`CLASS ACTION COMPLAINT
`
`

`

`Case 3:22-cv-00403-DMS-JLB Document 1-2 Filed 03/28/22 PageID.17 Page 7 of 25
`
`1 behavior of selling food made with PHO as "a food safety issue ... this is actually contamination." 10
`
`2
`
`25.
`
`The views of t~ese experts, and many others, show that, even before the FDA formally
`
`3 declared PHO to be unsafe for use in food in 2015, its use was still unlawful because there was not a
`
`4 consensus of scientific experts that PHO was a safe food additive.
`
`5
`
`6
`
`7
`
`B. The Artificial Trans Fat General Mills Added to Hamburger Helper Caused Cardiovascular
`
`Disease.
`
`26.
`
`Trans fat raises the risk of CHD more than any other known consumed substance. 11
`
`27.
`
`A I 999 estimate published in the New England Journal of Medicine found that removing
`
`8
`9 PHO fiuw Llit American diet ''would prevent approximately 30,000 premature coronary deaths per year,
`10 and epidemiologic evidence suggests this number is closer to 100,000 premature deaths annually." 12
`Dy raising LDL levels and lowering .HDL levels, trans fat causcG a wide variety of dangerous
`
`28.
`
`11
`12 heart conditions, including vasoconstriction, coronary artery disease, and primary cardiac arrest.
`In a 2005 joint Dietary Guidelines Advisory Committee Report, the Department of Health
`
`29.
`
`13
`14 and Human Services an<l the U.S. Department of Agriculture recognized that "[t]he relationship between
`trans fatty acid intake and LDL cholesterol is direct and progressive, increasing the riok of cardiovascular
`
`15
`
`disease." 13
`
`16
`
`30.
`
`The American Heart Association warns, "trans fats raise your bad (LDL) cholesterol levels
`
`17
`18 and lower your good (HDL) cholesterol levels. Eating trans fats increases your risk of developing heart
`
`disease." 14
`
`31.
`
`Even further back, in 2003, a review of literature on the connection between the
`
`consumption of artificial trans fat and coronary heart disease, the FDA concluded:
`
`[B]ased on the consistent results across a number of the most persuasive types of study designs
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`26
`
`10 Rebecca Coombes, Trans fats: chasing a global ban, 343 BRITISH MED. J. (2011 ).
`11 Mozaffarian, 354 NEW ENG. J. MED. at 1603.
`12 Alberto Ascherio et al., Trans Fatty Acids & Coronary Heart Disease, 340 NEW ENG. J. MED. 94, 94-8
`(1999).
`13 Dcp't ofliealth & Human Scrv. & U.S. Dcp't of Agric., 2005 Dietary Guidelines Advif:ory Committee
`27 Report, Section 10 (2005).
`
`28
`
`14 Am. Heart Ass'n., Trans Fats, available at https://www.heart.org/en/healthy--living/healthy-eating/eat(cid:173)
`smart/fats/trans-fat (Jast visited February 15, 2022).
`
`5
`
`CLASS ACTION COMPLAINT
`
`

`

`Case 3:22-cv-00403-DMS-JLB Document 1-2 Filed 03/28/22 PageID.18 Page 8 of 25
`
`1
`
`2
`
`3
`
`4
`
`(i.e., intervention trials and prospective cohort studies) that were conducted using a range of
`test conditions and across different geographical regions and populations . . . the available
`evidence for an adverse relationship between trans fat intake and CHD risk is strong. 15
`
`32.
`
`The FDA concluded in 20 IO that "there have been no reports issued by authoritative sources
`
`that provide a level of trans fat in the diet ... below which there is no risk of [Coronary Heart Disease]."
`
`5 75 Fed. Reg. 76526, 76542 (Dec. 8, 20 I 0). Rather, there "ia a poaitive linear trend between trana fatty acid
`6
`
`intake and L.DL cholesterol concentration, and therefore ther~ is a positive relationship between trans fatty
`
`7 acid intake and the risk of CHD." Id.
`8
`
`33.
`
`A study publis~ed in American Heart Association's Circulation found that the largest
`
`9 consumers of trans fat have t.hf:ee times the risk of suffering primary cardiac arrest, even after controlling
`
`1 O for a variety of medical and lifestyle risk factors. 16
`11
`
`Australian researchers observed that heart attack patients possess elevated amounta of tram,
`
`12
`
`13
`
`14
`
`fat in their adipose tissue (stored body fat) compared to controls. The effects of consuming trans fat ate
`
`therefore shown to be long-lived because of its ·storage within the body in place of natural fats. 17
`
`35.
`
`Cholesterol dysregulation and systemic inflammation/immw1e system dysregulation are the
`
`15 most important pathways through which PHO consumption causes morbidity and death. Another route fr,
`
`16 by promoting atherosclerosis by degrading the function of TG-F-13, a protein responsible for preventing the
`
`17 development of atherosclerotic lesions. 18
`18
`
`36.
`
`TGF-~ also functions to suppress cancerous tumors. Degradation ofTGF-J3 function is also
`
`19
`
`likely one route by which artificial trans fat consumption promotes cancers in fatty organs and the digestive
`
`20 system. Id.
`21
`
`22
`
`23
`
`24
`
`25
`
`26
`
`28
`
`15 FDA, Final Rule, 68 Fed. Reg. 41433; 41445 (July I I, 2003).
`16 Rozenn N. Lemaitre et al., Cell Membrane Trans-Fattj, Acids'andthe Risk of Prima,y Cardiac ~rrest,
`I 05 CIRCULATION 697, 697-701 (20q~)-
`.
`17 Peter M. Clifton et al., Trans Fat1y Acids In Adipose Tissue And The Food ,')'upply Are Associated With
`27 Myocardial Infarction. 134 J. NUTR. 874, 874-79 (2004).
`18 Chen, C.L. ot al., A mechanism by which diatary trans fats cause atherosolarosis, J. NUTll. BIOCII13MIE:TllY
`22(7) 649-655(2011).
`
`6
`
`CLASS ACTION COMPLAINT
`
`

`

`Case 3:22-cv-00403-DMS-JLB Document 1-2 Filed 03/28/22 PageID.19 Page 9 of 25
`
`C. The Artificial Trans Fat General Mills Added to Hamburger Helper Caused Type-2
`
`Diabetes.
`
`37.
`
`38.
`
`Artificial trans fat also causes type-2 diabetes. 19
`
`In particular, trans fat disrupts the body's glucose and insulin regulation system by
`
`incorporating itself into cell membranes, causing the insulin receptors on cell walls to misform and
`
`2
`
`3
`
`4
`
`5
`
`6 malfunction, and in tum elevating blood glucose levels and stimulating further release of insulin.
`
`39.
`
`Researchers at Northwestern University's medical school found that mice show multiple
`
`7
`8 markers of type-2 diabetes after eating PHO for only four weeks.20
`
`40.
`By the eighth week of _the study, mice fed the high trans fat diet showed a 500% increase
`9
`10 compared to the control group in hepatic interleukin- Ip gene expression, one such marker of diabetes,
`indicating the extreme stress even short-term exposure to artificial trans fat places on the body. Id.
`
`11
`
`41.
`
`A 14-year study of 84,204 women found that for every 2 percent increase in energy intake
`
`from artificial trans fat, the relative risk of type-2 diabetes was increased by 39 percent.21
`
`D. The Artificial Trans· Fat General Mills Added to Hamburger Helper Caused Breast,
`
`Prostate, and Colorectal Cancer.
`
`42.
`
`43.
`
`Trans fat is a carcinogen which causes breast, prostate, and colorectal cancer.
`
`A 13-year study of 19,934 French women sho\ved 75 percent more women contracted breast
`
`cancer in the highest quintiie of trans fat consumption than did those in the lowest. 22
`
`44.
`
`·Ina 25-year study of 14,916 American physicians; those in the highest quintile of trans fat
`
`consumption had more than double the risk of developing prostate cancer than the doctors in the lowest
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`24
`
`19 Am. Heart Ass'n., Trans Fats, available at https://www.heart.org/en/healthy-living/healthy-eating/eat-
`smart/fats/trans-fat (last visited February 15, 2022).
`20 Sean W. P. Koppe et al., Trans fat feeding results in higher serum alanine aminotransferase and
`25
`increased insulin resistance compared with a standard murine high-fat diet, 297 AM. J. PHYSIOL.
`26 GASTROINTEST LIVER PHYSIOL. 3 78 (2009).
`21 Jorge Salmeron et al., Dieta,y Fat Intake and Risk of Type 2 Diabetes in Women, 73 AM. J. CLINICAL
`27 NUTRITION 1019, 1023 (2001).
`
`28
`
`22 Veronique Chajes et al., Association betv.>een Serum Trans-Mo11ounsaturatcd Fatty Acids and Breast
`Cancer Risk in the E3N-EPIC Study. 167 AM. J. EPIDEMIOLOGY 1312, 1316 (2008).
`7
`
`CLASS ACTION COMPLAINT
`
`

`

`Case 3:22-cv-00403-DMS-JLB Document 1-2 Filed 03/28/22 PageID.20 Page 10 of 25
`
`1 quintile. 23
`
`2
`
`3
`
`45.
`
`A study of 1,012 American males observing trans fat intake and the risk of prostate cancer
`
`found "[c]ompared with the lowest quartile of total trans-fatty acid consumption, the higher quartiles gave
`
`4 odds ratios (ORs) equal to 1.58," meaning those in the highest quartile are 58% more likely to contract
`
`5 prostate cancer than those in the lowest. 24
`
`6
`
`7
`
`8
`
`46.
`
`A 600-person study found an 86 percent greater risk of colorectal cancer in the highest trans
`
`fat consumption quartile. 25
`
`47.
`
`A 2,910-person study found "trans-monounsaturated fatty acids ... were dose-dependently
`
`9 associated with colorectal cancer risk," which showed "the importance of type of fat in the etiology and
`
`10 prevention of colorectal cancer."26
`
`11
`
`12
`
`13
`
`E. The Artificial Trans Fat General Mills Added to Hamburger Helper Caused Alzheimer's
`
`Disease and Cognitive Decline.
`
`48.
`
`Trans fat causes Alzheimer's disease and cognitive decline.
`
`49.
`
`In a study examining 815 Chicago area seniors, researchers found "increased risk of incident
`
`14
`15 Alzheimer disease among persons with high intakes of .... trans-unsaturated fats. "27
`50.
`The study "observed a strong increased risk of Alzheimer disease with consumption of
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`.. - ........
`
`- - 26
`
`27
`
`28
`
`trans-unsaturated fat." Id.
`
`51.
`
`In a study of 1,486 women with type-2 diabetes, researchers found "[h]igber intakes of. ..
`
`trans fat since midlife ... were [] highly associated with worse cognitive decline .... "28
`
`23 Jorge Chavarro et al., A Prm,]Jective Study<~{ Blood Traos Fatty Acid Levels and Risk of Prostate Cancer.
`47 PROC. AM. Assoc. CANCER RESEARCH 95, 99 (2006).
`
`24 Xin Liu et al., Trans-Fatty Acid Intake and Increased Risk of Advanced Prostate Cancer: Modification
`by RNASEL R462Q Variant, 28 CARCINOGENESIS 1232, 1232 (2007).
`
`25 L.C. Vinikoor et al., Consumption of Trans-Fatty Acid and its Association with Colorectal Adenomas,
`168 AM. J. EPIDEMIOLOGY 289,294 (2008).
`
`26 Evropi Theodoratou et al., Dietary Fatty Acids and Colorectal Cancer: A Case-Control Study, 166 AM.
`J. EPIDEMIOLOG_Y 1_§!(2007) .... __ . _ . __ . _.
`. ~. -- ~
`-··
`-- ·· · -- · -- - -
`·
`
`27 Martha Clare Morris et al., Dieta,y Fats and the Risk of Incident Alzheimer Disease, 60 ARCH. NEUROL.
`194, 198-99 (2003).
`
`28 Elizabeth E. Devore et al., Dietary Fat Intake and Cogniitve Decline in Women with Type 2 Diabetes,
`32 DIABETES CARE 635 (2009).
`
`8
`
`CLA_SS AqlON COMPLAINT
`
`

`

`Case 3:22-cv-00403-DMS-JLB Document 1-2 Filed 03/28/22 PageID.21 Page 11 of 25
`
`1
`
`52.
`
`The study cautioned "[ d]ietary fat intake can alter glucose and lipid metabolism and is
`
`2
`
`related to cardiovascular disease risk in individuals with type 2 diabetes. Because insulin, cholesterol, and
`
`3 vascular disease all appear to play important roles in brain aging and cognitive impairments, dietary fat
`
`4 modification may be a particularly effective strategy for preventing cognitive decline, especially in
`
`5
`
`individuals with diabetes." Id (citations omitted).
`
`6
`
`53_
`
`Artificial trans fat also damages the brains of those who consume it. A study conducted by
`
`7 UCSD School of Medicine of 1,018 men, mostly younger men, found trans fat consumption to be strongly
`
`8 correlated with impaired memory.29 The authors of the study, appearing in Circulation, the American Heart
`
`9 Association's peer-reviewed journal, conclude that "[gr]eater dTFA [dietary trans fatty acid] was
`
`10
`
`significantly associated with worse word memory in adults aged 20-45 years, often critical years for career
`
`11 building."
`
`12
`
`54.
`
`Performing a word memory test, each additional gram per day of trans fat consumed was
`
`13 associated with 0.76 fewer words correctly recalled. The authors suggest trans fat's well-established pro-
`
`14 oxidant effect and its damage to cell energy processes is the pathway by which trans fat consumption
`
`15 damages memory ability. The young men with the highest traris fat consumption scored 12 fewer recalled
`
`16 words on the 104-word test. /di
`
`17
`
`18
`
`F. The Artificial Trans Fat General Mills Added to Hamburger Helper Caused Organ Damage.
`
`55_
`
`Artificial trans fat molecules are readily incorporated into blood and organ cells in place of
`
`19 natural fat molecules, which damages vital organs, including the heart, brain, and reproductive system.
`
`20
`
`21
`
`56_
`The uptake of chemically distinct trans fat into cells induces systemic inflammation, where
`the immune system fails to recognize the distorted cells as native to the body and becomes persistently
`
`22 overactive, leading to further organ damage. 30
`
`23
`
`24
`
`25
`
`29 Golomb, B. et aL, Trans Fat Consumption is Adversely Linked to Memory in Working-Age Adult~,
`CIRCULATION. 130:Al5572 (2014).
`-- ..... -- -- - -· - .. -- ______ ..,, -· --- ......... -
`27 Lopez-Garcia et al., Consumption of Trans Fat is Related to Plasma Markers of Inflammation and
`Endothelial Dysfunction, 135 J. NUTR. 562-66 (2005);
`
`28
`
`9
`
`CLASS ACTION COMPLAINT
`
`

`

`Case 3:22-cv-00403-DMS-JLB Document 1-2 Filed 03/28/22 PageID.22 Page 12 of 25
`
`1
`
`2
`
`57.
`
`58.
`
`Trans fat "intake increases systemic inflammation in generally healthy persons."31
`
`Such inducers of inflammation "alter the functionality of tissues and organs and leads to
`
`3 harmful induction of different barrier systems in the body" including "the blood-brain barrier, the blood-
`
`4
`
`retinal barrier, blood-nerve barrier, blood-lymph barrier and the blood-cerebrospinal fluid barrier."32
`
`This industrially produced artificial tram: fat "intake increa::;c::; the risk of cardiovascular
`
`6 disease (CVD) and type 2 diabetes as seen in large prospective cohort studies."33
`
`7
`
`8
`
`9
`
`10
`
`60.
`
`The inflammation it causes "leads to a wide range of tissue injuries and human diseases
`
`including cardiovascular diseases, diabetes, and multi-organ failure. " 34
`
`61.
`
`62.
`
`Further, trans fat_ conswnption "contribute[s] to and aggravate[s] atherosclerotic lesions."35
`
`Such "chronic low-grade systemic inflammation" also induces "DNA damage" and is one
`
`11
`
`"explanation for the relationship between chronic systemic inflammation and cancer. "36
`
`G. PHO Use is Unlawful in California, the United States, and European Nations.
`
`63.
`
`64.
`
`New York City banned trans fat in restaurants in 2006.
`
`A 2004 Danish law restricted all foods to fewer than 2 percent of calories from artificial
`
`12
`
`13
`
`14
`
`15
`
`Baer et al., Dietary fatty acids affect plasma markers of inflammation in healthy men fed controlled diets;
`16 a randomized crossover study, :19 AM. J. CUN. NUTR. 969-73 (2004t
`17 Mozaffarian & Clarke, Quantitative effects 011 cardiovascular risk factors and coronary heart disease risk
`of replacing partially hydrogenated vegetable oils with other fats and oils, 63 EURO. J. CLIN. NUTR. S22-
`18 33 (2009);
`
`20
`
`19 Mozaffari;m P.t al, Trnns Fatty acids and systemic inflammation in heartfailura, 80 AM. J. CUN. NUTR.
`1521-25 (2004).
`31 Mozaffarian, Trans Fatty acids and systemic inflammation in heart failure, 80 AM. J. CLIN. NuTR. 1521-
`25 (2004).
`32 Ronnback and Hansson, The Importance and Control of Low Grade Inflammation Due to Damage of the
`Cellular Barrier Systems that May Lead to Systemic Inflammation, 10 FRONTIERS IN NEUROLOGY 1-8
`(2019).
`33 Bendsen, Stender, Effect of industrially produr.P.d trans fat on- markers of systemic inflammation:
`evidence.from a randomized trial in women, 52 J. OF LIPID RESEARCH 1821-28 (2011).
`
`21
`
`22
`
`23
`
`24
`
`34 Glaros, Larsen, Macrophages and fibroblasts during in.fl.ammation, tissue damage and organ injury, 14
`25
`26 FRONTIERS IN BIOSCIENCE 3988-3993 (2009).
`35 Hadj, Correlation of trans fatty acids with the severity of coronary artery, disease lesions, 17 LIPIDS IN
`(
`HEALTH AND DISEASE 1-13 2018).
`
`27
`
`28
`
`36 Arimura, Ken et al., Chronic low-grade systemic inflammation causes DNA damage in the lungs of mice,
`190 LUNG 613-20 (2012).
`
`CLASS ACTION COMPLAINT
`
`

`

`Case 3:22-cv-00403-DMS-JLB Document 1-2 Filed 03/28/22 PageID.23 Page 13 of 25
`
`1
`
`trans fat, a test that Hamburger Helper did not meet during the Class Period.
`
`2
`
`3
`
`65.
`
`66.
`
`Switzerland passed the same restriction in 2008. 37
`
`A study of Denmark's 2004 trans fat ban concluded it "did not appreciably affect the quality,
`
`4 cost or availability of food" and did not have "any noticeable effect for the consumers."38
`
`5
`
`67.
`
`These laws were all motivated by the strong evidence trans fat is dangerous, showing that
`
`6 during the Class Period, there was not a scientific consensus that PHO was a safe food additive.
`
`7
`
`68.
`
`On June 17, 2015, the FDA released a declaratory order which it called its Final
`
`8 Determination Regarding Partially Hydrogenated Oils, finding that "PHOs arc not GRAS for any use in
`
`9 human food." 80 Fed. Reg. 34650, 34651 (June 17, 2015) ("Final Detennination").
`
`The FDA 's Final Determinati01i noted that "if there are data and information that
`
`69.
`11 demonstrates to a reasonable certainty that no haim will result from a specific use of a PHO in food, that
`12
`
`infom1ation could be submitted as part of a food additive petitioi1 to FDA seeking issuance of a regulation
`
`13
`
`to presc