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`R. Brent Wisner (SBN: 276023)
`rbwisner@baumhedlundlaw.com
`Pedram Esfandiary (SBN 312569)
`pesfandiary@baumhedlundlaw.com
`BAUM, HEDLUND, ARISTEI & GOLDMAN, P.C.
`10940 Wilshire Blvd., 17th Floor
`Los Angeles, CA 90024
`Tel: (310) 207-3233
`Fax: (310) 820-7444
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`Attorneys for Plaintiff
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`
`UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF CALIFORNIA
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` Case No.
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`COMPLAINT
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`DEMAND FOR JURY TRIAL
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`AG; HG; and XG, individually and
`represented by their mother and guardian ad
`litem VALENCIA GIBSON,
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`Plaintiffs,
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`PLUM, PBC; HAIN CELESTIAL GROUP,
`INC.; GERBER PRODUCTS COMPANY;
`NURTURE, INC; BEECH-NUT
`NUTRITION COMPANY; AND SPROUT
`FOODS INC.,
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`Defendants.
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`COMPLAINT
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`Case 3:21-cv-01600-LB Document 1 Filed 03/05/21 Page 2 of 50
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`TABLE OF CONTENTS
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`Page
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`TABLE OF CONTENTS ........................................................................................................................ 2
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`INTRODUCTION .................................................................................................................................. 4
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`PARTIES ................................................................................................................................................ 5
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`I.
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`II.
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`Plaintiffs .......................................................................................................................... 5
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`Defendants ...................................................................................................................... 5
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`JURISDICTION AND VENUE ............................................................................................................. 7
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`FACTUAL ALLEGATIONS ................................................................................................................. 8
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`I.
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`II.
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`Rising Concerns Regarding the Presence of Toxic Heavy Metals in Baby Foods ......... 8
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`Congressional Investigation Finds Substantial Presence of Heavy Metals in Baby
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`Foods Sparking National Outrage ................................................................................... 9
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`III.
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`Pediatric ASD ............................................................................................................... 16
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`IV.
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`Dangers of Toxic Heavy Metals to Babies and Children ............................................. 17
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`A.
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`Exposure to Toxic Heavy Metals Has Been Consistently Associated with
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`Autism in Pediatric Populations........................................................................ 19
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`V.
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`Defendants Knowingly Sold Baby Foods Containing Dangerous Levels of Toxic
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`Heavy Metals and Knew or Should Have Known of the Risks of Such Exposures in
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`Children......................................................................................................................... 22
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`A.
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`B.
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`C.
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`D.
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`E.
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`Nurture .............................................................................................................. 24
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`Hain ................................................................................................................... 26
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`Beech-Nut ......................................................................................................... 29
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`Gerber ............................................................................................................... 31
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`Plum and Sprout ................................................................................................ 31
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`VI.
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`Exemplary / Punitive Damages Allegations ................................................................. 33
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`PLAINTIFF-SPECIFIC ALLEGATIONS ........................................................................................... 34
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`CAUSES OF ACTION ......................................................................................................................... 34
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`COUNT I: STRICT PRODUCTS LIABILITY – FAILURE TO WARN .............................. 34
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`COUNT II: STRICT PRODUCTS LIABILITY – DESIGN DEFECT .................................... 38
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`COUNT III: STRICT PRODUCTS LIABILITY – MANUFACTURING DEFECT .............. 40
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`COUNT IV: NEGLIGENCE – FAILURE TO WARN ............................................................ 42
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`COUNT V: NEGLIGENT PRODUCT DESIGN ..................................................................... 45
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`COUNT VI: NEGLIGENT MANUFACTURING ................................................................... 47
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`COUNT VII: NEGLIGENT MISREPRESENTATION .......................................................... 48
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`JURY TRIAL DEMAND ..................................................................................................................... 50
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`PRAYER FOR RELIEF ....................................................................................................................... 50
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`COMPLAINT
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`Case 3:21-cv-01600-LB Document 1 Filed 03/05/21 Page 4 of 50
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`INTRODUCTION
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`1.
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`This case involves a group of manufacturers—namely Plum, PBC; Hain Celestial
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`Group, Inc.; Gerber Products Company; Nurture, Inc; Beech-Nut Nutrition Company; and Sprout
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`Foods Inc. (“Defendants” or “Defendant Baby Food Manufacturers”)—that knowingly sold baby food
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`products (“Baby Foods”) which contain dangerous levels of toxic heavy metals—mercury, lead,
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`arsenic, and cadmium (collectively “Toxic Heavy Metals”), which are all known to be severe
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`neurotoxins—and how such toxic exposures substantially contributed to Plaintiffs developing
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`lifelong brain damage and neurodevelopmental disorders. Plaintiffs AG, HG, and XG (“Plaintiffs”)
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`are three small siblings who live with debilitating Autism Spectrum Disorder (“ASD”) because they
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`consumed poisonous Baby Foods manufactured and sold by these Defendants. This case seeks to
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`hold the Defendant Baby Food Manufacturers accountable for their reprehensible conduct and ensure
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`they are punished for permanently affecting Plaintiffs’ ability to live a fulfilling life.
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`2.
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`That Defendants’ Baby Foods are laced with staggering amounts of Toxic Heavy
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`Metals recently made headlines following research and a Congressional investigation. In February
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`2021, the U.S. House of Representatives’ Subcommittee on Economic and Consumer Policy,
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`Committee on Oversight and Reform released a report containing shocking details of Defendants’
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`tainted Baby Foods based on the submission of internal test results and company documents.
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`Specifically, the Subcommittee found that Defendants sell Baby Foods containing as much as 180
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`parts per billion (“ppb”)1 inorganic arsenic, 6441 ppb lead, 10 ppb mercury, and manufacture their
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`Baby Foods using ingredients containing as much as 913.4 ppb arsenic, 886.9 ppb lead, and 344.55
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`ppb cadmium, far eclipsing domestic and international regulatory standards. By way of comparison,
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`the U.S. Food and Drug Administration (“FDA”) has set the maximum allowable levels in bottled
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`water at 10 ppb inorganic arsenic, 5 ppb lead, and 5 ppb cadmium, and the U.S. Environmental
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`Protection Agency (“EPA”) has capped the allowable level of mercury in drinking water at 2 ppb.
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`1 Ppb (or ppbm) is used to measure the concentration of a contaminant in soils, sediments, and water.
`1 ppb equals 1 µg (microgram) of substance per kg of solid (µg/kg). For the average baby weighing
`approximately 3kg, the quantities of Toxic Heavy Metals found in Defendants’ Baby Foods, as
`explained below, pose significant health risks.
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`4
`COMPLAINT
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`Case 3:21-cv-01600-LB Document 1 Filed 03/05/21 Page 5 of 50
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`With a chilling note the Subcommittee concluded that “[m]anufacturers knowingly sell these products
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`to unsuspecting parents, in spite of internal company standards and test results, and without any
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`warning labeling whatsoever.”2 (emphasis added).
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`3.
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`The high levels of Toxic Heavy Metals found in Defendants’ Baby Foods are, in part,
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`a function of the ingredients used by Defendants to manufacture their Baby Foods, the setting of
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`dangerously inflated internal limits which Defendants willingly flouted, disregard of regulatory
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`standards, and corporate policies which failed to test finished products before market distribution,
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`purchase by unknowing parents, and consumption by vulnerable infants.
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`4.
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`Defendants’ malicious recklessness and callous disregard for human life has wreaked
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`havoc on the health of countless vulnerable children, all so that Defendants could maximize profits
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`while deliberately misleading parents regarding the safety of their Baby Foods. Accordingly, this
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`lawsuit will not only ensure that Plaintiffs are duly compensated for their tragic injuries and
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`Defendants punished, but that future generations are protected from the poisonous products that
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`Defendants pander as “food”.
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`I.
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`Plaintiffs
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`PARTIES
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`5.
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`Plaintiffs are citizens of Arizona and no other state.
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`II.
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`Defendants
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`6.
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`Defendant Plum, PBC (“Plum”) is a citizen of Delaware and California with its
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`principal place of business located at 1485 Park Avenue, Suite 200, Emeryville, California. Plum
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`sells Baby Foods under the brand name Plum Organics. Plum’s products are divided into groups
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`according to the targeted infant or toddler age and/or type of food product. For example, there are
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`five groups designated for the youngest infants: Stage 1 (4+ months old), Stage 2 (6+ months old),
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`2 Staff Report, Subcommittee on Economic and Consumer Policy Committee on Oversight and
`Reform U.S. House of Representatives, Baby Foods Are Tainted with Dangerous Levels of
`Arsenic, Lead, Cadmium, and Mercury (Feb. 4, 2021) (“Subcommittee Report”) at 59, available at:
`https://oversight.house.gov/sites/democrats.oversight.house.gov/files/2021-02-
`04%20ECP%20Baby%20Food%20Staff%20Report.pdf.
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`COMPLAINT
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`Case 3:21-cv-01600-LB Document 1 Filed 03/05/21 Page 6 of 50
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`Stage 3 (6+ months old), “Super Puffs”, and “Little Teethers”. At all relevant times, Plum has
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`conducted business and derived substantial revenue from its manufacturing, advertising, distributing,
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`selling, and marketing of Baby Foods within this judicial district.
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`7.
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`Defendant Nurture, Inc (“Nurture”), is a citizen of Delaware and New York with its
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`principal place of business located at 40 Fulton St, 17th Floor, New York, NY 10038-1850. Nurture
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`owns Happy Family Brands (including Happy Family Organics) and sells Baby Foods under the
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`brand name HappyBaby. Nurture classifies its HappyBaby range of products according to three
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`categories: “baby”, “tot”, and “mama”. The “baby” category is comprised of foods, including
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`“starting solids”, intended for age groups 0-7+ months, the “tot” category covers 12+ months, and
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`“mama” includes infant formulas for newborn babies. At all relevant times, Nurture has conducted
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`business and derived substantial revenue from its manufacturing, advertising, distributing, selling,
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`and marketing of HappyBaby within this judicial district.
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`8.
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`Defendant Beech-Nut Nutrition Company (“Beech-Nut”) is a citizen of Delaware and
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`New York with its principal place of business located at 1 Nutritious Pl., Amsterdam, NY 12010.
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`Beech-Nut sells Baby Foods under the brand name Beech-Nut. Beech-Nut produces Baby Foods
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`aimed at infants 4+ months up to 12+ months and includes a variety of cereals, “jars”, and “pouches”
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`for these age groups. At all relevant times, Beech-Nut has conducted business and derived substantial
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`revenue from its manufacturing, advertising, distributing, selling, and marketing of Baby Foods
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`within this judicial district.
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`9.
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`Defendant Hain Celestial Group, Inc. (“Hain”) is a citizen of Delaware and New York
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`with its principal place of business located at 1111 Marcus Ave., Lake Success, NY 11042. Hain sells
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`Baby Foods under the brand name “Earth’s Best Organics”. Hain offers infant and baby formula and
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`foods as well as toddler foods covering products from “organic infant cereal” to “organic snacks for
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`toddlers and kids on the go”. At all relevant times, Hain has conducted business and derived
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`substantial revenue from its manufacturing, advertising, distributing, selling, and marketing of Baby
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`Foods within this judicial district.
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`10.
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`Defendant Gerber Products Company (“Gerber”) is a citizen of Michigan with its
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`principal place of business located at 445 State Street, Fremont, MI 49413-0001. Gerber sells Baby
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`COMPLAINT
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`Foods under the brand name Gerber. Gerber organizes its products into broad categories of
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`“formula”, “baby cereal”, “baby food”, “snacks”, “meals & sides” “beverages” and “organic”. At all
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`relevant times, Gerber has conducted business and derived substantial revenue from its
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`manufacturing, advertising, distributing, selling, and marketing of Baby Foods within this judicial
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`district.
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`Defendant Sprout Foods, Inc. (“Sprout”) is a citizen of Delaware and New Jersey with
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`its principal place of business located at 50 Chestnut Ridge Rd, Montvale, NJ 07645. Sprout sells
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`Baby Foods under the brand name Sprout Organic Foods. Sprout organizes its Baby Foods selection
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`according to three categories: Stage 2 (6 months+); Stage 3 (8 months+); and Toddler. At all relevant
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`times, Sprout has conducted business and derived substantial revenue from its manufacturing,
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`advertising, distributing, selling, and marketing of Baby Foods within this judicial district.
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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. There is
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`complete diversity of citizenship between the parties. In addition, Plaintiffs seek damages in excess
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`of $75,000, exclusive of interest and costs.
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`13.
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`This Court has personal jurisdiction over Plum because Plum is a citizen of the State
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`of California and resides within this judicial district. The Court has personal jurisdiction over Hain,
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`Nurture, Gerber, Beech-Nut, and Sprout insofar as each Defendant is authorized and licensed to
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`conduct business in the State of California, maintains and carries on systematic and continuous
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`contacts in this judicial district, regularly transacts business within this judicial district, and regularly
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`avails itself of the benefits of this judicial district.
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`14.
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`Additionally, Defendants caused tortious injury by acts and omissions in this judicial
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`district and caused tortious injury in this district by acts and omissions outside this jurisdiction while
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`regularly doing and soliciting business, engaging in a persistent course of conduct, and deriving
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`substantial revenue from goods used or consumed and services rendered in this judicial district.
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`15.
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` Venue is proper in this Court pursuant to 28 U.S.C. §1391 because all Defendants are
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`subject to the Court’s personal jurisdiction within this district. Plum is headquartered within this
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`judicial district and all Defendants maintain continuous, regular, and systematic contacts within this
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`COMPLAINT
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`Case 3:21-cv-01600-LB Document 1 Filed 03/05/21 Page 8 of 50
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`judicial district.
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`16.
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`Additionally, the Court has pendent personal jurisdiction over all Defendants.
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`FACTUAL ALLEGATIONS
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`I.
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`Rising Concerns Regarding the Presence of Toxic Heavy Metals in Baby Foods
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`17.
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`In October 2019, an alliance of nonprofit organizations, scientists and donors named
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`“Happy Babies Bright Futures” (“HBBF”), dedicated to designing and implementing “outcomes-
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`based programs to measurably reduce babies’ exposures to toxic chemicals”3, published a report
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`investigating the presence of Toxic Heavy Metals in baby foods.4 The HBBF Report tested 168
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`different baby foods sold on the U.S. market and concluded that “[n]inety-five percent of baby foods
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`tested were contaminated with one or more of four toxic heavy metals—arsenic, lead, cadmium and
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`mercury. All but nine of 168 baby foods contained at least one metal; most contained more than
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`one.”5 Specifically, the HBBF report identified “puffs and other snacks made with rice flour”,
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`“[t]eething biscuits and rice rusks”, “infant rice cereal”, “apple, pear, grape and other fruit juices”,
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`and “carrots and sweet potatoes” manufactured by baby food companies as particularly high in Toxic
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`Heavy Metals.6
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`18.
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`The results of the HBBF report were consistent with that of the FDA which had, in
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`2017, detected one or more of the four Toxic Heavy Metals in 33 of 39 types of baby food tested.7
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`However, the HBBF reported that “[f]or 88 percent of baby foods tested by HBBF—148 of 168 baby
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`foods—FDA has failed to set enforceable limits or issue guidance on maximum safe amounts.”8 To
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`that end, the HBBF, along with other concerned stakeholders, urged the FDA to, among other
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`3 https://www.hbbf.org/solutions.
`4 Healthy Babies Bright Futures, What’s in My Baby’s Food? A National Investigation Finds 95
`Percent of Baby Foods Tested Contain Toxic Chemicals That Lower Babies’ IQ, Including Arsenic
`and Lead (Oct. 2019) (“HBBF Report”), available at:
`www.healthybabyfood.org/sites/healthybabyfoods.org/files/2019-
`10/BabyFoodReport_FULLREPORT_ENGLISH_R5b.pdf).
`5 Id. at 6.
`6 Id. at 10-11
`7 Id. at 6.
`8 Id. at 6.
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`measures, “[s]et health-protective standards for heavy metals, prioritizing foods that offer FDA the
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`greatest opportunity to reduce exposure, considering additive effects of the multiple metals detected
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`in foods, and explicitly protecting against neurodevelopmental impacts… Implement a proactive
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`testing program for heavy metals in foods consumed by babies and toddlers…[and] [e]stablish a goal
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`of no measurable amounts of cadmium, lead, mercury, and inorganic arsenic in baby and children’s
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`food, in recognition of the absence of a known safe level of exposure, and work with manufacturers
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`to achieve steady progress.”9 The HBBF also invited baby food manufacturers to share its goal of
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`reducing “heavy metals in baby food to levels as low as reasonably achievable.”10
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`19.
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`The HBBF’s findings were by no means an outlier. Eight months prior to publication
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`of the HBBF report, a study conducted by scientists at the University of Miami and the Clean Label
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`Project “examined lead and cadmium concentrations in a large convenience sample of US baby
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`foods.”11 The study detected lead in 37% of samples, and cadmium in 57%.12 This was consistent
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`with findings by researchers examining baby food products in other parts of the world. In December
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`2019, Brazilian researchers observed that “[i]norganic contaminants, including those commonly
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`known as ‘heavy metals’ (cadmium, arsenic, lead and mercury)…may be present in baby foods such
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`as infant formulas, cereals, snacks, prepared meals, and jarred fruits and vegetables.”13 And, in 2011
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`Swedish scientists from the renowned Karolinska Institute noted that that “[h]igh levels of arsenic in
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`[infant] rice-based foods are of concern.”14
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`II.
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`Congressional Investigation Finds Substantial Presence of Heavy Metals in Baby Foods
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`9 Id. at 8-9.
`10 Id. at 9
`11 Gardener, et al., Lead and cadmium contamination in a large sample of United States infant
`formulas and baby foods, 651 SCI. TOTAL ENVIRON. 1, 822-827 (2019), available at:
`https://www.sciencedirect.com/science/article/abs/pii/S0048969718334442?via%3Dihub.
`12 Id.
`13 De Paiva, et al., Occurrence and determination of inorganic contaminants in baby food and infant
`formula, 30 CURR. OPIN. FOOD SCI. (2019), available at:
`https://www.sciencedirect.com/science/article/abs/pii/S2214799318301565#!.
`14 Bjorklund, et al., High concentrations of essential and toxic elements in infant formula and infant
`foods - A matter of concern 127 FOOD. CHEM (2011), available at:
`https://www.researchgate.net/publication/228471005_High_concentrations_of_essential_and_toxic_e
`lements_in_infant_formula_and_infant_foods_-_A_matter_of_concern/citation/download.
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`COMPLAINT
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`Case 3:21-cv-01600-LB Document 1 Filed 03/05/21 Page 10 of 50
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`Sparking National Outrage
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`20.
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`On February 4, 2021, the U.S. House of Representatives’ Subcommittee on Economic
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`and Consumer Policy, Committee on Oversight and Reform, published a report detailing its findings
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`that Toxic Heavy Metals—including arsenic, cadmium, lead, and mercury—were present in
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`“significant levels” in numerous commercial baby food products.15 Four companies—Hain, Gerber,
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`Nurture, and Beech-Nut —produced internal testing policies, test results for ingredients and finished
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`products, and documentation about what the companies did with ingredients and/or finished products
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`that exceeded their internal testing limits. Three companies—Plum, 16 Walmart, and Sprout—refused
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`to cooperate.17
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`21.
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`The Subcommittee reported that the data submitted by the companies unequivocally
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`revealed that a substantial number of Defendants’ finished products and/or ingredients used to
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`manufacture the Baby Foods are tainted with significant levels of Toxic Heavy Metals, namely
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`inorganic arsenic, lead, cadmium, and mercury.18
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`22.
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`Specifically, the Subcommittee concluded that:
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`ARSENIC was present in baby foods made by all responding companies:
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`a. Nurture (HappyBABY) sold baby foods after tests showed they contained as
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`much as 180 parts per billion (ppb) inorganic arsenic. Over 25% of the
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`products Nurture tested before sale contained over 100 ppb inorganic arsenic.
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`Nurture’s testing shows that the typical baby food product it sold contained 60
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`ppb inorganic arsenic.
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`b. Beech-Nut used ingredients after they tested as high as 913.4 ppb arsenic.
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`Beech-Nut routinely used high-arsenic additives that tested over 300 ppb
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`15 See generally Subcommittee Rpt.
`16 Plum’s parent corporation, Campbell’s, responded to the Subcommittee’s inquiries, and the
`Subcommittee Report references the parent corporation as opposed to Plum. However, as Plum is the
`Defendant in this lawsuit, any references to the Subcommittee’s findings regarding Campbell are
`attributed to Plum. The same Baby Foods are at issue.
`17 Subcommittee Rpt. at 2.
`18 Id. at 2-3.
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`Case 3:21-cv-01600-LB Document 1 Filed 03/05/21 Page 11 of 50
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`arsenic to address product characteristics such as “crumb softness.”
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`c. Hain (Earth’s Best Organic) sold finished baby food products containing as
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`much as 129 ppb inorganic arsenic. Hain typically only tested its ingredients,
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`not finished products. Documents show that Hain used ingredients testing as
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`high as 309 ppb arsenic.
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`d. Gerber used high-arsenic ingredients, using 67 batches of rice flour that had
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`tested over 90 ppb inorganic arsenic.
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`LEAD was present in baby foods made by all responding companies:
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`a. Nurture (HappyBABY) sold finished baby food products that tested as high as
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`641 ppb lead. Almost 20% of the finished baby food products that Nurture
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`tested contained over 10 ppb lead.
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`b. Hain (Earth’s Best Organic) used ingredients containing as much as 352 ppb
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`lead. Hain used many ingredients with high lead content, including 88 that
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`tested over 20 ppb lead and six that tested over 200 ppb lead.
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`c. Beech-Nut used ingredients containing as much as 886.9 ppb lead. It used
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`many ingredients with high lead content, including 483 that contained over 5
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`ppb lead, 89 that contained over 15 ppb lead, and 57 that contained over 20
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`ppb lead.
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`d. Gerber used ingredients that tested as high as 48 ppb lead; and used many
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`ingredients containing over 20 ppb lead.
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`CADMIUM was present in baby foods made by all responding companies:
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`a. Beech-Nut used 105 ingredients that tested over 20 ppb cadmium. Some tested
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`much higher, up to 344.55 ppb cadmium.
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`b. Hain (Earth’s Best Organic) used 102 ingredients in its baby food that tested
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`over 20 ppb cadmium. Some tested much higher, up to 260 ppb cadmium.
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`c. Sixty-five percent of Nurture (HappyBABY) finished baby food products
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`contained more than 5 ppb cadmium.
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`d. Seventy-five percent of Gerber’s carrots contained cadmium in excess of 5
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`Case 3:21-cv-01600-LB Document 1 Filed 03/05/21 Page 12 of 50
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`ppb, with some containing up to 87 ppb cadmium.
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`MERCURY:
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`a. Nurture (HappyBABY) sold finished baby food products containing as much
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`as 10 ppb mercury.
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`b. Gerber rarely tests for mercury in its baby foods and Hain (Earth’s Best
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`Organic) and Beech-Nut do not even test for mercury in baby food. 19
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`However, independent testing by HBBF of Hain’s Baby Foods confirm that
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`Hain’s products contain as much as 2.4 ppb of mercury.20
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`23.
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`These levels greatly surpass the limits allowed by U.S. regulatory agencies. Upon
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`information and belief, there are no FDA regulations governing the presence of Toxic Heavy Metals
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`in Baby Foods specifically; to the extent such regulations exist, the quantities of Toxic Heavy Metals
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`in Defendants’ Baby Foods far exceed any permissible FDA levels. To be sure, the FDA has set the
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`maximum contaminant levels (“MCL”) in bottled water at 10 ppb inorganic arsenic, 5 ppb lead, and 5
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`ppb cadmium, and the EPA has capped the allowable level of mercury in drinking water at 2 ppb.
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`However, these limits were created in reference to adult exposure, not infants. Compared to these
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`thresholds, the test results of the Defendants’ Baby Foods and their ingredients are 91 times (903
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`ppb) greater than permitted arsenic levels, 177 times (881 ppb) greater than permitted lead levels, 70
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`times (339 ppb) greater than permitted cadmium levels, and 5 times (8 ppb) greater than permitted
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`mercury levels.21
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`24. Moreover, compounding these troubling findings, the Defendants set internal limits
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`for the presence of Toxic Heavy Metals in their foods that were, themselves, dangerously high and
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`then routinely failed to abide by those inadequate standards. For example, the Subcommittee found
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`that Hain (Earth’s Best Organic) set an internal standard of 200 ppb for arsenic, lead, and cadmium in
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`some of its ingredients. But Hain routinely exceeded its internal policies, using ingredients
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`containing 353 ppb lead and 309 ppb arsenic. Hain justified these deviations based on “theoretical
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`19 Id. at 2-4.
`20 See HBBF Rpt. at 19.
`21 Subcommittee Rpt. at 3-4.
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`Case 3:21-cv-01600-LB Document 1 Filed 03/05/21 Page 13 of 50
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`calculations,” even after Hain admitted to the FDA that its testing underestimated final product toxic
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`heavy metal levels.22 Similarly, Beech-Nut set internal arsenic and cadmium standards at 3,000 ppb
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`in additives, such as vitamin mix, and 5,000 ppb lead for certain ingredients like BAN 800. The
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`Subcommittee observed that these standards are the highest of any responding manufacturer.23
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`25.
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`As found by the Subcommittee, Defendants have willfully sold—and continue to
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`sell—contaminated Baby Foods notwithstanding their full awareness of these unacceptably high
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`levels of Toxic Heavy Metals in their products. In August 2019, Hain held a closed-door meeting
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`with the FDA during which Hain delivered a presentation to the agency acknowledging the Toxic
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`Heavy Metal problem in its Baby Food.24 In the PowerPoint slides presented during the meeting—
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`only made public by the Subcommittee—Hain confirmed that some of the ingredients in its Baby
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`Food contain as much as between 108 to 129 ppb of arsenic, specifically noting “[p]reliminary
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`investigation indicates Vitamin/Mineral Pre-Mix may be a major contributing factor”25.
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`Additionally, the presentation revealed that:
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`a. Hain’s corporate policy to test only ingredients, not final products,
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`underrepresents the levels of toxic heavy metals in baby foods. In 100% of the
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`Hain baby foods tested, inorganic arsenic levels were higher in the finished
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`baby food than the company estimated they would be based on individual
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`ingredient testing. Inorganic arsenic was between 28% and 93% higher in the
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`finished products;
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`b. Many of Hain’s baby foods were tainted with high levels of inorganic
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`arsenic—half of its brown rice baby foods contained over 100 ppb inorganic
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`arsenic; its average brown rice baby food contained 97.62 ppb inorganic
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`arsenic; and
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`22 Id. at 4-5.
`23 Subcommittee Rpt. at 4.
`24 Hain, PowerPoint Presentation to Food and Drug Administration: FDA Testing Result
`Investigation (Aug. 1, 2019) (“2019 Hain & FDA Meeting”), available at:
`https://oversight.house.gov/sites/democrats.oversight.house.gov/files/2.pdf).
`25 Id. at *9.
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`Case 3:21-cv-01600-LB Document 1 Filed 03/05/21 Page 14 of 50
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`c. Naturally occurring toxic heavy metals may not be the only problem causing
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`the unsafe levels of toxic heavy metals in baby foods; rather, baby food
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`producers like Hain may be adding ingredients that have high levels of toxic
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`heavy metals into their products, such as vitamin/mineral pre-mix.26
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`26. Moreover, although Plum and Sprout refused to cooperate with the Subcommittee’s
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`investigation, independent data confirms that the Baby Food of these companies is similarly tainted.
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`27.
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`Instead of producing any substantive information, Plum provided the Subcommittee
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`with a self-serving spreadsheet declaring that every one of its products “meets criteria”,27 while
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`declining to state what the criteria were. Plum’s disingenuous testing summary speaks volumes since
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`the summary does not show the levels of Toxic Heavy Metals that the testing found or the levels that
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`would “meet criteria.” Disturbingly, Plum admitted that, for mercury (a powerful neurotoxin), the
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`company has no criterion whatsoever, stating: “No specific threshold established because no high-
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`risk ingredients are used.”28 However, despite Plum having no mercury threshold, it still marked
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`every food as “meets criteria” for mercury. The Subcommittee noted that “[t]his misleading
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`framing—of meeting criteria that do not exist—raises questions about what [Plum’s] other thresholds
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`actually are, and whether they exist.”29 Indeed, HBBF’s independent testing confirms the presence of
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`26 Subcommittee Report at 5-6
`27 Campbell, Product Heavy Metal Test Results (Dec. 11, 2019), available at:
`https://oversight.house.gov/sites/democrats.oversight.house.gov/files/12.pdf).
`28 Id. at 00046.
`29 Subcommittee Report at 45.
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`COMPLAINT
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`Case 3:21-cv-01600-LB Document 1