throbber
Case 1:21-cv-02417-NLH-SAK Document 89 Filed 12/16/21 Page 1 of 43 PageID: 1555
`
`MAYER BROWN LLP
`Dale J. Giali (admitted pro hac vice)
` dgiali@mayerbrown.com
`Keri E. Borders (admitted pro hac vice)
` kborders@mayerbrown.com
`350 S. Grand Ave., 25th Floor
`Los Angeles, CA 90071-1503
`Telephone: (213) 229-9500
`Facsimile: (213) 625-0248
`
`DECHERT LLP
`Christina Sarchio (Attorney ID 023731995)
`christina.sarchio@dechert.com
`502 Carnegie Center, Suite #104
`Princeton, NJ 08540-7814
`Telephone: (609) 955-3200
`Facsimile: (609) 955-3259
`Hope Freiwald (Attorney ID 023111990)
` hope.freiwald@dechert.com
`2929 Arch Street
`Philadelphia, PA 19104-2808
`Telephone: (215) 994-4000
`Facsimile: (215) 994-2222
`Mark Cheffo (pro hac vice to be submitted)
` mark.cheffo@dechert.com
`1095 Avenue of the Americas
`New York, NY, 10036-6797
`Telephone: (212) 698-3500
`Facsimile: (212) 698-3599
`Counsel
`for Defendants Campbell
`Soup Company and Plum, PBC
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY, CAMDEN VICINAGE
`
`IN RE PLUM BABY FOOD LITIGATION
`This Document Relates To:
`ALL ACTIONS
`
`Case No. 1:21-cv-02417-NLH-KMW
`Hon. Noel L. Hillman, U.S. District Judge
`DEFENDANTS’ NOTICE OF
`MOTION AND MOTION TO
`DISMISS, OR IN THE
`ALTERNATIVE, TO STAY;
`MEMORANDUM OF POINTS AND
`AUTHORITIES IN SUPPORT
`THEREOF
`Date: February 7, 2022
`Courtroom: Honorable Noel L. Hillman
`[[Proposed] Orders, Request for Judicial
`Notice, and Declaration of Keri E.
`Borders Filed Concurrently Herewith]
`
`

`

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`
`TABLE OF CONTENTS
`
`Page
`
`I.
`II.
`
`INTRODUCTION .......................................................................................... 1
`FACTUAL BACKGROUND......................................................................... 4
`A.
`FDA Is Responsible For Regulating Food Safety, Including
`Heavy Metals, In The U.S. Food Supply ............................................. 4
`FDA’s “Closer To Zero: Action Plan For Baby Foods” ...................... 6
`B.
`III. ARGUMENT .................................................................................................. 9
`A.
`Plaintiffs Lack Standing To Pursue Their Claims ............................... 9
`1.
`Plaintiffs Have Not Alleged a Cognizable Injury in Fact .......... 9
`2.
`Plaintiffs Lack Standing To Seek Injunctive Relief ................ 15
`Plaintiffs’ Claims Should Be Dismissed As Preempted .................... 17
`Plaintiffs’ Claims Fall Under FDA’s Primary Jurisdiction ................ 23
`Plaintiffs Fail To Plausibly Allege Deception ................................... 27
`Plaintiffs’ Breach Of Implied Warranty Claim Fails ......................... 32
`Campbell Soup Is Not A Proper Party And Should Be
`Dismissed ........................................................................................... 33
`IV. CONCLUSION ............................................................................................. 35
`
`B.
`C.
`D.
`E.
`F.
`
`i
`
`

`

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`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`In re Apple Processor Litig.,
`2019 WL 3533876 (N.D. Cal. Aug. 2, 2019) ..................................................... 11
`Axon v. Citrus World, Inc.,
`354 F. Supp. 3d 170 (E.D.N.Y. 2018) ................................................................ 30
`Axon v. Fla’s Nat. Growers, Inc.,
`813 F. App’x 701 (2d Cir. 2020) ........................................................................ 30
`Barreto v. Westbrae Nat.,
`2021 WL 76331 (S.D.N.Y. Jan. 7, 2021) ..................................................... 31, 32
`Baykeeper v. NL Indus., Inc.,
`660 F.3d 686 (3d Cir. 2011) ............................................................................... 24
`Bohac v. Gen. Mills, Inc.,
`2014 WL 1266848 (N.D. Cal. Mar. 26, 2014) ................................................... 32
`Brahamsha v. Supercell OY,
`2017 WL 3037382 (D.N.J. July 17, 2017) ......................................................... 16
`City of L.A. v. Lyons,
`461 U.S. 95 (1983) .............................................................................................. 15
`Coyle v. Hornell Brewing Co.,
`2010 WL 2539386 (D.N.J. June 15, 2010) ....................................... 23, 24, 25, 26
`Daigle v. Ford Motor Co.,
`713 F. Supp. 2d 822 (D. Minn. 2010) ................................................................. 32
`Dennis v. Whirlpool Corp.,
`2007 WL 9701826 (S.D. Fla. Mar. 13, 2007) .................................................... 32
`Diebler v. SanMedica Int’l, LLC,
`2021 WL 5013617 (D.N.J. Oct. 28, 2021) ......................................................... 34
`
`ii
`
`

`

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`
`Farina v. Nokia Inc.,
`625 F.3d 97 (3d Cir. 2010) ..................................................................... 18, 19, 21
`Fellner v. Tri-Union Seafoods LLC,
`539 F.3d 237 (3d Cir. 2008) ......................................................................... 21, 22
`Fid. Fed. Sav. & Loan Ass’n v. de la Cuesta,
`458 U.S. 141 (1982) ............................................................................................ 18
`Finkelman v. Nat’l. Football League,
`810 F.3d 187 (3d Cir. 2016) ............................................................................... 16
`Gaminde v. Lang Pharma Nutrition, Inc.,
`2019 WL 1338724 (N.D.N.Y. Mar. 25, 2019) ................................................... 11
`Geier v. Am. Honda Motor Co.,
`529 U.S. 861 (2000) ............................................................................................ 17
`In re Gen. Mills Glyphosate Litig.,
`2017 WL 2983877 (D. Minn. July 12, 2017) ..................................................... 30
`Giallorenzo v. Beaver Cnty.,
`2006 WL 3145126 (W.D. Pa. Oct. 31, 2006) ..................................................... 33
`Giallorenzo v. Beaver Cnty.,
`241 F. App'x 866 (3d Cir. 2007) ......................................................................... 33
`Gibson v. Quaker Oats Co.,
`2017 WL 3508724 (N.D. Ill. Aug. 14, 2017) ..................................................... 30
`Hauter v. Zogarts,
`14 Cal. 3d 104 (1975) ......................................................................................... 31
`Herrington v. Johnson & Johnson Consumer Cos, Inc.,
`2010 WL 3448531 (N.D. Cal. Sept. 1, 2010) ..................................................... 30
`Holk v. Snapple Beverage Corp.,
`575 F.3d 329 (3d Cir. 2009) ............................................................. 17, 18, 21, 22
`In re Johnson & Johnson Talcum Powder Prods. Mktg.,
`903 F.3d 278 (3d Cir. 2018) ........................................................................passim
`
`iii
`
`

`

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`
`Johnson v. Shop-Vac Corp.,
`2020 WL 3496957 (D.N.J. June 29, 2020) ......................................................... 31
`Johnson v. Shop-Vac Corp.,
`2021 WL 791830 (D.N.J. Feb. 26, 2021) ........................................................... 31
`In re KIND,
`209 F. Supp. 3d 689 (S.D.N.Y. 2016) ................................................................ 26
`Koronthaly v. L’Oreal USA, Inc.,
`2008 WL 2938045 (D.N.J. July 29, 2008) ......................................................... 13
`Koronthaly v. L’oreal USA, Inc.,
`374 F. App’x 257 (3d Cir. 2010) ........................................................................ 13
`In re Lipitor Antitrust Litig.,
`868 F.3d 231 (3d Cir. 2017) ................................................................................. 5
`MacQueen v. Huntington Ingalls Inc.,
`134 F. Supp. 3d 803 (D. Del. 2015).................................................................... 33
`MacQueen v. Union Carbide Corp.,
`2014 WL 6809811 (D. Del. Dec. 3, 2014) ........................................................ 33
`Maryland v. Louisiana,
`451 U.S. 725 (1981) ............................................................................................ 17
`Mason v. Coca-Cola, Co.,
`774 F. Supp. 2d 699 (D.N.J. 2011) ............................................................... 12, 13
`MCI Telecomms. Corp. v. Teleconcepts, Inc.,
`71 F.3d 1086 (3d Cir. 1995) ............................................................................... 23
`McNair v. Synapse Grp. Inc.,
`672 F.3d 213 (3d Cir. 2012) ......................................................................... 15, 16
`Medley v. Johnson & Johnson Consumer Cos.,
`2011 WL 159674 (D.N.J. Jan. 18, 2011) ............................................................ 12
`NVE, Inc. v. Dept. of Health and Hum. Servs.,
`436 F.3d 182 (3d Cir. 2006) ................................................................................. 5
`
`iv
`
`

`

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`
`Parks v. Ainsworth Pet Nutrition, LLC,
`2020 WL 832863 (S.D.N.Y. Feb. 20, 2020) ...................................................... 30
`Parks v. Ainsworth Pet Nutrition, LLC,
`377 F. Supp. 3d 241 (S.D.N.Y. 2020) ................................................................ 30
`Rivera v. Wal-Mart Stores, Inc.,
`2005 WL 2862246 (E.D. Pa. Oct. 31, 2005) ...................................................... 33
`Robinson v. Hornell Brewing Co.,
`2012 WL 1232188 (D.N.J. April 11, 2012) ........................................................ 16
`Schering Corp. v. Food and Drug Admin.,
`51 F.3d 390 (3d Cir. 1995) ................................................................................... 5
`Slimm v. Bank of Am. Corp.,
`2014 WL 1301508 (D.N.J. Mar. 31, 2014) ........................................................ 33
`Sportmart, Inc. v. Spirit Mfg.,
`1999 WL 350662 (N.D. Ill. May 17, 1999) ........................................................ 31
`Stearns v. Select Comfort Retail Corp.,
`2009 WL 1635931 (N.D. Cal. June 5, 2009) ...................................................... 32
`Thomas v. Costco Wholesale Corp.,
`2014 WL 5872808 (N.D. Cal. Nov. 12, 2014) ................................................... 32
`In re Toshiba Am. HD DVD Mktg. & Sales Pracs. Litig.,
`2009 WL 2940081 (D.N.J. Sept. 11, 2009) ........................................................ 29
`Tran v. Sioux Honey Ass’n,
`2020 WL 3989444 (C.D. Cal. July 13, 2020) ..................................................... 30
`U.S. v. W. Pac. R.R. Co.,
`352 U.S. 59 (1956) .............................................................................................. 23
`Viggiano v. Hansen Nat. Corp.,
`944 F. Supp. 2d 877 (C.D. Cal. 2013) ................................................................ 32
`Young v. Johnson & Johnson,
`2012 WL 1372286 (D.N.J. April 19, 2012) ........................................................ 13
`
`v
`
`

`

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`
`Yu v. Dr Pepper Snapple Grp.,
`2019 WL 2515919 (N.D. Cal. June 18, 2019) .................................................... 31
`Statutes
`21 U.S.C. § 331(a) ..................................................................................................... 4
`21 U.S.C. § 342 ................................................................................................ 4, 5, 20
`21 U.S.C. § 346 .................................................................................................... 4, 20
`21 U.S.C. § 350l ......................................................................................................... 5
`21 U.S.C. § 371 .......................................................................................................... 4
`21 U.S.C. § 393(b)(2)(A) ........................................................................................... 4
`Other Authorities
`21 C.F.R. §§ 7.1, et seq. ............................................................................................. 4
`21 C.F.R. § 10.30 ....................................................................................................... 5
`21 C.F.R. § 165.110 ................................................................................................. 20
`Food Labeling; Declaration of Ingredients, 56 Fed. Reg. 28592-01,
`28615 (Jun. 21, 1991) ......................................................................................... 20
`Fed. R. Civ. P. 8 ....................................................................................................... 35
`Fed. R. Civ. P. 9(b) .................................................................................................. 35
`Fed. R. Civ. P. 12(b)(6) ...................................................................................... 33, 35
`U.S. CONST. art. VI, cl. 2 ......................................................................................... 17
`
`vi
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`

`

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`
`I.
`
`INTRODUCTION
`Piggybacking off an alarmist staff report issued in early February 2021 by the
`Subcommittee on Economic and Consumer Policy of the U.S. House of
`Representatives (the “Subcommittee Report”),
`the Consolidated Amended
`Complaint (“CAC”) levels extreme—but unsupported—allegations that baby food
`products manufactured and sold by Plum, PBC (“Plum”) are unsafe due to the
`possible presence of low levels of naturally occurring heavy metals.1 Even though
`Plum unequivocally denies that its baby food products are unsafe, this class action
`lawsuit is not the appropriate manner or place to undertake that issue or the task of
`managing ubiquitous heavy metals in the nation’s food supply.
`The Food and Drug Administration (“FDA”), the agency responsible for
`managing and regulating food safety, quickly responded to the Subcommittee
`Report. Rather than endorsing it or the Subcommittee’s recommendations, FDA
`expressed serious concern over politicians making proposals that were not science-
`based and that could harm children by reducing their consumption of healthy and
`nutritious food. FDA also corrected a significant erroneous implication of the
`Subcommittee Report, i.e., that FDA had failed to act. In fact, FDA does actively
`monitor heavy metals in the food supply. Its past decision not to set “action levels”
`(maximum allowable levels) or engage in other rulemaking to regulate heavy metals
`
`1 Defendant Campbell Soup Company does not manufacture or sell Plum Organics
`baby food. From 2013 and, until it was acquired by Sun Maid Growers of California
`on May 31, 2021, Plum, PBC was a wholly owned, indirect subsidiary of Campbell
`Soup Company. As discussed in Section G, infra, Campbell Soup Company is not a
`proper party to this action and should be dismissed.
`
`1
`
`

`

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`
`in baby food reflected the results of FDA’s considered judgment that such actions
`were not warranted or necessary. FDA made clear that its “testing [. . .] shows that
`children are not at an immediate health risk from exposure to toxic elements in
`food.” Declaration of Keri E. Borders (“Borders Decl.”), Ex. E at 3. With these and
`other statements, FDA has reassured the public that packaged baby food has been
`and remains safe, and that consumers should continue to feed babies and toddlers
`packaged baby food. Id. at 4.
`Now, FDA is formally redoubling its efforts with a thorough, public
`investigation that seeks input of all relevant stakeholders. In implementing and
`publishing a thorough Action Plan, described below, FDA has made clear that if the
`agency deems it necessary—after extensive investigations by qualified scientific
`experts, not political staff—it may adopt regulations, including proposed and
`finalized action levels, regarding heavy metals in food. Because FDA is on the case,
`this Court should not proceed with this class action lawsuit, without even getting
`into the fact that plaintiffs here seek to impose remedies for nonexistent injuries,
`based on nonscientific reports with incomplete information.
`Apart from FDA’s ongoing investigation, this case should not proceed
`because this Court lacks jurisdiction. Plaintiffs fail to establish Article III standing
`because they have not alleged a cognizable injury. There are no allegations that
`plaintiffs or their children developed any adverse health consequences, and
`plaintiffs’ theory of economic injury is squarely foreclosed by Third Circuit
`precedent.
`
`2
`
`

`

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`Moreover, plaintiffs’ claims are nothing more than an implausible and
`preempted attempt to appropriate the mandate of FDA to develop and implement
`national food safety and labeling policy. With its expertise and significant resources,
`FDA is actively investigating and establishing national guidelines regarding the
`presence of heavy metals in baby food. Yet in the wake of the Subcommittee
`Report—a product of politicians and staff whose conclusions and methods have not
`been peer reviewed—plaintiffs’ lawyers rushed to file over 135 nearly identical class
`actions against every major manufacturer of baby food (because trace amounts of
`heavy metals are ubiquitous in the environment and might be found in all baby food).
`These circumstances call for a paradigmatic application of the doctrines of conflict
`preemption and primary jurisdiction, for there is no good reason for courts across
`the country to regulate individual producers by crafting a patchwork of inconsistent
`standards when FDA has already formed a comprehensive plan to investigate and
`regulate levels of heavy metals on a uniform, nationwide basis.
`For these reasons, as set forth more fully below, the motion to dismiss the
`CAC should be granted.
`
`3
`
`

`

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`
`II.
`
`FACTUAL BACKGROUND
`A.
`FDA Is Responsible For Regulating Food Safety, Including Heavy
`Metals, In The U.S. Food Supply.
`The Food Drug & Cosmetic Act (“FDCA”) requires FDA to (i) ensure that
`foods are safe, wholesome, sanitary, and properly labeled, (ii) promulgate
`regulations to enforce the provisions of the FDCA, and (iii) enforce its regulations
`through administrative proceedings. 21 U.S.C. §§ 371, 393(b)(2)(A), 21 C.F.R. §§
`7.1, et seq.
`The FDCA prohibits “[t]he introduction or delivery for introduction into
`interstate commerce of any food . . . that is adulterated[.]” 21 U.S.C. §§ 331(a). Food
`is deemed to be adulterated when it fails to meet certain standards, including when
`it is harmful to human health. See 21 U.S.C. § 342. Relevant here, a food is not
`deemed to be adulterated because of the presence of unavoidable heavy metals or
`any other substance “if the quantity of such substance in such food does not
`ordinarily render it injurious to health.” Id. (emphasis added). Further, federal law
`requires that when such a substance cannot be avoided in food and may be present
`at levels that could be harmful, FDA sets action levels that may not be exceeded. 21
`U.S.C. § 346. The action levels reflect considered scientific judgment and decision-
`making about when food may be rendered unsafe by the presence of poisonous or
`deleterious substances.
`All of this means that when a food contains harmful substances such that it is
`deemed adulterated under the law and unsafe to consume, the food is prohibited to
`be sold in interstate commerce. Following from this, FDA is and has been for
`
`4
`
`

`

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`
`decades well aware of heavy metals in the U.S. food supply and has been taking
`action it deems warranted and appropriate under the law, and declining to take action
`where action is unnecessary or unwarranted under the law.2
`Thus, where an allegedly poisonous or deleterious substance is in food and
`cannot be avoided entirely, FDA sets limits for the contaminant that may not be
`exceeded. FDA has not found it warranted or necessary to set a limit for most heavy
`metals in baby food. Significantly, that is because FDA limits substances when it
`determines that the substances may be present in harmful or dangerous levels and
`FDA has not made that determination. Moreover, if it is determined that food is
`adulterated within the meaning of Section 342, FDA has the authority to order a
`recall of that food. 21 U.S.C. § 350l. FDA confirms this in its February 16, 2021
`Constituent Update, when it states that if FDA finds that the products violate the law,
`including not being safe, “the agency takes steps to stop the product from being
`imported, takes court action to stop its sale or recalls it if it is in the domestic
`market.” Borders Decl., Ex. C at 2.
`
`2 If plaintiffs’ argument is that FDA is not following the law or meeting its
`obligations (and there is zero support in the CAC for that assertion), that challenge
`is properly brought in a citizen’s petition or a lawsuit directed at the agency itself.
`See 21 C.F.R. § 10.30; In re Lipitor Antitrust Litig., 868 F.3d 231, 273 (3d Cir. 2017)
`(challenging FDA response to citizen’s petition); Schering Corp. v. Food and Drug
`Admin., 51 F.3d 390, 393 (3d Cir. 1995) (challenging FDA regulation through
`citizen’s petition); NVE, Inc. v. Dept. of Health and Hum. Servs., 436 F.3d 182, 190
`(3d Cir. 2006) (challenging FDA regulation through litigation under the APA).
`Permitting plaintiffs to use the consumer class action device against food
`manufacturers to raise grievances that, at best for plaintiffs, should be directed to
`FDA threatens to upend the orderly and uniform national standard for food
`regulation. It would also lead to the untenable scenario of companies being held
`liable for following FDA regulations and guidance.
`
`5
`
`

`

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`Again, with respect to baby food, and in direct response to the Subcommittee
`Report, FDA informed the public that “testing shows that children are not at an
`immediate health risk from exposure to toxic elements in foods.” Borders Decl., Ex.
`E at 3. FDA also assured the public that it “routinely monitors” levels of heavy
`metals, and if the levels pose a health risk, FDA would take steps to remove the
`affected foods from the market. Id. at 4. FDA urged consumers not to throw out or
`stop feeding packaged baby foods to babies and children, cautioning that eliminating
`food groups from children’s diets could result in nutritional deficiencies and
`potential poor health outcomes. See id. In doing so, FDA recognized that given the
`ubiquitous nature of heavy metals, there are limits to how low the levels in food can
`be, and requiring levels that are neither justified nor feasible “could result in
`significant reductions in the availability of nutritious, affordable foods that many
`families rely on for their children.” Borders Decl., Ex. I at 1.
`B.
`FDA’s “Closer To Zero: Action Plan For Baby Foods”
`On April 8, 2021—in direct response to the Subcommittee Report—FDA
`announced its “Closer to Zero: Action Plan for Baby Foods,” a comprehensive multi-
`year plan identifying actions FDA “will take to reduce exposure to toxic elements
`from foods eaten by babies and young children—to as low as possible.” Borders
`Decl., Ex. B at 1. Significantly, the Action Plan recognizes that “[r]educing levels
`of toxic elements in foods is complicated and multifaceted,” and that it is “crucial”
`that measures taken not have unintended harmful consequences such as eliminating
`from the marketplace certain foods, committing itself to a “science-driven,
`
`6
`
`

`

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`
`transparent, and inclusive process that will include active stakeholder engagement
`and public sharing of data and information.” Id. at 2.
`The Action Plan has four specific stages: (1) evaluating the scientific basis for
`action levels, including establishing an interim reference level for certain toxic
`elements as appropriate; (2) proposing action levels for certain elements in
`categories of baby foods and other foods commonly eaten by babies and young
`children; (3) consulting with stakeholders regarding proposed action levels; and (4)
`finalizing those levels. Id. at 3-4.3
`Beginning in April 2021, FDA proposed a specific timeline for the four
`phases, and will “establish a timeframe for assessing industry’s progress toward
`meeting the action levels and recommence the cycle to determine if the scientific
`data supports efforts to further adjust the action levels.” Id. at 4. On November 18,
`2021, FDA conducted its first public meeting to receive stakeholder input on its
`Action Plan. Borders Decl., Ex. F. Officials from FDA and USDA opened the
`meeting by restating FDA’s longstanding and continued commitment to monitoring
`and evaluating levels of exposure to toxic elements, particularly that of young
`children and babies through food, and the need for FDA leadership to consult with
`other government agencies, researchers, industry, and caretakers in order to set safe,
`effective, and realistic exposure levels. See video recording for December 9, 2021
`FDA Closer
`to Zero Meeting, available at: https://www.fda.gov/science-
`
`3 FDA defines “[a]ction levels” as “a level of contamination at which a food may be
`regarded as adulterated within the meaning of section 402(a)(1) of the Federal Food,
`Drug, and Cosmetic Act.” Borders Decl., Ex. E at 2.
`
`7
`
`

`

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`research/fda-grand-rounds/closer-zero-12092021-12092021.4 For example, Dr.
`Janet Woodcock, Acting Commissioner of FDA remarked:
`
`It has long been an FDA priority to protect babies and
`young children from the harmful effects of contaminants
`such as lead and arsenic. . . . Our plan outlines a multi-
`phase, science-based, iterative approach to achieving our
`goal of getting levels of toxic elements in food closer to
`zero over time. . . . While we’ve already begun work on
`the plan, it’s also important to note that the FDA’s testing
`has shown there’s no immediate health risk to children
`from exposure to toxic elements at the levels currently
`found in food. Indeed, the plan is designed to address the
`potential health concerns of toxic elements in food, but to
`do so while taking into account the environmental and
`other realities surrounding this issue.
`
`Id. at 9:06.
`Unlike the remedies plaintiffs seek in this lawsuit, the Action Plan does not
`contemplate recalling existing baby food products or requiring warning labels or
`other disclosures regarding ubiquitous heavy metals in the food supply. Based on
`FDA’s announcements and established plans to date, there is no basis to assume, let
`alone conclude, that the final policy decisions implemented by FDA will require
`manufacturers to change their labeling or advertising in any way. Regardless,
`establishing labeling requirements—just like determining appropriate action levels
`
`4 Courts can take judicial notice of transcripts or recordings of public meetings. See
`Schubert v. City of Rye, 775 F. Supp. 2d 689, 695 n.3 (S.D.N.Y. 2011) (“[T]he
`minutes and recordings of the City Council meetings are matters of public record
`and therefore are the types of materials of which a court may take judicial
`notice.”); Barich v. City of Cotati, 2021 WL 3053204, at *6 (N.D. Cal. July 20,
`2021) (collecting cases and noting that “[c]ourts in this district have taken judicial
`notice of similar video recordings and minutes of public meetings”).
`
`8
`
`

`

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`
`for enforcement—is a decision for FDA as provided in the FDCA, not plaintiffs
`ostensibly acting under state law.
`III. ARGUMENT
`A.
`Plaintiffs Lack Standing To Pursue Their Claims.
`1.
`Plaintiffs Have Not Alleged a Cognizable Injury in Fact.
`As a threshold and dispositive matter, plaintiffs lack standing because they do
`not allege that they suffered an injury in fact. Specifically, plaintiffs have not alleged
`that they (or their children) suffered a physical (or cognizable economic) injury as a
`result of their past purchases of safe-to-consume baby food. “To establish standing,
`a plaintiff must have ‘(1) suffered an injury in fact, (2) that is fairly traceable to the
`challenged conduct of the defendant, and (3) that is likely to be redressed by a
`favorable judicial decision.’” In re Johnson & Johnson Talcum Powder Prods. Mktg.
`(“J&J”), 903 F.3d 278, 284 (3d Cir. 2018) (quoting Spokeo, Inc. v. Robins, 578 U.S.
`330, 338 (2016)).
`Plaintiffs’ CAC fails to satisfy the first constitutional prerequisite for standing
`for the same reasons the Third Circuit explained in J&J. In that case, a consumer
`alleged that she suffered economic injury by purchasing (and using) the defendant’s
`talcum powder baby powder, which she alleged could lead to an increased risk of
`developing ovarian cancer. Id. at 281–82. But like plaintiffs here, the J&J plaintiff
`did not allege any physical injury, did not allege an increased risk of developing any
`such injury in the future, and did not allege that the product “failed to adequately
`perform” its intended functions (in that case, keeping skin soft and dry). Id. Instead,
`the plaintiff there alleged that “had she been properly informed that using Baby
`
`9
`
`

`

`Case 1:21-cv-02417-NLH-SAK Document 89 Filed 12/16/21 Page 17 of 43 PageID: 1571
`
`Powder could lead to an increased risk of developing ovarian cancer, she would not
`have purchased the powder in the first place.” Id. at 282 (emphasis added). The Third
`Circuit found those allegations to be insufficient because in order to establish an
`economic injury, the plaintiff “must allege that she purchased Baby Powder that was
`worth less than what she paid for.” Id. at 287.
`Here, plaintiffs run into the same roadblock. Each alleges that when
`purchasing the baby foods in question he or she believed the product to be “safe,
`healthy and nutritious,” based on the packaging representations such as “organic,
`non-GMO, [using] whole and simple ingredients.” CAC ¶¶ 13, 14; see also, e.g., id.
`¶¶ 19. 21, 23 (identifying same verbatim belief and economic injury). Plaintiffs
`received exactly what was represented; they do not contest that the products were
`organic, non-GMO baby food. And there are zero allegations that any plaintiffs or
`their babies suffered any physical injury after feeding the products to their children.
`See, e.g., id. ¶¶ 19, 21, 23 (alleging each plaintiff “believed [he or she] was feeding
`her children healthy, nutritious baby food”). Those glaring omissions from the CAC
`are unsurprising given what the FDA has made clear: Packaged baby food is safe,
`and consumers should not throw out or cease feeding their children packaged baby
`food. Borders Decl., Ex. D at 2; id. Ex. E at 4.
`What the CAC does allege is that plaintiffs would not have purchased Plum
`products5 if they had been aware that the products (allegedly) contain heavy metals.
`
`5 Presumably, on this same logic, plaintiffs would not have purchased any foods
`containing vegetables, fruits or grains at all, considering all foods grown in soil,
`water and air may contain some amount of heavy metals from the environment.
`
`10
`
`

`

`Case 1:21-cv-02417-NLH-SAK Document 89 Filed 12/16/21 Page 18 of 43 PageID: 1572
`
`See, e.g., CAC ¶¶ 19, 21, 23, 25. Plaintiffs allege that they were deprived “the benefit
`of the bargain” because the products were “tainted” by the presence of heavy metals.
`E.g., CAC ¶¶ 15, 216, 224. Although their children consumed the foods without any
`alleged incident or harm, plaintiffs baldly proclaim the products “defective [and]
`worthless” and seek damages “in the amount of the purchase price they paid for
`Plum Baby Food.” CAC ¶¶ 15, 214; see e.g., id. ¶ 277 (seeking “restitution of all
`monies from the sale”), id. at Prayer, sub. (f), (g), (h) (seeking injunctive and
`declaratory relief).6
`Those limited allegations are insufficient under Third Circuit precedent,
`including J&J. As in that case, plaintiffs’ allegations boil down to regret over
`purchasing and consuming a product based on an allegation that plaintiff
`subsequently learned the product might pose an increased risk of adverse health
`
`6 Plaintiffs fail to allege that the specific baby food products they purchased
`contained any of the alleged contaminants,

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