In Re: Recalled Abbott Infant Formula Products Liability Litigation

Filing 48

CASE MANAGEMENT ORDER NO. 1 (Memorandum Opinion and Order on Motions to Dismiss Willoughby Complaint), signed by the Honorable Matthew F. Kennelly on 5/22/2023: For the reasons stated in the accompanying Memorandum Opinion and Order, the Court denie s defendant's motion to dismiss except with respect to plaintiffs' claims based on allegations of unsanitary conditions, plaintiff Willoughby's breach of the implied warranty of merchantability claim, and plaintiff Revord's unjust enrichment claim [dkt. no. 21]. This matter is set for an in-person status hearing on June 23, 2023 at 9:00 a.m., together with the case management conference set for that time in MDL 3037, Case No. 22 C 4148 (N.D. Ill.) A joint status report in the present matter is to be filed on June 16, 2023. (mk)

IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ILLINOIS
EASTERN DIVISION
IN RE: RECALLED ABBOTT
)
INFANT FORMULA PRODUCTS
)
LIABILITY LITIGATION
)
----------------------------------------------------- )
This document relates to:
)
Willoughby v. Abbott Labs.,
)
Case No. 22 C 1322
)

Case No. 23 C 338

CASE MANAGEMENT ORDER NO. 1
(Memorandum Opinion and Order on
Motions to Dismiss Willoughby Complaint)
MATTHEW F. KENNELLY, District Judge:
Eight plaintiffs—Charlotte Willoughby, Lakendrea Camille McNealy, Shaylynn
Doxie, Brittney Gray, Kataleena Helmick, Lani Holloway, Ashley Popa, and Deniege
Revord—filed suit against Abbott Laboratories. Abbott manufactures and distributes
Similac brand infant formula products. The plaintiffs (which the Court will collectively
call Willoughby) allege that the products contain heavy metals and were manufactured
in unsanitary conditions, both of which were not disclosed in the labeling. On January
23, 2023, the Executive Committee transferred this case to the Court under IOP 13(e)
for pretrial coordination purposes due to its overlap with the consumer class action
complaints in MDL 3037, In re Recalled Abbott Infant Formula Products Liability
Litigation, Case No. 22 C 4148.
In her consolidated amended complaint, Willoughby asserts claims on behalf of a
nationwide class and eight state classes for violations of state consumer fraud acts,
common law fraud, unjust enrichment, and breach of the implied warranty of
merchantability. Abbott has moved to dismiss all the claims under Federal Rule of Civil

Procedure 12(b)(1) for lack of standing and Rule 12(b)(6) for failure to state a claim. On
May 1, 2023, the Court held a hearing on Abbott's motion. For the reasons stated
below, the Court overrules Abbott's lack-of-standing argument, dismisses certain of
Willoughby's claims for failure to state a claim, and otherwise denies Abbott's motion.
Background
Abbott is a leading supplier of infant formula in the United States. It sells its
formula to consumers on its website and to major retailers who in turn sell it to
consumers. Willoughby purchased Abbott's Similac brand powdered infant formula
products. She has brought this putative class action on behalf of all purchasers from
March 1, 2016 to the present.
Willoughby alleges that recent testing on five types of Similac infant formula
products "confirmed the presence of Heavy Metals" in each product type tested,
including 2.0 parts per billion (ppb) of lead, 11.4 ppb of cadmium, 10.1 ppb of mercury,
and levels of arsenic ranging from 4.6 ppb to 9.7 ppb. Consol. Am. Compl. ¶¶ 19, 160.
Independent testing reported the presence of arsenic and lead in another Similac
formula product. The consolidated amended complaint also identifies several
investigation reports and studies confirming the presence of heavy metals in baby
foods.
Willoughby further alleges that "[t]here is no safe level of heavy metals" and that
even low levels of heavy metals "cause serious and often irreversible damage to brain
development." Id. ¶¶ 22, 87. Heavy metals "accumulate in the body, including in the
kidneys and other internal organs," such that "the risk they pose grows over time and
can remain in one's body for years." Id. ¶ 74. "[E]ven regular consumption of small

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amounts can increase the material risk of various health issues, including the material
risk of bladder, lung, and skin cancer; cognitive and reproductive problems; and type 2
diabetes." Id. ¶ 78. The FDA has prioritized reducing exposure to arsenic, cadmium,
lead, and mercury "in connection with its Toxic Elements Working Group." Id. ¶ 106.
Abbott does not disclose that its products "contained or had a material risk of
containing" heavy metals. Id. ¶ 3. Willoughby alleges that consumer surveys show that
reasonable consumers do not expect heavy metals to be present in Abbott's infant
formula after seeing the products' labeling.
Willoughby also alleges that Abbott's infant formula was "manufactured in
unsanitary conditions and with a lack of quality control." Id. ¶ 68. The consolidated
amended complaint refers to the FDA's conclusion that its inspections of the Sturgis,
Michigan facility "showed 'egregious unsanitary' conditions like cracks in key equipment
that allowed bacteria to enter, a leaking roof and water collecting on the floor." Id. ¶ 66.
Abbott also does not disclose that its products "lack . . . proper manufacturing controls"
or have a "material risk of contamination." Id. ¶ 69.
Willoughby alleges that she "would not have purchased" or "would not have paid
the price premium" for Abbott's infant formula had she known that the products were
"manufactured in 'egregiously unsanitary' conditions without proper quality control
procedures and contained (or had a material risk of containing) Heavy Metals." Id.
¶ 427.
Discussion
Willoughby asserts claims for violations of state consumer fraud acts, common
law fraud, unjust enrichment, and breach of the implied warranty of merchantability.

3

Abbott has moved to dismiss the claims for lack of standing under Rule 12(b)(1) and
failure to state a claim under Rule 12(b)(6).
In deciding a motion to dismiss for failure to state a claim, a court must accept as
true all well-pleaded factual allegations in the complaint and draw all reasonable
inferences in the plaintiff's favor. See NewSpin Sports, LLC v. Arrow Elecs., Inc., 910
F.3d 293, 299 (7th Cir. 2019). To survive a motion to dismiss, a plaintiff must allege
"factual content that allows the court to draw the reasonable inference that the
defendant is liable for the misconduct alleged." Bissessur v. Ind. Univ. Bd. of Trs., 581
F.3d 599, 602 (7th Cir. 2009) (quoting Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)).
Because Article III standing is a necessary component of federal jurisdiction, the
Court addresses it first. See Kithongo v. Garland, 33 F.4th 451, 454 (7th Cir. 2022)
("The 'first and fundamental question' [the] court must answer 'is that of jurisdiction.'"
(quoting Steel Co. v. Citizens for a Better Env't, 523 U.S. 83, 94 (1998))).
A.

Standing
"Article III of the Constitution limits federal judicial power to certain 'cases' and

'controversies,' and the 'irreducible constitutional minimum' of standing contains three
elements." Silha v. ACT, Inc., 807 F.3d 169, 172–73 (7th Cir. 2015) (quoting Lujan v.
Defs. of Wildlife, 504 U.S. 555, 559–60 (1992)). Only the first element is relevant here,
which is that the plaintiff must have suffered an "'injury in fact' that is (a) concrete and
particularized and (b) actual or imminent, not conjectural or hypothetical." Friends of the
Earth, Inc. v. Laidlaw Env't Servs. (TOC), Inc., 528 U.S. 167, 180 (2000). "As the party
invoking federal jurisdiction, a plaintiff bears the burden of establishing the elements of
Article III standing." Silha, 807 F.3d at 173.

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"In evaluating a challenge to subject matter jurisdiction, the court must first
determine whether a factual or facial challenge has been raised." Id. There are "two
forms of standing challenges." Flynn v. FCA U.S. LLC, 39 F.4th 946, 952 (7th Cir.
2022). "A facial challenge attacks standing on the pleadings, arguing that the plaintiff
lacks standing even if the well-pleaded allegations in the complaint are taken as true. A
factual challenge, by contrast, asserts that there is in fact no standing." Id. (citation
omitted). In this case, Abbott brings a facial challenge to standing, asserting that
Willoughby failed to plead any economic injury.
"[I]n evaluating whether a complaint adequately pleads the elements of standing,
courts apply the same analysis used to review whether a complaint adequately states a
claim: 'Courts must accept as true all material allegations of the complaint, and must
construe the complaint in favor of the complaining party.'" Silha, 807 F.3d at 173
(alterations accepted) (quoting Warth v. Seldin, 422 U.S. 490, 501 (1975)). "[W]hen
evaluating a facial challenge to subject matter jurisdiction under Rule 12(b)(1), a court
should use Twombly–Iqbal's 'plausibility' requirement, which is the same standard used
to evaluate facial challenges to claims under Rule 12(b)(6)." Id. at 174; see also
Reinoehl v. Centers for Disease Control & Prevention, No. 22-1401, 2022 WL
14461946, at *3 (7th Cir. Oct. 25, 2022) ("At the pleading stage, standing is evaluated
under the same analysis used to review whether a complaint adequately states a
claim.") (internal quotation marks omitted).
For both the unsanitary conditions and heavy metals claims, Willoughby
contends that she suffered an economic injury from a loss of the benefit of the bargain.
The Court addresses each theory in turn.

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1.

Unsanitary conditions

Willoughby cites Vanzant v. Hill's Pet Nutrition, Inc., 934 F.3d 730, 739 (7th Cir.
2019), for the proposition that "economic loss resulting from a price premium paid by a
consumer is a well-recognized actual injury that satisfies Article III standing." Pls.'
Resp. Br. at 7. But Abbott does not contest that a loss of the benefit of the bargain can
be a cognizable injury. See In re Aqua Dots Prod. Liab. Litig., 654 F.3d 748, 751 (7th
Cir. 2011) ("The plaintiffs' loss is financial: they paid more for the toys than they would
have, had they known of the risks the beads posed to children. A financial injury
creates standing."); In re Evenflo Co., Inc., Mktg., Sales Pracs. & Prod. Liab. Litig., 54
F.4th 28, 35 (1st Cir. 2022) ("This court has repeatedly recognized overpayment as a
cognizable form of Article III injury."); In re Johnson & Johnson Talcum Powder Prod.
Mktg., Sales Pracs. & Liab. Litig., 903 F.3d 278, 283 (3d Cir. 2018) ("Under the benefit
of the bargain theory, a plaintiff might successfully plead an economic injury by alleging
that she bargained for a product worth a given value but received a product worth less
than that value.").
Rather, Abbott contends that the plaintiffs have not lost the benefit of the bargain
in this case because the plaintiffs have not plausibly alleged that the products they
purchased were defective. Although Willoughby focuses on Abbott's omission of "its
unsanitary manufacturing practices," she contends that she did not receive the benefit
of the bargain because "they did not receive the Products' value and benefits which they
were promised (i.e., nutritious infant formula with superior ingredients)." Pls.' Resp. Br.
at 8–9. Willoughby does not allege that the products did not contain the ingredients or
the nutritional value that she expected. Rather, she contends that the alleged

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unsanitary conditions identified in the complaint resulted in a "material risk of
contamination." Consol. Am. Compl. ¶ 16.
Aqua Dots, upon which Willoughby relies, does not address this sort of
allegation. In that case, the plaintiffs alleged a uniform defect in every product.
Because every product was alleged to be defective, the plaintiffs did not also have to
allege that the defect manifested in physical injury to have standing. See Aqua Dots,
654 F.3d at 751 (holding that, where a manufacturer sold a toy with adhesive that posed
a hazard to children if ingested, the plaintiffs did not have to allege that their children
were physically injured to have standing); see also Evenflo, 54 F.4th at 33–35 (holding
that, where a manufacturer sold a car seat that was not designed or tested to function
as advertised, the plaintiffs did not have to allege that any plaintiffs suffered physical or
emotional harm). As the Fifth Circuit has explained, a uniform defect can cause
financial injury because "each plaintiff suffered economic injury at the moment she
purchased a [product] because each [product] was defective." Cole v. Gen. Motors
Corp., 484 F.3d 717, 723 (5th Cir. 2007).
In this case, however, Willoughby does not allege that every Abbott product of
the type at issue was contaminated with harmful bacteria. Nor does she allege that the
products she and the other plaintiffs purchased were contaminated. See, e.g., Consol.
Am. Compl. ¶ 16 ("Nowhere on the Infant Formulas’ packaging is the lack of proper
manufacturing controls or material risk of contamination from failing to ensure safe
manufacturing processes disclosed.") (emphasis added). In these circumstances,
Wallace v. ConAgra Foods, Inc., 747 F.3d 1025, 1030 (8th Cir. 2014), is instructive.
Like Willoughby, the plaintiffs in that case contended that they were "not required to

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allege the specific products or packages" that were defective. Id. The Eighth Circuit
rejected that proposition, holding that "[w]ithout any particularized reason to think the
consumers' own packages of Hebrew National beef actually exhibited the alleged nonkosher defect, the consumers lack Article III standing to sue ConAgra." Id. Other
circuits addressing allegations of non-uniform or speculative defects are in accord. See
Renfro v. Champion Petfoods USA, Inc., 25 F.4th 1293, 1305 (10th Cir. 2022)
("[A]rguing that they purchased dog food that was at risk of contamination—unlike
arguing that they purchased dog food that was contaminated—is insufficient for
standing because an alleged injury cannot be 'too speculative for Article III purposes.'")
(quoting Lujan, 504 U.S. at 564 n.2); Johnson & Johnson, 903 F.3d at 289 ("Although
Estrada contends that Baby Powder is 'unsafe,' her own allegations require us to
conclude that the powder she received was, in fact, safe as to her.").
Willoughby contends that her allegations are analogous to those the Court found
sufficient in Barnes v. Unilever U.S. Inc., No. 21 C 6191, 2023 WL 2456385 (N.D. Ill.
Mar. 11, 2023). The Court ruled in that case that "Barnes's theory of injury holds water
even if based on the proposition that she would not have purchased the product had
she known of the risk it contained benzene." Id. at *5 (quoting Barnes v. Unilever U.S.
Inc., No. 21 C 6191, 2022 WL 2915629, at *1 n.1 (N.D. Ill. July 24, 2022)). But in
Barnes, the Court placed particular emphasis on the latent effects of the alleged
contaminant. Id. ("This is particularly so in view of the fact that benzene is contended to
be a carcinogen and a substance that lingers in the human body, affecting several
organs and 'causing cells not to work correctly.'"). The plaintiffs in Barnes also provided
factual support to substantiate the alleged risk of contamination, including that benzene

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was detected in a majority of over a hundred product batches tested. Id. at *1. With
these allegations, it was plausible that the plaintiffs in Barnes had purchased products
contaminated with benzene. See Fishon v. Mars Petcare U.S., Inc., 501 F. Supp. 3d
555, 565 (M.D. Tenn. 2020) (holding that the plaintiffs alleged an injury in fact where
they alleged that test results confirmed the presence of unwanted ingredients in the
defendant's products, and "there [wa]s nothing in the [c]omplaint to suggest that only
some of" the products contained the unwanted ingredients, so a "fair reading" of the
complaint was that all the products contained the unwanted ingredients, including the
plaintiffs' purchased products); cf. Agee v. Kroger Co., No. 22 C 4744, 2023 WL
3004628, at *5 (N.D. Ill. Apr. 19, 2023) ("[B]ased on the FDA report and peer-reviewed
study referenced in Agee's complaint, it is plausible to infer, at least for purposes of a
motion to dismiss under Rule 12(b)(6), that Kroger's lidocaine patches routinely fail to
adhere to the body for the promised length of time.").
The same thing cannot be said for Willoughby's allegations in this case. First,
she has not alleged any facts regarding the percentage of products or lots sold by
Abbott that were contaminated. See Wallace, 747 F.3d at 1030–31 ("As we cannot
discern from the complaint how many packages were tainted with non-kosher beef, it is
unclear whether even a bare majority of Hebrew National packages were not kosher.").
Thus, "it is pure speculation to say the particular [products] sold to the consumers were
tainted by [bacteria], while it is quite plausible [Abbott] sold the consumers exactly what
was promised." Id. at 1031. Moreover, Willoughby has not alleged that there are any
latent effects from the sort of bacterial contamination she posits. This further
differentiates this case from Barnes, in which the contaminant was a human carcinogen

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whose effects might not be noticed for years. Here, none of the plaintiffs have yet
experienced any symptoms even though the most recent purchase date alleged by any
plaintiff is nearly four years ago, in July 2019. On this backdrop, there is no plausible
inference that the plaintiffs are at risk of latent effects from bacterial contamination.
Lastly, Willoughby has not even alleged that the products she purchased were
manufactured at the Sturgis facility, the only facility alleged in the complaint to have
unsanitary conditions. This further reduces any plausibility that the purchased products
were contaminated.
In sum, at least with respect to the alleged unsanitary conditions, Willoughby
received exactly what she contends she bargained for: safe infant formula. Indeed, if
Willoughby's standing contention were sufficient, any purchaser of a good that
functioned precisely as expected without any risk of future harm could bring suit if they
later discovered undisclosed information, even if it only affected others. This would
stretch "[t]he general rule . . . that plaintiffs must allege their own injuries to establish
standing" too far. Bria Health Servs., LLC v. Eagleson, 950 F.3d 378, 384 (7th Cir.
2020).
For these reasons, Willoughby does not have standing based on this theory of
harm. See Lewert v. P.F. Chang's China Bistro, Inc., 819 F.3d 963, 968 (7th Cir. 2016)
(declining to "push this theory beyond its current scope," which has "been adopted by
courts only where the product itself was defective or dangerous and consumers claim
they would not have bought it (or paid a premium for it) had they known of the defect").
She therefore may not pursue claims based on alleged unsanitary conditions. See
TransUnion LLC v. Ramirez, 141 S. Ct. 2190, 2208 (2021) ("[S]tanding is not dispensed

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in gross; rather, plaintiffs must demonstrate standing for each claim that they press and
for each form of relief that they seek (for example, injunctive relief and damages).").
2.

Heavy metals

A different result is warranted for Willoughby's heavy metals claims. Under this
theory of harm, Willoughby contends that she lost the benefit of the bargain because the
products "contained (or had a material risk of containing) Heavy Metals." Consol. Am.
Compl. ¶ 37.
Willoughby's allegations regarding heavy metals are similar to those the Court
found sufficient in Barnes. See Barnes, 2023 WL 2456385, at *5. As in Barnes,
Willoughby alleges that the effects of heavy metals are latent. See, e.g., Consol. Am.
Compl. ¶ 74 ("[T]he risk [heavy metals] pose grows over time and can remain in one's
body for years."). Willoughby also alleges that testing on five types of Abbott's Similac
infant formula products confirmed the presence of heavy metals in every product tested.
Furthermore, Willoughby's complaint points to several reports and studies identifying
heavy metals in baby foods. Because Willoughby has plausibly alleged that at least
most of Abbott's products contained heavy metals, it follows that she has plausibly
alleged that the products she purchased contained heavy metals. Indeed, although
Abbott contests the plausibility of this inference, it argued at the motion hearing and in
its supplemental brief that heavy metals cannot provide a basis for a claim because all
(or at least most) products contain heavy metals.
The Court thus concludes that Willoughby has plausibly alleged that she
purchased products containing a defect, namely, heavy metals. See Lewert, 819 F.3d
at 967–68 (holding that "allegations of standing," like other factual allegations, are

11

accepted as true for purposes of a motion to dismiss once they "cross the line from
conceivable to plausible" (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570
(2007))); John v. Whole Foods Mkt. Grp., Inc., 858 F.3d 732, 737 (2d Cir. 2017) ("[T]he
DCA's press release asserted that the mislabeling by Whole Foods was 'systematic' and
'routine,' and a facial attack on the pleadings is not the proper stage to determine
whether the DCA's sampling methods justified its declaration of widespread
overcharging.") (alterations accepted).
Abbott contends that even if all the products contained heavy metals, Willoughby
has not alleged a cognizable economic injury because the products did not contain a
hazardous level of heavy metals. Abbott argues that the heavy metal levels reported in
the complaint would be lower if the prepared formula, which is diluted with water, were
tested, rather than the powdered formula. At these lower levels, Abbott contends, its
products contain heavy metals in quantities significantly below the FDA's guidance for
analogous products and cannot cause harm.
Abbott's contention raises a factual dispute regarding the level at which heavy
metal contamination in food products intended for infants becomes dangerous.
Willoughby alleges that there is no safe level of heavy metals in infant formula, citing
several studies and reports. Because Abbott is bringing only a facial challenge to
standing, the Court must take Willoughby's well-pleaded factual allegations as true at
this stage. See Bazile v. Fin. Sys. of Green Bay, Inc., 983 F.3d 274, 279 (7th Cir.
2020). Willoughby's allegations that heavy metals are harmful even at low levels is
plausible. Indeed, the FDA's January 2023 draft guidance that Abbott cites supports
Willoughby's allegations by stating that "even low-level chronic exposure can be

12

hazardous over time" and that "[n]o safe level of lead exposure has been identified for
protecting children's health." Def.'s Suppl. Br. Ex. 1 at 4–5. Abbott's contention that the
FDA's guidance allows for higher levels of heavy metals in some products may be
evidence that the level of heavy metals in its products is in fact not hazardous, but that
is not dispositive of the standing inquiry at the motion to dismiss stage. The same is
true for the other asserted facts Abbott references in its briefing, such as the levels
suggested in proposed legislation and the FDA's statements about the risks of heavy
metals.
In sum, because Willoughby has plausibly alleged a uniform defect—the
presence of heavy metals—in Abbott's products, Willoughby has standing for her heavy
metals claims under Aqua Dots from her loss of the benefit of the bargain. See Aqua
Dots, 654 F.3d at 750–51.
3.

Injunctive relief

Abbott contends that Willoughby does not have standing to seek prospective
injunctive relief. As indicated earlier, standing must be established for each type of
relief sought by a plaintiff. See TransUnion, 141 S. Ct. at 2208.
Willoughby contends that she has "allege[d] an impending future harm" by
alleging that they "would be willing to purchase Similac® products in the future if [they]
could be certain that they were safely manufactured and do not contain (or have a
material risk of containing) Heavy Metals." Pls.' Resp. Br. at 21 (quoting Consol. Am.
Compl. ¶¶ 37, 40, 43, 46, 49, 52, 55, 58). This argument is foreclosed by Camasta v.
Jos. A. Bank Clothiers, Inc., 761 F.3d 732 (7th Cir. 2014). As the Seventh Circuit held
in Camasta, Willoughby is "now aware of [Abbott]'s sales practices," so she is "not likely

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to be harmed by the practices in the future." Id. at 740–41 ("[P]ast exposure to illegal
conduct does not in itself show a present case or controversy regarding injunctive
relief.") (citing O'Shea v. Littleton, 414 U.S. 488, 495 (1974)); see also Barnes, 2022 WL
2915629, at *2. Indeed, Willoughby's allegation confirms that she is now aware of the
alleged omissions and will not be harmed by them in the future. Willoughby accordingly
lacks standing to pursue prospective injunctive relief.
B.

Primary jurisdiction
Abbott also contends that Willoughby's heavy metals claims should be dismissed

under the primary jurisdiction doctrine. Both parties provided supplemental briefing
addressing the FDA's "action plan," named Closer to Zero, to reduce "toxic elements,
including lead, in foods over time." Def.'s Suppl. Br. Ex. 1 at 3. As part of Closer to
Zero, the FDA provided draft guidance in January 2023 on the levels of lead at which
the FDA "may regard a food as adulterated" in processed baby food. Id. The draft
guidance does not apply to infant formula. Id. at 3 n.2. The "draft guidance, when
finalized, will represent the current thinking" of the FDA, but will "not establish any rights
for any person and is not binding." Id. The guidance also does not address product
labeling.
"'Primary jurisdiction' is a permissive doctrine that applies when resolving a claim
'requires the resolution of issues which, under a regulatory scheme, have been placed
within the special competence of an administrative body.'" United States ex rel. Sheet
Metal Workers Int'l Ass'n v. Horning Invs., LLC, 828 F.3d 587, 592 (7th Cir. 2016)
(quoting United States v. Western Pac. R.R. Co., 352 U.S. 59, 63–64 (1956)). "[T]he
question is whether the reasons for the existence of the doctrine are present and

14

whether the purposes it serves will be aided by its application in the particular litigation."
Ryan v. Chemlawn Corp., 935 F.2d 129, 131 (7th Cir. 1991) (quoting Western Pac. R.R.
Co., 352 U.S. at 64).
Both parties refer to the following factors set out in Gilmore v. Southwestern Bell
Mobile Systems, L.L.C., 210 F.R.D. 212 (N.D. Ill. 2001), for determining whether to
apply the primary jurisdiction doctrine:
(a) whether the question at issue is within the conventional experience of
judges; (b) whether the question at issue involves technical or policy
issues within the agency's particular field of expertise; (c) whether a
determination would involve the exercise of agency discretion; (d) the
need for a consistent and uniform rule; (e) the likelihood of inconsistent
rulings if not referred to the agency; (f) whether the issue has already
been before the agency; (g) whether judicial economy is served by having
the agency resolve the issue; and (h) whether the referral will result in
substantial delay and added expense.
Id. at 221. Abbott contends that each factor weighs in favor of dismissal. It primarily
argues that the FDA has particular expertise in determining what amounts of heavy
metals in infant formula is harmful and is currently considering the issue, which involves
a "nuanced policy assessment." Def.'s Opening Mem. at 31. Willoughby contends that
the primary jurisdiction doctrine is inappropriate in this case because "action on heavy
metals is likely at least years away," and federal courts, not the FDA, determine
"[w]hether material omissions in the inducement of a consumer product purchase
violated state law." Pls.' Resp. Br. at 24–26.
The Court agrees with Willoughby and declines to apply the primary jurisdiction
doctrine in this case. First, Willoughby seeks monetary damages, which the FDA could
not provide. See Ryan, 935 F.2d at 131 ("[H]ers is a claim that seeks only monetary
damages, and as both parties agree that the EPA cannot provide the plaintiff with any

15

form of compensatory or punitive damages, we fail to understand what role the EPA can
play in this suit nor has the district court given this court any reason to rule otherwise.").
Abbott contends that the parties could "return to court for the resolution of any
remaining issues," such as damages. Def.'s Reply Br. at 14 (quoting Baker v. IBP, Inc.,
357 F.3d 685, 688 (7th Cir. 2004)). But "judicial economy will be better served by
allowing the plaintiff the opportunity to recover damages if she is entitled to any from the
only forum that can provide them, the court." Ryan, 935 F.2d at 132.
Second, Willoughby's "suit does not rely on federal law, but alleges . . .
independent state law cause[s] of action." Id. As in Ryan, Willoughby's state law claims
"are not dependent on any [FDA] provisions," and Willoughby "is not required to prove"
any violation of the FDA's regulations "in order to prevail on her complaint." Id.
Although Abbott contends that "whether the levels of heavy metals at issue present a
meaningful health risk" is within the FDA's field of expertise, Def.'s Opening Mem. at 29,
Abbott does not dispute that any guidance from the FDA would be neither binding nor
retroactive. Thus, even if the FDA ultimately provided guidance on this issue that
favored Abbott, "such a showing would not be dispositive." Ryan, 935 F.2d at 132.
Rather, it would simply provide evidence regarding the health risk of heavy metals that,
presumably, Willoughby will contest. Similar disputes "are regularly decided in the
courts." Id. ("For instance, there are thousands of state and federal tort cases brought
each year alleging an automobile design or safety defect that are decided in the courts
and not by the National Highway Safety and Transportation Board."). Staying the case
under the primary jurisdiction doctrine, therefore, would result in needless delay. See
Local 189, Amalgamated Meat Cutters v. Jewel Tea Co., 381 U.S. 676, 686 (1965)

16

("[T]he doctrine of primary jurisdiction is not a doctrine of futility; it does not require
resort to an expensive and merely delaying administrative proceeding when the case
must eventually be decided on a controlling legal issue wholly unrelated to
determinations for the ascertainment of which the proceeding was sent to the agency.")
(internal quotation marks omitted).
Lastly, the FDA has not provided a timeline for addressing infant formula and is
already behind its initial proposed schedule for providing guidance for levels of heavy
metals in other baby foods. Therefore, applying the primary jurisdiction doctrine in this
case would likely lead to "substantial delay and added expense." Gilmore, 210 F.R.D.
at 221; see also Advanced Dermatology v. Fieldwork, Inc., 550 F. Supp. 3d 555, 571
(N.D. Ill. 2021) ("[T]he uncertainty about when the FCC will issue its guidance . . .
weighs heavily against staying these proceedings.").
For these reasons, the Court declines to dismiss or stay Willoughby's heavy
metals claims under the primary jurisdiction doctrine.
C.

Rule 9(b)
Abbott contends that Willoughby has not satisfied Federal Rule of Civil

Procedure 9(b), which it argues applies to all of her claims. See Camasta, 761 F.3d at
737 ("[A] claim that sounds in fraud—in other words, one that is premised upon a course
of fraudulent conduct—can implicate 9(b)'s heightened pleading requirements.")
(internal quotation marks omitted). 1 Under Rule 9(b), a party alleging fraud or mistake
"must state with particularity the circumstances constituting fraud or mistake." Fed. R.

Willoughby disputes that Rule 9(b) applies to her implied warranty claims. The Court
need not decide this issue because it holds that Willoughby satisfies Rule 9(b) in any
event.

1

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Civ. P. 9(b). "Specifically, the complaint must identify the 'who, what, when, where, and
how' of the alleged fraud." Vanzant, 934 F.3d at 738.
First, Abbott argues that not all the plaintiffs alleged when and where they made
their purchases. 2 Abbott does not dispute that Willoughby and McNealy alleged these
facts. See, e.g., Consol. Am. Compl. ¶ 36 ("From May to July 2019, Plaintiff Willoughby
. . . purchased the Infant Formula for her children from a Jewel-Osco Grocery Store in
Palatine, Illinois, during that approximate applicable limitations period."). Abbott instead
emphasizes that other named plaintiffs provide less detail. See, e.g., id. ¶ 42 ("Plaintiff
Doxie purchased the Infant Formula for her child from retail outlets such as Target,
CVS, Rite Aid, Walmart, and Amazon during and within the applicable limitations
period."). But Rule 9(b) does not require plaintiffs to provide "the precise date, time,
and location." Camasta, 761 F.3d at 737; see Vanzant, 934 F.3d at 739 (holding that
the plaintiffs' allegations that they purchased the products "at PetSmart in February
2013 and thereafter" and "from PetSmart in November 2013 and thereafter" were
sufficient to allege "the 'when' and 'where' of the fraud"); Pirelli Armstrong Tire Corp.
Retiree Med. Benefits Tr. v. Walgreen Co., 631 F.3d 436, 442 (7th Cir. 2011)
("[B]ecause courts and litigants often erroneously take an overly rigid view of the
formulation, we have also observed that the requisite information . . . may vary on the
facts of a given case.").

Abbott also contends that Willoughby failed to allege that the products she purchased
were manufactured at the Sturgis facility. Because the Court has held that Willoughby
does not have standing to assert her claims regarding the bacteria-related sanitary
conditions at the Sturgis facility, the Court need not address Abbott's Rule 9(b)
argument related to the same claim.

2

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Abbott also contends that Willoughby failed to allege that she saw any alleged
misrepresentations on Abbott's website. Willoughby clarifies in her response brief that
she is only bringing claims based on alleged omissions, not misrepresentations. See
Pls.' Resp. Br. at 31 ("Defendant misconstrues Plaintiffs' allegations which are based
not on misrepresentations but omissions.").
D.

Fraud claims
Abbott contends that Willoughby's fraud and statutory consumer protection

claims fail for several reasons.
First, Abbott argues that Willoughby has not alleged actual damages "[f]or the
same reasons discussed" in Abbott's standing contentions. Def.'s Opening Mem. at 35.
For the same reasons the Court held that Willoughby has standing to bring her heavy
metals claims from her loss of the benefit of the bargain, the Court also holds that
Willoughby has sufficiently alleged actual damages. See Kim v. Carter's Inc., 598 F.3d
362, 365 (7th Cir. 2010) ("[A]ctual loss may occur if the seller's deception deprives the
plaintiff of 'the benefit of her bargain' by causing her to pay 'more than the actual value
of the property.'" (quoting Mulligan v. QVC, Inc., 382 Ill. App. 3d 620, 628, 888 N.E.2d
1190, 1197–98 (2008))); Miller v. William Chevrolet/GEO, Inc., 326 Ill. App. 3d 642, 653,
762 N.E.2d 1, 10 (2001) ("Illinois courts have generally allowed damages claims based
on diminished value of a product regardless of whether it has yet malfunctioned,
provided the product contains a manifested defect or current condition affecting value.");
Barnes, 2023 WL 2456385, at *4 ("Barnes has sufficiently alleged actual damages by
alleging that she 'paid a higher price' because the products were 'something less than
[she] expected.'" (quoting Vanzant, 934 F.3d at 739)).

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Second, Abbott contends that Willoughby has not sufficiently alleged that any of
its statements were false or misleading. Willoughby contends that Abbott's statements
that its products "nourish the journey of parents and their babies" and that "parents 'can
be confident in the nourishment of Similac'" could reasonably be construed "as
statements of fact that Similac products are healthy and safe." Pls.' Resp. Br. at 32
(quoting Consol. Am. Compl. ¶¶ 13, 115). But even if Willoughby's interpretation of
these statements were correct, these statements are from Abbott's website. Willoughby
disavowed any claims arising from website statements in response to Abbott's argument
that Willoughby failed to allege that any plaintiff read the website before making their
purchases. See Pls.' Resp. Br. at 31–32 ("Plaintiffs' main claims are based solely on
the Omissions from Defendant's product packaging – not about Abbott's website.").
Furthermore, in response to Abbott's contention that Willoughby does not allege that the
statements identified in her complaint are false, Willoughby reaffirms that her claims
"are based on Omissions." Id. at 33. Thus, any claims are dismissed to the extent they
are based on alleged misrepresentations on Abbott's website.
Abbott contends that Willoughby's omissions claims fail because it was under no
duty to disclose. Willoughby argues that the analysis of this issue depends on state
law. For each relevant state, Willoughby explains how each plaintiff's allegations
satisfied the duty, where it exists. Abbott does not contest that this issue varies across
states, yet it never provides a state-specific analysis. This amounts to forfeiture, for
purposes of a motion to dismiss, of any argument that Abbott did not have a duty to
disclose under the laws of a particular state. See Rock Hemp Corp. v. Dunn, 51 F.4th
693, 704 (7th Cir. 2022) ("Seventh Circuit precedent is clear that perfunctory and

20

undeveloped arguments, as well as arguments that are unsupported by pertinent
authority, are waived.") (internal quotation marks omitted).
In contending that it did not have a duty to disclose under any consumer
protection statute, Abbott primarily relies on Hodsdon v. Mars, Inc., 891 F.3d 857, 861–
65 (9th Cir. 2018). The Ninth Circuit held in Hodson that the defendant did not have a
duty to disclose "the existence of slave or child labor in [its] supply chain" because it did
not "affect[] the product's central function." Id. at 864. Accepting Willoughby's
allegations regarding the effects of heavy metals as true, as the Court must on a motion
to dismiss, the presence of heavy metals would affect the infant formula's central
function by making it unsafe to consume. Abbott also does not meaningfully contest
that some state consumer protection acts do not require a duty to disclose for omissionbased claims. See, e.g., Rockford Mem'l Hosp. v. Havrilesko, 368 Ill. App. 3d 115, 122,
858 N.E.2d 56, 62 (2006) ("[I]t is unnecessary to plead a common-law duty to disclose
in order to state a valid claim of consumer fraud based on an omission or
concealment.").
Abbott also contends that "to give rise to a duty to disclose under a theory of
common-law fraud, a (non-fiduciary) defendant must make an express representation
that is contrary to the omitted facts." Def.'s Opening Mem. at 37 (citing Crichton v.
Golden Rule Ins. Co., 576 F.3d 392, 397-98 (7th Cir. 2009)). Crichton does not go quite
so far, holding instead that "a duty to disclose may arise under Illinois law if the
defendant makes an affirmative statement that it passes off as the whole truth while
omitting material facts that render the statement a misleading 'half-truth.'" Crichton, 576
F.3d at 398. Willoughby contends that Abbott's omissions of heavy metals rendered its

21

"prior statements regarding the content and quality" of its products misleading. Pls.'
Resp. Br. at 35. Moreover, Willoughby argues that a duty to disclose exists in some
states where one party "has special knowledge of material facts to which the other party
does not have access." Id. (citing Driscoll v. Standard Hardware, Inc., 785 N.W.2d 805,
812 (Minn. Ct. App. 2010)). Willoughby alleges that Abbott had "exclusive knowledge of
. . . the physical and chemical make-up of the Infant Formulas, and whether the
ingredients contained Heavy Metals." Consol. Am. Compl. ¶ 187. 3 At this early stage,
this is sufficient to allege a duty to disclose. See In re Rust-Oleum Restore Mktg., Sales
Pracs. & Prod. Liab. Litig., 155 F. Supp. 3d 772, 828 (N.D. Ill. 2016) (holding that some
plaintiffs alleged a duty to disclose where they alleged "that [the defendant] was in the
unique position of having information not readily ascertainable to customers about the
alleged hidden defect, and based on the latent properties of the alleged defect, a
reasonable inference exists that it is not one readily ascertainable to customers").
E.

Implied warranty claims
Abbott contends that Willoughby's implied warranty claims fail because the

products were merchantable, Abbott did not receive pre-suit notice, and Willoughby
failed to allege privity. The Court addresses each contention in turn.

Abbott contends in a footnote that it does not have exclusive knowledge because "the
ubiquity of heavy metals in the food supply is a matter of widespread public discussion."
Def.'s Reply Br. at 17 n.17. This is a factual assertion that is contrary to Willoughby's
allegations that consumers do not expect the products to contain heavy metals and
could not know that they contain heavy metals without costly and time-consuming
testing. Moreover, the case Abbott cites in support of its contention is inapplicable
because it applies New York law, which is not relevant here, and was decided on
summary judgment. See Colangelo v. Champion Petfoods USA, Inc., No. 6:18-CV1228-LEKML, 2022 WL 991518, at *25 (N.D.N.Y. Mar. 31, 2022).

3

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1.

Merchantability

The parties agree that "[a] plaintiff who claims a breach of the implied warranty of
merchantability must show that the product 'did not possess even the most basic degree
of fitness for ordinary use.'" Viggiano v. Hansen Nat. Corp., 944 F. Supp. 2d 877, 896
(C.D. Cal. 2013) (quoting Mocek v. Alfa Leisure, Inc., 114 Cal. App. 4th 402, 406
(2003)). Willoughby argues that she met this standard by alleging that "the Infant
Formula is unfit for infants to consume based on the health risks." Pls.' Resp. Br. at 36
(citing Consol. Am. Compl. ¶¶ 70–111). Abbott contends that Willoughby has not
alleged that the formula was unfit for her because she consumed it without issue.
As discussed above, the Court concludes that Willoughby has plausibly alleged
that the products she purchased contained heavy metals, which can cause a variety of
serious health issues. It follows that she has plausibly alleged the products are unfit for
ordinary use.
2.

Pre-suit notice

Abbott next contends that Willoughby did not provide pre-suit notice. Abbott
argues that "[u]nder the Uniform Commercial Code (and each state's implementation
thereof), a plaintiff who fails to 'notify the seller of the alleged breach' 'within a
reasonable time after he discovers it' is 'barred from any remedy.'" Def.'s Opening
Mem. at 39–40 (alterations accepted) (quoting 810 ILCS 5/2-607(3)(a); Mich. Comp.
Laws Serv. § 440.2607; Tex. Bus. & Com. Code § 2.607(c)(1); Cal. Comm. Code.
§ 2607(3)(A); R.R.S. Neb. (U.C.C.) § 2-607). Two plaintiffs, Doxie and Holloway,
provided pre-suit notice. The remaining plaintiffs did not. For those two plaintiffs,
Abbott contends that the notice was still insufficient because it was sent five days prior

23

to filing suit, which Abbott argues did not give it "a reasonable opportunity to cure any
alleged defect." Id. at 40 (quoting Zylstra v. DRV, LLC, 8 F.4th 597, 609 (7th Cir.
2021)).
Willoughby contends that notice is not required in some states, and, where it is
required, notice of "its manufacturing processes" and "the Congressional release of
findings of the presence of heavy metals in baby foods" is sufficient. Pls.' Resp. Br. at
38 (citing Consol. Am. Compl. ¶¶ 187–189). Abbott does not respond to these
arguments on reply. See Bonte v. U.S. Bank, N.A., 624 F.3d 461, 466 (7th Cir. 2010)
("Failure to respond to an argument . . . results in waiver."). Although Abbott does
address these allegations from the complaint in its opening brief, it only cites to Illinois
law to argue that the allegations are insufficient.
To recover for breach of warranty under Illinois law, the buyer "must directly notify
the seller of the troublesome nature of the transaction or be barred from recovering."
Connick v. Suzuki Motor Co., 174 Ill. 2d 482, 492, 675 N.E.2d 584, 589 (1996); see also
815 ILCS 5/2-607(3)(a). There is an exception where the seller "has actual knowledge
of the defect of the particular product." Connick, 174 Ill. 2d at 492, 675 N.E.2d at 589.
But to meet this exception, Willoughby must allege more than simply that Abbott was
generally aware of heavy metals in its infant formula. See Anthony v. Country Life Mfg.,
LLC, 70 F. App'x 379, 384 (7th Cir. 2003). Allegations that Abbott "knew that its
products contained" unwanted ingredients and "therefore knew of the defect" is
insufficient to allege notice because the "notice of the breach required is . . . of buyer's
claim that [the facts] constitute a breach." Id. (quoting Connick, 174 Ill. 2d at 493, 675
N.E.2d at 590). Willoughby therefore has failed to allege that Abbott had actual

24

knowledge of the defect and accordingly has not alleged pre-suit notice under Illinois
law. See Agee, 2023 WL 3004628, at *7.
Although Willoughby argues that the sufficiency of notice is a question for the jury,
she fails to cite any Illinois law supporting this proposition. Indeed, under Illinois law,
"failure to allege sufficient notice is fatal to plaintiffs' breach of warranty claims."
Connick, 174 Ill. 2d at 495, 675 N.E.2d at 591. The Court therefore grants Abbott's
motion to dismiss Willoughby's claim for breach of the implied warranty of
merchantability.
For the remaining plaintiffs, however, Abbott has not cited any cases applying the
law of the relevant states nor responded to Willoughby's contention that her allegations
suffice to provide notice in those states. Thus, Abbott has forfeited any argument that
the remaining plaintiffs failed to sufficiently allege pre-suit notice under the laws of their
respective states. Webb v. Frawley, 906 F.3d 569, 581 (7th Cir. 2018) ("Webb has
waived any counterarguments he may have had by not responding to Frawley's
argument on this topic in his reply brief."). The Court accordingly declines to dismiss
the remaining plaintiffs' claims for breach of the implied warranty of merchantability
based on lack of notice.
3.

Privity

Lastly, Abbott briefly contends that the plaintiffs from California and Michigan 4
cannot state an implied warranty claim because those states' laws require vertical
privity. This is incorrect, and Abbott does not press the issue further in its reply brief.

Because the Court has dismissed Willoughby's implied warranty claim for lack of
notice, it does not address Abbott's contention that this claim should be dismissed for
the additional reason that Illinois law requires privity.

4

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See Pack v. Damon Corp., 434 F.3d 810, 820 (6th Cir. 2006) ("Michigan has
abandoned the privity requirement for implied-warranty claims . . . ."); Farley v. Country
Coach Inc., 403 F. App'x 973, 977 (6th Cir. 2010) ("[D]icta in recent opinions of the
Michigan Court of Appeals reaffirm the Pack court's conclusion that implied-warranty
claims do not carry a privity requirement under Michigan law, when the plaintiffs in those
cases sought only economic damages."); Warnshuis v. Bausch Health U.S., LLC, No.
19 C 1454 AWI BAM, 2020 WL 7239588, at *3 (E.D. Cal. Dec. 9, 2020) ("For the
implied warranty of merchantability, the vertical privity requirement is excused with
respect to manufacturers of foodstuffs and 'medicines.'" (citing Gottsdanker v. Cutter
Labs., 182 Cal. App. 2d 602, 607 (1960))).
F.

Unjust enrichment
Abbott contends that Willoughby's unjust enrichment claims should be dismissed

because Willoughby "fail[s] to allege that Abbott breached any legal obligation that it
owed to them or caused them any injury whatsoever." Def.'s Opening Mem. at 42.
Because the Court concludes that Willoughby has sufficiently alleged an injury and
claims for relief, it overrules this contention. 5
Next, Abbott argues that Willoughby's unjust enrichment claims should be
dismissed because Willoughby has adequate remedies at law. Most courts in the
relevant states hold that unjust enrichment can be alleged in the alternative, though
there is some disagreement even within states. See Fisher v. Ethicon, Inc., No. 20 C

Abbott also contends that the unjust enrichment claims based on the conditions at the
Sturgis facility fail because it offered a refund. Because the Court dismissed
Willoughby's claims based on alleged unsanitary conditions for lack of standing, it does
not address this argument.
5

26

1365, 2021 WL 5889522, at *7 (C.D. Ill. Dec. 13, 2021) ("At present, because at least
one of its supporting Counts survives, Plaintiff's unjust enrichment persists as a claim in
the alternative."); Phillips v. Caliber Home Loans, Inc., No. 19 C 2711 (WMW/LIB), 2020
WL 5531588, at *4 (D. Minn. Sept. 15, 2020) ("[A] plaintiff may plead an unjustenrichment claim in the alternative to a breach-of-contract claim."); Jeong v. Nexo Fin.
LLC, No. 21-CV-02392-BLF, 2022 WL 174236, at *27 (N.D. Cal. Jan. 19, 2022) ("Courts
in the Ninth Circuit are divided on how exacting of a standard Sonner [v. Premier
Nutrition Corp., 971 F.3d 834, 841–44 (9th Cir. 2020)] imposes on plaintiffs who plead
claims for equitable and legal remedies at the pleading stage."). As this is only a
pleading issue that will not affect the scope of discovery, the Court declines to dismiss
Willoughby's unjust enrichment claims on this basis. See Sandee's Catering v. Agri
Stats, Inc., No. 20 C 2295, 2021 WL 963812, at *7 (N.D. Ill. Mar. 15, 2021) ("The Court
need not analyze each state's laws. Other Courts that have confronted this identical
argument have refused to dismiss on these grounds at the pleading stage, finding that
Rule 8(d)(2)'s permissiveness allows for pleading in the alternative.").
For plaintiff Revord specifically, Abbott contends that her claim fails because
Michigan law requires a direct purchaser relationship. See Schechner v. Whirlpool
Corp., 237 F. Supp. 3d 601, 618 (E.D. Mich. 2017) ("[T]o state a claim for unjust
enrichment, Michigan law requires a direct benefit or some sort of direct interaction
between Plaintiffs and Whirlpool."). Willoughby does not respond to Abbott's
contention, forfeiting the issue. See Bonte, 624 F.3d at 466 ("Failure to respond to an
argument . . . results in waiver."). The Court therefore dismisses plaintiff Revord's
unjust enrichment claim.

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Conclusion
For the reasons stated above, the Court denies defendant's motion to dismiss
except with respect to plaintiffs' claims based on allegations of unsanitary conditions,
plaintiff Willoughby's breach of the implied warranty of merchantability claim, and
plaintiff Revord's unjust enrichment claim [dkt. no. 21]. This matter is set for an inperson status hearing on June 23, 2023 at 9:00 a.m., together with the case
management conference set for that time in MDL 3037, Case No. 22 C 4148 (N.D. Ill.)
A joint status report in the present matter is to be filed on June 16, 2023.
________________________________
MATTHEW F. KENNELLY
United States District Judge

Date: May 22, 2023

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