Chavez v. Church and Dwight Co., Inc.
Filing
45
MEMORANDUM Opinion and Order Signed by the Honorable John J. Tharp, Jr on 5/16/2018: For the reasons set forth in the Memorandum Opinion and Order, the defendant's motion to dismiss 22 is granted in part and denied in part. A status hearing is set for 5/31/18 at 9:00 a.m. Mailed notice(air, )
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IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ILLINOIS
EASTERN DIVISION
DAVID CHAVEZ, individually and on
behalf of others similarly situated,
Plaintiff,
v.
CHURCH & DWIGHT CO., INC.
Defendant.
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No. 17 C 1948
Judge John J. Tharp, Jr.
MEMORANDUM OPINION AND ORDER
With due respect to Mae West, sometimes too much of a good thing isn’t wonderful. In
this consumer fraud action, Defendant Church & Dwight Co., Inc. (“Church”) is accused of
understating the amount of folic acid found in its Vitafusion B Complex Adult Vitamin
Gummies dietary supplement (“Vitafusion”). Plaintiff David Chavez, an Illinois consumer,
alleges that Vitafusion contains more than three times the amount of folic acid per serving
declared on the label and that this overabundance is potentially harmful. Chavez seeks, on behalf
of himself and several classes of consumers, including nationwide and multistate classes, to hold
Church liable for deceptive business practices, fraud, breach of express and implied warranties,
and unjust enrichment. Church responded to the amended complaint by filing a motion to
dismiss under Rule 12(b)(6), arguing that Chavez’s claims are preempted by federal nutrition
labeling laws. Alternatively, Church asks the Court to abstain from hearing this case until the
Federal Drug Administrative (“FDA”) resolves a technical issue at the heart of this dispute. And,
as a last resort, Church argues that Chavez cannot represent a class of consumers outside of
Illinois due to a lack of standing and personal jurisdiction. Having reviewed the parties’
submissions, the Court grants in part and denies in part the motion to dismiss.
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BACKGROUND 1
Church is a publically traded Delaware corporation based out of New Jersey that
manufactures and distributes household products, including dietary supplements. (Am. Compl.
¶¶ 19, 36, ECF No. 6.) Vitafusion is one of many dietary supplements that Church produces and
sells. (Id. ¶¶ 1, 39-40.) Church markets Vitafusion as an excellent source of certain B vitamins,
including folic acid. 2 (Id. ¶ 40.) According to the nutrition facts listed on the back of a bottle of
Vitafusion, one serving (that is, one gummy) provides 400 mcg 3 of folic acid, 4 which is equal to
100% of one’s “Daily Value” of the vitamin. (Id. ¶¶ 41-42.) Church also advertises on its website
that it delivers “high quality dietary supplements in the gummy vitamin industry” and “place[s]
the utmost importance on nutritional accuracy and high product quality.” (Id. ¶ 38.)
Testing by Chavez’s counsel shows that Vitafusion gummies contain 1232.2 mcg of folic
acid—more than three times the amount listed on the label. (Id. ¶ 46.) According to the Office of
Dietary Supplements at the National Institute of Health (“NIH”), the Upper Tolerable Intake
Limit (“UTIL”) for folic acid in a supplement is 1,000 mcg. (Id. ¶¶ 32-33.) Consuming more
than this amount may cause adverse health effects and, “in some circumstances,” could “be
dangerous.” (Id. ¶¶ 29, 33.) The effects include, among others, increasing the risk of heart attack,
increasing the risk of certain precancerous tumors becoming malignant, and exacerbating
1
As it must on a Rule 12(b)(6) motion to dismiss, the Court accepts as true all wellpleaded facts in the amended complaint and draws all reasonable inferences in the Chavez’s
favor. Deb v. Sirva, Inc., 832 F.3d 800, 810 (7th Cir. 2016).
2
Folic acid is the synthetic form of the B9 vitamin; in its natural state, the vitamin is
referred to as folate (or folacin). See Folate Dietary Supplement Fact Sheet, National Institute of
Health, (updated Mar. 2, 2018), https://ods.od.nih.gov/factsheets/Folate-HealthProfessional/;
(Am. Compl. ¶¶ 5, 23). The parties appear to use the terms folate and folic acid interchangeably
in their briefing. For purposes of this motion, the Court refers to the vitamin only as folic acid.
3
One “mcg” is a microgram, or 1/1000 of a milligram (mg).
4
The label specifically lists the vitamin as “Folate, Folic Acid, Folacin.” (Id. ¶ 41.)
2
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anemia. (Id. ¶¶ 30-33.) Chavez purchased and consumed Vitafusion on a number of occasions
over the last few years believing that it would provide him with the amount of B vitamins stated
on the bottle and benefit his health. (Id. ¶¶ 58-60, 62.) He alleges that he would not have done so
had he known that the product contained a level of folic acid above the UTIL. (Id. ¶¶ 61, 63.)
Chavez brought suit in March 2017 and seeks to represent three classes of Vitafusion
consumers: one nationwide, one multistate, and one based in Illinois. (Id. ¶¶ 64, 66.) Although
the amended complaint comprises six counts, it asserts four claims for relief. The first claim is
that Church mislabels the amount of folic acid found in Vitafusion. In Counts I and II, Chavez
contends that the mislabeling violates several state consumer laws, including the Illinois
Consumer Fraud and Deceptive Business Practices Act (“ICFA”). Count III asserts that the label
is fraudulent under Illinois common law, while Counts IV and V contend that the label breaches
several express and implied warranties under the Uniform Commercial Code in all fifty states
and the District of Columbia. Finally, in Count VI, Chavez seeks to disgorge Church’s
Vitafusion revenues under an unjust enrichment theory because the product is mislabeled.
Chavez’s other three claims also relate to Church’s alleged mislabeling of Vitafusion, but
are nonetheless distinct. His second claim for relief is that the Vitafusion label fails to disclose
that it contains an “unsafe” level of folic acid, while his third claim is that Church misrepresents
on its website the quality of its dietary supplements and the level of accuracy of its nutrition
labels. Chavez’s legal theory for these claims is that Church’s lack of disclosure and online
misrepresentations violate state consumer protection laws (Counts I and II) and constitutes fraud
(Count III). Chavez’s final claim, embodied only in Count V, is that because Vitafusion contains
an unsafe level of folic acid, the supplement is unfit for consumption.
3
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Church responded to the amended complaint by moving to dismiss. Church argues that
Chavez’s claims should be dismissed or stayed on several grounds, including preemption,
primary jurisdiction, lack of standing, and lack of personal jurisdiction. The Court addresses each
argument in turn, beginning with preemption.
DISCUSSION
I.
Federal Preemption
Church argues first and foremost that the amended complaint should be dismissed on
federal preemption grounds. A dismissal based on federal preemption is a Rule 12(b)(6)
dismissal on the merits for failure to state a claim. See Healy v. Metro. Pier & Exposition Auth.,
804 F.3d 836, 840-41 (7th Cir. 2015) (citing Turek v. Gen. Mills, Inc., 662 F.3d 423, 425 (7th
Cir. 2011)). Under Rule 12(b)(6), “a plaintiff must allege ‘enough facts to state a claim to relief
that is plausible on its face.’” Boucher v. Fin. Sys. of Green Bay, Inc., 880 F.3d 362, 365-66 (7th
Cir. 2018) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 570 (2007)). “A claim has facial
plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable
inference that the defendant is liable for the misconduct alleged.” Id. at 366 (quoting Ashcroft v.
Iqbal, 556 U.S. 662, 678 (2009)). This Court “must accept as true all factual allegations in the . .
. complaint and draw all permissible inferences” in Chavez’s favor. W. Bend Mut. Ins. Co. v.
Schumacher, 844 F.3d 670, 675 (7th Cir. 2016) (internal quotation marks omitted) (quoting Bible
v. United Student Aid Funds, Inc., 799 F.3d 633, 639 (7th Cir. 2015)). However, “[w]hile a
plaintiff need not plead ‘detailed factual allegations’ to survive a motion to dismiss, he still must
provide more than mere ‘labels and conclusions or a formulaic recitation of the elements of a
4
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cause of action’ for [his] complaint to be considered adequate under [Rule] 8.” Bell v. City of
Chicago, 835 F.3d 736, 738 (7th Cir. 2016) (quoting Iqbal, 556 U.S. at 678). 5
There are three types of preemption: express preemption, conflict preemption, and field
preemption. Bible, 799 F.3d at 651-52 (citing Aux Sable Liquid Prods. v. Murphy, 526 F.3d
1028, 1033 (7th Cir. 2008)). Church relies only on express preemption, which “occurs when a
federal statute explicitly states that it overrides state law or local law.” Aux Sable, 526 F.3d at
1033 (citation omitted). There is a strong presumption against preemption, Patriotic Veterans,
Inc. v. Indiana, 736 F.3d 1041, 1046 (7th Cir. 2013); see also Wyeth v. Levine, 555 U.S. 555, 565
(2009) (“[W]e start with the assumption that the historic police powers of the States were not to
be superseded by the Federal Act . . . .”) (internal quotation marks and citation omitted), and
Church bears the burden of overcoming it, Russian Media Grp., LLC v. Cable Am., Inc., 598
F.3d 302, 309 (7th Cir. 2010) (citation omitted).
A.
Preemption under the NLEA
The issue here is whether the amended complaint is preempted by the labeling
requirements of the Food, Drug, and Cosmetic Act (“FDCA”), as amended by the Nutrition
Labeling and Education Act (“NLEA”). The NLEA includes an express preemption provision
that prohibits states from establishing any requirements that are “not identical to” certain federal
requirements for the labeling of food and dietary supplements. 21 U.S.C. § 343-1(a); see also
Krommenhock v. Post Foods, LLC, 255 F. Supp. 3d 938, 951 (N.D. Cal. 2017) (discussing
5
Although Counts I, II, and III assert causes of action for fraud and deceptive business
practices, Church does not challenge those counts on the basis Rule 9(b). As such, the Court does
not consider in this motion whether Chavez has stated “with particularity the circumstances”
underlying those causes of action. Fed. R. Civ. P. 9(b).
5
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general framework of preemption under the NLEA). 6 In particular, the provision expressly
preempts any state requirements for nutrition labeling that are not identical to the requirements of
section 343(q) of the FDCA. 21 U.S.C. § 343-1(a)(4). It also preempts states from imposing
requirements on nutrient-content or health-related claims made on a label that are not identical to
the requirements set forth in section 343(r) of the Act. Id. § 343-1(a)(5).
The phrase “not identical to” means that a state requirement imposes an obligation that is
“not imposed by or contained in” or “[d]iffer[s] from those specifically imposed by or contained
in” the FDCA or FDA regulations. 21 C.F.R. § 100.1(c)(4); see also Fidelity Fed. Sav. & Loan
Ass’n v. de la Cuesta, 458 U.S. 141, 153 (1982) (“Federal regulations have no less pre-emptive
effect than federal statutes.”). Moreover, the Supreme Court has explained that the preemptive
effect of the “requirements” language in § 343-1 “reaches beyond positive enactments, such as
statutes and regulations, to embrace common-law duties.” Bates v. Dow Agrosciences LLC, 544
U.S. 431, 443 (2005). Chavez’s claims then, whether rooted in positive or common state law, are
preempted if they directly or indirectly impose a labeling requirement on Church that is not
already “imposed by § 343(q), § 343(r), or the implementing regulations for those provisions.”
Gubala v. CVS Pharmacy, Inc., No. 14 C 9039, 2016 WL 1019794, at *4 (N.D. Ill. Mar. 15,
2016). Conversely, Chavez’s claims survive dismissal if they merely seek to enforce those
requirements; litigants may “enforce a violation of the Act as a violation of state law.” Turek,
662 F.3d at 426 (“This is important because the [FDCA] does not create a private cause of
action.”); see also Beverages: Bottled Water, 60 Fed. Reg. 57076, 57120 (Nov. 13, 1995)
6
Dietary supplements are deemed to be “food” under the FDCA, 21 U.S.C. § 321(ff), so
the NLEA’s preemption provision extends to labeling requirements for supplements as well.
Moreover, the parties do not dispute that Vitafusion meets the definition of dietary supplement.
6
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(adding that “if the State requirement does the same thing that the Federal law does, . . . then it is
effectively the same requirement as the Federal requirement” and not subject to preemption).
B.
FDA Regulation of Folic Acid Declarations
The first step in unpacking Church’s preemption defense is to determine what the FDCA
has to say about the labeling of folic acid in dietary supplements. Under certain circumstances
that are not in dispute here, the Act requires manufacturers to list folic acid as an ingredient on a
supplement’s nutrition label. See 21 U.S.C. § 343(q)(5)(F)(i); 21 C.F.R. § 101.9(c)(8)(ii); 21
C.F.R. § 101.36(b)(2). When folic acid is declared on a label, the FDCA dictates that the label
include “the quantity of [folic acid] per serving.” 21 U.S.C. § 343(q)(5)(F)(ii); see also 21 C.F.R.
§ 101.9(c)(8)(iii) (“The quantitative amounts of vitamins and minerals, excluding sodium, shall
be the amount of the vitamin or mineral included in one serving of the product.”). Moreover, the
Act requires that the label accurately report the amount of folic acid found in the supplement;
otherwise, the label is misbranded. See 21 U.S.C § 343(a) (“A food shall be deemed misbranded
[if] its labeling is false or misleading in any particular . . . .”).
FDA regulations specify when a labeled amount of folic acid is deemed to be accurate.
Folic acid is a Class I nutrient (at least in the context of this litigation), 7 so the Court must look
to 21 C.F.R. § 101.9(g)(4)(i) for guidance. Under that provision, a dietary supplement that
includes a vitamin declaration “shall be deemed to be misbranded under [21 U.S.C. § 343(a)]
unless” the content of the vitamin in the supplement is “at least equal to” the amount of the
7
Class I nutrients are those “[a]dded . . . in fortified or fabricated foods[.]” 21 C.F.R.
§ 101.9(g)(3)(i). They stand in contrast to Class II nutrients, which are “[n]aturally occurring
(indigenous) nutrients.” Id. § 101.9(g)(3)(ii). The parties seem to agree that the folic acid added
to Vitafusion is a Class I nutrient, (see Def. Mot. to Dismiss 6, ECF No. 23; Am. Comp. ¶ 12),
and the Court see no reasons to alter that characterization.
7
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vitamin declared on the label. 21 C.F.R. § 101.9(g)(4)(i). 8 That is, a nutrition label is deemed
inaccurate (or misbranded in FDCA parlance) when it overstates the amount of folic acid in a
supplement. A supplement that contains more folic acid than the label suggests would not run
afoul of this particular requirement.
Section 101.9(g)(4)(i), moreover, is not the only regulation that bears on the accuracy of
a folic acid declaration. When folic acid is understated on a label, section 101.9(g)(6) enters the
fray. That provision provides: “Reasonable excesses of vitamins . . . over labeled amounts are
acceptable within current good manufacturing practice.” 21 C.F.R. § 101.9(g)(6). The FDA does
not define reasonable excess, but it does provide guidance on current good manufacturing
practice (“cGMP”). Relevant to this dispute is a cGMP regulation that requires manufacturers to
keep track of “any intentional overage amount of a dietary ingredient.” 21 C.F.R. § 111.210(e).
An overage refers to the quantity of an ingredient added to ensure that the ingredient meets the
amount specified on the label throughout the product’s shelf life. Current Good Manufacturing
Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements,
72 Fed. Reg. 34752, 34884 (June 25, 2007). When the FDA initially proposed this regulation, it
referred to the additional amount as an “intentional excess.” Current Good Manufacturing
Practice in Manufacturing, Packaging, Labeling, or Holding Dietary Ingredients or Dietary
Supplements, 68 Fed. Reg. 12158, 12203 (Mar. 13, 2003). But in enacting the final regulation,
the FDA commented that the additional amount was more commonly known as an “overage” in
the supplement industry, and so adopted that term. 72 Fed. Reg. at 34884. In either case, the
FDA cautioned that the provision “is not intended to allow a manufacturer to add . . . unspecified
amounts [of an ingredient] that would be in excess of the amount actually needed to meet the
8
Although the provision applies explicitly to “food” labels, 21 C.F.R. § 101.36(f)(1)
extends the provision’s reach to dietary supplement label as well.
8
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label declaration.” 68 Fed. Reg. at 12158; accord 72 Fed. Reg. at 34884 (“As discussed in the
preamble to the 2003 CGMP Proposal . . . , the amount of overage should be limited to the
amount needed to meet the amounts listed in accordance with final § 111.210(d).”).
C.
Express Preemption of Plaintiff’s Claims
With this framework in mind, the Court turns to the preemption dispute, which focuses
almost exclusively on Chavez’s mislabeling claim. Church believes that the mislabeling claim is
preempted for two reasons, the first of which is that it fails to address the reasonable excess
exception. (Def. Mot. 5-6.) According to Church, for the mislabeling claim to survive dismissal,
Chavez “must plausibly allege the excess [in Vitafusion] is not consistent with current good
manufacturing practice for ensuring that the folate level does not fall below the labeled amount
during the product’s shelf life.” (Def. Reply in Supp. of Mot. to Dismiss 10, ECF No. 28.)
Because Chavez fails to even mention the exception in the amended complaint, Church
continues, the claim must be dismissed. Chavez rejoins that he need not plead around the
exception but, even if he does, he has alleged more than enough facts to infer that the excess
folic acid in Vitafusion is unreasonable and outside of good manufacturing practices. (Pl. Resp.
to Def. Mot. to Dismiss 6-7, ECF No. 27.)
At the outset, the Court agrees with Church that the mislabeling claim must be consistent
with the reasonable excess exception to survive dismissal. Chavez contends that he need only
allege that the Vitafusion label “list an inaccurate quantity” of folic acid for his mislabeling
claim to avoid preemption. (Id. at 6.) What Chavez means by inaccurate here is that any
discrepancy between the actual and labeled amounts of folic acid in a supplement constitutes a
violation of the FCDA. But that is not so. To be sure, the Act flatly bars Church from overstating
the amount of folic acid in Vitafusion. See CreAgri, Inc. v. USANA Health Sci., Inc., 474 F.3d
626, 631 (9th Cir. 2007) (“Because the actual amount of hydroxytyrosol (at most 3mg) was less
9
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than the values . . . declared on Olivenol’s label (25 mg and 5mg), [the] product was . . . in
violation of 21 C.F.R. § 101.9(g)(4)(i).”). But, as explained above, the FDCA permits
manufacturers to under declare folic acid by a reasonable amount. Chavez seeks to hold Church
liable for understating the quantity of folic acid, so whether the mislabeling claim is preempted
turns on whether the folic acid discrepancy in Vitafusion was within the “reasonable excess”
provision of the regulation.
Where the Court parts ways with Church is its contention that the amended complaint
does not plausibly allege a violation of the reasonable excess provision. Chavez alleges that the
concentration of folic acid in Vitafusion is over 300% greater than the amount listed on the label.
(Am. Compl. ¶¶ 41, 46.) He further asserts that the actual amount of folic acid in Vitafusion is
potentially dangerous and may cause severe adverse health effects. (Id. ¶¶ 31-33, 45.) This is not,
as Church maintains, “rank speculation.” (Def. Reply 6.) Given that the Court is required to
accept all well-pleaded facts as true and construe all reasonable inferences in the Chavez’s favor,
these allegations are enough to suggest that Church added more folic acid to Vitafusion than was
necessary to ensure that the level of folic acid meets the labeled amount over the course of the
supplement’s shelf life. It is surely plausible to infer that adding dangerous amounts of folic acid
to Vitafusion is not consistent with cGMP. Thus, even under Church’s reading of the reasonable
excess provision (more on that below), the mislabeling claim is plausibly consistent with federal
labeling law. To be sure, it remains to be seen whether the predicate for Chavez’s argument bears
up under scrutiny. But his claim that including harmful levels of folic acid falls outside the
bounds of reasonableness or cGMP is by no means implausible.
Before moving on, there are two issues concerning Church’s reading of the reasonable
excess provision that merit discussion. First, Church assumes that Chavez bears the burden under
10
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§ 101.9(g)(6); that is, he bears the burden to plead and prove that the amount of folic acid was
unreasonable in light of cGMP. But it is not clear whether that is the case. The issue boils down
to how the “at least equal to” and “reasonable excess” provisions should be read together. It is
possible to interpret the two regulations, as Church seems to, to mean that a label that understates
the content of a nutrient is FDA compliant unless the difference between the labeled and actual
amount is an unreasonable excess. When viewed in this light, Chavez would bear the burden of
showing that any excess was unreasonable. But another possible way to read these regulations—
especially in light of the FDCA’s general prohibition against false and misleading statements—is
that any discrepancy between the actual and labeled amounts constitutes a prima facie
misbranding violation. Under this view, the reasonable excess provision serves as a safe harbor
and Church would bear the burden of seeking its protection. See, e.g., EEOC v. Chicago Club, 86
F.3d 1423, 1429 (7th Cir. 1996) (“It is a commonly accepted canon that [o]ne who claims the
benefit of an exception for the prohibition of a statute has the burden of proving that his claim
comes within the exception.”) (internal quotation marks and citation omitted). The Court need
not resolve this question now, as it concludes that Chavez plausibly states a claim for mislabeling
even if he bears the burden of proof. But the parties may need to address this issue going forward
if the litigation proceeds past the discovery stage.
Second, Church suggests that the application of the reasonable excess provision turns
solely on whether an excess is necessary to ensure a nutrient declaration is accurate during the
shelf life of product. 9 Put somewhat differently, Church argues that “excesses” and “overages”
are one in the same. But it is not evident from the FDA’s commentary whether overages are
9
In its opening brief, Church states that the shelf-life issue is only “one question [the]
FDA would consider” in addressing the reasonable excess provision. (Def. Mot. 6.) But Church
goes further in its reply, arguing that the Chavez “must plausibly allege” that the additional folic
acid in Vitafusion is not an overage. (Def. Reply 10.)
11
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synonymous with, or merely a subset of, excesses. In theory, an excess could result from some
reason other than addressing shelf-life concerns, such as when a variance occurs a result of the
manufacturing process itself. The Court need not unravel this issue either; it suffices at this point
to note that Church has not shown that the degradation of a nutrient over the product’s shelf life
is the only relevant consideration under § 101.9(g)(6).
Church advances one other challenge to Chavez’s mislabeling claim, but it too is wanting
at this stage. Church contends that the claim is preempted because the FDA has not set an upper
limit on the amount of folic acid that may be added to supplements. (Def. Mot. 6-7.) While the
NIH may recommend a UTIL of 1,000 mcg, Church argues, a manufacturer does not violate the
FDCA by exceeding that threshold. But even assuming Church is correct in asserting that the
FDA does not recognize a UTIL for folic acid—an issue Chavez disputes—it does not follow
that the mislabeling claim is preempted. Chavez’s theory is that the Vitafusion label misleads
consumers because it grossly understates the amount of folic acid. That the actual amount of
folic acid in Vitafusion exceeds the UTIL set by the NIH is relevant because it is evidence—
though by no means conclusive—that the excess folic acid in Vitafusion is unreasonable and thus
inconsistent with § 101.9(g)(6). To be sure, whether the FDA recognizes a 1,000 mcg upper limit
bears on the reasonable excess analysis as well. But contrary to Church’s contention, it does not
resolve the issue conclusively. At bottom then, Chavez plausibly alleges that Vitafusion is
misbranded within the confines of the FDCA and thus the Court cannot conclude at this stage
that his mislabeling claim is preempted.
Nor can the Court conclude that Chavez’s other three claims are preempted. Church
argues that because Chavez’s claims are all “premised on the same allegations,” the rest of the
claims are preempted for the same reason as the mislabeling claim. (Def. Mot. 8.) Given that the
12
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Court finds the mislabeling claim is not subject to preemption at the pleading stage, this
argument lacks any force. But even setting that argument aside, two of the remaining three
claims are not even implicated by the NLEA’s preemption statute. As Church points out, the
statute applies only to claims that impose requirements on the labeling or packaging of food—or
in this case, dietary supplements. (Id. at 5 (citing Reyes v. McDonald’s Corp., No. 06 C 1604,
2006 WL 3253579, at *5 (N.D. Ill. Nov. 8, 2006).) Unlike his mislabeling claim, though,
Chavez’s misrepresentation claim is based on statements made on Church’s website, not on any
product label or packaging. See Sciortino v. Pepsico, Inc., 108 F. Supp. 3d 780, 807 (N.D. Cal.
2015) (rejecting application of NLEA preemption to statements made on defendant’s website
because defendant “pointed to no provision of the FDCA or FDA regulations that preempts
claims based on such alleged misrepresentations, which are not alleged to be included on product
labels or packaging”). And as for Chavez’s fitness claim, the crux of that claim is that Vitafusion
is not fit for consumption. (Am. Compl. ¶¶ 13, 40, 120.) Thus, it does not implicate any of the
FDCA’s labeling or packaging requirements either.
The Court is left then only with Chavez’s claim that Vitafusion fails to warn consumers
that it contains an unsafe level of folic acid. This claim falls squarely within the reach of § 343(a)
as it impliedly requires Church to add an additional warning to the Vitafusion label. The problem
here is that Church does not provide the Court with a basis to conclude that such a warning goes
beyond the requirements of the FDCA. Church vigorously contends that the amount of folic acid
in Vitafusion is in fact safe, but does not address the relevant question for preemption: does the
FDCA impose any requirements on manufacturers to disclose potential adverse effects of
consuming certain levels of nutrients? To be sure, Church’s position likely is that no such
requirement exists, especially given that it argues elsewhere that the FDA does not limit the
13
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amount of folic acid that may be used in supplements. But Church does not stake out that
position in its brief. Nor does its discussion about the limits of folic acid usage (or lack thereof)
make clear whether the FDA imposes any sort of obligation to warn consumers about
overconsumption of nutrients and if so, under what circumstances. Church bears the initial
burden to properly put the defense of preemption before the Court, Russian Media, 598 F.3d at
309, but has failed to meet that burden with regard to the nondisclosure claim. The Court cannot
conclude, on the basis of Church’s argument, that the non-disclosure claim is preempted.
Church’s motion to dismiss based on federal preemption is denied.
II.
Primary Jurisdiction
As a back stop to preemption, Church asks the Court to stay or dismiss this case under the
doctrine of primary jurisdiction to allow the FDA to determine whether the amount of folic acid
in Vitafusion is in fact protected by the reasonable excess provision. 10 Primary jurisdiction
encompasses two concepts; one of exclusive agency jurisdiction and one of abstention. Arsberry
v. Illinois, 244 F.3d 558, 563 (7th Cir. 2001). Church invokes the latter concept here, under
which, a district court may refer an issue over which it has jurisdiction to an agency with
specialized expertise or knowledge for resolution. Reiter, 507 U.S. at 268 (stating that the
doctrine “requires the court to enable a ‘referral’ to the agency, . . . so as to give the parties
reasonable opportunity to seek an administrative ruling”); In re StarNet, Inc., 355 F.3d 634, 639
(7th Cir. 2004) (explaining that the doctrine, “in its weaker sense” allows “a court to refer an
issue to an agency that knows more about the issue”). There is no “fixed formula” for deciding
10
Although Church seeks either a stay or dismissal, a dismissal would not be warranted
even if the doctrine applies. See Reiter v. Cooper, 507 U.S. 258, 268 (1993) (stating that the
doctrine results in “staying further proceedings”) (emphasis added) (citation omitted); see also
Ryan v. Chemlawn Corp., 935 F.2d 129, 132 n.2 (7th Cir. 1991) (discussing in dicta strong
preference for issuing stay, rather than dismissal without prejudice, on primary jurisdiction
grounds). As such, the Court will consider only whether a stay is warranted.
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whether to abstain under primary jurisdiction; rather, a case-by-case determination must be made
in light of the purpose of the applicable statute and the relevance of the administrative expertise.
Ryan, 935 F.2d at 131 (citation omitted). Considerations that animate this decision include
whether (1) invoking the doctrine promotes consistency and uniformity, (2) the agency is
uniquely qualified to resolve a complex issue that is outside the conventional experience of the
courts, and (3) the application of the doctrine serves judicial economy because the dispute may
be decided within the agency. Id. (citations omitted).
Church believes that abstention is warranted for two reasons. First, the principal issue in
this case requires scientific and industry expertise that the FDA has and this Court lacks. (Def.
Mot. 10-12.) In particular, Church contends that the dispute turns on the reasonable excess
provision and construing that provision will require knowledge of folate levels, folate safety, and
cGMP in the vitamin field. (Id. at 11.) Second, interpreting the regulation is a matter of first
impression and, as such, the Court should default to the FDA to ensure consistency and
uniformity in the field of nutrition labeling. (Id.) Chavez counters that the Court should press
forward with this case because it is capable of interpreting regulations and because Church has
failed to show that the FDA is contemplating issuing specific guidance on the reasonable excess
provision. (Pl. Resp. 10-13.) Chavez has the better of this argument.
The principal difficulty with applying the primary jurisdiction doctrine here is that
Church has not identified any relevant proceedings to which this Court should defer in resolving
the reasonable excess issue. Absent some plausible proposal for obtaining a determination from
the FDA, a stay would do nothing more than hold Chavez’s claim in limbo. If Church were
serious about deferring this issue to the FDA, it presumably would have explained what
administrative proceedings could be initiated that would definitively interpret the provision and
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adjudicate Vitafusion’s compliance. See Natural Res. Def. Council v. Metro. Water Reclamation
Dist. of Greater Chi., 175 F. Supp. 3d 1041, 1048 (N.D. Ill. 2016) (rejecting primary jurisdiction
argument on same basis); Biffar v. Pinnacle Foods Grp., LLC, No. 16-0873-DRH, 2016 WL
7264973, at *2 (S.D. Ill. Dec. 15, 2016) (declining to stay action on primary jurisdiction grounds
in suit alleging muffin mix label was deceptive because benefits of stay were speculative and
stay would unduly prejudice plaintiff).
Church also overstates the need to rely on the FDA’s expertise. Federal district courts are
well equipped to interpret agency regulations, including those involving current good
manufacturing practices. See Gubala, 2016 WL 1019794, at *16 (stating that district courts are
“well qualified to interpret [agency] regulation” in rejecting primary jurisdiction argument);
Bausch v. Stryker Corp., 630 F.3d 546, 556 (7th Cir. 2010) (stating that interpretation cGMP
regulations “present[s] questions of law for the court to decide” that is “subject to the usual
processes for reconciling conflicting views”). Moreover, this case primarily concerns allegations
of false and misleading representations, the sort of allegations that district courts routinely
address. See, e.g., Biffar, 2016 WL 7264973, at *2 (adding that district courts are “well-suited to
entertain . . . consumer fraud case[s]”). To be sure, the Court may need to evaluate scientific
evidence at some point in this case. But it is not apparent at this stage that the FDA’s expertise
will be required in order to do so, especially when Church has not articulated exactly how the
agency would adjudicate the reasonable excess issue at hand.
Finally, while Church’s concerns about consistency and uniformity carry some weight,
they do not tip the scale in favor of a stay. The FDA somewhat recently has indicated that it is
contemplating additional guidance relevant to the reasonable excess provision. In a final rule
issued in May 2016, the FDA reported that it had received comments that “expressed concern
16
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that firms may include large excesses (greater than 120 percent of the declared amount) to
remain in compliance with requirements for Class I nutrients and other dietary ingredients over
the shelf life of the product.” Food Labeling: Revision of the Nutrition and Supplement Facts
Labels, 81 Fed. Reg. 33742, 33964 (May 27, 2016). In response to those public comments, the
FDA stated that “[p]roduct loss over the shelf-life of a product is a complex issue” as to which it
“needs additional time to review available information and to make a determination whether to
propose changes with respect to the requirements for Class I nutrients.” Id. at 33965. What the
Court gleans from these statements is that the FDA may issue overage requirements or
restrictions for folic acid and other Class I nutrients. The problem with issuing a stay on this
basis is that there is no indication of when, if ever, the FDA will act. Even if the FDA does act in
the near future, there also is no guarantee that it would squarely address the issues raised in this
litigation. See Krommenhock, 255 F. Supp. 3d at 969 (declining to issue stay due to the lack of
“evidence that final action (or any further clarification as to the scope of the FDA’s review of the
regulation at issue) is imminent”); Burton v. Hodgson Mill, Inc., No. 16-CV-1081-MJR-RJD,
2017 WL 1282882, at *8 (S.D. Ill. Apr. 6 2017) (rejecting argument that court should grant stay
to allow FDA time to formulate definition of term “all natural” because agency had not issued
timeframe for decision and stay would unnecessarily protract litigation). Therefore, given the
uncertainty and the likely prejudice Chavez would face if granted, the Court declines to issue a
stay based on the primary jurisdiction of the FDA.
III.
Nationwide and Multistate Class Claims
Church’s next argument is that Chavez is barred from asserting any claims on behalf of
putative class members outside of Illinois. According to Church, there are two reasons why that
17
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is the case: lack of standing and lack of personal jurisdiction.11 Because the Court agrees with
Church that the claims of out-of-state residents do not provide this Court with a basis to exercise
personal jurisdiction over Church, it need not consider the standing challenge.
Although Church’s motion expressly invokes only Rule 12(b)(6), a dismissal for lack of
personal jurisdiction is governed by Rule 12(b)(2). A complaint is not required to include facts
alleging personal jurisdiction, but when a defendant moves to dismiss under Rule 12(b)(2), the
plaintiff bears the burden of demonstrating personal jurisdiction over the defendant. N. Grain
Mktg., LLC v. Greving, 743 F.3d 487, 491 (7th Cir. 2014). Where, as here, the parties rely solely
on written materials, the plaintiff need only establish a prima facie case for personal jurisdiction.
Id. In determining whether that burden has been met, the Court resolves any factual disputes in
the plaintiff’s favor, id.; though, the facts material to jurisdiction in this case are not in dispute.
Where no federal statute authorizes nationwide service of process, federal courts look to
state law to determine the limits of their personal jurisdiction over a party. Fed. R. Civ. P.
4(k)(1)(A). The Illinois long-arm statute permits courts to exercise personal jurisdiction up to the
limits of the Due Process Clause of the Fourteenth Amendment. 735 ILCS 5/2-209(c); Kipp v.
Ski Enter. Corp. of Wis., 783 F.3d 695, 697 (7th Cir. 2015). “Thus, the state statutory and federal
constitutional requirements merge.” Brook v. McCormley, 873 F.3d 549, 552 (7th Cir. 2017).
The Due Process Clause limits the power of courts to render judgments over nonresident
defendants; personal jurisdiction arises only when the defendant has “certain minimum contacts
11
Although Church raised its personal jurisdiction challenge for the first time in its reply
brief, the Court declines to deem that argument as waived for two reasons. First, the argument is
premised squarely on Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017), a
decision that was not handed down until after Church filed its motion to dismiss. (Def. Reply
14.) Second, Chavez had an adequate opportunity to respond. He preemptively addressed
Bristol-Myers in his response brief, (Pl. Resp. 14), and also filed a sur-reply, (Pl. Sur-Reply in
Opp’n to Def. Mot. to Dismiss, ECF No. 32). While Chavez did not use his sur-reply to address
personal jurisdiction, he could have had he thought it was necessary.
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with [the forum state] such that the maintenance of the suit does not offend ‘traditional notions of
fair play and substantial justice.’” Int’l Shoe Co. v. Washington, 326 U.S. 310, 316 (1945)
(citations omitted). Although physical presence in the forum is not required, the defendant must
have sufficient minimum contacts such that it “should reasonably anticipate being haled into
court there.” Burger King Corp. v. Rudzewicz, 471 U.S. 462, 474 (1985) (quoting World-Wide
Volkswagen Corp. v. Woodson, 444 U.S. 286, 297 (1980)).
In Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017), the Supreme
Court considered several suits in California state court by a number of California residents and
nonresidents against a pharmaceutical manufacturer who was not subject to general jurisdiction
in California. Id. at 1778. The plaintiffs alleged that they were harmed by the manufacturer’s
drug Plavix; however, none of the nonresidents had purchased, consumed, or were prescribed
Plavix in California. Id. The California Supreme Court held that there was specific jurisdiction
over the nonresidents’ claims because they were “similar in several ways to the claims of the
California residents (as to which specific jurisdiction was uncontested).” Id. at 1778-79. The
United States Supreme Court disagreed, holding that there was an insufficient link between
California and the nonresidents’ claims to support specific jurisdiction given that none of the
conduct giving rise to those claims occurred in California. Id. at 1781. The Court explained,
“[t]he mere fact that other plaintiffs were prescribed, obtained, and ingested Plavix in
California—and allegedly sustained the same injuries as did the nonresidents—does not allow
the State to assert specific jurisdiction over the nonresidents’ claims.” Id. In so holding, the Court
emphasized two principles of personal jurisdiction. It first reiterated that the “primary focus of
[the] personal jurisdiction inquiry is the defendant’s relationship with the forum state.” Id. at
1779. It then reaffirmed that the jurisdictional inquiry “encompasses the more abstract matter of
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submitting to the coercive power of a State that may have little legitimate interest in the claims in
question.” In some cases, the Court continued, the Due Process Clause of the Fourteenth
Amendment, “acting as an instrument of interstate federalism” serves to “divest the State of its
power to render a valid judgment.” Id. (quoting World-Wide Volkswagen, 444 U.S. at 294).
Relying on Bristol-Myers, Church contends that, because it is not subject to general
jurisdiction in Illinois, 12 it may be sued in Illinois only by consumers whose claims arise out of
Church’s contacts with Illinois, i.e., those who purchased or consumed Vitafusion in Illinois.
(Def. Reply 14.) The import of this argument is that Chavez may not assert claims on behalf of
either a nationwide or multistate class. Chavez does not argue that Church’s understanding of
Bristol-Myers is flawed; rather, he contends that the holding is inapplicable here because that
case involved a mass action while this suit is a class action. (Pl. Resp. 14 n.5.) In support,
Chavez cites to Justice Sotomayor’s dissent in Bristol-Myers, in which she noted that the
majority left open the question of whether its holding “would also apply to a class action in
which a plaintiff injured in the forum State seeks to represent a nationwide class of plaintiffs, not
all of whom were injured there.” 137 S. Ct. at 1789 n.4.
Whether Bristol-Myers extends to class actions is a question that has divided courts
across the country. A number of district courts have concluded that the distinction between mass
and class actions limits the reach of the Supreme Court’s holding. E.g., In re ChineseManufactured DryWall Prods., Civ. Act. MDL No. 09-2047, 2017 WL 5971622, at *13-16 (E.D.
La. Nov. 30, 2017) (finding Bristol-Myers to be inapplicable to class actions, in part, because
12
The parties agree that Church is incorporated in Delaware and has its principal place of
business in New Jersey. (Am. Compl. ¶ 20; Def. Reply 14.) Moreover, Chavez does not allege
any facts that give rise to the inference that Church’s operations are so substantial in Illinois as to
render it essentially at home in the state. See BNSF Ry. Co. v. Tyrrell, 137 S. Ct. 1549, 1558
(2017) (citations omitted).
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class actions have due process safeguards under Rule 23 that mass actions lack); FitzhenryRussell v. Dr. Pepper Snapple Grp., Inc., No. 17-cv-00564 NC, 2017 WL 4224723, at *5 (N.D.
Cal. Sept. 22, 2017) (holding that “Bristol-Myers is meaningfully distinguishable based on that
case concerning a mass tort action, in which each plaintiff was a named plaintiff”). Other district
courts, including several within this district, have concluded that the distinction is irrelevant and
have applied Bristol-Myers to class actions. E.g., Practice Mgmt. Support Servs., Inc. v. Cirque
du Soleil, Inc., No. 14 C 2032, 2018 WL 1255021, at *16 (N.D. Ill. Mar. 12, 2018) (holding that
defendants cannot “distinguish the Supreme Court’s basic holding in Bristol-Myers simply
because this is a class action”); DeBernardis v. NBTY, Inc., No. 17 C 6125, 2018 WL 461228, at
*2 (N.D. Ill. Jan. 18, 2018) (“The Court believes that it is more likely than not . . . that the courts
will apply Bristol-Myers Squibb to outlaw nationwide class actions . . . where there is no general
jurisdiction over the Defendants.”); McDonnell v. Nature’s Way Prods., LLC, No. 16 C 5011,
2017 WL 4864910, at *4 (N.D. Ill. Oct. 26, 2017) (stating that “the analysis used in BristolMyers Squibb Co. is instructive in considering whether the Court has personal jurisdiction over
the claims” of non-Illinois class members).
This Court finds the latter line of cases to be persuasive. Nothing in Bristol-Myers
suggests that its basic holding is inapplicable to class actions; “rather, the Court announced a
general principle—that due process requires a ‘connection between the forum and the specific
claims at issue.’” Greene v. Mizuho Bank, Ltd., No. 14 C 1437, 2017 WL 7410565, at *4 (N.D.
Ill. Dec. 11, 2017) (citing Bristol-Myers, 137 S. Ct. at 1781). To the contrary, the Court’s
concerns about federalism suggest that it seeks to bar nationwide class actions in forums where
the defendant is not subject to general jurisdiction. See DeBernardis, 2018 WL 461228, at *2.
And, as Judge Durkin recently pointed out, “[u]nder the Rules Enabling Act, a defendant’s due
21
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process interest should be the same in the class context” as it is in individual or mass actions.
Practice Mgmt., 2018 WL 1255021, at *16 (“Rule 23’s [class action] requirements must be
interpreted in keeping with Article III constraints, and with the Rules Enabling Act, which
instructs that the [federal court] rules of procedure shall not abridge, enlarge, or modify any
substantive right.”) (alterations in original) (internal quotation marks omitted) (quoting Amchem
Prods., Inc. v. Windsor, 521 U.S. 591, 592 (1997)).
Further, the Court is unpersuaded by the reliance of some district courts on the fact that
the citizenship of unnamed class members is disregarded for purposes of determining diversity—
that is, subject matter—jurisdiction. The question here is not whether this Court has subject
matter jurisdiction, but whether, consistent with due process, this Court may exercise specific
personal jurisdiction over a defendant with regard to claims that have no connection with this
state beyond their similarity to claims asserted by other plaintiffs who are residents of this state.
The focus of the due process inquiry is on whether the defendant’s contacts with the state of
Illinois give rise to the claims of nonresident plaintiffs. Whether the citizenship of unnamed class
members should be disregarded for purposes of determining whether diversity jurisdiction exists
simply has no relevance to the answer to that question.
The Court therefore concludes that Bristol-Myers extends to class actions, and that
Chavez is therefore foreclosed from representing either a nationwide and multistate class
comprising non-Illinois residents in this suit. Accordingly, the Court dismisses those claims
under Rule 12(b)(2) without prejudice to being reasserted in a court that can exercise personal
jurisdiction over the defendant. See DeBernardis, 2018 WL 462338, at *2 (granting motion to
dismiss the claims of “out-of-state plaintiff classes”); McDonnell, 2017 WL 4864910, at *4-5
(dismissing claims of non-Illinois class members).
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IV.
Remaining Arguments
Before closing, the Court must address two arguments that Church raises in footnotes in
its opening brief—neither of which prompted a response from Chavez. 13 First, Church contends
that Chavez’s online misrepresentation claim fails because he does not allege that he read any of
the statements on Church’s website before purchasing Vitafusion. (Def. Mot. 7 n.4.) The Court
agrees. To succeed on his misrepresentation claim, which is predicated on the ICFA and
common law fraud, Chavez must plead and prove that the online statements proximately caused
the harm he claims (ICFA) or that he justifiably relied on the statements to his detriment
(common law fraud). Newman v. Metro. Life. Ins. Co., 855 F.3d 992, 1000, 1003 (7th Cir. 2018)
(outlining elements of both causes of action). By failing to allege that he read the statements on
Church’s website, there is no basis to conclude that Chavez relied on them in purchasing
Vitafusion or that they induced him to purchase the supplement. Thus, the Court dismisses
Chavez’s online misrepresentation claim pursuant to Rule 12(b)(6). The dismissal, however, is
without prejudice; Chavez has leave to re-plead his claim to address this issue, if he is able.
Second, Church challenges the viability of Count VI. It contends that unjust enrichment
is not an independent cause of action and must be dismissed because it is predicated on Chavez’s
claims under the ICFA. (Def. Mot. 8 n.5.) Church is wrong on both accounts. For starters, the
Illinois Supreme Court on several occasions has described unjust enrichment as an independent
cause of action. See, e.g., Raintree Homes, Inc. v. Village of Long Grove, 209 Ill. 2d 248, 807
N.E.2d 439, 445 (2004) (observing that “plaintiffs have no substantive claim grounded in tort,
contract, or statute; therefore the only substantive basis for the claim is restitution to prevent
13
The Court cautions the parties going forward about raising arguments in footnotes. The
Seventh Circuit has reiterated time and again that skeletal and undeveloped arguments raised in
footnotes are subject to waiver. See, e.g., Harmon v. Gordon, 712 F.3d 1044, 1053 (7th Cir.
2013); Hernandez v. Cook Cty. Sherriff’s Office, 634 F.3d 906, 913 (7th Cir. 2011).
23
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unjust enrichment”). Church’s argument to the contrary is based not on more recent Illinois
Supreme Court authority than Raintree, but on the Seventh Circuit’s decision in Pirelli
Armstrong Tire Corp. Retiree Medical Benefits Trust v. Walgreen Co., a case in which the Court
of Appeals held that unjust enrichment is not a standalone claim under Illinois law. 631 F.3d
436, 447 (7th Cir. 2011). But Church fails to realize that the Seventh Circuit altered course
several months later in Cleary v. Phillip Morris Inc., 656 F.3d 511 (7th Cir. 2011). After
examining the issue more closely, the Court of Appeals acknowledged that it was an open
question as to whether unjust enrichment may be redressed through a separate cause of action.
Id. at 518. In all events, the distinction matters little here. Because Chavez’s mislabeling claim
survives, Count VI survives even if it is tied to that claim under the ICFA.
*
*
*
For the above reasons, Church’s motion to dismiss is granted in part and denied in part.
Chavez’s claim that Church mispresents the quality of its dietary supplements and labeling on its
website is dismissed without prejudice. Chavez’s claims also are dismissed to the extent they are
asserted on behalf of any putative class members who did not purchase or consume Vitafusion
within Illinois. The Court lacks personal jurisdiction over Church with respect to claims asserted
by such consumers and, as a result, any claims asserted on their behalf are denied without
prejudice to being reasserted in a court that can exercise personal jurisdiction over the defendant.
In all other respects, Church’s motion is denied. A status hearing is set for May 31, 2018.
John J. Tharp, Jr.
United States District Judge
Date: May 16, 2018
24
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