Muir v. NBTY, Inc. et al

Filing 38

MEMORANDUM Opinion and Order Signed by the Honorable Rebecca R. Pallmeyer on 9/22/2016. Mailed notice. (etv, )

UNITED STATES DISTRICT COURT
NORTHERN DISTRICT OF ILLINOIS
EASTERN DIVISION
MICHAEL MUIR, individually and on
behalf of all others similarly situated,
Plaintiff,
v.
NBTY, INC., REXALL SUNDOWN, INC.,
NATURE’S ORIGIN, LLC, NATURE’S
BOUNTY, INC., VITAMIN WORLD, INC.,
and PURITAN’S PRIDE, INC.,
Defendants.

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No. 15 C 9835
Judge Rebecca R. Pallmeyer

MEMORANDUM OPINION AND ORDER
Plaintiff Michael Muir purchased a bottle of the dietary supplement St. John’s Wort from
a Walgreens store in Illinois in 2015. The label states that the product is “[s]tandardized to
contain 0.3% Hypericin, 0.9 mg.” Muir claims the product actually contains a far lower amount
of hypericin, purportedly the active ingredient in St. John’s Wort. Muir filed this action on behalf
of a nationwide class of persons who purchased St. John’s Wort Standardized Extract from any
of five different manufacturers. Defendants move to dismiss the complaint for lack of standing
and failure to state a claim. For the reasons explained here, the motion is granted in part and
denied in part. Muir has leave to file an amended complaint against the manufacturer of the
supplement he himself purchased.
BACKGROUND
On November 3, 2014, Muir filed this class action on behalf of all persons in the United
States “who purchased the dietary supplements St. John’s Wort Standardized Extract” from
Defendants, five manufacturers of nutritional supplements, and their joint corporate parent.
(Compl. [1] ¶¶ 1, 46.) Plaintiff alleges that the dietary supplements sold by Defendants “did not
contain consistent amounts of the sole active ingredient Standardized Extract Hypericin listed
on their labels” and that Defendants’ advertising and distribution of the products was false,
misleading, and deceptive.

(Id. ¶¶ 5, 6.)

Muir himself, a resident of Lake Zurich, Illinois,

purchased the product from a retailer, Walgreens, in July 2015. (Id. ¶ 13.) Defendants are
allegedly “licensed” in Delaware and have their principal places of business in New York.
(Id. ¶¶ 14-20.)

Defendant NBTY, Inc. is the parent company of the other five Defendants.

(Id. ¶ 14.)
Plaintiff alleges that there is no legal or regulatory definition of the term “standardized,”
but that a standardized extract is understood to have “one or more components present in a
specific, guaranteed amount, usually expressed as a percentage,” and that the “intention behind
standardization of herbs is to guarantee that the consumer is getting a product in which the
chemistry is consistent from batch to batch.” (Id. ¶¶ 23, 24.) He asserts that when purchasers
shop for a St. John’s Wort Product, they expect to receive the “guaranteed” amount on the label.
(Id. ¶ 26.) Included in the complaint are images of the labels of the products distributed by
Defendants, each of them bearing the figure “300 mg.,” and stating that the product is
“[s]tandardized to contain 0.3% Hypericin, 0.9 mg.”

(Id. ¶¶ 27-28.)

In fact, however, the

products actually contain different amounts of hypericin, all far less than the amount listed on
the label. (Id. ¶ 29.) Attached to the complaint as Exhibits A through E are test results of the
products distributed by the Defendant manufacturers. For the five products tested, the total
amount of hypericin per serving ranged from as little as 0.166 milligrams to 0.615 milligrams.
None contained an amount close to 0.9 milligrams. (Test Results, Exs. A-E to Compl.).
St. John’s Wort is “promoted as an anti-depressant herb” that has “shown benefits” in
the dosage amount of 0.9 milligrams per day—the “exact amount” that the packaging touts as
present in Defendants’ products. (Id. ¶¶ 31, 32.) In fact, as Defendants knew, the products
“contain less of the standardized extract than claimed.” (Id. ¶ 32.) Plaintiff alleges that he and
other class members purchased and consumed the products in reliance on the misleading
labeling, and would not have done so had they realized that the products contained less of the
standardized extract than the labels stated. (Id. ¶ 36.) The difference between what the labels
stated and what was actually delivered in the products is “significant,” Plaintiff alleges, and has
2

“real impacts on the benefits provided to consumers.” (Id. ¶ 38.) He contends that the false
statements in Defendants’ labeling violate federal and state laws which prohibit “misbranding” of
food and nutritional supplement with labels that contain a statement “false or misleading in any
particular.” (Id. ¶¶ 39-42 (citing 21 U.S.C. § 343(a)(1); 410 ILCS 620/11, 620/21).) 1
Plaintiff brings this case on behalf of himself and all persons in the United States who
purchased the products.

He also seeks to assert consumer fraud claims on behalf of all

purchasers in the states of California, Florida, Illinois, Massachusetts, Michigan, Minnesota,
Missouri, New Jersey, New York, and Washington, referred to as the “multi-state class.” (Id.
¶ 46.) The complaint alleges four counts: A claim of violation of state consumer fraud acts on
behalf of the multi-state class (Count I); a claim of violation of the Illinois Consumer Fraud Act,
815 ILCS 505/1, et seq., on behalf of Illinois purchasers (Count II); a claim of unjust enrichment
on behalf of the nationwide class (Count III); and a claim of breach of express warranty on
behalf of the nationwide class (Count IV). He claims each member of the class has been
damaged “in the amount of the purchase price of the products and any consequential damages
resulting from the purchases.” (Id. ¶ 81.)
Defendants have moved to dismiss the complaint in its entirety. They raise several
arguments: First, they contend the court has no jurisdiction over this case because Plaintiff has
not alleged any harm resulting from the hypericin level in any product he bought, and therefore
lacks standing.

Second, Defendants assert that none of them are subject to personal

jurisdiction in this court. Defendants’ third argument is that the complaint fails as a matter of law
because federal law expressly preempts his claims and because the sampling method on which
the complaint rests is inadequate. Moreover, Defendant urges, federal law allows for “natural
1

For obvious reasons, both parties in this case assume that St. John’s Wort has
therapeutic value, and that hypericin is the source of the treatment effect. That assumption
could be questioned. As early as 2002, the National Institutes of Health reported that a
randomized, double-blind trial compared the use of a standardized extract of St. John’s Wort to
a placebo, and found the extract no more effective than placebo in treating major depression of
moderate severity. Press Release, Nat’l Insts. of Health, Study Shows St. John’s Wort
Ineffective for Major Depression of Moderate Severity (Apr. 9, 2002), https://nccih.nih.gov/
news/2002/stjohnswort/pressrelease.htm.
3

variability” in the nutrient content of foods, and the allegations do not establish that the nutrient
level of any of Defendants’ products falls outside the range of natural variability. Plaintiff has
misinterpreted the term “standardized,” Defendants assert. They argue, further, that because
Plaintiff did not purchase any product directly from any Defendant, and because he did not
notify Defendants before suing them, as required by Illinois law, the court must dismiss the
breach-of-warranty claim.

The flaws in Plaintiff’s consumer claim requires dismissal of his

unjust-enrichment claim, as well, they assert. Finally, Defendants argue that Plaintiff has not
pleaded fraud with particularity, as required by federal pleading standards, and has not
established any right to injunctive relief. The court concludes that several of these arguments
have merit.

The complaint in its current form will be dismissed without prejudice, for the

reasons explained here.
I.

Standing
A.

Plaintiff has standing to sue for the product he purchased

Defendants’ threshold argument is that Plaintiff lacks standing because he has not
identified an “injury in fact” that is both concrete and particularized. In support, Defendants note
that Plaintiff has not specified which of their products he purchased and cannot allege that the
one he did purchase in July 2015 was in fact low in hypericin or that it was of no benefit to him.
Defendants are correct that Plaintiff has not identified which of the products he took, but
he did allege that he and other class members “purchased and consumed” the products in
reliance on labels that assured them the products contained particular quantities of the desired
ingredient. (Compl. ¶ 33.) Plaintiff’s failure to identify any physical harm that he may have
suffered, or even to allege that the product did not “work” is not fatal to his claim. He has
alleged a financial loss—specifically, that he and the class members would not have purchased
the products at issue, had they known that the quantity of hypericin in those products was
“significantly lower” than what was stated on the label. The Seventh Circuit has recognized that
one who has allegedly paid more for a product in reliance on misrepresentations about the
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product’s quality has standing to sue for recovery of the financial loss. In Aqua Dots Prods.
Liability Litig., 654 F.3d 748 (7th Cir. 2011), plaintiffs alleged that a children’s toy consisted of
beads that resembled candy but were harmful if swallowed. The Seventh Circuit concluded that
parents of children who had not been physically injured nevertheless had standing because,
having paid more for the toys than they would have, had they known of the hazard, the parents
had suffered financial injury. “A financial injury creates standing,” the court observed. 654 F.3d
at 749. Judge Feinerman of this court followed Aqua Dots in Muir v. Playtex Prods., LLC, 983
F. Supp. 2d 980, 983 (N.D. Ill. 2013), where plaintiff and a class he sought to represent had
purchased defendant’s “Diaper Genie” product at a premium price, in reliance on the
defendant’s claim—defeated by independent testing--that the product had been “Proven #1 in
Odor Control.” And in Askin v. Quaker Oats Co., 818 F. Supp. 2d 1081, 1084 (N.D. Ill. 2011),
Judge Kim agreed with plaintiffs that they had standing to pursue a claim that defendant had
falsely touted its oatmeal and granola products as being “wholesome” and “heart healthy” when
those products in fact contained trans fats.
Defendants contend that the Seventh Circuit has walked back a bit from this thinking.
They cite Remijas v. Neiman Marcus Group, LLC, 794 F.3d 688, 694 (7th Cir. 2015), where the
court recognized that credit card holders had a claim only for amounts they paid to protect
themselves from the consequences of a retailer’s data breach. In reaching that conclusion, the
court also considered plaintiffs’ alternative argument that the data breach resulted in their
overpaying for products; the court was “dubious” that the overpayment injury was one that
would establish standing. Significantly, however, the Remijas court explicitly distinguished the
data breach situation from the circumstances in Chicago Faucet Shoppe, Inc. v. Nestle Waters
North America, Inc., 24 F. Supp. 3d 750 (N.D. Ill. 2014). Plaintiff there had claimed it overpaid
for bottled water it purchased from defendant in reliance on false statements on defendant’s
website that the water was “100% natural spring water.” Judge Tharp of this court dismissed
that complaint on other grounds, but was satisfied that plaintiff’s alleged overpayment was
5

sufficient to establish “injury and causation for purposes of Article III standing.” Id. at 756. The
Remijas court’s effort to distinguish Chicago Faucet Shoppe suggests that overpayment for
products is a viable theory of harm. Plaintiff here has standing to recover for the amounts he
overpaid for the St. John’s Wort product he purchased.
B.

Plaintiff lacks standing for products he did not purchase

As Defendants observe, however, Plaintiff has not bothered to reveal what product that
is. Thus, Defendants urge, even if Plaintiff has standing to sue one of the five distributors of St.
John’s Wort, he has no standing to sue the remaining four. Both parties cite Payton v. City of
Kane, 308 F.3d 673, 682 (7th Cir. 2002), where six named plaintiffs filed a class action against
19 Illinois counties that had charged arrestees a “bond fee” as a condition of their being
released, a practice permitted by Illinois statute. Despite the fact that the named plaintiffs
resided in just two of the 19 counties, the Court of Appeals concluded that the district court
erred in refusing to consider “whether these named plaintiffs may represent a class that includes
people from the other 17 named counties.” Id. at 680. The court was willing to address the
propriety of class certification first and then assess the standing issue “with reference to the
class as a whole, not simply with reference to the individual named plaintiffs.” Id. Plaintiff
believes this rationale supports the conclusion that he may proceed here against all Defendants
who made what he believes to be the same misrepresentations. The court is less certain. In
Payton, the named plaintiffs were challenging a bail fee practice authorized, in their home
counties and several others, by a single state law: “These putative representatives were
personally injured by the operation of the very same statute that caused the injuries to all other
members of the proposed class.” Id. at 682 (emphasis added).
This case differs. Plaintiff alleges that the various St. John’s Wort distributors made
identical representations about the hypericin concentration, but he has not alleged that their
actual formulations are identical or that the discrepancy between the stated amounts and actual
amounts of hypericin was the product of a single decision or policy. The fact that Plaintiff has
6

named the distributors’ joint corporate parent does not cure this defect. 2 In pursuing a claim on
behalf of purchasers of products he never himself purchased, Plaintiff appears to be attempting
to “acquire [standing] through the back door of a class action.” Payton, 308 F.3d at 682. In
similar circumstances, other courts in this district have refused to recognize standing to assert a
consumer fraud claim for a product that the plaintiff himself did not purchase. Gubala v. Allmax
Nutrition, Inc., No. 14 C 9299, 2015 WL 6460086 (N.D. Ill. Oct. 26, 2015); Pearson v. Target
Corp., No. 11 C 7972, 2012 WL 7761986 (N.D. Ill. Nov. 9, 2012); Padilla v. Costco Wholesale
Corp., No. 11 C 7686, 2012 WL 2397012 (N.D. Ill. June 21, 2012); but see Quinn v. Walgreen
Co., 958 F. Supp. 2d 533, 541-42 (S.D.N.Y. 2013) (collecting and discussing cases, and citing,
with approval Brown v. Hain Celestial Grp., Inc., 913 F. Supp. 2d 881, 890 (N.D. Cal. 2012) for
the proposition that “a plaintiff may have standing to assert claims for unnamed class members
based on products he or she did not purchase so long as the products and alleged
misrepresentations are substantially similar.”)

Purchasers of St. John’s Wart from other

manufacturers may choose to become part of this case. Plaintiff Muir’s claim is limited to the
product he himself purchased.
II.

Personal Jurisdiction
Defendants, all located in New York and Delaware, contend the court lacks personal

jurisdiction over them. They contend, correctly, that general personal jurisdiction requires a
showing that the corporation’s “affiliations with [Illinois] are so ‘continuous and systematic’ as to
render [it] essentially at home” here. Daimler AG v. Bauman, 134 S. Ct. 746, 761 (2014). A
corporation is ordinarily “at home” in its state of incorporation and the state where it has its
principal place of business. Kipp v. Ski Enterprise Corp., 783 F. 3d 695, 698 (7th Cir. 2015).
2

And, though Defendant NBTY, Inc., has not separately argued the matter, the
court notes that in the absence of an allegation that it directed or controlled the pricing or
formulation of its subsidiaries’ products, Plaintiff has offered no basis for imposing liability on the
corporate parent of the source of the product he purchased. See Esmark Inc. v. N.L.R.B., 887
F.2d 739, 753 (7th Cir. 1989) (“[A] parent corporation may not be held to account for the
liabilities of a subsidiary unless the legal separateness of parent and subsidiary has been
disregarded in a wide range of corporate matters.”)
7

Disappointingly, in response, Plaintiff cites no case that post-dates Daimler, though it is
well recognized that Daimler “raised the bar” for a claim of general personal jurisdiction. Kipp,
783 F. 3d at 698. Instead, he argues that the court can exercise specific jurisdiction over
Defendants because they “formulated, manufactured, warranted, advertised, and sold the
Products” in Illinois (Compl. ¶ 4); and “regularly conduct business” here (id. ¶ 58); and because
Plaintiff and the class he seeks to represent purchased products in Illinois (id. ¶ 59). The court
has specific jurisdiction “if the defendant has ‘purposefully directed’ his activities at residents of
the forum, and the litigation results from alleged injuries that ‘arise out of or relate to’ those
activities.” Burger King Corp. v. Rudzewicz, 471 U.S. 462, 472, (1985) (citations omitted).
Contacts relevant to specific jurisdiction are those contacts with the forum state that are both
related to the lawsuit and created by the defendant. Walden v. Fiore, 134 S. Ct. 1115, 1121-22
(2014).
The claim of specific jurisdiction fails, Defendants contend, because Plaintiff did not
make such a claim in his complaint, instead emphasizing that Defendants “conduct substantial
business in the State of Illinois.” (Defs.’ Mem. [21] at 6; Compl. ¶ 10.) But Plaintiff also alleged
that Defendants have “significant continuous and pervasive contacts” with this state (Compl.
¶ 10), a factor relevant to specific jurisdiction as well.

See Daimler, 134 S. Ct. at 761

(confirming that the “continuous and systematic” standard relates to specific jurisdiction).
Defendants’ only other objection is the more general concern that one Defendant is a parent
corporation and that, of the remaining five, four of those did not make any product Plaintiff
bought. The court has concluded that Plaintiff has standing only to challenge the mislabeling of
the product he actually purchased. Once he has identified that product, the court will be in a
position to determine whether its manufacturer had systematic contacts with this state such that
the court can exercise personal jurisdiction over that manufacturer for a claim arising out of
Plaintiff’s purchase.

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III.

Failure to State a Consumer Fraud Claim (Counts I and II)
Defendants’ most complicated challenge to the complaint goes to the sufficiency of the

allegations. Defendants allege that Plaintiffs have not stated a claim. As Plaintiff concedes, the
federal Food, Drug, and Cosmetics Act expressly preempts any state law claims for false or
misleading product labeling, if that claim seeks to impose requirements that are not identical to
those imposed by the federal law. 21 U.S.C. § 343-1(a)(1)-(5). As Defendants understand this
principle, it means that Plaintiff must allege he has complied with the testing standards that
federal regulators adhere to in determining whether a food product’s label accurately states the
product’s nutrient content. Further, Defendants urge, Plaintiff has ignored the fact that federal
regulations allow for some variation in nutrient content, and has misinterpreted the word
“standardized” on the products’ labels to mean “guaranteed.”
A.

Product Sampling

The court begins with the product sampling requirements.

Defendants cite federal

regulations directing that nutrient content is determined by averaging test results from a
representative sample of products in the marketplace. Specifically, for food products, “[t]he
sample for nutrient analysis shall consist of a composite of 12 subsamples (customer units),
taken 1 from each of 12 different randomly chosen shipping cases, to be representative of a lot.”
21 C.F.R. § 101.9(g)(2). For nutritional supplements, the regulations similarly call for testing of
“a composite of 12 subsamples” or “10 percent of the number of packages” in a single
inspection lot.

21 C.F.R. § 101.36(f)(1).

The objective of the sampling technique “is to

determine whether the average, within a given lot . . . meets label claims.” Nutrition Labeling,
38 Fed. Reg. 2125, 2162. Because federal regulations require only that the average nutrient
levels, in an entire lot of product, meet label requirements, Defendants assert, “every court to
consider the question has held that a state law claim attacking the veracity of a food label’s
nutrient content claim must allege tests of a proper sample of 12 consumer products from a
single lot, one each taken from 12 randomly chosen shipping cases.”
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(Defs.’ Mem. at 8

(emphasis in original).) Plaintiff has not alleged tests of a “proper sample of 12 consumer
products,” Defendants urge; the test results attached to the complaint reveal testing of only one
or two samples of each of the five Defendants’ products, meaning that the complaint must be
dismissed.
Plaintiff effectively concedes he has not performed the 12-product sampling Defendants
insist is required. Indeed, the court is uncertain how a plaintiff, prior to discovery, would have
access to “randomly chosen shipping cases” from which he could have selected 12 consumer
samples that he could be sure had come “from a single lot.”

3

In any event, the law is not as

unequivocal as Defendants suggest. No controlling authority addresses the question of whether
chapter-and-verse compliance with FDA testing is a pleading requirement, though some district
courts have so held. See Salazar v. Honest Tea, Inc., 74 F. Supp. 3d 1304, 1310 (E.D. Cal.
2014) (failure to allege compliance with FDA testing protocols requires dismissal of plaintiff’s
claims as preempted); Mee v. I A Nutrition Inc., No. 14-cv-05006-MMC, 2015 WL 2251303, at *3
(N.D. Cal. May 13, 2015) (same); Dougherty v. Source Naturals, Inc., 148 F. Supp. 3d 831, 836
(E.D. Mo. 2015) (same); Burke v. Weight Watchers Int’l, Inc., 983 F. Supp. 2d 476 (D.N.J. 2013)
(same).
But there is contrary authority, as well. In Clay v. Cytosport, Inc., No. 15-cv-165 L
(DHB), 2015 WL 5007884 (S.D. Cal. Aug. 19, 2015), the court considered allegations that
defendant misrepresented the ingredients and characteristics of its “Muscle Milk” product,
specifically alleging that the product provided less protein than advertised on the product label.
Defendant moved to dismiss the complaint as preempted, noting the absence of any allegations
that the sample plaintiffs had tested “consisted of a composite of twelve subsamples taken from
each of twelve different randomly chosen shipping cases.” Id. at *3. The court acknowledged
that this is the appropriate standard, but disagreed that plaintiffs’ failure to allege testing in
3

In their reply memorandum, Defendants suggest that Plaintiff has overstated the
difficulty of obtaining the appropriate samples at the pleading stage. (Defs.’ Reply [27] at 9.)
Yet the language Defendants call out as an overstatement (“randomly chosen shipping cases”)
appears in Defendants’ own opening memorandum. (Defs.’ Mem. at 8.).
10

accordance the FDA methodology required dismissal. The simple allegation that the product
violates federal law by providing less of the nutrient than advertised was sufficient to give notice
of plaintiffs’ claim. Id. at *3-4. Similarly, in Smith v. Allmax Nutrition, No. 15-cv-007454-SAB,
2015 WL 9434768, at *7 (E.D. Cal. Dec. 24, 2015), another mislabeling case, the court
concluded that laboratory reports showing testing of just one sample were sufficient to support a
plausible inference that the more comprehensive 12-sample test would support plaintiff’s claims.
More recently, two judges of this court have reached similar conclusions.

First, in

Gubala v. CVS Pharmacy, Inc., No. 14 C 9039, 2016 WL 1019794 (N.D. Ill. Mar. 15, 2016),
Judge Durkin considered allegations that defendant made false and misleading statements in
the label of its protein power supplement—statements that suggested the product contained
more whey protein than was actually present. Defendant argued that this claim was preempted,
but the court recognized that a state-law claim survives so long as it enforces requirements
identical to those imposed by the FDCA. Id. at *4. That meant, in defendant’s view, that plaintiff
was required to allege that he had tested the protein content of the product in the manner
prescribed by FDCA regulations, using a “composite of 12 subsamples . . . 1 from each of 12
different randomly chosen cases, to be representative of a lot.” Id. at *7 (quoting 21 C.F.R.
§ 101.9(g)(2)). The plaintiff in Gubala had not done so. Instead, he attached to his complaint
the result of a single test on a single product sample. Id. In a comprehensive and thoughtful
opinion, Judge Durkin acknowledged that other courts have concluded that compliance with the
12-sample test is a pleading requirement, but he noted that the apparent origin of that doctrine
is a district court case, Vital v. One World Co., LLC, No. SACV 12-00314-CJC(MLGx), 2012
U.S. Dist. LEXIS 186203 (C.D. Cal. Nov. 30, 2012), that was decided not on a motion to
dismiss, but on summary judgment, after an opportunity for discovery. At the 12(b)(6) stage, the
complaint need only overcome two “easy-to-clear hurdles”: describing the claim “in sufficient
detail to give defendant fair notice,” and “plausibly suggest[ing] that the plaintiff has a right to
relief . . . .” Gubala, 2016 WL 1019794, at * 8 (citing Tamayo v. Blagojevich, 526 F.3d 1074,
11

1084 (7th Cir. 2008)). Gubala’s complaint met that test, the court concluded. Plaintiff was not
required to prove his case at the pleading stage, and the test results he attached to his
complaint were sufficient to “nudge his claims . . . ‘across the line from conceivable to
plausible.’” Id. *8 (quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007)). Still more
recently, the same plaintiff brought another mislabeling case against the seller of another
protein supplement. Adhering to the same rationale, Judge Ellis of this court concluded that
plaintiffs were not required to plead compliance with the 12-sample testing protocol and that
their allegations, supported by the results of tests performed by a third party, were sufficient to
“plausibly claim” that the label was false. Gubala v. HBS Intern. Corp., No. 14 C 9299, 2016 WL
2344583, at *4 (N.D. Ill. May 4, 2016).
Neither of the Gubala decisions had been rendered at the time of the briefing in this
case, but Plaintiff brought both to the court’s attention by way of Notices of Supplemental
Authority [29], [34]. Defendants did not respond at all to the second Notice, and their effort to
distinguish Gubala v. CVS, at least on the matter of testing compliance, is unsuccessful. First,
they urge that the testing regulation relevant to the nutrition supplements they manufacture is
not 21 C.F.R. § 101.9(g)(2) but 21 C.F.R. § 101.35(f)(1). (Response to Plaintiff’s Notice of
Supplemental Authority [30] at 2.) But Defendants’ opening memorandum referred to the two
regulations as “very similar,” and faulted Plaintiff for failing to allege that he has performed a test
of a “composite of 12 consumer packages or 10 percent of the number of packages in the
inspection lot, whichever is smaller.” (Defs.’ Mem. at 8, 9.) Second, Defendants emphasize
that “a private plaintiff’s proof of a violation of the regulations must be based on the 12-sample
method.” Like its colleagues, this court declines to decide what Plaintiff will need to prove in
order to establish its claims, 4 merely holding here that compliance with the 12-sample testing
4

See Gubala v. CVS, 2016 WL 1019794, at *9 (“whether § 101.9(g)92) is in fact a
substantive requirement that Plaintiff would have to meet to establish liability on the part of CV
is simply not clear to the Court at this point in time.”); Gubala v. HBS, 2016 WL 2344583, *4 n.5
(“At this time the Court is not ruling on whether Plaintiffs are ultimately required to conduct
testing compliant with § 101.9(g)(2) in order to prevail.”) Compare Smith v. Allmax, 2015 WL
12

protocol is not a requirement at the pleading stage.
B.

Allowance for Test Variability

Even if 12-sample testing is not a pleading requirement, Defendants urge that Plaintiff’s
claim is preempted because it does not acknowledge what Defendants refer to as the “80%
rule” and Plaintiff calls the “safe harbor provision” of 21 C.F.R. § 101.9(g)(4)(ii). The regulations
distinguish between “Class I nutrients,” which are nutrients added to “fortified or fabricated” food
products, and “Class II nutrients,” which occur naturally as the result of differences in season,
soil, weather, and “processing that a food undergoes.” 21 C.F.R. § 101.9(g)(3)(i), (ii); 58 Fed.
Reg. at 2161. For Class II nutrients, federal regulations require that the nutrient content of a
labeled food product must be at least 80% of “the value for that nutrient declared on the label.”
§ 101.9(g)(4)(ii).
It is undisputed that hypericin occurs naturally in the St. John’s Wort plant. Plaintiff
nevertheless insists the safe harbor does not apply here because the hypericin in Defendants’
products is not a Class II nutrient. This is because the manufacturing process does not simply
package the chemical composition of the plant in its natural state. Instead, Plaintiff asserts, in
the manufacturing process, hypericin is extracted from the plant and then “pushed back into the
finished products so Defendants can add a higher level of the extract than occurs naturally.”
(Pl.’s Resp. [24] at 12.) Hypericin is therefore properly categorized as a Class I nutrient, Plaintiff
contends, thus subject to the requirement that the nutrient content “must be formulated to be at
least equal to the value for that nutrient declared on the label.” § 101.9(g)(4)(i).
Defendants’ reply memorandum suggests, at most, that there may be a factual dispute
about the manufacturing process. Defendants note that the complaint does not allege how St.
John’s Wort tablets are manufactured, meaning that there is no basis in the record for Plaintiff’s
claim that extra hypericin is added to those tablets. (Defs.’ Reply at 10.) But Defendants do not
9434768, at *8 n.1 (“The parties are advised that while the Court finds that pleading the 12sample methodology is not required to survive a motion to dismiss, any adjudication of the
claims on the merits other than by the 120-sample methodology as set forth in section 101.9(g)
would be preempted ty the FDA.”)
13

deny Plaintiff’s account of the manufacturing process, instead noting that the regulations
themselves recognize that nutrients may be present in varying amounts as a result of
“processing that a food undergoes.” The court is uncertain what that phrase means, and there
is apparently no case law addressing the question of whether a process that fortifies an herb
supplement with additional amounts of the active ingredient removes it from Class II status.
Plaintiff’s contention that this is indeed the manufacturing process is a plausible one. If
Defendants are doing nothing more than converting the St. John’s Wort plant to tablet form, it is
not clear what is meant by the words “standardized extract.” Rexall Sundown, Inc. v. Perrigom,
651 F. Supp. 2d 9, 14 (E.D.N.Y. 2009) arose in a completely different context, and involves an
unrelated product, but as Plaintiff notes, in that case brought by Rexall Sundown (a Defendant
in this case), the court used the word “standardized” in a way suggesting that standardization
means increasing the amount of an ingredient that would naturally occur at lower levels. The
court here presumes that “standardized” means that the amount of hypericin in the tablets is
adjusted in some fashion as to make the active ingredient at least roughly equal across the
production process. 5 For purposes of this ruling, however, the court need not resolve the
question of whether the 80% rule applies. Even if it does, the test results attached to Plaintiff’s
complaint show that Defendants’ products did not even contain 80% of the nutrient levels shown
on the product labels. The largest tested amount of hypericin—0.615 milligrams—is just 68% of
the .9 milligrams called for by the label. And the court declines Defendants’ invitation to water
down the 80% standard still further to account for a further “error or variance rate,” as there is
no basis for determining what that “error rate” might be. (Defs.’ Mem. at 10-11.) Defendants’
motion to dismiss this complaint under the “safe harbor” regulations is denied.

5

As explained on the National Institute of Health website, “[s]tandardization is a
process that manufacturers may use to ensure batch-to-batch consistency of their products,” but
“no legal or regulatory definition exists in the United States for standardization as it applies to
dietary supplements.” Nat’l Insts. of Health, Dietary Supplements, https://ods.od.nih.gov/
factsheets/DietarySupplements-HealthProfessional/ (last visited September 21, 2016).
14

C.

Pleading Fraud with Particularity

A consumer fraud claim is governed by the ordinary fraud pleading standards. See
Gallagher Corp. v. Mass. Mut. Life Ins. Co., 940 F. Supp. 176, 180 (N.D. Ill. 1996) (citing Illinois
cases requiring that Consumer Fraud Act claims be pleaded with particularity). Specifically,
plaintiffs must state “the identity of the person making the misrepresentation, the time, place,
and content of the misrepresentation, and the method by which the misrepresentation was
communicated.” Schiffels v. Kemper Fin. Servs., Inc., 978 F.2d 344, 352 (7th Cir.1992) (quoting
Bankers Trust Co. v. Old Republic Ins. Co., 959 F.2d 677, 683 (7th Cir. 1992)). Defendants
urge that much of this information is missing from the complaint, but for the most part, the court
is less mystified. Plaintiff has identified the “who and what” of his claim by providing images of
each of the manufacturers’ products, each bearing labels prominently assuring the consumer of
the products’ hypericin content. The “when and where” questions are arguably answered, as
well: the allegedly misleading statements were made at the point of sale of the product, when
consumers purchased bottles of St. John’s Wort in reliance on claims appearing on the labels.
That leaves the issue of “how” Plaintiff was misled—or even, in this case, whether he
was misled at all. Defendants point out that the testing records Plaintiff has attached all include
disclaimers, warning that the test results related solely to the individual tested sample. (Defs.’
Mem. at 4.) Most significantly, Defendants point out, the tests were ordered in May and June
2015, well before Plaintiff made his purchase in July 2015. For what purpose was the test
performed? If Plaintiff purchased his product in July 2015 with full knowledge of the test results,
he was either very foolish or attempting to purchase a lawsuit. In either event, there would be
no basis for the conclusion that Plaintiff was reasonably misled. For purposes of this motion,
the court assumes Plaintiff Muir was unaware of the alleged inadequacy of the product at the
time he purchased it. Should this prove untrue, it may be a basis for summary judgment.
IV.

Failure to State an Unjust Enrichment Claim (Count III)
Defendants’ challenge to Plaintiff’s unjust enrichment claim is presented in a total of five
15

sentences—three in the opening memorandum and two in the reply—and a single case citation.
(Defs.’ Mem. at 13; Defs.’ Reply at 14.) In the case Defendants rely on, Cleary v. Philip Morris,
Inc., 656 F.3d 511, 516 (7th Cir. 2011), the court addressed a question that has generated
substantial litigation: whether unjust enrichment is an independent claim for relief that can
“stand untethered from any underlying claim.” Without answering that question definitively, the
Seventh Circuit explained:
Unjust enrichment is a common-law theory of recovery or restitution that arises
when the defendant is retaining a benefit to the plaintiff's detriment, and this
retention is unjust. What makes the retention of the benefit unjust is often due to
some improper conduct by the defendant. And usually this improper conduct will
form the basis of another claim against the defendant in tort, contract, or statute.
So, if an unjust enrichment claim rests on the same improper conduct alleged in
another claim, then the unjust enrichment claim will be tied to this related claim—
and, of course, unjust enrichment will stand or fall with the related claim.
Id. at 517. Cleary was a consumer fraud claim alleging that defendant tobacco companies had
conspired to conceal the truth about the dangers of cigarette smoking. The court noted as
“crucial” the fact that plaintiffs did not allege that they had been harmed, that they had relied on
defendants’ marketing, or that they would have behaved differently had defendants told the
truth. Id. at 518. This doomed their effort to allege unjust enrichment, the court concluded,
whether or not it can stand alone as an independent cause of action. Plaintiffs here have
alleged all of these things—harm, reliance on defendant’s statements, and conduct in reliance
on those statements.
This court is uncertain that Cleary establishes what Defendants say it does: that when
an unjust enrichment claim rests on the same facts alleged in support of a consumer fraud
action, dismissal of the consumer fraud claim dooms the unjust enrichment claim, as well.
Again, however, the court need not answer the question. The court is not prepared to dismiss
Plaintiffs’ consumer fraud claims on the merits. There may be other bases for dismissal of the
unjust enrichment claim, but Defendants have not raised them. The motion to dismiss Count III
is denied.

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V.

Breach of Warranty (Count IV)
Plaintiff alleges that he (and the other consumers he seeks to represent) purchased a

“standardized” St. John’s Wort product; reviewed the label before dong so; and made the
purchase in reliance on the claims made on the label. These allegations, Plaintiff urges, state a
claim for breach of express warranty against all of the Defendant manufacturers and their
corporate parent. Defendants object to Plaintiff’s breach of warranty claim for two reasons—
lack of privity and a failure to give pre-suit notice. Both of these objections appear to have
merit.
First, Plaintiff himself has alleged a single purchase of St. John’s Wort, from a
Walgreens store in July 2015. He did not purchase the product directly from any of the
Defendants, and for all but one, he did not purchase the product at all. Defendants could not
have warranted the quality or chemistry of a product that Plaintiff never purchased or used. And
had Plaintiff’s complaint identified the particular product he himself purchased, his breach-ofwarranty claim against that manufacturer would fail for another reason: In order to recover
under a claim for breach of express or implied warranty under Illinois law, a plaintiff must
establish that she provided defendant with notice of the alleged breach “within a reasonable
time after she discover[ed] or should have discovered [it].” See Connick v. Suzuki Motor Co.,
Ltd., 174 Ill. 2d 482, 494, 675 N.E.2d 584, 591-92 (Ill. 1996) (citing 810 ILCS 5/2-607(3)(a));
There are two exceptions to the notice requirement. Direct notice is not required when: (1) the
defendant had “actual knowledge” of the product's defect, or (2) where the plaintiff suffered
personal injury. Ibarrola v. Kind, LLC, 83 F. Supp. 3d 751, 760 (N.D. Ill. 2015) (citing Connick,
174 Ill. 2d at 494, 675 N.E.2d at 591). Neither exception to the notice requirement applies in
this case. Plaintiff has not alleged any physical injury as a result of his purchase. He contends
that the notice requirement is inapplicable here because the manufacturer knew of the defect at
the time of the sale. (Compl. ¶¶ 13, 32-33.) Plaintiff cites three district court cases that appear
to excuse the pre-suit notice requirement where the manufacturer is alleged to have had actual
17

knowledge of the design flaws or dangerous nature of a product line. Stella v. LVMH
Perfumes & Cosmetics USA, Inc., 564 F. Supp. 2d 833, 837 (N.D. Ill. 2008); Mednick v. Precor,
Inc., No. 14 C 4231, 2014 WL 6474915, at *6 (N.D. Ill. Nov. 13, 2014); Hedges v. Earth, Inc.,
No. 14 C 9858, 2015 WL 1843029 (N.D. Ill. Apr. 21, 2015). Respectfully, this court notes
language from the Illinois Supreme Court holding that this kind of generalized knowledge is not
sufficient to excuse the pre-suit notice requirement. In Connick, the Illinois Supreme Court
noted that even if a manufacturer “is aware of problems with a particular product line,” a
purchaser must provide pre-suit notice of a breach of warranty claim unless the manufacturer is
“somehow apprised of the trouble with the particular product purchased by a particular buyer.”
174 Ill. 2d at 494, 675 N.E.2d at 591-92.
Plaintiff has alleged that each of the Defendants was aware of the defective nature of the
St. John’s Wort product, but he offers no specific information that would support this conclusion.
No allegations at all suggest any Defendant had knowledge of any specific problem with the
bottle Plaintiff himself purchased. Plaintiff has not identified the manufacturer or that bottle, and
has not alleged that the bottle he purchased was itself ever tested. His breach of warranty claim
is dismissed.
VI.

Injunctive Relief
In addition to damages, Plaintiff seeks injunctive relief funder the ICFA. (Compl. ¶ 54.)

Defendants argue, however, that injunctive relief would be inappropriate here, citing Camasta v.
Jos. A. Bank Clothiers, 761 F.3d 732, 741 (7th Cir. 2014): “Since [plaintiff] is now aware of
[defendant’s] sales practices, he is not likely to be harmed by the practices in the future.
Without more than the speculative claim that he will again be harmed by [defendant], [plaintiff] is
not entitled to injunctive relief.” (Defs.’ Mem. at 15.) This is essentially an argument that
Plaintiff lacks standing to pursue injunctive relief.
Camasta. For one thing,

18

But Defendants overstate the holding of

the Camasta court merely repeated the well-accepted rule that the standing
inquiry for the purpose of injunctive relief is probabilistic, i.e., is there “likelihood”
that some harm will be suffered by the plaintiff in the future? Interpreting the
Camasta court's dicta to instead announce a broad rule that strips a prospective
plaintiff of standing to seek an injunction solely because they are aware of a past
wrong overreads that court's language and leads to anomalous results. For
example, just because someone is aware that the police have acted brutally in
the past does not automatically deprive that person of standing to enjoin brutal
police activity so long as they can show such brutality is likely to harm him/her in
the future. Cf. Schirmer v. Nagode, 621 F.3d 581, 588 (7th Cir. 2010)
(highlighting that, in such a case, official action conducted pursuant to a policy
and/or procedure may be sufficient to establish Article III standing).
Le v. Kohls Dep't Stores, Inc., 160 F. Supp. 3d 1096, 1111 (E.D. Wis. 2016).
Just as importantly, the complaint in Camasta included a single allegation related to the
likelihood the plaintiff would suffer future harm, namely, that “there is a substantial danger that
[the defendant’s] wrongful retail practices will continue.” Camasta v. Jos. A. Bank, Clothiers,
Inc., No. 12-CV-7782, 2013 WL 474509, at *6 (N.D. Ill. Feb. 7, 2013). The complaint in this
case, meanwhile, alleges that “Defendants continue to advertise, distribute, label, manufacture,
market, and sell the Products in a false, misleading, unfair, and deceptive manner.” (Compl.
¶ 6.) This is enough to establish, at this stage in the proceedings, that Plaintiff has standing to
seek injunctive relief. See, e.g., Le, 160 F. Supp. 3d at 1111 (denying motion to dismiss a claim
for injunctive relief on standing grounds where the complaint contained similar allegations).
CONCLUSION
For the reasons explained here, Defendants’ motion to dismiss [20] is granted in part
and denied in part. All claims against the corporate parent, NBTY, Inc., are dismissed. Plaintiff
has standing to sue the single Defendant manufacturer from whom he purchased the product.
His claims of consumer fraud and unjust enrichment against that single manufacturer survive
this motion. His breach-of-warranty claim is dismissed. Leave is granted to file an amended
complaint within 21 days.

ENTER:

Dated: September 22, 2016

_________________________________________
REBECCA R. PALLMEYER
United States District Judge
19