Anglin et al v. Edgewell Personal Care Company et al
Filing
45
MEMORANDUM AND ORDER IT IS HEREBY ORDERED that Defendants Motion to Dismiss or Stay Plaintiffs Complaint, or, in the Alternative, Strike the Nationwide Class Allegations (Doc. 21 ) is GRANTED, in part, and DENIED, in part. IT IS FURTHER ORDERED th at Defendants motion to dismiss or stay the proceedings based on the primary jurisdiction doctrine (Doc. 21 1) is DENIED, without prejudice. IT IS FURTHER ORDERED that Defendants motion to dismiss based on federal preemption (Doc. 21 2) is GRANTED , in part. IT IS FURTHER ORDERED that Defendants motion to dismiss the New York General Business Law § 349 (Count V), New York General Business Law § 350 (Count VI), New Jersey Consumer Fraud Act, N.J.S.A. 56:8-1, et seq. (Count VII), New Jersey Truth in Consumer Contract, Warranty, and Notice Act, N.J.S.A. 56:12-14 et seq. (Count VIII), California Unfair Competition Law, Cal. Bus. & Prof. Code §§ 17200, et seq. (Count X), and California Consumers Legal Remedies Act, C al. Civil Code §§ 1750, et seq. (Count XI) (Doc. 21 3) is DENIED, as moot. IT IS FURTHER ORDERED that Defendants motion to strike Plaintiffs nationwide class allegations (Doc. 21) is DENIED, without prejudice. IT IS FINALLY ORDERED that Plaintiffs shall file a first amended complaint no later than thirty (30) days from the date of this Order.. Signed by Magistrate Judge Noelle C. Collins on 12/07/2018. (KCB)
UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF MISSOURI
EASTERN DIVISION
INGRID ANGLIN, COLLEEN GORMAN,
PAUL LAMBRAKIS, ELIJAH NATAL,
MATTHEW NELSON, COURTNEY
PARKER, and SHAYAN TARI,
Individually and on Behalf of All Others
Similarly Situated,
Plaintiffs,
v.
EDGEWELL PERSONAL CARE
COMPANY; EDGEWELL PERSONAL
CARE BRANDS, LLC; EDGEWELL
PERSONAL CARE LLC; PLAYTEX
PRODUCTS, LLC; and SUN
PHARMACEUTICALS, LLC,
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Case No. 4:18-CV-00639-NCC
Defendants.
MEMORANDUM AND ORDER
This matter is before the Court on Defendants’ Motion to Dismiss or Stay Plaintiffs’
Complaint, or, in the Alternative, Strike the Nationwide Class Allegations. (Doc. 21.) The seven
named Plaintiffs in this putative class action and Defendants have consented to the jurisdiction of the
undersigned United States Magistrate Judge pursuant to 28 U.S.C. 636(c)(1). (Doc. 13.) The
Motion is fully briefed and ready for disposition. For the following reasons, Defendants’ Motion
will be GRANTED, in part, and DENIED, in part.
I. BACKGROUND
Plaintiffs Ingrid Anglin, Colleen Gorman, Paul Lambrakis, Elijah Natal, Matthew
Nelson, Courtney Parker, and Shayan Tari (“Plaintiffs”) bring this putative class action mislabeling
lawsuit against Defendants Edgewell Personal Care Company; Edgewell Personal Care Brands,
LLC; Edgewell Personal Care LLC; Playtex Products, LLC; and Sun Pharmaceuticals, LLC
(“Defendants”), on behalf of themselves and all other similarly situated persons who purchased
Banana Boat Kids Tear-Free Sting-Free Continuous Spray Sunscreen (“Banana Boat Kids Spray”),
Banana Boat Baby Tear-Free Sting-Free Continuous Spray Sunscreen (“Banana Boat Baby Spray”),
and Banana Boat Baby Tear-Free Sting-Free Lotion Sunscreen (“Banana Boat Baby Lotion”),
labeled as “SPF 50” or “SPF 50+” (“Products”).1 (Doc. 1 ¶ 3.)
The individual Plaintiffs allege they each purchased one or more of these Products and allege
that the Products were labeled as having an “SPF 50” or “SPF 50+” but, in fact, had a lower SPF.
(Id. ¶¶ 8, 17–23, 36.) Plaintiffs allege that “[i]n actuality, rigorous scientific testing has revealed that
the Products do not provide an SPF of 50, much less ‘50+’.” (Id. ¶ 36.) Specifically, Plaintiffs
allege that Consumer Reports magazine reported in May 2016 that “its own testing had revealed that
Banana Boat Kids SPF 50 sunscreen lotion had an SPF of only 8.” (Id. ¶ 37.) In addition, Plaintiffs
allege that they conducted their own independent testing utilizing FDA methods and that such tests
demonstrated the Products had SPFs lower than listed on the label. (See id. ¶¶ 38–41.) Plaintiffs
allege that Defendants knew or should have known, based on testing, that these Products have a
lower SPF than stated on the label. (Id. ¶ 7.) Had they known the Products contained less UV
protection than advertised, Plaintiffs and the putative class members would not have purchased the
sunscreen, relied on it to protect them, or paid as much for the product. (Id. ¶ 11, 54.) As a result of
Defendants’ false, misleading, deceptive, and reckless labeling and marketing of the Products,
Plaintiffs claim they and putative class members have suffered economic injury by paying for a
falsely advertised product and being deprived of the full intended use of their purchased sunscreen.
(Id. ¶¶ 5, 9, 12, 55, 57–58.)
1
In their Class Action Complaint, Plaintiffs seek certification of a nationwide class and five statespecific subclasses (New York, New Jersey, Florida, Illinois, and California) each pertaining to
individuals who purchased the Products from March 2, 2014, to the present. (Doc. 1 ¶¶ 64–66.)
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Based on these allegations, Plaintiffs seek damages and equitable remedies as set out in the
following eleven counts: Breach of Warranty (Count I), Breach of Implied Contract (Count II),
Unjust Enrichment (Count III), Illinois Consumer Fraud & Deceptive Business Practices Act, 815
ILCS 505/1, et seq. (Count IV), New York General Business Law § 349 (Count V), New York
General Business Law § 350 (Count VI), New Jersey Consumer Fraud Act, N.J.S.A. 56:8-1, et seq.
(Count VII), New Jersey Truth in Consumer Contract, Warranty, and Notice Act, N.J.S.A. 56:12-14
et seq. (Count VIII), Florida Deceptive and Unfair Trade Practices Act, Fla. Stat. §§ 501.201, et seq.
(Count IX), California Unfair Competition Law, Cal. Bus. & Prof. Code §§ 17200, et seq. (Count
X), and California Consumers Legal Remedies Act, Cal. Civil Code §§ 1750, et seq. (Count XI).2
Defendants moved to dismiss or stay the case or, in the alternative, strike the nationwide
class allegations. (Doc. 21.) They argue that Plaintiffs’ claims fall under the primary jurisdiction of
the U.S. Food & Drug Administration (“FDA”), and, as a result, the primary jurisdiction doctrine
compels dismissal or a stay of the case. (Id. ¶ 1.) Defendants argue the Complaint should also be
dismissed because Plaintiffs’ claims are preempted in their entirety by federal law. (Id. ¶ 2) In the
alternative, Defendants argue several of the state law claims should be dismissed because Plaintiffs
have not pleaded essential elements of their state law claims, and thus fail to state a claim for relief.
(Id.¶ 3.) Finally, and also in the alternative, Defendants move this Court to enter an order striking
Plaintiffs’ nationwide class allegations, arguing that individual issues predominate. (Docs. 21, 22.)
2
Plaintiffs bring Counts I, II and III on behalf of the putative nationwide class and each subclass.
They bring Count IV by Plaintiff Gorman on behalf of the Illinois Subclass; Counts V and VI by
Plaintiffs Lambrakis and Nelson on behalf of the New York Subclass; Counts VII and VIII by
Plaintiffs Natal and Parker on behalf of the New Jersey Subclass; Count IX by Plaintiff Anglin on
behalf of the Florida Subclass; and Counts X and XI by Plaintiff Tari on behalf of the California
Subclass.
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II. LEGAL STANDARD
Federal Rule of Civil Procedure 8(a)(2) requires “a short and plain statement of the claim
showing that the pleader is entitled to relief.” Federal Rule of Civil Procedure 12(b)(6) provides for
a motion to dismiss based on the “failure to state a claim upon which relief can be granted.” To
survive a motion to dismiss a complaint must show “‘that the pleader is entitled to relief,’ in order to
‘give the defendant fair notice of what the . . . claim is and the grounds upon which it rests.’” Bell
Atlantic Corp. v. Twombly, 550 U.S. 544, 555 (2007) (quoting Conley v. Gibson, 355 U.S. 41, 47
(1957)). “Threadbare recitals of the elements of a cause of action, supported by mere conclusory
statements, do not suffice” to defeat a motion to dismiss. Ashcroft v. Iqbal, 556 U.S. 662, 678
(2009) (citing Twombly, 550 U.S. at 555). “[O]nly a complaint that states a plausible claim for relief
survives a motion to dismiss.” Iqbal, 556 U.S. at 679 (citing Twombly, 550 U.S. at 556). “The
plausibility standard is not akin to a ‘probability requirement,’ but it asks for more than a sheer
possibility that a defendant has acted unlawfully.” Iqbal, 556 U.S. at 678 (citation omitted). The
pleading standard of Rule 8 “does not require ‘detailed factual allegations,’ but it demands more
than an unadorned, the-defendant-unlawfully-harmed-me accusation.” Iqbal, 556 U.S. at 678
(quoting Twombly, 550 U.S. at 555). “When ruling on a defendant’s motion to dismiss, a judge must
accept as true all of the factual allegations contained in the complaint.” Erickson v. Pardus, 551
U.S. 89, 94 (2007). The Court must “draw all reasonable inferences in favor of the nonmoving
party.” Coons v. Mineta, 410 F.3d 1036, 1039 (8th Cir. 2005). However, “[w]here the allegations
show on the face of the complaint there is some insuperable bar to relief, dismissal under Rule
12(b)(6) is appropriate.” Benton v. Merrill Lynch & Co., 524 F.3d 866, 870 (8th Cir. 2008).
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III. ANALYSIS
A. Primary Jurisdiction Doctrine
Defendants first argue that the FDA has primary jurisdiction over Plaintiffs’ claims and, as a
result, the primary jurisdiction doctrine compels dismissal or a stay of the case. Defendants argue
that sunscreen is one of the most highly regulated consumer products, particularly for SPF, and is
statutorily regulated by the FDA under the Food, Drug, and Cosmetic Act (“FDCA”) as an over-the
counter drug. Because it falls within the FDA’s statutory mandate, the FDA has primary jurisdiction
over the at-issue Products. In fact, Defendants argue, the FDA published a “sunscreen Final Rule,”
codified in 21 C.F.R. § 201.327, mandating a whole host of highly specialized, highly scientific, and
precise technical and scientific protocols that manufacturers must follow relating to testing and
labeling. Defendants further contend a stay or dismissal is warranted particularly since the FDA is
actively engaged in regulating issues central to the case. For these reasons, Defendants argue the
Court should defer to the FDA and dismiss, or, at a minimum, issue a stay pending resolution of the
FDA’s ongoing agency action and investigation. (Doc. 22.)
Primary jurisdiction is a common law doctrine used to coordinate judicial and administrative
decision making. George v. Blue Diamond Growers, No. 4:15-CV-962-CEJ, 2016 WL 1464644, at
*1 (E.D. Mo. Apr. 14, 2016) (citing City of Osceola, Ark. v. Entergy Arkansas, Inc., 791 F.3d 904,
908–09 (8th Cir. 2015) (quotation and citation omitted). Even when jurisdiction is proper in a given
case, a court must consider whether an executive agency has primary jurisdiction. Entergy
Arkansas, 791 F.3d at 908. The primary jurisdiction doctrine “‘applies where a claim is originally
cognizable in the courts, and comes into play whenever enforcement of the claim requires the
resolution of issues which, under a regulatory scheme, have been placed within the special
competence of an administrative body.’” Alpharma, Inc. v. Pennfield Oil Co., 411 F.3d 934, 938
(8th Cir. 2005) (quoting United States v. W. Pac. R. R. Co., 352 U.S. 59, 63-64 (1956)). The
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doctrine allows a court with jurisdiction to refer a case to the appropriate administrative agency for
initial decision. Thornton v. Pinnacle Foods Grp., LLC, No. 4:16-CV-00158-JAR, 2016 WL
5793193, at *1 (E.D. Mo. Sept. 30, 2016).
There is no “fixed formula” for deciding whether an agency has primary jurisdiction over a
case. Entergy Arkansas, 791 F.3d at 909. Instead, the applicability of the doctrine depends on
whether the reasons for the doctrine are present and whether applying the doctrine will aid the
purposes for which the doctrine was created. Access Telecomms. v. Sw. Bell Tel. Co., 137 F.3d 605,
608 (8th Cir. 1998). The Eighth Circuit has stated that courts apply the doctrine for two main
reasons. Id. First, the doctrine may be applied “to obtain the benefit of an agency’s expertise and
experience,” as “the principle is firmly established that ‘in cases raising issues of fact not within the
conventional experience of judges or cases requiring the exercise of administrative discretion,
agencies created by Congress for regulating the subject matter should not be passed over.’” Id.
(quoting Far East Conference v. United States, 342 U.S. 570, 547 (1954)). “In fact, agency
expertise is the most common reason for applying the doctrine.” Id. Second, courts apply the
doctrine is “to promote uniformity and consistency with the particular field of regulation.” Id.; see
also Entergy Arkansas, 791 F.3d at 909 (“courts consider whether ‘desirable uniformity’ would
result from an agency determination and whether ‘the expert and specialized knowledge’ of the
agency is needed”) (citations omitted) (quoting W. Pac. R. R. Co., 352 U.S. at 64); Alpharma, 411
F.3d at 938 (“Among the reasons and purposes served are the promotion of consistency and
uniformity within the areas of regulation and the use of agency expertise ‘in cases raising issues of
fact not within the conventional experience of judges or cases requiring the exercise of
administrative discretion.’”)
“When it is determined that primary jurisdiction to resolve an issue lies with an agency, a
court otherwise having jurisdiction over the case may stay or dismiss the action pending the agency's
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resolution of the question.” George, 2016 WL 1464644, at * 1 (citing Alpharma, 411 F.3d at 938).
However, the doctrine is to be “invoked sparingly, as it often results in added expense and delay.”
Thornton, 2016 WL 5793193, at *1 (quoting Alpharma, 411 F.3d at 938).
Considering the reasons for applying the doctrine, and in light of the Eighth Circuit’s caution
that this doctrine should be invoked sparingly, the Court declines to apply the primary jurisdiction
doctrine in this case.
1. Agency Expertise versus Conventional Experience of Judges
While this Circuit has not addressed the primary jurisdiction doctrine in the context of
sunscreen labeling cases, cases in several other circuits have. In each instance, the courts have
declined to apply the primary jurisdiction doctrine. The Court is persuaded by those cases.
Consistent with those cases, the Court finds that Plaintiff’s claims falls within the conventional
wisdom of judges. Plaintiffs clearly note they are not claiming that the FDA’s sunscreen Final Rule
is improper, that the FDA should change its testing procedures, or that the FDA should adopt new
testing procedures for SPF. (Doc. 26 at 14.) Instead, Plaintiffs claim that, based on the longestablished SPF testing procedures and standards, Defendants overstated the SPF content of the
Products in violation of various state consumer laws. (Id.) In other words, “[t]he gravamen of
Plaintiffs’ claims is that Defendants violated [state] consumer protection statutes by marketing their
sunscreen products in a false and/or misleading manner so as to induce consumers to purchase those
products. Whether Defendants did so is the type of factual question that is routinely committed to
the courts.” Corra v. Energizer Holdings, Inc., 962 F. Supp. 2d 1207, 1216 (E.D. Cal. 2013)
(declining to apply primary jurisdiction doctrine); Dapeer v. Neutrogena Corp., 95 F. Supp. 3d
1366, 1376 (S.D. Fla. 2015) (declining to apply the doctrine because “determining whether a
[sunscreen] manufacturer has misled consumers,” including determining whether the sunscreen
manufacturer’s “marketing of its high SPF products is false and misleading” because it did not
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provide the marketed SPF protection, “is squarely within the judicial function”); Langan v. Johnson
& Johnson Consumer Cos., 95 F. Supp. 3d 284, 292 (D. Conn. 2015) (declining to apply primary
jurisdiction doctrine and holding claims relating to whether a manufacturer misled consumers and
violated state consumer laws in using the phrase “all natural” on a sunscreen label are “one[s] to
which courts are eminently well suited, even well versed”) (citations omitted). In fact, in two
pending Banana Boat SPF mislabeling cases, judges have found the courts are well equipped to
address such claims. See, e.g., In re Edgewell Personal Care Co. Litig., Case No. 1:16-CV-3371KAM-RLM, slip. op. at 13 (E.D.N.Y. Sept. 4, 2018) (collecting cases from various circuits and
concluding “[c]ourts are well-equipped to assess whether a [sunscreen] label is misleading.”);
Keskinen v. Edgewell Personal Care Co., Case No. 2:17-CV-07721-AB (PJWx), slip. op. at 6 (C.D.
Cal. Apr. 17, 2018) (citation omitted) (declining to apply doctrine in Banana Boat sunscreen case,
noting “[c]ourts are generally well-equipped to handle state-law challenges to labeling of FDAregulated products” and, “[t]hus, courts ‘routinely retain jurisdiction over false advertising cases
involving such products, even when some scientific examination might be necessary”).
Citing to the codified sunscreen Final Rule, Defendants assert this Court will undoubtedly be
called upon to determine whether Plaintiffs’ or Defendants’ tests followed the technical and
scientific requirements of that Rule. (Doc. 22 at 10.) Defendants argue the FDA possesses the
experience and discretion to interpret these scientific and technical protocols for determining a
sunscreen’s SPF. (Id.) Defendants rely on non-binding, non-sunscreen cases in support of their
argument. (Id. at 9–10.) However, multiple courts have declined to apply the primary jurisdiction
doctrine in sunscreen cases even when the label relates to a scientific or technical claim, as is the
case with SPF labeling. See, e.g., In re Edgewell, at 14; Dapeer, 95 F. Supp. 3d at 1376; Keskinen,
at 7 (reasoning, “Plaintiff alleges Defendants affirmatively and intentionally misrepresented the
results of their SPF tests on the Sunscreen Products’ labels. If that allegation is true, then discovery
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is likely to resolve Plaintiff’s claims without the need to resort to a technical examination of
Defendants’ SPF testing procedures”). And even assuming this Court will be called upon to assess
whether Plaintiffs’ or Defendants’ tests complied with the FDA regulations, this Court is equipped
to address such technical and scientific questions, as this and other courts routinely do on a regular
basis. Finally, the argument that the FDA is in the “best” position to interpret the sunscreen Final
Rule does not mean this Court cannot do the same or that this Court is compelled to apply the
primary jurisdiction doctrine. See, e.g., In re Edgewell, at 18 (“To the extent defendants argue that
SPF testing [of Banana Boat sunscreen products] itself is so technical, complicated, and/or scientific
that only the FDA can resolve plaintiff’s claims of inaccuracy, the court is unconvinced”); Keskinen,
at 7 (finding that whether SPF tests complied with FDA regulations “can be proved or disproved
scientifically,” that courts “frequently deal with such determinations,” and that the court “is capable
of doing the same in this case”).3
2. Uniformity and Consistency
Defendants also argue that failure to dismiss or stay the case presents an “issue of consistent
or uniform regulation,” as the FDA is engaged in regulating issues central to this case. Defendants
primarily rely on three FDA actions in support of their argument. First, Defendants note that the
FDA solicited bids in a July 2016 “Request for Quote” (“RFQ”) for determining the SPF of twenty
U.S. marketed sunscreen products using the procedure in the sunscreen Final Rule. Second,
3
As noted previously, Defendants cite to non-binding, non-sunscreen cases in arguing this Court
must abstain from determining whether a regulated product meets technical or scientific agency
requirements. However, as pointed out in both In re Edgewell and Keskinen, what differentiates the
sunscreen cases from some other cases cited by Defendants is the fact that while the FDA
regulations provide mandatory SPF testing procedures, “the FDA’s involvement in this case’s
central question ends there.” Keskinen, at 6. Manufacturers, not the FDA, perform those SPF tests.
See 21 C.F.R. § 201.327(i–j). Moreover, the manufacturers are not required to obtain pre-marketing
review or approval of their labels from the FDA. Keskinen, at 6. Therefore, “while the FDA
provides rules for SPF testing, it is up to Defendants to follow those rules and properly label their
Sunscreen Products.” Id. Like in those cases, here, Plaintiffs “allege[] that Defendants have failed
to do so.” Id. Therefore, like in those cases, Plaintiffs’ claims do not require resolution of an issue
within the unique province of a regulatory agency. See id.; In re Edgewell, at 19.
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Defendants note that in May 2018, the FDA issued a public statement entitled “Statement from FDA
Commissioner Scott Gottlieb, M.D., on new FDA action to keep consumers safe from the harmful
effects of sun exposure, and ensure the long-term safety and benefits of sunscreens” (“FDA
Statement”). Third, and related to the FDA Statement, the FDA also issued a “Guidance for
Industry” in May 2018, reaffirming that SPF testing must be conducted according to the specific
method specified in the sunscreen Final Rule. (Doc. 22 at 11–12.)4
In the RFQ, the FDA has solicited bids for testing to be performed on twenty U.S. marketed
sunscreen products, including eight SPF 50 products. (Doc. 22-2 at 2.) That testing will be
performed off-site by a contractor and must be consistent with the testing procedures outlined in the
sunscreen Final Rule. (Id.) Defendants argue that the test results from the RFQ “will provide
guidance that will promote a uniform interpretation of the Final Rule.” (Doc. 22 at 11.) However,
the Court finds this argument to be speculative at this point.
First, it is unknown if or when these test results will be completed, and even if the testing is
completed, it is not certain that the FDA will issue any relevant formal ruling based on those
possible results. In re Edgewell, at 21–22. Thus, contrary to Defendants’ contention, it not certain
at this point when the FDA “will provide guidance” or that any such guidance “will promote”
uniformity. (See Doc. 22 at 11.) Defendants argue that the Guidance for Industry states that
4
When ruling on a motion to dismiss under Rule 12(b)(6), the Court generally may not consider
materials outside the pleadings. Noble Sys. Corp. v. Alorica Cent., LLC, 543 F.3d 978, 982 (8th Cir.
2008). It may, however, consider public records or materials that are necessarily embraced by the
pleadings. Id.; Stahl v. U.S. Dep’t of Agric., 327 F.3d 697, 700 (8th Cir. 2003). The Court takes
judicial notice of these three sources as they are publicly available documents from the FDA, a
source “whose accuracy cannot reasonably be questioned.” Fed. R. Evid. 201; see also Thompson v.
Allergan USA, Inc., 993 F. Supp. 2d 1007, 1011 (E.D. Mo. 2014) (concluding court could consider
publicly-available FDA documents). Plaintiffs do not object to or contest the substance of these
documents. In their Reply brief, Defendants point to an additional source, an FDA request for
comments on SPF labeling and testing for over-the-counter sunscreen drug products, published on
August 22, 2018, in the Federal Register. (Doc. 34 at 14 n.6.) For similar reasons discussed in this
section of the Court’s Order, this source does not alter the Court’s analysis on primary jurisdiction.
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“‘[s]everal other ongoing and planned rulemaking proceedings will also address [over the counter
sunscreens].’” (Doc. 34 at 14.) However, even if the FDA issues future formal rulings, there is no
indication that such rulings will have any retroactivity. Thus, it is speculative whether those rulings
would have impact on actions or testing that occurred relating to this pending litigation. Defendants
also argue that the FDA has consistently made known its “continued undertakings” in the field of
SPF testing. Thus, Defendants contend this case is distinguishable from Alpharma, “where the
Eighth Circuit noted ‘substantial delay would result[] from staying or dismissing the cases,
particularly since the FDA ha[d] taken no action . . . [for] nearly two years’ on the regulated product
at issue.” (Doc. 22 at 11) (citing Alpharma, 411 F.3d at 939). Yet that seems to be the situation
here. As noted in In re Edgewell, as of September 2018 and confirmed by the parties in that case, “it
appears that no action has been taken pursuant to the FDA RFQ.” In re Edgewell, at 21 n.11.5
Therefore, it has been over two years since that RFQ, with no concrete action resulting, which seems
to implicate at least some of the same concerns as in Alpharma.
Second, the Court finds that Defendants’ arguments based on the RFQ are speculative
because only eight SPF 50 products will be tested, and the RFQ does not specify which products will
be tested. (See generally Doc. 22-2.) Nowhere does the RFQ mention any particular sunscreen,
including the Banana Boat Products at issue in this case. (Id.) The Court takes judicial notice of the
fact that there are many SPF 50 products marketed in the United States. There is no guarantee the
Products at issue in this case will be part of the RFQ testing. In re Edgewell, at 23. Moreover, as
Plaintiffs note—and Defendants do not contest—there is no indication that the FDA is testing
Defendants’ Products or investigating the accuracy of Defendants’ SPF label on the at-issue
5
There is overlap between the plaintiffs and defendants in the Banana Boat SPF mislabeling cases
pending in the United States District Court for the Eastern District of New York and this matter.
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Products, and Defendants have not applied, as they are entitled to do so, to have the FDA complete
such testing or investigation.6 (Doc. 26 at 17.)
Next, Defendants argue that the May 2018 FDA statement and Guidance for Industry require
a dismissal or stay. Defendants maintain that the FDA statement “left no doubt about [the FDA’s]
place in the field of [SPF efficacy],” as it states the FDA is committed to “making sure the products
consumers use deliver their advertised benefits.” (Doc. 22 at 11.) Defendants also argue that the
Guidance for Industry, which reiterated that SPF testing must be conducted according to the method
proscribed in the sunscreen Final Rule, warrants deference to the FDA. (Id. at 12.) However,
“[n]othing in the FDA Statement or the Guidance for Industry indicates that the FDA will, or is even
contemplating, issuing a ruling on the issue at hand in this action — namely whether defendants
improperly labeled the Products with an SPF 50 rating.” In re Edgewell, at 25.
Therefore, the Court finds that these sources, considered either singularly or in combination,
do not warrant the application of the primary jurisdiction doctrine.7
6
Importantly, as Plaintiffs note and Defendants do not contest, the FDA Statement indicates that the
FDA is not investigating Defendants, as the FDA has identified just three companies who were
subject to FDA investigation and who received warning letters due to deceptive warning practices.
(Doc. 26 at 16.) Defendants were not included on that list and did not receive a warning letter. (Id.)
Defendants concede it is unclear whether the testing will include the Products at issue here. (Doc.
34 at 14.) This further suggests that abstention based on primary jurisdiction is unwarranted. See
Keskinen, at 7 (finding that “Defendants present no reason for the Court to believe that the FDA will
resolve the issue of whether the SPF ratings on their Sunscreen Products are accurate” because “it
does not appear [from the RFQ] that the Sunscreen Products will be among those tested.”) Should it
become clear at some point that one or more of the Products at issue in this case will be tested
pursuant to the RFQ or otherwise investigated by the FDA, Defendants may make a motion for this
Court to revisit this issue.
7
The Court is mindful that there are multiple sunscreen cases pending involving the same
manufacturers (and, in some instances, the same products). Defendants argue that the more these
matters are litigated and resolved in varying judicial settings, uniformity and consistency will be
further threatened. (Doc. 22 at 15.) However, that does not warrant the application of primary
jurisdiction, as there are separate mechanisms in place for addressing such concerns should they
persist, including potential transfer or other consolidation of the actions. See, e.g., 28 U.S.C. §§
1404, 1407.
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B. Preemption
Defendants also argue for dismissal asserting that, as pleaded, Plaintiffs’ claims are
preempted by federal law. (Doc. 22 at 12–16.) Defendants argue that Plaintiffs must rely on FDAcompliant testing, but the Consumer Reports and independent testing they reference in the
Complaint did not comply with FDA regulations. (Id. at 13–16.) Since Plaintiffs have failed to
plead sufficient facts to plausibly assert that their claims are founded on the sunscreen Final Rule,
they fail to state a claim for relief. (Id. at 13.)
The Supremacy Clause of the Constitution provides that “the Laws of the United States . . .
shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any
Thing in the Constitution or Laws of any State to the Contrary notwithstanding.” U.S. Const. art. VI,
cl. 2. Therefore, any state law conflicting with an existing federal law is considered to be “without
effect” and preempted by the federal law. Baker v. NNW, LLC, No. 15-00222-CV-W-GAF, 2015
WL 12843827, at *2 (W.D. Mo. July 8, 2015) (citing Maryland v. Louisiana, 451 U.S. 725, 746
(1981).
Relevant to this matter, the FDCA contains an express preemption clause. Section 379r,
“National uniformity for nonprescription drugs,” of the FDCA states in relevant part:
(a) In general
Except as provided in subsection (b), (c)(1), (d), (e), or (f), no State or political
subdivision of a State may establish or continue in effect any requirement—
...
(2) that is different from or in addition to, or that is otherwise not identical with, a
requirement under this chapter . . . .
21 U.S.C. § 379r(a)(2);8 see also Carrol v. S.C. Johnsons & Son, Inc., No. 17-CV-05828, 2018 WL
1695421, at *2 (N.D. Ill. Mar. 29, 2018) (in sunscreen SPF mislabeling case, noting section 379r
8
Common law causes of action “constitute [state] ‘requirements’ within the meaning of FDCA
preemption” and, thus, also are preempted. Riegel v. Medtronic, Inc., 552 U.S. 312, 323–25 (2008).
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“expressly preempts claims seeking to enforce state requirements that differ from those established
by the FDA”); Dayan v. Swiss-Am. Prod., Inc., No. 15CIV6895DLIVMS, 2017 WL 9485702, at *2
(E.D.N.Y. Jan. 3, 2017), report and recommendation adopted, No. 15CV6895DLIVMS, 2017 WL
1214485 (E.D.N.Y. Mar. 31, 2017) (noting 379r(a) is an express preemption clause). The FDCA
regulates over-the-counter drugs, including non-prescription sunscreen. See, e.g., 21 U.S.C. §
360fff–6.
In addition, and as both parties agree, the FDA has enacted regulations relating SPF testing
procedures and labeling requirements for the Products. The federal requirements for sunscreen
labeling and testing are codified in a “sunscreen Final Rule,” 21 C.F.R. § 201.327 (“Over-thecounter sunscreen drug products; required labeling based on effectiveness testing”). Among other
things, that regulation sets out the SPF labeling requirements and lengthy, detailed scientific and
technical procedures and parameters for testing a sunscreen’s SPF. See id. § 201.327(i). The
methodology in § 201.327 is used to determine whether SPF claims comply with the regulation. In
the preemption analysis, “federal regulations carry the same preemptive effect as federal statutes.”
Baker, 2015 WL 12843827, at *2 (citing Fid. Fed. Savings & Loan Ass’n v. de la Cuesta, 458 U.S.
141, 153 (1982)).
The Eighth Circuit Court of Appeals has affirmed the dismissal of actions on federal
preemption grounds at the pleading stage. See, e.g., Brinkley v. Pfizer, Inc., 772 F.3d 1133, 1139
(8th Cir. 2014) (finding design defect and implied warranty claims were preempted by the FDCA
and affirming the lower court's dismissal pursuant to a motion for judgment on the
pleadings); Moretti v. Mut. Pharm. Co., 518 Fed. App’x 486, 487 (8th Cir. 2013) (affirming district
court’s grant of judgment on the pleadings on the basis of FDA preemption); see also Ideus v. Teva
Pharm. USA, Inc., No. 4:16-CV-3086, 2017 WL 6389630, at *2 (D. Neb. Dec. 12, 2017) (internal
quotations and citation omitted) (dismissal is nonetheless appropriate under Rule 12(b)(6) if the facts
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alleged in the complaint do not plausibly give rise to a claim that is not preempted.”); Dougherty v.
Source Nats., Inc., 148 F. Supp. 3d 831, 835–36 (E.D. Mo. 2015) (granting motion to dismiss in
labeling case based on FDCA preemption). To avoid preemption under the FDCA, Plaintiffs’ state
law claim must fit in a narrow gap. Dougherty, 148 F. Supp. 3d at 834. “‘[I]n order for a state law
claim to survive, plaintiff's claim “must be premised on conduct that both (1) violates the FDCA and
(2) would give rise to a recovery under state law even in the absence of the FDCA.’” Id. (quoting
Riley v. Cordis Corp., 625 F. Supp. 2d 769, 777 (D. Minn. 2009)).
The Court agrees that to the extent Plaintiffs’ state law claims do not seek to impose any
requirements on Defendants beyond those which federal law already requires (Docs. 1 ¶ 60–61; 26
at 3), those claims are not preempted. See 21 U.S.C. § 379r(f); see also, e.g., Baker, 2015 WL
12843827, at *2 (“a state law is not preempted when the state law seeks to impose liability [for
mislabeling] consistent with the FDCA.”); Curran v. Bayer Healthcare LLC, No. 17 C 7930, 2018
WL 2431981, at *3 (N.D. Ill. May 30, 2018) (in SPF mislabeling case, holding “to the extent
plaintiff is merely seeking to use state-law causes of action to enforce the labeling requirements set
out in 21 C.F.R. § 201.327, his claims are not preempted.”). To the extent Plaintiffs seek to add or
change the requirements for sunscreen labeling or testing, however, those claims would be
preempted. See, e.g., Curran, 2018 WL 2431981, at *3. Further, if Plaintiffs rely on FDAcompliant testing of the Products in “an attempt to enforce the identical requirements of the FDCA
as it applies to SPF labeling . . . [such] claims are not preempted.” Curran, 2018 WL 2431981, at
*3. If, however, Plaintiffs’ testing is not in compliance with the sunscreen Final Rule, and if
Plaintiffs seek to use that testing in support of their Complaint, as they have so alleged, they would
in essence be asking this Court to find Defendants liable based on a change or deviation from the
testing requirements as set out in the Final Rule. Cf. Corra v. Energizer Holdings, Inc., 962 F. Supp.
2d 1207, 1215 (E.D. Cal. 2013) (finding sunscreen claims not preempted when a plaintiff’s claims
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“are not based on (and do not require interpretation of) the Final Rule”);9 Lombardo v. Johnson &
Johnson Consumer Companies, Inc., No. 13-60536-CIV, 2014 WL 10044838, at *4 (S.D. Fla. Sept.
10, 2014) (finding sunscreen claims not preempted when plaintiff did not allege that the SPF values
on labels were inaccurate).
The parties agree that 21 C.F.R. § 201.327 applies to this case. They disagree about what
suffices to avoid preemption and whether testing must comply with the FDA methodology in order
to avoid preemption. See, e.g., Mee v. I A Nutrition, Inc., No. C-14-5006 MMC, 2015 WL 2251303,
at *4 (N.D. Cal. May 13, 2015) (“As each district court to have considered the matter has found,
where, as here, an FDA regulation provides that the question of compliance must be determined
using the method specified therein, a state law claim that seeks to establish a violation of such
regulation by a different methodology is preempted.”) (collecting cases); see also Dougherty, 148. F.
Supp. 3d at 835, 836 (quoting Mee with approval for this proposition and stating “state law claims
that rely on a different methodology to demonstrate such labeling violations are inconsistent with the
FDCA and are thus preempted”).
Plaintiffs allege that Consumer Reports article sets forth “in May 2016 that its own testing
had revealed ‘that Banana Boat Kids SPF 50 sunscreen lotion had an SPF of only 8 and stated “the
most problematic products were Banana Boat Kids Tear-Free, Sting-Free Lotion . . . which [was]
labeled as SPF 50 but [was] found to have only SPF 8.’” (Doc. 1 ¶ 37.) The Court agrees with
Defendants that Plaintiffs include no allegations about the methodology of the Consumer Reports
9
In Corra, the plaintiffs brought suit against sunscreen manufacturers regarding their labeling of
some products with an SPF of 85 to 110. Corra, 962 F. Supp. 2d at 1214. As the Court noted, and
unlike the matter before this Court, the plaintiffs did not argue that the “SPF 85–110 ratings on
Defendants’ products are themselves per se false or misleading.” Id. Instead, the plaintiffs argued
that the products were marketed in such a way that led customers to buy them even though there was
evidence tending to show products with an SPF above fifty did not provide proportionally greater
protection than lower-rated SPF products. Id. at 1214–15. Therefore, because the plaintiffs’ claims
were not based on and did not require an interpretation of the Final Rule, the court found those
claims were not preempted. Id.
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testing or any facts demonstrating that such testing complied with FDA-prescribed methodology.
(See Doc. 22 at 14.) In fact, Plaintiffs clarify and concede in their response to Defendants’ Motion
to Dismiss that “Plaintiffs’ claims are not actually based on the Consumer Reports testing.”
(emphasis in original) (Doc. 26 at 7.)10 Nor could they be, as Plaintiffs have not included any
allegations in support of the notion that the Consumer Reports testing complies with the regulations
for testing sunscreen as codified in the Final Rule. (See, e.g., Doc. 1 ¶ 37.) Indeed, in their strong
statements of non-reliance on the Consumer Reports testing, Plaintiffs seem to at least implicitly
concede that the testing does not, in fact, comply with those regulations. (See Doc. 26 at 7.)
Therefore, to the extent Plaintiffs seek to rely on or otherwise invoke the Consumer Reports testing
in support of their claims, those claims are preempted. See, e.g., Curran, 2018 WL 2431981, at *3
(“To the extent plaintiff is claiming that the sunscreen’s label needed to reflect the [SPF] testing
conducted by Consumer Reports, those claims are preempted, because such labeling is not identical
to the requirements set out in federal law.”); Baker, 2015 WL 12843827, at *2 (dismissing complaint
as preempted because plaintiff failed to allege testing of the subject product used relevant FDAmandated methodology).
10
Plaintiffs assert that the “Complaint makes clear” that “while the Consumer Reports article first
alerted Plaintiffs to the potential inaccuracy in Defendants’ labels,” Plaintiffs’ claims are actually
based on their independent testing, not the Consumer Reports testing. (Doc. 26 at 7.) The Court
disagrees that the Complaint made this clear. Instead, Plaintiffs’ allegations, on their face, place
reliance on the Consumer Reports testing. (See Doc. 1 ¶¶ 36–37) (“[R]igorous scientific testing has
revealed that the Products do not provide an SPF of 50, much less ‘50+’ . . . . Such testing includes,
but is not limited to, testing conducted by the noted consumer protected periodical Consumer
Reports . . . .”) The Court declines to decide at this time the general admissibility of such testing as
background information said to have “first alerted Plaintiffs to the potential inaccuracy in
Defendants’ SPF labels.” (Doc. 26 at 7.)
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The Court will now address Plaintiffs’ independent SPF testing. Defendants argue that if
Plaintiffs rely on testing that “does not employ the precise methodology found in the Final Rule,
[Plaintiffs’] claims are preempted.” (Doc. 22 at 13.) In part, the relevant allegations are as follows:
38. In addition, Plaintiffs conducted their own independent testing of the
Products, utilizing the methodology for SPF testing mandated by the FDA.
39. Specifically, the independent testing conducted by Plaintiffs was
conducted in compliance with all FDA testing methods embodied in FDA Final Rule,
21 CFR Parts 201 and 310, (Federal Register/Vol 76, No 117/Friday, June 17,
2011/Rules and Regulations, including 21 CFR 201.327).
40. The results of the independent testing conducted by Plaintiffs were
consistent with the results suggested by Consumer Reports’ test results and confirmed
that the Products had actual SPFs substantially lower than the claimed SPF 50 or
“50+”.
41. Plaintiffs’ investigation concluded that all three products, clearly labeled
as containing SPF 50 or “50+”, contained an SPF of less than 37.8 and no more than
a 30.1.
(Doc. 1.) Defendants argue Plaintiffs have “failed to plead facts sufficient to make plausible their
assertion that their claims are founded on the Final Rule Method.” (Doc. 22 at 13.) More
specifically, Defendants argue that Plaintiffs’ “naked assertions” regarding their independent testing,
which are “undetailed” and void of facts, amount to a “legal conclusion” and are insufficient to state
a plausible claim for relief. (See Doc. 22 at 15–16; Doc. 34 at 1, 3–12.) Defendants argue Plaintiffs’
bare allegations are particularly insufficient given that the some claims sounds in fraud and
misrepresentation, and such claims must be pleaded with particularity in accordance with Eighth
Circuit and Supreme Court precedent. (See, e.g., Doc. 22 at 16–17.) Plaintiffs do not contest the
notion that their independent testing must comply with the methodology as codified in the FDA
Final Rule. Plaintiffs instead maintain that their description of testing methods in the Complaint is
sufficient to avoid dismissal under federal pleading standards. (Doc 26 at 9.) However, Plaintiffs
are prepared to file an amended pleading providing additional details regarding their independent
testing if the Court orders otherwise. (Id.)
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The relevant allegations demonstrate that Plaintiffs’ claims are premised on and dependent
upon the independent product testing results. (See Doc. 1 ¶¶ 36, 38–41.) But if Plaintiffs are relying
on testing that does not comply with FDA methodology in support of their claims, Plaintiffs cannot
show that Defendants’ statements on the product labels violated the FDCA labeling requirements.
Thus, they cannot establish a violation of the FDCA. And as a result, they face preemption. See,
e.g., Salazar v. Honest Tea, Inc., 74 F. Supp. 3d 1304, 1313 (E.D. Cal. 2014). As an initial matter,
Plaintiffs’ claims must be premised on conduct that violates the FDCA in order to survive. See
Dougherty, 148 F. Supp. 3d at 834. Therefore, the Court finds that compliance with FDA-mandated
testing is a threshold issue in this case.11
The Court further finds that even under a liberal reading of the Complaint, Plaintiffs’
allegations regarding their independent testing are insufficient to avoid dismissal under preemption
at this stage of the litigation. The crux or centerpiece of Plaintiffs’ Complaint is that all three
Products do not in fact meet the stated SPF on their respective labels. All claims flow from and are
premised on that presumption. Yet in their thirty-four page, one-hundred-and-sixty paragraph,
Complaint, Plaintiffs devote just four paragraphs to their testing. (See Doc. 1 at ¶¶ 38–42.) And
only one of those paragraphs, just over three lines, mentions anything about the specific
methodology employed. (See id. ¶ 39.) In that sole paragraph, Plaintiffs offer nothing more than a
conclusory statement that the testing complied with the FDA Final Rule, an ultimate question this
Court may be called upon to decide in the future. See, e.g., Wiles v. Capitol Indemnity Corp., 280
F.3d 868, 870 (8th Cir. 2002) (“While the court must accept allegations of fact as true when
considering a motion to dismiss, the court is free to ignore . . . legal conclusions cast in the form of
factual allegations.”); Baker, 2015 WL 12843827, at *1 (quoting Ashcroft v. Iqbal, 556 U.S. 662,
678 (2009) (“courts are ‘not bound to accept as true a legal conclusion couched as a factual
11
Defendants recognize that if Plaintiffs’ testing complies with FDA requirements, Plaintiffs’
claims may not be preempted. (Doc. 22 at 16.)
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allegation’ and such ‘labels and conclusions’ or “‘formulaic recitation[s] of the elements of a cause
of action will not do.’”); Ladd v. St. Louis Bd. of Police Comm’rs, No. 405CV916UNA RHK/AJB,
2006 WL 2862165, at *2 (E.D. Mo. Oct. 4, 2006) (quoting Kaylor v. Fields, 661 F.2d 1177, 1182
(8th Cir. 1981)) (“Courts need not consider conclusory allegations, however, or ‘blindly accept legal
conclusions drawn by the pleader of the facts’”). Moreover, even under a liberal reading of the
Complaint, it is uncertain whether Plaintiffs have FDA-compliant test results relating to all three
Products even though the Products have differences. (See id. ¶¶ 38–42 and Figures 1–3; see also
Doc. 34 at 10–11.) Another district court interpreting near-identical independent SPF sunscreen
testing allegations recently found that a sunscreen SPF labeling claim “is preempted if it seeks to
enforce a labeling requirement that is not identical; and, in order to make his claim plausible,
plaintiff must do more than insert a conclusory allegation that the testing was identical.” Curran,
2018 WL 2431981, at *4. That reasoning applies with equal force here.
Therefore, the Court finds that Plaintiffs have not pleaded sufficient facts to avoid
preemption at this stage. Plaintiffs implicitly, if not explicitly, recognize the need for FDAcompliant SPF testing in this matter, but it is ambiguous whether Plaintiffs have testing on all
products that complies with the FDA-mandated methodologies. Given the threshold nature of this
issue, the Court finds it prudent to grant Defendants’ motion to dismiss on this basis, as the
allegations do not suffice under the pleading standards for the reasons stated. See, e.g., Dougherty,
148 F. Supp. 3d at 833 (alteration in original) (citation omitted) (quoting Benton v. Merrill Lynch &
Co., 524 F.3d 866, 870 (8th Cir. 2008) (finding “‘[w]here the allegations show on the face of the
complaint there is some insuperable bar to relief, dismissal under Rule 12(b)(6) is appropriate.’”);
Crump v. Boester, No. 4:14 CV-01975-RWS, 2016 WL 1624017, at *3 (E.D. Mo. Apr. 25, 2016)
(quoting Iqbal, 556 U.S. at 678–79) (noting “‘[r]ule 8 . . . does not unlock the doors of discovery for
a plaintiff armed with nothing more than conclusions’”).
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This conclusion is consistent with holdings of some other district courts in this and other
circuits when analyzing independent testing-related allegations in the context of the FDCA. The
substance of the allegations is particularly important in determining the sufficiency of those
allegations in situations where, as here, the governing FDA regulation imposes a specific, lengthy,
and very detailed methodology for testing the products, including the specific number of subjects to
be tested, timelines for testing, etc. See, e.g., Dougherty, 148 F. Supp. 3d at 835–36 (in mislabeling
case involving the amount of vitamins and minerals in an over-the-counter vitamin, dismissing
claims as preempted when the allegations regarding plaintiff’s independent testing did not allege
product testing complied with the twelve-sample testing method, were based on a random sample, or
used bottles from the same lot, as required by the applicable FDA-mandated testing regulation);
Baker, 2015 WL 12843827, at 3–4 (in mislabeling case involving whey protein, dismissing claims
as preempted when plaintiff did not allege he tested the product “under the twelve-subsample
analytical methodology mandated by [the applicable codified regulation]” and otherwise “failed to
articulate any precise methodology he used”); see also, e.g., Curran, 2018 WL 2431981, at *4 (in
case with virtually identical allegations in sunscreen SPF case, holding that plaintiff failed to state a
plausible claim to avoid preemption when “plaintiff offer[ed] nothing more than his conclusion that
his testing was the same as is required by the FDA”);12 Mee, 2015 WL 2251303, at *4 (in dietary
12
The relevant allegations the Curran court analyzed stated the following:
37. In addition, Plaintiff conducted his own independent testing of Coppertone
Sport High Performance SPF 30 sunscreen spray, utilizing the methodology for SPF
testing mandated by the FDA.
38. The independent testing performed by Plaintiff was conducted in
compliance with all FDA testing methods embodied in FDA Final Rule, 21 CFR
Parts 201 and 310, Federal Register/Vol 76, No 117/Friday, June 17, 2011/Rules and
Regulations, including 21 CFR 201.327.
Curran, No. 1:17-CV-07930 (N.D. Ill. Nov. 2, 2017), ECF No. 1 ¶¶ 37–38.
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supplement mislabeling case, holding that claims were preempted because plaintiff’s independent
testing attached to complaint did not comply with FDA-mandated twelve sample methodology);
Salazar v. Honest Tea, Inc., 74 F. Supp. 3d 1304, 1313 (E.D. Cal. 2014) (granting 12(b)(6) dismissal
based on preemption in tea mislabeling case when plaintiff failed to allege he tested correct number
of samples as required by the FDA-mandated regulation, reasoning “Consequently, the Complaint
does not show that defendant’s statements on the product labels violates the FDCA’s labeling
requirements. Because plaintiff’s allegations do not show a violation of the FDCA, plaintiff’s state
law claims are preempted; if allowed to proceed, the state law claims would impose liability
inconsistent with the FDCA.”); Burke v. Weight Watchers Int’l, Inc., 983 F. Supp. 2d 478, 483
(D.N.J. 2013) (dismissing complaint as preempted when plaintiff made conclusory allegation that
testing complied with a specific FDA-mandated regulatory provision, reasoning the allegations were
insufficient to establish a violation of the FDCA because plaintiff “has not pled that she tested the
[product] using every one of the Five Methods [specified in the regulation] . . . has not pled that
every one of the test results [failed to meet the standards set out in the regulation] and also failed to
test each of the at-issue products).13
13
Two of the cases Plaintiffs rely upon in their argument are distinguishable because the plaintiffs
in those cases attached the independent testing to their complaints, but Plaintiffs have not chosen to
do the same here. See, e.g., Muir v. NBTY, Inc., No. 15 C 9835, 2016 WL 5234596, at *5–6 (N.D.
Ill. Sept. 22, 2016) (plaintiff attached multiple independent testing results to the complaint in dietary
supplement mislabeling case); Gubala v. CVS Pharmacy, Inc., No. 14 C 9039, 2016 WL 1019794, at
*8 (N.D. Ill. Mar. 15, 2016) (citation omitted) (in protein powder mislabeling case, holding
“Plaintiff may rely on the [independent] testing results attached to the amended complaint to nudge
his claims based on an overstated declaration of protein content ‘across the line from conceivable to
plausible.’”). While the Carrol court allowed the plaintiffs to avoid dismissal when the allegations
did not state independent testing was in compliance with FDA methodology, the court specifically
relied upon district court case law within that circuit allowing mislabeling claims based on
preliminary testing that was not completed in compliance with FDA standards. See Carrol v. S.C.
Johnsons & Son, Inc., No. 17-CV-05828, 2018 WL 1695421, at *3 (N.D. Ill. Mar. 29, 2018). The
district courts in this circuit (e.g., Dougherty and Baker) have taken a different approach, consistent
with multiple district courts from other circuits.
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However, in the interests of justice and given the early stage of this litigation, the Court also
finds it prudent to allow Plaintiffs to amend their Complaint to address Defendants’ concerns about
their independent testing, consistent with other courts interpreting FDA testing requirements at the
pleading stage. See, e.g., Curran, 2018 WL 2431981, at *4 (allowing plaintiff to amend, stating
plaintiff “needs to include at least some facts” about his testing procedure “in order to make it
plausible that defendant’s [sunscreen SPF] label was not in compliance with the requirements of 21
C.F.R. § 201.327.”); Dougherty, 148 F. Supp. 3d at 837 (allowing plaintiff to amend when, as here,
plaintiff requested she be allowed to amend in event court granted motion to dismiss); Mee, 2015
WL 2251303, at *4 (allowing leave to amend); Salazar, 74 F. Supp. 3d at 1318 (E.D. Cal. 2014)
(same); Burke, 983 F. Supp. 2d at 484 (same). In fact, in another Banana Boat sunscreen SPF
mislabeling case involving almost identical allegations and parallel preemption arguments, the court
in the Eastern District of New York ordered plaintiffs to file an amended complaint addressing
concerns regarding plaintiffs’ compliance with FDA testing results. In re Edgewell, Case No. 1:16CV-3371-KAM-RLM (E.D.N.Y. Oct. 23, 2018), ECF Minute Entry.14
For these reasons, the Court will grant Defendants’ motion to dismiss based on preemption in
part, allowing Plaintiffs leave to amend their Complaint.
14
Defendants argue in their Memorandum in Support and Reply some specific ways in which they
assert Plaintiffs’ allegations are deficient and could be remedied. (See Doc. 22 at 15–16; Doc. 34 at
6–8, 10–12). It would be improper for the Court to order with specificity how Plaintiffs should
amend their Complaint. However, like in Curran and In re Edgewell, the Court would expect that
Plaintiffs will address the issues raised here and include facts about the testing procedure of each of
the three products in order to make it plausible that each individual product was not in compliance
with the FDA regulation. Plaintiffs must decide whether to attach such testing. See Curran, 2018
WL 2431981, at *4; Curran, No. 1:17-CV-07930 (N.D. Ill. June 25, 2018), ECF No. 87.
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C. Class Action Certification
Plaintiffs seek to bring this case as a class action pursuant to Federal Rule of Civil Procedure
23(b)(2) or 23(b)(3). (Doc. 1 ¶ 64.) Plaintiffs seek certification of a nationwide class. (Id. ¶ 65.)
Additionally, or alternatively, Plaintiffs seek certification of defined state sub-classes for New York,
New Jersey, Florida, Illinois, and California. (Id. ¶ 66.) Defendants move to strike the nationwide
class allegations, arguing that individual issues predominate. (Doc. 21.) More specifically,
Defendants argue that individual issues predominate on Plaintiffs’ claims for unjust enrichment,
implied contract, and breach of warranty asserted on behalf of a purported nationwide class. (Doc.
22 at 22.) Because the elements of such claims are variable among the laws of the states, and
because there are significant outcome-determinative conflicts across the laws of the fifty states and
the District of Columbia, Defendants argue the Court should strike those nationwide class
allegations now. (Id.) Though the Court need not decide the issue at this juncture given the ruling
on preemption, the Court deems it helpful to address it now to provide guidance to the parties in
light of the upcoming Scheduling Conference pursuant to Federal Rule of Civil Procedure 16. A
class action may be maintained if Federal Rule of Civil Procedure Rule 23(a) is satisfied and if “the
court finds that the questions of law or fact common to class members predominate over any
questions affecting only individual members, and that a class action is superior to other available
methods for fairly and efficiently adjudicating the controversy.”15 Because the dispositive inquiry
here is whether Plaintiffs’ class allegations can plausibly meet Rule 23(b)(3)’s predominance
requirement, the Court need not address the Rule 23(a) factors or Rule 23(b)(3)’s superiority
15
Rule 23(a) contains the prerequisites for class actions, namely that a class member can sue on
behalf of a class only if (1) the class is so numerous that joinder of all members is impracticable; (2)
there are questions of law or fact common to the class; (3) the claims or defenses of the
representative parties are typical of the claims or defenses of the class; and (4) the representative
parties will fairly and adequately protect the interests of the class. See Fed. R. Civ. P. 23(a). The
Court need not determine today whether the prerequisites are met in ruling on this Motion.
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requirement at this time. See, e.g., Kraetsch v. United Service Auto. Ass’n, 2015 WL 1457015, at *4
(E.D. Mo. Mar. 30, 2015).
In the Eighth Circuit, “class claims that fail to meet the requirements of Rule 23 may be
properly dismissed by granting a Rule 12(b)(6) motion.” McCrary v. Stifel, Nicolaus & Co., 687
F.3d 1052, 1059 (8th Cir. 2012); see also In re Zurn Pex Plumbing Products Liab. Litig., 644 F.3d
604, 611 (8th Cir. 2011) (same); Blades v. Monsanto Co., 400 F.3d 562, 566 (8th Cir. 2005) (“If, to
make a prima facie showing on a given question, the members of a proposed class will need to
present evidence that varies from member to member, then it is an individual question”); Kraetsch,
2015 WL 1457015, at *5 (internal quotations and citation omitted) (striking class claims and stating
“[a]t the core of Rule 23(b)(3)'s predominance requirement is the issue of whether the defendant's
liability to all plaintiffs may be established with common evidence.”). Indeed, Federal Rule of Civil
Procedure Rule 23(c)(1)(A) provides “[a]t an early practicable time after a person sues or is sued as
a class representative, the court must determine by order whether to certify the action as a class
action.” However, while judges enjoy liberal discretion to strike pleadings, the Eighth Circuit has
also recognized that striking a party’s pleading “is an extreme and disfavored measure.” BJC Health
Sys. v. Columbia Cas. Co., 478 F.3d 908, 917 (8th Cir. 2007); see also Doyel v. McDonald's Corp.,
No. 4:08-CV-1198-CAS, 2009 WL 350627, at *5 (E.D. Mo. Feb. 10, 2009) (noting that “[s]triking
plaintiffs’ class action allegations prior to discovery and the class certification stage is a rare
remedy”); Knowles v. Standard Fire Ins. Co., No. 4:11-CV-04044, 2013 WL 6497097, at *2 (W.D.
Ark. Dec. 11, 2013) (noting that “in many cases, a motion to strike or dismiss a plaintiff's class
allegations prior to discovery on class-related issues and prior to the submission of a motion for class
certification would be premature.”); Nobles v. State Farm Mut. Auto. Ins. Co., No. 10-04175-CV-CNKL, 2012 WL 4090347, at *2 (W.D. Mo. Sept. 17, 2012) (“[t]he weight of authority indicates that
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courts should meet motions to dismiss class allegations at the 12(b)(6) stage with a great deal of
skepticism.”)
Defendants contend that nationwide class certification of Plaintiffs’ breach of warranty,
unjust enrichment, and implied contract claims is not appropriate. See, e.g., In re
Bridgestone/Firestone Tires Prods. Liab. Litig., 288 F.3d 1012, 1015 (7th Cir. 2002) (holding that
“warranty . . . suits may not proceed as nationwide classes”); True v. Conagra Foods, Inc., No. 0700770-CV-W-DW, 2011 WL 176037, at *9 (W.D. Mo. Jan. 4, 2011) (citation omitted) (declining to
certify nationwide class on unjust enrichment, finding that “[p]erhaps the greatest discrepancy in
state law is found in Plaintiffs' claim for unjust enrichment” and “[c]ourts have repeatedly
recognized that ‘the law of unjust enrichment varies materially from state to state”); Tyler v. Alltel
Corp., 265 F.R.D. 415, 422 (E.D. Ark. Feb. 23, 2010) (declining to certify a nationwide class on
unjust enrichment); Thompson v. Jiffy Lube Int’l, Inc., 250 F.R.D. 607, 626 (D. Kan. 2008) (finding
“there are differences nationwide in the very definition of unjust enrichment and its availability as a
remedy . . . [and] [b]ecause of such variations, federal courts have generally refused to certify a
nationwide class based upon a theory of unjust enrichment.”);16 Avritt v. Reliastar Life Ins. Co., 615
F.3d 1023, 1030–31 (8th Cir. 2010) (declining to certify a nationwide class on breach of contract
claims where “liability to the entire class for breach of contract [could not] be established with
common evidence” and further declining to certify the class because establishing a duty of good
faith and fair dealing would require evidence of the understanding each purchaser attached to the
16
In fact, one district court in this circuit recently dismissed plaintiffs’ claims for a nationwide
unjust enrichment class based on federal common law, finding that “Plaintiffs fail to identify any
source of law that would serve as a basis for a national unjust enrichment class,” and “[a]s a
threshold matter, ‘there is no federal general common law.’” In re: Dollar Gen. Corp. Motor Oil
Mktg. & Sales Practices Litig., No. 16-02709-MD-W-GAF, 2017 WL 3863866, at *5 (W.D. Mo.
Aug. 3, 2017).
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contract and “would be essential to establishing liability”).17 As a result, the Court expresses some
preliminary concerns over whether Plaintiffs will ultimately be able to satisfy the predominance
requirement for these claims.
Plaintiffs do not challenge this case law. Instead, Plaintiffs merely assert that striking the
pleadings is an extreme remedy and that subsequent discovery and briefing is necessary. However,
while the Court has doubts regarding whether Plaintiffs can ultimately meet the standards set forth
in Rule 23, at this stage in the proceedings these doubts must be resolved in favor of Plaintiffs. In
fact, in all of the cases cited by Defendants in support of their arguments on these nationwide class
allegations, the courts reached their decisions at the class certification stage after motion by the
plaintiffs, not at the pleadings stage.
Going forward, Plaintiffs may likely have difficulty satisfying the predominance
requirements on these nationwide claims based on the case law cited by Defendants. At this point in
the proceeding, however, the Court finds it proper to allow plaintiffs to conduct discovery or to
motion the Court and provide additional briefing to determine whether the prerequisites of Rule
23 can be satisfied. See, e.g., In re: Dollar Gen. Corp. Motor Oil Mktg. & Sales Practices Litig.,
No. 16-02709-MD-W-GAF, 2017 WL 3863866, at *5 (W.D. Mo. Aug. 3, 2017) (“Plaintiffs propose
that the Court should delay ruling on whether the proposed class should be stricken or certified until
Plaintiffs are allowed to fully brief a case-management strategy and provide an analysis of varying
state laws . . . [and] such a course follows the majority of guidance from the various circuit courts of
17
The Court also notes that in the consolidated Banana Boat cases pending in the Eastern District of
New York, the judge dismissed in its entirety Plaintiffs’ claim for breach of implied contact on
behalf of the nationwide class and each subclass. In re Edgewell Personal Care Co. Litig., Case No.
1:16-CV-3371-KAM-RLM, slip. op. at 25–27 (E.D.N.Y. Sept. 4, 2018). Plaintiffs alleged an
implied-in-law contract between plaintiffs and defendants regarding plaintiffs’ purchases of Banana
Boat SPF 50 sunscreen lotion. (Id. at 25–26.) Defendants argued there is no implied covenant
without a contract, and an implied-in-law contract is not a contract. (Id. at 26.) The court agreed,
reasoning contracts implied-in-law are not true contracts, and in the absence of a contact, there is no
implied covenant of good faith and fair dealing. (Id. at 26–27.) As a result, the court dismissed the
breach of implied contract claims with prejudice. (Id. at 27.)
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appeal, which caution that plaintiffs seeking to certify a nationwide class “must credibly
demonstrate, through an ‘extensive analysis’ of state law variances, ‘that class certification does not
present insuperable obstacles.’”) (emphasis in original) (citations omitted); Knowles, 2013 WL
6497097, at *3 (“in an abundance of caution” and “construing the class claims liberally,” denying
motion to strike when “it appears unlikely that Plaintiff will prevail on a motion for class
certification, even after class discovery is completed . . . [but] [o]n the other hand, the Court
recognizes that Plaintiff has not had the opportunity to take any meaningful discovery on class
certification issues, and the Court is therefore hesitant to issue an order foreclosing the possibility of
any class-wide remedy at this stage of litigation”); Doyel, 2009 WL 350627, at *5–6 (declining to
strike class allegations at pleading stage and instead allowing class certification discovery).
Therefore, the Court will exercise its discretion and decline to strike the nationwide class
allegations at this time.
IV. CONCLUSION
Accordingly,
IT IS HEREBY ORDERED that Defendants’ Motion to Dismiss or Stay Plaintiff’s
Complaint, or, in the Alternative, Strike the Nationwide Class Allegations (Doc. 21) is GRANTED,
in part, and DENIED, in part.
IT IS FURTHER ORDERED that Defendants’ motion to dismiss or stay the proceedings
based on the primary jurisdiction doctrine (Doc. 21 ¶ 1) is DENIED, without prejudice.
IT IS FURTHER ORDERED that Defendants’ motion to dismiss based on federal
preemption (Doc. 21 ¶ 2) is GRANTED, in part.
IT IS FURTHER ORDERED that Defendants’ motion to dismiss the New York General
Business Law § 349 (Count V), New York General Business Law § 350 (Count VI), New Jersey
Consumer Fraud Act, N.J.S.A. 56:8-1, et seq. (Count VII), New Jersey Truth in Consumer Contract,
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Warranty, and Notice Act, N.J.S.A. 56:12-14 et seq. (Count VIII), California Unfair Competition
Law, Cal. Bus. & Prof. Code §§ 17200, et seq. (Count X), and California Consumers Legal
Remedies Act, Cal. Civil Code §§ 1750, et seq. (Count XI) (Doc. 21 ¶ 3) is DENIED, as moot.
IT IS FURTHER ORDERED that Defendants’ motion to strike Plaintiffs’ nationwide class
allegations (Doc. 21) is DENIED, without prejudice.
IT IS FINALLY ORDERED that Plaintiffs shall file a first amended complaint no later
than thirty (30) days from the date of this Order.
Dated this 7th day of December, 2018.
/s/ Noelle C. Collins
NOELLE C. COLLINS
UNITED STATES MAGISTRATE JUDGE
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