Corbett v. PharmaCare U.S., Inc.Corbett v. PharmaCare U.S., Inc.
Case Information
UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF CALIFORNIA MONTIQUENO CORBETT, DAMARIS Case No.: 21cv137-GPC(AGS) LUCIANO, and ROB DOBBS, individually and on behalf of all others ORDER GRANTING IN PART AND similarly situated, DENYING IN PART DEFENDANT’S MOTION TO DISMISS THE FIRST
Plaintiffs, AMENDED COMPLAINT v. [Dkt. No. 35.]
PHARMACARE U.S., INC.,
Defendant.
Before the Court is Defendant’s motion to dismiss the first amended complaint pursuant to Federal Rule of Civil Procedure 9(b), 12(b)(1) and 12(b)(6). (Dkt. No. 35.) Plaintiffs filed an opposition to which Defendant replied. (Dkt. Nos. 39, 41.) The Court finds that the matter is appropriate for decision without oral argument pursuant to Local Civ. R. 7.1(d)(1). Based on the reasoning below, the Court GRANTS in part and DENIES in part Defendant’s motion to dismiss.
I. FACTUAL BACKGROUND
On January 25, 2021, Plaintiffs Montiqueno Corbett (“Corbett”), Damaris Luciano (“Luciano”) and Rob Dobbs (“Dobbs”) (collectively “Plaintiffs”) filed a putative class action complaint against Defendant PharmaCare U.S., Inc. (“Defendant” or “PharmaCare”) for violations of consumer fraud statutes for its sale of Sambucol, a dietary supplement that contains a proprietary extract of black elderberry. (Dkt. No. 1, Compl. ¶ 1, 22.) Pursuant to the Court’s order granting in part and denying in part Defendant’s motion to dismiss the complaint, (Dkt. No. 29), Plaintiffs filed a first amended putative class action complaint (“FAC”) on July 7, 2021. (Dkt. No. 31, FAC.) The operative putative first amended action complaint alleges seven causes of action based on the alleged misleading labeling, advertising and sale of twelve dietary supplement products [1] (“Products”) under the name Sambucol for violations of 1) California’s Unfair Competition Law (“UCL”) pursuant to California Business & Professions Code section 17200 et seq . on behalf of a national class and the California subclass; 2) California’s False Advertising Law (“FAL”) under California Business & Profession Code section 17500 et seq . on behalf of the California subclass; 3) California’s Consumer Legal Remedies Act (“CLRA”) under California Civil Code section 1750 et seq . on behalf of the California subclass; 4) violations of Massachusetts General Laws Chapter 93A, section 2, Mass. Gen. Laws. Ch. 93A, § 2 (“M.G.L. ch. 93A”), on behalf of the Massachusetts subclass; 5) Missouri Merchandising Practices Act (“MMPA”) pursuant to Mo. Ann. Stat. section 407.010 et seq . on behalf of the Missouri subclass; 6) breach of express warranties on behalf of a national class and the subclasses; and 7) breach of the implied warranty of merchantability on behalf of a national class and the subclasses. (Dkt. No. 31, FAC.)
Elderberry is derived from a flowering plant called Sambucus which has become a popular dietary supplement, and due to the popularity of “natural remedies”, has recently generated over $100 million in sales in the United States. ( Id. ¶¶ 2, 3.) In March 2020, sales of the elderberry supplements increased by 415% over prior years as consumers sought to buy products that would offer “immune support” from the coronavirus. ( Id. ¶ 4.) Defendant’s Products contain a proprietary extract of black elderberry labeled as “Elderberry Extract.” ( Id. ¶ 22.)
Plaintiffs allege two theories of consumer fraud: 1) an illegal products theory; and 2) false and misleading labels, packaging and advertising theory as well as omissions claims. On the first theory, Plaintiffs claim that Defendant’s Products are illegal to sell and are mislabeled as dietary supplements under the Food, Drug and Cosmetic Act (“FDCA”), 21 U.S.C. § 321(ff), and the Dietary Supplement Health and Education Act, (“DSHEA”) which passed in 1994 and established a new framework to govern the “composition, safety, label, manufacturing and marketing of dietary supplements” as well as California’s Sherman Law, California Health & Safety Code section 110095, which adopted the federal labeling regulation. ( Id. ¶¶ 23-27, 36.)
A dietary supplement is a “product (other than tobacco) intended to supplement the diet” and contain one or more of the following; 1) vitamins, 2) minerals, 3) herbs or other botanicals, 4) amino acid, 5) a supplement meant to increase total dietary intake, or 6) a concentrate, metabolite, constituent, extract or combination of any of the listed ingredients. ( Id. ¶ 26 (citing 21 U.S.C. § 321(ff)(1).) Under the DSHEA, a “new” dietary ingredient (those not used in the United States before 1994), may be used in dietary supplements but must first be submitted to the FDA prior to sale unless the ingredient has been “present in the food supply as an article used for food without being chemically altered.” ( Id. ¶¶ 28, 30 (quoting 21 U.S.C. § 350b(a)(1).) A manufacturer or distributor must provide the FDA with information that demonstrates “history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary ingredient will reasonably be expected to be safe.” ( ¶ 31 quoting 21 U.S.C. § 350b(a)(2).) After receiving information about the new dietary ingredient (“NDI”), the FDA may then determine whether the manufacturer or distributor has provided an adequate basis to conclude that the NDI is reasonably expected to be safe. ( Id. ¶ 32.) Dietary supplements that contain undisclosed NDIs are “adulterated” for purposes of the FDCA. ( Id. ¶ 34.) Because the elderberry extract was not marketed as a dietary ingredient in the U.S. before 1994, and is an NDI, the FAC maintains that Defendant did not notify the FDA with the required NDI notification for its elderberry extract. ( Id . ¶¶ 29, 33.) As such, Plaintiffs allege that Defendant’s Products are illegal to sell because the elderberry extract is adulterated and misbranded under the FDCA and California’s Sherman. ( Id . ¶ 36.)
On their illegal products theory, Plaintiffs allege three additional violations of the FDCA. First, they contend that Defendant, by marketing the Products as “scientifically tested”, “virologist developed”, “developed by a world renowned virologist”, as well as advertising that the Products “support[] immunity” or claim “immunity support”, is making implied disease claims under 21 C.F.R. § 101.93(g)(2) and misbranded under 21 U.S.C. § 343(r)(6). ( Id. ¶¶ 38-42, 44, 50 (citing 21 U.S.C. § 343(r)(6).) Under the FDCA, these phrases improperly promise that the Products have the ability to mitigate, treat, cure, or prevent diseases. ( Id. ¶ 38.) Second, Plaintiffs allege the Products are misbranded under 21 U.S.C. § 352(f)(1) because the labeling fails to include adequate directions for use and violate 21 U.S.C. § 331(a) of the FDCA. ( Id. ¶¶ 57-60.) Third, Plaintiffs claim that the Products are misbranded by stating the Products have “high antioxidant levels” and fail to comply with 21 C.F.R. § 101.54(g). ( Id. ¶¶ 61-69.)
Plaintiffs’ second theory alleges that the claim that the Products have been “scientifically tested” is misleading and deceptive because no published studies that test the Products exist and those that do exist do not contain the same elderberry extract formulation used in published studies. ( Id . ¶¶ 70-73.) Also, “scientifically tested” improperly suggests that the products are effective in keeping consumers safe from diseases which is false. ( ¶ 73.)
Plaintiff Corbet is a resident and citizen of San Diego, California, Plaintiff Luciano is a resident and citizen of Holyoke, Massachusetts, and Plaintiff Dobbs is a resident and citizen of Florissant, Missouri. ( Id. ¶¶ 14-16.) They all purchased certain of the Products at issue after being exposed to, saw and relied on Defendant’s materially misleading representations on the either the Products’ packaging and labeling, on advertisements on T.V. or on websites. ( Id. ¶¶ 80-102.) When they purchased the Products, they believed they were legally sold supplements and they all claim they experienced no improvement in their health after using the Products. ( Id. ¶¶ 82, 83, 90, 91, 98, 99.)
Plaintiffs seek to certify a national class defined as: “During the fullest period allowed by law, all persons in the United States who purchased the Products (the ‘National Class’) for personal use and not for resale.” ( Id. ¶ 103.) They also seek to certify a California, Massachusetts and Missouri subclass. ( )
II. JUDICIAL NOTICE AND LEGAL STANDARDS
A. Request for Judicial Notice
Defendant requests judicial notice of (1) a copy of one side of a package of Sambucol’s 4 oz. Black Elderberry Syrup taken from the Sambucolusa.com website on August 2, 2012; (2) the FDA's Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body, 65 Fed. Reg. 1000 (Jan. 6, 2000); (3) a copy of a webpage from Sambucolusa.com website on August 2, 2012; and (4) Plaintiffs’ December 30, 2020 demand letter from Whitfield Bryson LLP. (Dkt. No. 35-2, D’s RJN.) Plaintiffs did not file an opposition.
Under Federal Rule of Evidence 201, courts can take judicial notice of facts that
are not subject to reasonable dispute because they are either generally known or can be
readily determined by reference to sources whose accuracy cannot reasonably be
questioned. Fed. R. Evid. 201. “A court may, however, consider certain materials—
documents attached to the complaint, documents incorporated by reference in the
complaint, or matters of judicial notice—without converting the motion to dismiss into a
motion for summary judgment.”
United States v. Ritchie
,
First, courts addressing motions to dismiss product-labeling claims take judicial
notice of images of the product packaging if they are referenced or the images are in the
complaint.
See Lam v. General Mills, Inc.,
Second, the contents of the Federal Register are noticeable as a matter of law.
See
44 U.S.C. § 1507 (“The contents of the Federal Register shall be judicially noticed . . .
.”);
Bayview Hunters Point Cmty. Advocates v. Metro. Transp. Comm'n
,
Finally, Defendant requests judicial notice of the pre-notice demand letter sent by
Plaintiffs’ counsel on December 30, 2020. Plaintiffs do not oppose notice of the letter
and in fact rely on it in their opposition and attaches it as an exhibit. Because the letter is
incorporated by reference in the FAC in paragraphs 147, 161, the Court GRANTS
Defendant’s request for judicial notice of the demand letter.
See Asghari v. Volkswagen
Group of America, Inc
.,
B. Legal Standard on Federal Rule of Civil Procedure 12(b)(1)
Federal Rule of Civil Procedure (“Rule”) 12(b)(1) provides for dismissal of a
complaint for lack of subject-matter jurisdiction. Fed. R. Civ. P. 12(b)(1). “A Rule
12(b)(1) jurisdictional attack may be facial or factual.”
Safe Air for Everyone v. Meyer
,
Defendant does not specify what arguments are raised under Rule 12(b)(1)
[2]
but
appears to bring a Rule 12(b)(1) challenge based on preemption.
See McCray v. Marriott
Hotel Servs., Inc
.,
C. Legal Standard on Federal Rule of Civil Procedure 12(b)(6)
Federal Rule of Civil Procedure12(b)(6) permits dismissal for “failure to state a
claim upon which relief can be granted.” Fed. R. Civ. P. 12(b)(6). Dismissal under Rule
12(b)(6) is appropriate where the complaint lacks a cognizable legal theory or sufficient
facts to support a cognizable legal theory.
See Balistreri v. Pacifica Police Dep’t
., 901
F.2d 696, 699 (9th Cir. 1990). Under Rule 8(a)(2), the plaintiff is required only to set
forth a “short and plain statement of the claim showing that the pleader is entitled to
relief,” and “give the defendant fair notice of what the . . . claim is and the grounds upon
which it rests.”
Bell Atlantic Corp. v. Twombly,
A complaint may survive a motion to dismiss only if, taking all well pleaded
factual allegations as true, it contains enough facts to “state a claim to relief that is
plausible on its face.”
Ashcroft v. Iqbal
,
D. Legal Standard on Federal Rule of Civil Procedure 9
Where a claim alleges fraud or is grounded in fraud, Rule 9(b) requires a plaintiff
to “state with particularity the circumstances constituting fraud or mistake.” Fed. R. Civ.
P. 9(b). However, “[m]alice, intent, knowledge, and other conditions of a person's mind
may be alleged generally.” A party must set forth “the time, place, and specific
content of the false representations as well as the identities of the parties to the
misrepresentation.”
Odom v. Microsoft Corp
.,
Allegations of fraud must be “specific enough to give defendants notice of the
particular misconduct which is alleged to constitute the fraud charged so that they can
defend against the charge and not just deny that they have done anything wrong.”
Semegen v. Weidner
,
/ / /
/ / /
/ / / III. LEGAL DISCUSSION
A. Statutory Standing
1. California UCL, FAL and CLRA
“In 2004 . . . the voters of California passed Proposition 64, which restricts
standing for individuals alleging UCL and FAL claims to persons who have suffered
injury in fact and have lost money or property as a result of the unfair competition.”
Hinojos v. Kohl's Corp
.,
In the instant case, Defendant argues that all state law claims based on Plaintiffs’ illegal products theory fail for lack of statutory standing because they do not allege facts establishing that the misrepresentations they relied on were false or misleading. (Dkt. No. 35-1 at 14. [3] ) According to Defendant, statutory standing requirements are not met by the claim that “Pharmacare’s alleged violations of the FDCA made it unlawful for them to legally sell the Products, [and thus] Pharmacare’s representations induced them to purchase ‘illegal’ products.’” ( ) Plaintiffs respond they have established statutory standing by alleging material misrepresentations on the Products’ labels, reliance on these misrepresentations and that they would not have purchased the Products absent those misrepresentations. (Dkt. No. 39 at 11.)
On a motion to dismiss, “actual reliance . . . is inferred from the misrepresentation
of a material fact” because “whether a misrepresentation is sufficiently material to allow
for an inference of reliance is generally a question of fact that cannot be decided at the
motion to dismiss stage.”
Moore v. Mars Petcare U.S., Inc
.
In the instant case, Defendant misunderstands or misinterprets Plaintiffs’
allegations concerning the illegal products theory by arguing that under Plaintiffs’ illegal
products theory, any consumer would have standing to bring a class action lawsuit for
any purported regulatory violations regardless of any injury. (Dkt. No. 35-1 at 14 n.2.)
However, in this case, all three Plaintiffs allege that they viewed the alleged
misrepresentations on the Products’ label, on Defendant’s website, third party websites,
on T.V. advertisements and in stores, relied on these representations when purchasing the
Products and suffered economic injury because the representations were false based on
violations of the FDA. (Dkt. No. 31, FAC ¶¶ 80-102.) They do not merely allege a
regulatory violation but base their claims on misrepresentations arising from regulatory
violations. On a motion to dismiss, these allegations are sufficient to establish standing
under the UCL, FAL and CLRA.
See Moore
,
Defendant relies on district court cases that are distinguishable from the present
case and selectively quotes language in those cases to support its argument that district
courts have repeatedly rejected Plaintiff’s “Illegal Products” theory. For example, in
Brazil,
the district court held that because the plaintiff had not viewed the defendant’s
misleading health claims on its website, he did not have standing under the UCL, FAL
and CLRA.
Brazil v. Dole Food Co., Inc.,
Case No.: 12–CV–01831–LHK, 2013 WL
5312418 at *8-9 (N.D. Cal. Sept. 23, 2013). In this case, Plaintiffs allege they saw and
relied on the Defendant’s misleading representations. Notably, in
Brazil,
the defendants
did not challenge the plaintiff’s numerous other labeling claims that violated provisions
of the FDCA that he viewed, such as nutrient content claims, fresh claims, all natural
claims, sugar free claims and antioxidant claims. at *2-4. In
Kane
, another case cited
by Defendant, the district court held that the plaintiffs did not have standing because they
did not sufficiently plead reliance because they had never viewed the defendant’s website
that contained the “no sugar added” claim.
Kane v. Chobani, Inc.
, Case No.: 12–CV–
02425–LHK,
2. Missouri Merchandise Law
“To prevail on a claim under the MMPA, a plaintiff must plead and prove he or she
(1) purchased merchandise (which includes services) from defendants; (2) for personal,
family or household purposes; and (3) suffered an ascertainable loss of money or
property; (4) as a result of an act declared unlawful under the Merchandising Practices
Act.”
Murphy v. Stonewall Kitchen, LLC
,
3. Massachusetts UCL
Next, Massachusetts General Law, Chapter 93A prohibits “[u]nfair methods of
competition and unfair or deceptive acts or practices in the conduct of any trade or
commerce.” Mass. Gen. Laws ch. 93A, § 2(a). To allege a violation of the
Massachusetts Consumer Protection Act . . . a plaintiff must show that the defendant
engaged in trade or business and committed an unfair or deceptive practice, causing
economic injury to the plaintiff.
Mass. Eye & Ear Infirmary v. QLT Phototherapeutics,
Inc.,
Because the Court concludes that Plaintiffs have sufficiently alleged reliance and causation under the California consumer fraud statutes, the Court also concludes that the FAC sufficiently alleges causation under the Massachusetts and Missouri’s consumer fraud provisions and standing has been sufficiently alleged.
4. Express and Implied Warranties
As to the breach of express and implied warranty claims, Defendant summarily
argues, in a string citation, that such claims under California, Massachusetts and Missouri
also require causation and reliance. (Dkt. No. 35-1 at 14.) First of all, for California,
Defendant relies on a pre-UCC
[4]
law express warranty case,
Williams v. Beechnut
, 185
Cal. App. 3d 135, 142 (1986), to argue that reliance is a required element but courts have
held that reliance is no longer required under the California Commercial Code.
See
Weinstat v. Dentsply Int’l, Inc
.,
In conclusion, the Court holds that Plaintiffs have alleged standing under California, Massachusetts and Missouri’s consumer fraud statutes as well as the breach of express and breach of implied warranty claims; thus, the Court DENIES Defendant’s motion to dismiss all state law claims for lack of statutory standing.
B. NLEA Preemption
“Federal preemption may be either express or implied, and ‘is compelled whether
Congress' command is explicitly stated in the statute's language or implicitly contained in
its structure and purpose.’”
Fidelity Fed. Sav. & Loan Assn. v. De la Cuesta
, 458 U.S.
141, 152-53 (1982) (quoting
Jones v. Rath Packing Co
.,
Under implied preemption, there are two types: field preemption and conflict
preemption.
Gade v. Nat'l Solid Wastes Mgmt. Ass'n
,
The Food, Drug and Cosmetic Act (“FCDA”), 21 U.S.C. § 301
et seq
., as amended
by the Nutrition Labeling and Education Act (“NLEA”), 21 U.S.C. § 343
et seq
. govern
the labeling of food, including dietary supplements. In 1994, Congress further amended
the FDCA with the Dietary Supplement Health and Education Act (“DSHEA”), Pub. L.
No. 103-417, 108 Stat. 4325.3. “The NLEA and DSHEA together established a new
category of food products—specifically, dietary supplements—that have unique safety,
labeling, manufacturing, and other related standards.”
Kroessler
,
Because all proceedings “for the enforcement, or to restrain violations, of” the
FDCA must “be by and in the name of the United States”, 21 U.S.C. § 337(a), private
plaintiffs may not seek to enforce violations of the FDCA.
Id.
Private plaintiffs may,
instead, “bring analogous state law claims as long as the FDCA does not preempt those
claims.” (citing
In re Farm Raised Salmon Cases
,
“The FDA has limited authority under the Federal Food, Drug, and Cosmetic Act
(FDCA) to regulate dietary supplements, which include vitamin, botanical, enzyme, and
amino acid products.”
Greenberg v. Target Corp
.,
1. Express Preemption
In order to establish a national uniform labeling standard and avoid a patchwork of
different state standards,
In re Farm Raised Salmon Cases
,
In this case, Defendant challenges Plaintiffs’ implied disease claims arguing they are preempted by the FDCA because they are proper structure/function claims under § 343(r). [5] Specifically, Defendant argues its use of the phrase “supports the immune system” is an acceptable structure/function claim. (Dkt. No. 35-1 at 19.) Plaintiffs oppose maintaining that their implied disease claim is not limited to solely the phrase “supports the immune system” but a number of phrases, considered collectively, that promise that the Products have the ability to mitigate, treat, cure, or prevent disease. (Dkt. No. 39 at 20-23.)
For dietary supplements, the FDCA permits a manufacturer to make
“structure/function” claims but not “disease claims.”
See
21 U.S.C. § 343(r)(6). ”The
FDCA's preemption provision covers structure/function claims because its requirements
appear in section 343(r)(6), which falls under the preemption provision's umbrella.”
Geenberg
,
Structure/function claims must meet three requirements: 1.The manufacturer must have substantiation that the statement is truthful and not misleading; 2. The statement must contain a prominent disclaimer that the FDA has not
evaluated the statement and that the product “is not intended to diagnose, treat, cure, or prevent any disease”; and 3. The statement itself may not “claim to diagnose, mitigate, treat, cure, or
prevent” disease.
Greenberg
,
In 2000, the FDA promulgated final Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body which established guidance and criteria for determining when a dietary supplement claim is an acceptable structure/function claim or a prohibited disease claim. 65 Fed. Reg. 1000 (Jan. 6, 2000); 21 C.F.R. § 101.93. The FDA warned that the rule is not “intended establish whether any particular structure/function claim is appropriate for any specific product,” and that “an otherwise acceptable structure/function claim might nevertheless be false or misleading for other reasons.” 65 Fed. Reg. 1000 at 1002. Disease claims include, “supports the body's antiviral capabilities” or “supports the 23 body's ability to resist infection.” [6] at 1028. An appropriate structure/function claim 24
25
[6]
The FDA explained, “[a]n intact immune system has several functions. In addition to their role in the
26
defense against pathogens, certain components of the immune system, namely white blood cells, have
other important functions. For example, white blood cells play an essential role in the phagocytosis and
27
disposal of aging red blood cells or otherwise damaged cells. A statement of support for the immune
system, by itself, conveys no specific reference to disease treatment or prevention. The claim that
vitamin A is necessary to maintaining a healthy immune response does not imply that a specific disease
includes, “supports the immune system”, because this phrase is “[a] more general
reference to an effect on a body system that did not imply prevention or treatment of a
disease state . . . ” The FDA explained that the distinction “is one of specificity.”
Id.
at 1029. Therefore, if a structure/function claim meets the FDCA's requirements, then a
state law claim seeking to impose additional requirements are preempted by the FDCA.
See Greenberg
,
Here, Defendant argues that its labeling claims of “supports the immune system”
“helps you . . . stay healthy” and “arms you with the best protection nature has to offer”
are acceptable structure/function claim because they describe a “general well-being from
consumption of a dietary ingredient.” By themselves, the Court agrees with Defendant.
However, Plaintiffs’ allegations of the implied disease claim rely on a number of
advertising statements on the Products’ labels and extra-label statements on Defendant’s
website.
Cf. Kroessler
,
The FAC specifically alleges that when the claims on the packaging are “viewed in their totality, they are either explicitly or implicitly claiming to mitigate or prevent disease.” (Dkt. No. 31, FAC ¶ 39.) By advertising the Products as “scientifically tested”, “[v]irologist [d]eveloped”, contain “the most extensively researched” extract “in the world” and “[d]eveloped by a world renowned Virologist,” they necessarily imply the Products are preventing disease because a virologist is an expert that deals with viruses or class of diseases will be prevented. In contrast, a claim that a product ‘supports the body's antiviral capabilities’ represents a claim of treatment or prevention of a specific class of diseases, those caused by viruses (e.g., colds, hepatitis, or HIV infection).” 65 Fed. Reg. 1000, 1029 (Jan. 6, 2000). and the disease they cause. ( Id. ¶¶ 40-42.) Moreover, the FAC alleges that the labels implicitly suggest that the Products will prevent a cold or flu by claiming that it “provides strong immune system support to help you and your family stay healthy throughout the year” and “arms you with some of the best protection nature has to offer”, ( id. ¶ 43), and the website promises that “elderberries can help empower your immune system by fighting free radicals that damage it”, ( id. ¶ 46), and the Products will help them “stay healthy through the toughest season”, ( id. ¶ 50). Also, on its website, in response to the FAQ, “What are the traditional uses of black elderberry?”, the response answers that black elderberry is “used in traditional remedies for colds, coughs, and upper respiratory infections.” ( Id . ¶ 52.) Additionally, the website states that Sambucol is a “pharmacist Recommended Brand” implying that the Products are drugs or meant to treat diseases. ( Id. ¶ 54.) Finally, the homepage of Defendant’s website states, “Get that NOT WORRIED ABOUT A 5 HOUR FLIGHT IN THE MIDDLE SEAT kinda feeling”, a reasonable consumer would understand this statement as protecting them from the COVID virus or other transmissible diseases. ( Id. ¶ 55.) Specific reference to respiratory infections, colds, and implicitly referencing the COVID virus present an implied disease claim. The Court concludes that Defendant’s claims, collectively, imply that the Products can treat, cure, or prevent disease, and are thus not expressly preempted.
The case of
Hughes v. Ester C Co
.,
For the first time in its reply, Defendant presents the argument that Plaintiffs cannot avoid express preemption by implied disease claims that are based on representations that Plaintiffs never saw or relied on, (Dkt. No. 41 at 11-12). Defendant does not offer any caselaw to support this newly raised argument in support of express preemption. More significantly, the FAC contains allegations regarding the Plaintiffs’ review and reliance on representations regarding the multiple health benefits associated with the Products. (Dkt. No. 31, FAC ¶¶ 81, 89, 97.)
On a Rule 12(b)(1) motion, in accepting as true all facts in the FAC and drawing
all reasonable inferences in favor of Plaintiffs,
al Kidd
,
2. Implied Preemption
Again, without much explanation or relevant legal support, Defendant also argues that the FDCA impliedly preempts [7] Plaintiffs’ illegal products theory of liability because Plaintiffs are, in essence, bringing suit because Defendant’s conduct purportedly violates the FDCA and seeks to enforce the FDCA. (Dkt. No. 35-1 at 17-19.) Plaintiffs argue that they merely seek to hold Defendant to standards provided in the FDCA through parallel state law. (Dkt. No. 38 at 17-18.)
“The party contending that a claim is preempted bears the burden of establishing
preemption.”
Dorsett v. Sandoz, Inc
.,
In support, Defendant solely relies on
Buckman Co., v. Plaintiffs’ Legal Comm.
,
In fact, “[d]istrict courts have routinely rejected arguments that state-law UCL,
FAL, and CLRA food-labeling claims and related claims under the Sherman Law are
impliedly preempted under § 337(a) and
Buckman
.”
Sandoval v. PharmaCare US, Inc
.,
C. Plaintiffs’ Theory of Deception
Defendant summarily argues that Plaintiffs’ theory of deception fails as a matter of law because it is solely predicated on simple regulatory violations. (Dkt. No. 35-1 at 22- 25.) In response, Plaintiffs note that Defendant fails to analyze any element of the consumer protection claims, and as such, does not seek to dismiss any specific cause of action; nonetheless, they argue Defendant’s argument is without merit because Plaintiffs allege that Defendant made unlawful claims on the Products’ labeling, that Plaintiffs viewed and relied upon these misrepresentations and Defendant failed to disclose material information. (Dkt. No. 39 at 24.) In response to Plaintiffs’ observation concerning Defendant’s failure to dismiss a specific cause of action, Defendant, without providing any legal analysis, summarily replies that the Court must dismiss the causes of action for violations of the UCL, FAL, CLRA, M.G.L. ch. 93A and the MMPA. (Dkt. No. 41 at 13.)
The Court agrees with Plaintiffs that Defendant, in its moving brief, fails to tether
its deception argument to a specific cause of action. It fails to specifically explain what
element of each of the consumer fraud statute requires deception and why they fail under
each cause of action. On a motion to dismiss, it is the defendant’s burden to demonstrate
that plaintiff has failed to state a claim.
See Avalanche Funding, LLC v. Five Dot Cattle
Co
., No. 2:16-cv-02555-TLN-KJN,
Here, Defendant, in reply, simply lumps all consumer fraud causes of action, including California, Massachusetts and Missouri law, into its argument that Plaintiffs’ theory of deception fails. [9] Because Defendant provides summary arguments and analyses seeking dismissal of all causes of action without addressing how its argument apply to each cause of action, Defendant failed to meet its burden under Rule 12(b)(6), and the Court DENIES the motion to dismiss based on the “theory of deception.” D. Rule 9(b)
Defendant next avers that the consumer protection claims grounded in fraud fails to sufficiently plead particularity as required under Rule 9(b) because Plaintiffs do not allege facts to establish the falsity of the statements or explain why they are misleading, and the “how, when, where, what and who” of the alleged misrepresentations. (Dkt. No. 35-1 at 25-27.) Plaintiffs disagree arguing they have addressed the deficiencies the Court noted in its prior order. (Dkt. No. 39 at 25-27.)
In its prior order, the Court granted dismissal of the fraud based state law claims because Plaintiffs did not comply with the specificity requirement under Rule 9(b) and granted Plaintiffs leave to amend. (Dkt. No. 29 at 11-14.) In that order, the Court concluded that Plaintiffs failed to sufficiently alleged the “what, when and where” of the alleged misrepresentations. The Court directed that Plaintiffs must identify a time period “when” they saw the false advertisements, “where” they saw each of the alleged false misrepresentations and provide a full list of “what” misrepresentations they relied on. ( Id. at 13-14.) The Court concludes that Plaintiffs have addressed the deficiencies noted in the Court’s prior order.
The FAC alleges that Plaintiff Corbett purchased the Sambucol Black Elderberry Capsules, Sambucol Black Elderberry Syrup Original, and Sambucol Black Elderberry Gummies from November 2017 through January 2020 on Amazon and at CVS Pharmacy. (Dkt. No. 31, FAC ¶ 80.) Prior to purchasing these products, Corbett relied on Defendant’s materially misleading representations on the Products’ packaging and labeling, the Sambucol website, Amazon’s website, and Google advertisements that the elderberry ingredient was developed by a virologist, supports immunity and the immune system, has been clinically and scientifically tested, has been used in clinical studies, has high antioxidant levels, helps you and your family stay healthy throughout the year, and arms you with the best protection nature has to offer. ( Id . at ¶ 81.) He also believed they were legally sold supplements. ( Id. ¶ 82.) Corbett’s decision to purchase Defendant’s Products was based on these materially misleading representations. ( Id. ¶ 84.) If he had known that the Products were not legally sold supplements and knew about the materially misleading misrepresentations and omissions, he would not have purchased the Products. ( Id. ¶ 85.)
Plaintiff Luciano purchased Sambucol Black Elderberry Gummies at Walgreens in Holyoke, Massachusetts starting in late 2018 to early 2019 and continuing through February 2020. ( Id. ¶ 88.) A couple of months prior to purchasing them, Luciano started seeing commercials on a major network, most likely NBC, which indicated that Sambucol would help prevent her from getting sick. ( Id. ¶ 89.) Before and at the time she purchased the Product, she was exposed to, saw and relied on Defendant’s materially misleading representations on the Products’ packaging and labeling at Walgreens and on a website describing the Sambucol products which claims that the Products support immunity, support the immune system, have high antioxidant levels and have been clinically and scientifically tested. ( ) When she purchased the Products, she believed they were legally sold supplements. ( Id. ¶ 90.) Luciano’s decision to purchase Defendant’s Products was caused by the materially misleading representations. ( Id. ¶ 92.) She would not have purchased the Products had she known the truth about the materially misleading representations and omissions and that the Products were not legally sold supplements. ( Id. ¶ 93.)
Plaintiff Dobbs purchased Sambucol Black Elderberry Gummies from August 2019 to April 2020 through Amazon. ( Id. ¶ 96.) Prior to purchasing the Sambucol products, Dobbs was exposed to, saw, and relied on Defendant’s materially misleading representations on the Products’ packaging and labeling, in television commercials on a major network, on the Sambucol website and on the Amazon website. ( Id. ¶ 97.) He saw the commercial several times in the weeks prior to his first purchase in August 2019 and relied on the representations that the elderberry ingredient supports the immunity system. ( Id. ) He reviewed the marketing, advertising and labeling on the Amazon and Sambucol websites in the days prior to the initial purchase where he saw and relied on Defendant’s claims that the elderberry ingredient was developed by a world renowned virologist and that it supports immunity and the immune system, has been scientifically tested, has been used in clinical studies, has high antioxidant levels, helps you and your family stay healthy throughout the year and arms you with the best protection nature has to offer. ( Id. ) When he purchased the Products, he believed they were legally sold supplements. ( Id. ¶ 98.) Dobbs’ decision to buy the Products was directly impacted by the misleading representations that the Elderberry Products. ( Id. ¶ 100.) Had he known that the Products were not legally sold supplements and the truth about the misleading representations and omissions, he would not have purchased them. ( )
In the FAC, Plaintiffs have narrowed the time period when they saw the false misrepresentations. They state they first saw the misleading representations a couple of months or weeks before their first purchase. (Dkt. No. 31, FAC ¶¶ 81, 89, 97.) Then Plaintiffs continually saw those misrepresentations as they continued to purchase the Products. They also specify the specific misrepresentations they relied on and where they saw them. Plaintiffs have satisfied the specificity requirements under Rule 9(b). 1 Accordingly, the Court DENIES Defendant’s motion to dismiss under the specificity requirements of Rule 9(b).
E. Breach of the Implied Warranty of Merchantability
Defendant next maintains that the breach of the implied warranty of merchantability claim fails for alleging the food and drug exception to privity and fails to allege facts establishing a third-party beneficiary exception to the privity requirement. [10] (Dkt. No. 35-1 at 27-29.) Plaintiffs respond that the Products, “consumable nutritional supplements” fall within the category of products covered under the food and drugs exception to privity and additionally, they are the intended third-party beneficiaries of the manufacturer, another exception to privity. (Dkt. No. 39 at 27-29.)
On the breach of implied warranty claim, the FAC alleges that privity is not required because the claim relates to food or other substances intended for human consumption. (Dkt. No. 31, FAC ¶ 197.) The FAC also alleges, “Plaintiffs and the Class Members purchased the Elderberry Products manufactured and marketed by Defendant by and through Defendant’s authorized sellers for retail sale to consumers, or were otherwise expected to be the third-party beneficiaries of Defendant’s contracts with authorized sellers, or eventual purchasers when bought from a third party” and “Defendant entered into contracts with the authorized retailers from whom Plaintiffs and the Class Members purchased the Products, and Plaintiffs and Class Members were the intended third-party beneficiaries of those contracts, an exception to the privity requirement.” ( ¶¶ 193, 198.) In the prior order, the Court held that Plaintiffs had failed to allege the third-party beneficiary exception to privity. (Dkt. No. 29 at 19.)
The California Commercial Code “implies a warranty of merchantability that
goods ‘[a]re fit for ordinary purposes for which such goods are used.’”
Birdsong v.
Apple, Inc
.,
In
Clemens
, the Ninth Circuit identified a number of specific exceptions to the
privity rule such as cases when a “plaintiff relies on written labels or advertisements of a
manufacturer” and other “special cases involving foodstuffs, pesticides, and
pharmaceuticals, and where the end user is an employee of the purchaser.” at 1023
(citing
Burr v. Sherwin Williams Co
.,
The FAC relies on the food and drug exception to privity to allege a breach of implied warranty cause of action. (Dkt. No. 31, FAC ¶ 197.) Defendant argues that the food and drug exception does not apply because Plaintiffs do not allege physical injuries resulting from ingesting the Products. (Dkt. No. 35-1 at 27-28.) Plaintiffs disagree arguing that physical injury is not required for the food and drug exception to apply. (Dkt. No. 39 at 28.)
The California Supreme Court recognized an exception to the privity requirement
for breach of implied warranty “in cases involving foodstuffs, where it is held that an
implied warranty of fitness for human consumptions runs from the manufacturer to the
ultimate consumer.”
Burr v. Sherwin Williams Co.
,
Courts are divided on whether a plaintiff must allege a physical injury to state a
claim under this exception.
Compare Shade Foods, Inc. v. Innovative Prods. Sales &
Mktg
.,
The Court is not persuaded by cases relying on
Peterson
and
Klein
to hold that the
foodstuff exception for breach of implied warranty should be limited to physical harm
because the issue of economic harm was not before the court in
Peterson
or
Klein
and
neither case foreclosed a plaintiff from seeking economic injury under the food and drug
exception to privity. Accordingly, the Court DENIES Defendant’s motion to dismiss the
breach of implied warranty of merchantability claim.
See Benavides
, 2011 WL
13269720, at *7 (noting that case law does not limit exception to physical harm only).
Because the Court denies dismissal based on the food and drug exception, it declines to
1
address Plaintiffs’ additional argument claiming an exception to privity under the third-
party beneficiary theory, and for the first time in their opposition but not raised in the
FAC, Plaintiffs rely on the exception for “written labels or advertisements of a
manufacturer”,
Clemens,
F. Breach of Express Warranty
Defendant, relying solely on California law, [11] contends that Plaintiffs have not stated a valid breach of express warranty claim because they fail to identify the “exact terms” of the express warranty or specific representations that would create an express warranty. (Dkt. No. 35-1 at 29-30.) It asserts that there is no express warranty on the labels that the Products are legal to sell. ( Id. ) Furthermore, it avers that Plaintiffs have not alleged facts showing their reasonable reliance on any purported express warranty and Defendant’s breach of it. ( Id. at 30.) Plaintiffs respond that they have alleged a breach of express warranty because by labeling products as a “dietary supplement”, Defendant promises or expressly warrants that the Products are legal dietary supplements. (Dkt. No. 39 at 30.) Moreover, they have alleged the express warranty was a part of the benefit of the bargain when they purchased the Products, and they were harmed. ( at 30-31.)
On a breach of express warranty claim, a plaintiff must allege that a seller “(1)
made an affirmation of fact or promise or provided a description of its goods; (2) the
promise or description formed part of the basis of the bargain; (3) the express warranty
was breached; and (4) the breach caused injury to the plaintiff.”
Viggiano v. Hanse1n
Natural Corp.
,
The FAC alleges that Defendant breached the express warranty by selling products that are illegally labeled as dietary supplements. (Dkt. No. 31, FAC ¶ 182.) Plaintiffs allege that they relied on this affirmation of fact when they purchased the Products. ( Id. ¶¶180, 183.)
The Court disagrees with Defendant’s argument that there is no label claiming that the Products are legal to sell and concludes that Plaintiffs have sufficiently alleged an express promise describing the Products as “dietary supplements”, when in fact, they are not because Defendant allegedly failed to provide the FDCA with the required NDI notification. ( Id. ¶¶ 30-34.) Advertising a product as a “dietary supplement” creates a reasonable impression to the consumer that it has been designated or has features of a supplement based on some criteria set by the FDA. Therefore, in drawing all reasonable inferences in favor of Plaintiffs, the Court DENIES Defendant’s motion to dismiss the express warranty claim under California law.
G. Pre-Suit Notice Requirement under the CLRA and M.G.L. ch. 93A
First, Defendant argues that Plaintiffs failed to strictly comply with the pre-notice
provisions of the CLRA and the claim must be dismissed. (Dkt. No. 35-1 at 31-34.)
Specifically, Defendant claims that Plaintiffs did not deliver the pre-suit notice to its
principal place of business in California and did not mention what provisions of section
1770 it has violated. ( at 32.) Plaintiffs maintain they provided adequate pre-suit
notice under the CLRA, and if the Court disagrees, they seek leave to provide proper
notice, and subsequently amend the complaint. (Dkt. No. 39 at 32.)
1
Prior to filing an action for damages, the CLRA requires a plaintiff to provide
notice to a defendant of the CLRA violations by certified or registered mail 30 days or
more before filing an action for damages. Cal. Civ. Code § 1782(a).
[12]
The notice must
be sent to the place where the transaction occurred or to the person’s principal place of
business in California.
Id.
The notice must also specify the “particular alleged
violations” of the CLRA and demand that the person “correct, repair, replace or
otherwise rectify” the alleged violations.
Id.
“The purpose of the notice requirement of
section 1782 is to give the manufacturer or vendor sufficient notice of alleged defects to
permit appropriate corrections or replacements.”
Outboard Marine Corp. v. Superior Ct.
,
In this case, the original complaint sought only injunctive relief and indicated that a letter under section 1782(a) had been sent notifying Defendant of the alleged CLRA violations. (Dkt. No. 1, Compl. ¶¶ 144, 145.) The complaint further alleged that if Defendant did not correct its business practices, Corbett would amend the complaint to add claims for monetary relief under the CLRA. ( Id .)
The FAC, filed on July 7, 2021, alleges that prior to filing of the complaint, Corbett provided notice of the alleged violations of the CLRA, demanded that Defendant correct the violations and provided it with an opportunity to correct its business practices which it did not. (Dkt. No. 31, FAC ¶ 147; see Dkt. No. 35-6, D’s RJN, Ex. D.) However, the notice letter does not identify what conduct under section 1770 is being violated as required by section 1782(a). Section 1782(a) requires that the notice must “(1) [n]otify the person alleged to have employed or committed methods, acts, or practices declared unlawful by Section 1770 of the particular alleged violations of Section 1770.” Cal. Civ. Code § 1782(a). Plaintiffs does not address this deficiency but argues that the letter states that Defendant violated the CLRA and provided a brief summary of the facts. (Dkt. No. 39 at 31.)
Because Plaintiffs failed to assert what provision under section 1770 is being
violated in the notice letter, the Court GRANTS Defendant’s motion to dismiss the
CLRA cause of action for damages for failing to comply with section 1782(a).
See
Munning v. Gap, Inc
., Case No. 16-cv-03804-TEH
Moreover, Plaintiffs sent a certified letter on December 30, 2020 to Defendant’s registered agent in Dover, Delaware and not its principal place of business in California as required by section 1782(a). (Dkt. No. 35-6, Ex. D.) The letter was eventually forwarded to Defendant’s counsel in San Francisco, California. (Dkt. No. 35-6, D’s RJN, Ex D at 4.) Defendant’s principal place of business is alleged to be in San Diego, CA, (Dkt. No. 31, FAC ¶ 17); however, Plaintiffs failed to send the notice letter to Defendant in San Diego as required by section 1782(a) and provides another basis for dismissal of the CLRA claim for damages. The question becomes whether the dismissal should be with prejudice or without prejudice.
Prior to
Morgan v. AT & T Wireless Servs., Inc
.,
Accordingly, the Court GRANTS Defendant’s motion to dismiss the claim for damages on the CLRA claim with leave to amend once Corbett complies with the notice requirement.
On the M.G.L. ch. 93A claim, Defendant argues Plaintiff Luciano failed to comply with the pre-notice provision because she filed her complaint less than thirty days after sending the letter on December 30, 2020, and failed to “set out specifically any activities . . .” as to which she seeks relief. (Dkt. No. 35-1 at 34.) Plaintiffs generally assert they provided proper notice. (Dkt. No. 39 at 32.)
M.G.L. ch. 93A, § 9(3) requires
[a]t least thirty days prior to the filing of any such action, a written demand for relief, identifying the claimant and reasonably describing the unfair or deceptive act or practice relied upon and the injury suffered, shall be mailed or delivered to any prospective respondent. Any person receiving such a demand for relief who, within thirty days of the mailing or delivery of the demand for relief, makes a written tender of settlement which is rejected by the claimant may, in any subsequent action, file the written tender and an affidavit concerning its rejection and thereby limit any recovery to the relief tendered if the court finds that the relief tendered was reasonable in relation to the injury actually suffered by the petitioner.
M.G.L. ch. 93A, § 9(3).
A plaintiff alleging a claim under M.G.L. ch. 93A is required to provide a written
demand for relief to the potential defendant no less than thirty days before filing suit.
Mass. Gen. Laws ch. 93A, § 9(3). The demand requirement “is not merely a procedural
nicety, but, rather, ‘a prerequisite to suit’” and “must be alleged in the plaintiff's
complaint.”
Rodi v. S. New Eng. Sch. of Law
,
Here, Luciano did not comply with the notice provision because she filed the
complaint less than 30 days after the providing the notice letter.
See
M.G.L. ch. 93A, §
9(3). Thus, the Court grants Defendant’s motion to dismiss the M.G.L. ch. 93A claim
without prejudice.
See Barricello v. Wells Fargo Bank, N.A
.,
As to Defendant’s argument concerning the content of her letter, Plaintiff Luciano
has complied with G.L. ch. 93A, § 9(3). “The demand letter required under G.L. c. 93A
does not require claimants to set forth every specific statutory or regulatory violation
alleged, so long as it fairly notifies the prospective respondent of the actions or practices
of the respondent and the injury suffered by those actions.”
Casavant v. Norwegian
Cruise Line Ltd
.,
(1) any express reference to c. 93A; (2) any express reference to the consumer protection act; (3) any assertion that the rights of the claimants as consumers have been violated; (4) any assertion that the defendant has acted in an unfair or deceptive manner . . .; (5) any reference that the claimants anticipate a settlement offer within thirty days . . .; or (6) any assertion that the claimant will pursue multiple damages and legal expenses, should relief be denied.
Costello v. Bank of America, N.A
., Civil Action No. 13–cv–11424–DJC, 2014 WL
293665, at *4 (D. Mass. Jan. 27, 2014) (quoting
Cassano v. Gogos
,
IV. CONCLUSION
Based on the above, the Court GRANTS in part and DENIES in part Defendant’s motion to dismiss without prejudice. Specifically, the Court GRANTS dismissal of the CLRA claim for damages and the cause of action under Mass. Gen. Law ch. 93A without prejudice. Plaintiff may file its Second Amended Complaint within 45 days in order to address the Notice deficiencies identified in section III(G). The Defendant shall thereafter file an answer to the FAC within the time prescribed by the Federal Rules of Civil Procedure.
IT IS SO ORDERED.
Dated: October 19, 2021
Notes
[1] The 12 Elderberry Products at issue are 1) Sambucol Black Elderberry Original Syrup, 2) Sambucol Black Elderberry Advanced Immune Syrup, 3) Sambucol Black Elderberry Sugar Free Syrup, 4) Sambucol Black Elderberry Syrup for Kids, 5) Sambucol Black Elderberry Gummies, 6) Sambucol Black Elderberry Gummies for Kids, 7) Sambucol Black Elderberry Advanced Immune Capsules, 8) Sambucol Black Elderberry Effervescent Tablets, 9) Sambucol Black Elderberry Chewable Tablets, 10) Sambucol Black Elderberry Pastilles (Throat Lozenges), 11) Sambucol Black Elderberry Daily Immune Drink Powder, and 12) Sambucol Black Elderberry Infant Drops. (Dkt. No. 31, FAC ¶ 1.)
[2]
[2] Defendant’s motion is also devoid of the legal standards to apply for its Rule 12 motion. ( See Dkt. No. 35-1.)
[7]
[3] Page numbers are based on the CM/ECF pagination.
[11]
[4] Uniform Commercial Code
[14]
[5] Defendant does not articulate which state law causes of action the FDCA preempts. Implicitly, it appears that Defendant is arguing that all state law claims are preempted. However, Defendant fails to address preemption as it relates to the Missouri and Massachusetts consumer fraud claims and the breach of express and implied warranty claims. Accordingly, these state law claims have not been considered in the preemption analysis.
[18]
[7] Again, Defendant does not articulate which state law claims are impliedly preemption.
[22]
[8] Defendant also rely on
Borchenko v. L’Oreal
but the case is not persuasive because the case concerned
a “drug” claim under the FDCA, not a dietary supplement claim, and the district court relied on
Buckman
and
Perez
to supports its ruling on preemption.
[23]
[9] Moreover, in this section concerning theory of deception, Defendant confusingly throws in various arguments, some of which were already raised in the motion, such as failure to comply with Rule 9(b) and preemption, that do not relate to deception and fails to provide sufficient and proper analysis on a number of these arguments. (Dkt. No. 35-1 at 22-24.) The Court declines to decipher Defendant’s hodgepodge of unrelated arguments.
[25]
[10] Again, Defendant only argues that the breach of implied warranty claim under California law fails to state a claim.
[28]
[11] Because Plaintiff noted that Defendant did not argue that the breach of express warranty claim under 26 Massachusetts and Missouri law failed to state a claim, (Dkt. No. 39 at 31), in reply, Defendant cites to one case addressing Massachusetts law and one case addressing Missouri law. (Dkt. No. 41 at 15.) 27 However, the Court declines to consider new issues raised in the reply and also to consider an argument raised merely by citing to a case. Thus, the Court only considers Defendant’s argument addressing breach of express warranty under California law.
[32]
[12] “(a) Thirty days or more prior to the commencement of an action for damages pursuant to this title, 24 the consumer shall do the following: (1) Notify the person alleged to have employed or committed methods, acts, or practices declared 25 unlawful by Section 1770 of the particular alleged violations of Section 1770. 26 (2) Demand that the person correct, repair, replace, or otherwise rectify the goods or services alleged to be in violation of Section 1770. 27 The notice shall be in writing and shall be sent by certified or registered mail, return receipt requested, to the place where the transaction occurred or to the person's principal place of business within California.” Cal. Civ. Code § 1782(a).
[34]