Corbett v. PharmaCare U.S., Inc.

District Court, S.D. California·Decided June 17, 2021·No. 3:21-cv-00137·Unknown

Opinion

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 AND Plaintiffs, DENYING DEFENDANT’S MOTION v. TO STRIKE [Dkt. No. 6.] Defendant. Defendant Pharmacare U.S., Inc. filed a motion to dismiss the complaint pursuant to Federal Rule of Civil Procedure 9(b), 12(b)(1) and 12(b)(6) and motion to strike under Rule 12(f). (Dkt. No. 6.) Plaintiffs filed an opposition to which Defendant replied. (Dkt. Nos. 12, 17.) 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 and DENIES Defendant’s motion to strike. Background On January 25, 2021, Plaintiffs Montiqueno Corbett, Damaris Luciano and Rob Dobbs (“Plaintiffs”) filed a putative class action complaint against Defendant PharmaCare U.S., Inc. (“Defendant” or “PharmaCare”) for violations of California’s consumer fraud statutes for its sale of twelve dietary supplement products (“Products”) under the name Sambucol that include elderberry.1 (Dkt. No. 1, Compl. ¶ 1.) Elderberry is derived from a flowering plant called Sambucus which has become a popular dietary supplement and has recently generated $100 million in sales in the United States. (Id. ¶¶ 2, 3.) 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, California’s consumer protection laws that incorporate the FDCA (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

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 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.” (Id. ¶ 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.) The complaint avers that Defendant did not notify the FDA with the required NDI notification for its elderberry extract. (Id. ¶ 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 Law. (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” are 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).) These phrases promise the Products have the ability to mitigate, treat, cure, or prevent diseases which are barred by the FDCA’s requirement that a product cannot make a claim to “diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases.” (Id.) 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. ¶¶ 56-59.) 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. ¶¶ 60- 68.) 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. ¶¶ 69-72.) Also, “scientifically tested” improperly suggests that the products are effective in keeping consumers safe from diseases which is false. (Id. ¶ 73.) Plaintiffs Montiqueno Corbet is a resident and citizen of San Diego, California, Damaris Luciano is a resident and citizen of Holyoke, Massachusetts, and Rob 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. ¶¶ 79-93.) 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. ¶¶ 80, 81, 87, 88, 94, 95.) Plaintiffs seek to certify a national class of “All persons in the Unite

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Corbett v. PharmaCare U.S., Inc., (S.D. Cal. 2021).

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