Haney, Inc. v. Axium Bioresearch

CourtDistrict Court, S.D. California
DecidedSeptember 25, 2025
Docket3:23-cv-01990
StatusUnknown

This text of Haney, Inc. v. Axium Bioresearch (Haney, Inc. v. Axium Bioresearch) is published on Counsel Stack Legal Research, covering District Court, S.D. California primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Haney, Inc. v. Axium Bioresearch, (S.D. Cal. 2025).

Opinion

1 2 3 4 5 6 UNITED STATES DISTRICT COURT 7 SOUTHERN DISTRICT OF CALIFORNIA 8 9 HANEY, INC., an Idaho corporation, Case No.: 3:23-cv-01990-RBM-JLB doing business under the assumed name 10 UTEST, ORDER: 11 Plaintiff, (1) GRANTING IN PART AND 12 v. DENYING IN PART DEFENDANTS’ 13 MOTION TO DISMISS AXIUM BIORESEARCH, a California PLAINTIFF’S FIRST AMENDED 14 corporation, doing business as DrugExam; COMPLAINT PURSUANT TO RULE and SERGIUS ALBERT SALVATORE, 15 12(B)(1) AND 12(B)(6); AND an individual,

16 Defendants. (2) DENYING DEFENDANTS’ 17 MOTION TO STRIKE PURSUANT TO RULE 12(F) 18

19 [Doc. 18]

21 Pending before the Court is Defendants Axium BioResearch (“Defendant Axium”) 22 and Serguis Salvatore’s (“Defendant Salvatore”) (collectively, “Defendants”) Motion to 23 Dismiss Plaintiff Haney, Inc.’s First Amended Complaint Pursuant to Fed. R. Civ. P. 24 12(b)(1) and 12(b)(6) and Motion to Strike Pursuant to Fed. R. Civ. P. 12(f) (“Motion”). 25 (Doc. 18.) Plaintiff Haney, Inc. (“Haney”) filed an Opposition to the Motion 26 (“Opposition”) (Doc. 19), and Defendants filed a Reply (“Reply”) (Doc. 20). 27 28 1 Pursuant to Civil Local Rule 7.1, the Court finds the instant matter suitable for 2 determination on the papers and without oral argument. For the reasons set forth below, 3 the Motion is GRANTED IN PART and DENIED IN PART. 4 I. BACKGROUND1 5 Plaintiff brings the instant action against Defendants for false advertising and unfair 6 business practices. Defendants previously filed a motion to dismiss Plaintiff’s initial 7 complaint, which was granted on August 1, 2024 for lack of Article III standing with leave 8 to amend. (Doc. 14 at 4.)2 Plaintiff filed the First Amended Complaint (“FAC”) on August 9 21, 2024. (Doc. 15 [“FAC”].) On August 29, 2024, this action was transferred to the 10 undersigned. (Doc. 16.) In the instant Motion, Defendants seek to dismiss the FAC, 11 arguing primarily that Plaintiff has not suffered an injury sufficient to grant it Article III 12 standing and that the FAC fails to state a claim under Rule 12(b)(6). (Doc. 18.) 13 In the FAC, Plaintiff asserts five causes of action for: (1) violation of California’s 14 Unfair Competition Law, Cal. Bus. & Prof. Code §§ 17200, et seq. (“UCL”) (FAC ¶¶ 67– 15 80); (2) violation of California’s False Advertising Law, Cal. Bus. & Prof. Code §§ 17500, 16 et seq. (“FAL”) (id. ¶¶ 81–90); (3) violation of Idaho’s Consumer Protection Act, Idaho 17 Code §§ 48-601, et seq. (“ICPA”) (id. ¶¶ 91–99); (4) violation of the Lanham Act, 15 18 U.S.C. § 1125(a) et seq. (“Lanham Act”) (id. ¶¶ 100–108); and (5) intentional interference 19 with a prospective economic advantage (“IIPEA”) (id. ¶¶ 109–116). 20 A. The Parties 21 Advin Biotech, Inc (“Advin”), who is not a party to this action, is a San Diego-based 22 developer and manufacturer of multi-level strip drug testing kits for private at-home use. 23 (Id. ¶ 31.) Advin distributes its drug testing kits to resellers, who then repackage the kits 24

25 1 The factual summary in this section reflects Plaintiff’s allegations, not conclusions of fact 26 or law by this Court. Well-pleaded factual allegations are accepted as true for purposes of 27 this Motion. See Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009).

28 2 1 under their own private labels for resale to the general public. (Id. ¶ 33.) 2 Plaintiff, an Idaho corporation doing business as “UTEST,” is a reseller of Advin’s 3 drug testing kits that operates its business through its company website and various other 4 online retailers such as Amazon.com and Walmart.com. (Id. ¶ 22.) 5 Defendant Axium, a California corporation doing business as “DrugExam,” is also 6 a reseller of Advin’s drug testing kits. (Id. ¶¶ 23–24.) Plaintiff and Defendant Axium both 7 purchase the same or similar drug testing kits from the same manufacturer, Advin, and 8 resell such kits to the general public through Amazon and Walmart’s websites. (Id. ¶ 23.) 9 Defendant Salvatore is the sole founder of Defendant Axium. (Id. ¶ 25.) He is also 10 Defendant Axium’s Chief Executive Officer (“CEO”), Secretary, Chief Financial Officer 11 (“CFO”), and sole Director. (Id.) Defendant Salvatore previously worked for Advin until 12 September 2020. (Id. ¶ 41.) 13 B. Advin’s Drug Testing Kits and Package Insert 14 Since 2013, Advin has obtained 510(k) clearances from the United States Food and 15 Drug Administration (“FDA”) for 14 different drug testing kits. (Id. ¶ 31.) Its drug testing 16 kits are 100% “Made in USA” (id. ¶ 31) and include “a cassette and cap, reactive strip, foil 17 pouch, and two separate stickers” (id. ¶ 33). Advin’s drug testing kits also include a 18 comprehensive written package insert which describes its research and preliminary 19 analytical test results (the “Package Insert”). (Id. ¶¶ 31, 42.) 20 To develop its drug testing kits, Advin allegedly invested substantial time and 21 financial resources “in conducting research aimed at creating” the Package Insert. (Id.) 22 C. Requirements for the Manufacturing and Sale of Medical Devices 23 There are certain requirements resellers must meet to use Advin’s FDA accreditation 24 and the Package Insert. (See id. ¶¶ 34, 42.) To use Advin’s accreditation, distributors who 25 purchase Advin’s drug testing kits for resale to the general public, can obtain a Clinical 26 Laboratory Improvement Amendments (“CLIA”) certification. (Id. ¶ 34.) This 27 certification is overseen by the FDA and ensures the quality of laboratory test assembling 28 in the United States. (Id.) “Under CLIA regulations, clinical laboratories [i.e. Advin 1 Biotech’s resellers/distributors, to wit, Defendant Axium] must apply for and receive both 2 a state registration or license, and a federal CLIA certificate, before being permitted to 3 accept samples for assembling purposes (i.e. resale).” (Id.) A CLIA certification also 4 allows distributors “to replicate and utilize Advin’s documented analytical test results, as 5 presented in the Package Insert, for the marketing and sale of their . . . private label drug 6 test kits to the general public.” (Id. ¶ 42.) 7 Additionally, Plaintiff alleges that California state law requires manufacturers to 8 obtain a Medical Device Manufacturing License issued by the California Department of 9 Health Services, Food and Drug Branch (“FDB”) before they can lawfully manufacture 10 medical devices. (Id. ¶¶ 9, 35.) 11 D. Defendant Axium’s Drug Testing Kits 12 Defendant Salvatore incorporated Defendant Axium on June 20, 2016, while he was 13 still employed at Advin. (Id. ¶ 37; see Doc. 18-6, Ex. D at 2.) Plaintiff alleges that, upon 14 information and belief, from June 2018 to September 8, 2022, Defendants manufactured, 15 marketed, and sold their “DrugExam” drug testing kits to the public without a Medical 16 Device Manufacturing License from the FDB, as required under California law and FDA 17 regulations. (Id. ¶¶ 12, 36.) Plaintiff further alleges that from June 2018 to the present 18 day, Defendants have purchased “knockoff” component parts similar to those used in 19 Advin’s drug testing kits, including test cassettes and cap, reactive strip, foil pouch, and 20 two separate stickers, from manufacturers in India and China that are not FDA approved 21 or made in the United States. (Id. ¶ 38.) Defendants allegedly ordered, and continue to 22 order, test cassettes and caps from Tonisha Electronic, based in New Delhi, India similar 23 to those used in Advin’s drug testing kits. (Id. ¶ 53; see id.

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Haney, Inc. v. Axium Bioresearch, Counsel Stack Legal Research, https://law.counselstack.com/opinion/haney-inc-v-axium-bioresearch-casd-2025.