Telebrands Corp. v. VindEx Solutions LLC

CourtDistrict Court, N.D. California
DecidedApril 8, 2022
Docket5:21-cv-00898
StatusUnknown

This text of Telebrands Corp. v. VindEx Solutions LLC (Telebrands Corp. v. VindEx Solutions LLC) is published on Counsel Stack Legal Research, covering District Court, N.D. California primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Telebrands Corp. v. VindEx Solutions LLC, (N.D. Cal. 2022).

Opinion

1 2 3 UNITED STATES DISTRICT COURT 4 NORTHERN DISTRICT OF CALIFORNIA 5 SAN JOSE DIVISION 6 7 TELEBRANDS CORP., Case No. 21-cv-00898-BLF

8 Plaintiff, ORDER GRANTING MOTION FOR 9 v. DEFAULT JUDGMENT

10 VINDEX SOLUTIONS LLC, et al., [Re: ECF No. 61] 11 Defendants.

12 13 Before the Court is Plaintiff Telebrands Corp.’s (“Telebrands”) motion for default judgment 14 against Defendants Henan Derun New Material Technology Co. (“Henan Derun”) and XNH US 15 (“XNH”) (collectively, “Defendants”) in this unfair competition case based on Defendants’ alleged 16 sales of transcutaneous electrical nerve stimulation (“TENS”) units without clearance from the U.S. 17 Food and Drug Administration (“FDA”). 18 Based on the below reasoning, the Court GRANTS Telebrands’ motion. 19 I. BACKGROUND 20 A. Regulatory Background 21 The Federal Food, Drug, and Cosmetic Act (“FDCA”) provides requirements for medical 22 devices according to a three-tiered system—Class I, II, and III devices. See 21 U.S.C. § 360c-(a)(1). 23 TENS units, the devices at issue in this litigation, are classified as Class II devices. See 21 C.F.R. 24 § 882.5890. Before a manufacturer can bring a Class II device to market, the FDCA requires filing 25 a 510(k) premarket submission with the FDA. 21 U.S.C. § 360(k); Medtronic, Inc. v. Lohr, 518 26 U.S. 470, 477–79 (1996). Under the 510(k) process, if the Class II device is deemed “substantially 27 equivalent” to a pre-existing device with prior clearance, it can be put on the market. See 21 C.F.R. 1 equivalent” to a predicate device when it has the same intended use and the same technological 2 characteristics like materials, design, and energy source. See 21 C.F.R. § 807.100(b). 3 B. Factual Background 4 Defendants are Chinese corporations with their principal places of business in China. See 5 Complaint, ECF No. ¶¶ 19, 21. Defendants allegedly conduct business throughout the United States 6 through online promotion of their TENS products. See id. Telebrands is a New Jersey corporation 7 with its principal place of business in New Jersey, which allegedly conducts business throughout 8 the United States. See id. ¶ 13. 9 This action involves TENS units, which are medical devices used for pain relief that deliver 10 electrical impulses through electrodes placed on a user’s skin. Telebrands allegedly markets a 11 product called the Hempvana Rocket, which is a wireless, electronic TENS unit. See id. ¶ 33. On 12 November 19, 2020, Telebrands allegedly entered into a license agreement with Healthcare 13 Innovations LLC, which had obtained a 510(k) premarket clearance from the FDA to sell—and for 14 its licensees to sell—the Hempvana Rocket within the United States. See id. ¶ 34. Telebrands sells 15 the Hempvana Rocket nationally, including on a proprietary website and on third-party websites 16 like Amazon and Facebook. See id. ¶ 35. 17 Telebrands alleges that Defendants have competing products available on Amazon within 18 the United States. See id. ¶ 36. Henan Derun markets the Massager Pen under its UniforU brand. 19 See id. ¶ 36(f). XNH markets the Meridian Energy Acupuncture Pen under its FOHYLOY brand. 20 See id. ¶ 36(h). Telebrands alleges that it consulted with Exponent, Inc., which determined that 21 Defendants’ products are TENS units for which Defendants did not obtain the requisite 510(k) 22 clearance. See id. ¶¶ 38–44. 23 Telebrands alleges that Defendants have caused it irreparable harm by selling the Accused 24 Products in the U.S. without the requisite clearance. First, Telebrands alleges that Defendants 25 unfairly avoided the cost of obtaining 510(k) clearance and now can avail themselves of the 26 popularity of the Hempvana Rocket. See id. ¶ 49. Telebrands alleges that its business model is to 27 make large advertising expenditures for the launch of a new product to create a recognizable brand 1 advertising related to the Hempvana Rocket, including because websites like Amazon show similar 2 products in search results. See id. ¶¶ 45, 47. Second, Telebrands alleges that the sales of 3 Defendants’ TENS products will lead to the dilution of the market for handheld TENS devices, 4 including because consumers will be misled into thinking the Accused Devices are safe and 5 equivalent to the Hempvana Rocket despite lacking 510(k) clearance. See id. ¶¶ 51–53. 6 Telebrands alleges violations of (1) California’s Unfair Competition Law, Cal. Bus. & Prof. 7 C. § 17200 et seq; (2) Florida’s Deceptive and Unfair Trade Practices Act, Fla. Stat. § 501.201 et 8 seq; (3) the Pennsylvania Unfair Trade Practices and Consumer Protection Law, 73 Pa. Stat. Ann. 9 § 201-1 et seq; (4) the Delaware Deceptive Trade Practices Act, 6 Del. C. § 2531 et seq; and (5) the 10 Colorado Consumer Protection Act, Colo. Rev. Stat. § 6-1-101. See Complaint, ECF No. 1 11 ¶¶ 56–96. Telebrands seeks a permanent injunction restraining Defendants from “directly or 12 indirectly continuing to lawfully distribute [their] uncleared TENS units through third party 13 marketplaces such as Amazon, or any person or entity acting in concert with Defendants, from 14 continuing to unlawfully distribute [their] uncleared TENS units through third-party marketplaces 15 such as Amazon, in retail stores or through any other medium within the United States.” Id. 16 at 17–18. 17 C. Procedural Background 18 Telebrands filed the Complaint on February 4, 2021, asserting claims against Defendants 19 VindEx Solutions LLC (“VindEx”); Cornerstone Trading LLC (“Cornerstone”); Gloria Business, 20 Inc. (“Gloria”); Techno Zone, LLC (“Techno Zone”); Okapi, LLC (“Okapi”); Henan Derun; 21 Shen Zhen Hei Shi Investment Ltd. (“Shen Zhen”); and XNH. See ECF No. 1. On the same date, 22 Telebrands filed an application for a temporary restraining order “enjoining Defendants, and all of 23 those acting in concert or participation with Defendants, from directly or indirectly, continuing to 24 unlawfully distribute Defendants’ unauthorized TENS units either through third-party marketplaces 25 such as Amazon, by telephone, in retail stores or through any other medium within the United 26 States.” ECF No. 3. 27 On February 8, 2021, the Court ordered Defendants to respond to Telebrands’ application 1 email no later than February 8, 2021. See Order, ECF No. 9. On February 10, 2021, upon 2 Telebrands’ request, the Court permitted Telebrands to serve Defendants through Amazon Seller 3 Messaging Assistant, which Telebrands did as authorized. See Order, ECF Nos. 11, 12. The Court 4 heard Telebrands’ application on February 11, 2021, and only counsel for VindEx, Techno Zone, 5 Okapi, and Gloria appeared. See Order, ECF No. 26 at 1. The Court issued a temporary restraining 6 order and ordered the other Defendants, including Henan Derun and XNH, to show cause why the 7 preliminary injunction should not issue. See id. at 2. When they failed to respond, the Court issued 8 a preliminary injunction ordering that these Defendants were “restrained and enjoined from 9 distributing . . .

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Telebrands Corp. v. VindEx Solutions LLC, Counsel Stack Legal Research, https://law.counselstack.com/opinion/telebrands-corp-v-vindex-solutions-llc-cand-2022.