Telebrands Corp. v. VindEx Solutions LLC

District Court, N.D. California·Decided April 8, 2022·No. 5:21-cv-00898·Unknown

Opinion

TELEBRANDS CORP., Case No. 21-cv-00898-BLF

Plaintiff, ORDER GRANTING MOTION FOR v. DEFAULT JUDGMENT

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

Before the Court is Plaintiff Telebrands Corp.’s (“Telebrands”) motion for default judgment against Defendants Henan Derun New Material Technology Co. (“Henan Derun”) and XNH US (“XNH”) (collectively, “Defendants”) in this unfair competition case based on Defendants’ alleged sales of transcutaneous electrical nerve stimulation (“TENS”) units without clearance from the U.S. Food and Drug Administration (“FDA”). Based on the below reasoning, the Court GRANTS Telebrands’ motion. A. Regulatory Background The Federal Food, Drug, and Cosmetic Act (“FDCA”) provides requirements for medical devices according to a three-tiered system—Class I, II, and III devices. See 21 U.S.C. § 360c-(a)(1). TENS units, the devices at issue in this litigation, are classified as Class II devices. See 21 C.F.R. § 882.5890. Before a manufacturer can bring a Class II device to market, the FDCA requires filing a 510(k) premarket submission with the FDA. 21 U.S.C. § 360(k); Medtronic, Inc. v. Lohr, 518 U.S. 470, 477–79 (1996). Under the 510(k) process, if the Class II device is deemed “substantially equivalent” to a pre-existing device with prior clearance, it can be put on the market. See 21 C.F.R. equivalent” to a predicate device when it has the same intended use and the same technological characteristics like materials, design, and energy source. See 21 C.F.R. § 807.100(b). B. Factual Background Defendants are Chinese corporations with their principal places of business in China. See Complaint, ECF No. ¶¶ 19, 21. Defendants allegedly conduct business throughout the United States through online promotion of their TENS products. See id. Telebrands is a New Jersey corporation with its principal place of business in New Jersey, which allegedly conducts business throughout the United States. See id. ¶ 13. This action involves TENS units, which are medical devices used for pain relief that deliver electrical impulses through electrodes placed on a user’s skin. Telebrands allegedly markets a product called the Hempvana Rocket, which is a wireless, electronic TENS unit. See id. ¶ 33. On November 19, 2020, Telebrands allegedly entered into a license agreement with Healthcare Innovations LLC, which had obtained a 510(k) premarket clearance from the FDA to sell—and for its licensees to sell—the Hempvana Rocket within the United States. See id. ¶ 34. Telebrands sells the Hempvana Rocket nationally, including on a proprietary website and on third-party websites like Amazon and Facebook. See id. ¶ 35. Telebrands alleges that Defendants have competing products available on Amazon within the United States. See id. ¶ 36. Henan Derun markets the Massager Pen under its UniforU brand. See id. ¶ 36(f). XNH markets the Meridian Energy Acupuncture Pen under its FOHYLOY brand. See id. ¶ 36(h). Telebrands alleges that it consulted with Exponent, Inc., which determined that Defendants’ products are TENS units for which Defendants did not obtain the requisite 510(k) clearance. See id. ¶¶ 38–44. Telebrands alleges that Defendants have caused it irreparable harm by selling the Accused Products in the U.S. without the requisite clearance. First, Telebrands alleges that Defendants unfairly avoided the cost of obtaining 510(k) clearance and now can avail themselves of the popularity of the Hempvana Rocket. See id. ¶ 49. Telebrands alleges that its business model is to make large advertising expenditures for the launch of a new product to create a recognizable brand advertising related to the Hempvana Rocket, including because websites like Amazon show similar products in search results. See id. ¶¶ 45, 47. Second, Telebrands alleges that the sales of Defendants’ TENS products will lead to the dilution of the market for handheld TENS devices, including because consumers will be misled into thinking the Accused Devices are safe and equivalent to the Hempvana Rocket despite lacking 510(k) clearance. See id. ¶¶ 51–53. Telebrands alleges violations of (1) California’s Unfair Competition Law, Cal. Bus. & Prof. C. § 17200 et seq; (2) Florida’s Deceptive and Unfair Trade Practices Act, Fla. Stat. § 501.201 et seq; (3) the Pennsylvania Unfair Trade Practices and Consumer Protection Law, 73 Pa. Stat. Ann. § 201-1 et seq; (4) the Delaware Deceptive Trade Practices Act, 6 Del. C. § 2531 et seq; and (5) the Colorado Consumer Protection Act, Colo. Rev. Stat. § 6-1-101. See Complaint, ECF No. 1 ¶¶ 56–96. Telebrands seeks a permanent injunction restraining Defendants from “directly or indirectly continuing to lawfully distribute [their] uncleared TENS units through third party marketplaces such as Amazon, or any person or entity acting in concert with Defendants, from continuing to unlawfully distribute [their] uncleared TENS units through third-party marketplaces such as Amazon, in retail stores or through any other medium within the United States.” Id. at 17–18. C. Procedural Background Telebrands filed the Complaint on February 4, 2021, asserting claims against Defendants VindEx Solutions LLC (“VindEx”); Cornerstone Trading LLC (“Cornerstone”); Gloria Business, Inc. (“Gloria”); Techno Zone, LLC (“Techno Zone”); Okapi, LLC (“Okapi”); Henan Derun; Shen Zhen Hei Shi Investment Ltd. (“Shen Zhen”); and XNH. See ECF No. 1. On the same date, Telebrands filed an application for a temporary restraining order “enjoining Defendants, and all of those acting in concert or participation with Defendants, from directly or indirectly, continuing to unlawfully distribute Defendants’ unauthorized TENS units either through third-party marketplaces such as Amazon, by telephone, in retail stores or through any other medium within the United States.” ECF No. 3. On February 8, 2021, the Court ordered Defendants to respond to Telebrands’ application email no later than February 8, 2021. See Order, ECF No. 9. On February 10, 2021, upon Telebrands’ request, the Court permitted Telebrands to serve Defendants through Amazon Seller Messaging Assistant, which Telebrands did as authorized. See Order, ECF Nos. 11, 12. The Court heard Telebrands’ application on February 11, 2021, and only counsel for VindEx, Techno Zone, Okapi, and Gloria appeared. See Order, ECF No. 26 at 1. The Court issued a temporary restraining order and ordered the other Defendants, including Henan Derun and XNH, to show cause why the preliminary injunction should not issue. See id. at 2. When they failed to respond, the Court issued a preliminary injunction ordering that these Defendants were “restrained and enjoined from distributing . . . uncleared TENS units within the United States either through third-party marketplaces including Amazon or Facebook, by telephone, in retail stores, or through any other medium within the United States,” including “Defendant Henan Derun New Material Technology Co., Ltd.’s UniforU brand Massager pen” and “Defendant XNH US’s FOHYLOY brand Meridian Energy Acupuncture Pen.” Order, ECF No. 37 at 8. On April 19, 2021, the Court granted Telebrands’ motion to serve Henan Derun and XNH with the Complaint and the order granting Telebrands’ application for a temporary restraining order via Amazon Seller Messaging Assistant. See Order, ECF No. 46. Telebrands voluntarily dismissed its claims against Gloria, Shen Zhen, Okapi, Techno Zone, Cornerstone, and VindEx. See ECF Nos. 31, 32, 41

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