BioTE Medical, LLC v. Jacobsen

District Court, E.D. Texas·Decided June 1, 2020·No. 4:18-cv-00866·Unknown

Opinion

United States District Court EASTERN DISTRICT OF TEXAS SHERMAN DIVISION

BIOTE MEDICAL, LLC, § Plaintiff, § § Civil Action No. 4:18-cv-866 v. § Judge Mazzant § KENT JACOBSEN, et al. § Defendants. § § §

MEMORANDUM OPINION AND ORDER Pending before the Court are Plaintiff’s Rule 12(b)(1) and 12(b)(6) Motion to Dismiss and Brief in Support (Dkt. #157) and Third-Party Defendants’ Rule 12(b)(1), 12(b)(2), and 12(b)(6) Motion to Dismiss and Brief in Support (Dkt. #162). After consideration, the Court is of the opinion that the motions should be DENIED. BACKGROUND I. Factual Summary Plaintiff BioTE provides hormone replacement therapy to individuals who experience hormonal imbalances in their body through a method called Pellet Therapy, which inserts hormone pellets into the subcutaneous fat layer of the patient through an incision. BioTE’s Pellet Therapy uses BioTE’s custom and proprietary hormone pellet formula (“BioTE Formula”), which utilizes bio-identical and natural ingredients that maintain a patient’s hormone levels throughout the day. On December 13, 2018, BioTE filed the present action in United States District Court for the Eastern District of Texas (Dkt. #1) against Evexias/Farmakeio Defendants1 and Individual

1 The Evexias/Farmakeio Defendants include: Kent Jacobson, Jeni Guinn, Daniel D. DeNeui, Terri J. DeNeui, Jeff DeNeui, Dustin C. DeNeui, John Thomas, MD, Gunter Mueller, Dan Mikals, Lisa Mikals, Wendy Sandoval, Nicole Turcotte, Justin Graves, Robert Alan Harris, Martin Groves, Neal Rouzier, MD, Forget About It, Inc., Evexias Health Solutions, LLC, EvexiPEL, a Division of Evexias Health Solutions, LLC, Evexias Holding Co, Evexias HRT, LLC Defendants2 (Evexias/Farmakeio Defendants and Individual Defendants are referred to collectively as “Defendants”). BioTE alleges that Defendants are: (1) unlawfully manufacturing and selling unapproved new drugs under the false guise that they are engaged in lawful “compounding;” and (2) engaging in false and misleading advertising and promotion of their

unapproved new drugs, in violation of Section 43 of the Lanham Act, codified at 15 U.S.C. § 1125(a)(1)(B). BioTE also alleges that Defendants conducted and continue to conduct their business through legitimate and illegitimate means in the form of an association-in-fact enterprise, in violation of the Racketeer Influenced and Corrupt Organizations Act (“RICO”), codified at 18 U.S.C. § 1961 (2018). The following is a summary of BioTE’s allegations: a. That Defendants misrepresented, in their marketing and advertising materials, that Defendant EvexiPEL had developed a proprietary hormone replacement pellet, when it had not; b. That Defendants misrepresented, in their marketing and advertising materials, that Defendant Terri DeNeui had participated in the development of the allegedly proprietary hormone pellet; when she had not and when she could not legally do so; c. That Defendants misrepresented, in their marketing and advertising materials, that providers and patients would have access to the exclusive EvexiPEL Pellet; when no such pellet existed; d. That Defendants misrepresented, in their marketing and advertising materials, that Defendant Farmakeio had a federally required 503B “registration pending”; when there is no such thing and no paperwork for any such registration had been submitted; e. That Defendants misrepresented, in their marketing and advertising materials, that the EvexiPEL Pellet “has been shown to produce better outcomes for patients too”; when there was nothing that showed any such thing; f. That Defendants misrepresented, in their marketing and advertising materials, that the EvexiPEL Pellets with Triamcinolone resulted in far fewer extrusions; when there was no substantiating unbiased, viable “study” or even retrospective chart analysis to back it up, or even attempted;

f/k/a Hormonal Health and Wellness Centers, LLC, Evexias Medical Centers, PLLC f/k/a Terri Suresh ACNP, PLLC a/k/a Hormonal Health Wellness & Skin Center a/k/a Hormonal Health Wellness and Aesthetics Center a/k/a Hormonal Health & Wellness, Evexias Management, LLC, Evexias Metrita-Columbia, LLC, Evexias-Anthem Columbia, LLC, Evexias-Anthem Alaska, LLC, North American Custom Laboratories, LLC a/k/a Farmakeio, Farmakeio Nutraceuticals, LLC, Farmakeio Outsourcing, LLC, and Nilus, LLC. 2 The Individual Defendants include: Mark Burns, Jeff Hill, Dominic Verrilli, Kimberley Meegan, Andrea Jones g. That Defendants misrepresented, in their marketing and advertising materials, that the EvexiPEL Pellets with Triamcinolone resulted in far fewer boosts; when there was no substantiating study, or even a retrospective chart analysis to back it up, or even attempted]; h. That Defendants misrepresented, in their marketing and advertising materials, that the EvexiPEL Pellets with Triamcinolone resulted in quicker absorption; when there was no substantiating study, or even a retrospective chart analysis to back it up, or even attempted; i. That Defendants misrepresented, in their marketing and advertising materials, that the EvexiPEL Pellets with Triamcinolone resulted in more consistent absorption; when there was no substantiating study, or even a retrospective chart analysis to back it up, or even attempted; j. That Defendants misrepresented, in their marketing and advertising materials, that the EvexiPEL Pellets with Triamcinolone resulted in increased patient satisfaction; when there was no substantiating study, or even a retrospective chart analysis to back it up, or even attempted; k. That Defendants misrepresented, in their marketing and advertising materials, that the EvexiPEL Pellets with Triamcinolone resulted in increased practitioner satisfaction; when there was no substantiating study, or even a retrospective chart analysis to back it up, or even attempted; l. That Defendants misrepresented, in their marketing and advertising materials, that Farmakeio was “a leading pharmacy in the U.S.”; when it had just been formed and started operating; m. That Defendants misrepresented, in their marketing and advertising materials, that Dan DeNeui and Terri DeNeui are “founders” of BioTE Medical when neither have ever owned an interest in the company and it was formed and operating before either of them ever associated with it.

(Dkt. #142 at p. 2–3). On September 13, 2019, Evexias/Farmakeio Defendants filed their answer to BioTE’s complaint and their affirmative defenses, counterclaims, and third-party claims (Dkt. #151) (“Counterclaim and Third-Party Complaint”). Specifically, in the Counterclaim and Third-Party Complaint, Evexias/Farmakeio Defendants asserted a counterclaim against BioTE for invasion of privacy (Dkt. #151). Moreover, Evexias/Farmakeio Defendants asserted claims against Third- Party Defendants3 for tortious interference with prospective and continuing business relations; business disparagement and defamation; and for conspiracy to accomplish the same (Dkt. #151).

3 The Third-Party Defendants include: Gary Donovitz, Mark Hincher, Terry Weber, Cory Rice, Mark Orr, and Amy Pitarra. II. Procedural History On October 22, 2019, BioTE filed a 12(b)(1) and 12(b)(6) motion to dismiss the Counterclaim and Third-Party Complaint (Dkt. #157). On January 9, 2020, the Evexias/Farmakeio Defendants filed a response (Dkt. #168). On January 24, 2020, BioTE filed a

reply (Dkt. #174). On December 6, 2019, Third-Party Defendants filed a 12(b)(1), 12(b)(2), and 12(b)(6) motion to dismiss the Counterclaim and Third-Party Complaint (Dkt. #162). On January 9, 2020, Evexias/Farmakeio Defendants filed a response (Dkt. #170). On January 24, 2020, Third-Party Defendants filed a reply (Dkt. #174). LEGAL STANDARD I.

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