BioTE Medical, LLC v. Jacobsen

          MEMORANDUM OPINION AND ORDER

          AMOS L. MAZZANT UNITED STATES DISTRICT JUDGE

         Pending before the Court is Plaintiff BioTE Medical, LLC's (“BioTE”) Application for Injunctive Relief (Dkt. #40). On May 30, 2019; June 27, 2019; and June 28, 2019; the Court held a preliminary injunction hearing on BioTE's application and thereafter instructed the Parties to file post-hearing briefing addressing the propriety BioTE's requested injunctive relief. The Court, having considered BioTE's application, the evidence presented at the hearing, the and Parties' briefing, finds that BioTE's request for an injunction should be denied.

         BACKGROUND

         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 act to 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 Defendants^[1] and Individual Defendants^[2] (Evexias/Farmakeio Defendants and Individual Defendants are referred to collectively as “Defendants”). BioTE alleges that Defendants are unlawfully manufacturing and selling unapproved new drugs under the false guise that they are engaged in lawful “compounding” and are engaging in false and misleading advertising and promotion of their unapproved new drugs, in violation of the Lanham Act, § 43, 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), 18 U.S.C. § 1961 (2018). The following is a summary of BioTE's allegations:

a. Defendants misrepresented, in their marketing and advertising materials, that Defendant EvexiPEL had developed a proprietary hormone replacement pellet, when it had not;

b. 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. 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. 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. 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. Defendants misrepresented, in their marketing and advertising materials, that the EvexiPEL Pellets with Triamcinolone resulted; when there was no substantiating unbiased, viable “study” or even retrospective chart analysis to back it up, or even attempted;

g. 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. 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. 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. 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. 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. 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. 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 January 9, 2019, BioTE filed an Application for Injunctive Relief (Dkt. #40) requesting that the Court preliminarily enjoin Defendants from the following:

• Marketing, selling, distributing, prescribing and/or dispensing the Evexias Hormone Pellets; o Representing, orally or in writing, expressly or by implication, in any advertising, promotion, offering for sale, sale, prescription, consultation and/or patient visit that the Evexias Hormone Pellets: a) Are approved; b) Are safe; or c) Are as effective or more effective than competing products;

• Promoting or representing (orally or in writing, expressly or by implication) that Defendants' drugs are manufactured, marketed, distributed, sold and/or dispensed ...