United States District Court, E.D. Texas, Sherman Division
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
...