Hi-Tech Pharmaceuticals, Inc. v. Dynamic Sports Nutrition, LLC et al

Filing 261

OPINION & ORDER. The Court GRANTS IN PART and DENIES IN PART Plaintiff's 212 Motion in Limine and GRANTS Defendants' 213 Motion in Limine regarding ABC Testing. The Court will address the portion of Defendants' Motion in Limine seeking to exclude testimony from Linda Gilbert in a separate order. Signed by Judge Michael L. Brown on 5/24/2021. (bgt)

IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF GEORGIA
ATLANTA DIVISION
Hi-Tech Pharmaceuticals Inc.,
Plaintiff,
Case No. 1:16-cv-949-MLB

v.
Dynamic Sports Nutrition, LLC, et
al.,
Defendants.
________________________________/

OPINION & ORDER
Before the Court are motions in limine filed by both parties. (Dkts.
212; 213.) Having considered the record and the parties’ arguments at
various hearings, the Court grants in part and denies in part each
motion.1

Defendants’ motion in limine also includes a motion to exclude
Plaintiff’s expert, Linda Gilbert, pursuant to the standards set forth in
Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 587 (1992).
The Court will address that potion of Defendants’ motion in limine in a
separate order addressing Plaintiff’s Motions to Exclude Expert
Testimony (Dkts. 236 and 238).

1

I.

Background
Plaintiff Hi-Tech Pharmaceuticals Inc. manufactures and sells

dietary supplement products, including DIANABOL® and a number of
products designed for muscle and body building, hormone boosters, and
weight loss. (Dkt. 163-2 at 2–3.) On February 5, 2008, the United States
Patent and Trademark Office (“PTO”) issued a registration for
DIANABOL® as a trademark (Registration No. 3,378,354) for use in the
pharmaceutical class of trademarks (Class 5) in connection with certain
“dietary supplements, excluding anabolic steroids.” (Dkt. 64-1.)
For more than a decade Defendant Dynamic Sports Nutrition, LLC,
(“DSN”) has sold and marketed dietary supplement products, including
something known as D-Anabol 25. (Dkt. 160-1 ¶ 22.) In March 2011,
DSN applied to the PTO to register D-Anabol 25 as a trademark for
dietary supplements. (Dkt. 62 ¶ 21.) On June 28, 2011, the PTO issued
an office action refusing the registration because (1) there was a
likelihood of confusion with the DIANABOL® trademark; (2) D-Anabol
25 was merely descriptive of a feature of the product; and in the
alternative, (3) the product was deceptively misdescriptive. (Dkt. 62-2 at
2–5.)

2

On February 5, 2014, Plaintiff filed an affidavit with the PTO
certifying that (1) the goods associated with DIANABOL® have been in
continuous use for five consecutive years and are still in use in commerce;
(2) no final decision exists that is adverse to the owner’s claim of
ownership of DIANABOL® for such goods, or to the owner’s right to
register the same or to keep the same on the register; and (3) there is no
proceeding involving the trademark rights pending in the PTO or in a
court.

(Dkt. 54-17.)

The PTO found Plaintiff’s affidavit met the

requirements of the Trademark Act, 15 U.S.C. §§ 1058 and 1065, and the
DIANABOL® mark was thus incontestable. (Dkt. 54-18.)
Plaintiff then sued DSN and its owner, Brian Clapp. (Dkt. 1.) The
Complaint includes claims for trademark infringement (Counts I & II);
false designation of origin and unfair competition (Counts III & IV); false
advertising (Count V); violation of the Georgia Deceptive Trade Practices
Act (Count VI); common law unfair competition (Count VII); and
violations

of

the

Georgia

Racketeer

Influenced

and

Corrupt

Organizations Act (“RICO”) (Counts VIII through X). (Id.) Defendants
assert several defenses, including that DIANABOL® is generic, that the
DIANABOL® trademark was obtained by fraud, and that Plaintiff has

3

unclean hands. (Dkt. 67.) As the parties prepared for trial, they filed
motions in limine to control or limit the admission of evidence. (Dkts.
212; 213).
II.

Legal Standard
Trial judges may rule on motions in limine under the inherent

authority to manage the course of trials. Luce v. United States, 469 U.S.
38, 41 n.4 (1984). “The real purpose of a Motion in Limine is to give the
trial judge notice of the movant’s position so as to avoid the introduction
of damaging evidence which may irretrievably affect the fairness of the
trial.” Soto v. Geico Indem. Co., No. 6:13-cv-181, 2014 WL 3644247, at *1
(M.D. Fla. July 21, 2014) (citation omitted) (alterations to original). “The
court will grant a motion in limine to exclude evidence only if the
evidence in question is clearly inadmissible,” with the moving party
bearing the “burden of proving that the evidence sought to be excluded is
inadmissible.” Wilson v. Pepsi Bottling Grp., Inc., 609 F. Supp. 2d 1350,
1359 (N.D. Ga. 2009).
The Court grants or denies these motions in limine based on the
proffers made and agreed to by the parties, the arguments of counsel, and
the Court’s current understanding of the matter and the parties’

4

respective positions. If during the trial, either party believes the basis
for the Court’s decision has changed such that evidence the Court
excludes herein has become admissible or evidence the Court finds
admissible herein become inadmissible, the party may make a proffer for
reconsideration of the Court’s order. Absent extenuating circumstances,
this must be done outside the presence of the jury at the start of the day,
the end of the day, or at some other time such that the Court may
consider the issue without delaying the jury. This is not intended to allow
parties to re-argue issues the Court decides herein, but rather in
recognition of the fact that circumstances may change prior to or during
the trial of this matter and that such changes may impact the
admissibility of evidence discussed herein.
III. Discussion
A.

Plaintiff’s Motion in Limine
1.

Presence of Anabolic Steroids in Plaintiff’s
Products

Defendants retained an expert to conduct chemical testing of
Plaintiff Hi-Tech’s DIANABOL® product.
anabolic

steroids

in

DIANABOL®,

That expert found two
androstenedione

and

dihydrotestosterone (DHT). (Dkts. 160-9; 160-21 at 89:11–90:3; 163-5–
5

7.)

Defendants claim this evidence shows Plaintiff knowingly and

intentionally “spiked” DIANABOL® with steroids.

(Dkt. 215 at 7.)

Defendants further claim the presence of steroids in DIANABOL® is
relevant for several purposes, including to show Plaintiff’s DIANABOL®
mark was obtained through fraudulent filings and that Plaintiff has
unclean hands. (Id. at 7, 9, 17.) More specifically, they say the evidence
will show that “Hi-Tech and Wheat have engaged in an on-going, twentyyear scheme of USPTO-related fraud by obtaining marks similar or
identical in name to common, illegal muscle-building steroids and then
spiking those supposedly legal products with banned anabolic steroids[,
that] include[] DIANABOL®.” (Id. at 8.)
Plaintiff retained an expert who opined that the presence of
androstenedione in DIANABOL® can be explained by its use as a
“starting material” in the synthesis of a substance known as
dehydroepiandrosterone (“DHEA”) that Plaintiff admittedly uses to
manufacture DIANABOL®. (Dkt. 163-3 at 10.) In other words, the
expert claims the first steroid is merely a by-product of the
manufacturing process. (Id.) He claims the levels of both steroids in
DIANABOL® are so small—what Plaintiff refers to as “trace amounts”—

6

that they have no biological effect on the consumer. (Id.; see also Dkt.
212 at 11.) In short, Plaintiff denies any suggestion it intentionally
“spiked” its product with illegal steroids. As to the unclean hands claim,
Plaintiff says the presence of “trace amounts” of steroids in DIANABOL®
does not affect the “equitable relations between the parties” in the subject
of this litigation because Defendants also sell a product that contains at
least one of the same steroids. (Dkt. 212 at 10.) They say “the equities
are, therefore, the same on both sides” or, put differently, their hands are
equally dirty. (Id.) Plaintiff seeks to exclude any evidence of anabolic
steroids in DIANABOL® (or any of its other products).
The Court agrees that whether Plaintiff intentionally “spiked”
DIANABOL® is a relevant issue in this case. First, it is relevant to
Defendants’ claim that Plaintiff’s trademark was obtained by fraud and
is thus invalid. “In any action involving a registered mark, a court may
order the cancellation of the registration, in whole or in part, when such
action is warranted.” Angel Flight of Ga., Inc. v. Angel Flight Am., Inc.,
522 F.3d 1200, 1209 (11th Cir. 2008) (citing 15 U.S.C. § 1119). “One
ground on which a party may petition to cancel a registered service mark
is that the registration was obtained fraudulently.” Id. (citing 15 U.S.C.

7

§ 1064(3)). “Fraud occurs when an applicant knowingly makes false,
material representations of fact in connection with an application for a
registered mark.”

Id. (citing Metro Traffic Control, Inc. v. Shadow

Network Inc., 104 F.3d 336, 340 (Fed. Cir. 1997)).

“Fraud further

requires a purpose or intent to deceive the PTO in the application for the
mark.” Sovereign Military Hospitaller Order of Saint John of Jerusalem
of Rhodes & of Malta v. Fla. Priory of the Knights Hospitallers of the
Sovereign Order of Saint John of Jerusalem, Knights of Malta, The
Ecumenical Order, 702 F.3d 1279, 1289 (11th Cir. 2008) (citing In re Bose
Corp., 580 F.3d 1240, 1243, 1245 (Fed. Cir. 2009)).
In this case, Defendants bear the burden of proving the alleged
fraud by clear and convincing evidence. Angel Flight, 522 F.3d at 1209.
Defendants argue Plaintiff represented to the PTO that DIANABOL®
would not contain anabolic steroids, but then spiked DIANABOL® to
include anabolic steroids. Such conduct could show Plaintiff obtained the
trademark through fraud. After all, Plaintiff obtained the mark for a
dietary supplement that does not include steroids. (Dkt. 62 at ¶ 15.)
Second, evidence of “spiking” is relevant to Defendants’ argument
that the unclean hands doctrine bars Plaintiff from recovering on its false

8

advertising claims because Plaintiff misled consumers by selling
supplements that contain illegal steroids. (Dkt. 160 at 16.) “The defense
of unclea[n] hands applies to a Lanham Act claim and is established by a
showing that ‘the plaintiff’s conduct is inequitable and that the conduct
relates to the subject matter of its claim.’” DS Waters of Am., Inc. v.
Fontis Water, Inc., No. 1:10-cv-0335-SCJ, 2012 WL 12873771, at *24
(N.D. Ga. Sept. 13, 2012) (applying the unclean hands doctrine in context
of a Lanham Act claim) (quoting Campagnolo S.R.L. v. Full Speed Ahead,
Inc., 258 F.R.D. 663, 665–66 (W.D. Wash. 2009)), amended by 2012 WL
12873620 (N.D. Ga. Dec. 4, 2012).
[W]hen the owner of a trade-mark applies for an injunction to
restrain the defendant from injuring his property by making
false representations to the public, it is essential that the
plaintiff should not in his trade-mark, or in his
advertisements and business, be himself guilty of any false or
misleading representations; that if the plaintiff makes any
material false statement in connection with the property
which he seeks to protect, he loses the right to claim the
assistance of a court of equity; that where any symbol or label
claimed as a trademark is so constructed or worded as to make
or contain a distinct assertion which is false, no property can
be claimed on it, or, in other words, the right to the exclusive
use of it cannot be maintained.
Shatel Corp. v. Mao Ta Lumber & Yacht Corp., 697 F.2d 1352, 1355 (11th
Cir. 1983) (quoting Worden & Co. v. Ca. Fig Syrup Co., 187 U.S. 516, 528

9

(1903)).

While the Court previously denied Defendants’ motion for

summary judgment on Plaintiff’s false advertising claims, it recognized
the existence of “a genuine dispute of material fact regarding the
androstenedione

and

DIANABOL®® product.”

DHT

allegedly

(Dkt. 181 at 25.)

detected

in

Plaintiff’s

In doing so, the Court

recognized the relevance of “spiking” evidence.

It reaffirms that

determination here.
The Court thus denies Plaintiff’s motion in limine regarding
reference to the presence of steroids in DIANABOL® or other Hi-Tech
products, subject to specific objections as to any particular evidence.
2.

Evidence of Prior Crimes and Wrongdoings

Plaintiff and its owner (Jared Wheat) have a long and colorful
history of criminal and civil litigation, including (a) Mr. Wheat’s 1990
conviction for the sale of MDMA and 1995 violation of supervised release
for marijuana possession, (b) Mr. Wheat’s and Plaintiff’s 2008 convictions
for conspiracy to commit mail and wire fraud and to introduce
adulterated, misbranded, and unapproved new drugs with the intent to
defraud, (c) a 2013 forfeiture action brought by the Federal Food and
Drug Administration (“FDA”) to seize Plaintiff’s products containing a

10

food additive known as DMAA, (d) a 2017 order in the Northern District
of Georgia finding Plaintiff and Mr. Wheat in violation of a 2008
injunction the Federal Trade Commission obtained against them
regarding unsubstantiated representations they made related to weight
loss products, and (e) a 2017 indictment currently pending against Mr.
Wheat and related civil forfeiture case. Plaintiff seeks to exclude all of
this evidence (except Plaintiff concede Mr. Wheat’s and its 2008
convictions are admissible to attack their character for truthfulness
pursuant to Federal Rule of Evidence 609). (Dkt. 21 at 2–9.)
Defendants argue this evidence is admissible for the purposes set
forth in Federal Rule of Evidence 404(b). (Dkt. 215 at 14-19.) The
Eleventh Circuit sets out a three-part test for determining whether
evidence of a prior bad act is admissible under Rule 404(b). See United
States v. Miller, 959 F.2d 1535, 1538 (11th Cir. 1992). For evidence to be
admissible, the party seeking to introduce the evidence must show: (1)
the evidence is relevant to an issue other than the defendant's character;
(2) there is sufficient proof of the extrinsic act; and (3) the evidence’s
probative value is not substantially outweighed by the risk of undue

11

prejudice under Rule 403. See id.; United States v. Ramirez, 724 F. App’x
704, 716 (11th Cir. 2018).
Evidence of a party’s prior bad acts is admissible to prove a party’s
motive, intent, plan, or absence of mistake of accident. Fed. R. Evid.
404(b). Where extrinsic act evidence is offered to prove a party’s intent,
“its relevance is determined by comparing the [party’s] state of mind in
perpetrating both the extrinsic and charged offenses.” United States v.
Barrington, 648 F.3d 1178, 1186 (11th Cir. 2011) (quoting United States
v. Dorsey, 819 F.2d 1055, 1060 (11th Cir.1987)). The first prong of the
Rule 404(b) test is satisfied “when the state of mind required for the
charged offense and the extrinsic act is identical.” Id. So, for example,
when a defendant in a fraud case claims he or she did not intend to
commit fraud, prior instances in which the defendant defrauded others
in a similar manner is admissible to prove the defendant’s intent to
defraud. United States v. Ellisor, 522 F.3d 1255, 1267 (11th Cir. 2008).
That concept could apply here.
At the heart of Defendants’ 404(b) argument is their claim that
Plaintiff knowingly and intentionally “spiked” DIANABOL® with
steroids and falsely advertised it as not containing steroids. (Dkt. 215 at

12

7.) In response, Plaintiff contends it did not intend to defraud the PTO
by spiking DIANABOL® with anabolic steroids or its customers by
falsely advertising that its product contained no steroids.

Given

Plaintiff’s response, Defendants have identified a proper purpose under
Rule 404(b). Evidence of prior spiking or false advertising could show
Plaintiff intended to spike DIANABOL® with anabolic steroids (in other
words, the presence of such steroids was not an accident or unknowing
by-product as Plaintiff contends) and that Plaintiff intended to mislead
consumers by advertising DIANABOL® as a nutritional supplement
when they knew it contained steroids.
This is simply to say Defendants identified a theory under which it
could introduce evidence of Mr. Wheat’s and Plaintiff’s other “bad acts.”
But, upon review of the parties initial briefing, the Court was
unconvinced any of Defendants’ proffered evidence had probative value
as to Defendants’ theory of admissibility. The Court invited Defendants
to present additional details as to the prior “bad acts” it sought to
introduce in order for the Court to apply the three part test. Defendants
did so. (Dkt. 249.) The Court now concludes that, with few exceptions,

13

Defendants’ alleged evidence does not satisfy its theory of admissibility
and is not admissible under Rule 404(b).
Alternatively, Defendants argue that evidence of prior crimes and
wrongdoings is admissible under Rule 405 for the separate purpose of
showing that Plaintiff has “an abysmal and well-publicized history of
criminal violations and activities that repeatedly endangered the health
and well-being of unknowing consumers” and that this reputational
evidence is admissible to “counter and offset Plaintiff’s damages-related
calculations and claims.” (Dkt. 215 at 12.) Plaintiff responds that it does
not intend to introduce evidence of its good reputation and that this
evidence is thus irrelevant. (Dkt. 221 at 8.) The Court finds Defendants
have not presented any basis for the admission of this evidence under
Rule 405.
a)

1990 Conviction
Violation

and

1995

Probation

In 1990, Mr. Wheat pled guilty in the Northern District of Alabama
to conspiracy to distribute MDMA. (See Dkt. 160-5; United States v.
Wheat, et al., 90PT120S (N.D. Ala.)). After being released from prison,
Mr. Wheat violated the conditions of his supervised release when law
enforcement stopped him for driving under the influence and found him
14

in possession of twenty pounds of marijuana. (Dkt. 160-5 at 8.) Not
admirable conduct. But Mr. Wheat’s conduct in the 1990s did not involve
any claims of “spiking” or false advertising. As such, it is not probative
of any proper purpose under Rule 404(b)—it does not provide any basis
to

suggest

Plaintiff

intentionally

spiked

or

falsely

advertised

DIANABOL®.
Nor is this evidence admissible under Rule 405 as evidence of
character or reputation, even assuming Plaintiff introduces evidence of
its good character. The relevant period of damages in this case begins in
September 2011, so any effects from the 1990 conviction and the 1995
probation violation were already “baked” into the market. Any hit to
Plaintiff’s reputation as a result of Mr. Wheat’s conviction occurred long
before the alleged damages period in this case and could not be an
alternative cause of any difficulties at issue here. This evidence has no
probative value. And, even if it had some probative value, the prejudicial
impact of admitting this evidence would outweigh any value it may have
to the jury. The Court grants Plaintiff’s motion to exclude evidence of
Mr. Wheat’s 1990 conviction and 1995 supervised release violation.

15

b)

2008 Conviction for Mail and Wire Fraud

In 2008, Mr. Wheat and Plaintiff pled guilty in United States v.
Wheat, et al., 1:06-CR-382-JTC (N.D. Ga.). Although the indictment
charged forty-six offenses, Plaintiff and Mr. Wheat pled guilty to one
count—conspiracy to commit mail and wire fraud and to introduce into
interstate commerce adulterated, misbranded, and unapproved new
drugs with the intent to defraud and mislead.

(Dkt. 160-6 at 107.)

Defendants argue that this evidence is admissible because it shows
Plaintiff “was selling illegal anabolic steroids and other controlled
substances in interstate commerce at the same time it was selling
DIANABOL.” (Dkt. 215 at 8.) In support, Defendants cite Plaintiff’s and
Mr. Wheat’s August 15, 2008 guilty plea hearing transcripts, contending
that the transcripts “do not exclude the manufacture and sale of anabolic
steroids from the factual basis.” (Dkt. 249 at 3, 5.)
Plaintiff

and

Mr.

Wheat

pled

guilty

to

manufacturing

pharmaceuticals and other drugs in Belize in a manner that violated
United States law and then subsequently sold those unauthorized drugs
into the United States. (Dkt. 249-3 at 17–19.) For sure, their conduct
involved the illegal manufacturing and sale of steroids. But that does not

16

satisfy the first prong of the Rule 404(b) test. There was no suggestion
Plaintiff or Mr. Wheat were misrepresenting or mislabeling any of the
ingredients in the drugs they illegally manufactured and sold. (Id. at 21.)
They

were

making

properly

identified

generics,

but

without

authorization to do so and through an unauthorized manufacturing
process, as required by United States law for sale to United States
customers.

(Id.)

The steroids at issue in that case were properly

identified as steroids—there were no allegations of spiking or
mislabeling. There also was no allegation of false advertising or the
intention to deceive customers.
Defendants nonetheless contend that evidence Plaintiff sold illegal
steroids in the United States establishes Plaintiff’s plan or motive to
spike its product in this case—that a jury could find the presence of
steroids in DIANABOL® was intentional because Plaintiff had
previously sold steroids in the United States and thus had motive to do
so again. In other words, Defendants say Plaintiff wanted to sell steroids
before and such evidence is relevant to show it has the intent to sell
steroids now. But the Court is unpersuaded that evidence relating to
Plaintiff’s 2008 conviction involving the sale of illegally manufactured,

17

but properly identified, steroids is relevant to the “spiking” and false
advertising allegations at issue in this case. The 2008 conduct is not even
remotely analogous to the conduct alleged in this case such that proof of
the former is probative of intent for the latter. Moreover, the prejudicial
impact of admitting the 2008 convictions far outweighs any trace of
relevance. Evidence of the 2008 convictions is admissible only for the
limited purpose identified in Rule 609(a)(1)(A).2
c)
In

2013,

DMAA Case

Plaintiff

sold

weight

loss

products

containing

Dimethylamylamine, commonly known as DMAA. The FDA seized a
large amount of Plaintiff’s product, claiming they were subject to seizure
because DMAA was a food additive that was not generally recognized as
safe.

Plaintiff filed a claim in the subsequent forfeiture action to

challenge the FDA’s classification of DMAA.

See United States v.

Quantities of Finished & In-process Foods, et al., 1:13-CV-3675 (N.D.
Ga.). (Dkt. 249-8.) In its claim, Plaintiff argued DMAA was a botanical

The Court concludes evidence of the 2008 convictions is also not
admissible under Rule 405 for the same reasons the 1990 conviction is
not admissible—Plaintiff’s reputation at the start of the relevant period
already reflected the impact of the 2008 convictions.

2

18

rather than a food additive and its products were thus not subject to
seizure.

That was an issue of first impression.

After considering

arguments by the parties and experts’ opinions, the district court ruled
against Plaintiff, and the Eleventh Circuit affirmed.
Defendants argue this evidence is relevant to show Plaintiff has
sold another product containing an illegal ingredient, making it
probative under Rule 404(b) to show opportunity and absence of mistake
as to the presence of steroids in DIANABOL®. (Dkt. 215 at 17.) The
Court disagrees. There was no evidence in the DMAA case that Plaintiff
“spiked” or intentional misrepresented its weight loss product to hide the
presence of DMAA. Indeed, DMAA was included on the label.

Absent

evidence that Plaintiff intentionally misbranded the product containing
DMAA or continued selling the product after the court ruled that it was
illegal to do so, the Court concludes evidence of the DMAA case fails to
satisfy the first prong of the Rule 404(b) analysis.
Additionally, Defendants have not demonstrated the DMAA case
had any impact on Plaintiff’s reputation to render it admissible pursuant
to Rule 405. And any potential relevancy for that purpose is outweighed
by the prejudicial impact of the evidence. Accordingly, the Court grants

19

this motion subject to reconsideration upon the introduction of additional
evidence.3
d)

2017 Finding
Sanctions

of

Civil

Contempt

and

In 2004, the Federal Trade Commission (“FTC”) sued Plaintiff, Mr.
Wheat,

and

others

claiming

they

had

made

unsubstantiated

representations about the efficacy of two weight loss products—
Thermalean and Lipodrene. (Dkts. 160-7 at 3; 240-6 at 129.) After
lengthy litigation, the court concluded the defendants violated the Trade
Commission Act, granted summary judgment in favor of the FTC, and
imposed a permanent injunction against Plaintiff, Mr. Wheat, and the
others precluding them from making representations about the efficacy
of weight loss products unless the representations were based upon
“competent and reliable scientific evidence that substantiates the
representations.” (Dkts. 160-7 at 15; 240-6 at 142.) The court entered
that injunction in 2008, and the Eleventh circuit affirmed.

The Court recognizes that Defendants have filed additional evidence
they seek to admit in relation to the DMAA matter. (Dkt. 255.) The
Court will consider this evidence after Plaintiff responds.

3

20

In 2011, the FTC brought a sanctions case claiming Plaintiff, Mr.
Wheat, and others had violated the injunction by making representations
about four weight loss products—Fastin, Stimerex-ES, Benzedrine, and
a reformulated version of Lipodrene—that lacked the requisite
substantiation. (Dkt. 160-7 at 5.) The FTC also claimed Plaintiff failed
to include the required yohimbine warning on each of the four products,
in violation of Section VI of the injunction. (Id.) After lengthy litigation
that lasted until 2017, the court found Plaintiff, Mr. Wheat, and the
others understood the requirements of the injunction, knew the
company’s representations violated those requirements, intentionally
violated the terms of the injunction by not possessing competent and
reliable scientific evidence to substantiate the representations they made
about the weight loss products, and misled consumers. (Dkt. 160-7 at
32–41, 63–78, 117–18, 127.)
While this matter does not appear to have involved “spiking” of
products with steroids or other substances, it did involve the accuracy of
Plaintiff’s advertisements in regard to the prior injunction. The court
concluded

that

Plaintiff

knew

the

requisite

standard

for

its

advertisements and intentionally did not abide the standard. In other

21

words, the company intentionally misled consumers about the efficacy of
its products. Here, Plaintiff argues that Defendants have engaged in
false advertising by intentionally representing that their products
contain steroids when they in fact do not. In response, Defendants assert
an unclean hands defense, claiming that Plaintiff cannot recover on a
false advertising claim because Plaintiff has engaged in false advertising
for its own products, including DIANABOL®. Plaintiff responds that any
failure to identify anabolic steroids in DIANABOL® was an error
(because it did not know the steroids were there) or irrelevant (because
the steroids are only present in trace amounts).
The accuracy of Plaintiff’s advertisements and whether Plaintiff
knew they were inaccurate is at issue here. From evidence Plaintiff
intended to misrepresent its products in the injunction case, a jury could
conclude it intended to do so in this case. A jury could conclude from the
prior event that Plaintiff did not act innocently and mistakenly in failing
to disclose anabolic steroids in DIANABOL®. The evidence is relevant
to an issue other than the defendant’s character. The contempt order
also provides sufficient proof of the extrinsic act and the evidence’s
probative value is not substantially outweighed by the risk of undue

22

prejudice. The Court thus denies Plaintiff’s motion to exclude evidence
of Plaintiff’s violation of the 2008 injunction.
e)

2017 Indictment and Related Forfeiture Case

Plaintiffs seek to exclude all evidence relating to a criminal case
currently pending against Plaintiff and Mr. Wheat, United States v.
Wheat, et al., 1:17-cr-00229-ATCMS (N.D. Ga.), and a related civil
forfeiture proceeding. (Dkt. 212 at 7.) These matters involve claims that
Plaintiff, Mr. Wheat, and others provided false Good Manufacturing
Practice certificates upon the export of their products. (Dkt. 160-8.) It
includes a charge for conspiracy to introduce misbranded drugs into
interstate

commerce,

claiming

Plaintiff,

Mr.

Wheat

and

their

co-defendant sold a dietary supplement called Choledrene without
disclosing that it included lovastatin, making it a “drug” rather than a
“dietary supplement” under the FDCA. (Id. at 8.) While this may be
relevant to Defendants’ unclean hands defense, neither Plaintiff nor Mr.
Wheat has entered a plea in that case. Mere evidence of the indictment
is insufficient to satisfy the first prong of the Rule 404(b) test.
Defendants argue that, while the indictment itself may not be
admissible, other evidence relating to the pending criminal matter might

23

be. (Dkt. 215 at 20.) The Court agrees that, if Defendants have proof of
some extrinsic act related to this pending matter (like alleged spiking of
Choledrene), that evidence could be relevant and admissible pursuant to
Rule 404(b). But Defendants have provided no such evidence. Nor have
Defendants made a showing that this matter impacted Plaintiff’s
reputation so as to be admissible pursuant to Rule 405. Based on the
evidence presented so far, the Court grants Plaintiff’s motion in limine to
exclude evidence of the pending criminal case and the related forfeiture
action.
3.

Evidence and Testimony from Oliver Catlin

Plaintiff seeks to exclude evidence and testimony from Oliver
Catlin, the president of a company known as Banned Substances Control
Group (“BSCG”) that Defendants retained to test DIANABOL®. (Dkt.
212 at 12.) BSCG did not conduct the testing itself but rather hired
Trudasil Laboratories Inc. (“Trudasil”) to do so.

(Id.)

Dr. Anthony

Fontana, the Technical Director of Trudasil, issued an expert report
about that testing. (Id.)
Plaintiff argues Catlin was not involved with the testing or the
creation of the Fontana report, so any testimony he could offer would be

24

hearsay and needlessly cumulative of that provided by Dr. Fontana. (Id.
at 13.) Plaintiff further argues that Catlin was not properly identified as
an expert and should not be permitted to give expert testimony. (Dkts.
212 at 12; 221 at 11.) At a May 19, 2021 pretrial conference, Defendants
stipulated that Catlin will not give expert testimony and that his
testimony is primarily needed to establish chain of custody. The Court
finds such testimony relevant and admissible for that purpose. He may
testify as a fact witness as to what (if anything) he did but may offer no
expert testimony about Trudasil’s analysis.
4.

Evidence of Plaintiff Making False or Misleading
Product Claims and All Plaintiff Advertising
Outside the Relevant Time Period

Plaintiff seeks to exclude all evidence relating to allegations that it
has made false product claims, as well as all evidence of its advertising
outside the relevant time period. (Dkt. 212 at 17–19.) The Court finds
evidence relating to Plaintiff’s alleged false advertising relevant to
Defendants’ unclean hands defense for the reasons already explained.
Evidence of this nature may also be probative as to whether the presence
of anabolic steroids in DIANABOL® resulted from Plaintiff’s intentional
conduct rather or from its innocent mistake or accident during the

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manufacturing process. Such evidence may be probative regardless of
whether the advertising occurred outside the relevant time period. The
Court denies Plaintiff’s request to exclude this evidence categorically
subject to specific objections by Plaintiff as to any specific evidence.
5.

Evidence that DIANABOL® is Generic

Plaintiff also seeks to exclude all evidence relating to DIANABOL®
being generic for anything other than “dietary supplements, excluding
anabolic steroids.” (Id. at 20.) Defendants have asserted, among other
defenses, that Plaintiff’s DIANABOL® trademark is invalid because it is
a generic for an anabolic steroid. (Dkt. 215 at 4–5.) Plaintiffs argue this
evidence should be excluded because anabolic steroids are outside the
class of goods identified in the DIANABOL® registration and thus this
evidence has no relevance to the genericness inquiry. (Dkt. 212 at 20–
21.) The Court asked the parties at a pretrial conference to file a letter
brief regarding the issue of genericism, which the parties filed on April
28, 2021. (Dkts. 247; 248.)
The Court finds evidence related to whether DIANABOL® is
generic for an anabolic steroid to be relevant and admissible.

And

whether a given term is generic is a question of fact for the jury. Pods

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Enters., Inc. v. U-Haul Int’l, Inc., No. 8:12-cv-01479, 2015 WL 1097374,
at *5 (M.D. Fla. Mar. 11, 2015) (explaining that U-Haul introduced
several items of evidence suggesting that storage containers placed on
top of vehicles were generically called “pods,” but “the jury did not have
to accept that the use of the term ‘pod’ to refer to a roof-mounted
container on RVs described the same kind of product as the
PODS-branded containers”). The jury is entitled to know the market and
the conditions in which the product existed.

Accordingly, the Court

denies this motion.
6.

Evidence that the DIANABOL® Ingredient List is
False or Misleading

Plaintiff seeks to exclude all evidence relating to DIANABOL®’s
ingredient list being false or misleading, specifically arguing that
Defendants should not be permitted to introduce evidence that Plaintiff
failed to properly identify DHEA on the DIANABOL® ingredient list.
(Dkt. 212 at 21.)

The DIANABOL® label identifies the ingredient

“dehydroepiandosterone acetate.” (Id.) Defendants seek to admit two
excerpts from the official website of the Environmental Protection
Agency (“EPA”)—one describing the chemical characteristics of DHEA
and

the

other

describing

the
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chemical

characteristics

of

“dehydroepiandrosterone acetate” (“DHEA Acetate”). (Dkt. 215 at 20.)
Defendants intend to offer the EPA documents at trial to show DHEA
and DHEA Acetate are not the same compound and thus Plaintiff failed
to identify DHEA as an ingredient in DIANABOL®. (Id. at 21.) Plaintiff
contends this evidence is inadmissible because the evidence related to
chemical properties and molecular formulas requires expert testimony
and because it is irrelevant to Defendants’ false advertising and unclean
hands defenses. (Dkt. 212 at 21–22.)
The Court finds evidence relating to whether the DIANABOL®
ingredient list is false or misleading relevant to Defendants’ false
advertising and unclean hands defenses.

Whether there is an

undisclosed ingredient present in DIANABOL® is clearly at issue in this
case, and this evidence is directly relevant to that issue. But evidence
relating to the distinguishable chemical properties of DHEA and DHEA
Acetate, while relevant, is sufficiently complex to fall beyond the grasp of
an ordinary layperson. See Fed. R. Evid. 701; Burkhart v. R.J. Reynolds
Tobacco Co., No. 3:09-cv-10727, 2014 WL 12617550, at *8 (M.D. Fla. Apr.
30, 2014) (excluding layperson testimony as to the comparative addictive
properties of nicotine and other substances because such evidence “is not

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within the common experience of a layperson but is scientific or
specialized knowledge”).
Defendants may not use a website excerpt to establish facts that
require testimony from a qualified expert absent some foundation.
Accordingly, the Court will exclude the excerpts from the EPA website.
The Court will not exclude, however, testimony from a properly disclosed
and qualified expert relating to whether the ingredients listed on the
DIANABOL® product label are false or misleading, including as to the
difference (if any) between DHEA and DHEA Acetate. Alternatively,
Defendants can seek to admit this testimony from a lay witness, provided
they can provide the proper foundation. Two printouts from a website
with no explanation, however, is not permitted.
7.

References to Derege Lucas Rais Holdings, LLC’s
Trademark Applications

Plaintiff seeks to exclude all evidence relating to Derege Lucas Rais
Holdings, LLC’s (“DLRH’s”) application for the trademark “Dianabol”
and “Anavar” for “dietary and nutritional supplements,” both of which
the PTO denied, inter alia, based upon a likelihood of confusion with
Plaintiff’s DIANABOL® and ANAVAR® trademarks. (Dkt. 212 at 23.)
Defendants seek to admit this evidence to show that the Plaintiff’s
29

DIANABOL® trademark is generic. (Dkt. 215 at 5–6.) Plaintiff argues
that the evidence lacks probative value and is irrelevant and confusing.
(Dkt. 212 at 23–24.)
The Court finds evidence regarding the DLRH trademark relevant
to Defendants’ genericism defense and the jury is entitled to consider it,
as previously addressed herein. The Court denies this motion.
8.

A Picture of Mr. Wheat with Cash

Plaintiff seeks to exclude a photo of Mr. Wheat posing with cash.
Defendants consented to this exclusion at a pretrial conference on April
21, 2021. Accordingly, the Court grants this motion.
B.

Defendants’ Motion in Limine

Defendants seek to exclude reports of non-party product testing
performed by ABC Testing and disclosed by Plaintiff after the close of
discovery. (Dkt. 213 at 5.) Plaintiff intends to use the testing reports to
refute Defendants’ claim that Plaintiff intentionally spiked DIANABOL®
with steroids, as the reports reflect trace amounts of androstenedione in
twelve third-party products which also contain DHEA. (Dkt. 214 at 24–
25.) Discovery in this matter closed on June 30, 2017. On December 18,
2017, Plaintiff filed its response to Defendants’ summary judgment
motion, which included ABC Testing’s results. (Dkt. 163-3.) The report
30

indicates that ABC Testing received the supplements to be tested on July
27, 2017 and issued its report on August 2, 2017. (Id.) All of this after
discovery ended.
“If a party fails to provide information[,] . . . the party is not allowed
to use that information . . . at a trial, unless the failure was substantially
justified or is harmless.” Fed. R. Civ. P. 37(c)(1). Here, the testing of the
products and subsequent issuing of the report occurred a month after the
close of discovery. The report was then not disclosed until almost six
months after discovery ended. Plaintiff argues that its delayed disclosure
is justified because the testing was not completed until the close of
discovery, and thus there were no test results to disclose until after the
discovery period had ended. (Dkt. 214 at 24–25.)

The Court is

unpersuaded that Plaintiff’s own failure to conduct testing before the
close of discovery renders its untimely disclosure of the test results
justified.

To hold otherwise would render discovery deadlines

meaningless. And Plaintiff provides no explanation whatsoever for why
it waited until December 18, 2017 to disclose the report created on
August 2, 2017. Moreover, to permit Plaintiff now to introduce the report
at trial would not be “harmless” to Defendants. Accordingly, the Court

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grants this motion and precludes Plaintiff from presenting evidence of
ABC Testing’s analysis.
IV.

Conclusion
For the reasons set forth above, the Court GRANTS IN PART and

DENIES IN PART Plaintiff’s Motion in Limine (Dkt. 212) and
GRANTS Defendants’ Motion in Limine (Dkt. 213) regarding ABC
Testing. The Court will address the portion of Defendants’ Motion in
Limine seeking to exclude testimony from Linda Gilbert in a separate
order.
SO ORDERED this 24th day of May, 2021.

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