UNITED STATES OF AMERICA v. BIOANUE LABORATORIES INC et al
Filing
47
ORDER DENYING 32 Motion for Relief from Injunction re 27 Order; DENYING 42 AMENDED MOTION Amending 32 MOTION for Relief from Injunction re 27 Order; DENYING 36 Motion for Relief from Injunction re 27 Order; DENYING 37 Motion to Produce; and DENYING 41 Motion to Strike. Ordered by US DISTRICT JUDGE MARC THOMAS TREADWELL on 3/30/2018. (tlh)
IN THE UNITED STATES DISTRICT COURT
FOR THE MIDDLE DISTRICT OF GEORGIA
MACON DIVISION
UNITED STATES OF AMERICA,
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Plaintiff,
v.
BIOANUE LABORATORIES, INC.,
GLORIA D. RABER, and KELLY
RABER,
Defendants.
CIVIL ACTION NO. 5:13-CV-188 (MTT)
ORDER
Defendants Gloria Raber and Kelly Raber have moved for relief from the Court’s
order permanently enjoining the Defendants.1 Docs. 32; 42. The Defendants have also
filed various motions related to their request for relief from the injunction. See Docs. 36
(request to be “disjoined” from the injunction); 37 (request for production of the
telephone transcript); 41 (motion to strike the Government’s responses). For the
following reasons, the motions are DENIED.
I. BACKGROUND
On May 29, 2013, the Government filed a complaint for injunctive relief against
the Defendants, alleging that the Defendants violated various provisions of the Federal
Food, Drug, and Cosmetic Act (“the Act”) by misbranding and adulterating unapproved
1
The Rabers claim that BioAnue Laboratories, Inc. is defunct. Doc. 32 at 4. As used in this Order,
“Defendants” refers only to the Rabers.
new drugs and dietary supplements while selling them in interstate commerce. Doc. 1 ¶
1(a)-(e) (citing 21 U.S.C. § 331(a), (d), (k)).
On July 23, 2014, the Court granted the Government’s motion for summary
judgment. Doc. 26. In that Order, the Court concluded that (1) the Defendants violated
the Act because their products are “new drugs” that have not been approved by the
Food and Drug Administration (“FDA”) and are not generally recognized as safe and
effective; (2) even if the products were dietary supplements rather than drugs, the
Defendants “still have violated the law by not adhering to FDA regulations in their
manufacturing process and causing their food products to become ‘adulterated;’” and
(3) Defendant Kelly Raber acted in concert with BioAnue Laboratories, Inc. and Gloria
Raber when formulating BioAnue products. Id. at 12, 15.
The Court also entered an order permanently enjoining the Defendants from
selling any drug or dietary supplement unless and until certain requirements were met.
Doc. 27 ¶ 8. These requirements are listed in Paragraph 8 of the injunction. Id. ¶ 8(A)(J). Notably, the injunction states:
Unless otherwise ordered, all decisions specified in this Order shall be
vested in the discretion of FDA and shall be final. If contested, FDA’s
decisions under this Order shall be reviewed by the Court under the
arbitrary and capricious standard set forth in 5 U.S.C. § 706(2)(A).
Review shall be based exclusively on the written record before FDA at the
time the decision was made. No discovery shall be taken by either party.
Id. ¶ 23. The injunction also states that the Court would convene a hearing with the
parties to “discuss the disposition of the drugs and dietary supplements.” Id. ¶ 10. That
hearing was held on August 1, 2014, at which the Court advised the parties that the
inventory of the products “will remain secured and will not be relabeled.” Doc. 29. To
the Court’s knowledge, the Defendants’ products remain in the Defendants’ possession.
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Again, the Defendants allege BioAnue is defunct. Doc. 32 at 4. However, the
Defendants have placed in the record a letter from the FDA, which states that BioAnue’s
website, www.bioanuelabs.com, “redirects visitors to the website for BioAnue Health
Products (www.bioanuehealth.com), a company that has been in business ‘[s]ince
January 2016.’” Doc. 42-3 at 2. In its brief, the Government makes a similar
allegation—that BioAnue’s website is now www.bioanuehealth.com—which the
Defendants do not dispute. Doc. 35 at 3, 6.
On May 15, 2017, the Defendants filed a “Petition for Relief from Injunction.”
Doc. 32. In that petition, they argue that they complied with the requirements, at least
those they claim are possible to satisfy, set forth in the injunction. See generally id. On
August 9, 2017, after the Government responded to their initial petition, the Defendants
filed a “Second Request for Relief from Order of Permanent Injunction.” Doc. 42.
Therein, they argue that Federal Rule of Civil Procedure 60 provides a basis for
granting them relief from the injunction. Id. at 3.
II. DISCUSSION
A.
Defendants’ Motions for Relief from Permanent Injunction
1. Standards of Review
The order enjoining the Defendants provides that all decisions specified in the
injunction are vested in the FDA’s discretion and that these decisions, if contested, are
subject to an arbitrary and capricious standard of review under 5 U.S.C. § 706(2)(A).
Doc. 27 ¶ 23. This statutory standard of review is appropriate because, to secure relief
from the injunction, the Defendants must show that the FDA improperly rejected their
efforts to seek relief through administrative channels. In other words, the standard of
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review provided in the injunction is the same standard of review that courts apply in this
type of challenge to the FDA’s action. See, e.g., United States v. Livdahl, 356
F.Supp.2d 1289, 1295-96 (S.D. Fla. 2005) (noting that the FDA’s determination of
whether the defendants are in compliance with the order enjoining them from selling
drugs is reviewed under an arbitrary and capricious standard).
Under the arbitrary and capricious standard, which is highly deferential to the
agency decisionmakers, the Court’s role “is limited to determining whether [the FDA’s
decision] was made rationally and in good faith—not whether it was right.” Anderson v.
Ciba-Geigy Corp., 759 F.2d 1518, 1522 (11th Cir. 1985) (quotation marks and citations
omitted). If a rational basis exists for the agency decision, “it must be upheld as not
being arbitrary or capricious, even if there is evidence that would support a contrary
decision.” Jett v. Blue Cross and Blue Shield of Alabama, Inc., 890 F.2d 1137, 1140
(11th Cir. 1989). Thus, as the moving party, the Defendants must show not merely that
the record contains evidence to support their position but that the record is devoid of
reasonable evidence that would support the FDA’s decision to deny the expert reports.
See Tackitt v. Prudential Ins. Co. of America, 758 F.2d 1572, 1575 (11th Cir. 1985)
(noting there was a rational connection between the evidence presented and the
agency’s decision).
The parties assume that the standard of review is determined by Federal Rule of
Civil Procedure, specifically Rule 60(b)(5), which governs relief from an injunction.2
Docs. 35 at 4; 42 at 3; see Griffin v. Secretary, Florida Dept. of Corrections, 787 F.3d
1086, 1089 (11th Cir. 2015) (“The Supreme Court has made it clear that Rule 60(b)(5)
2
In fact, the parties do not discuss the arbitrary and capricious standard of review in their briefs. Both the
arbitrary and capricious standard and the standard pursuant to Rule 60 apply in this case.
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applies in ordinary civil litigation where there is a judgment granting continuing
prospective relief, such as an injunction. . . .”). Rule 60(b)(5) provides, in pertinent part,
that a party may obtain relief from an injunction when “it is no longer equitable that the
judgment should have prospective application, not when it is no longer convenient to
live with the terms of a consent decree.” Rufo v. Inmates of Suffolk Cnty. Jail, 502 U.S.
367, 383 (1992) (quotation marks omitted) (citing Rule 60(b)(5)). Accordingly, to modify
a court order, the movant has the initial burden to show by conclusive evidence3 a
“significant change in circumstances”—either in factual conditions or in law. Id. at 38384; see AIG Baker Sterling Heights, LLC v. American Multi-Cinema, Inc., 579 F.3d
1268, 1273 (11th Cir. 2009) (noting that to receive relief under Rule 60(b)(5) the
movants must produce conclusive evidence that they partially satisfied the judgment). If
this showing is made, then the Court must determine whether the proposed modification
“is suitably tailored to the changed circumstance.” Rufo, 502 U.S. at 383.
Here, the parties dispute only over whether the first requirement—significant
change in circumstances—has been met.4 The Supreme Court observed that a
significant change in circumstances can arise in any of at least three situations: (1)
“changed factual conditions make compliance with the decree substantially more
onerous” than was contemplated; (2) the decree “proves to be unworkable because of
unforeseen obstacles,” or (3) “enforcement of the decree without modification would be
3
At least one commentator has presumed this showing must be made by clear and convincing evidence.
See Roger S. Haydock & Jeffrey W. Stempel, Fundamentals of Litigation Practice § 31:2.7 (2017) (noting
a party attacking an injunction must demonstrate by a strong showing, “presumably by clear and
convincing evidence,” that the changed circumstances justify relief).
4
The Defendants only argue that there has been a significant change in factual conditions, not in law.
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detrimental to the public interest.” Johnson v. Florida, 348 F.3d 1334, 1342 (11th Cir.
2003) (quoting Rufo, 502 U.S. at 384-85).
Whatever standard is applied, the Defendants are not entitled to the relief they
seek—they have not established that the FDA’s actions are arbitrary and capricious and
they have not shown by conclusive evidence a significant change in circumstances.
2. Petition for Relief from Injunction
In their initial petition for relief, the Defendants argue they have complied with the
injunction, summarizing each provision of the injunction and providing underneath their
responses. Doc. 32 at 2-7. For example, they claim that they removed all labels from
their products and all information about their products from all websites and media
within their control. Id. at 3. To establish that they have complied with the injunction,
the Defendants allege that they hired an independent expert5 to inspect BioAnue’s
product labels, paperwork, facility, and manufacturing processes but the FDA arbitrarily
“denied and refused to accept his reports.” Id. However, the Defendants have only put
one of the expert reports, the report of a Dietary Supplement Expert, in the record to
support their allegation that the FDA arbitrarily denied that report. Doc. 38-9. To prove
their allegations regarding the other report, the report of a Labeling Expert, the
Defendants rely on a December 19, 2014 letter from the FDA, in which the FDA
explained at length why the FDA was denying both expert reports.6 See generally Doc.
30-1. Based on this record, it is clear the FDA had a rational basis for denying the
5
The Defendants retained the same person, Mr. Fucetola, to be their Labeling Expert and Dietary
Supplement cGMP Expert. Doc. 30-1 at 3.
6
The Defendants did not attach this document to their “Petition for Relief from Injunction” but rather
attached it to their letter filed with the Court on December 20, 2016, in which they requested the Court to
“intervene between the FDA and [them].” Doc. 30 at 1.
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Defendants’ expert reports, and the Defendants have not established by conclusive
evidence that a significant change in circumstances has occurred.
In the FDA’s response to the Defendants’ expert reports, the FDA states the
Labeling Expert’s “Preliminary Review” of the Defendants’ product labels and his
“Certification of Retained Expert Pursuant to Order for Permanent injunction of July 23,
2014” (“Expert Certification”) fail to comply with the requirements under Paragraph 8(C)
and 8(D) of the injunction. Doc. 30-1 at 2-3. Paragraph 8(C) states that the Labeling
Expert must perform a comprehensive inspection of all the Defendants’ product labels,
labeling, promotional materials, and any Internet websites owned or controlled by or
related to the Defendants. Doc. 27 ¶ 8(C). Paragraph 8(D)(iii) states that the expert’s
certification must provide “a full and complete detailed report of the results” of the
inspection. Doc. 27 ¶ 8(D)(iii).
The FDA determined that the Labeling Expert’s “Preliminary Review” was just
that, an initial assessment of the Defendants’ product labels. Doc. 30-1 at 3. The
Preliminary Review simply noted that the “labels need some work,” that the product
names may need to be “changed to a more neutral name,” and that the “product names,
at first look, present some problems, as health conditions are named.” Id. Further, the
“Expert Certification provided, without further detail, that [the expert] reviewed ‘the
labels, web sites, and literature’ and cross references the Preliminary Review.” Id.
(quoting the Expert Certification). The FDA determined that the Preliminary Review was
insufficient to constitute “a full and complete detailed report.” Based on the record, this
is a reasonable determination.
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The Defendants have also failed to establish compliance with Paragraph 8(D)(i)(ii) of the injunction. Id. Paragraph 8(D)(i)-(ii) require the Labeling Expert to certify in
writing to the FDA that he has conducted the inspection described in Paragraph 8(C)
and to certify that the Defendants have removed all claims from each of their product
labels, labeling, promotional materials, and websites that cause any of the Defendants’
products to be drugs. Doc. 27 ¶ 8(D)(i), (ii). The Defendants’ expert neither certified in
writing that he conducted the inspection nor certified that the Defendants have removed
all claims from their product labels. Doc. 30-1 at 3. Accordingly, the Court finds
reasonable the FDA’s decision to reject the alleged conclusions of the Defendants’
Labeling Expert.
The Court also finds reasonable the FDA’s decision to reject the conclusions of
the Defendants’ Dietary Supplement cGMP Expert. The FDA concluded that the
expert’s inspection of the facility and his report and certification failed to comply with
Paragraph 8(F) and 8(G) of the injunction. Doc. 30-1 at 4. Paragraph 8(F) requires the
Dietary Supplement cGMP Expert to perform a comprehensive inspection of the
Defendants’ “facility and the methods, processes, and controls that [the] Defendants
used to manufacture, prepare, pack, label, hold, and distribute dietary supplements and
the labeling for all of [the] Defendants’ dietary supplements. . . .” Doc. 27 ¶ 8(F).
Paragraph 8(G) states that the Dietary Supplement Expert must certify in writing to the
FDA that the inspection was conducted and provide, as part of the certification, “a full
and complete detailed report of the results” of the inspection. Id. ¶ 8(G).
Regarding the required comprehensive inspection, the Dietary Supplement
Expert conducted a “recorded visual inspection of the BioAnue facility via Skype.” Doc.
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30-1 at 3. The expert provided an internet address that allegedly linked to his Skype
audit, but the FDA was “not able to access the content.” Doc. 30-1 at 3. Moreover, the
FDA concluded that, even if the video was accessible, “a virtual inspection is insufficient
to meet the requirements of Paragraph 8(F)” because the expert “must be able to freely
inspect the BioAnue facility with full control over what he is or is not seeing.” Id. In the
end, the FDA determined that the remote Skype audit did not offer the expert the
“firsthand sensory experience necessary to adequately and comprehensively inspect
the physical conditions at the BioAnue facility.” Id. This determination is reasonable.
The FDA also concluded that the expert’s cGMP Audit report did not constitute
the “full and complete detailed report” required by Paragraph 8(G). Id. at 4. Indeed,
while the cGMP Audit report lists cGMP requirements set forth in 21 C.F.R. Part 111, as
the FDA points out, the expert merely “provide[d] summary, nonspecific, and unclear
‘Auditor Comments’ such as ‘Observed,’ ‘Per SOPs and GMP training,’ ‘See general
400+ page SOPs that were developed by the Company staff,’ and ‘Confirmed post
audit.’” Id.; see generally Doc. 38-9. The expert report also contains an “Audit
Evaluation” column with a list of items, “Acceptable, Not Acceptable,” “Not Observed,”
and “N/A” next to bubbles meant to be checked off. See generally Doc. 38-9. Certainly,
it is reasonable to conclude that these “Auditors Comments” and “Audit Evaluation” are
an inadequate means of evaluating the Defendants’ compliance with cGMP.7
In sum, the Court finds that the FDA’s conclusion that the Defendant’s expert
reports failed to establish compliance with the requirements of the injunction was not
7
The FDA also concluded that the Expert Certification, which is not in the record, did not “address all of
the items listed in paragraph 8(G).” Doc. 30-1 at 4. This is yet another reasonable basis for the FDA to
believe that the Defendants are not in compliance with the injunction.
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arbitrary and capricious. Accordingly, because the Defendants cannot show that they
have fully complied with the injunction, the Court need not address whether the
Defendants are in compliance with the other requirements listed in Paragraph 8.8
3. Second Request for Relief from Order of Permanent Injunction
In their second request for relief from the injunction, the Defendants argue that
Federal Rule of Civil Procedure 60(b)(5) provides a basis for granting them relief
because “circumstances have drastically changed since FDA’s inspection in 2012.”9
8
The FDA states in its December 19, 2014 letter that it “will inspect the BioAnue facility after the
Paragraph 8(A) through (H) requirements are complete.” Doc. 30-1 at 4.
9
The Defendants also argue that Rule 60(b)(3),(6), and Rule 60(d)(1),(3) are applicable to their request
for relief. Doc. 42 at 3. They are not. First, their request for relief under Rule 60(b)(3), a ground for relief
for fraud by an opposing party, is unavailable because it is untimely. See Fed. R. Civ. P. 60(c) (“A motion
under Rule 60(b) must be made within a reasonable time—and for reasons (1), (2), and (3) no more than
a year after the entry of the judgment or order or the date of the proceeding.”) (emphasis added). While
the Defendants could then rely on Rule 60(d)(3), which they do, to assert that judgment should be set
aside for fraud on the court, that assertion is not supported by clear and convincing evidence. See
Booker v. Dugger, 825 F.2d 281, 285 (11th Cir. 1987) (noting the movant has the burden to show by clear
and convincing evidence that there was fraud on the court). Though the Defendants claim the
Government engaged in fraudulent behavior when it used quotes from an alleged phone conversation
between an undercover FDA agent and Defendant Gloria Raber to show the Defendants’ noncompliance
with the injunction and thereafter could not produce the full transcript of the conversation when requested,
this is not evidence of fraud. Doc. 42 at 9. As the Government explains, the FDA did not transcribe the
telephone conversation, and the quotes used to support its opposition to the Defendants’ petition for relief
“were not intended in any way to serve as a ‘partial transcript’ (or any transcript).” Doc. 40 at 1-2. But
even if the Government did intend to use the quotes as a transcript, as discussed below, the Court did not
consider these quotes in ruling on the Defendants’ motions for relief from the injunction. The Defendants’
assertion that the “Summary Judgment granted to Plaintiff FDA in July 2014, was based upon fraudulent
evidence and claims” is also not supported by clear and convincing evidence. Doc. 42 at 9.
The Defendants also cannot obtain relief under Rule 60(d)(1). Rule 60(d)(1) states that a court may
“entertain an independent action to relieve a party from a judgment, order, or proceeding.” To the extent
the Defendants argue that the alleged fraud discussed above creates an independent action for relief, this
argument fails because they cannot show that (1) there was fraud, or (2) relief is required “to prevent a
grave miscarriage of justice.” Aldana v. Del Monte Fresh Produce N.A., Inc., 741 F.3d 1349, 1359 (11th
Cir. 2014) (quotation marks and citation omitted); see also United States v. Beggerly, 524 U.S. 38, 47
(1998) (holding that “an independent action [to relieve a party from a judgment] should be available only
to prevent a grave miscarriage of justice” and that the Government failing to thoroughly search its records
and make full disclosure to the Court does “not nearly approach this demanding standard”).
Finally, there is no relief under Rule 60(b)(6)’s catchall provision: “any other reason that justifies relief.”
Relief under this provision is only available under “sufficiently extraordinary circumstances.” See Galbert
v. West Caribbean Airways, 715 F.3d 1290, 1295 (11th Cir. 2013) (noting the movants’ attempt to raise
arguments that they failed to raise initially in their opposition to a motion to dismiss does not constitute
“sufficiently extraordinary circumstances to warrant Rule 60(b)(6) relief”). At best, the Defendants are
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Doc. 42 at 3, 8. Specifically, they list the following “changes” to show “it is no longer
possible to follow the demands of the Injunction:” (1) there is no manufacturing facility;
(2) there are no employees; (3) there are no raw products; (4) there are no finished
products; (5) there is no money or bank account; (6) there is no company; and (7)
Defendant Gloria Raber is “financially ruined and has no finances or credit with which to
construct the company she once oversaw and successfully operated.” Id. at 8.
This argument is difficult to understand. The injunction imposes obligations only
if the Defendants want to restart their business, either through BioAnue Laboratories,
Inc. or their apparently new entity, BioAnue Health Products, LLC. And the Defendant’s
expert reports clearly suggest their intent to relabel their products and do just that. If the
Defendants have no plans to market products regulated by the FDA, they have nothing
to be concerned about. If, on the other hand, they want to return to the dietary
supplement market, the continued need for the injunction is apparent, notwithstanding
BioAnue’s demise. In any event, the record does not establish that the Defendants are
“financially ruined,” except, possibly, to the extent that their illegal business operations
have been thwarted. That is not a change in circumstances that warrants relief from a
prohibition against further illegal activity.
No doubt, the injunction is inconvenient and bad for business. But the
Defendants’ business was bad. If the Defendants want to return to that business, they
must comply with the injunction. Again, a party may obtain relief under Rule 60(b)(5)
raising arguments that they should have raised initially, and in fact, for some, already did raise, when they
opposed the Government’s motion for summary judgment, such as “Unlawful Joining,” “Violation of Free
Speech,” “Violation of the Dietary Supplement Health and Education Act,” and “Targeted for Products that
Worked.” Doc. 42 at 3-8. Clearly, this attempt to raise these arguments does not constitute “sufficiently
extraordinary circumstances” to warrant relief under Rule 60(b)(6).
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when “it is no longer equitable that the judgment should have prospective application,
not when it is no longer convenient to live with the terms of a consent decree.” Rufo,
502 U.S. at 383 (emphasis added). Accordingly, the Defendants’ first and second
motion for relief from the injunction are DENIED.
B.
Defendants’ Other Motions
In addition to their motions for relief from the injunction, the Defendants have filed
three related motions: (1) a motion to be “disjoined” from the injunction (Doc. 36); (2) a
motion to produce a full telephone transcript (Doc. 37); and (3) a motion to strike the
Government’s response (Doc. 41). The Court will address these motions in turn.
In their “Request to be Disjoined in the Order of Permanent Injunction,” the
Defendants argue that Kelly Raber was unlawfully joined to the case because he “did
not work for Gloria Raber or her company, BioAnue Labs,” but rather “was an
independent writer, formulator, and international lecturer who had a separate website
dedicated to educating his readers about nutrition.” Doc. 36 at 2. They also argue that
under the Georgia Married Women’s Property Act of 1866, it is unlawful to join Gloria
Raber’s business to that of her husband because she has the legal right to own and
operate a separate business without her husband’s consent. Id.
Notwithstanding that married women have the right to own and operate separate
businesses, the Defendants are merely rehashing the arguments that their counsel had
raised at the hearing on the Government’s motion for summary judgment. Doc. 26 at
12. In its Order granting summary judgment to the Government, the Court determined
the argument that Kelly Raber was “merely a writer who enjoys expressing his thoughts
about BioAnue products” was frivolous because the Defendants admitted that Kelly
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Raber was responsible for formulating BioAnue products, his name was on the address
from which BioAnue products were shipped, he was a trustee and co-owner with Gloria
Raber of the trust that owned the trademarks under which BioAnue products were sold,
he communicated with customers on behalf of BioAnue, and he recorded lengthy video
lectures about the benefits of BioAnue products while BioAnue’s website address was
plastered across the screen.10 Id.
Thus, as the Government points out, because the Defendants are attempting to
raise an issue—whether the individual Defendants have been properly joined and
included in the injunction—that has already been decided by this Court, the Defendants’
request is barred by the law of the case doctrine. Doc. 39 at 4. “Under the law of case
doctrine, a legal decision made at one stage of the litigation, unchallenged in a
subsequent appeal when the opportunity existed, becomes the law of the case for future
stages of the same litigation, and the parties are deemed to have waived the right to
challenge that decision at a later time.” United States v. Escobar-Urrego, 110 F.3d
1556, 1559 (11th Cir. 1997) (quotation marks and citations omitted). This doctrine has
three exceptions, none of which applies in this case. The Defendants do not present
any evidence that was not already known to them over three years ago, do not describe
any change in controlling law, and do not show that the Court’s prior decision was
10
In their “Second Request for Relief from Order of Permanent Injunction,” the Defendants object to these
factual findings regarding Kelly Raber’s involvement, stating that their counsel “failed to make corrections
to the record” and “failed miserably especially during oral arguments.” Doc. 42 at 9. But rather than
making these alleged corrections to the record themselves, the Defendants decided to “suck it up and
follow the procedures outlined in the Injunction.” Id. at 2. In fact, the Defendants waited until three years
after the Court entered its order enjoining the Defendants to make the alleged corrections to the record.
Id. Notwithstanding this long delay to seek correction, as discussed below, the law of the case doctrine
bars the Defendants’ request to be “disjoined.”
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clearly erroneous. Id. at 1561. Accordingly, the Defendants’ “Request to be Disjoined
in the Order of Permanent Injunction” (Doc. 36) is DENIED.11
The Defendants’ remaining two motions merit little discussion. Their motion to
produce a full telephone transcript and motion to strike derive from a single incident that
occurred on May 30, 2017. Doc. 35-1 at 3. On that date, an undercover FDA agent
contacted Defendant Gloria Raber by telephone and asked whether some of the
BioAnue products were for sale. Id. In response, Defendant Gloria Raber allegedly
stated that the FDA “filed an injunction to stop the sale of [the Defendants’] products so
they aren’t currently available” and that with the “new administration,” the Defendants
are “hoping to make the products available again.” Id. at 3-4. The Government uses
these quotes in its response brief to show why the Defendants should not be granted
relief from the injunction. Doc. 35 at 7. The Defendants “object to the incomplete
sentence quotes” and argue that it is “unethical and unlawful to present only a partial
transcript in an argument against [them].” Doc. 37 at 1. They therefore request that the
Court order the Government to produce the entire telephone transcript and strike the
partial quotes and any reference to the quotes. Docs. 37 at 1; 41 at 1. However,
because the Court considered neither the quotes nor the Government’s responses
related to the quotes in denying the Defendants’ motions for relief from the injunction, it
is unnecessary to rule on the motion to produce and motion to strike. Accordingly,
these motions are DENIED as moot.
11
Even construing the Defendants’ request to be “disjoined” as a “Motion for Reconsideration” under
Local Rule 7.6 or a “Motion to Alter or Amend a Judgment” under Federal Rule of Civil Procedure 59(e),
that request would be untimely. See M.D. Ga. L.R. 7.6 (“[M]otions for Reconsideration shall be filed
within fourteen (14) days after entry of the order.”); Fed. R. Civ. P. 59(e) (“A motion to alter or amend a
judgment must be filed no later than 28 days after the entry of the judgment.”).
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III. CONCLUSION
For the foregoing reasons, the Defendants’ “Petition for Relief from Injunction”
(Doc. 32), “Second Request for Relief from Order of Permanent Injunction” (Doc. 42),
and “Request to be Disjoined in the Order of Permanent Injunction” (Doc. 36) are
DENIED. The Defendants’ “Request for Production of Documents” (Doc. 37) and
“Motion to Strike” (Doc. 41) are DENIED as moot.
SO ORDERED, this 30th day of March, 2018.
S/ Marc T. Treadwell
MARC T. TREADWELL, JUDGE
UNITED STATES DISTRICT COURT
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