United States District Court, M.D. Georgia
T. TREADWELL, JUDGE
Gloria Raber and Kelly Raber have moved for relief from the
Court's order permanently enjoining the
Defendants. 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.
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 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)).
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.
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
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.
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.
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.
Defendants' Motions for Relief from Permanent
Standards of Review
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 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
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).
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.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) 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
evidence a “significant change in
circumstances”-either in factual conditions or in law.
Id. at 383-84; 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.
the parties dispute only over whether the first
requirement-significant change in circumstances-has been
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