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United States v. Bioanue Laboratories Inc.

United States District Court, M.D. Georgia

March 30, 2018

UNITED STATES OF AMERICA, Plaintiff,
v.
BIOANUE LABORATORIES, INC., GLORIA D. RABER, and KELLY RABER, Defendants.

          ORDER

          MARC T. TREADWELL, JUDGE

         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 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.

         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 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) 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[3] 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.

         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 ...


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