Opinion
Civil Action No. 1:06-cv-0406-GET.
March 13, 2006
ORDER
The above-styled matter is presently before the court on:
1) Hi-Tech Pharmaceuticals, Inc.'s ("Hi-Tech") motion for leave to file excess pages [docket no. 4];
2) Hi-Tech's motion for preliminary injunction [docket no. 5].
On February 22, 2006, plaintiff filed a complaint for forfeiture of dietary supplement products and ingredients containing ephedrine alkaloids. The government contends that the products are liable to seizure and condemnation because they are adulterated within the meaning of the Federal Food, Drug and Cosmetic Act ("FDCA") 21 U.S.C. § 342 (f) (1) (A), by presenting a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling or, if the labeling does not discuss it, under ordinary conditions of use. On February 23, 2006, US Marshals entered Hi-Tech's premises and seized the defendant-products.
On February 27, 2006, Hi-Tech filed a statement of interest as the sole owner and one of the persons entitled to the seized property. On the same date, Hi-Tech filed a third-party complaint seeking declaratory judgment against the United States Food and Drug Administration ("FDA"); the Department of Health and Human Services ("HHS"), Andrew C. Von Eschenbach, M.D., Acting Commissioner of FDA; and Michael O'Leavitt, Secretary of HHS. Hi-Tech alleges that the FDA Rule banning the sale of dietary supplements containing ephedrine alkaloids violates FDA's statutory authority from the FDCA, as amended by the Dietary Supplement Health and Education Act of 1994 ("DSHEA"), and the Administrative Procedures Act ("APA"), Section 706 (2) (a) (c) Further, Hi-Tech alleges that the rule is arbitrary and capricious under the APA, and that the third-party defendants violated Hi-Tech's due process rights. On February 27, 2006, Hi-Tech also filed a motion for preliminary injunction seeking the return of the products seized on February 23, 2006, and a motion for leave to file excess pages in its motion seeking injunction.
Motion for Leave to File Excess Pages
Hi-Tech requests leave to file a brief in support of its motion for preliminary injunction that exceeds page limitations imposed by the Local Rules. Hi-Tech contends that the extra pages are necessary because the discussion includes complex issues of law and FDA regulatory authority.
Local Rule 7.1B requires that "any party opposing a motion shall serve the party's response . . . not later than ten (10) days after service of the motion," and further provides that, "[f]ailure to file a response shall indicate that there is no opposition to the motion." LR 7.1B, ND Ga. As of the date of this order, the government has not responded to Hi-Tech's motion for leave to file excess pages, which included a certificate of service. Accordingly, the court GRANTS AS UNOPPOSED Hi-Tech's motion for leave to file excess pages [docket no. 4].
Motion for Preliminary Injunction
This court may issue preliminary injunctions pursuant to Fed.R.Civ.P. 65(a). The court may issue a preliminary injunction, though the right to permanent relief is uncertain, in order to protect a party from irreparable harm and preserve the court's power to render a meaningful decision on the merits. Alabama v. U.S. Army Corps of Eng'rs, 424 F.3d 1117, 1128 (11th Cir. 2005). Because a preliminary injunction is issued before the case has been fully and fairly heard, the court must take great care to assure that it does not result in unwarranted harm to the defendant or the public. Id.
Accordingly, a district court may grant preliminary injunctive relief when the moving party shows that: (1) it has a substantial likelihood of success on the merits of the underlying case when the case is ultimately tried; (2) irreparable injury during the pendency of the suit will be suffered unless the injunction issues immediately; (3) the threatened injury to the movant outweighs whatever damage the proposed injunction may cause the opposing party; and (4) if issued, the injunction would not be adverse to the public interest.Id. The decision to issue a preliminary injunction lies within the sound discretion of the district court. Compact Van Equip. Co., Inc. v. Leggett Platt, Inc., 566 F.2d 952, 954 (5th Cir. 1978).
Hi-Tech argues that it can make a showing of each of the four elements required for a preliminary injunction. Hi-Tech citesNutraceutical Corp. v. Crawford, 364 F. Supp. 2d 1310 (D. Utah 2005), overturning the Rule relied upon by the FDA in seizing the products in order to show a high likelihood of success on the merits, and includes evidence of the economic effect such seizures will have on its business. In response, the government argues that this court lacks the jurisdiction to issue a preliminary injunction against the FDA requiring a return of seized products.
The court does not have unlimited jurisdiction to enjoin federal officials conducting a seizure action. In Southeastern Minerals, Inc. v. Harris, the Fifth Circuit Court of Appeals overturned a district court's order enjoining various federal officials charged with enforcing the FDCA from interfering with the manufacturing and marketing of a food additive. 622 F.2d 758 (5th Cir. 1980). Citing Ewing v. Mytinger Casselberry, Inc., 339 U.S. 594, 70 S. Ct. 870 (1950), the Fifth Circuit held that the district court had acted in excess of its jurisdiction because Congress specifically provided seizure actions for the speedy protection of the public. Id. at 763. In a footnote, the Fifth Circuit noted that Ewing expresses "a total and complete proscription of the district court's power to enjoin federal officials from acting upon that determination [of probable cause of violation] by seizing products or initiating enforcement proceedings under the act." Harris, at 763 n. 10.
The policy cited by the Supreme Court and the Fifth Circuit apply equally to the instant matter. Both courts based their decisions on the policy of permitting federal officials to seize allegedly adulterated products without the interference of the district court. "If the District Court can step in, stay the institution of seizures, and bring the administrative regulation to a halt until it hears the case, the public will be denied the speedy protection which Congress provided by multiple seizures . . . Congress weighed the potential injury to the public from misbranded articles against the injury to the purveyor of the article from a temporary interference with its distribution and decided in favor of the speedy, preventative device of multiple seizures. We would impair or destroy the effectiveness of the device if we sanctioned the interference which a grant of jurisdiction to the District Court would entail." Id., citingEwing at 601, 70 S. Ct. at 874.
Releasing seized property would also interfere with the Congressionally provided remedy of removing allegedly dangerous products from the market until a determination on the merits of whether the product is adulterated. Therefore, this court agrees with the Fifth Circuit that "[w]hen a complaint seeks forfeiture of articles of property alleged to be in violation of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 334(b), the United States is entitled to secure a warrant for seizure and to maintain its seizure of the property described until a seizing court hears the matter on the merits of the conflicting claims."U.S. v. Proplast II, 946 F. 2d. 422 (5th Cir. 1991); see In re US, 140 F.2d 19 (5th Cir. 1943).
Therefore, this court does not have the jurisdiction to release articles seized by the FDA until after it makes a determination on the merits. Consequently, it need not evaluate whether Hi-Tech made the necessary showing entitling it to a preliminary injunction. Further, even if this court did have jurisdiction to evaluate Hi-Tech's showing, the courts' deference to Congress's determination that the public's interest in the immediate removal of potentially dangerous products immediately removed from the market outweighs the distributor's interest precludes the court from finding in Hi-Tech's favor on the fourth element, that the injunction would not be adverse to the public interest. Accordingly, and for all the aforementioned reasons, Hi-Tech's motion for preliminary injunction [docket no. 5] is hereby DENIED. Consequently, Hi-Tech's oral request for a hearing on its motion is MOOT at this time.
Summary
1) Claimant Hi-Tech's motion for leave to file excess pages [docket no. 4] is GRANTED;
2) Hi-Tech's motion for preliminary injunction [docket no. 5] is DENIED. Hi-Tech's oral request for a hearing on its motion is therefor MOOT at this time.
SO ORDERED.