Opinion ID: 597212
Heading Depth: 1
Heading Rank: 4

Heading: standard for issuing preliminary injunctions

Text: 14 The principal issue in this appeal is whether the district court applied the correct legal standard in denying the government's motion for preliminary injunction. Generally, to obtain a preliminary injunction, the moving party must show either (1) a combination of probable success on the merits and the possibility of irreparable injury or (2) that serious questions are raised and the balance of hardships tips in its favor. United States v. Odessa Union Warehouse Co-op, 833 F.2d 172, 174 (9th Cir.1987) (citing Benda v. Grand Lodge of the Int'l Ass'n of Machinists & Aerospace Workers, 584 F.2d 308, 314-15 (9th Cir.1978), cert. dismissed, 441 U.S. 937, 99 S.Ct. 2065, 60 L.Ed.2d 667 (1979)). These two formulations represent two points on a sliding scale in which the required degree of irreparable harm increases as the probability of success decreases. Id. (citing Oakland Tribune, Inc. v. Chronicle Publishing Co., 762 F.2d 1374, 1376 (9th Cir.1985)).
15 Both the government and Nutri-cology argue that the district court erred in determining the government's likelihood of success on the merits of its claim. The government contends that it established conclusively that Nutri-cology violated the FDCA. Nutri-cology, on the other hand, contends that its products cannot possibly be considered drugs or new drugs under the FDCA. 16 Essentially, the parties are requesting that we reach the merits. We decline to do so. We review here the denial of a preliminary injunction. Whether Nutri-cology's products are drugs or food has not been fully addressed or finally decided by the district court and is therefore not ripe for review. Los Angeles Memorial Coliseum Comm'n v. National Football League, 634 F.2d 1197, 1198, 1200 (1980). 17 In its preliminary determination regarding the merits of the government's claims, the district court applied the definitions of drug and new drug found in 21 U.S.C. § 321(g)(1)(B) and 21 U.S.C. § 321(p)(1). In addition, the district court accorded the FDA the deference appropriate to an agency entrusted with enforcing the provisions of the FDCA. California ex rel. Van de Kamp v. Tahoe Regional Plan Agency, 766 F.2d 1308, 1313 (9th Cir.1985); Hawaiian Elec. Co. v. United States Envtl. Protection Agency, 723 F.2d 1440, 1470 (9th Cir.1984). Nonetheless, the district court found that the government had made merely a colorable showing that Nutri-cology was violating the FDCA by marketing its products. We cannot say that the district court erred.
18 The government relies on our opinion in Odessa Union, 833 F.2d 172, when it contends that, because this is a statutory enforcement action, it was not required to make a showing of irreparable harm. We disagree. 19 In Odessa Union, the parties conceded that the FDCA was violated. 833 F.2d at 175, n. 3. We therefore found that the conventional requirement of showing the possibility of irreparable injury was inapplicable. Specifically, we held that [w]here an injunction is authorized by statute, and the statutory conditions are satisfied as in the facts presented here, the agency to whom the enforcement of the right has been entrusted is not required to show irreparable injury. Id. (emphasis added) (footnote omitted) (citing Navel Orange Admin. Comm. v. Exeter Orange Co., 722 F.2d 449, 453 (9th Cir.1983)). In Navel Orange, we did not require a showing of irreparable harm where two of the three corporate defendants admitted that they had not complied with the orders issued by the federal agency. 722 F.2d at 453. In Navel Orange, the evidence supported the conclusion that the government was likely to prevail on the merits. In American Fruit Growers v. United States, 105 F.2d 722, 735 (9th Cir.1939), a case relied on in Navel Orange, we found that an injunction was authorized solely upon a showing of a statutory violation. In American Fruit Growers, the defendant did not dispute the factual finding that it was violating the federal agency's order. 105 F.2d at 725. 20 In this case, the FDCA violation is substantially disputed, and has been disputed since 1982. The district court found that the government submitted sufficient evidence to survive a motion for a directed verdict, but did not submit sufficient evidence to show that it was likely to succeed on the merits of the case. July 19, 1991 Order at 7. 21 Thus, the government's showing did not reach the level of the showing in Odessa Union, i.e., of an undisputed statutory violation. Moreover, it did not even match the government's showing in Navel Orange, i.e., that it was likely to prevail on the merits. Consequently, the government is not entitled to a presumption, rebuttable or otherwise, of irreparable injury. 22 In statutory enforcement cases where the government has met the probability of success prong of the preliminary injunction test, we presume it has met the possibility of irreparable injury prong because the passage of the statute is itself an implied finding by Congress that violations will harm the public. Odessa Union, 833 F.2d at 175; United States v. Diapulse Corp., 457 F.2d 25, 28 (2d Cir.1972). Therefore, further inquiry into irreparable injury is unnecessary. However, in statutory enforcement cases where the government can make only a colorable evidentiary showing of a violation, the court must consider the possibility of irreparable injury. 23 Here, the government did not show that it would probably prevail on the merits. Therefore, it was not entitled to a presumption of irreparable injury. 24 Relying on language in Odessa Union, the district court gave the government the benefit of a rebuttable presumption of irreparable injury. This was error. However, the district court would have reached the same result had it not initially presumed irreparable injury. 25 Because the government failed to demonstrate any harm to consumers and because Nutri-cology submitted extensive evidence to the contrary, the district court did not abuse its discretion in finding that the government did not make the requisite showing of irreparable harm. The district court, moreover, did not abuse its discretion in denying the government's motions for preliminary injunction and for reconsideration. 26 AFFIRMED.