Note. The Ninth Circuit ruled in the government's favor in this case. United States v. Argent Chemical Laboratories, Inc., 93 F.3d 572 (9th Cir. 1996). This is the reply brief; see the Civil Resource Manual at 147 for the original brief.
In our opening brief, we showed that the government's seizure of Argent's drugs pursuant to the Federal Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. 334(a),(b), and the Supplemental Rules for Certain Admiralty and Maritime Claims ("Supplemental Rules") did not violate the Fourth Amendment.
As we explained, there is an exception to the Fourth Amendment (the "Colonnade-Biswell exception") applicable to searches of and seizures in commercial establishments doing business in pervasively regulated industries, where the regulatory scheme is justified by a substantial government interest, the search or seizure would further that interest, and the regulatory scheme provides a constitutionally adequate substitute for a warrant. See New York v. Burger, 482 U.S. 691, 700-03 (1987). The Fourth Amendment, as we showed, thus permits the government to randomly inspect businesses -- like Argent -- that are engaged in the manufacture, marketing and storage of human and animal drugs, as well as to act swiftly to protect the public by removing from the stream of commerce those drugs whose safety and effectiveness cannot be assured.
Argent's primary contention in response is that this case is controlled by the decision in United States v. An Article of Device * * * Labeled * * * "Theramatic", 641 F.2d 1289 (9th Cir. 1981) ("Theramatic I"), in which this Court overturned the government's in rem seizure of a medical device from a doctor's office, and by criminal cases in which in rem seizures have been held invalid. Brief for Defendant-Appellee ("Argent Br.") at 3-8. Argent also claims that businesses engaged in the manufacture and storage of veterinary drugs (as opposed to drugs for human consumption) are not pervasively regulated within the meaning of the Colonnade-Biswell exception. Id. at 8-11. Finally, Argent asserts that the Colonnade-Biswell exception does not apply where the government is not conducting a random inspection, but is aware of specific items that may be subject to seizure. Id. at 11-14. We reply briefly to each of these assertions.[FN1]
FN1. As a threshold matter, we note that throughout its responsive brief, Argent minimizes the burden it faces in demonstrating that the seizure provisions of the FDCA and the Supplemental Rules are unconstitutional. Congress has specifically provided in the FDCA that adulterated or misbranded drugs may be seized in accordance with procedures that "conform, as nearly as may be, to the procedure in admiralty." 21 U.S.C. 334(a), (b). Those procedures, as governed by the Supplemental Rules, provide that in actions for federal statutory violations, the clerk shall issue a warrant for arrest of the property "forthwith" upon the government's forfeiture complaint. Suppl. Rule C(3). Congress' actions in passing the FDCA's seizure provisions, and the Supreme Court's actions in approving the Supplemental Rules, see 28 U.S.C. 2072, 2074, are presumed constitutional. See Turner Broadcasting Sys., Inc.. v. FCC, 113 S. Ct. 1806, 1807 (1993) (Rehnquist, C.J.) (in chambers); United States v. Articles of Drug * * * WANS, 526 F. Supp. 703, 705 n.2 (D.P.R. 1981).
1. As explained in our opening brief (U.S. Br. at 15-16), Argent's reliance on this Court's decision in Theramatic I is misplaced.
In Theramatic I, this Court held that the government's seizure of a "diathermy machine" from the offices of a Honolulu neurosurgeon, Dr. Ralph B. Cloward, violated the Fourth Amendment. 641 F.2d at 1295. This Court acknowledged that the Supreme Court in Colonnade and Biswell had allowed "warrantless searches of businesses subject to pervasive and traditional regulation," but declined to apply the Colonnade-Biswell exception to the seizure before it, because "Biswell and Colonnade involved statutes specifically authorizing searches of firearms and liquor dealers, whereas the search at issue here was not part of any statutory program to inspect physician's offices * * * ." Ibid.
Theramatic I is thus easily distinguishable from the present case. Unlike the private physician in Theramatic I, whose practice is not generally regulated by the FDA, see Heckler v. Chaney, 718 F.2d 1174, 1179 & n. 13 (D.C. Cir. 1983), rev'd on other grounds, 470 U.S. 821 (1985); United States v. Evers, 453 F. Supp. 1141, 1149 (M.D. Ala. 1978), aff'd, 643 F.2d 1043 (5th Cir. 1981), Argent's operations are at every step subject to comprehensive and longstanding FDA oversight. 21 U.S.C. 301 et seq.; 21 C.F.R. 500-599.
Moreover, unlike the seizure at issue in Theramatic, which did not arise out of any "statutory program to inspect physician's offices," 641 F.2d at 1295, the seizure of Argent's drugs resulted directly from prior government inspections of Argent's facilities pursuant to the authority vested in the agency by express provisions of the FDCA. See 21 U.S.C. 374; United States v. Jamieson-McKames Pharmaceuticals, 651 F.2d 532, 536-39 (8th Cir. 1981), cert. denied, 455 U.S. 1016 (1982).
This point is crucial, for the Theramatic I Court limited its concerns to the "warrantless seizure of property * * * situated on private premises to which access is not otherwise available for the seizing officer," and distinguished warrantless seizures of "property resting in an open area or seizable without an intrusion into privacy." Id. at 1292 (quoting G.M. Leasing Corp. v. United States, 429 U.S. 338, 354 (1977) (emphasis added)). In this case, access to Argent's premises was "otherwise available" to the government under the governing statutory scheme, which authorizes inspection of businesses engaged in the manufacture, marketing, and storage of animal drugs without a judicial warrant. Argent thus cannot claim that the seizure of its drugs stemmed from an unlawful intrusion into privacy.
2. Argent's reliance on various decisions that have invalidated in rem seizures under statutes criminalizing illegal gambling, drug, or money laundering operations (Argent Br. at 3-5) is also misplaced. Contrary to Argent's suggestion, the unconstitutionality of such seizures has by no means been settled. See United States v. Daccarett, 6 F.3d 37, 49-50 (2d Cir. 1993), cert. denied, 114 S. Ct. 1294 (1994); United States v. TWP 17 R 4, 970 F.2d 984, 989 (1st Cir. 1992); United States v. Turner, 933 F.2d 240, 245 (4th Cir. 1991) (all upholding federal criminal seizures under the Supplemental Rules).
In any event, none of the cases upon which Argent's relies involved seizures from enterprises, like Argent, that do business in a closely regulated industry, and none had any occasion to discuss the Colonnade-Biswell exception. The decisions are therefore irrelevant to the issues raised by the seizures from Argent under the FDCA in this case.
Finally, the decisions cited by Argent involve seizures pursuant to statutes intended to punish and deter those involved in illegal activity by depriving them of the fruits of or property used in their crimes. By contrast, the government's goal in effecting a seizure under the FDCA is to protect American consumers by taking potentially dangerous or ineffective drugs off the market. Ewing v. Mytinger & Casselberry, 339 U.S. 594, 601 (1950). Thus, as the court recognized in United States v. Life Ins. Co. of Va., 647 F. Supp. 732, 740 (W.D.N.C. 1986), "the danger to the health of the public" that FDCA seizures address "makes [them] distinguishable" from cases involving criminal drug and gambling forfeitures. See also United States v. 38 Cases * * * Figlia Mia Brand, 99 F. Supp. 460, 463-64 (S.D.N.Y. 1951) (distinguishing FDCA seizures from forfeiture of vehicles used in transporting contraband goods).
3. Argent next claims that the veterinary drug industry, unlike the human drug industry, does not have the "long tradition of close government supervision" required for application of the Colonnade-Biswell exception. Argent Br. at 10 (citation omitted).
Argent is mistaken. Federal food and drug laws have long regulated the manufacture, marketing and storage of animal as well as human drugs. Thus, section 6 of the original Food and Drugs Act of 1906 defined "drug" to include "any substance or mixture of substances intended to be used for the cure, mitigation, or prevention of disease of either man or other animals." Act of June 30, 1906, ch. 3915, § 6, 34 Stat. 769 (emphasis added). And the FDCA, both as enacted in 1938 and in its current form, continues to apply to both human and animal drugs. See Act of June 25, 1938, ch. 675, § 201(g), 52 Stat. 1041 ("drug" includes "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals," as well as "articles (other than food) intended to affect the structure or any function of the body of man or other animals") (emphasis added); 21 U.S.C. 321(g)(1) (same). Indeed, Congress specifically addressed the regulation of animal drugs in the Animal Drug Amendments of 1968, Pub. L. No. 90-399, 82 Stat. 342. See also 21 U.S.C. 360b (governing new animal drug applications).
The FDA has for many years employed this statutory authority to regulate the manufacture, marketing and storage of animal drugs. See, e.g., United States v. John Dobry Mfg. Co., No. 1287 (N.D. Iowa Apr. 4, 1923), reprinted in U.S Dep't of Agric., Decisions of Courts in Cases Under the Federal Food and Drugs Act 1085 (1934) (guilty verdict in case of misbranded drugs intended to cure hog cholera and tuberculosis); United States v. 7 Jugs, Etc., of Dr. Salsbury's Rakos, 53 F. Supp. 746 (D. Minn. 1944); (upholding seizure of drugs intended to treat certain poultry diseases); United States v. 14/105 Pound Bags, More or Less, Mineral Compound, 118 F. Supp. 837 (D. Idaho 1953) (upholding seizure of drug intended to treat bloat in sheep and cattle); United States v. 18 Cases, Etc. "Barton's Cannibalism Remedy", Civ. No. 10-55 (D. Neb. June 26, 1956), reprinted in Vincent A. Kleinfeld & Charles W. Dunn, Federal Food, Drug and Cosmetic Act: Judicial and Administrative Record 1953-1957, at 73 (upholding seizure of drug intended to cure cannibalism in poultry). The regulation of animal drugs is thus plainly not, as Argent would have it (Argent Br. at 10), a matter of "relatively recent" federal concern.
Moreover, although the duration of federal regulation "has some relevancy," New York v. Burger, 482 U.S. 691, 705 (1987), "it is the pervasiveness and regularity of the federal regulation that ultimately determines whether a warrant is necessary * * *." Donovan v. Dewey, 452 U.S. 594, 606 (1981) (upholding warrantless inspection of stone quarries, which first became subject to federal regulation in 1966). Accord Rush v. Obledo, 756 F.2d 713, 719-20 (9th Cir. 1985) (upholding warrantless inspections of family day care homes). Thus, even if federal regulation of animal drugs were of recent vintage, the Colonnade-Biswell exception would still apply to this case, because there can be no dispute that under current law, the manufacture, storage and labeling of animal drugs is pervasively and regularly subject to federal oversight. See, e.g., 21 U.S.C. 351(a) (regulating drug manufacture), 351(b) (regulating drug strength and purity), 352(a), (b), (f), (g), (h), (p) (packaging and labeling), 360b (new animal drug approvals); 21 C.F.R. 500-599.
While the regulation of animal drugs may be "primarily motivated by economic considerations," (Argent Br. at 10), federal regulation is also driven by concerns for human safety, since drugs used in animals intended for human consumption can remain in animal tissue after processing and can be ingested by human consumers. See United States v. 9/1 KG Containers * * * Drug for Veterinary Use, 854 F.2d 173, 174 (7th Cir. 1988) ("FDA requires thorough experimentation to determine both the drug's effects on animals and whether its residues persist in the animals and enter the food chain"), cert. denied, 489 U.S. 1010 (1989); Diethylstilbestrol; Withdrawal of Approval of New Animal Drug Applications; Commissioner's Decision, 44 Fed. Reg. 54,852 (1979) (detailing human health effects of drug used in cattle and sheep). See also 21 U.S.C. 360b(d)(1)(I)(ii) (prohibiting approval of cancer-causing animal drugs except where "no residue" is found in any edible portion of the animal or in any food derived therefrom).
Argent also greatly overstates the differences between human and animal drug regulation. Argent Br. at 10. As courts have recognized, "the regulatory scheme for human and animal drugs are basically the same." United States v. Undetermined Quantities * * * Equidantin, 675 F.2d 994, 999 (8th Cir. 1982), cert. denied, 460 U.S. 1051 (1983); see also United States v. Algon Chemical, Inc., 879 F.2d 1154, 1155 (3d Cir. 1989); United States v. An Article of Drug * * * Entrol-C Medicated, 513 F.2d 1127, 1128 (9th Cir. 1975). Thus, manufacturers of animal drugs are not, as Argent suggests, relieved of their responsibility for demonstrating that animal drugs are safe and effective. Argent Br. at 10. On the contrary, a new animal drug application may not be approved unless there is sufficient information to determine that it is safe, 21 U.S.C. 360b(d)(1)(D), and substantial evidence, including well-controlled field investigations, that the drug is effective. Id. 360b(d)(1)(E); 360b(d)(3). See United States v. Articles of Food and Drug * * * Entrol-P, 518 F.2d 743, 746 (5th Cir. 1975). In any event, the relevant inquiry under the Fourth Amendment is not whether the federal government regulates animal drugs in exactly the same way as it regulates human drugs, but whether federal regulation of animal drugs is pervasive.
4. Finally, Argent contends that the Colonnade-Biswell exception "permits warrantless inspections pursuant to a statutory inspection program," but "does not authorize warrantless intrusions to seize specific, identified items." Argent Br. at 11. As explained in our opening brief (U.S. Br. at 16-17), nothing in the text of the Fourth Amendment or in the governing cases draws a distinction between warrantless searches and seizures. Indeed, as we noted, Colonnade and Biswell themselves involved suits for the return of property (liquor and firearms, respectively) that had been seized in the course of a warrantless inspection, but the Court drew no distinction between the searches and the seizures for purposes of its analysis. Ibid.
The fact that the seizure here was of identified items does not take the case out of the Colonnade-Biswell exception. On the contrary, the fact that specific items were seized of necessity imposes limits on the scope of any intrusion into privacy that are not necessarily present in the ordinary inspection, which can involve government examination of an entire commercial premises. U.S. Br. at 17-18 n.5.
Argent's argument also turns governing principles upside down. Under Argent's view, the government does not need a warrant to enter into and inspect a regulated commercial establishment when it has no particularized reason to suspect any noncompliance with regulatory obligations, but the government must obtain a warrant when, as here, it has specific information regarding regulatory noncompliance. But the fact that the government has identified specific items subject to seizure lessens any intrusion on Argent's Fourth Amendment expectation of privacy, thereby strengthening the government's ability to act without a judicial warrant.[FN2]
FN2. In Theramatic I, this Court noted that the FDA "had a specific target in mind" in seizing Dr. Cloward's diathermy machine. 641 F.2d at 1294. In concluding that the Colonnade-Biswell exception did not apply, however, the decision relied upon this Court's determination that the government's search was not "part of any statutory program to inspect physician's offices." Id. at 1295. See p. ___ supra.
Moreover, Argent's argument is inconsistent with the result in Biswell, which involved the seizure of specific firearms discovered as the result of a warrantless government inspection. United States v. Biswell, 406 U.S. 311, 312-13 (1972). The government did not obtain a warrant once the inspection had uncovered the items subject to seizure. Yet, relying on the same principles of pervasive regulation justifying the warrantless inspection, the Court upheld the warrantless seizure as "not unreasonable under the Fourth Amendment." Id. at 317. Biswell thus supports the proposition that once the government has conducted a lawful inspection, it need not obtain a warrant simply because it has, as a result of the inspection, identified specific items subject to seizure.
Argent also contends that forcing the government to obtain a warrant would not "have unduly hampered the [government] in this case," observing that approximately three months elapsed from the time Argent's facilities were last inspected until the government seized its drugs. Argent Br. at 15. But Argent has made no showing that such a period was unreasonable, given the administrative review every FDA seizure action undergoes, see U.S. Br. at 24-25, the limits to the enforcement resources of the government, and the issues raised by its case.
More important, the length of time elapsed between inspection and seizure in a particular case is irrelevant to the issue of whether the government's actions are protected by the Colonnade-Biswell exception to the warrant requirement. Because Argent does business in a pervasively regulated industry, substantial government interests are advanced by warrantless seizures of drugs whose safety and effectiveness cannot be assured, and the Supplemental Rules provide a constitutionally adequate substitute for a judicial warrant, the government is not required to obtain such a warrant, whether it seizes drugs in the course of an inspection or three months later.
In sum, as Congress has long recognized, where the safety and effectiveness of the nation's therapeutic drugs are concerned, government must be vested with the power to proceed swiftly to protect the public's well-being. In this case, the because of Argent's failure to conform to good manufacturing practices, the government determined that the safety and effectiveness of Argent's drugs could not be assured, and thus the drugs should be removed from the marketplace. As shown above, that action was entirely consistent with Argent's Fourth Amendment expectations, and the district court thus erred in overturning the government's seizure in this case.
For the foregoing reasons, as well as those contained in our opening brief, the district court's order quashing the government's warrant for arrest should be reversed, and the case remanded to the district court for further proceedings on the government's complaint for forfeiture.
FRANK W. HUNGER Assistant Attorney General
KATRINA C. PFLAUMER United States Attorney
DOUGLAS N. LETTER (202) 514-3602
OF COUNSEL: GERALD C. KELL (202) 514-1586 MARGARET JANE PORTER Chief Counsel JACOB M. LEWIS (202) 514-5090
NEAL B. PARKER Attorneys Assistant Chief Counsel Civil Division,Room 3167 U.S. Food and Drug Administration Department of Justice 5600 Fishers Lane 9th and Penna Ave. N.W. Rockville, MD 20857 Washington, D.C. 20530
[updated October 2008]
[cited in Civil Resource Manual 147]