Reply Brief Defending a Seizure Against an Attack Based on the Fourth
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
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.
F.2d at 1295. This Court acknowledged that the Supreme Court in
Colonnade and Biswell had allowed "warrantless
businesses subject to pervasive and traditional regulation," but
declined to apply the Colonnade-Biswell exception to
seizure before it, because "Biswell and Colonnade
statutes specifically authorizing searches of firearms and liquor
dealers, whereas the search at issue here was not part of any
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
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
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
4. Finally, Argent contends that the
exception "permits warrantless inspections pursuant to a statutory
inspection program," but "does not authorize warrantless intrusions
seize specific, identified items." Argent Br. at 11. As explained
opening brief (U.S. Br. at 16-17), nothing in the text of the
Amendment or in the governing cases draws a distinction between
warrantless searches and seizures. Indeed, as we noted,
and Biswell themselves involved suits for the return of
(liquor and firearms, respectively) that had been seized in the
of a warrantless inspection, but the Court drew no distinction
the searches and the seizures for purposes of its analysis.
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
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.
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
government did not obtain a warrant once the inspection had
the items subject to seizure. Yet, relying on the same principles
pervasive regulation justifying the warrantless inspection, the
upheld the warrantless seizure as "not unreasonable under the
Amendment." Id. at 317. Biswell thus supports the
proposition that once the government has conducted a lawful
it need not obtain a warrant simply because it has, as a result of
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
FRANK W. HUNGER
KATRINA C. PFLAUMER
DOUGLAS N. LETTER
OF COUNSEL: GERALD C. KELL
MARGARET JANE PORTER
Chief Counsel JACOB M. LEWIS
NEAL B. PARKER
Assistant Chief Counsel Civil
U.S. Food and Drug Administration Department
5600 Fishers Lane 9th and
Rockville, MD 20857 Washington,
[updated October 2008]
Civil Resource Manual 147]