Opposition Brief — Argent Chemical Laboratories, Inc. v. United States

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\o/ FEB 14 1997

| Supreme Court, U.S.

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No. 96-766 i

.

Gn the Supreme Court of the Gnited States

OCTOBER TERM, 1996

ARGENT CHEMICAL LABORATORIES, INC., ETC.,

PETITIONER

UNITED STATES OF AMERICA

ON PETITION FOR A WRIT OF CERTIORARI TO

THE UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

BRIEF FOR THE UNITED STATES IN OPPOSITION

WALTER DELLINGER

Acting Solicitor General

FRANK W. HUNGER

Assistant Attorney General

DOUGLAS N. LETTER

JACOB M. LEWIS

Attorneys

Department of Justice

Washington, D.C. 20530-0001

202) 514-2217

QUESTION PRESENTED

Whether the seizure of veterinary drugs pursuant

to a warrant for arrest in rem issued by the district

court in conformity with the procedures outlined in

the Federal Food, Drug, and Cosmetic Act and the

Supplemental Rules for Certain Admiralty and Mari-

time Claims, after an uncontested warrantless in-

spection of petitioner’s premises, violates the Fourth

Amendment.

(I)

TABLE OF CONTENTS

Page

FR EE ee ae 1 "

an Se a 1

Statement ............ Suuseenuseenvetabeseoesebesetoadneseeeseeseessesonsebonces l

ETE 5

STII siitiessichltthidianantlisestestitnaeadeecseackdecaavievecencseeveeeees 14

TABLE OF AUTHORITIES

Cases:

Colonnade Catering Corp. v. United States, 397

ER 3, 5, 6, 1

Donovan v. Dewey, 452 U.S. 594 (1981) .............. 5, 9,

Ewing v. Mytinger & Casselberry, Inc., 339 U.S. 594

SUITE diliiladuivsnidbadnseiesintniaubisiantadbednensenesteceessecseecenes 7,10

G.M. Leasing Corp. v. United States, 429 U.S. 338

TET Seliicidibidninseebnenenteeseubageccteecessteinbcebrterecceseccoveees 5

Horton v. California, 496 U.S. 128 (1990) ............... 7

Katz v. United States, 389 U.S. 347 (1967) ............. 6

Minnesota v. Dickerson, 508 U.S. 366 (1993) .......... 6

New York v. Burger, 482 U.S. 691 (1987) .......... 4, 5, 6,

8, 9, 13

S & S Pawn Shop, Inc. v. City of Del City, 947 F.2d

es 13

See v. City of Seatlle, 387 U.S. 541 (1967) ......cccccc0c. 5

Skinner v. Railway Labor Executives’ Ass’n,

EEE ncn ee a 6-7, 9

National Treasury Employees Union v. Von Raab,

REE. Ea Re 10-11

United States v. 9/1 KG Containers, 854 F.2d 173

(7th Cir.1988), cert. denied, 489 U.S. 1010 (1989) .... 8

United States v. Biswell, 406 U.S. 311 (1972) ......... 3, 5,

6, 12

United States v. Device, Labeled “Theramatic”,

Re We BAP COE Ge BURT) cocececceccccecccnccsceccooceeeees 14

IV

Cases—Continued: Page

United States v. Dotterweich, 320 U.S. 277 (1943) .. 9

Unied States v. Edwards, 415 U.S. 800 (1974) ........ 12

United States v. Jacobsen, 466 U.S. 109 (1984) .... 12

United States v. Jamieson-McKames Pharmaceu-

ticals, Inc., 651 F.2d 532 (8th Cir. 1981), cert.

ORS BO Oe 7

Winters v. Board of County Commissioners, 4 F.3d

848 (10th Cir. 1993), cert. denied, 114 S. Ct. 1539

COED ccincnicincctabidedinesibaininGhetissiitadcetnliiensinaiictsaenien 13

Wisniewski v. United States, 353 U.S. 901 (1957) ... 14

Constitution, statutes, regulation and rules:

U.S. Const. Amend. IV .............. 3, 5, 6, 7, 10, 11, 12, 13

Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301

et seq.: ™

Be Fes SD .nccctecciscnsvsadinectarsententctcianadinell 2

Fe Felis ME ciliscttchicssascctcnttntessdsicdiininiaiaieabesdiieeia 7,13

Se UE ee NEED cccninsosdtnburasentctivecepuduins 2, 9, 10

IEC TED” aiinsicicciieittiaiieenainentitenieametniniaunie 2,9

iiss ae See 10

EE, TED susiisiniicnsscutiinntanvenemmianantnaudinidaanits

Tk. SER CIIIIEEIED ncessbicsuessenmsepennebedenietinoniies

Be Mn MITE a hiss ccterennenesnniitiicanndieiasaieissctionaiaiaie

Oe ia ia

Be Re IIE ccccansnacceneessdenmmusasidccospaiasticesbaneuaniaies

Se TER IED kcitianecasovenisddbtdernietaidobiaiestbentinnen

BF a ee IEE siiiscccdhicerentictnckaceibinanciedetiiiticanbeantins

FD Pe Sttlericinicstsabiccisiniccctinnpticcinndunandiioes

Bt | FS a SE rE SEE Sy ee

i es ED chiseiniviciiiensidveilibiibeniamesiaiietibitiatanaie

Oe RD Giiciinintcaciidesiiennieiienenslidiaehaiend 7

Bs kN ERR ES aN ee

Admiralty Suppl. R.:

a

Rte SEE NRE RCI FO, Se Ni ann PE ay

ee

CeHAININIIVANANSIwOA

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ee ee a nee

Rules—Continued:

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RRL Ee iat sett ee ae I « ccitausmmbakoniets

RE PE AR tae PS PRL aE RENN Ma EP ECO Re

Miscellaneous:

FDA Regulatory Practices Manual, Ch. 6 (Aug.

1995)

COCO EEE EEE EEE EEE EEE H EEE EEE EEE HEE E EEE EEE EEEEEEHEE EEE

Page

2, 10

2,3

10

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In the Supreme Court of the Gnited States

OCTOBER TERM, 1996

No. 96-766

ARGENT CHEMICAL LABORATORIES, INC., ETC.,

PETITIONER

Vv.

UNITED STATES OF AMERICA

ON PETITION FOR A WRIT OF CERTIORARI TO

THE UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

BRIEF FOR THE UNITED STATES IN OPPOSITION

OPINIONS BELOW

The opinion of the court of appeals (Pet. App. Al-

Al4) is reported at 93 F.2d 572. The opinion of the

district court (Pet. App. B1-B10) is unreported.

JURISDICTION

The judgment of the court of appeals was entered on

August 16, 1996. The petition for a writ of certiorari

was filed on November 14, 1996. The jurisdiction of

this Court is invoked under 28 U.S.C. 1254(1).

STATEMENT

1. The Federal Food, Drug, and Cosmetic Act

(FDCA) prohibits persons from adulterating medical

or veterinary drugs in interstate commerce, and from

selling or receiving such drugs that have been adul-

(1)

2

terated. 21 U.S.C. 331(a)-(c). The FDCA expressly

provides that any article of a drug that has been

adulterated “shall be liable to be proceeded against

while in interstate commerce, or at any time thereaf-

ter, on libel of information and condemned in any

district court of the United States * * * within the

jurisdiction of which the article is found.” 21 U.S.C.

334(a)(1). The statute further states that “[t]Jhe

article * * * proceeded against shall be liable to

seizure by process pursuant to the libel, and the

procedure in cases under this section shall conform,

as nearly as may be, to the procedure in admiralty.”

21 U.S.C. 334(b).

The Supplemental Rules for Certain Admiralty and

Maritime Claims (Supplemental Rules) “apply to the

procedure in statutory condemnation proceedings

analogous to maritime actions in rem, whether within

the admiralty and maritime jurisdiction or not.”

Admiralty Suppl. R. A. Under the Supplemental

Rules, an action in rem may be brought “[wJhenever a

statute of the United States provides for a maritime

action in rem or a proveeding analogous thereto.”

Admiralty Suppl. R. C(1)(b). Such an action is com-

menced by a complaint, which must “be verified on

oath or solemn affirmation,” and which must “de-

scribe with reasonable particularity the property that

is the subject of the action.” Admiralty Suppl. R.

C(2).

The Supplemental Rules require prior judicial re-

view of the complaint before the issuance of a warrant

for arrest of the property subject to the action, “[e]x-

cept in actions by the United States for forfeitures

for federal statutory violations.” Admiralty Suppl. R.

C(3). Where an action by the United States for a for-

feiture for a federal statutory violation is involved,

3

the Supplemental Rules explicitly provide that the

“the clerk, upon filing of the complaint, shall

forthwith issue a summons and warrant for the arrest

of the vessel or other property without requiring a

certification of exigent circumstances.” I[bid.

2. Petitioner Argent Chemical Laboratories is en-

gaged in the business of manufacturing and repackag-

ing veterinary drugs. Pet. App. A2. On July 29, 1994,

as the result of several FDA inspections of peti-

tioner’s facilities, the United States obtained a war-

rant for arrest of certain of petitioner’s drugs from

the deputy clerk of the United States District Court

for the Western District of Washington, in accor-

dance with the Supplemental Rules. Pet. App. A2-A3;

Pet. 3.

Petitioner filed a motion to quash the government’s

warrant on the ground that the seizure of its

drugs without a prior judicial warrant violated the

Fourth Amendment. Pet. App. A3. The district court

granted petitioner’s motion, concluding that, notwith-

standing the FDCA and the Supplemental Rules, the

government was required by the Fourth Amendment

to “obtain[{] a warrant based upon probable cause and

authorized by a detached judicial officer.” Jd. at B9.

It therefore ordered the seized drugs returned to

petitioner. Ibid.

3. The court of appeals reversed. Pet. App. Al-A14.

After reviewing this Court’s cases dealing with

Fourth Amendment protections applicable to “closely

regulated” businesses, see Colonnade Catering

Corp. v. United States, 397 U.S. 72 (1970); United

States v. Biswell, 406 U.S. 311 (1972), the court

concluded that the seizure of petitioner’s drugs did

not violate the Fourth Amendment. Pet. App. Al4.

4

The court first reviewed the extensive regulations

applicable to the preparation, packaging and promo-

tion of animal drugs (Pet. App. A6-A7), and concluded

that the veterinary drug industry is “closely re-

gulated” under Colonnade-Biswell. The court also

found that the other criteria for application of the

Colonnade-Biswell doctrine had been met: (1) the

government has a “substantial interest” in regulat-

ing the safety and effectiveness of animal drugs, (2)

warrantless searches and seizures further the regu-

latory scheme by deterring violations of regulatory

requirements and removing nonconforming products

from the marketplace, and (3) by advising the com-

mercial owner that the premises are subject to

search, while at the same time limiting the scope of

that search, the statute and the Supplemental Rules

“provide a constitutionally adequate substitute for a

warrant.” Jd. at A8-A9. See generally New York v.

Burger, 482 U.S. 691, 701-702 (1987).

The court of appeals rejected as “untenable” pe-

titioner’s contention that the Colonnade-Biswell

doctrine applies only to inspections and not to sei-

zures, observing that decisions of this Court have

applied the exception to “seizures of contraband dis-

covered during the unwarranted inspections,” and

have “approved the use of evidence seized in the

course of the inspection.” Pet. App. Al0. The court

also “attach[ed] no significance” to the fact that the

warrant for arrest of petitioner’s drugs was executed

“some time after” the FDA’s last inspection of peti-

tioner’s premises. Jd. at Al3. “If a random, unan-

nounced inspection does not violate [petitioner’s]

Fourth Amendment rights of privacy,” the court

stated, “we see no reason why the unannounced exe-

cution of a warrant under the Supplemental Rules

5

would do so.” Jbid. In short, the court concluded,

because the seizure of petitioner’s drugs was from

“the premises of a closely regulated manufacturer”

and was “conducted within the regulatory scheme in

j the manner Congress has authorized,” there was “no

\ need to brigade the seizure with an inspection in

order to legitimize it.” Ibid.

ARGUMENT

The decision below is correct and does not conflict

with the decision of any other court of appeals. This

case thus does not warrant further review.

1. Although the Fourth Amendment’s protections

apply to commercial as well as residential premises,

see, ¢.g., See v. City of Seattle, 387 U.S. 541, 545-546

(1967), “a business, by its special nature and volun-

tary existence, may open itself to intrusions that

would not be permissible in a purely private context.”

G.M. Leasing Corp. v. United States, 429 U.S. 338,

353 (1977). Thus, a judicial warrant is not always

required when the government seeks to conduct a

search of a business “long subject to close super-

vision and inspection,” Colonnade Catering Corp. v.

United States, 397 U.S. 72, 77 (1970), or that has been

“pervasively regulated.” United States v. Biswell,

406 U.S. 311, 316 (1972).

The so-called Colonnade-Biswell exception to the

Fourth Amendment’s judicial warrant requirement

derives from the fact that owners of commercial prop-

| erty subject to comprehensive government super-

vision have a “reduced expectation of privacy,” New

y York v. Burger, 482 U.S. 691, 702 (1987), and “an

inspection program may in some cases be a neces-

sary component of federal regulation.” Donovan v.

Dewey, 452 U.S. 594, 599 (1981). Under the exception,

6

the government may conduct a search of a “closely

regulated” commercial business without a warrant if

three criteria are met. Burger, 482 U.S. at 702.

First, the regulatory scheme authorizing the war-

rantless inspection must be supported by a “sub-

stantial” government interest. Jbid. Second, war-

rantless inspections must be “necessary to further

[the] regulatory scheme.” Jbid. Third, “the statute’s

inspection program, in terms of the certainty and

regularity of its application, [must] provid[e] a consti-

tutionally adequate substitute for a warrant.” Jd. at

703.

The Colonnade-Biswell exception applies to sei-

zures as well as searches, as the court of appeals

recognized. Pet. App. Al0. Colonnade itself was a

suit for return of “seized liquor,” 397 U.S. at 72, and

this Court there took care to emphasize Congress’s

“broad authority to fashion standards of reasonable-

ness for searches and seizures” in the liquor indus-

try. Id. at 77 (emphasis added). Similarly, in Biswell,

the issue involved the admissibility of two unlicensed

firearms that had been seized during a warrantless

search. See 406 U.S. at 312. Moreover, the Fourth

Amendment is concerned with “reasonable expecta-

tions of privacy.” Katz v. United States, 389 U.S. 347,

361 (1967) (Harlan, J., concurring); see Burger, 482

U.S. at 699-701. In the present context, the intrusion

on an owner’s privacy expectations is no greater from

the government’s seizure of commercial goods than

from the government’s inspection of the same items.

See Minnesota v. Dickerson, 508 U.S. 366, 377 (1993)

(“The seizure of an item whose identity is already

known occasions no further invasion of privacy”); see

also Skinner v. Railway Labor Executives’ Ass’n,

489 U.S. 602, 618 n.4 (1989) (“It is not necessary to our

7

analysis * * * to characterize the taking of * * *

samples as a seizure * * *, for the privacy

expectations protected by this characterization are

adequately taken into account by our conclusion that

such intrusions are searches”).

2. The in rem seizure of petitioner’s drugs did not

violate the Fourth Amendment under the Colonnade-

Biswell principles. Businesses engaged in the manu-

facture, packaging and storage of human and animal

drugs plainly are “closely regulated” within the

meaning of the Colonnade-Biswell exception. United

States v. Jamieson-McKames Pharmaceuticals, Inc.,

651 F.2d 532, 537 (8th Cir. 1981), cert. denied, 455 U.S.

1016 (1982). The FDCA, as well as the FDA’s regula-

tions promulgated thereunder, regulate “virtually

every phase of the drug industry * * * from

packaging, labeling and certification of expiration

dates, to prior FDA approval before new drugs can be

marketed.” 651 F.2d at 537 (footnote omitted). See,

e.g., 21 U.S.C. 351(a) (regulating manufacture), 21

U.S.C. 351(b) (regulating strength and purity), 21

U.S.C. 352(a), (b), (f), (g), (h) and (p) (packaging and

labeling), 21 U.S.C. 355 (new drug approvals); 360b

! Of course, a seizure affects a claimant’s possessory inter-

ests in a way that an inspection does not. See Horton v.

California, 496 U.S. 128, 133 (1990). But a claimant’s posses-

sory interests in alleged contraband do not override the public’s

interest in having potentially hazardous or ineffective drugs

removed temporarily from the stream of commerce. See

Ewing v. Mytinger & Casselberry, Inc., 339 U.S. 594, 601

(1950). And the claimant is fully protected against being per-

manently dispossessed of its goods by the statutori)y-protected

opportunity to contest the government’s action for’ permanent

forfeiture. See 21 U.S.C. 334; Admiralty Suppl. R. C; Ewing,

339 U.S. at 598.

8

(new animal drug approvals); 21 C.F.R. Pts. 200-599.

As a company engaged in the manufacture, packaging

and storage of veterinary drugs, petitioner operates

in a business long subject to pervasive and

comprehensive government regulation. Pet. App. A7-

A8 & n.3

There can also be little doubt that the regulatory

scheme governing the drug industry furthers a sub-

stantial government interest. See Burger, 482 U.S.

at 702. Drugs intended to treat diseases in human

beings that are manufactured, packaged or stored

without proper safeguards pose an obvious health and

safety risk to those who use them, for in the absence

of compliance with regulatory standards, there can be

no assurance that the drug is safe for its intended

use, or “has the identity and strength, and meets the

quality and purity characteristics, which it purports

or is represented to possess.” 21 U.S.C. 351(a)(2)(B).

The government similarly has a substantial interest

in the safety and effectiveness of animal drugs since

unsafe or ineffective animal drugs pose a serious risk

to the health and safety of the animals for whom they

are prescribed. Indeed, unsafe or ineffective animal

drugs may pose a significant risk to human health,

when the diseases for which they are prescribed

affect animals destined for human consumption. See

United States v. 9/1 KG Containers, 854 F.2d 173, 174

(7th Cir. 1988), cert. denied, 489 U.S. 1010 (1989). In

short, as the court of appeals concluded, whether the

government’s interest in the safety and effectiveness

of animal drugs “is human health, economic health, or

beth * * * it is substantial.” Pet. App. A8.

The authority to seize adulterated goods without a

judicial warrant is also a necessary aspect of the

regulatory scheme governing the preparation, pack-

9

aging and storage of human and animal drugs. See

Burger, 482 U.S. at 709-710. A drug that has been im-

properly manufactured, packaged, or stored, or as to

which there is no documentation that regulatory

standards have been followed, poses an obvious risk to

the physical—and economic—health and safety of

those who would use it. Eliminating that threat is

not simply a matter of determining that a regulatory

violation has occurred, and imposing a penalty or

other sanction on the manufacturer. To eliminate the

threat to the public the offending drugs must be

removed from the marketplace. See Pet. App. Ag.

Drugs are easily sold, and there may be few means—-

apart from strict compliance with the FDCA’s re-

quirements—for a consumer to know whether the

drug he or she has purchased is safe and effective for

its intended use. See United States v. Dotterweich,

320 U.S. 277, 285 (1943).

Finally, the FDCA and the Supplemental Rules

provide a “constitutionally adequate substitute for a

warrant.” Burger, 482 U.S. at 711. See Pet. App. A9.

The FDCA expressly informs those who manufac-

ture, package or store human or animal drugs that

adulterated or misbranded drugs “shall be liable to

be proceeded against * * * on libel of information

and condemned” in federal district court, 21 U.S.C.

334(a)(1), in accordance with procedures that “con-

form, as nearly as may be, to the procedure in admi-

ralty.” 21 U.S.C. 334(b). Thus, petitioner could not

“help but be aware” that its drugs would be subject to

seizure if they proved adulterated. Dewey, 452 U.S.

at 600; see also Skinner, 489 U.S. at 622. The FDCA

also “narrowly define[s]” the scope of the seizures it

authorizes. See Burger, 482 U.S. at 711. Government

officials are empowered to seize only those drugs that

10

are “adulterated or misbranded,” 21 U.S.C. 334(a)(1),

terms that the statute defines in detail. See, e.g.,

21 U.S.C. 351, 352. Moreover, consistent with the

Fourth Amendment’s admonition that “the persons or

things to be seized” must be “particularly described,”

U.S. Const. Amend. IV, the Supplemental Rules

require that the complaint that commences an action

to enforce a forfeiture for federal statutory violations

“shall describe with reasonable particularity the

property that is the subject of the action and state

that it is within the district or will be during the

pendency of the action,” as well as stating “the place

of seizure.” Admiralty Suppl. R. C(2).? Like the

Fourth Amendment, moreover, the Supplemental

Rules provide that the government’s complaint for

forfeiture “shall be verified on oath or solemn affirma-

tion.” Ibid. Finally, a decision to commence a forfei-

ture action is not lightly undertaken. As the court of

appeals recognized, in most cases one of FDA’s 21

district offices, the appropriate FDA Center in head-

quarters, the agency’s Office of Enforcement, as well

as the Office of Chief Counsel and the Department of

Justice all review the merits of a case before a seizure

is recommended. Pet. App. A9-Al0 (citing FDA

Regulatory Practices Manual, Ch. 6, at 173-185 (Aug.

1995)). See Ewing, 339 U.S. at 599. “The discretion

of Government officials to determine what” items to

seize “is thus directly curtailed by the regulatory

scheme.” Dewey, 452 U.S. at 605; see also National

2 See also Admiralty Suppl. R. E(2)(a) (requiring the

complaint to “state the circumstances from which the claim

arises with such particularity that the defendant or claimant

will be able, without moving for a more definite statement, to

commence an investigation of the facts and to frame a respon-

sive pleading”).

1]

Treasury Employees Union v. Von Raab, 489 U.S.

656, 667 (1989).

3. Petitioner does not dispute that it engages in a

business that is so closely and comprehensively regu-

lated by the federal government as to fall within the

Colonnade-Biswell exception. Nor does petitioner

assert that the warrantless inspections of its prop-

erty violated the Constitution or that the govern-

ment’s actions in obtaining an in rem arrest warrant

were unauthorized by the FDCA. Petitioner’s sole

argument is that the government’s use of the FDCA’s

in rem arrest procedures in this case violated the

Fourth Amendment because, in its view of the cir-

cumstances of this particular case, those procedures

were not “necessary” to advance the government’s

interests, under the FDCA, because government offi-

cials “waited 94 days” after the last regulatory in-

spection before seizing petitioner’s drugs. Pet. 7.

The length of time elapsed between inspection and

seizure in a particular case is, however, irrelevant to

the issue of whether the government’s actions are

protected by the Colonnade-Biswell exception. “If

a random, unannounced inspection does not violate

[petitioner’s] Fourth Amendment right of privacy,”

there is “no reason why the unannounced execution of

a warrant under the Supplemental Rules would do

so.” Pet. App. Al3. Nor is there reason to adopt a

rule that would have the constitutional inquiry turn

on a case-by-case analysis of whether federal officials

will be able to obtain a judicial warrant without un-

dermining administrative enforcement. Petitioner is

willing to assume that “the regulatory inspections

may have been necessary to further the regulatory

scheme.” Pet. 7 (emphasis added). Since this Court’s

decisions make clear that the government can seize

12

contraband discovered in the course of such inspec-

tions, see Colonnade, 397 U.S. at 72; Biswell, 406

U.S. at 312, there is no basis on which to conclude

that a seizure subsequent to a warrantless inspection

invades Fourth Amendment interests in a manner

different from a seizure contemporaneous with a

warrantless inspection. Compare United States v.

Jacobsen, 466 U.S. 109, 120-121 (1984) (seizure of

contraband by law enforcement was reasonable where

prior to that seizure the owner’s “privacy interest

* * * had been largely compromised” by a private

search); United States v. Edwards, 415 U.S. 800, 806-

807 (1974). In short, as the court of appeals stated,

there is no need to require the government “to bri-

gade the seizure with an inspection in order to legiti-

mize it.” Pet. App. A13.

Petitioner also suggests that the subsequent sei-

zure was unreasonable because it was “particular-

ized.” See Pet. 7,9. But the fact that the government

has identified specific items subject to seizure limits,

rather than magnifies, the intrusion on petitioner’s

Fourth Amendment privacy expectations. Moreover,

petitioner’s suggestion is inconsistent with Biswell,

which upheld the seizure of specific firearms dis-

covered as the result of a warrantless government

inspection. Biswell, 406 U.S. at 312-313. Indeed, it

would be odd to conclude that the government does not

need a judicial warrant to enter into and inspect a

regulated commercial establishment when it has no

particular reason to suspect noncompliance with

regulatory ebligations, but that it must obtain such a

warrant when, as here, it has information that spe-

cific items are being held in violation of regulatory

requirements—especially in light of the Fourth

Amendment’s stated preference for particularity in

13

government searches and seizures. U.S. Const.

Amend. IV.

4. Petitioner also contends (Pet. 11-12) that the

decision below conflicts with the Tenth Circuit’s

reasoning in Winters v. Board of County Commis-

stoners, 4 F.3d 848 (1993), cert. denied, 114 S. Ct. 1539

(1994), which invalidated a police seizure of a stolen

ring from an Oklahoma pawn shop. The Winters

court, however, based its decision on its conclusion

that the seizure of the ring was the_result of

“pretextual” inspection of the shop, which failed to

give the police “a lawful right of access” to the seized

property. 4 F.3d at 854; compare Burger, 482 U.S. at

717 n.27.

In this case, by contrast, it is undisputed that the

seizure of petitioner’s drugs resulted from a lawful

administrative search of petitioner’s premises, pur-

suant to the FDCA and the Supplemental Rules,

which—unlike the Oklahoma statute in Winters—

expressly authorize seizures of adulterated drugs

without a judicial warrant. See 21 U.S.C. 334. In

addition, the consequences from the delayed seizure

of a ring are, to say the least, decidedly different from

those presented by the failure to seize drugs that may

be unfit or unsafe for their intended use.*

Petitioner also contends that the decision of the

court of appeals conflicts with its prior decision in

% The concerns expressed by the Tenth Circuit in S & S

Pawn Shop, Inc. v. City of Del City, 947 F.2d 432, 441 (1991)

(see Pet. 11)—a decision that actually upheld the facial con-

stitutionality of the Oklahoma pawnshop inspection scheme—

similarly related to allegations that specific pawnshop in-

spections “were conducted not as part of a pre-planned and

dispassionate administrative procedure but instead pursuant to

direct criminal suspicion.”

14

United States v. Device, Labeled “Theramatic”, 641

F.2d 1289 (9th Cir. 1981) (Theramatic I, which invali-

dated the warrantless seizure of an allegedly mis-

branded medical device from a doctor’s office under

the FDCA. As the court of appeals explained, how-

ever, the seizure in Theramatic I “was effectuated by

an impermissible invasion of the * * * right of

privacy” of a physician whose business (unlike that of

petitioner) was “not closely regulated by the FDA”;

thus “(t]he Colonnade-Biswell exception did not

apply” at all. Pet. App. All-Al2. And even if there

were an intracircuit conflict within the Ninth Cir-

cuit, the matter would be more appropriate for the

court of appeals, rather than for this Court, to re-

solve. See Wisniewski v. United States, 353 U.S. 901,

902 (1957).

CONCLUSION

The petition for a writ of certiorari should be

denied.

Respectfully submitted.

WALTER DELLINGER

Acting Solicitor General

FRANK W. HUNGER

Assistant Attorney General

DOUGLAS N. LETTER

JACOB M, LEWIS

Attorneys

FEBRUARY 1997