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IV. LEGAL ISSUES
A. Specific Statutes Involved
1. Title 18, United States Code, Section 371 (conspiracy)
states in
pertinent part:
If two or more persons conspire . . . to commit any offense
against the United States . . . or any agency thereof in any manner
or
for any purpose, and one or more of such persons do any act to
effect
the object of the conspiracy, each shall be fined not more than
$10,000
or imprisoned not more than five years, or both.[FN26]
FN26. Pursuant to Title 18, United States Code, Section
3571(b)(3), an individual found guilty of a felony offense as
charged
under Counts 1 through 6 may be fined as much as $250,000 per
count.
2. Title 21, United States Code, Section 331 (prohibited
acts) states
in pertinent part:
The following acts and the causing thereof are
prohibited:
(a) The introduction or delivery for introduction into
interstate commerce of any . . . drug . . . that is adulterated or
misbranded.
. . .
(c) The receipt in interstate commerce of any . . . drug . .
. that is adulterated or misbranded, and the delivery or proffered
delivery thereof for pay or otherwise.
. . .
3. Title 21, United States Code, Section 333(b) (penalties
for violations of Section 331)[FN27] states in pertinent
part:
Notwithstanding the provisions of subsection (a) of this
section, if any person . . . commits such a violation [a violation
of
section 331] with the intent to defraud or mislead, such person
shall be
imprisoned for not more than three years or fined not more than
$10,000,
or both.[FN28]
FN27. Effective July 22, 1988, 21 U.S.C. § 333(b)
was
recodified as 21 U.S.C. § 333(a)(2).
FN28. See footnote 27,
supra.
4. Title 21, United States Code, Section 321 (definitions)
states in pertinent part:
For the purposes of this chapter--
(g)(1) The term "drug" means . . . (B) articles intended for
use in the diagnosis, cure, mitigation, treatment, or prevention of
disease in man or other animals; . . .
. . .
(w) The term "new animal drug" means any drug intended
for
use for animals other than man . . .
(1) the composition of which is such that such drug
is not
generally recognized, among experts qualified by scientific
training and
experience to evaluate the safety and effectiveness of animal
drugs, as
safe and effective for use under the conditions prescribed,
recommended,
or suggested in the labeling thereof; . . . .
5. Title 21, United States Code, Section 351 (adulterated
drugs)
states in pertinent part:
A drug . . . shall be deemed to be
adulterated--
(a) . . . (5) if it is a new animal drug which is
unsafe
within the meaning of section 360b of this title . . .
.
6. Title 21, United States Code, Section 360b (unsafe new
animal
drugs) states in pertinent part:
(a)(1) A new animal drug shall, with respect to any
particular use or intended use of such drug, be deemed unsafe for
the
purposes of section 351(a)(5) . . . of this title unless--
(A) there is in effect an approval of an application
filed
pursuant to subsection (b) of this section with respect to such use
or
intended use of such drug . . . .
7. Title 21, United States Code, Section 352 (misbranded
drugs) states in pertinent part:
A drug . . . shall be deemed to be misbranded--
. . .
(b) If in package form unless it bears a label containing
(1) the name and place of business of the manufacturer, packer, or
distributor . . . .
. . .
(f) Unless its labeling bears (1) adequate directions for
use . . . .
B. Elements of the Offense
1. Count One
The crime of conspiracy as charged under Count 1 of the
Indictment
has four essential elements, which are:
One, in or about December 1985, two or more persons
knowingly
and willfully reached an agreement or came to an understanding to
violate, with intent to defraud or mislead, the Food and Drug Act
in at
least one of the ways described in the Indictment.
Two, the defendant voluntarily and intentionally joined
in
the agreement or understanding, either at the time it was first
reached
or at some later time while it was still in effect;
Three, at the time the defendant joined in the agreement
or
understanding, he knew the purpose of the agreement or
understanding;
and
Four, while the agreement or understanding was in
effect, and
after September 16, 1987,[FN29] person who had joined in the
agreement
knowingly did at least one of the "overt acts" described in the
Indictment in furtherance of the agreement or understanding.
FN29. To not be barred by the statute of limitations,
the
government must prove that one or more overt act occurred within
five
years of the date of indictment, which in this case would be after
September 16, 1987. See United States v.
Alfonso-Perez,
535 F.2d 1362 (2d Cir. 1976).
2. Counts 2-6
The crimes charged in Counts 2 through 6 of the Indictment, the
introduction or delivery for introduction into interstate commerce
of
animal drugs that were misbranded, each have three essential
elements,
which are:
One, on or about the date given, the defendant
introduced or
caused to be introduced into interstate commerce an animal
drug;Two, the drug was "misbranded" in that its labeling
failed
to bear adequate directions for use; and
Three, the defendant acted with the intent to defraud or
mislead.
C.XXXXXXX's Liability Under These Principles
XXXXXXXX's liability for the conspiracy is plain. Two of his
black
market sources for the bulk drugs, both of whom have pleaded guilty
to
charges in connection with their own distribution of bulk animal
drugs,
will testify that the defendant was a knowing and willing
participant in
a scheme to: (1) with the intent to defraud and mislead, acquire
and
distribute new animal drug products that had not been approved for
use
by the FDA (and were therefore adulterated, see 21 U.S.C.
§
351(a)(5)); and (2) with the intent to defraud and mislead, acquire
and
distribute bulk animal drugs that did not bear proper labeling
and/or
adequate directions for use (and were therefore misbranded,
see
21 U.S.C. §§ 352(b)(1), 352(f)(1)). Similarly, the
defendant's
customers will testify as to the defendant's role in the sale of
these
same drugs.
The proof is equally compelling as to the defendant's
culpability as
to Counts 2-6. In support of each count, the defendant's customer,
a
veterinarian in Viborg, South Dakota, and the veterinarian's
employees
will testify as to the nature of the receipt of each identified
bulk
animal drug from the defendant. This testimony will include a
description of the product received, including its general
appearance,
and the fact that none of the drugs bore adequate directions for
use.
This testimony will be corroborated by, among other things, the
coded
invoices supplied by the defendant along with the associated
cancelled
checks from the customer to the defendant.
Moreover, the defendant's furtive conduct designed as it were
to
evade FDA scrutiny is more than ample to establish his felonious
intent
to defraud or mislead. The defendant's conduct, as described above,
rises easily to the level found to support felony convictions in
United States v. Arlen, supra, and United States
v.
Bradshaw, supra. In Arlen, the Fifth Circuit held
that
a defendant who took "active steps to avoid detection and
regulation by
the FDA" had the requisite intent to defraud or mislead to support
a
felony conviction.[FN30] Arlen, 947 F.2d at 144. Similarly,
in
Bradshaw, the Eleventh Circuit upheld a defendant's felony
convictions where the government's proof of intent to defraud or
mislead
consisted of acts of deception directed to evade FDA and state
enforcement authorities. Bradshaw, 840 F.2d at 873-75.
Recognizing that the overriding purpose of the FDCA is "consumer
protection -- the protection of the public against any misbranded
or
adulterated food, drug, device, or cosmetic," the Eleventh Circuit
concluded that a defendant who "misled . . . governmental agencies,
thereby frustrating their efforts to protect the public," was
properly
convicted.[FN31] Id. at 874.
FN30. In Arlen, the defendant was careful not to
generate or maintain any records of his steroid dealings, stopped
accepting blank money orders because they would create a record,
rented
a private postal box under a fictitious name, and used fake names
and
addresses when mailing steroid packages. Id., 947 F.2d at
143-44.
FN31. Among other things, the defendant in
Bradshaw
engaged in the following acts: he moved from state to state
frequently,
used mail drops rather than his home address when mailing drugs to
customers, used false names, mislabeled packages as vitamins, and
discussed "methods of avoiding detection with . . . customers."
Id. at 873.
D.Anticipated Defenses
The government does not anticipate that XXXXXXXX will contest
the
government's proof that he sold the various specified products on
the
dates alleged. Nor does the government believe that XXXXXXXX will
seriously contend that the products were labelled properly under
the
law. Nor does the government believe that XXXXXXXX will raise a
serious
challenge to the evidence establishing that he bought products from
black market sources and that he subsequently distributed those
products
to his customers.
Rather, the government anticipates that the defendant may make
three
arguments as to the substantive counts. First, the defendant may
argue
that the products he acquired and distributed were bulk chemicals,
not
drugs. Second, the defendant may assert that the distribution of
the
bulk drugs to veterinarians was lawful. And third, the defendant
may
concede that he illegally distributed bulk new animal drugs
(thereby
confessing misdemeanor liability), but contend that he did not have
the
requisite intent to defraud or mislead to support a felony
conviction.
None of these defenses are valid.
1.The bulk products were drugs
The first anticipated defense fails in light of the facts and
applicable law. A "drug" is defined as any "articles intended for
use in
the diagnosis, cure, mitigation, treatment, or prevention of
disease in
man or other animals . . . ."[FN32] "Intended use" may be derived
or
inferred from labeling, promotional material, advertising, oral
statements, or any other relevant source. E.g., United
States
v. Storage Spaces Designated Nos. 8 & 49, 777 F.2d 1363, 1366
(9th
Cir. 1985), cert. denied, 479 U.S. 1086 (1987);
United
States v. Article . . . Consist. of 216 Carton Bottles . . .
"Sudden
Change", 409 F.2d 734, 739 (2d Cir. 1969) (citing cases);
V.E.
Irons v. United States, 244 F.2d 34, 44 (1st Cir.),
cert.
denied, 354 U.S. 923 (1957); Alberty Food Products v.
United
States, 194 F.2d 463 (9th Cir. 1952). A product intended for
use as
a drug may be regulated as a drug regardless of its composition.
"Sudden Change", 409 F.2d at 739 (citing cases in which
peppermint tea leaves, honey, mineral water, and animal hearts have
been
found to be "drugs"). The determination of whether a product is a
"drug"
is conducted on an objective basis, taking into consideration all
relevant sources. Id.; Kellogg Co. v. Mattox, 763 F.
Supp.
1369, 1383 (N.D. Tex. 1991), aff'd mem., 940 F.2d
1530
(5th Cir. 1991) (and cases cited therein).
FN32. 21 U.S.C. § 321(g)(1)(B).
By any objective criteria, the intended use of the products
acquired
and distributed by XXXXXXXX must be considered drugs. The defendant
represented the substances to be (and the purchasers believed the
substances to be) antibiotics for veterinary use. Moreover, his
customers were veterinarians who sought and used the products in
the
treatment of animals. Any contention to the contrary has no basis
in
fact.
2. The FDCA applies to deliveries of
bulk drugs to veterinarians
Appellate courts have uniformly upheld the view that the FDCA
applies to veterinarians receiving and distributing bulk drugs.
See generally Algon, supra; 9/1 Kg.
Containers, supra.
3.Requisite intent to defraud or mislead
The defendant appears poised to make two separate arguments why
his
conduct did not involve the requisite intent to defraud or mislead
necessary to support felony convictions. First, the government
anticipates that the defendant will renew the claim, made in his
earlier
motion to dismiss the Indictment (dkt. 31), that he relied in good
faith
upon two district court decisions that were subsequently overturned
on
appeal.[FN33] Second, the defendant will contend that evidence
sufficient to establish an "intent to defraud or mislead" must
include
evidence of intent to cause a monetary fraud.
FN33. United States v. 9/1 Kg. Containers, 674
F.
Supp. 1344 (C.D. Ill. 1987); rev'd, 854 F.2d 173 (7th Cir.
1988),
cert. denied, 489 U.S. 1010 (1989); United States
v.
Algon Chemical, Inc, 689 F. Supp. 394 (D.N.J. 1988),
rev'd,
879 F.2d 1154 (3d Cir. 1989).
As discussed at pages 13-18 of the government's March 8, 1993,
Opposition to Defendant's Second Motion to Dismiss (dkt. 38),
defendant's "mistake of law" of defense has no colorable basis in
law or
fact.[FN34]
FN34. Rather than repeat arguments previously made, the
government incorporates by reference its discussion at pages 13
through
18 of this response.
Of particular note is that (1) the sequence of events
contradicts
any claim of good-faith reliance on the erroneous district court
decisions (the first decision was handed down in December 1987, two
years after the start of the conspiracy and more than a year after
the
defendant acknowledged the government's position that the sale of
bulk
animal drugs without a proper NADA was illegal); (2) the legal
issues in
the two cases did not even purport to cover conduct engaged in by
the
defendant -- namely, the sale and distribution of
non-approved
drugs (i.e., drugs that were not covered by an approved NADA
even
at their source) and of drugs having no labeling at all);
and (3)
the defendant's claim of good-faith reliance is wholly inconsistent
both
with his misrepresentations to the FDA and with his clandestine
activities designed to evade detection.
Equally devoid of merit is defendant's claim that "intent to
defraud
or mislead" requires proof of intent to cause a monetary loss. As
will
be discussed at greater length in the government's opposition to
defendant's motion in limine concerning this issue, the defendant's
argument is wholly misguided. For one thing, it completely ignores
the
fact that the government can meet its burden of proof by
establishing
either an "intent to defraud" or an "intent to mislead." No
explanation has been offered by the defendant why an intent to
"mislead"
requires proof of monetary loss nor can the government fathom one.
Moreover, as recognized by the Supreme Court in McNally v.
United
States, 483 U.S. 350, 359 n.3 (1987), the term "defraud" by
itself
does not require evidence of a monetary loss. Rather, the term
"defraud"
must be construed in light of the specific statute and statutory
scheme.
Thus, while the Supreme Court concluded that "intent to defraud" as
used
in the mail fraud statute, 18 U.S.C. § 1341, requires loss of
money
or property, decisions subsequent to McNally have made clear
that
no proof of monetary loss is required to prove an "intent to
defraud" in
the context of other statutory schemes -- be it the FDCA,[FN35] or
another statutory framework.[FN36]
FN35. See Bradshaw, 840 F.2d at 875 n.8
(McNally inapplicable to the FDCA); Arlen, 947 F.2d
at
142-43 (following Bradshaw); Mitcheltree, 940 F.2d at
1347, 1352 (same); Cambra, 933 F.2d at 755
(same).
FN36. E.g., United States v. Murphy, 957
F.2d
550, 553 (8th Cir. 1992) (affirming conviction of conspiring to
defraud
the government under 18 U.S.C. § 371 in connection with the
leaking
of information about an FBI investigation); United States v.
Elkins, 885 F.2d 775, 781 (11th Cir. 1989) (conspiracy to
defraud
the government of its right to implement foreign policy), cert.
denied, 494 U.S. 1005 (1990); United States v. Kato, 878
F.2d
267, 270 (9th Cir. 1989) ("[C]onspiracy to defraud the United
States
under 18 U.S.C. § 371 does not require an agreement to defraud
the
government of money or property").
E.Admissibility of Unalleged Conspiratorial Conduct
An issue as to the admissibility of unalleged overt acts in
support
of the conspiracy may arise. Such evidence is properly admissible.
See, e.g., United States v. Lewis, 759 F.2d 1316,
1344
(8th Cir.), cert. denied, 474 U.S. 994 (1985); United
States
v. Ruiz-Altschiller, 694 F.2d 1104, 1109 (8th Cir. 1982),
cert.
denied, 462 U.S. 1134 (1983); Culp v. United States, 131
F.2d
93, 100 (8th Cir. 1942).
F. Admissibility of Co-Conspirator Statements
Statements made "by a coconspirator of a party during the
course and
in furtherance of the conspiracy" are not hearsay. Fed. R. Evid.
801(d)(2)(E); United States v. Edwards, 994 F.2d 417, 421
(8th
Cir. 1993), cert. denied, 114 S. Ct. 701 (1994). To
meet
the requirements under this rule, the government must demonstrate
three
elements by a preponderance of the evidence: "(1) that a conspiracy
existed; (2) that the defendant and the declarant were part of the
conspiracy; and (3) that the declaration was during the course and
in
furtherance of the conspiracy." United States v. Sileven,
985
F.2d 962, 966-67 (8th Cir. 1993).
In determining whether a statement is in "furtherance" of a
conspiracy, the court should interpret the term "furtherance"
broadly.
Edwards, 994 F.2d at 433. So long as the overall effect of
the
conversation is to facilitate the conspiracy, this prong is
satisfied.
Id.
In United States v. Bell, 573 F.2d 1040, 1044 (8th Cir.
1978), the Eighth Circuit set forth the procedure for handling
coconspirator statements. Under this procedure, coconspirator
statements
may be admitted conditionally, and the court may determine at the
close
of the government's evidence whether the government had established
the
existence of the conspiracy at the time of the statements in
question.
Id.; see Edwards, 994 F.2d at 421. The
declaration
in question is properly considered in determining the existence of
the
three elements set forth above. Bourjaily v. United States,
483
U.S. 171, 180-81 (1987); United States v. Hoey, 983 F.2d
890, 893
(8th Cir. 1993).
G. Evidence of Plea Agreements with Government
Witnesses
The government will call certain witnesses who have entered
into
plea agreements requiring their cooperation with the government's
investigation of the illegal distribution and/or receipt of bulk
animal
drugs. These witnesses have already pled guilty and served their
sentences.
In its direct examination of each such witness, the government
is
entitled to elicit testimony concerning the fact that the witness
pled
guilty to particular charges, the details of those charges, and the
nature of the cooperation agreement with the government. The
testimony
can properly include testimony concerning the requirement in the
plea
agreement that the witness provide only truthful testimony and can
be
prosecuted if he commits perjury. The plea agreement itself is
admissible. United States v. Drews, 877 F.2d 10, 12 (8th
Cir.
1989) (confederate's plea agreement is admissible on direct
examination
as evidence of the witness' credibility or acknowledgement of
participation in the offense).
H. Admissibility of Audio Tape Evidence
The government's evidence will include tapes of telephone
conversations between XXXXXXXX and cooperating witnesses, which
were
made by the cooperating witnesses. Introduction of such evidence
does
not implicate any fourth amendment rights when, as here, an
individual
simultaneously records his conversation with the defendant with
electronic equipment and has consented to the taping and monitoring
of
that conversation. United States v. White, 401 U.S. 745,
748-54
(1971); United States v. McMillan, 508 F.2d 101, 104 (8th
Cir.
1974), cert. denied, 421 U.S. 916 (1975).
The standard for admitting taped conversations is set forth in
McMillan. Introduction of taped conversations is appropriate
when
the following requirements are satisfied:
(1) That the recording device was capable of taking the
conversation being offered into evidence;
(2) That the operator of the device was competent to operate
the
device;
(3) That the recording is authentic and correct;
(4) That changes, additions or deletions have not been made in
the
recording;
(5) That the recording was preserved in a manner that is shown
to
the court;
(6) That the speakers are identified;
(7) That the conversation elicited was made voluntarily and in
good
faith, without any kind of inducement.
Id. at 104.
When, as here, the tapes were made by an individual acting at
the
government's behest, many of these elements -- such as the
authenticity
and correctness of the recording, the tapes having not been
modified,
the identity of the speakers, and the conversation being made
voluntarily and in good faith -- will be satisfied by that
individual's
testimony.
Moreover, the first element (capability of the recording
device) may
be established by the very existence of the taped conversation:
"'[t]he
very fact that the tape recording[] exist[s] establishes that the
recording device was capable of picking up sounds and taking the
conversation offered.'" United States v. Risken, 788 F.2d
1361,
1370 (8th Cir.) (quoting United States v. McCowan, 706 F.2d
863,
865 (8th Cir. 1983) (per curiam)), cert. denied, 479
U.S.
923 (1986). Similarly, the fact that the witness successfully
recorded
the conversation is proof of his competency to use the recording
device.
Id.
Because the tapes in this case are of conversations in which
the
defendant was a participant, their contents are admissible as
admissions
of a party opponent under Fed. R. Evid. 801(d)(2)(A). See
United States v. Coco, 926 F.2d 759, 760 (8th Cir. 1991).
Although at the time of the conversations, the individuals with
whom the
defendant was speaking were no longer members of the conspiracy,
that
fact, in and of itself, does not render the substance of the
conversations admissible only pursuant to Fed. R. Evid. 404(b).
See United States v. Nunn, 940 F.2d 1128, 1131 (8th
Cir.
1991). Given the contents of the taped conversations in which the
defendant discusses his activities relating to the purchase of bulk
animal drugs, the defendant's statements are relevant evidence of
the
defendant's knowledge and participation in the ongoing conspiracy
to
which the defendant still belonged. Thus, the tapes constitute
direct
evidence of the defendant's participation in the charged
conspiracy.
Id. (taped statements of defendant to cooperating witness
implying threats of harm should individual cooperate are admissible
as
evidence of defendant's participation in the conspiracy).
I. Use of Transcripts
McMillan also sets forth the proper procedure for
introduction of transcripts of taped conversations.
McMillan, 508
F.2d at 105-06. Allowing the government to use transcripts to
assist the
jury in following taped conversations is left to the court's
discretion:
"[i]t may be appropriate, in the sound discretion of the trial
judge, to
furnish the jurors with copies of a transcript to assist them in
listening to tapes. In the ordinary case this will not be
prejudicially
cumulative . . ." Id. at 105.
Should the court admit the transcript as evidence, a limiting
instruction governing the use and weight of the transcript should
be
given. United States v. Foster, 815 F.2d 1200, 1203 (8th
Cir.
1987).
J. Use of Summary Exhibits
The government may offer summary exhibits in its case-in-chief
in
lieu of introducing supporting underlying documents, such as
telephone
tolls, checks, and invoices. Pursuant to Fed. R. Evid. 1006:
The contents of voluminous writings, recordings, or
photographs which cannot conveniently be examined in court may be
presented in the form of a chart, summary, or calculation. The
originals, or duplicates, shall be made available for examination
or
copying, or both, by other parties at reasonable and place. The
court
may order that they be produced in court.
With the adoption of Rule 1006, courts have held that summary
charts
themselves may be introduced into evidence and sent to the jury at
the
judge's discretion. United States v. Possick, 849 F.2d 332,
339
(8th Cir. 1988); United States v. Robinson, 774 F.2d 261,
275-76
(8th Cir. 1985). The evidence underlying the summary chart need not
be
so voluminous that it would literally be impossible to examine all
underlying documents. Possick, 849 F.2d at 339. Rather,
admission
of summary charts is appropriate where in-court examination would
be an
inconvenience. Id. (upholding district court's admission of
chart
summarizing telephone tolls).
"[W]here charts which fairly summarize the evidence are used as
an
aid in understanding the testimony already introduced and the
witness
who prepares the charts is subject to cross-examination with all
documents used to prepare the summary, the use of the chart is
proper."
United States v. Orlowski, 808 F.2d 1283, 1289 (8th Cir.
1986)
(internal quotation omitted), cert. denied, 482 U.S.
927
(1987). Should the government offer summary exhibits, the
individual who
prepared the charts will testify as to the manner in which the
charts
were prepared and the underlying basis for the information
contained in
the charts, as well as attest to their completeness and accuracy.
Moreover, the government will not seek to admit any such charts
until
after it has established a basis for the admissibility of all of
the
underlying documents.[FN37] Under such circumstances, the
determination
whether to admit the charts will lie within the court's
considerable
discretion. See Orlowski, 808 F.2d at 1289;
Robinson, 774 F.2d at 275.
FN37. A literal reading of Rule 1006 would suggest that
the
underlying documents need not themselves be introduced at trial,
and the
Fourth Circuit has so held. United States v. Strissell, 920
F.2d
1162, 1164 (4th Cir. 1990) (Rule 1006 only requires that underlying
evidence for a summary be admissible and available to the opponent
for
cross-examination); see also Eighth Circuit Model
Instruction No. 4.12 (1992) ("You may use those
[schedules][summaries][charts] as evidence, even though the
underlying
documents are not here."); United States v. Clements, 588
F.2d
1030, 1039 (5th Cir.), cert. denied, 440 U.S. 982
(1979).
When summary exhibits are sent to the jury, the Eighth Circuit
has
endorsed the giving of a limiting instruction concerning those
exhibits.
Possick, 849 F.2d at 339.
K. Admission of Various Documentary Records
The government anticipates introducing several forms of
records,
including, among other things, invoices pertaining to the
defendant's
illegal sale of bulk drugs, cancelled checks used as payment to the
defendant for the bulk drugs, cancelled checks used as payment from
the
defendant to his suppliers for the bulk drugs, and laboratory
analyses
of drugs illegally sold by the defendant.
The government anticipates that the invoices will be admissible
pursuant to, among others, Fed. R. Evid. 803(6) as business
records. A
proper foundation for business records does not require testimony
from a
witness who physically prepared the record in question. United
States
v. Gregg, 829 F.2d 1430, 1440 (8th Cir. 1987), cert.
denied, 486 U.S. 1022 (1988); United States v.
Pfeiffer,
539 F.2d 668, 671 n.2 (8th Cir. 1976). Rather, the admitting
witness
need only be sufficiently familiar with the records and the manner
in
which they were regularly received and maintained in the ordinary
course
of business. Pfeiffer, 539 F.2d at 671; see
also
United States v. Keplinger, 776 F.2d 678, 693-94 (7th Cir.
1985),
cert. denied, 476 U.S. 1183 (1986); United States
v.
Parker, 749 F.2d 628, 633 (11th Cir. 1984); United States v.
Flom, 558 F.2d 1179, 1182 (5th Cir. 1977).
The government anticipates that the witnesses who provided
checks to
the defendant or who received checks from the defendant as payment
for
bulk drugs will testify as to the authenticity of those checks.
Fed. R.
Evid. 901(b)(1). Moreover, the checks are self-authenticating under
Fed.
R. Evid. 902(9). See United States v. Little, 567
F.2d
346, 349 n.1 (8th Cir. 1977), cert. denied, 435 U.S.
969
(1978).
Similarly, laboratory analyses of drugs conducted on a routine
basis
are admissible as business records under Fed. R. Evid. 803(6).
United
States v. Baker, 855 F.2d 1353, 1359-60 (8th Cir. 1988),
cert. denied, 490 U.S. 1069 (1989). The government
need
only establish that the records were made in the ordinary course of
business, and the witness through which it seeks to admit the
reports
can testify that the governmental body kept the records under its
care,
custody, and control. Id. at 1560.
L. Admissibility of Physical Exhibits
The government intends to offer in evidence several physical
samples
of animal drugs distributed in interstate commerce by the
defendant.
So long as the government can establish that there is a
reasonable
probability that the physical evidence has not been changed or
altered,
the district court may admit the evidence. United States v.
Miller, 994 F.2d 441, 443 (8th Cir. 1993); United States v.
Pazzanese, 982 F.2d 251, 252 (8th Cir. 1992). Factors to be
considered in making a determination of the admissibility of an
object
include the nature of the object, the circumstances surrounding its
preservation and custody, and the likelihood that others tampered
with
it. United States v. Mays, 822 F.2d 793, 796 (8th Cir.
1987). The
government need not introduce the testimony of every individual who
handled the evidence or whose initials appear on the evidence.
Miller, 994 F.2d at 443. "The integrity of evidence is
presumed
to be preserved unless there is a showing of bad faith, ill will,
or
proof that the evidence has been tampered with." Id.
M. Self-Authenticating Records
The government will introduce certain documents for which no
testimony from a document custodian will be necessary. Among other
things, these documents will show that the defendant never received
from
the FDA an NADA covering any new animal drug from the FDA, and that
all
NADAs for the new animal drug dimetridazole were withdrawn in July
1987.
The information in these documents is admissible pursuant to Fed.
R.
Evid. 902(4), 902(1), and 803(10); Fed. R. Crim. P. 27; and Fed. R.
Civ.
P. 44.
The government also anticipates introducing certified records
from
the Iowa Secretary of State pertaining to the defendant's
connection to
Cigar. These records are self-authenticating and may be introduced
pursuant to Fed. R. Evid. 902(4), 902(1), and 803(8); Fed. R. Crim.
P.
27; and Fed. R. Civ. P. 44.
V. ADDITIONAL SUBMISSIONS
The government respectfully requests leave to file supplemental
memoranda as may become necessary before or during trial.
Dated: February __, 1994 Respectfully submitted,
STEPHEN JOHN RAPP
United States Attorney
GREGORY T. EVERTS
JAMES E. ARNOLD
Attorneys
Office of Consumer Litigation
U.S. Department of Justice
P.O. Box 386
Washington, D.C. 20044
(202) 514-0516/307-01744
[cited in USAM 4-8.205]
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