GOVERNMENT'S OPPOSITION TO
DEFENDANT'S FIRST MOTION IN LIMINE
I. INTRODUCTION
In his First Motion in Limine, the defendant seeks an
order
either barring the testimony of Dr. XXXXX XXXXXX,[FN1] the
government's
expert witness, or, in the alternative, requiring the government to
provide a detailed proffer in advance of trial relating to the
subject
matter of Dr. XXXXX's testimony. In support of this motion, the
defendant alleges that the government's only reason for calling Dr.
XXXXXX as a witness is to introduce testimony "about the evils of
bulk
drugs or the alleged possible harm to the public as a consequence
of the
sale of bulk animal drugs." (Motion, at ¶ 3).
FN1. X. XXXXXX XXXXXX, Dean of the College of
Veterinary
Medicine at Mississippi State University, is qualified to be an
expert
witness on the issues outlined in this brief. As shown by his
curriculum vitae, which has been provided to the
defense
as part of the government's discovery, Dr. XXXXXX has expert
knowledge,
experience, training, and education in Pharmacology and Veterinary
Toxicology. Moreover, among other things, his research has focused
on
the absorption, distribution, metabolism and excretion of drugs in
food
animals.
The defendant's motion both misstates the nature and relevancy
of
Dr. XXXXXX's likely testimony, and mischaracterizes the
government's motives
in introducing such testimony. Accordingly, his motion is without
merit
and should be denied.
II. DISCUSSION
The defendant has provided no legitimate basis for barring the
government's expert testimony. Dr. XXXXXX's testimony is relevant
--
and, therefore, admissible -- because it relates to essential
elements
of the government's case.
Rule 702 of the Federal Rules of Evidence provides:
If scientific, technical, or other specialized
knowledge
will assist the trier of fact to understand the evidence or to
determine
a fact in issue, a witness qualified as an expert by knowledge,
skill,
experience, training, or education, may testify thereto in the form
of
an opinion or otherwise.
Fed. R. Evid. 702 ("Testimony by Experts"). "Rule 702 reflects
an
attempt to liberalize the rules governing the admission of expert
testimony. . . . Rule 702 is one of admissibility rather than
exclusion." Arcoren v. United States, 929 F.2d 1235, 1239
(8th
Cir.) (citing cases), cert. denied, 112 S. Ct. 312
(1991).
Expert testimony in this case will help the jury determine two
essential elements: (1) whether the drugs at issue were
"adulterated"
because they were "new animal drugs" that lacked an FDA-approved
"new
animal drug application" ("NADA"); and (2) whether these drugs were
"misbranded" in that their labeling lacked "adequate directions for
use.[FN2]
FN2. The defendant errs in framing the issue as
"[w]hether,
assuming that the substances sold by the Defendant were "New
Animal
Drugs", those substances were "misbranded" within the meaning
of the
relevant statutes." (Combined Memorandum in Support of Defendant
XXXXXXXX's Pending Pretrial Motions in Limine, at 4 (emphasis
added).)
The underscored portion of the above statement is erroneous because
the
"new animal drug" status of a drug is irrelevant to whether the
drug is
"misbranded." All drugs, regardless of whether they are "new animal
drugs," must be labeled with adequate directions for use. 21 U.S.C.
§ 352(f)(1).
A. "New Animal Drug"
Count One of the Indictment charges the defendant with
conspiring to
violate the Food, Drug, and Cosmetic Act ("Food and Drug Act") by,
among
other things, distributing "adulterated" drugs -- i.e., "new
animal drugs" that were not covered by an approved "new animal drug
application" or "NADA". (Indictment, at ¶ 9; see
id.
at ¶ 5). As an essential element of one of the objects of the
conspiracy, therefore, the jury will need to make a finding that
the
drugs at issue in this case -- carbadox, dimetridazole, gentamycin,
furazolidone, and oxytetracycline -- were, under the law, "new
animal
drugs."
Proof that a product is a "new animal drug" requires evidence
that,
among other things, the drug is not generally recognized among
qualified
experts as being safe and effective. 21 U.S.C. § 321(w)(1). As
stated in the Food and Drug Act:
(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; . . . .
21 U.S.C. § 321(w)(1) (emphasis added).
Thus, by its very terms, the Food and Drug Act limits "new
animal
drugs" to only those products that are not "generally recognized"
by
qualified experts as "safe and effective for use" under specified
conditions. As a result, unlike cases arising under the provisions
of
the Controlled Substances Act in which the government need only
establish that a substance is a specified, identifiable drug, in
cases
involving "new animal drugs" the government is required to
introduce
evidence concerning whether the drugs in question are generally
recognized by qualified experts as being safe and effective.
"[G]eneral recognition [of safety and effectiveness] requires
a two-step
showing: first, that there is general recognition in fact,
i.e.,
that there is an expert consensus that the product is effective;
and
second, that the expert consensus is based upon 'substantial
evidence'
as defined in the [Food, Drug, and Cosmetic] Act and in FDA
regulations." United States v. An Article of Drug . . . 4,680
Pails, 725 F.2d 976, 985 (5th Cir. 1984). At trial, therefore,
the
government will need to establish, among other things, that there
is no
general consensus among experts as to the safety and effectiveness
of
the bulk drug products sold by the defendant.
To prove this fact, the government will present testimony from
Dr.
XXXXXX, who will explain the health and safety risks associated
with the
use of the unlabeled, bulk drugs purchased and sold by the
defendant.
Dr. XXXXXX will further testify that, in light of the health and
safety
risks associated with these drugs, there is no consensus among
experts
as to their safety and efficacy. Such testimony is therefore both
relevant and proper because it will help the jury to decide whether
the
drugs at issue here were recognized by qualified experts as safe
and
effective for their intended uses -- i.e., whether these
drugs
were "new animal drugs."
B. "Adequate Directions for Use"
Counts One through Six of the Indictment also allege that the
drugs
distributed by the defendant were "misbranded" in that their
labeling
lacked "adequate directions for use." See 21 U.S.C. §
352(f)(1) ("A drug . . . shall be deemed to be misbranded-- . . .
(f)
Unless its labeling bears (1) adequate directions for use . . .
.").
Although this phrase may appear, on initial glance, to require no
further elucidation, that is not the case.
As described more fully in the government's trial memorandum
(at 5-8),
the Food and Drug Act establishes a comprehensive drug approval
system
that is designed to ensure that drugs are safe and effective to use
for
their intended purpose. Among other things, the implementing
regulations
of the Food and Drug Act require that the following be specified:
(a) Statements of all conditions, purposes, or uses
for which such drug is intended, including conditions, purposes, or
uses
for which it is prescribed, recommended, or suggested in its oral,
written, printed, or graphic advertising, and conditions, purposes,
or
uses for which the drug is commonly used; except that such
statements
shall not refer to conditions, uses, or purposes for which the drug
can
be safely used only under the supervision of a practitioner
licensed by
law and for which it is advertised solely to such
practitioner.
(b) Quantity of dose, including usual quantities for
each of the uses for which it is intended and usual quantities for
persons of different ages and different physical
conditions.
(c) Frequency of administration or
application.
(d) Duration of administration or
application.
(e) Time of administration or application (in
relation to time of meals, time of onset of symptoms, or other time
factors).
(f) Route or method of administration.
(g) Preparation for use, i.e., shaking, dilution,
adjustment of temperature, or, other manipulation or
process.
21 CFR § 201.5.
In proving that the various drugs purchased and sold by the
defendant
bore no adequate directions for use and were thus misbranded, the
government must establish that, for the purposes for which the
drugs
were being used, the labeling was inadequate. See,
e.g.,
United States v. Article of Drug . . . B-Complex Cholinos
Capsules, 362 F.2d 923, 925 (3d Cir. 1966) ("Whether labeling
contains 'adequate directions for use' of an article necessarily
depends
upon what it is intended to be used for."). Dr. XXXXXX's testimony
will
go directly to this issue.
Dr. XXXXXX will describe the preliminary scientific work that
must be
undertaken to ascertain the conditions, purposes, and uses for
which a
given drug product may be prescribed or recommended. He will also
testify as to the scientific studies that must be conducted to
ascertain
the proper dosages to be prescribed for a drug, as well as to
determine
the frequency of administration, the duration of administration,
the
timing of administration, and the proper method of administration.
This
testimony is necessary to convey to the jury what information
should
have been included on the labeling of the drugs sold by the
defendant in
order for those products to have had "adequate directions for
use."
Dr. XXXXXX will also testify as to the specific dangers that
may result
where drugs are distributed in highly concentrated form and without
any
instructions to end-users untrained in drug manufacturing or
pharmacology, who then mix or blend those drugs to make medicated
feed
or dosage-form drug products. Further, Dr. XXXXXX will describe the
instructions necessary to be deemed adequate when dealing with
certain
drugs that are inherently dangerous to handle due to their
explosive or
toxic properties.[FN3] Dr. XXXXXX's testimony on these issues will
assist the jury in determining whether the directions on the
labeling of
the drugs distributed in this case were "adequate directions."
FN3. Such testimony is particularly relevant in this
case
where one of the drugs at issue is carbadox. (Indictment, at ¶
3).
Carbadox, for example, is not only dangerous if consumed through
residues left in food animals, it is also dangerous when handled in
bulk
form. It is extremely explosive, has associated fumes that are
pulmonary
toxicants, and may cause chromosomal aberrations and adversely
affect
spermatogenesis. See Government's Trial Memorandum at 11,
n.26.
C. Expert Testimony As To The Issues Of Adulteration And
Misbranding
Is Admissible
The admissibility of expert testimony on questions relating to
whether a
drug is "adulterated" or "misbranded" was expressly upheld by the
Eighth
Circuit in United States v. Hiland, 909 F.2d 1114 (8th Cir.
1990). In Hiland, the defendants were charged with
distributing
E-Ferol, a drug used in premature infants, that the government
alleged
was an unapproved new drug which lacked adequate directions for
use. In
so doing, the Eighth Circuit stated:
The challenged medical testimony helped to show that
E-Ferol was dangerous when administered in accordance with dosage
directions and other recommendations for use in its labeling. It
was
therefore plainly relevant to establishing that E-Ferol was both
misbranded and a new drug, essential elements of the government's
case.
Id. at 1134; see also Weinberger v. Bentex
Pharmaceuticals, Inc., 412 U.S. 645, 652 (1973) ("Whether a
particular drug is a "new drug," depends in part on the expert
knowledge
and experience of scientists based on controlled clinical
experimentation and backed by substantial support in scientific
literature.").
In Hiland, moreover, the Eighth Circuit, on facts far
more
sympathetic than those presented here, rejected the defendants'
claim of
unfair prejudice. The medical testimony there, in part, related to
the
death of infants from the use of E-Ferol. "As relevant evidence,
this
testimony was inherently prejudicial in the sense of being
detrimental
to the defendants' case." Hiland, 909 F.2d at 1134-35. The
evidence was nonetheless admissible because, as the Eighth Circuit
recognized, "Rule 403 is not directed at this type of prejudice,
but
rather protects only against unfair prejudice." 909 F.2d at
1135
(emphasis added). See also United States v.
Dennis,
625 F.2d 782, 797 (8th Cir. 1980) (en banc) ("In weighing the
probative
value of evidence against the dangers and considerations enumerated
in
Rule 403, the general rule is that the balance should be struck in
favor
of admission.")
To the extent that the defendant's motion is a challenge based
on Fed.
R. Evid. 403, therefore, it should be denied. Expert testimony in
this
case will assist the jury in deciding essential elements of the
government's case, both (1) whether the drugs at issue were "new
animal
drugs" that required an approved NADA because they were not
generally
recognized by qualified experts as safe and effective for their
intended
uses (the "adulteration" issue) and (2) whether the drugs at issue
were
distributed with "adequate directions for use" (the "misbranding"
issue).
On both issues, expert testimony is relevant and admissible. It
is
prejudicial only in the sense that it is probative and, therefore,
helps
to establish the defendant's guilt.
III. CONCLUSION
For the foregoing reasons, defendant's First Motion in Limine
should be
denied.
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) 514-0516/307-017444
[cited in Civil Resource Manual 15]
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