GOVERNMENT'S OPPOSITION TO
DEFENDANT'S FIRST MOTION IN LIMINE
In his First Motion in Limine, the defendant seeks an
either barring the testimony of Dr. XXXXX XXXXXX,[FN1] the
expert witness, or, in the alternative, requiring the government to
provide a detailed proffer in advance of trial relating to the
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
drugs or the alleged possible harm to the public as a consequence
sale of bulk animal drugs." (Motion, at ¶ 3).
FN1. X. XXXXXX XXXXXX, Dean of the College of
Medicine at Mississippi State University, is qualified to be an
witness on the issues outlined in this brief. As shown by his
curriculum vitae, which has been provided to the
as part of the government's discovery, Dr. XXXXXX has expert
experience, training, and education in Pharmacology and Veterinary
Toxicology. Moreover, among other things, his research has focused
the absorption, distribution, metabolism and excretion of drugs in
The defendant's motion both misstates the nature and relevancy
Dr. XXXXXX's likely testimony, and mischaracterizes the
in introducing such testimony. Accordingly, his motion is without
and should be denied.
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
of the government's case.
Rule 702 of the Federal Rules of Evidence provides:
If scientific, technical, or other specialized
will assist the trier of fact to understand the evidence or to
a fact in issue, a witness qualified as an expert by knowledge,
experience, training, or education, may testify thereto in the form
an opinion or otherwise.
Fed. R. Evid. 702 ("Testimony by Experts"). "Rule 702 reflects
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
Cir.) (citing cases), cert. denied, 112 S. Ct. 312
Expert testimony in this case will help the jury determine two
essential elements: (1) whether the drugs at issue were
because they were "new animal drugs" that lacked an FDA-approved
animal drug application" ("NADA"); and (2) whether these drugs were
"misbranded" in that their labeling lacked "adequate directions for
FN2. The defendant errs in framing the issue as
assuming that the substances sold by the Defendant were "New
Drugs", those substances were "misbranded" within the meaning
relevant statutes." (Combined Memorandum in Support of Defendant
XXXXXXXX's Pending Pretrial Motions in Limine, at 4 (emphasis
The underscored portion of the above statement is erroneous because
"new animal drug" status of a drug is irrelevant to whether the
"misbranded." All drugs, regardless of whether they are "new animal
drugs," must be labeled with adequate directions for use. 21 U.S.C.
A. "New Animal Drug"
Count One of the Indictment charges the defendant with
violate the Food, Drug, and Cosmetic Act ("Food and Drug Act") by,
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
at ¶ 5). As an essential element of one of the objects of the
conspiracy, therefore, the jury will need to make a finding that
drugs at issue in this case -- carbadox, dimetridazole, gentamycin,
furazolidone, and oxytetracycline -- were, under the law, "new
Proof that a product is a "new animal drug" requires evidence
among other things, the drug is not generally recognized among
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
for use for animals other than man . . .
21 U.S.C. § 321(w)(1) (emphasis added).
(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
conditions prescribed, recommended, or suggested in the labeling
thereof; . . . .
Thus, by its very terms, the Food and Drug Act limits "new
drugs" to only those products that are not "generally recognized"
qualified experts as "safe and effective for use" under specified
conditions. As a result, unlike cases arising under the provisions
the Controlled Substances Act in which the government need only
establish that a substance is a specified, identifiable drug, in
involving "new animal drugs" the government is required to
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
showing: first, that there is general recognition in fact,
that there is an expert consensus that the product is effective;
second, that the expert consensus is based upon 'substantial
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,
government will need to establish, among other things, that there
general consensus among experts as to the safety and effectiveness
the bulk drug products sold by the defendant.
To prove this fact, the government will present testimony from
XXXXXX, who will explain the health and safety risks associated
use of the unlabeled, bulk drugs purchased and sold by the
Dr. XXXXXX will further testify that, in light of the health and
risks associated with these drugs, there is no consensus among
as to their safety and efficacy. Such testimony is therefore both
relevant and proper because it will help the jury to decide whether
drugs at issue here were recognized by qualified experts as safe
effective for their intended uses -- i.e., whether these
were "new animal drugs."
B. "Adequate Directions for Use"
Counts One through Six of the Indictment also allege that the
distributed by the defendant were "misbranded" in that their
lacked "adequate directions for use." See 21 U.S.C. §
352(f)(1) ("A drug . . . shall be deemed to be misbranded-- . . .
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
the Food and Drug Act establishes a comprehensive drug approval
that is designed to ensure that drugs are safe and effective to use
their intended purpose. Among other things, the implementing
of the Food and Drug Act require that the following be specified:
21 CFR § 201.5.
(a) Statements of all conditions, purposes, or uses
for which such drug is intended, including conditions, purposes, or
for which it is prescribed, recommended, or suggested in its oral,
written, printed, or graphic advertising, and conditions, purposes,
uses for which the drug is commonly used; except that such
shall not refer to conditions, uses, or purposes for which the drug
be safely used only under the supervision of a practitioner
law and for which it is advertised solely to such
(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
(c) Frequency of administration or
(d) Duration of administration or
(e) Time of administration or application (in
relation to time of meals, time of onset of symptoms, or other time
(f) Route or method of administration.
(g) Preparation for use, i.e., shaking, dilution,
adjustment of temperature, or, other manipulation or
In proving that the various drugs purchased and sold by the
bore no adequate directions for use and were thus misbranded, the
government must establish that, for the purposes for which the
were being used, the labeling was inadequate. See,
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
upon what it is intended to be used for."). Dr. XXXXXX's testimony
go directly to this issue.
Dr. XXXXXX will describe the preliminary scientific work that
undertaken to ascertain the conditions, purposes, and uses for
given drug product may be prescribed or recommended. He will also
testify as to the scientific studies that must be conducted to
the proper dosages to be prescribed for a drug, as well as to
the frequency of administration, the duration of administration,
timing of administration, and the proper method of administration.
testimony is necessary to convey to the jury what information
have been included on the labeling of the drugs sold by the
order for those products to have had "adequate directions for
Dr. XXXXXX will also testify as to the specific dangers that
where drugs are distributed in highly concentrated form and without
instructions to end-users untrained in drug manufacturing or
pharmacology, who then mix or blend those drugs to make medicated
or dosage-form drug products. Further, Dr. XXXXXX will describe the
instructions necessary to be deemed adequate when dealing with
drugs that are inherently dangerous to handle due to their
toxic properties.[FN3] Dr. XXXXXX's testimony on these issues will
assist the jury in determining whether the directions on the
the drugs distributed in this case were "adequate directions."
C. Expert Testimony As To The Issues Of Adulteration And
FN3. Such testimony is particularly relevant in this
where one of the drugs at issue is carbadox. (Indictment, at ¶
Carbadox, for example, is not only dangerous if consumed through
residues left in food animals, it is also dangerous when handled in
form. It is extremely explosive, has associated fumes that are
toxicants, and may cause chromosomal aberrations and adversely
spermatogenesis. See Government's Trial Memorandum at 11,
The admissibility of expert testimony on questions relating to
drug is "adulterated" or "misbranded" was expressly upheld by the
Circuit in United States v. Hiland, 909 F.2d 1114 (8th Cir.
1990). In Hiland, the defendants were charged with
E-Ferol, a drug used in premature infants, that the government
was an unapproved new drug which lacked adequate directions for
so doing, the Eighth Circuit stated:
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
and experience of scientists based on controlled clinical
experimentation and backed by substantial support in scientific
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
therefore plainly relevant to establishing that E-Ferol was both
misbranded and a new drug, essential elements of the government's
In Hiland, moreover, the Eighth Circuit, on facts far
sympathetic than those presented here, rejected the defendants'
unfair prejudice. The medical testimony there, in part, related to
death of infants from the use of E-Ferol. "As relevant evidence,
testimony was inherently prejudicial in the sense of being
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,
rather protects only against unfair prejudice." 909 F.2d at
(emphasis added). See also United States v.
625 F.2d 782, 797 (8th Cir. 1980) (en banc) ("In weighing the
value of evidence against the dangers and considerations enumerated
Rule 403, the general rule is that the balance should be struck in
To the extent that the defendant's motion is a challenge based
R. Evid. 403, therefore, it should be denied. Expert testimony in
case will assist the jury in deciding essential elements of the
government's case, both (1) whether the drugs at issue were "new
drugs" that required an approved NADA because they were not
recognized by qualified experts as safe and effective for their
uses (the "adulteration" issue) and (2) whether the drugs at issue
distributed with "adequate directions for use" (the "misbranding"
On both issues, expert testimony is relevant and admissible. It
prejudicial only in the sense that it is probative and, therefore,
to establish the defendant's guilt.
For the foregoing reasons, defendant's First Motion in Limine
Dated: February __, 1994
STEPHEN JOHN RAPP
United States Attorney
GREGORY T. EVERTS
JAMES E. ARNOLD
Office of Consumer Litigation
U.S. Department of Justice
P.O. Box 386
Washington, D.C. 20044
[cited in Civil Resource Manual 15]