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28.

Animal Drug Prosecutions -- Sample Memorandum re Expert Drug Testimony

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]