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25.

Animal Drug Prosecutions -- Sample Jury Instructions

[Introduction regarding instructions]

Members of the jury, the instructions I gave you at the beginning of the trial and during the trial remain in effect. I will now give you some additional instructions.

You must, of course, continue to follow the instructions I gave you earlier, as well as those I give you now. You must not single out some instructions and ignore others, because all are important. This is true even though some of the instructions I gave you at the beginning of the trial and during the trial are not repeated here.

The instructions I am about to give you now are in writing and will be available to you in the jury room. I emphasize, however, that this does not mean they are more important than my earlier instructions. Again, all instructions, whenever given and whether in writing or not, must be followed.

Eighth Circuit Model Instruction No. 3.01

[Duty of jury]

It is your duty to find from the evidence what the facts are. You will then apply the law, as I give it to you, to those facts. You must follow my instructions on the law, even if you thought the law was different or should be different.

Do not allow sympathy or prejudice to influence you. The law demands of you a just verdict, unaffected by anything except the evidence, your common sense, and the law as I give it to you.

Eighth Circuit Model Instruction No. 3.02

[Overview of charges]

The indictment in this case charges the defendant with four different crimes.

Under Count I, the indictment charges that the defendant conspired with others to violate provisions of the Federal Food, Drug, and Cosmetic Act, which throughout my instructions to you I will simply refer to as the Food and Drug Act.

Under Counts II, III, and IV, the indictment charges that the defendant, on three separate occasions, each being a separate crime, actually violated certain provisions of the Food and Drug Act.

The defendant has pleaded not guilty to each of the charges against him.

As I told you at the beginning of the trial, an indictment is simply an accusation. It is not evidence of anything. To the contrary, the defendant is presumed to be innocent. Thus the defendant, even though charged, begins the trial with no evidence against him. The presumption of innocence alone is sufficient to find the defendant not guilty and can be overcome only if the government proves, beyond a reasonable doubt, each essential element of the crimes charged.

Keep in mind that each Count charges a separate crime. You must consider each Count separately, and return a separate verdict for each Count.

Eighth Circuit Model Instruction No. 3.06

[Reasonable doubt]

A reasonable doubt is a doubt based upon reason and common sense, and not the mere possibility of innocence. A reasonable doubt is the kind of doubt that would make a reasonable person hesitate to act. Proof beyond a reasonable doubt, therefore, must be proof of such a convincing character that a reasonable person would not hesitate to rely and act upon it. However, proof beyond a reasonable doubt does not mean proof beyond all possible doubt.

Eighth Circuit Model Instruction No. 3.11

[Count I - overview of elements]

The crime of conspiracy as charged under Count I of the indictment has four essential elements, which are:

One, by December 1987, or some time reasonably near to that date, two or more persons reached an agreement or came to an understanding to violate provisions of the Food and Drug Act which, as I will instruct you in more detail later, make it unlawful under certain circumstances, with intent to defraud or mislead, to receive, manufacture, package, distribute, or introduce into interstate commerce animal drugs that are or become misbranded or adulterated;

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, the defendant, or other persons with whom he conspired, knowingly did one or more of the "overt acts" described in the indictment for the purpose of carrying out or carrying forward the agreement or understanding.

In a moment, I will give you further instructions that will add more detail to the description of the four elements that I just related.

For you to find the defendant guilty of the crime of conspiracy, the government must prove all of these essential elements beyond a reasonable doubt; otherwise, you must find the defendant not guilty.

Eighth Circuit Model Instruction No. 5.06A [as modified]

[Count I - meaning of agreement or understanding]

As I just stated, the crime of conspiracy involves the defendant reaching an agreement or understanding with at least one other person. It makes no difference that the persons with whom the defendant reached an agreement or understanding are not named or charged in the indictment.

The agreement or understanding need not be an express or formal agreement or be in writing or cover all the details of how it is to be carried out. Nor is it necessary that the persons joining in it have directly stated between themselves the details or purpose of the scheme.

An agreement or understanding may be inferred from all the circumstances and the conduct of the persons alleged to have joined in it.

Eighth Circuit Model Instruction No. 5.06B [as modified]

[Count I - introductory remarks]

As I just instructed you, the first element of the crime of conspiracy, as charged under Count I of the indictment, involves an agreement or understanding to violate certain provisions of the Food and Drug Act. To assist you in determining whether there was such an agreement or understanding, I will now instruct you in more detail as to certain provisions of the Food and Drug Act that are relevant to the alleged objects of the conspiracy charged in Count I.

Eighth Circuit Model Instruction No. 5.06C [as modified]

[Drug]

The term "drug" as used in the indictment and in these instructions is defined in the Food and Drug Act. As so defined, an article is a drug if it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.

21 U.S.C. § 321(g)(1)

[New animal drug]

The term "new animal drug" as used in the indictment and in these instructions is also defined in the Food and Drug Act. If an article was composed wholly or partly of chloramphenicol, then it was a "new animal drug" so long as it was intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals. If an article was not composed of chloramphenicol, but was intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals, then -- for purposes of this case -- it still is a "new animal drug" if it is not generally recognized by qualified experts as being safe and effective under the conditions recommended or suggested in its labeling.

21 U.S.C. §§ 321(g)(1), 321(w)(1), 321(w)(3)

NOTE: As of November 16, 1988, Title 21, United States Code, section 321(w) no longer makes explicit reference to chloramphenicol and several other drugs. The government submits that the "new animal drug" status of chloramphenicol -- and the other drugs formerly enumerated in section 321(w)(3) -- was not altered by the change in statutory language, which in any event took effect after all times relevant to the indictment in this case.

[Adulteration]

The term "adulteration" as used in the indictment and in these instructions also has a special meaning under the Food and Drug Act. A drug can be adulterated in one of several different ways. For purposes of this case, a drug is adulterated if it is a new animal drug that has not been approved by the United States Food and Drug Administration with respect to its intended use. Accordingly, if you find that an article was a new animal drug and that it had not been approved by the Food and Drug Administration for its intended use, then you must find that such drug was adulterated.

21 U.S.C. §§ 352(a)(5), 360b(a)(1)(A)

[Adequate directions for use]

"Adequate directions for use" as used in the indictment and in these instructions also has a special meaning under the Food and Drug Act. The term means directions sufficient to enable a layperson to use a drug safely and effectively.

United States v. Article of Drug, 625 F.2d 665, 672-73 (5th Cir. 1980); United States v. "Vita Safe Formula M", 226 F. Supp. 266, 278 (D.N.J. 1964), modified on other grounds sub nom. United States v. Vitasafe Corp., 345 F.2d 864 (3d Cir.), cert. denied, 382 U.S. 918 (1965).

[Interstate commerce]

The term "interstate commerce" as used in the indictment and in these instructions is also defined in the Food and Drug Act. As so defined that term encompasses commerce between any State or Territory of the United States or commerce between any foreign country and any State or Territory of the United States.

In addition, shipment and receipt in interstate commerce is not limited to the first or last shipment of an animal drug or one of its components. Instead, if you find that at some point an animal drug or one of its components was shipped from one State or Territory of the United States to another, or from any foreign country to any State or Territory, you must find that the drug was shipped and received in interstate commerce. You must so find regardless of whether there were shipments which occurred only within the same State or Territory or whether the last shipment occurred only within the same State or Territory.

21 U.S.C. §§ 321(a)(1) and 321(b); see, e.g., United States v. Sullivan, 332 U.S. 689, 696 (1948); De Freese v. United States, 270 F.2d 737, 739 (5th Cir. 1959), cert. denied, 362 U.S. 944 (1960); Archambault v. United States, 224 F.2d 925, 928 (10th Cir. 1955); Marshall v. United States, 258 F.2d 94 (10th Cir. 1958), rev'd on other grounds, 360 U.S. 310 (1959)

[Intent to defraud or mislead]

You can find that the defendant acted with "the intent to defraud or mislead," as that term is used in these instructions and in the indictment, if you find that he acted with an intent to deceive the United States Food and Drug Administration or other federal or state agencies and thereby to hinder such agencies in carrying out their regulatory responsibilities. You can also find that the defendant acted with "the intent to defraud or mislead" if you find that he acted with an intent to deceive persons with whom he engaged in business or with whom he did business. Intent ordinarily may not be proved directly, because there is no way of fathoming or scrutinizing the operations of the human mind. But you may infer the defendant's intent from the surrounding circumstances.

21 U.S.C. § 333(b) [since July 22, 1988, recodified as 21 U.S.C. § 333(a)(2)]; United States v. Bradshaw, 840 F.2d 871, 874 (11th Cir.), cert. denied, 488 U.S. 924 (1988); D. & B. § 14.13 [as modified]

[Count I - objects of the conspiracy]

Keeping in mind those definitions that I just provided to you, I will now give you instructions concerning the violations of the Food and Drug Act that are charged as objects of the conspiracy in this case. Those alleged violations are of two general types.

The first type of violation of the Food and Drug Act that is charged as an object of the conspiracy are felony violations involving drugs that were adulterated. The elements of this type of violations are:

One, a person introduced an adulterated drug in interstate commerce, or a person received an adulterated drug in interstate commerce and proffered the delivery of that drug for pay, or a person manufactured, packaged, or distributed an adulterated drug after the drug or a component of that drug had been shipped in interstate commerce; and

Two, the person acted with the intent to defraud or mislead.

Keep in mind that in Count I the indictment charges a conspiracy to commit the Food and Drug Act violations that I just described, and not that any of these violations was itself actually committed.

The second type of violation of the Food and Drug Act that is charged as an object of the conspiracy are felony violations involving drugs that were misbranded. The elements of this type of violations are:

One, a person introduced a misbranded drug in interstate commerce, or a person received a misbranded drug in interstate commerce and proffered the delivery of that drug for pay, or a person manufactured, packaged, or distributed a misbranded drug after the drug or a component of that drug had been shipped in interstate commerce; and

Two, the person acted with the intent to defraud or mislead.

For purposes of the conspiracy charge, a drug was misbranded if its labeling was false or misleading; if its labeling lacked the name and place of business of the manufacturer, packer, or distributor; or if its labeling lacked adequate directions for use.

Again keep in mind that, under Count I, the indictment charges a conspiracy to commit these violations, and not that any of this second type of violation was itself actually committed.

It is not necessary for the government to prove a conspiracy to commit all of these types of violations. It is sufficient if the government has proven, beyond a reasonable doubt, a conspiracy to commit one of these violations; but, in that event, in order to return a verdict of guilty to the crime of conspiracy as charged under Count I, you must unanimously agree upon at least one particular violation that was the object of the conspiracy. If you cannot agree in that manner, you must find the defendant not guilty of the crime of conspiracy.

Eighth Circuit Model Instruction Nos. 5.06C and 5.06F [both as modified]; 21 U.S.C. §§ 331(a), 331(c), 331(k), 333(b) [since July 22, 1988, recodified as 21 U.S.C. § 333(a)(2)], 351(a)(2)(B), 351(a)(5), 352(a), 352(b), 352(f)(1), and 360b; United States v. Bradshaw, 840 F.2d 871 (11th Cir.), cert. denied, 488 U.S. 924 (1988)

[Count I - joining voluntarily and intentionally]

As I told you before, the second element of the crime of conspiracy involves the defendant voluntarily and intentionally joining in an agreement or understanding.

You should understand that merely acting in the same way as others or merely associating with others does not prove that a person has joined in an agreement or understanding. A person who has no knowledge of a conspiracy, but who happens to act in a way which advances some purpose of one, does not thereby become a member of the conspiracy.

Eighth Circuit Model Instruction No. 5.06B [as modified]

[Count I - knowledge of the purpose of the agreement or understanding]

As I told you before, the third element of the crime of conspiracy involves the defendant's having knowledge of the purpose of the agreement of understanding.

A person may join in an agreement or understanding without knowing all the details of the agreement or understanding, and without knowing who all the other members are. It is sufficient that the defendant know that the agreement or understanding has an unlawful purpose; in this case, that is -- as I previously have described -- the receipt, manufacturing, packaging, and introduction into interstate commerce of animal drugs that were misbranded or adulterated within the meaning of the Food and Drug Act.

Eighth Circuit Model Instruction No. 5.06B [as modified]; D & B § 27.05 [as modified]

[Count I - overt acts]

As I told you before, the fourth element of the crime of conspiracy involves the doing of an "overt act" in furtherance of the conspiracy by the defendant or by other persons with whom he conspired. It is not necessary that any "overt act" done in furtherance of the conspiracy be in itself unlawful. The "overt act" may be perfectly innocent in itself.

It is not necessary that the government prove, beyond a reasonable doubt, that more than one act was done in furtherance of the conspiracy. It is sufficient if the government proves, beyond a reasonable doubt, one such act; but in that event, in order to return a verdict of guilty, you must unanimously agree upon which act was done.

Eighth Circuit Model Instruction No. 5.06D

[Count I - success]

It is not necessary for the government to prove that the defendant and persons with whom he conspired actually succeeded in accomplishing their unlawful plan.

Eighth Circuit Model Instruction No. 5.06E [as modified]

[Acts and declarations of coconspirators]

NOTE: Before giving this instruction, the court must make a preliminary finding that there was a conspiracy involving the declarant and the defendant, and that the statement or act was made or done in the course of and in furtherance of the conspiracy. The court must find that these matters are established by a preponderance of the evidence. In making this determination, the court may consider any evidence including any proffered hearsay statements. See Bourjaily v. United States, 483 U.S. 171, 176-79 (1987).

If you find beyond a reasonable doubt that a conspiracy existed and that the defendant was one of its members, then you may consider acts knowingly done and statements knowingly made by any of the defendant's coconspirators during the existence of the conspiracy, and in furtherance of it, as evidence pertaining to the defendant even though the acts or statements were done or made in the absence of and without the knowledge of the defendant. This includes acts done or statements made by conspirators before the defendant had joined the conspiracy, for a person who knowingly, voluntarily and intentionally joins an existing conspiracy is responsible for all of the conduct of the coconspirators from the beginning of the conspiracy.

Eighth Circuit Model Instruction No. 5.06I

[Actual date need not be proved]

You will note that the indictment charges that crimes were committed "on or about" a certain date or during a period of months beginning and ending "in or about" certain months. The government does not need to prove with certainty the exact date, or the exact period of time, of a crime charged. It is sufficient that the evidence establish beyond a reasonable doubt that a crime was committed on a date or during a period of months reasonably near to that alleged.

D & B § 13.05 [as modified]

[Food and Drug Act]

The government has also charged the defendant with three separate violations of the Food and Drug Act. The purpose of that Act is to protect the public health and welfare, including the protection of those who, in circumstances of modern society, are largely beyond self-protection.

United States v. An Article of Drug . . . Bacto-Unidisk, 394 U.S. 784, 798 (1969); 62 Cases, More or Less, Each Containing Six Jars of Jam v. United States, 340 U.S. 593, 596 (1967); United States v. Dotterweich, 320 U.S. 277, 280 (1943)

[Counts II-IV]

Counts II, III, and IV of the indictment charge that the defendant, with intent to defraud or mislead, received in interstate commerce and proffered the delivery for pay of animal drugs that were misbranded within the meaning of the Food and Drug Act. Those crimes have three essential elements, which are:

One, on or about the dates set forth in Counts II, III, and IV -- that is, on or about December 7, 1987, June 21, 1988, and August 12, 1988, respectively -- the defendant received in interstate commerce and proffered the delivery for pay of a quantity of chloramphenicol, which was a drug within the meaning of the Food and Drug Act;

Two, at the time of the receipt in interstate commerce and proffered delivery, the chloramphenicol was misbranded within the meaning of the Food and Drug Act either because its labeling was false and misleading in that it did not indicate that the substance was chloramphenicol, or because its labeling did not bear adequate directions for use in that it failed to state, among other things, that chloramphenicol should not be administered to food-producing animals; and

Three, the defendant acted with the intent to defraud or mislead.

For you to find the defendant guilty of the crimes charged in Counts II, III, and IV, the government must prove all of these essential elements beyond a reasonable doubt; otherwise, you must find the defendant not guilty. With regard to the second element, you must unanimously agree on at least one of the alternative ways in which the chloramphenicol was misbranded.

A separate crime is charged against the defendant in each of Counts II, III, and IV. Each crime and the evidence pertaining to it should be considered separately. The fact that you may find the defendant guilty or not guilty as to one of the crimes charged should not control your verdict as to any other crime charged.

Eighth Circuit Model Instruction No. 3.09 [as modified]; D & B § 11.07 [as modified]; 21 U.S.C. §§ 331(c), 333(b) [since July 22, 1988, recodified as 21 U.S.C. § 333(a)(2)], 352(a), and 352(f)(1); United States v. Bradshaw, 840 F.2d 871 (11th Cir.), cert. denied, 488 U.S. 924 (1988)

[What is not evidence]

I have mentioned the word "evidence." The "evidence" in this case consists of the testimony of witnesses, the documents and other things received as exhibits, the facts that have been stipulated -- that is, formally agreed to by the parties, and the facts that have been judicially noticed -- that is, facts which I say you may, but are not required to, accept as true, even without evidence.

You may use reason and common sense to draw deductions or conclusions from facts which have been established by the evidence in the case.

Certain things are not evidence. I shall list those things again for you now:

        1. Statements, arguments, questions and comments by lawyers
        representing the parties in the case are not evidence.

2. Objections are not evidence. Lawyers have a right to object when they believe something is improper. You should not be influenced by the objection. If I sustained an objection to a question, you must ignore the question and must not try to guess what the answer might have been.

3. Testimony that I struck from the record, or told you to disregard, is not evidence and must not be considered.

4. Anything you saw or heard about this case outside the courtroom is not evidence.

Finally, if you were instructed that some evidence was received for a limited purpose only, you must follow that instruction.

Eighth Circuit Model Instruction No. 3.03

[Credibility of witnesses]

In deciding what the facts are, you may have to decide what testimony you believe and what testimony you do not believe. You may believe all of what a witness said, or only part of it, or none of it.

In deciding what testimony to believe, consider the witness's intelligence, the opportunity the witness had to have seen or heard the things testified about, the witness's memory, any motives that the witness may have for testifying a certain way, the manner of the witness while testifying, whether that witness said something different at an earlier time, the general reasonableness of the testimony, and the extent to which the testimony is consistent with any evidence that you believe.

In deciding whether or not to believe a witness, keep in mind that people sometimes hear or see things differently and sometimes forget things. You need to consider therefore whether a contradiction is an innocent misrecollection or lapse of memory, or an intentional falsehood, and that may depend on whether it has to do with an important fact or only a small detail.

Eighth Circuit Model Instruction No. 3.04

[Experts]

You have heard testimony from persons described as experts. Persons who, by knowledge, skill, training, education or experience, have become expert in some field may state their opinions on matters in that field and may also state the reasons for their opinions.

Expert testimony should be considered just like any other testimony. You may accept or reject it, and give it as much weight as you think it deserves, considering the witness's education and experience, the soundness of the reasons given for the opinion, and all other evidence in the case.

Eighth Circuit Model Instruction No. 4.10 [as modified]

[Testimony under plea bargain]

You have heard evidence that Andrew Cotten has made a plea agreement with the government, and that a part of that agreement states that his testimony will not be used against him in a criminal case. His testimony was received in evidence and may be considered by you. You may give his testimony such weight as you think it deserves. Whether or not his testimony may have been influenced by the plea agreement is for you to determine.

The witness's guilty plea cannot be considered by you as any evidence of this defendant's guilt. The witness's guilty plea can be considered by you only for the purpose of determining how much, if at all, to rely upon the witness's testimony.

Eighth Circuit Model Instruction No. 4.04 [as modified]

[Testimony of associates]

You have heard testimony from Terry Mangold and Peggy Griffith, each of whom stated that in some ways they associated with the defendant on matters within the scope of the indictment. Their testimony was received in evidence and may be considered by you. You may give their testimony such weight as you think it deserves. Whether or not their testimony may have been influenced by their desire to please the government or to strike a good bargain with the government about their own situation is for you to determine.

Eighth Circuit Model Instruction No. 4.05 [as modified]

[Rule 1006 summaries - accuracy not challenged]

You will remember that certain summaries were admitted in evidence. You may use those summaries as evidence.

Eighth Circuit Model Instruction No. 4.12

[Notes]

Throughout the course of the trial, you have been allowed to take notes of the testimony. These notes may be taken with you into the jury room for use in your deliberations. However, the court cautions you as to the use of these notes. Remember, these are notes and not evidence. Generally, they reflect a recollection or an impression of evidence, as viewed by the person taking them, and they may be subject to inaccuracies or incompleteness. You may merely use them for recollection to aid you in your deliberations.

Upon reaching a verdict, the notes must be destroyed.

[Exhibits]

Exhibits have been admitted into evidence and are to be considered along with the other evidence to assist you in reaching a verdict. You are not to tamper with the exhibits or their contents and each exhibit should be returned into open court, along with your verdict, in the same condition as when you received it.

[Deliberation instructions]

In conducting your deliberations and returning your verdict, there are certain rules you must follow. I shall list those rules for you now.

First, when you go to the jury room, you must select one of your members as your foreperson. That person will preside over your discussions and speak for you here in court.

Second, it is your duty, as jurors, to discuss this case with one another in the jury room. You should try to reach agreement if you can do so without violence to individual judgment, because a verdict -- whether guilty or not guilty -- must be unanimous.

Each of you must make your own conscientious decision, but only after you have considered all the evidence, discussed it fully with your fellow jurors, and listened to the views of your fellow jurors.

Do not be afraid to change your opinions if the discussion persuades you that you should. But do not come to a decision simply because other jurors think it is right, or simply to reach a verdict.

Third, if the defendant is found guilty, the sentence to be imposed is my responsibility. You may not consider punishment in any way in deciding whether the government has proved its case beyond a reasonable doubt.

Fourth, if you need to communicate with me during your deliberations, you may send a note to me through the marshal or bailiff, signed by one or more jurors. I will respond as soon as possible either in writing or orally in open court. Requests regarding the instructions are not encouraged. Remember that you should not tell anyone -- including me -- how your votes stand numerically.

Fifth, your verdict must be based solely on the evidence and on the law which I have given to you in my instructions. The verdict, whether guilty or not guilty, must be unanimous. Nothing I have said or done is intended to suggest what your verdict should be -- that is entirely for you to decide.

Finally, the verdict form is simply the written notice of the decision that you reach in this case. A copy of a verdict form is attached to these instructions. You will take this form to the jury room, and when each of you has agreed on the verdicts, your foreperson will fill in the form with your verdict as to each Count, sign and date the form, and advise the marshal or bailiff that you are ready to return to the courtroom.

Eighth Circuit Model Instruction No. 3.12

[cited in USAM 4-8.245]