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24.

Animal Drug Prosecutions -- Sample Jury Instructions

[INTRODUCTION]

MEMBERS OF THE JURY, THE INSTRUCTIONS I GAVE YOU AT THE BEGINNING OF THE TRIAL AND DURING THE TRIAL REMAIN IN EFFECT. I 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 THOSE I GAVE YOU [AT THE BEGINNING OF] [DURING] TRIAL ARE NOT REPEATED HERE.]

[THE INSTRUCTIONS I AM ABOUT TO GIVE YOU NOW [AS WELL AS THOSE I GAVE YOU EARLIER] 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 (1992).

[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 (1992).

[EVIDENCE; LIMITATIONS]

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,] [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 (1992).

[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 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.

[YOU SHOULD JUDGE THE TESTIMONY OF THE DEFENDANT IN THE SAME MANNER AS YOU JUDGE THE TESTIMONY OF ANY OTHER WITNESS.]

Eighth Circuit Model Instruction No. 3.04 (1992).

[DESCRIPTION OF CHARGES; INDICTMENT NOT EVIDENCE; PRESUMPTION OF INNOCENCE; BURDEN OF PROOF (SINGLE DEFENDANT, MULTIPLE COUNTS)]

THE INDICTMENT IN THIS CASE CHARGES THE DEFENDANT WITH SIX DIFFERENT CRIMES.

COUNT 1 OF THE INDICTMENT CHARGES THAT THE DEFENDANT CONSPIRED WITH PERSONS KNOWN AND UNKNOWN TO VIOLATE PROVISIONS OF THE FEDERAL FOOD AND DRUG ACT BY AGREEING TO DISTRIBUTE AND BY DISTRIBUTING DRUGS INTENDED FOR USE IN FOOD-PRODUCING ANIMALS THAT WERE "ADULTERATED" (THAT IS, UNAPPROVED) AND "MISBRANDED" (THAT IS, IMPROPERLY LABELED).

COUNTS 2 THROUGH 6 OF THE INDICTMENT CHARGE THAT THE DEFENDANT, ON FIVE OCCASIONS, EACH BEING A SEPARATE CRIME, VIOLATED THE FOOD AND DRUG ACT BY INTRODUCING OR CAUSING TO BE INTRODUCED INTO INTERSTATE COMMERCE DRUGS INTENDED FOR USE IN FOOD-PRODUCING ANIMALS THAT WERE IMPROPERLY LABELED.

THE DEFENDANT HAS PLEADED NOT GUILTY TO EACH OF THESE CHARGES.

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.

BEFORE EXPLAINING TO YOU THE ELEMENTS OF EACH OF THOSE CHARGES, I WILL GIVE YOU SOME DEFINITIONS THAT YOU WILL NEED FOR YOUR DELIBERATIONS.

Eighth Circuit Model Instruction No. 3.06 (1991) [modified].

[PURPOSE OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT]

THE DEFENDANT IS CHARGED WITH CONSPIRING OR AGREEING TO VIOLATE, AND WITH ACTUALLY VIOLATING, THE FOOD AND DRUG ACT. THE PURPOSE OF THE FOOD AND DRUG 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 (1951); United States v. Dotterweich, 320 U.S. 277, 280 (1943).

[DEFINITION OF DRUG]

THE TERM "DRUG" IS DEFINED IN THE FOOD AND DRUG ACT.

A PRODUCT IS A "DRUG" IF IT IS INTENDED FOR USE IN THE DIAGNOSIS, CURE, TREATMENT, OR PREVENTION OF DISEASE IN MAN OR OTHER ANIMALS. IT IS THE INTENDED USE OF A PRODUCT THAT DETERMINES WHETHER THAT PRODUCT IS A DRUG AND NOT WHETHER THE PRODUCT, IN FACT, IS SUCCESSFUL IN THE DIAGNOSIS, CURE, TREATMENT, OR PREVENTION DISEASE. IN DETERMINING WHETHER A PRODUCT IS A DRUG, THE PRODUCT'S ACTUAL CHEMICAL COMPOSITION IS IRRELEVANT AS IS THE ISSUE OF WHETHER THE PRODUCT WAS IN FACT THE CHEMICAL SUBSTANCE IT WAS REPRESENTED TO BE.

IN DETERMINING WHETHER A PRODUCT WAS INTENDED TO BE USED AS A DRUG, YOU MAY TAKE INTO ACCOUNT THE LABELING, PROMOTIONAL MATERIAL, ADVERTISING, MARKETING, AND ANY OTHER INFORMATION OR REPRESENTATION SUGGESTIVE OF ITS INTENDED USE. THE INTENDED USE OF A PRODUCT IS THAT USE WHICH A REASONABLE PERSON WOULD CONCLUDE, BASED ON ALL RELEVANT INFORMATION, WAS THE INTENDED USE.

21 U.S.C. § 321(g)(1)(B); Nutrilab, Inc. v. Schweiker, 713 F.2d 335 (7th Cir. 1983); United States v. An Article . . . "Line Away", 415 F.2d 369 (3d Cir. 1969); United States v. An Article . . . "Sudden Change", 409 F.2d 734 (2d Cir. 1969).

[DEFINITION OF NEW ANIMAL DRUG]

A DRUG IS A "NEW ANIMAL DRUG" IF IT IS INTENDED FOR USE IN ANIMALS OTHER THAN MAN (INCLUDING ANY DRUG INTENDED FOR USE IN ANIMAL FEED) AND ITS COMPOSITION IS SUCH THAT THE DRUG IS NOT GENERALLY RECOGNIZED BY QUALIFIED EXPERTS AS BEING SAFE AND EFFECTIVE FOR USE UNDER THE CONDITIONS PRESCRIBED, RECOMMENDED OR SUGGESTED IN ITS LABELING. A DRUG IS NOT "GENERALLY RECOGNIZED" AS SAFE AND EFFECTIVE FOR AN INTENDED USE UNLESS THERE IS A CONSENSUS AMONG EXPERTS AND THAT CONSENSUS IS FOUNDED UPON SUBSTANTIAL EVIDENCE -- THAT IS, EVIDENCE CONSISTING OF ADEQUATE AND WELL-CONTROLLED STUDIES THAT ARE PUBLISHED AND GENERALLY AVAILABLE TO THE SCIENTIFIC COMMUNITY.

21 U.S.C. §§ 321(w)(1); Weinberger v. Hynson, Westcott, and Dunning, Inc., 412 U.S. 609, 617-619 (1973); Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 652-53 (1973);

United States v. An Article of Drug . . . 4,680 Pails,

725 F.2d 967, 976 (5th Cir. 1984).

[DEFINITION OF INTERSTATE COMMERCE]

THE TERM "INTERSTATE COMMERCE" MEANS COMMERCE BETWEEN ANY STATE OF THE UNITED STATES AND ANY OTHER STATE, OR COMMERCE BETWEEN ANY FOREIGN COUNTRY AND ANY STATE OF THE UNITED STATES.

21 U.S.C. §§ 321(a)(1), 321(b); United States v. Sullivan, 332 U.S. 689, 696 (1948).

[COUNT 1 (CONSPIRACY) -- ESSENTIAL ELEMENTS]

I WILL NOW INSTRUCT YOU AS TO THE ESSENTIAL ELEMENTS OF THE CRIMES CHARGED IN THE INDICTMENT. THE CRIME OF CONSPIRACY, AS CHARGED IN COUNT 1 OF THE INDICTMENT, HAS FOUR ESSENTIAL ELEMENTS, WHICH ARE:

ONE, IN OR ABOUT DECEMBER 1985, TWO PERSONS KNOWINGLY AND WILLFULLY REACHED AN AGREEMENT OR CAME TO AN UNDERSTANDING TO VIOLATE THE FOOD AND DRUG ACT, WITH INTENT TO DEFRAUD OR MISLEAD, 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, A 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.

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 (1991) [modified].

[CONSPIRACY: "AGREEMENT" EXPLAINED]

THE GOVERNMENT MUST PROVE THAT THE DEFENDANT REACHED AN AGREEMENT OR UNDERSTANDING WITH AT LEAST ONE OTHER PERSON. IT MAKES NO DIFFERENCE WHETHER THAT OTHER PERSON IS NAMED 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 MEMBERS HAVE DIRECTLY STATED BETWEEN THEMSELVES THE DETAILS OR PURPOSE OF THE SCHEME.

YOU SHOULD UNDERSTAND THAT MERELY BEING PRESENT AT THE SCENE OF AN EVENT, OR 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.

BUT A PERSON MAY JOIN IN AN AGREEMENT OR UNDERSTANDING, AS REQUIRED BY THIS ELEMENT, WITHOUT KNOWING ALL THE DETAILS OF THE AGREEMENT OR UNDERSTANDING, AND WITHOUT KNOWING WHO ALL THE OTHER MEMBERS ARE. FURTHER IT IS NOT NECESSARY THAT A PERSON AGREE TO PLAY ANY PARTICULAR PART IN CARRYING OUT THE AGREEMENT OR UNDERSTANDING. A PERSON MAY BECOME A MEMBER OF A CONSPIRACY EVEN IF THAT PERSON AGREES TO PLAY ONLY A MINOR PART IN THE CONSPIRACY, AS LONG AS THAT PERSON HAS AN UNDERSTANDING OF THE UNLAWFUL NATURE OF THE PLAN AND VOLUNTARILY AND INTENTIONALLY JOINS IN IT.

IN DETERMINING WHETHER THE ALLEGED CONSPIRACY EXISTED YOU MAY CONSIDER THE ACTIONS AND STATEMENTS OF ALL THE ALLEGED PARTICIPANTS. THE AGREEMENT MAY BE INFERRED FROM ALL THE CIRCUMSTANCES AND THE CONDUCT OF THE ALLEGED PARTICIPANTS. IN DETERMINING WHETHER THE DEFENDANT BECAME A MEMBER OF THE CONSPIRACY YOU MAY CONSIDER ONLY THE ACTS AND STATEMENTS OF THE DEFENDANT.

KEEP IN MIND THAT COUNT ONE OF THE INDICTMENT CHARGES THE EXISTENCE OF A CONSPIRACY OR AGREEMENT TO VIOLATE THE FOOD AND DRUG ACT, AND NOT THE ACTUAL COMMISSION OF SPECIFIC VIOLATIONS OF THIS KIND.

Eighth Circuit Model Instruction No. 5.06B (1992) [modified].

[CONSPIRACY: SUBSTANTIVE OFFENSES: ELEMENTS]

THE INDICTMENT CHARGES THAT THE DEFENDANT CONSPIRED TO COMMIT SEPARATE CRIMES OR OFFENSES:

THE DISTRIBUTION OR RECEIPT OF DRUGS THAT WERE "ADULTERATED"; AND
THE DISTRIBUTION OR RECEIPT OF DRUGS THAT WERE "MISBRANDED".
IT IS NOT NECESSARY FOR THE GOVERNMENT TO PROVE A CONSPIRACY TO COMMIT ALL OR MOST OF THOSE OFFENSES. IT WOULD BE SUFFICIENT THAT THE GOVERNMENT PROVES, BEYOND A REASONABLE DOUBT, A CONSPIRACY TO COMMIT ONE OF THOSE OFFENSES; BUT, IN THAT EVENT, IN ORDER TO RETURN A VERDICT OF GUILTY, YOU MUST UNANIMOUSLY AGREE UPON WHICH OF THE OFFENSES WAS THE SUBJECT OF THE CONSPIRACY. IF YOU CANNOT AGREE IN THAT MANNER, YOU MUST FIND THE DEFENDANT NOT GUILTY.

Eighth Circuit Model Instruction Nos. 5.06C (1992) [modified], No. 5.06F (1992) [modified].

[CONSPIRACY: SUBSTANTIVE OFFENSES: DISTRIBUTION OR RECEIPT OF ADULTERATED DRUGS]

TO ASSIST YOU IN DETERMINING WHETHER THERE WAS AN AGREEMENT OR UNDERSTANDING, AS CHARGED IN THE INDICTMENT, TO VIOLATE THE FOOD AND DRUG ACT BY DISTRIBUTING OR RECEIVING ADULTERATED DRUGS, YOU ARE ADVISED THAT THE ELEMENTS OF THESE TYPES OF VIOLATIONS ARE AS FOLLOWS:

ONE, A PERSON INTRODUCED OR CAUSED TO BE INTRODUCED IN INTERSTATE COMMERCE AN ANIMAL DRUG; OR A PERSON RECEIVED IN INTERSTATE COMMERCE AN ANIMAL DRUG AND PROFFERED THE DELIVERY OF IT;
TWO, THE DRUG WAS "ADULTERATED" -- THAT IS, IT WAS A "NEW ANIMAL DRUG" THAT WAS NOT APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION AS SAFE AND EFFECTIVE FOR ITS INTENDED USE; AND

THREE, THE PERSON ACTED WITH THE INTENT TO DEFRAUD OR MISLEAD.

21 U.S.C. §§ 331(a), 331 (c); 21 U.S.C. § 333(b) [since July 22, 1988, recodified as 21 U.S.C. § 333(a)(2)]; 21 U.S.C. § 351(a)(5); 21 U.S.C. § 360b(1).

[CONSPIRACY: SUBSTANTIVE OFFENSES: DISTRIBUTION OR RECEIPT OF MISBRANDED DRUGS]

TO ASSIST YOU IN DETERMINING WHETHER THERE WAS AN AGREEMENT OR UNDERSTANDING, AS CHARGED IN THE INDICTMENT, TO VIOLATE THE FOOD AND DRUG ACT BY DISTRIBUTING OR RECEIVING MISBRANDED DRUGS, YOU ARE ADVISED THAT THE ELEMENTS OF THESE TYPES OF VIOLATIONS ARE AS FOLLOWS:

ONE, A PERSON INTRODUCED OR CAUSED TO BE INTRODUCED IN INTERSTATE COMMERCE AN ANIMAL DRUG; OR A PERSON RECEIVED IN INTERSTATE COMMERCE AN ANIMAL DRUG AND THEREAFTER PROFFERED THE DELIVERY OF IT;

TWO, THE DRUG WAS "MISBRANDED" BECAUSE ITS LABELING FAILED TO BEAR ADEQUATE DIRECTIONS FOR USE OR ITS LABEL DID NOT CONTAIN THE NAME AND PLACE OF BUSINESS OF THE MANUFACTURER, PACKER, OR DISTRIBUTOR; AND

THREE, THE PERSON ACTED WITH THE INTENT TO DEFRAUD OR MISLEAD.

21 U.S.C. §§ 331(a), 331(c); 21 U.S.C. § 333(b) [since July 22, 1988, recodified as 21 U.S.C. § 333(a)(2)]; 21 U.S.C. §§ 352(b)(1), 352(f)(1).

[CONSPIRACY -- "OVERT ACT" EXPLAINED]

IT IS NOT NECESSARY THAT AN ACT DONE IN FURTHERANCE OF THE CONSPIRACY BE IN ITSELF UNLAWFUL. IT MAY BE PERFECTLY INNOCENT IN ITSELF.

IT IS NOT NECESSARY THAT THE DEFENDANT HAVE PERSONALLY COMMITTED THE ACT, KNOWN ABOUT IT, OR WITNESSED IT. IT MAKES NO DIFFERENCE WHICH OF THE CONSPIRATORS DID THE ACT. THIS IS BECAUSE A CONSPIRACY IS A KIND OF "PARTNERSHIP" SO THAT UNDER THE LAW EACH MEMBER IS AN AGENT OR PARTNER OF EVERY OTHER MEMBER, AND EACH MEMBER IS BOUND BY OR RESPONSIBLE FOR THE ACTS OF EVERY OTHER MEMBER DONE TO FURTHER THEIR SCHEME.

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.

IN THIS CASE, SUCH AN ACT MUST HAVE OCCURRED AFTER SEPTEMBER 16, 1987, AND, IN ORDER TO RETURN A VERDICT OF GUILTY, YOU MUST UNANIMOUSLY AGREE UPON WHICH ACT WAS DONE AFTER THAT DATE.

Eighth Circuit Model Instruction No. 5.06D (1992) [modified]; see United States v. Alfonso-Perez, 535 F.2d 1362 (2d Cir. 1976).

[ACTS AND DECLARATIONS OF CO-CONSPIRATORS][FN1]

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. Bourjaily v. United States, 483 U.S. 171, 176-79 (1987); United States v. Bell, 573 F.2d 1040, 1044 (8th Cir. 1978). See also United States v. Coco, 926 F.2d 759, 761 (8th Cir. 1991); United States v. Meggers, 912 F.2d 246, 248 (8th Cir. 1990); United States v. Wood, 851 F.2d 185, 187 (8th Cir. 1988).

IF YOU HAVE FOUND 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 A DEFENDANT'S CO-CONSPIRATORS DURING THE EXISTENCE OF THE CONSPIRACY AND IN FURTHERANCE OF IT AS EVIDENCE PERTAINING TO THE DEFENDANT EVEN THOUGH THEY WERE DONE OR MADE IN THE ABSENCE OF AND WITHOUT THE KNOWLEDGE OF THE DEFENDANT. THIS INCLUDES ACTS DONE OR STATEMENTS MADE 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 CO-CONSPIRATORS FROM THE BEGINNING OF THE CONSPIRACY.

Eighth Circuit Model Instruction No. 5.06I (1992).

[COUNTS 2 THROUGH 6 -- ESSENTIAL ELEMENTS]

COUNTS 2 THROUGH 6 OF THE INDICTMENT CHARGE THAT THE DEFENDANT, WITH THE INTENT TO DEFRAUD OR MISLEAD, INTRODUCED OR CAUSED TO BE INTRODUCED INTO INTERSTATE COMMERCE ANIMAL DRUGS THAT WERE MISBRANDED WITHIN THE MEANING OF THE FOOD AND DRUG ACT.EACH COUNT CHARGES A SEPARATE OFFENSE.

THE CRIMES CHARGED IN COUNTS 2 THROUGH 6 HAVE THREE ESSENTIAL ELEMENTS, WHICH ARE:

ONE, ON OR ABOUT THE DATES GIVEN IN THE INDICTMENT, THE DEFENDANT INTRODUCED OR CAUSED TO BE INTRODUCED INTO INTERSTATE COMMERCE AN ANIMAL DRUG;

TWO, THE DRUG WAS "MISBRANDED"; AND

THREE, THE DEFENDANT ACTED WITH THE INTENT TO DEFRAUD OR MISLEAD.

FOR YOU TO FIND THE DEFENDANT GUILTY ON ANY OF COUNTS 2 THROUGH 6, THE GOVERNMENT MUST PROVE FOR EACH SUCH CRIME ALL OF THE ESSENTIAL ELEMENTS JUST LISTED BEYOND A REASONABLE DOUBT; OTHERWISE, YOU MUST FIND THE DEFENDANT NOT GUILTY.

Eighth Circuit Model Instruction No. 3.09 (1992) [modified]; 21 U.S.C. § 331(a); 21 U.S.C. § 333(b) [since July 22, 1988, recodified as 21 U.S.C. § 333(a)(2)]; 21 U.S.C. § 352(f)(1); see also United States v. Hiland, 909 F.2d 1114, 1127 (8th Cir. 1990).

[DEFINITION OF MISBRANDED AND ADEQUATE DIRECTIONS FOR USE]

ADEQUATE DIRECTIONS FOR USE MEANS DIRECTIONS SUFFICIENT TO ENABLE A LAY PERSON TO USE THE DRUG SAFELY AND EFFECTIVELY. IN DETERMINING WHETHER A DRUG HAS ADEQUATE DIRECTIONS FOR USE, YOU SHOULD CONSIDER THE FOLLOWING:

FIRST, WHETHER THE LABELING STATES ALL CONDITIONS, PURPOSES, OR USES FOR WHICH THE DRUG MAY BE PRESCRIBED, RECOMMENDED, OR SUGGESTED, OR STATES THAT THE DRUG CAN BE USED ONLY UNDER THE SUPERVISION OF A PRACTITIONER LICENSED BY LAW;

SECOND, WHETHER LABELING STATES WHAT DOSAGE OF THE DRUG SHOULD BE GIVEN FOR ITS INTENDED PURPOSE;

THIRD, WHETHER THE LABELING STATES THE HOW FREQUENTLY THE DRUG SHOULD BE ADMINISTERED;

FOURTH, WHETHER THE LABELING STATES OVER WHAT LENGTH OF TIME THE DRUG SHOULD BE ADMINISTERED;

FIFTH, WHETHER THE LABELING STATES THE CIRCUMSTANCES UNDER WHICH THE DRUG SHOULD BE ADMINISTERED;

SIXTH, WHETHER THE LABELING STATES THE PROPER ROUTE OR METHOD OF ADMINISTERING THE DRUG; AND

SEVENTH, WHETHER THE LABELING STATES HOW THE DRUG SHOULD BE PREPARED FOR ADMINISTRATION.

I INSTRUCT YOU THAT, AS A MATTER OF LAW, A DRUG THAT FAILS TO LIST ON ITS LABELING THE DRUG'S SPECIFIC INTENDED PURPOSE DOES NOT BEAR ADEQUATE DIRECTIONS FOR USE.

21 U.S.C. § 352(f)(1); 21 C.F.R. § 201.5; United States v. Article of Device, 731 F.2d 1253, 1261 (7th Cir.), cert. denied, 469 U.S. 882 (1984); United States v. Article of Drug, 625 F.2d 665, 672-73 (5th Cir. 1980); United States v. El-O-Pathic Pharmacy, 192 F.2d 62, 77 (9th Cir. 1951); Alberty Food Products Co. v. United States, 185 F.2d 321, 325 (9th Cir. 1950); 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); United States v. Articles of Device (Acuflex; Pro-Med, 426 F. Supp. 366, 369 (W.D. Pa. 1977); United States v. 38 Dozen Bottles . . . Labeled in Part Tryptacin, 114 F. Supp. 461, 463 (D. Minn. 1953); United States v. Various Quantities . . . "Instant Alberty Food, 83 F. Supp. 882, 885-86 (D.D.C. 1949); United States v. 150 Packages . . . Labeled In Part Bush Mulso Tablets, 83 F. Supp. 875, 880 (E.D. Mo. 1947).

[DEFINITION: "INTENT TO DEFRAUD OR MISLEAD"]

THE THIRD ELEMENT REQUIRES YOU TO FIND THAT THE DEFENDANT ACTED WITH THE "INTENT TO DEFRAUD OR MISLEAD." INTENT ORDINARILY MAY NOT BE PROVED DIRECTLY BECAUSE THERE IS NO WAY OF FATHOMING OR SCRUTINIZING THE OPERATIONS OF THE HUMAN MIND. HOWEVER, YOU MAY INFER THE DEFENDANT'S INTENT FROM SURROUNDING CIRCUMSTANCES. TO THAT END, YOU MAY CONSIDER ANY STATEMENT MADE AND DONE OR OMITTED BY THE DEFENDANT, AND ALL OTHER FACTS AND CIRCUMSTANCES IN EVIDENCE WHICH INDICATE HIS STATE OF MIND.

YOU ARE INSTRUCTED THAT TO ACT WITH THE "INTENT TO DEFRAUD" MEANS TO ACT WITH THE SPECIFIC INTENT TO DECEIVE OR CHEAT. IT IS NOT NECESSARY TO PROVE THAT ANYONE WAS, IN FACT, DEFRAUDED SO LONG AS IT IS ESTABLISHED BEYOND A REASONABLE DOUBT THAT THE DEFENDANT ACTED WITH THE INTENT TO DEFRAUD.

YOU ARE INSTRUCTED THAT TO ACT WITH THE "INTENT TO MISLEAD" MEANS TO ACT WITH THE SPECIFIC INTENT TO CREATE A FALSE IMPRESSION BY MISSTATING, OMITTING OR CONCEALING FACTS. ONCE AGAIN, IT IS NOT NECESSARY TO PROVE THAT ANYONE WAS, IN FACT, MISLED, SO LONG AS IT IS ESTABLISHED BEYOND A REASONABLE DOUBT THAT THE DEFENDANT ACTED WITH THE INTENT TO MISLEAD.

A DEFENDANT CAN ACT WITH THE INTENT TO DEFRAUD OR MISLEAD IF THE DEFENDANT ACTS WITH THE INTENT TO DEFRAUD OR MISLEAD EITHER A GOVERNMENTAL AGENCY, SUCH AS THE U.S. FOOD AND DRUG ADMINISTRATION, OR A USER OR PURCHASER OF THE DEFENDANT'S PRODUCT.TO ACT WITH THE INTENT TO DEFRAUD OR MISLEAD A GOVERNMENTAL AGENCY MEANS TO ACT WITH THE SPECIFIC INTENT TO INTERFERE WITH OR OBSTRUCT A LAWFUL GOVERNMENT FUNCTION OF THAT AGENCY BY DECEIT, CRAFT OR TRICKERY, OR AT LEAST BY MEANS THAT ARE DISHONEST. INTENT TO DEFRAUD OR MISLEAD THE GOVERNMENT CAN BE ESTABLISHED BY PROVING BEYOND A REASONABLE DOUBT THAT THE DEFENDANT TOOK AFFIRMATIVE STEPS TO CONCEAL, OR ATTEMPT TO CONCEAL, HIS ACTIVITIES FROM A GOVERNMENT AGENCY CHARGED WITH REGULATING THOSE ACTIONS.

TO ACT WITH THE INTENT TO DEFRAUD OR MISLEAD A USER OR PURCHASER OF THE DEFENDANT'S PRODUCT MEANS TO ACT WITH THE SPECIFIC INTENT TO DECEIVE OR MISLEAD THAT USER OR PURCHASER ABOUT THE NATURE OF THE PRODUCT BEING USED OR PURCHASED.

Devitt, Blackmar, Wolff & O'Malley § 17.07 (1992) [modified]; 21 U.S.C. § 333(b) [since July 22, 1988, recodified as 21 U.S.C. § 333(a)(2)]; Dennis v. United States, 384 U.S. 855, 860-61 (1966); Hammerschmidt v. United States, 265 U.S. 182, 188 (1924); United States v. Arlen, 947 F.2d 139, 141-44 (5th Cir. 1991), cert. denied, 112 S.Ct. 1480 (1992); United States v. Cambra, 933 F.2d 752, 755 (9th Cir. 1991); United States v. Bradshaw, 840 F.2d 871, 874 (11th Cir.), cert. denied, 488 U.S. 924 (1988); United States v. Pintar, 630 F.2d 1270, 1278 (8th Cir. 1980); see Eighth Circuit Model Instruction No. 7.05 (1992) [modified].

[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 (1992).

[ACTUAL DATE NEED NOT BE PROVED]

ALL OF THE COUNTS IN THE INDICTMENT CHARGE THAT CRIMES WERE COMMITTED "IN OR ABOUT" CERTAIN MONTHS.

ALTHOUGH IT IS NECESSARY FOR THE GOVERNMENT TO PROVE BEYOND A REASONABLE DOUBT THAT THESE OFFENSES WERE COMMITTED ON DATES REASONABLY NEAR TO THOSE ALLEGED, IT IS NOT NECESSARY FOR THE GOVERNMENT TO PROVE THAT THE OFFENSES WERE COMMITTED PRECISELY IN THE MONTHS CHARGED.

Devitt, Blackmar, Wolff & O'Malley § 13.05 (1992) [modified].

[EXPERT TESTIMONY]

YOU HAVE HEARD TESTIMONY FROM A PERSON DESCRIBED AS AN EXPERT. 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 OPINION.

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, THE ACCEPTABILITY OF THE METHODS USED, AND ALL OTHER EVIDENCE IN THE CASE.

Eighth Circuit Model Instruction No. 4.10 (1992).

[RULE 1006 SUMMARIES - ACCURACY NOT CHALLENGED]

YOU WILL REMEMBER THAT CERTAIN SUMMARIES OR CHARTS WERE ADMITTED IN EVIDENCE. YOU MAY USE THOSE SUMMARIES OR CHARTS AS EVIDENCE EVEN THOUGH THE UNDERLYING DOCUMENTS AND RECORDS ARE NOT HERE.

Eighth Circuit Model Instruction No. 4.12 (1992) [modified].

[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 INANY 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. 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. THE FORM READS (READ FORM). 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, SIGN AND DATE IT, AND ADVISE THE MARSHAL OR BAILIFF THAT YOU ARE READY TO RETURN TO THE COURTROOM.

Eighth Circuit Model Instruction No. 3.12 (1992).

[cited in USAM 4-8.245]