THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
Go to Shellow
Collection Table of Contents
Federal Food, Drug, and Cosmetic Act (21 USC 301 (et seq.))
1. Specific Intent To
Defraud Or Mislead Required Under FD & C Act
2. Link Between Intent To
Defraud And Misbranding Or Adulteration
3. Meaning Of "Intent
To Defraud And Mislead" Under FD & C Act
4. "Intent to Defraud
or Mislead" Defined
5. Meaning Of
"Dishonesty"
6. When Labeling Is
Misleading
7. Intent Requires Actual
Knowledge That Drug At Issue Was Unapproved
And Not Properly Labeled Or Safe
8. Actual Knowledge Of
Unsafe Quality Required
9. Meaning Of
"Food"
10. Definition Of "Food
Additive"
11. Definition Of "Food:"
Intent Of Buyer-Consumer
12. Intent To Disobey Law Required
13. Covert Action Alone Not Intent To
Mislead Or Defraud
14. Knowledge Of Food And Drug Act
Requirements
15. Conspirator Must Know Government
Functions
16. Conspiracy To Defraud, Not To
Commit Offense
17. Multiple Agency: Unanimity On
Conspiracy's Object
18. Scientific Literature As
Indicator Of Safeness And Effectiveness
19. 21 USC 321(g)(1)(C): Food Or Drug
20. Definition Of "Animal
Drug"
21. Intent Of Seller
22. Clenbuterol: Drug or Food
23. Identity Of Clenbuterol
24. Dutiable Nature Of Animal
Feedstuffs
25. Credibility Of Government Testing
26. Reliability Of Government Testing
27. Knowledge Of Drug Status: Terms
Must Be Clear And Unambiguous
28. False Description: Burden Of
Proof
29. Good Faith Belief That Conduct
Was Lawful: Factors To Consider
30. Sample Defense Theory Instruction
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
1. Specific Intent To Defraud Or Mislead Required Under FD & C Act
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
For purposes of Count(s) _____, you may not convict a defendant unless the government has satisfied you beyond a reasonable doubt that the defendant at issue specifically intended to mislead or defraud either a natural person or a governmental agency.
AUTHORITIES:
United States v. Arlen, 947 F.2d 139, 143 (5th Cir. 1991), cert. denied, 112 S.Ct. 1480 (1992); United States v. Mitcheltree, 940 F.2d 1329, 1349-52 (10th Cir. 1991); United States v. Hiland, 909 F.2d 1114, 1129 (8th Cir. 1990); United States v. Industrial Laboratories Co., 456 F.2d 908, 910-11 (10th Cir. 1972).
RELATED SHELLOW MATERIALS:
See also THE SHELLOW COLLECTION: Elements: Criminal
Intent.
RELATED NCJIC MATERIALS:
See generally NCJIC Chapter 45: Criminal Intent.
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
2. Link Between Intent To Defraud And Misbranding Or Adulteration
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
In considering whether the government has met its burden of proof under Count(s) _____, I instruct you that there must be demonstrated link between the misbranding or adulteration, if you find that, and an intent to mislead or defraud the FDA. Merely distributing drugs in knowing violation of federal and state regulatory systems and rules is too general to satisfy this requirement.
AUTHORITIES:
United States v. Mitcheltree, 940 F.2d 1329, 1349 (10th Cir. 1991).
RELATED SHELLOW MATERIALS:
See also THE SHELLOW COLLECTION: Elements: Criminal
Intent.
RELATED NCJIC MATERIALS:
See generally NCJIC Chapter 45: Criminal Intent.
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
3. Meaning Of "Intent To Defraud And Mislead" Under FD & C Act
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
As used in Count(s) _____, the phrase "intent to defraud or mislead" requires two forms of proof: first, that the defendant(s) knew of the underlying violation of the statute or regulation; and second, that the defendant(s) specifically intended to mislead or defraud a government agency in connection to that underlying statutory violation.
AUTHORITIES:
United States v. Mitcheltree, 940 F.2d 1329, 1351 (10th Cir. 1991); United States v. Richardson, 684 F.2d 952, 955 (7th Cir. 1982).
RELATED SHELLOW MATERIALS:
See also THE SHELLOW COLLECTION: Elements: Criminal
Intent.
RELATED NCJIC MATERIALS:
See generally NCJIC 3.2.6 [Duty To Define Terms With Specialized/Technical Meaning; No Duty To Define Common Terms].
See generally NCJIC Chapter 45: Criminal Intent.
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
4. "Intent To Defraud Or Mislead" Defined
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
The defendant must prove beyond a reasonable doubt that the defendant acted with the intent to defraud or mislead the FDA in order to convict under Count(s) ____. The intent to defraud or mislead must be linked to the specific alleged FDA violation in each of Count(s) ______ In other words, in order to convict under Count(s) _____, the government must prove beyond a reasonable doubt that the defendant acted with the intent to defraud specifically in connection with the alleged shipments in interstate commerce described in those counts.
AUTHORITIES:
United States v. Mitcheltree, 940 F.2d 1329 (10th Cir. 1991).
RELATED SHELLOW MATERIALS:
See also THE SHELLOW COLLECTION: Elements: Criminal
Intent.
RELATED NCJIC MATERIALS:
See generally NCJIC 3.2.6 [Duty To Define Terms With Specialized/Technical Meaning; No Duty To Define Common Terms].
ee generally NCJIC Chapter 45: Criminal Intent.
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
5. Meaning Of "Dishonesty"
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
Under Count ____, the defendant must conspire to impede or impair the functions of a government agency through dishonesty. The failure to file a new animal drug application or an investigational new animal drug application is not, by itself, dishonesty.
RELATED NCJIC MATERIALS:
See generally NCJIC 3.2.6 [Duty To Define Terms With Specialized/Technical Meaning; No Duty To Define Common Terms].
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
6. When Labeling Is Misleading
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
If an article is alleged to be misbranded because the labeling is misleading, then in determining whether the labeling is misleading you shall take into account, among other things, not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling fails to reveal facts material in light of such representations or material with respect to consequences which may result from use of the article to which the labeling relates under the conditions of use prescribed in the labeling thereof or under such conditions of use as are customary or usual.
AUTHORITIES:
21 USC 321(n).
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
7. Intent Requires Actual Knowledge That Drug At Issue Was Unapproved And Not Properly Labeled Or Safe
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
In order to have the required intent to defraud or mislead for purposes of Count(s) ____, a defendant must have actual knowledge that the drug at issue was unapproved and not properly labeled or safe.
AUTHORITIES:
United States v. Hiland, 909 F.2d 1114, 1128 (8th Cir. 1990); United States v. Industrial Laboratories Co., 456 F.2d 908, 910-11 (10th Cir. 1972).
RELATED SHELLOW MATERIALS:
See also THE SHELLOW COLLECTION: Elements: Knowledge.
See also THE SHELLOW COLLECTION: Elements: Criminal Intent.
RELATED NCJIC MATERIALS:
See generally NCJIC Chapter 45: Criminal Intent.
See generally NCJIC Chapter 47: Knowledge.
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
8. Actual Knowledge Of Unsafe Quality Required
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
You may not convict the defendants of adulterating a new animal drug, unless the government has proven beyond a reasonable doubt that the defendants at the time actually knew that the substance at issue was not generally recognized by experts in the field as safe and effective for the use that the defendants intended under the conditions prescribed, recommended, or suggested in the labeling thereof.
RELATED SHELLOW MATERIALS:
See also THE SHELLOW COLLECTION: Elements: Knowledge.
RELATED NCJIC MATERIALS:
See NCJIC Chapter 47: Knowledge.
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
9. Meaning Of "Food"
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
Food is a substance fed to man or animals primarily for its taste, aroma, or nutritive value.
AUTHORITIES:
21 USC 321(f); Nutrilab, Inc. v. Schweiker, 713 F.2d 335, 338 (7th Cir. 1983).
RELATED NCJIC MATERIALS:
See generally NCJIC 3.2.6 [Duty To Define Terms With Specialized/Technical Meaning; No Duty To Define Common Terms].
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
10. Definition Of "Food Additive"
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
The term "food additive" means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food, except that the term does not include a new animal drug.
AUTHORITIES:
21 USC 321(s).
RELATED NCJIC MATERIALS:
See generally NCJIC 3.2.6 [Duty To Define Terms With Specialized/Technical Meaning; No Duty To Define Common Terms].
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
11. Definition Of "Food:" Intent Of Buyer-Consumer
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
In determining whether a substance is a food, you must examine the intent of the buyer-consumer.
RELATED NCJIC MATERIALS:
See generally NCJIC 3.2.6 [Duty To Define Terms With Specialized/Technical Meaning; No Duty To Define Common Terms].
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
12. Intent To Disobey Law Required
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
Before may convict a defendant on any of Count(s) ____, the government must satisfy you beyond a reasonable doubt that the defendant at issue acted with the specific purpose to disobey or disregard the law.
AUTHORITIES:
United States v. Industrial Laboratories Co., 456 F.2d 908, 911 (10th Cir. 1972).
RELATED SHELLOW MATERIALS:
See also THE SHELLOW COLLECTION: Elements: Criminal
Intent.
RELATED NCJIC MATERIALS:
See generally NCJIC Chapter 45: Criminal Intent.
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
13. Covert Action Alone Not Intent To Mislead Or Defraud
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
Keep in mind in considering the misbranding counts that "covert criminal activity involving drugs is not synonymous with misbranding with an intent to mislead or defraud." The government must prove more than just that the defendants' activities were covert, meaning covered up or hidden, to establish the required intent mislead or defraud.
AUTHORITIES:
United States v. Mitcheltree, 940 F.2d 1329, 1352 (10th Cir. 1991).
RELATED SHELLOW MATERIALS:
See also THE SHELLOW COLLECTION: Elements: Criminal
Intent.
RELATED NCJIC MATERIALS:
See generally NCJIC Chapter 45: Criminal Intent.
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
14. Knowledge Of Food And Drug Act Requirements
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
Under Count ____, the defendant must know that the merchandise had been imported in violation of the federal Food and Drug Act that prohibits the introduction of adulterated goods into interstate commerce. Knowledge that required duties, if any, had not been paid or knowledge that the general requirements of the customs laws for importation had been violated cannot satisfy the requirement that the defendant, as charged in Count ____, know that the merchandise had been imported contrary to the law prohibiting the shipment of adulterated drugs.
Furthermore, in Count ____ the government must prove that the defendant knew that the merchandise was an unapproved new animal drug, as that term is defined under federal law, and that the federal Food and Drug Act prohibits the introduction of such goods from outside the country into the United States.
AUTHORITIES:
United States v. Hiland, 909 F.2d 1114, 1129 (8th Cir. 1990) [21 USC 331(d) and 333(a)(2) case].
RELATED SHELLOW MATERIALS:
See also THE SHELLOW COLLECTION: Elements: Knowledge.
See also THE SHELLOW COLLECTION: Elements: Criminal Intent.
RELATED NCJIC MATERIALS:
See generally NCJIC Chapter 45: Criminal Intent.
See generally NCJIC Chapter 47: Knowledge.
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
15. Conspirator Must Know Government Functions
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
To knowingly and intentionally become a member of the charged conspiracy, the defendant must know the lawful functions of the Customs Service and the Food and Drug Administration, and must intend to impair, impede, or defeat those lawful functions through dishonest means.
AUTHORITIES:
Dennis v. United States, 384 U.S. 855, 861-62 (1966).
RELATED SHELLOW MATERIALS:
See also THE SHELLOW COLLECTION: Conspiracy.
RELATED NCJIC MATERIALS:
See NCJIC Chapter 83: Conspiracy.
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
16. Conspiracy To Defraud, Not To Commit Offense
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
If you find that the defendant conspired to violate various laws of the United States, but have a reasonable doubt as to whether the defendant conspired to defraud the government, then you must acquit the defendant.
AUTHORITIES:
Stirone v. United States, 361 U.S. 212 (1960) [18 USC 1951 case].
RELATED SHELLOW MATERIALS:
See also THE SHELLOW COLLECTION: Conspiracy.
RELATED NCJIC MATERIALS:
See NCJIC Chapter 83: Conspiracy.
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
17. Multiple Agency: Unanimity On Conspiracy's Object
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
Before you may convict on Count ___, the conspiracy charge, you must agree unanimously either that the conspiracy encompassed a plan to defraud both the _______ (other agency e.g., Customs Service) and the Food and Drug Administration, or that the conspiracy encompassed a plan to defraud one of those agencies. If the conspiracy concerned just one of those agencies, you must agree unanimously which agency that was.
AUTHORITIES:
Seventh Circuit Instructions, vol. II, p. 90; United States v. Beros, 833 F.2d 455, 461 (3d Cir. 1987).
RELATED SHELLOW MATERIALS:
See also THE SHELLOW COLLECTION: Conspiracy.
RELATED NCJIC MATERIALS:
See NCJIC Chapter 83: Conspiracy.
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
18. Scientific Literature As Indicator Of Safeness And Effectiveness
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
In determining whether an alleged drug is generally recognized as safe and effective, published literature is one, but not the only, indicator of such general recognition.
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
19. 21 USC 321(g)(1)(C): Food Or Drug
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
In considering Count(s) ____, if you find that the substance charged in a particular count is food and not intended to cure, treat or prevent disease, or that a reasonable doubt remains that the substance may be such a food, you must find the defendants not guilty on that count.
AUTHORITIES:
21 USC 321(g)(1)(C).
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
20. Definition Of "Animal Drug"
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
If you find that these substances in fact were present, you must decide whether ___________ (substances e.g., clenbuterol, avoparcine, zinc bacitracin, furazolidone and nitrofurazone) are drugs. Something is a drug only if (a) the person or company selling it actually intended that the substance be used in the diagnosis, cure, mitigation, treatment, or prevention of disease; or (b) the person or company intended the substance to affect the structure or any function of the body of an animal, so long as the substance is not food. Food is not a drug unless the food is actually intended to cure, treat or prevent disease.
If you find that the government has proven beyond a reasonable doubt that the defendants intended a given substance to be used as a drug, then you may proceed to consider whether the government has proven the other required elements in the specific count under consideration. If you are not satisfied that the government has proven that the defendants intended a given substance to be used as a drug, you should not address the remaining elements of that charge and must find the defendants not guilty on the count under consideration.
AUTHORITIES:
United States v. Articles of Drug for Veterinary Use, 50 F.3d 497, 500 (8th Cir. 1995); United States v. Pro-Ag, Inc., 796 F. Supp. 1219, 1224 (D. Minn. 1991), aff'd, 968 F.2d 681 (8th Cir. 1992); United States v. Storage Spaces, 777 F.2d 1363, 1366 (9th Cir. 1985), cert. denied sub nom., Nescco, Inc. v. United States, 479 U.S. 1086 (1987); 21 U.S.C. §321(g)(1).
RELATED NCJIC MATERIALS:
See generally NCJIC 3.2.6 [Duty To Define Terms With Specialized/Technical Meaning; No Duty To Define Common Terms].
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
21. Intent Of Seller
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
In determining whether a substance is a drug because of its intended use, you must examine the intent of the seller. The intent to treat disease or to alter the structure or function of the body must be the seller's intent. In determining the seller's intent, you may take into account the labeling, promotional material, advertising, and marketing originating with the seller.
AUTHORITIES:
United States v. Articles of drugs for Veterinary Use, 50 F.3d 497, 500 (8th Cir. 1995); United States v. Hiland, 909 F.2d 1114, 1129 (8th Cir. 1990).
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
22. Clenbuterol: Drug Or Food
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
To find that clenbuterol or any substance containing clenbuterol was a drug, you must find that clenbuterol is not food and that the defendant intended for the clenbuterol to be used to promote growth and feed efficiency in veal calves.
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
23. Identity Of Clenbuterol
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
In order to conclude that clenbuterol was present as charged in the indictment, you must find that the substance alleged to be clenbuterol was the racemic mixture of the isomers of clenbuterol. You may not reach a conclusion that clenbuterol was present if you have not found beyond a reasonable doubt that the racemic mixture of those isomers was present.
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
24. Dutiable Nature Of Animal Feedstuffs
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
Animal food, composed of at least 6% grain products, and also containing vitamins, minerals, and other nutrition sources, is duty free under the Customs laws of the United States.
AUTHORITY:
Vitek Supply Co. v. United States, 17 CIT 111, 1993 WL 35206 (CIT) 1993 Ct. Intl. Trade LEXIS 6 (1993).
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
25. Credibility Of Government Testing
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION # 1:
You will be considering evidence about FDA testing for _______(substance e.g., clenbuterol, avoparcine, zinc bacitracin, furazolidone, and nitrafurazone). In considering the credibility of such evidence, I instruct you that the FDA had adopted specific regulations concerning how its tests must be conducted. Under such regulations, the FDA is required to use methods of analysis established by the Association of Official Analytical Chemists. If there is no AOAC method with respect to a particular product, the Commissioner of the FDA must formally adopt a particular method that the FDA must use. In evaluating the tests conducted by the FDA in this case, you are to consider whether the FDA followed these requirements.
AUTHORITY:
21 CFR 2.18.
SAMPLE INSTRUCTION # 2:
In considering the credibility of the evidence provided by FDA chemists, I instruct you that the FDA requires laboratories to use established, scientifically sound and appropriate specifications, standards, sampling plans, and test procedures.
AUTHORITIES:
21 CFR 211.160.
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
26. Reliability Of Government Testing
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
In evaluating the quality of the FDA testing in this case, I instruct you that the FDA has specific regulations which govern how such testing is to be conducted. One of those regulations requires that the laboratory have statements with respect to all the methods used in testing any sample which must establish that the methods used in testing need proper standards of accuracy and reliability as applied to the product that is tested. The method may be one which is in the United States Pharmacopeia, National Formulary, Association of Official Analytical Chemists, Book of Methods, or another recognized standard reference. The suitability of all testing methods must be verified under actual conditions of use.
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
27. Knowledge Of Drug Status: Terms Must Be Clear And Unambiguous
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
In determining whether the defendants knowingly and intentionally committed offenses involving drugs or new animal drugs, you must consider whether the defendant knew that the substances in question were drugs or new animal drugs. You must find beyond a reasonable doubt that the terms "drug" and "new animal drug" were so clear and unambiguous that the defendant knew that the substances in question were drugs or new animal drugs, as those terms are defined by law.
AUTHORITIES:
United States v. Hiland, 909 F.2d 1114, 1127 & n.17 (8th Cir. 1990).
RELATED SHELLOW MATERIALS:
See also THE SHELLOW COLLECTION: Elements: Knowledge.
See also THE SHELLOW COLLECTION: Elements: Criminal Intent.
RELATED NCJIC MATERIALS:
See generally NCJIC Chapter 45: Criminal Intent.
See generally NCJIC Chapter 47: Knowledge.
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
28. False Description: Burden Of Proof
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
In Count(s) _____, the defendants are charged with falsely describing the merchandise in each count as ________ (description e.g., unmedicated calf premix). The government must prove beyond a reasonable doubt that the substances in these shipments, even if containing ________ (substances e.g., avoparcine or zinc bacitracin), could not be honestly described as ________ (description e.g., unmedicated calf premix) and that the defendant knew that the substances could not be honestly described as ________ (description e.g., unmedicated calf premix).
AUTHORITIES:
19 USC 1481(a)(3).
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
29. Good Faith Belief That Conduct Was Lawful: Factors To Consider
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION # 1:
In determining whether the defendants held the good faith belief that the conduct alleged in Count(s) _____ was lawful, you may consider the evidence that on several occasions FDA officials inspected ________’s (name of defendant/company) records, that these records reflected that ________ (name of defendant/company) had sold _______ (substance e.g., avoparcine and zinc bacitracin), and that the FDA never warned the defendants, or otherwise advised them, that these substances could not lawfully be distributed in interstate commerce. Although a belief does not need to be reasonable in order to be in good faith, nevertheless, evidence of a belief's reasonableness tends to negate a finding of willfulness and to support a finding that the defendants' belief was held in good faith.
AUTHORITIES:
United States v. Lankford, 955 F.2d 1545, 1550-51 (11th Cir. 1992).
SAMPLE INSTRUCTION # 2:
You have heard evidence that on several occasions FDA officials inspected ________’s (name of defendant/company) records, that these records reflected that ________ (name of defendant/company) had sold _______ (substance e.g., avoparcine and zinc bacitracin), and that the FDA never warned the defendants, or otherwise advised them, that these substances could not lawfully be distributed in interstate commerce. You should consider this evidence in determining whether the government has proven beyond a reasonable doubt that it did not mislead the defendants into believing that their conduct was lawful.
THE SHELLOW COLLECTION
Jury Instructions By James M. Shellow of Wisconsin
30. Sample Defense Theory Instruction
ALERT: Carefully review the Caveats and Disclaimers before using these materials.
SAMPLE INSTRUCTION:
It is a part of the defendants' theory of the case that Avotan, zinc bacitracin, and vitamins all fall within the general designation of animal feed or animal feed premixes for Customs purposes and that there was no fraud or dishonesty in describing these products as veal premix, calf premix, or lamb premix. The government must prove beyond a reasonable doubt that the defendants knew that the substances were falsely described and were falsely described in order to avoid a duty that was owed or to gain an impermissible entry into the country.
It is a further part of the defendants' theory of the case that clenbuterol, zinc bacitracin, Avotan, and NFZ were not animal drugs or new animal drugs, but were food or food additives. As to each of these substances, the government must prove beyond a reasonable doubt that it was a drug or a new animal drug, and not a food or food additive. Moreover, the government must prove beyond a reasonable doubt that the defendants knew that these substances were drugs or new animal drugs, and not food or food additives.
It is a further part of the defendants' theory of the case that FDA inspectors regularly visited the _______ (name of company) premises and saw that zinc bacitracin and Avotan were listed in _______’s (name of company) inventory records, as well as being stored on the premises, and these inspectors never asserted to defendants that there was a legal prohibition on the use of zinc bacitracin or Avotan. The government must prove beyond a reasonable doubt that these inspections did not mislead the defendants into believing that they were in compliance with federal law.
It is a further part of the defendants' theory of the case that the government's chemical testing in this case was unvalidated and unreliable. The government must prove beyond a reasonable doubt that each of the alleged substances has the chemical identity alleged for it in the indictment.