United States v. Industrial Laboratories Co., 71-1651.

Decision Date03 April 1972
Docket NumberNo. 71-1651.,71-1651.
PartiesUNITED STATES of America, Plaintiff-Appellee, v. INDUSTRIAL LABORATORIES CO. and David Paul Ochs, Defendants-Appellants.
CourtU.S. Court of Appeals — Tenth Circuit

Gregory B. Hovendon, Atty., Department of Justice (Richard W. McLaren, Asst. Atty. Gen., James L. Treece, U. S. Atty., C. Coleman Bird, Atty., Department of Justice, Peter Barton Hutt, Asst. Gen. Counsel, Food, Drugs, and Environmental Health Division, Eugene M. Pfeifer, Robert E. Wilmoth and Marc H. Bozeman, Attys., United States Department of Health, Education, and Welfare, of counsel, on the brief), for plaintiff-appellee.

Lawrence M. Henry, Denver, Colo., for defendants-appellants.

Before HILL, BARRETT and DOYLE, Circuit Judges.

WILLIAM E. DOYLE, Circuit Judge.

The appellants Industrial Laboratories Company and David Paul Ochs (the latter being the Laboratories' Chief Chemist) were convicted by a jury in U. S. District Court for Colorado on two counts each of causing, with intent to mislead and defraud, the introduction and the delivery for introduction into interstate commerce of an adulterated drug in violation of § 301(a) of the Federal Food, Drug and Cosmetic Act, as amended, 21 U.S.C. § 331(a).1

Also submitted to the jury were the misdemeanor charges resulting from alleged violations of 21 U.S.C. § 331(a). The jury was told that these were lesser included offenses and it was to consider them only if the jury concluded that the defendants were not guilty of committing the offense with intent to defraud or mislead as defined by § 333(b), supra. The sole question presented is whether the trial court failed to instruct the jury adequately on the question of the specific intent requirement set forth in § 333(b), supra. See Note 1.

Industrial Laboratories Co. is engaged in making analyses of food and drug products. The defendant Ochs is the Chief Operating Officer of this company as well as its Chief Chemist. He unquestionably was shown to have been the responsible person in the operation and was also shown to have been personally involved in the transactions tried.

There were two shipments which were found by the jury to have been adulterated. The defendants had for some time been performing analyses for Denver Veterinary Labs, Inc. particularly of a substance known as Dextrose Solution 50% which Denver produced for shipment to Viobin Veterinary Products, Ltd. of Canada. Prior to March 1967, Industrial Laboratories performed but one test on the substance, but in March 1967, Viobin notified Denver by letter that the test results in that form would no longer be considered sufficient to satisfy the standards of the Canadian government. Certain other tests were requested. Following receipt of this letter a discussion was had between the Denver Laboratories director and Ochs, and following this a new report was devised. This listed several other tests. But the evidence established that Industrial Laboratories continued to perform only the test that had previously been performed. Furthermore, the evidence established that the two lots of drugs that are referred to in the indictment were in fact adulterated.

The verdicts were clear enough. The two forms on which the jury returned verdicts of guilty called for a finding that there was an intent to defraud or mislead. Hence there could have been no question on the part of the jury that they had to find existence of the intent2, and so the only question is whether the instruction clearly delineated to the jury the necessity for finding a specific intent to defraud and also whether the jury was told in clear terms the meaning of intent in this context. The trial court instructed the jury as to the provision of the statute in question, § 333(b), supra.3

The trial court referred to the necessity for proof of intent when it told the jury about the lesser included offense of introducing into interstate commerce without any intent to mislead or defraud. It thus differentiated the two grades of offense and went on to say that if the jury was convinced that the defendants caused the drugs to be shipped in interstate commerce without the intent to mislead and defraud, the jury was at liberty to find the defendants guilty of a lesser included offense.

In lining out the elements of the felony charge the jury was told that in order for it to find the defendant guilty it must find beyond a reasonable doubt first, that the drug involved was shipped in commerce; second, that it was adulterated, describing what constitutes adulteration; third, as to the defendant Ochs, that he had a responsible position and was responsible for the preparation of an analyses report showing that certain tests were performed. But there was no mention of intent as an essential element. At another place in the charge the court stated that anyone who causes an adulterated drug to be introduced into commerce knowingly violates the law. The court went on to say that the government did not have to prove that the defendant knew that the drug was adulterated and that it was not necessary for the government to prove that the defendant intended to violate the law.

As we view it, there was reason for misunderstanding and confusion as to the necessity to find the existence of a specific intent to defraud or mislead. The jury was told generally that the government was not required to prove a specific intent to violate the law. Undoubtedly this was directed to the lesser included offense. However, its inapplicability to the felony count was not pointed out. We must hold that it was essential that the jury be told that under § 333(b) intent to mislead or defraud was an essential ingredient. The jury should have been further directed that it was necessary for it to find that the defendant knew that the several tests had not been made, that Ochs intentionally misrepresented that they had, and that he did so for the purpose of misleading and defrauding the consignee and the Canadian authorities that such several tests had in fact been performed.4 The jury should have been further instructed that an act is done willfully if done voluntarily and intentionally, and with specific intent to do something the law forbids, that is to say, with bad purpose either to disobey or to disregard the law.5

This court has repeatedly recognized the duty of the trial court to instruct on the elements of the offense. See, e. g., Jones v. United States, 251 F.2d 288 (10th Cir. 1958), cert. denied 356 U.S. 919, 78 S.Ct. 703, 2 L.Ed.2d 715 (1958). See also Kolod v. United States, 371 F.2d 983, 993 n. 4 (10th Cir. 1967), set aside on other grounds, 390 U.S. 136, 88 S.Ct. 752, 19 L.Ed.2d 962. The Supreme Court in Screws v. United States, 325 U.S. 91, 65 S.Ct. 1031, 89 L.Ed. 1495 (1945), held that plain error is committed when an essential ingredient of the crime charged is not adequately presented to the jury.

The Court of Appeals for the Fifth Circuit has held that the specific intent element is not presented to the jury adequately when the jury is merely told that the actor is held to intend the natural consequences of his acts.6

In United States v. Kemble, 197 F.2d 316 (3rd Cir. 1952), the failure of the trial court in a case in which the only defense was lack of felonious intent to charge on a specific intent was ruled plain error.

This court has recognized on numerous occasions the necessity for adequately charging on the issue of intent. See Hayes v. United States, 227 F.2d 540 (10th Cir. 1955), and Haskell v. United States, 241 F.2d 790 (10th Cir. 1957), cert. denied 354 U.S. 921, 77 S.Ct. 1379, 1 L.Ed.2d 1436.

We conclude that since intent is an essential element of the crime and since the instructions do not contain a clear and unambiguous description of specific intent as an essential element, and do not contain a definition of intent...

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    ...as the FDA or a similar governmental agency. The case law from this circuit recognizes such a result. In United States v. Industrial Laboratories Co., 456 F.2d 908 (10th Cir.1972), the defendant company and its chief chemist were convicted of introducing an adulterated drug into interstate ......
  • U.S. v. Hiland
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    • 19 Julio 1990
    ...addressing the meaning of Sec. 333(a)(2)'s intent requirement adheres to this basic principle. See United States v. Industrial Laboratories Co., 456 F.2d 908, 909-11 (10th Cir.1972). 18 Given the fraud that the government alleged and sought to prove in the instant case, we think it is quite......
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    ...940 F.2d 1329, 1345 (10th Cir.1991); United States v. Bradshaw, 840 F.2d 871, 872 (11th Cir.1988); United States v. Industrial Lab. Co., 456 F.2d 908, 910 (10th Cir.1972). Because the concept of "defrauding" under 21 U.S.C. § 333(a)(2) has not been as broadly construed as its linguistically......
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