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United States v. Lee.

November 22, 1939

UNITED STATES
v.
LEE.



Appeal from the District Court of the United States for the Eastern District of Wisconsin; Patrick T. Stone, Judge.

Author: Kerner

Before MAJOR, TREANOR, and KERNER, Circuit Judges.

KERNER, Circuit Judge.

The defendant, Royal Lee (trading as the Vitamin Products Company of Milwaukee, Wisconsin), appeals from a judgment which pronounced a sentence upon him after conviction by jury. In four counts, the indictment charged him with the interstate shipment of his product "Catalyn" on October 23 and November 2 of 1933, and with the misbrading of Catalyn, thereby violating Sections 2 and 8 of the Food and Drug Act of 1906, as amended. See 21 U.S.C.A. §§ 2, 9, 10; see also Secs. 1 and 7.

Counts 1 and 3 of the indictment charged that certain representations, pertaining to the curative and therapeutic effect of Catalyn and printed on the bottle labels, wrappers and enclosures, were false and fraudulent. 21 U.S.C.A. § 10. In this regard, it was alleged that by these means defendant intended to deceive buyers and to create in their minds the impression that Catalyn contained ingredients effective to cure, mitigate, or prevent over fifty enumerated ailments, e.g., dropsy, goiter, heart trouble, and stomach ulcers.

Counts 2 and 4 of the indictment charged that certain statements pertaining to the contents or ingredients of Catalyn were false and misleading. 21 U.S.C.A. § 9. In this connection, it was alleged that the particular information on the bottle labels indicated falsely that Catalyn contained definite proportions of the various vitamins. On this appeal, the fact finding of interstate commerce, amply supported by the evidence, was not contested. 21 U.S.C.A. § 2.

The defendant was tried before the jury and convicted on all four counts. The court imposed sentence and the defendant appealed therefrom. In his appeal, defendant urges consideration of the following assigned errors: (1) refusal to discharge defendant at the close of plaintiff's case; (2) justice not done; (3) misconduct of trial judge; (4) improper admission and rejection of evidence; (5) improper assessment of costs; (6) refusal to grant bill of particulars; and (7) erroneous instructions. Our considerations follow.

Refusal to Discharge Defendant at close of Plaintiff's Case. In order to consider the error here assigned, it is necessary to analyze the Government's evidence in the light of the charge made in the indictment. In this case, defendant holds his Catalyn tablet out to the buying public as containing various vitamins and definite proportions thereof; he also states that Catalyn is effective for the treatment of certain enumerated diseases and ailments. On the other hand, the Government alleges in the indictment that Catalyn does not contain the named vitamins or definite proportions thereof, and that Catalyn's therapeutic claims are exaggerated and intended to deceive the public. Has the Government proved its case?

Evidence adduced in the form of physical and documentary exhibits clearly show Lee's representations concerning the contents and curative effect of Catalyn. The bottle label stated that the bottle "Contains Vitamins: A-B-C-D-E-F-& G; in such proportions as to most effectively restore normal metabolism where abnormality is present." The blue circular accompanying the bottle of Catalyn tablets stated, in substance and among other things, that Catalyn was effective for the treatment of Pernicious Anemia, Dropsy, Goiter, Heart Trouble, Underweight, Pneumonia, Bright's Disease, St. Vitus Dance in Children and Stomach Ulcers. Booklets advertising Catalyn revealed such statements as "Catalyn * * * Recommended and Guaranteed for Goiter, Heart Trouble, * * * Insomnia, * * * Anemia, * * * Dropsy * * * ."

The Government introduced evidence relating to the composition and constituent ingredients of Catalyn. The testimony in this regard disclosed that Catalyn did not contain vitamins A, C or D, and that it did contain 1 3/10 international units of vitamin B and vitamin G equal to 1/7 gram of dried yeast. Further testimony indicated that vitamin G is now known as vitamin B, and pointed out that the user would have to take 150 Catalyn tablets per day to meet the body's daily minimum need therefor.

It is obvious that this evidence refutes defendant's representations that Catalyn consisted of vitamins A-B-C-D-E-F-G in "such proportions as to most effectively restore normal metabolism where abnormality is present." In addition, this evidence also militates against defendant's assertions that Catalyn possessed therapeutic value, for Catalyn's curative powers are necessarily based on the named vitamins.

The source of the evidence discussed above is the biological analysis of Catalyn conducted by the Vitamin Division of the United States Food and Drug Administration. This vitamin assay of Catalyn was made under the supervision of Nelson, a recognized authority on vitamins and vitamin standards. Nelson was aided by Irish (chemist), who directly determined the vitamin contents of Catalyn and who also made a chemical analysis in the case of vitamin C. This bioassay analysis was supported by a qualitative examination by Yakowitz (analytic chemist), microscopic examination by Keenan (microanalyst), and a quantitative examination by Light-body (pharmacologist).

The bioassay test used here, namely, the biological method of measuring the vitamin contents of a given product by employing experimental animals (white rats and guinea pigs), is the test accepted and the method officially recognized by the consensus of expert opinion in the field of medicine, pharmacy, and nutrition. In this case, the accuracy of the biological analysis and the evidence obtained therefrom stands uncontradicted and unquestioned.

In this connection, it is interesting to note that defendant's witness Dr. Barrett, in discussing the bioassay test, remarked that it is "the best way we now have" to determine the presence or absence of vitamins in a given product. Moreover, defendant's witness Dr. Kanoky testified that "if I wanted to know how much vitamin there was in a Catalyn pill I would turn it over to a biologist" and that the bioassay method is the accepted method by the profession to determine the quantity of vitamins in a given product."

The Government then adduced expert testimony relating to the therapeutic or curative value of Catalyn. In substance, the physicians called by the Government testified to and agreed on two propositions: (1) that assuming the accuracy of the vitamin analysis (and, as we have stated before, the accuracy thereof is not attacked), Catalyn lacks therapeutic merit; (2) that assuming Catalyn contained the represented vitamins, its curative value would nevertheless be confined to vitamin-deficiency cases, which excludes such diseases and ailments as measles, anemia, dropsy, goiter, valve leakage of the heart, pneumonia, Bright's disease, St. Vitus Dance, leg ulcers, and stomach ulcers.

These physicians - Drs. Hart, Sevringhaus, Quick, Lettenberger, Brussock, and Goldwater - explicitly added that their testimonies expressed opinions that represented the consensus of reliable medical knowledge. to us it is significant that defendant's expert witnesses did not controvert these expressions. Such an omission suggests to us that the opinions of defendant's expert witnesses, as to whether the above enumerated maladies are vitamin-deficiency diseases, were personal ones and not in accord with the consensus of reliable medical knowledge.

Dr. Goldwater also testified that he had administered Catalyn to patients. These tests on human beings convinced him that Catalyn was ineffective, and he so informed the defendant almost a year before the Information was filed. The defendant, however, continued to make the representations in question and to state that "There may be some persons (professional and laymen) who, because of ignorance, or becaus of belief in obsolete therapeutic theories, may cavil 'Catalyn'. Some may even intimate the ineffectiveness of vitamins for some of the ailments we list."

In addition, the advertising booklet devoted considerable space to a series of detailed reports concerning users of Catalyn. In the booklet it was stated that the case reports were "authentic" and represented "Convincing Evidence of the Merits of Catalyn." In this case, the Government introduced evidence refuting the authenticity of some of the case reports, and for our purpose it is sufficient to relate one instance.

The case report of J. M. Reidy disclosed that he was "badly bloated" with dropsy and that he suffered from heart trouble, enlarged prostate gland, and shortness of breath. The report further represented that Reidy started to take Catalyn on December 19 and that by January 28 he was "back to work," with "heart apparently O.K." and "no more shortness of breath."

The Government introduced refuting testimony by Reidy's two daughters and his attending physician. Evelyn Reidy testified that "the only trouble he did suffer from was a heart ailment" and that he did not go back to work on January 28. Mrs. Cyrillus Reidy Nichol, a registered nurse, testified that Reidy was not suffering from dropsy. In addition to verifying the testimonies above, Dr. Farrell, the attending physician, stated that Reidy was not suffering from an enlarged prostate gland. Dr. Farrell added that he had not prescribed Catalyn tablets for Reidy and that he knew Reidy "wasn't taking them."

This evidence clearly bears on the issue of intent and permits the submission of the question of fraud to the common sense judgment of the jury to find whether under the particular facts and circumstances the acts of the defendant were honest, however mistaken, or false and fraudulent. See United States of America v. Dr. David Roberts Veterinary Co., Inc., et al., 7 Cir., 104 F.2d 785, 788. So, we are convinced and conclude that, at this stage of the trial, at the close of the Government's case, the evidence clearly showed that the Government had proved its case, and for this reason we believe that defendant's assigned error thereon lacks substance.

Justice Has Not Been Done. This general assignment of error is based fundamentally on the contention that the evidence as a whole does not prove defendant guilty of the particular offense beyond a reasonable doubt. We have analyzed the Government's evidence and have concluded that at that stage of the trial the court had not erred in refusing to discharge the defendant. We shall now examine the defendant's evidence, keeping in mind that the gist of the offense charged is misbranding and misrepresenting the contents and therapeutic value of Catalyn.

It is interesting to note that the defendant's witnesses, lay and expert, did not state that Catalyn contained the named vitamins. Nor did they question the accuracy of the bioassay evidence. Nor had they made any analysis of Catalyn. The defendant testified as to how Catalyn was made and what vegetable and animal sources went into the making thereof. At most, the inference that a product made from vitamin-bearing matter contains vitamins creates conflicting evidence, the credibility of which falls within the province of the jury.

Such an inference is not equal to the assuring representation that all the vitamins were present, and almost disappears when matched against uncontradicted evidence that vitamin A,C, and D are absent. Significant here is Lee's answer, when asked what vitamins Catalyn contained, that it "contains materials to produce the effect of all the vitamins." Interesting, too, is Dr. S's statement that although he did not know what was in Catalyn he felt that it helped his patients.

We observe also that the thesis of the expert testimony for the defense is that Catalyn has helped to cure patients subjected to diseases such as enumerated earlier in this opinion. At this point, we must remember that this curative power of Catalyn is ascribed to the vitamins that Catalyn is represented as containing. Of course, this testimony conflicts with the Government's expert testimony, already stated as expressing the consensus of reliable medical knowledge, that even if Catalyn did contain all of the vitamins it would not help cure the diseases so enumerated, because they are not of the vitamin deficiency type.

Moreover, Dr. Goldwater, testifying for the Government, claimed that he administered Catalyn to some of his patients and found it ineffective. In addition to this, defendant's expert witnesses do not question the bioassay evidence. In this regard, Dr. Kanoky admitted that if the bioassay test was accurate the effect of Catalyn on his patients must have been "absolutely worthless," ...


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