Woodard Laboratories v. United States
| Decision Date | 29 August 1952 |
| Docket Number | No. 13259.,13259. |
| Citation | 198 F.2d 995 |
| Parties | WOODARD LABORATORIES, Inc., et al. v. UNITED STATES. |
| Court | U.S. Court of Appeals — Ninth Circuit |
Eugene M. Elson, Los Angeles, Cal., for appellant.
Walter S. Binns, U. S. Atty., Ray Kinnison, Tobias G. Klinger, Asst. U. S. Attys., Los Angeles, Cal. (Arthur A. Dickerman, Atty., U. S. Food & Drug Administration, Federal Security Agency, Los Angeles, Cal., of counsel), for appellee.
Before STEPHENS, BONE and ORR, Circuit Judges.
This is an appeal from judgments of conviction on an information charging appellants with violation of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.A. § 301 et seq. Appellant Woodard Laboratories packaged and shipped in interstate commerce certain drugs manufactured by Crest Laboratories. Appellants Murphy and Sullivan are, respectively, president and general manager of Woodard Laboratories. The information charged the appellants in ten counts with five interstate shipments of alpha-estradiol tablets whose strength was below that declared on the labels; each shipment was the basis for two counts, one relating to adulteration and one to misbranding. 21 U.S.C.A. §§ 331(a), 351(c), and 352(a). The District Court, sitting without a jury, found each of the defendants guilty on the five counts relating to adulteration. A total fine of $2500 was imposed upon Woodard and a total fine of $250 was imposed on each of the individual defendants.
The tablets in question are shipped under the trade name "Estrocrine" and contain alpha-estradiol, a female sex hormone which is dispensed only by or on the prescription of a physician. Samples of the tablets were subjected to laboratory analysis by the Food and Drug Administration; the results of these assays led directly to the filing of the information. A drug distributor has an absolute liability for adulterated and misbranded drugs that he introduces into interstate commerce. "Balancing relative hardships, Congress has preferred to place it on those who have at least the opportunity of informing themselves of the existence of conditions imposed for the protection of consumers before sharing in illicit commerce, rather than to throw the hazard on the innocent public who are wholly helpless." United States v. Dotterweich, 1943, 320 U.S. 277, 285, 64 S.Ct. 134, 138, 88 L.Ed. 48. The appellants contend, however, that the evidence was insufficient to sustain the judgment. A determination of this question requires a brief summarization of the evidence.
Two witnesses testified for the Government. They are outstanding authorities in the general field of pharmaceutical chemistry and both have had a large experience in the study of estrogenic hormones.1 They described in detail the methods of assay used in determining whether the Woodard tablets contained the 22 mcgs. of alpha-estradiol their labels represented the tablets to possess.
Witness Carol used what is known as the infra-red method of analysis in order to double check on the United States Pharmacopoeia, known as U.S.P., method used by the other Government chemists in analyzing samples from the shipments in question. He testified that special procedures were used in an effort to insure complete extraction of the alpha-estradiol from the tablets. Carol stated that his assays disclosed that the amount of alpha-estradiol present per tablet ranged from 23% to 68% of the amount declared on the label.
Witness Carol also described the results of assays conducted by his associate, Dr. Edward Haenni, upon samples from three of the shipments by means of the U.S.P. method2 which had been developed by Mr. Carol and his associates. Dr. Haenni's assays indicated that the alpha-estradiol content of the tablets in these three shipments ranged from 32% to 63% of the amount declared on the label. Witness Carol further testified that he had previously tested a number of samples of other commercially prepared alpha-estradiol tablets containing 22 mcgs. by means of the U.S.P. method with successful results.
Dr. Banes, using the U.S.P. method, assayed samples taken from all five of the shipments in question. He then conducted further special experimental procedures not required by the U.S.P. method, involving additional extractions and the use of a simulated tablet mix, to verify his findings which indicated that the alpha-estradiol content of the tablets ranged from 30% to 73% of the stated amount. Dr. Banes also testified that in the development of the U.S.P. method of assay the developing chemists made certain the method would extract all but a minute portion of the alpha-estradiol in the particular tablets regardless of the ratio of the drug to excipients.
The appellants do not dispute the fact that less than the purported 22 mcgs. of alpha-estradiol was extracted from the tablets packaged, as measured by the U.S.P. procedure. Their argument is that the U.S.P. method, while perhaps effective in analyzing tablets of greater potency, is inaccurate and unsuitable in extracting alpha-estradiol when combined with the large mass of excipients present in these particular tablets.3
A Mr. Galindo, Vice-President of Crest Laboratories, identified worksheets which purported to indicate meticulous care by Crest in the manufacture of the tablets. He testified that an overage of 5% more alpha-estradiol was used than necessary to make a tablet containing 22 mcgs. of the drug. The worksheets were said to show the process of manufacture, step by step, and disclose that the required amount of the drug was placed in the tablets.
Dr. C. E. P. Jeffreys, consulting chemist and technical director of Truesdail Laboratories, testified that he was asked by Woodard to run an assay on tablets from the shipments in question. Using the U.S.P. procedure, he was able to extract only 8.1 to 9.5 mcgs. of alpha-estradiol from the tablets.4 Dr. Jeffreys stated that he believed the U.S.P. method of assay did not extract all of the alpha-estradiol present in tablets of such low potency because of adsorption to the solid surface of the excipients, and was thus not a suitable method.5
Dr. Hoyt and Dr. Sobel, associated with the Cedars of Lebanon Hospital, testified to certain experiments conducted at the request of the appellants subsequent to the hearing before the Food and Drug Administration. These experiments, involving assays upon pure estradiol, tablets specially manufactured by Crest to insure the presence of a stated quantity of alpha-estradiol, and tablets containing all the excipients of the usual tablet manufactured by Crest into which Dr. Hoyt and Dr. Sobel personally added certain quantities of alpha-estradiol,...
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