Bell v. Goddard, 15124.

Citation366 F.2d 177
Decision Date11 August 1966
Docket NumberNo. 15124.,15124.
PartiesGeorge N. BELL, doing business as George N. Bell Manufacturing Chemists, Petitioner, v. James L. GODDARD, Commissioner, Food and Drug Administration, Respondent.
CourtUnited States Courts of Appeals. United States Court of Appeals (7th Circuit)

Donald C. Beelar, Washington, D.C., Lawrence Gunnels, Chicago, Ill., William M. Osborn, Indianapolis, Ind., for petitioner.

William W. Goodrich, Asst. Gen. Counsel, Alvin L. Gottlieb, Attorney, U. S. Department of Health, Education & Welfare, Washington, D.C., Fred M. Vinson, Asst. Atty. Gen., Criminal Division, Harold S. Shapiro, Chief, Administrative Regulations Section, Department of Justice, Joanne S. Sisk, Attorney, United States Department of Health, Education & Welfare, Washington, D. C., of counsel, for respondent.

Before SCHNACKENBERG, CASTLE, and SWYGERT, Circuit Judges.

SWYGERT, Circuit Judge.

This is an appeal under 21 U.S.C. § 355(h) from an order of the Deputy Commissioner of the Food and Drug Administration withdrawing approval of a new drug application held by the petitioner George N. Bell, doing business as George N. Bell Manufacturing Chemists, Indianapolis, Indiana.

In July 1957 the petitioner filed a new drug application for "Stilboserts" covering the manufacture and sale of a pellet of his own formula containing diethylstilbestrol1 and intended for use in producing caponette poultry.2 The application became conditionally effective on January 11, 1958 and fully effective on March 24, 1959.

On December 10, 1959 the Secretary of Health, Education, and Welfare announced that a recently completed re-examination of the use of stilbestrol in the poultry industry had led him to the conclusion that it was desirable to eliminate a potential cancer hazard to the consuming public occasioned by the ingestion of stilbestrol-treated poultry.3 Shortly thereafter, this administrative proceeding was initiated by the Commissioner of Food and Drugs pursuant to 21 U.S.C. § 355 (e) to determine whether new drug applications covering drugs containing DES for use in poultry production should be suspended. Notices of hearing were issued to the petitioner, to Mattox & Moore, Inc., Indianapolis, Indiana, and to Vineland Poultry Laboratories, Vineland, New Jersey. Consolidated hearings were held.4

The hearing examiner found that all products involved were "unsafe" within the meaning of 21 U.S.C. § 355(e) except for the products "No Brood," covered by a new drug application held by Mattox & Moore, and "Anti-Brood," covered by a new drug application held by Vineland, and recommended suspension of all the new drug applications except those covering the latter products. Exceptions to the examiner's tentative order were considered by the Commissioner. He issued a final order with findings of fact and conclusions of law suspending all the new drug applications involved, including the drugs exempted by the hearing examiner.5 Thereafter the petitioner instituted this appeal.6 A summary of the pertinent findings of the Commissioner follows.

The drug involved, Stilboserts, consists of pellets containing either 12 or 15 milligrams of diethylstilbestrol. The pellets, to be implanted in live poultry, are designed to provide for the gradual release of DES over a period of weeks. The labeling submitted with the new drug application recommends the implantation of one tablet in chickens of any age four to six weeks before marketing, and two tablets in turkeys six weeks before marketing. Implantation is "under the loose skin just below the head." Stilboserts were recommended for poultry fattening and to produce tenderized, flavorized, upgraded poultry, and to improve feed efficiency.

DES is a synthetic estrogenic drug which was first used in medical practice in 1939; the use of natural estrogens in medicine dates to about 1920. The first new drug application for the use of DES in medicine was approved in 1941; a new drug application for use of DES in poultry production was first approved in 1947. The fact that oral administration of DES had been shown to produce cancer in test animals was known at that time, and DES was suspected of being carcinogenic to humans. It was believed, however, that no significant residue of the drug remained in the edible tissue of treated poultry.

Beginning in 1955, a team of scientists of the Food and Drug Administration headed by Dr. Ernest Umberger developed a bio-assay method for detecting and measuring the estrogenic residue remaining in edible tissues of poultry treated with drugs containing DES. This test was confirmed by a series of chemical experiments conducted in the spring of 1960 by Dr. Daniel Banes. The bioassays detected the presence of DES activity; the chemical tests were specific for DES. Based upon the data from these tests, Dr. Umberger was able to calculate that the petitioner's product, Stilboserts, in 15 and 12 milligram doses, under the conditions of use in the petitioner's new drug application, results in the following residues of added DES four weeks after chickens are treated:

15 milligrams of diethylstilbestrol leaves a residue of 25 to 50 parts per billion, or from 10 to 20 micrograms per pound of liver; 12 milligrams of diethylstilbestrol leaves a residue of 20 to 50 parts per billion, or from 9 to 20 micrograms per pound of liver.
Added diethylstilbestrol residues are also found in the skin fat and kidneys.

DES is a synthetic organic compound which, when administered to man or animals, has all the biological effects of the naturally-occurring female sex hormones known as estrogens. Except for quantitative differences, the effects of DES or other estrogenic substances, on either humans or animals are identical, however administered.

DES and other estrogens, when administered to test animals in controlled experiments, have been shown to cause cancers of the breast, endometrium, uterine cervix, pituitary, testes, ovaries, adrenals, and kidneys, and leukemia, in mice, rats, rabbits, hamsters and dogs; often more than one of these cancers appear in a particular species or strain. In addition, fibroid tumors have been produced in guinea pigs.

In humans, chronic estrogenic stimulation of the uterus, whether due to excessive ovarian production or abnormalities of the reproductive cycle, results in increased cancer of the endometrium. Such cancer has also been observed to develop in women during or following estrogen therapy. Women in these two categories show a higher incidence of cancer of the endometrium than women who are not subject to such additional endogenous or exogenous estrogens.

There is a histologically remarkable similarity between cancers of the endometrium in humans and animals. The female C3H strain mouse has a similarly high incidence of cancer of the breast as human females; male C3H mice rarely develop such cancer. However, administration of DES will cause cancer of the breast in male C3H mice, pathologically similar to human breast cancer. And, the cancers have been caused in male C3H mice by exposure to estrogens within the so-called "natural" or physiological range of estrogens excreted by female C3H mice. Histologically, the cancers of the breast in male and female C3H mice are similar. Thus, exposure of male mice to estrogens causes them to have the same type of cancers that occur spontaneously in female mice which excrete natural estrogens.

Humans, both male and female, under estrogen therapy have been observed to develop cancer of the breast. Human breast cancers in the female are sustained and grow upon the estrogens normally secreted by the ovaries and adrenals; the adrenals normally secrete from 15-50 micrograms per day. Removal of those organs results in observable clinical improvement of female breast cancer.

On the basis of animal tests and clinical experience, experts have concluded that DES is a carcinogen to man. Prolonged exposure to small amounts of carcinogenic substances has been shown to be more dangerous than single or short term exposure to the same or larger quantities. There is no known threshold or safe level for DES, either as a cause or stimulator of cancer, and there is no known methodology by which such a level can be established.

Based upon these facts, the Commissioner determined that the addition of diethylstilbestrol to poultry, resulting in residues in the edible portions, was unsafe to the consuming public.

The statutory authority for the suspension of the petitioner's new drug application, 21 U.S.C. § 355(e), provided7 that the effectiveness of an application could be suspended if "clinical experience, tests by new methods, or tests by methods not deemed reasonably applicable when such application became effective" showed that the drug was "unsafe" for use under the conditions upon which the application became effective. The petitioner contends that the final approval of his application was improperly suspended because the suspension was not based upon any evidence from tests or clinical experience occurring after the effective date of his application. He points out that the Food and Drug Administration knew about the diethylstilbestrol residue in caponette poultry treated with Stilboserts and the cancer-producing propensities of diethystilbestrol and in fact withheld approval of his application pending further study of the same tests later used as evidence to support the suspension of his application....

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  • Mississippi Poultry Ass'n, Inc. v. Madigan, 92-7420
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    ...1153 (D.C.Cir.1981); Armour & Co. v. Ball, 468 F.2d 76 (6th Cir.1972); Borden Co. v. Freeman, 369 F.2d 404 (3d Cir.1966); Bell v. Goddard, 366 F.2d 177 (7th Cir.1966); Pacific Meat Co. v. Otagaki, 47 Haw. 652, 394 P.2d 618 (1964).4 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984).5 21 U.......
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