78 F. Supp. 721 | N.D. Iowa | 1947
UNITED STATES
v.
9 BOTTLES, MORE OR LESS, etc., "COLUSA NATURAL OIL," et al. (and 5 other cases), (COLUSA REMEDY CO., Intervenor).
District Court, N. D. Iowa, E. D.
Tobias E. Diamond, U. S. Dist. Atty. and Wm. B. Danforth, Asst. U. S. Dist. Atty., both of Sioux City, Iowa, and Bernard D. Levinson, Attorney, Federal Security Administration, of Washington, D. C., for libelant.
Walter Gleason, of San Francisco, Cal., and Benjamin F. Butler, of Waterloo, Iowa, for intervenor.
GRAVEN, District Judge.
Under the provisions of 21 U.S.C.A. § 334(b), it was stipulated between the libelant and the intervenor Colusa Remedy Company that all of the above-entitled cases should be consolidated for trial in the Eastern Division of the Northern District of Iowa. Pursuant thereto, consolidated trials of the above-entitled cases were had before the Court at the Federal Court House at Waterloo, Iowa, on November 13th, 14th, 17th and 18th, 1947. United States District Attorney Tobias E. Diamond, Assistant United States District Attorney Wm. B. Danforth and Bernard D. Levinson appeared as attorneys for the libelant. Walter Gleason and B. F. Butler appeared as attorneys for the intervenor Colusa Remedy Company. On November 18th, 1947, the trials were completed and the cases submitted to the Court and by the Court taken under advisement. Now, to-wit, on this 26th day of November, 1947, the Court now being fully advised in the premises makes the following Findings of Fact, Conclusions of Law and Order for Decrees.
Findings of Fact.
1. The intervenor Colusa Remedy Company is a corporation organized and existing under and by virtue of the laws of the State of Nevada with its principal place of business at Los Angeles, California.
2. The intervenor has for a number of years been shipping in interstate commerce bottles containing a liquid known as Colusa Natural Oil and bottles containing capsules which capsules are known as Colusa Natural Oil Capsules.
3. In each of the above-entitled cases the libelant has seized a number of bottles containing Colusa Natural Oil and Colusa Natural Oil Capsules by libel proceedings under the provisions of 21 U.S.C.A. § 334(a). In each case the bottles so seized had been shipped in interstate commerce by the intervenor.
4. The contents of each and all of the bottles so seized was intended for the treatment of disease and as such constituted a drug under the provisions of 21 U.S.C.A. § 321(g) (2).
*722 5. The libel proceedings in each case were instituted by the libelant upon the ground that the bottles proceeded against were misbranded under the provisions of that portion of 21 U.S.C.A. § 352, which provides as follows: "A drug * * * shall be deemed to be misbranded (a) If its labelling is false or misleading in any particular."
6. Each of the bottles of Colusa Natural Oil seized in the above-entitled cases had the following label attached:
"A natural unrefined petroleum oil intended for use in treatment of Psoriasis, Eczema, Athlete's Foot and Leg Ulcers. Directions: apply to affected parts and rub it in thoroughly morning and night. For open sores saturate cotton pad with oil and bind on by gauze. Change to fresh dressing morning and night. For tender skin oil can be diluted 50% with olive oil. Continue treatment until skin is smooth and comfortable. We suggest in treatment of Psoriasis, Eczema and Leg Ulcers using Colusa Natural Oil externally as above directed and Colusa Natural Oil Capsules internally as directed on bottle containing Colusa Natural Oil capsules."
7. Each of the bottles containing Colusa Natural Oil Capsules seized in the above-entitled cases had the following label attached:
"A natural unrefined petroleum oil in capsules intended for internal use in treatment of Psoriasis, Eczema, Leg Ulcers. Directions: For adults start with one capsule at bedtime then after 3 days change to one capsule after each meal until skin is smooth and comfortable. For children under ten one capsule or its content squeezed into milk or water at bedtime until skin is smooth and comfortable. We suggest use of capsules as above directed in conjunction with liquid Colusa Natural Oil applied externally to affected parts as directed on bottle containing Colusa Natural Oil in liquid form."
8. In each of the above-entitled cases the Colusa Remedy Company has appeared and asked for the release of the seized bottles and the dismissal of the cases upon the ground that the bottles so seized were not misbranded under the provisions of 21 U.S. C.A. § 352 referred to.
9. The composition of the liquid contained in the seized bottles labeled Colusa Natural Oil is identical with that of the liquid in the capsules contained in the seized bottles labelled Colusa Natural Oil Capsules. The composition of the Colusa Natural Oil and Colusa Natural Oil Capsules seized in each case is identical with that seized in each of the other cases. The issue as to misbranding is the same in all of the above-entitled cases.
10. Natural unrefined petroleum oil is one and the same as crude petroleum. The liquid contained in the seized bottles labelled Colusa Natural Oil is crude petroleum. The liquid in the capsules contained in the seized bottles labelled Colusa Natural Oil Capsules is crude petroleum. As to whether the intervenor purchased the crude petroleum contained in the bottles involved in this case in the open market or obtained the same from a particular oil well or oil field does not definitely appear.
11. Psoriasis, Eczema, Leg Ulcers and Athlete's Foot are diseases of the skin. Wherever hereafter the term "patient" is used, it means one who has one of those diseases.
12. The causative factor or factors of Psoriasis are obscure and difficult of ascertainment. Psoriasis is a very difficult and frequently baffling disease to treat. Manifestations of the disease will appear and disappear without any apparent reason or cause. There is no known certain permanent cure for Psoriasis.
13. There are a great many types of Eczema and many causes for it. There are different stages of the disease. In some cases of Eczema the causative factor or factors are easily ascertained. In other cases of Eczema the causative factor or factors are difficult of ascertainment. In other cases of Eczema the causative factor or factors cannot be ascertained. In cases of Eczema where the causative factor or factors are unknown, they may cease, and the disease cease without the patient or his doctor being aware of what brought about the cessation of the disease. In the cases *723 of Eczema where the causative factor or factors are unknown, they may become inactive or less active and the patient may have a partial cure or have relief without the patient or his doctor being aware of what brought about such partial cure or relief. Different kinds of treatment for Eczema are used by the medical profession for different types of the disease. Different kinds of treatment for Eczema are used by the medical profession at different stages of the disease.
14. There are many types and kinds of Leg Ulcers. There are many causes for Leg Ulcers. A great many Leg Ulcers are chronic in nature and difficult to cure. In a great many cases the causative factor or factors of Leg Ulcers are difficult of ascertainment. In a great many cases of Leg Ulcers the causative factor or factors cannot be ascertained. Different kinds of treatment for Leg Ulcers are used by the medical profession for different types of the disease. Different kinds of treatment are used by the medical profession at different stages of the disease. Where the causative factor or factors of Leg Ulcers are unknown, they may cease and the disease cease without the patient or his doctor being aware of what brought about a cessation of the disease. Where the causative factor or factors of Leg Ulcers are unknown, they may become inactive or less active and the patient may have a partial cure or have relief without the patient or his doctor being aware of what brought about such partial cure or relief.
15. Athlete's Foot is a fungus infection. In a great many cases the disease quickly responds to treatment. In other cases the disease can be extremely resistant to treatment. In some cases the disease is apparently resistant to any treatment. In some cases the human body will, over a period of time, build up sufficient resistance to the disease so as to overcome it. In the present cases the matter of the disease of Athlete's Foot is involved only as to Colusa Natural Oil, as the labels on the bottles containing Colusa Natural Oil Capsules do not refer to Athlete's Foot.
16. The intervenor Colusa Remedy Company contends: (a) that it does not claim that Colusa Natural Oil will cure Psoriasis, Eczema, Athlete's Foot and Leg Ulcers, or that Colusa Natural Oil Capsules will cure Psoriasis, Eczema and Leg Ulcers; (b) that it does claim that those remedies will assist or relieve in the treatment of the diseases referred to; and (c) that the most that can be claimed as to the labels in question is that they only represent that the remedy will assist or relieve in the treatment of the diseases referred to and no more.
17. The label on each of the bottles of Colusa Natural Oil in question, when considered in its entirety, would be understood by a person of average intelligence who was suffering from one of the diseases referred to therein, and who was seeking a remedy for such disease as representing that if he would use Colusa Natural Oil as directed, that such Oil would cure or alleviate Psoriasis, Eczema, Athlete's Foot and Leg Ulcers of all types and kinds and at all stages thereof.
18. The label on each of the bottles in question containing Colusa Natural Oil Capsules, when considered in its entirety, would be understood by a person of average intelligence who was suffering from one of the diseases referred to therein, and who was seeking a remedy for such disease as representing that if he would use Colusa Natural Oil Capsules as directed, that such capsules would cure or alleviate Psoriasis, Eczema and Leg Ulcers of all types and kinds and at all stages thereof.
19. There is no credible or adequate scientific or medical foundation for any claim or representation that Colusa Natural Oil, when used externally, will cure Psoriasis, Eczema, Athlete's Foot or Leg Ulcers or will alleviate such diseases, or will give relief from such diseases or will assist in the treatment of them. The Colusa Natural Oil in question is worthless and without value in the treatment of any or all of said diseases at any stage thereof. The external use by a patient will, under certain conditions, have the harmful effect of causing infection in an open sore.
20. There is no credible or adequate scientific or medical foundation for any claim or representation that Colusa Natural *724 Oil Capsules, when used internally, will cure Psoriasis, Eczema or Leg Ulcers or will give relief from such diseases, or will alleviate such diseases or will assist in the treatment of them. The Colusa Natural Oil Capsules in question are worthless and without value in the treatment of any or all of said diseases at any stage thereof.
21. The contents of Colusa Natural Oil Capsules, when taken internally, do not absorb into the human system except to an insignificant extent. When the contents of Colusa Natural Oil Capsules are introduced into a human stomach, they have a slightly irritating and cathartic effect and tend to retard the absorption of food.
22. The labelling of the bottles of Colusa Natural Oil seized in the above-entitled cases is false and misleading.
23. The labelling of the bottles containing the Colusa Natural Oil Capsules seized in the above-entitled cases is false and misleading.
Conclusions of Law.
1. That this Court has jurisdiction of the subject matter in each of the above-entitled cases and of the parties thereto.
2. That the bottles of Colusa Natural Oil seized in each of the above-entitled cases are misbranded within the provisions of 21 U.S.C.A. § 352(a).
3. That the bottles containing the Colusa Natural Oil Capsules seized in each of the above-entitled cases are misbranded within the provisions of 21 U.S.C.A. § 352(a).
Order for Decrees
It is hereby ordered that a decree shall be entered in each of the above-entitled cases decreeing:
1. That the bottles of Colusa Natural Oil seized in each case are misbranded within the provisions of 21 U.S.C.A. § 352 (a) and condemning them as such.
2. That the bottles seized in each case containing Colusa Natural Oil Capsules are misbranded within the provisions of 21 U.S.C.A. § 352(a) and condemning them as such.
3. Awarding against the intervenor Colusa Remedy Company in each of the above-entitled cases the costs provided for under 21 U.S.C.A. § 334(e).
Order
It is hereby ordered that these Findings of Fact, Conclusions of Law and Order for Decree shall be filed in each of the above-entitled cases as the Findings of Fact, Conclusions of Law and Order therein.
It is further ordered that similar decrees shall be filed in each of the above-entitled cases.