United States v. Article of Drug Labeled Decholin, Civ. A. No. 24029.
| Decision Date | 10 February 1967 |
| Docket Number | Civ. A. No. 24029. |
| Citation | 264 F. Supp. 473 |
| Parties | UNITED STATES of America, Libelant, v. An ARTICLE OF DRUG consisting of approximately 69 100-tablet bottles, 2 500-tablet bottles and 2 1000-tablet bottles, LABELED in part: (Btl.) "—DECHOLIN—Each tablet contains Dehydrocholic Acid 250 mg. (3¾ grains) —Ames Company, Inc., Elkhart, Indiana —Indications: Indigestion—After Meal Discomfort and Fullness—Excessive Belching—Constipation—Control No.—" and Miles Laboratories, Inc. (as successor to Ames Company, Inc.), Claimant. |
| Court | U.S. District Court — Western District of Michigan |
Walter E. Byerley, Dept. of Health, Education & Welfare, Food and Drug Division, Washington, D. C., Milton J. Trumbauer, Asst. U. S. Atty., Detroit, Mich., for libelant.
Bruce J. Brennan, Washington, D. C., John B. Buckley, Elkhart, Ind., John K. Worley, Detroit, Mich., for claimant.
These cross motions for summary judgment, pressed by the United States and the claimant, present significant questions of first impression under the 1951 amendment to the Federal Food, Drug and Cosmetic Act.
The Government commenced the case by filing a libel of information for condemnation of seventy-three packages bearing appproximately ten thousand tablets, each of which contained 250 milligrams (3¾ grains) of dehydrocholic acid and was marketed under the trade name "Decholin." Ames Company, Inc., the manufacturer of Decholin, intervened in this in rem proceeding as claimant of the seized articles.1
The action is predicated upon Federal Food, Drug and Cosmetic Act, § 304, as amended, 21 U.S.C. § 334, providing:
"Any article of food, drug, device, or cosmetic that is adulterated or misbranded when introduced into or while in interstate commerce or while held for sale (whether or not the first sale) after shipment in interstate commerce * * * shall be liable to be proceeded against while in interstate commerce, or at any time thereafter, on libel of information and condemned in any district court of the United States within the jurisdiction of which the article is found * * *."
The only substantive provision of concern is Federal Food, Drug and Cosmetic Act, § 503, as amended, 21 U.S.C. § 353, reading in pertinent part:
It is agreed that Decholin is a drug within the meaning of the Act and that the seized tablets had moved in interstate commerce. It is also undisputed that the labels on the libeled packages give no indication that Decholin may not lawfully be dispensed without prescription. The precise legal consideration raised by these motions is whether amended section 503 causes Decholin to be misbranded because its containers fail to carry such a precautionary statement.
Since the Decholin label is the center of this controversy, its material contents are set forth at this point. The printed matter on one side of each of the seized packages reads insofar as relevant:
The reverse side of the containers gives this additional information:
In support of its request for summary judgment, each movant relies almost exclusively upon a number of affidavits which it has procured. These include the statements of qualified physicians specializing in gastroenterology, several of whom are on the faculties of leading medical schools, relative to whether harm can come to a layman who, without consulting a medical practitioner, takes Decholin for relief of the indicative symptoms listed above. The claimant also calls attention to the fact that, in answer to claimant's interrogatories, the United States has admitted that it is unaware of any actual case in which a layman was injured under these circumstances.
There is only one fundamental issue presented by these motions: is Decholin unsafe as a drug intended for human use without a prescription? Nevertheless, recognizing that in section 503(b) (1) (B) Congress listed a number of ostensibly different reasons why a drug may be unsafe for self-medication and attempting to deal with the parties' arguments in an organized fashion, the motions will be viewed as raising two issues. First, is the pharmacological effect of Decholin such that, unless it is taken pursuant to and in accordance with a physician's directions, reactions sufficient to cause the product to be unsafe may result from its ingestion? This will be called the "toxicity question."2 Second, does the fact that Decholin may be taken by a person who, although experiencing the indications set out on the label, has an ailment which Decholin cannot cure, coupled with the fact such an individual may postpone a visit to his physician in reliance upon the over-the-counter availability of Decholin, cause the drug to be unsafe? Because the gist of the Government's argument on this issue is that an immediate professional diagnosis to detect the underlying cause of the symptoms in a particular case is a step which must precede or accompany use in order for the drug to be considered safe, this point will be called the collateral measures question. Unfortunately, some of the subissues and contentions underlying each of these two topics are so similar that the effort to pinpoint two distinct inquiries will not be totally successful.
At the basis of both questions lies the fact that the indications mentioned on the Decholin container can stem from any one of what, for present purposes, will be considered as three types of causes: biliary tract obstruction, organic disease and various minor factors. These last include a host of elements ranging from pregnancy through dietary indiscretions, such as skipping meals, and on to old age. Claimant willingly agrees with the Government that Decholin would not be prescribed by a physician to cure either a tract obstruction or an organic disease.
If the record showed clearly why a practitioner would not order Decholin for a person suffering from an obstruction or an organic disease, the toxicity question could be in a better posture for summary disposition. However, the affidavits of the experts suggest different reasons which may be grounded upon conflicting views on a factual issue, the pharmacological effect of the drug. The statements of claimant's authorities suggest that they would not prescribe Decholin in the presence of one of these major ailments primarily, if not exclusively, just because the drug would do no good for the patient. However, these experts are quick to point out that they have never heard of an instance in which a person with either an obstruction or an organic disease sustained any ill effect from self-medication with Decholin; and at least several of them doubt that harm would ever come to an individual who takes the drug under these circumstances. Therefore, Ames would consider Decholin safe for unrestricted distribution.
While all of the Government's experts also assert that Decholin is ineffective to relieve either a tract obstruction or an organic disease, and while they agree among themselves that the drug is unsafe unless taken on a physician's advice —a proposition which insofar as it attempts to state a legal conclusion is not, of course, for them to express,—the affidavit of Dr. Manuel Sklar, an assistant professor of clinical medicine at Wayne State University, is most helpful in showing why the Government considers the drug properly dispensed only on prescription. He believes that the consumption of Decholin by an individual who has an obstruction would lead to an increase in the accumulation of bile ahead of the intestine, and because of the blockage, the fluid could not pass into the intestine as it normally would during the course of digestion. Furthermore, according to Dr. Sklar, the accumulated bile will eventually become absorbed into the bloodstream, leading to the likelihood of serious harm. Although he does not explicitly say so, doubtless this expert would see a potentiality for the same end result if Decholin were taken by a person with at least those organic diseases which affect the ability of the body to handle bile flow in the usual manner. Therefore, in his opinion, the product solely by virtue of its composition can be injurious to an individual with an ailment giving rise to Decholin's indications but beyond...
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