Alberty Food Products Co. v. United States

• Decision Date: 20 November 1950
• Docket Number: No. 12483.,12483.
• Citation: 185 F.2d 321
• Parties: ALBERTY FOOD PRODUCTS CO. v. UNITED STATES.
• Court: U.S. Court of Appeals — Ninth Circuit

185 F.2d 321 (1950)

ALBERTY FOOD PRODUCTS CO. v. UNITED STATES.

No. 12483.

United States Court of Appeals Ninth Circuit.

November 20, 1950.

George H. Hauerken, Cyril Viadro, and Hauerken & St. Clair, all of San Francisco, Cal., for appellant.

Frank J. Hennessy, U. S. Atty., Edgar R. Bonsall, Asst. U. S. Atty., San Francisco, Cal., (Arthur A. Dickerman, Atty., U. S. Food & Drug Adm., Washington, D. C., of counsel), for appellee.

Before HEALY, BONE and POPE, Circuit Judges.

BONE, Circuit Judge.

Appellee filed a libel under which it seized appellant's drug here involved (33 bottles of Ri-Co Tablets) charging therein that the drug was "misbranded" in violation of 21 U.S.C.A. § 352(f) (1) of the Federal Food, Drug, and Cosmetic Act, referred to hereafter as the Act. The specific ground of complaint was that the "labeling" of the drug failed to bear adequate directions for use since it did not state the purpose or condition for which the drug was intended. The only directions for use on the label attached to the bottle read as follows: "Three tablets with a cupful of hot water. Take four times daily. Before meals and on going to bed."

At the hearing below two newspaper advertisements from daily publications in large cities were introduced. These ads show that appellant's drug was there represented and recommended by appellant for use in the treatment, mitigation, and cure of arthritis and rheumatism. The two advertisements read as follows:

"Rocky Mountain News Tuesday, Oct. 1, 1946

"Arthritis Rheumatism Rico Tablets Another Alberty Product

"Do you suffer from Arthritis or Rheumatism, two of the most painful ailments that afflict mankind?

"These ailments arise from the same underlying cause — two much acidity that permits deposits of urates in joints or muscles that cause excruciating pain.

"Science has spent many years searching for remedies for these ailments. If you have tried many remedies without relief Try Rico, a formula discovered by a famous Homeopathic physician for relief of the pains of Arthritis and Rheumatism. For over 15 years this formula has been used by many eminent Homeopathic Physicians.

"Rico is harmless and does not upset the digestive tract or affect the heart.

"275 Tablets ....................... $2.00

"In Colorado, include 2% state sales tax

"Sent Postpaid When Remittance Accompanies Order.

"Leeds Health House "Under new ownership Ethel Barnes and Helen Olson "725 15th St. KE. 9214

"2 Doors from Denver Dry Goods."

"San Francisco Chronicle Monday, June 7, 1948 Page 13

"Troubled with Symptoms of Arthritis Rheumatism? Alberty's Rico Tablets

"Why Suffer From The Pains Of The Symptoms Of Arthritis And Rheumatism When Rico May Give You Amazing Palliative Relief Like It Has Done For Countless Others?

"Some 25 years ago a famous Homeopathic Physician attacked this problem from the homeopathic point of view. He combined certain ingredients according to the theories of homeopathy for relieving certain symptoms of arthritis and rheumatism. This formula has stood the test of time and it has been widely used by many Homeopathic Physicians.

"Alberty's Rico Tablets

"Rico is made by the same formula originated by the famous Homeopathic Physician. And, according to the principles of Homeopathy, improves the symptoms of muscular or ligamentous pain and stiffness due to Arthritis or Rheumatism except when accompanied by a febrile condition. They are not a Sedative; do not upset the Digestive Tract Or Affect The Heart.

"Try Rico today ____ "an Alberty Product "$1.00, Two Weeks' Supply. "Economy Size, $2.00 "San Francisco "Health Foods Store "415 Sutter St. Ex. 2-8477"

Appellant appeared as claimant of the drug and filed exceptions to the libel. In essence the exceptions were that the Act does not require the labeling of a drug to state the disease condition for which it is to be used. In this connection it contended that the misbranding here charged was merely a failure to include upon the label of the container information to consumers which was not required by the Act to be included thereon either as directions for its use or otherwise. As a consequence the libel failed to state a cause of action because the alleged misbranding was not a misbranding at all. Appellant's exceptions were overruled by the trial court. Appellant's subsequent answer to the libel admitted that the seized Ri-Co Tablets were a drug that had been shipped in interstate commerce.

After the answer, appellee filed a motion for summary judgment which asserted (1) there were no facts in dispute and (2) the only legal issue had been decided in favor of appellee when the lower court overruled claimant's exceptions to the libel. It supported this motion by (1) an affidavit of a food and drug representative incorporating photostats of the complete labeling on the drug container and the two newspaper advertisements above noted, and (2) the affidavits of four physicians (licensed to practice in California) attesting to the complete worthlessness of Ri-Co Tablets in the treatment or cure of arthritis or rheumatism or their symptoms.¹

Appellant filed no counter-affidavits, and after hearing the court granted appellee's motion for summary judgment, made and entered Findings and Conclusions and a Decree pursuant thereto. The Decree condemned the drug, ordered it destroyed² and awarded certain costs to appellee. The appeal is from this Decree.³

In urging reversal appellant presents five claims of error committed by the lower court and it simplifies the problem in this case by stating that these errors relate to only two basic issues. Claims 4 and 5 both relate to the procedural question of whether a summary judgment was proper in this case. Claims of error, 1, 2 and 3 all relate to the question of whether or not the Act requires that the directions (on the bottles) for the use of the tablets include a statement of the conditions for which the tablets are used.

In appellant's argument on the issues as thus narrowed, it says:

"With the exception therefore of the procedural issues of whether a summary judgment can be granted in a condemnation proceeding and whether a summary judgment should have been granted in this proceeding, the only issue before this court is the issue of whether the Act requires that the directions for the use of the tablets include a statement of the conditions for which they are used.

* * * * * *

"The directions printed on the label of Ri-Co Tablets are adequate for their use in all conditions for which they are prescribed, recommended, suggested, or commonly and effectively used. The Act does not require a label to include a statement of those conditions and the decree should accordingly be reversed with instructions to dismiss the libel. In the alternative, the decree should be reversed, and the question of whether the directions are adequate for the intelligent and effective use of the tablets should be left to the determination of a jury." (Emphasis supplied.) (As later appears this reference in the last sentence refers to the propriety of the summary judgment in this case.)

As respects the legal sufficiency of the label appearing on its bottle appellant clarifies its position by the further argument: "The Government * * * contends that no information could be more essential to the consumer regarding a drug which he can purchase without prescription than a statement of the conditions for which the drug is used. We agree that no one is likely to purchase a drug without knowing the conditions for which the drug is used. That knowledge, however, must be imparted to the consumer by means other that the label. He must have it before he gets close enough to the label to be able to read its fine print. In other words, he will not buy the drug unless he learns of the conditions for which it is used from sources outside the label, as by prescription, recommendation, suggestion, or common and effective usage. By the time he sees the label, he needs only to be protected by being told how to use the drug for the condition for which he is purchasing it. If `4 times daily' is an adequate direction for the use of the drug in that condition, the label complies with the Act irrespective of whether it refers to that condition." (Emphasis supplied.)

The foregoing argument conclusively shows that appellant relied exclusively upon these "outside sources," namely, the newspaper advertisements, to provide all of the information which could possibly enlighten prospective purchasers of its drug concerning "the conditions" for which the drug was to be used by them.

Appellant also offers some reasons for its failure to include on the bottle label nothing more than the dosage recommended. In substance it argues that: a statement of all conditions or symptoms for which the drug is used would be so long that it could not be included within the limits of the label. While it is true that Sec. 352(f)(1) requires "directions for use" on the labeling, and Sec. 321(m) defines "labeling" as including the "label" on the immediate container and all other "accompanying" literature, still this use of the more inclusive term "labeling" is nullified by Sec. 352(c) which deems a drug misbranded unless all information required to appear on the labeling be placed thereon in such manner as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

The arguments in the preceding paragraph lack persuasiveness and merit.

The Basic Issue

Two recent cases present a material bearing on the issue before us. Kordel v. United States, 335 U.S. 345, 69 S.Ct. 106, 93 L.Ed. 52, and United States v. Urbuteit, 335 U.S. 355, 69 S.Ct. 112, 93 L.Ed. 61. The Kordel case involved the shipment and sale of a drug — a charge of misbranding was made because of certain representations in "accompanying" leaflets, circulars and pamphlets supplied by Kordel, and distributed by his...