United States v. 23 7/12 DOZEN BOTTLES, 35-CENT SIZE, ETC.

• Decision Date: 17 October 1930
• Docket Number: No. 3331.,3331.
• Citation: 44 F.2d 831
• Court: U.S. District Court — District of Connecticut
• Parties: UNITED STATES v. 23 7/12 DOZEN BOTTLES, 35-CENT SIZE, AND 12 2/3 DOZEN BOTTLES, 70-CENT SIZE, OF AN ARTICLE OF DRUGS LABELED IN PART "LEE'S SAVE THE BABY."

44 F.2d 831 (1930)

UNITED STATES v. 23 7/12 DOZEN BOTTLES, 35-CENT SIZE, AND 12 2/3 DOZEN BOTTLES, 70-CENT SIZE, OF AN ARTICLE OF DRUGS LABELED IN PART "LEE'S SAVE THE BABY."

No. 3331.

District Court, D. Connecticut.

October 17, 1930.

John Buckley, U. S. Atty., and George H. Cohen, Asst. U. S. Atty., both of Hartford, Conn., and Elton L. Marshall, Sol. of United States Department of Agriculture, and John F. Morse, Asst. to the Solicitor, both of Washington, D. C., for libelant.

Ransom H. Gillett, of Albany, N. Y. (Raymond E. Hackett, of Stamford, Conn., of counsel), for claimant.

THOMAS, District Judge.

This is a proceeding in rem against a certain drug preparation known as "Lee's Save the Baby," which name is and has been registered in the United States Patent Office for many years. The United States filed its libel for condemnation against certain bottles and their contents, shipped in interstate commerce, and prayed that the same be condemned upon the ground that they were misbranded within the meaning of the Food and Drug Act of June 30, 1906, § 8 (34 Stat. 768), as amended by the Act of August 23, 1912 (37 Stat. 416), 21 USCA §§ 9, 10.

The libel charges that:

"Said article of drugs * * * is and was * * * misbranded within the meaning of the Act, * * * in that the following statements regarding the curative and therapeutic effect of the said article are false and fraudulent."

"(Front bottle label): `Save the Baby'

"(Back bottle label): `For Croup apply with the hand or by saturating * * * cloth and laying it over the throat and chest; also apply over the nose. In severe cases, where relief does not follow in half an hour, give a half teaspoonful internally every half hour. * * * For Sore Throat apply on the throat; also take one-half a teaspoonful internally. For coughs * * * apply on the chest, also take one teaspoonful morning and night. For ague in breast, apply to the parts affected. * * *'"

"(Carton) (Small): `* * * Save the Baby * * * Croup Mixture * * * For Croup, * * * Coughs and Sore Throat * * * used in cases of Grippe, Bronchitis, Laryngitis, Tonsilitis, Pneumonia, etc. * * *'

"(Carton) (Large): `* * * Save the Baby For Croup, Coughs, * * * etc. * * *'

"(Circular): `Save the Baby * * * for Croup * * * Coughs, Tonsilitis, Bronchitis, Sore Throat and similar ailments. * * * What Mother or Father has not been alarmed when awakened in the night by the childish cry of pain and the dread sound of croup? Or who of us has not shuddered when whooping cough, pneumonia or a hard cold has racked our children with pain and coughing spasms. It was because of a child's suffering that "Save the Baby" came into being * * * a wee girl lay seriously sick with croup * * * he administered a remedy of his own compounding * * * found * * * child completely out of danger. This physician prescribed the remedy * * * in other cases, always with gratifying results. * * * "Save the Baby," * * * by that name it had come to be known. * * * "Save the Baby" for use in * * * croup, tonsilitis, bronchitis, sore throat and all similar ailments in children and adults. * * * Use It. * * * The results will be beneficial. For Adults — "Save the Baby" works * * * with as good results for adults as it does for children. The * * * relief given in coughs, bronchitis, pneumonia and other congested conditions of the head, throat or lungs * * * "Save the Baby" * * * effective when used Hot. For Croup: * * * In severe cases, where relief does not follow in half an hour, give a half teaspoonful internally every half hour. * * * For Coughs. * * * Apply on chest and throat; also take one teaspoonful morning and night. Influenza, Grippe and Pneumonia: * * * use "Save the Baby" * * * In severe cases give a half teaspoonful internally every half hour. * * * Use "Save the Baby" * * * For Sore Throat and Tonsilitis: Apply on the throat and along the cord that runs from behind the ear down the neck; also take one half teaspoonful internally. Take from one half to one teaspoonful internally for all chest congestions and gathering of phlegm * * *'

"— in this, that the article contains no ingredient or combination of ingredients capable of producing the effects claimed, and that the same were applied to the said article knowingly and in reckless and wanton disregard of their truth or falsity, so as to represent falsely and fraudulently to the purchasers thereof, and create in the minds of the purchasers thereof, the impression and belief, that the article was, in whole or in part, composed of, or contained ingredients or medicinal agents effective in the diseases and conditions named therein."

The jurisdictional allegations as well as the shipment in interstate commerce are admitted, but the essential and last-quoted allegations of the libel as to the product are denied. Certain stipulations were filed eliminating the necessity of proving certain facts as to which it is unnecessary to make reference except as to the ingredients of the product. One of the stipulations sets forth that an analysis was made by an analyst of the United States Department of Agriculture of a sample of the shipment seized in these proceedings which shows that the composition and ingredients of the preparation are:

"Lard approximately 70% "Alcohol approximately 6% "Canada Balsam approximately 10% "Volatile Oils, including "Camphor, Rosemary Oil and "Origanum Oil, approximately 15%"

To establish the fact that this preparation is misbranded within the meaning of the Food and Drug Act, the government must prove by a preponderance of the evidence: First, that the label, carton, or circular carries some statement, design, or device regarding the contents of the package or the ingredients in the mixture which is false and misleading in some particular; and, second, that the statement made or the design or device carried on the label or carton or in the circular regarding the curative or therapeutic effects of the same are false and fraudulent. Such being the case, the fraud alleged must be established by competent proof and by credible and convincing evidence.

The sections of the act (21 USCA §§ 9, 10) here applicable provide as follows:

"§ 9. Misbranded; meaning and application. The term `misbranded,' * * * shall apply to all drugs, * * * the package or label of which shall bear any statement, design, or device regarding such article, or the ingredients or substances contained therein which shall be false or misleading in any particular,"

"§ 10. * * * An article shall be deemed to be misbranded. * * *

"In case of drugs:

"Imitation or use of name of other article. —

"First. * * * Removal and substitution of contents of package, or failure to state on label quantity or proportion of narcotics therein. — Second. * * * False statement of curative or therapeutic effect. — Third. If its package or label shall bear or contain any statement, design, or device regarding the curative or therapeutic effect of such article or any of the ingredients or substances contained therein, which is false and fraudulent."

It appears that the government contends that this product contains no ingredients or combination of ingredients capable of producing the effects claimed for it, and that the claims that are made for it are false and fraudulent and were applied by the manufacturers knowingly and in disregard of their truth or falsity, so as to falsely and fraudulently represent to the purchasers and create in their minds the impression and belief that the article was in whole or in part composed of or contained ingredients effective in the diseases mentioned in the carton and circular.

The claimant denies misbranding within the purview of the Food and Drug Act, and particularly denies that the statements regarding the curative and therapeutic effects of this product are false and fraudulent or were made in wanton disregard of their truth. It then affirmatively alleges that this product is capable of producing and has actually produced the curative or therapeutic effects claimed for it, and has offered credible evidence in support of his contentions.

From the quoted allegations of the libel it appears that certain words and directions contained in the circular were omitted from the libel. Under familiar rules of pleading and evidence, the government is precluded from complaining of the omitted words; but it is only fair, in order to reach a proper conclusion respecting the issues presented, that we consider the entire label and all that is contained in the so-called literature and directions which accompany the bottle as bearing upon the good faith of the manufacturer of the product, because if it appears from all the evidence and I conclude that the claims made for this remedy are true, then it necessarily follows that they cannot be false or fraudulent.

In the use of the words "therapeutic" and "curative," as set forth in the statute, it seems clear that these words were intended by the Congress to be given their ordinarily accepted meaning, and while they have a certain meaning to the expert doctor, nevertheless they are a part of the vocabulary of any intelligent person. Therapeutic to the medical world means to heal; to make well; to restore to health. It is that branch of medicine dealing with the proper use of the right medicines in the treatment of diseases. The medical student studies "Therapeutics" for the purpose of learning about different medicines to prescribe for the many ills to which the flesh is heir, in order to assist nature to make a sick patient well. The ordinary definitions found in the dictionaries are as follows: "Having healing qualities; curative; alleviative; a medicine efficacious in curing or alleviating disease." Webster defines therapeutics as "that part of medical science which treats of the discovery and application of remedies for diseases." The word "curative" is not found in the medical dictionaries. The regular dictionaries define...