Searching over 5,500,000 cases.


searching
Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.

UNITED STATES v. 2000 PLASTIC TUBULAR CASES

June 25, 1964

UNITED STATES of America
v.
'2000 PLASTIC TUBULAR CASES, MORE OR LESS, each containing 2 TOOTHBRUSHES anda Leaflet Labeled in Part: (Case) 'Toothbrush Dr. Knox's Gumbrush Training Kit Conqueror of Gum Disease Trench Mouth Pyorrhea Two Brushes & Instructions* * * Cancer Seldom Occurs in a Mouth Correctly Brushed from Youth. * * * Knox Gumbrush Co. Shamokin, Pa." (Leaflet in Case) 'Read before Using * * * Instructions* * *' and '500 Display Cards, Reading in Part: Did You Know the Toothbrush Was Misnamed? * * *'



The opinion of the court was delivered by: SHERIDAN

This is a motion by the United States, libelant, for summary judgment pursuant to Rule 56 of the Federal Rules of Civil Procedure.

The underlying case is a civil action in rem arising under the provisions of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.A. § 301 et seq. wherein the Government seeks to condemn as misbranded while held for sale after shipment in interstate commerce 2,000 plastic tubular cases, each containing two toothbrushes, together with accompanying instructions and advertising literature. An answer to the libel was filed by Dr. Eugene J. Knox, claimant and owner of the toothbrushes.

 The contention of the Government is that the article is misbranded because the case label, instruction leaflet in each case, and display card accompanying the article contain statements which represent and suggest that the article is 'adequate and effective as a treatment for preventing and overcoming gum disease, pyorrhea, and trench mouth; to prevent cancer, heart disease, defective offspring and loss of teeth; which statements are false and misleading, since the article is not adequate and effective for such purposes'.

 Claimant denies that he ever stated or represented that the brushes are adequate and effective as a treatment for preventing and overcoming pyorrhea, gum disease and trench mouth, but avers that gum brushing is adequate as an aid in preventing these diseases. Claimant agrees that gum brushing is not adequate in preventing cancer, heart disease and defective offspring and loss of teeth, and denies ever having so claimed. He avers that gum brushing is an aid in the prevention of these diseases.

 The case label describes the article as Dr. Knox's Gumbrush Training Kit and includes statements (a) 'Conqueror of Gum Disease Trench Mouth Pyorrhea,' (b) 'Cancer seldom occurs in a mouth correctly brushed from youth,' and (c) 'Most teeth are lost because people brush incorrectly.' The instruction sheet contains statements similar to (c). The display card includes statements similar to (a) and (c), except that the word 'preventive' precedes the word 'conqueror,' and trench mouth and pyorrhea are in parenthesis, and a statement that the article is 'a must for engaged couples as the best aid for prevention of cancer, heart disease, and defective birth of their offspring.'

 Before considering the merits of the Government's motion, certain background data should be noted in explanation of the papers filed in this action, the basis for the Government's motion, and the steps taken to permit claimant to submit data in support of his position.

 Subsequent to the filing of claim and answer to the libel, claimant's attorney died. Claimant has submitted papers and letters to show that while he desires representation by counsel, he has been unable to engage any attorney to take up his cause. The Government based its motion on the matters contained in the pleadings, including an amended answer and claim filed by claimant's attorney before his death, answers to interrogatories filed by claimant, and an affidavit by a Government medical doctor. The motion was brought on for hearing just prior to the amendment of Rule 56, which amendment sets forth the matters outside the pleadings which the court may consider in passing on the motion, and points to the importance of counter-affidavits. At and just prior to the hearing on the motion, claimant filed various documents intended apparently to counter the Government's motion and supporting papers, but he did not file an affidavit or other sworn document. After the effective date of the amendment to Rule 56 of the Federal Rules of Civil Procedure, claimant was given an opportunity to file affidavits or other sworn documents in response to the Government's sworn matter. This claimant did, with himself as the affiant. Subsequently, a hearing was held for argument by the parties on the motion for summary judgment, as supplemented.

 Since the first hearing on the motion, claimant, in addition to his affidavit in response to the Government's affidavit, filed or submitted numerous 'affidavits,' papers, documents, articles and other data, all of which have much in common. They contain hearsay statements with which claimant attempts to support his position, many statements which are irrelevant to this lawsuit, much repetition, and much impertinent and scandalous matter. Some attack the Masons, Jews, persons within the American Dental association, the American Medical Association and the Food and Drug Administration, newspapers, and others and various individuals. Others, apparently prepared by claimant, are complimentary to him. In one of these he describes himself as 'A man who richly deserves the Nobel Prize for medicine and dentistry.' (Some of the subjects covered are: 'The Only Fool-Proof Plan Guaranteed To Prevent Atomic Attack On The United States,' 'Open Letter to the Hon. Congressman George Rhodes from Democrats for Linnet Committee,' 'Some Comments On How Culture Affects A Scientist,' 'The Catholic Church and the American Idea,' and 'Segregation.'

 The Government has not filed a motion to strike this irrelevant, impertinent and scandalous matter. Since the Government's motion for summary judgment will be granted, the court has not ordered it stricken on its own initiative, as permitted by Rule 12(f), Fed.R.Civ.P. See American Machine & Metals, Inc. v. De Bothezat Impeller Co., Inc., S.D.N.Y.1948, 8 F.R.D. 306.

 Claimant has admitted that: the article under seizure is a toothbrush, intended for use in the prevention and treatment of disease in man; the unlabeled and unassembled cases and toothbrushes were shipped in interstate commerce by the Ownes Bruch Company, Iowa City, Iowa, to claimant in Pennsylvania, within this district, prior to and on or about October 27, 1961; the toothbrushes and cases were assembled and labeled and were accompanied by instructions and display cards as previously described, and were in the possession of Knox Gumbrush Company, a sole proprietorship of claimant, who held such articles for sale; and the article is identical in every respect to a common ordinary toothbrush, to be employed for the same purposes that a toothbrush should be used, and is not superior in design but of the same limited utility as any common ordinary toothbrush, and as such cannot get in between the teeth or into difficult areas of the mouth.

 The article is a device within the meaning of 21 U.S.C.A. § 321(h), which was branded while held for sale after shipment in interstate commerce. The question presented is whether the device was misbranded by labeling which is false or misleading in any particular so as to be subject to seizure and condemnation. 21 U.S.C.A. §§ 334(a), 352(a).

 The wording on the case label, instruction sheet and display card is admitted in answers to interrogatories to be a true and accurate description of the wording on the literature which accompanied the brushes seized in this action. The first disagreement is in the impression created by the wording, the Government contending that the wording makes claim that the brushes are adequate and effective as a treatment to prevent and overcome certain diseases, and to prevent others, while claimant alleges that the literature shows that gum brushing is adequate as an aid in the prevention of all of the listed diseases.

 The next question is whether the claim that gum brushing will overcome or cure, or prevent gum disease, pyorrhea, and trench mouth is true. As to this question also there is no genuine issue as to any material fact. The Government produced an affidavit by Dr. Joseph B. Davis that gum brushing is ineffective to prevent and overcome gum disease, pyorrhea, and trench mouth; that pyorrhea, trench mouth and other gum disease are caused also by factors other than poor dental and mouth hygiene; and that the frequency and manner of brushing will not prevent or overcome these conditions. The affidavit filed by claimant pursuant to the court's direction so that claimant could meet the requirements of Rule 56 of the Federal Rules of Civil Procedure, is not responsive to the Government's affidavit in many respects. Rule 56(e) provides that 'Supporting and opposing affidavits shall be made on personal knowledge, shall set forth such facts as would be admissible in evidence, and shall show affirmatively that the affiant is competent to testify to the matters stated therein.' The matters in question are within the realm of expert opinion, but claimant, the affiant, has not set forth his training and experience to show his competency to testify to such matters. ...


Buy This Entire Record For $7.95

Download the entire decision to receive the complete text, official citation,
docket number, dissents and concurrences, and footnotes for this case.

Learn more about what you receive with purchase of this case.