It is clear that the Ellis Micro-Dynameter, as an instrument or apparatus intended for use in the diagnosis of the diseases of man, is an article of device § (321(h)).
Section 352 of the Act provides, in part:
' § 352. Misbranded drugs and devices
'A drug or device shall be deemed to be misbranded --
'(a) If its labeling is false or misleading in any particular.
'(f) Unless its labeling bears (1) adequate directions for use; * * *.'
Labeling is defined to mean 'all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.' ( § 321(m)).
The literature which was shipped with the device and that which was shipped to claimant thereafter was all designed for use in the distribution and sale of the device, therefore accompanied it and constituted 'labeling' as defined in the Act, 321(m); Kordel v. United States, 335 U.S. 345, 69 S. Ct. 112, 93 L. Ed. 52 (1948); United States v. Urbuteit, 335 U.S. 355, 69 S. Ct. 112, 93 L. Ed. 61 (1948); United States v. 47 Bottles, etc., R. J. Formula, 320 F.2d 564 (3rd Cir. 1963); United States v. 353 Cases Mountain Valley Mineral Water, 247 F.2d 473 (8th Cir. 1957).
If any claim made in the labeling is false or misleading, the drug or device is misbranded under § 352(a). United States v. 95 Barrels, etc., of Vinegar, 265 U.S. 438, 44 S. Ct. 529, 68 L. Ed. 1094 (1924); United States v. 47 Bottles, etc., R. J. Formula, supra; United States v. Hoxsey Cancer Clinic, 198 F.2d 273 (5th Cir. 1952), cert. denied 344 U.S. 928, 73 S. Ct. 496, 97 L. Ed. 714 (1953), rehearing denied 345 U.S. 914, 73 S. Ct. 642, 97 L. Ed. 1348 (1953); United States v. One Device, Intended for Use as a Colonic Irrigator, 160 F.2d 194 (10th Cir. 1947). Many false claims were admittedly made in the literature which accompanied the Micro-Dynameter, but claimant argues that, since he was not misled by them, the false claims in the labeling did not constitute misbranding. Little need be said about that contention. Such an interpretation would require replacing the disjunctive 'or' in § 352(a) with the conjunctive 'and', which would not only be an unwarranted disregard of the clear meaning of words, it would also run counter to the purpose and intent of the Act to keep misbranded drugs and devices out of the channels of commerce. United States v. Dotterweich, 320 U.S. 277, 64 S. Ct. 134, 88 L. Ed. 48 (1943). The word 'misleading' in § 352(a) is obviously not intended to narrow the scope of misbranding but to broaden it to cover situations in which, although a claim is not technically false, or even if literally true, the drug or device may nevertheless be misbranded if the total effect of the labeling is to deceive or mislead. United States v. 95 Barrels, etc., of Vinegar, supra. Further, under § 334(a),
misbranding, and therefore liability to condemnation, is determined by the state of facts existing at the time of the introduction of the device into interstate commerce, or while in interstate commerce. Condemnation, therefore, cannot be made to depend upon the happenstance of the knowledge, training or degree of gullibility of the person into whose hands the misbranded article falls and upon whether that person, in fact, relied upon the false claims. United States v. Olsen, 161 F.2d 669 (9th Cir. 1947), cert. denied 332 U.S. 768, 68 S. Ct. 79, 92 L. Ed. 353 (1947); and see United States v. 47 Bottles, etc., R. J. Formula, supra, in which literature, even though not actually used, was held to be labeling and therefore misbranding under § 352(a).
Since the Ellis Micro-Dynameter was admittedly incapable of all uses claimed for it, adequate directions for the claimed uses which is was incapable of performing could not be written and the device, therefore, was also misbranded under § 352(f). Alberty Fook Products v. United States, 194 F.2d 463 (9th Cir. 1952).
The motion of the United States for summary judgment will be granted.