367. Misbranding of Axlne Plates. IT. S. v. Walter Gordon Pervis. Tried to the court and a jury. Verdict of guilty. Defendant sentenced to 6 months In jail and $1,000 fine. Jail sentence suspended and defendant placed on probation for 2 years. (F. D. C. No. 958. Sample No. 72023-D.) The labeling of this device bore false and misleading representations and designs regarding its efficacy in the conditions indicated below. On June 1, 1940, the United States attorney for the Middle District of Georgia filed an information against Walter Gordon Pervis, of Tennille, Ga., alleging shipment on or about September 30,1939, from the State of Georgia into the State of Missouri of a quantity of Axine Plates which were misbranded. Accompany- ing the article was a circular headed "Health Without Medicine" which bore a design showing two individuals, one an invalid on crutches opposite whom was a figure purporting to be the same individual but healthy and vigorous. Emanating from the heels of the healthy individual were radiations indicating electrical energy. Underneath the design were the words "Vigor" and "Produced by Electricity in the Human Body." Examination showed that the article consisted of two plates, of which one consisted essentially of copper and the other consisted essentially of zinc. The article was alleged to be misbranded in that the above-described design and certain statements in the circular represented that it would produce health and vigor by means of electricity in the human body; would relieve the stiffness of old age and make one feel young again; would rid the blood of uric acid; would be efficacious in the mitigation, treatment, and prevention of high blood pressure, low blood pressure, headache, asthma, paralysis, kidney trouble, rheumatism and diabetes, eczema, cold hands and feet, poor circula- tion; and would be efficacious "to draw the acid from the larynx glands and thus stop excessive coughing of asthma," were false and misleading since the article would not be efficacious for such purposes. The article was alleged to be misbranded further in that certain statements in the circular were false and misleading since they represented that uric acid forms in the stomach; that it forms as the result of eating food that disagrees with the stomach; that the acid then filters through the blood and travels through the blood as a very fine crystal; that the device consisted of a composition of metals which "would act upon the human electricity, and would make human electricity fast"; that it would heat the blood about 2 degrees, and thus dissolve uric acid in the blood; that uric acid would pass through the blood into the device, i. e., metal plates worn in the heels of the shoes; whereas uric acid does not form in the stomach, it does not form as the result of eating food that disagrees with the stomach; it does not filter through the blood and travel through the blood as a very fine crystal; the device would not act upon human electricity, and would not make human electricity fast; it would not heat the blood about 2 degrees, and would not dissolve uric acid in the blood; and uric acid would not pass through the blood into the device. The article was alleged to be mis- branded further in that certain statements in the circular represented that the cause of high blood pressure is the uric acid crystals stopping in the arteries, hardening the arteries and enlarging the heart; that the device would stimulate one's own electric current; that the electric current would pass through the brain and dissolve and draw away clot on the brain caused by high blood pressure; whereas the cause of high blood pressure is not uric acid crystals stopping in the arteries, hardening the arteries and enlarging the heart; the device would not stimulate one's own electric current; and the electric current would not pass through the brain and dissolve and draw away the clot on the brain caused by high blood pressure. It was alleged to be misbranded further in that certain statements in the labeling represented that uric acid stiffens the prostate gland; that because of uric acid the prostate gland stands open and will not "pan down"; that failure of the prostate glands to "pan down" causes diabetes; that the device would produce heat by the metals acting as a battery on the human electricity; that the heat produced by the device would cause the prostate gland to "pan down" and relieve the patient, which representations were entirely false and misleading, since uric acid does not stiffen the prostate gland and cause it to stand open and fail to "pan down"; the failure of the prostate gland to "pan down" does not cause dia- betes ; the device would not produce heat by the metals acting as a battery on the human electricity; and it would not cause the prostate gland to "pan down" and relieve the patient entirely. On November 11, 1940, a plea of not guilty having been entered, the case came on for trial before the court and jury. The trial was concluded on November 13, 1940, on which date the court delivered the following instructions to the jury: DEAVER, Judge: "Gentlemen of the Jury. Without attempting to state to you all the provisions of the Food and Drug Act, it is only necessary for me to state one provision of it, and that is very short and simple. Congress has made it a crime to ship in interstate commerce, that is to say from one State into another State, any device which is misbranded. Now, misbranded under the terms of the statute is this: A device is misbranded when the label and statements in connection with it are false or misleading. That is the whole provision of the law applicable to this case. "Now, the information in this case, which you will have out with you, is somewhat long but it charges in substance that this defendant shipped in inter- state commerce a certain device, which you already know about, certain heel plates known as Axine Plates, from this State into another State, and that the shipment was misbranded, that the device was misbranded; that is to say, that the statements or representations on the label or these circulars, which you have seen here in evidence and which you will have out with you, are false or mis- leading. Now, that is the question that you are to determine, whether the label or statements in connection with this device are false or misleading. "Now, you will find in this indictment set out, I take it-I haven't read it but I think that you will find that true, you may read it all if you care to- the statements which were either on the label or in these circulars and the allegations in the information that certain things in here are false or misleading, and you will follow that right straight on through. ' It sets out one provision after another and then alleges that those statements are false or misleading in certain respects. "Now, to that charge the defendant has entered on the back of this informa- tion a plea of not guilty. That plea is in substance a denial of every essential allegation in the information, and the information together with the plea of not guilty makes up an issue of fact, a question of fact, for this jury to determine. "Then, the trial begins and the burden is on the Government to produce evi- dence sufficient to convince the jury beyond a reasonable doubt that the defendant is guilty, as charged. "In the beginning of the trial, the defendant is presumed to be innocent and that presumption continues unless it is overcome by the testimony in the case, testimony sufficient to overcome the presumption and to convince the jury beyond a reasonable doubt that the defendant is guilty. "The testimony has been somewhat long, necessarily long. There is no criti- cism of anybody in that connection because it was necessary to bring you the evidence bearing on this question and you are to take all of that evidence on both sides and consider all of it, oral testimony and documentary testimony, and say from it all what you honestly believe about it, what your honest conviction is as to whether the statements made by the defendant in these circulars or printed matter sent out with the shipment are false or misleading. If those statements are false and misleading, then the shipment was misbranded and, therefore, the shipping constituted a crime. "That is all there is to the case. I say there is a lot of testimony but the question to be decided is very simple and easy to state. "Now, I might just repeat it this one time: You determine from all the evi- dence in the case whether the statements made by this defendant in connection with the shipment of these heel plates are false or misleading. Oh, of course, there are a great many facts set out here in the information that are necessary with reference to jurisdiction and shipment in interstate commerce and various things of that sort, but, as you have heard here in the trial of this case, there is really no dispute between the parties here as to any of those things, and that's the reason why I say you haven't got but one question. It is admitted, I believe, here that the shipments were made in interstate commerce, that they contained these circulars and these representations and all those various things, and for that reason I say you have, in substance, only the one question to decide: Were these statements false or misleading? If they were, then he is guilty. If they were not, or if the Government has failed to convince you beyond a reasonable doubt that they are, then you ought to turn the defendant loose. "You will write your verdict on the back of this information. There is a blank verdict there that you can fill out and let your foreman sign it, date it, and, if you think under all this testimony that the statements and representations made are false or misleading, then you ought to find this verdict, 'We the jury find the defendant guilty.' If you think the Government has failed to carry the burden of showing that fact, then your verdict ought to be, 'We the jury find the defendant not guilty.'" Mr. DAVIS. "Your Honor, will you charge the jury that if they find that any of the statements are false, they should find the defendant guilty? There are quite a number of statements on there. They wouldn't have to find all of them were false." "Yes, any of the statements, gentlemen of the jury, which in this information are alleged to be false or misleading. It wouldn't be necessary to prove that every statement in the circular or every statement set out in the copy of the circulars or representations in this information is false or misleading, but it is necessary to find, in order for you to find the defendant guilty, that some state- ment copied in this information and alleged to be false or misleading is false or misleading." The jury retired and after due deliberation returned a verdict of guilty, and the court sentenced the defendant to 6 months in jail and imposed a fine of $1,000. On December 12, 1940, the court suspended the 6-months' jail sentence and placed the defendant on probation for 2 years.