Pruvo Pharmacal Company

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In tye MATTER OF PRUVO PHARMACAL COMPANY ET AL.

COMPLAINT, DECISION, FINDINGS, AND ORDER IN REGARD TO THE ALLEGED VIOLATION OF SEC. 5 OF AN ACT OF CONGRESS APPROVED SEPT. 26, 1914 Docket 5778. Complaint, May 19, 1950—Decision, May 15, 1958 The terms “arthritis” and “rheumatism” are general terms, sometimes used interchangeably, which refer to any of a number of diseases or pathological conditions including, among others, neuritis, sciatics, neuralgia, gout, fibrositis, bursitis, rheumatoid arthritis, osteoarthritis, rheumatie fever and infectious arthritis, all of which are characterized by one or more of such symptoms or manifestations as pain, stiffness, and inflammatory and destructive changes in the joints and tissues of the body. The various pathological conditions generally referred to as “arthritis” and “yheumatism” progress and develop differently. Likewise, they require different treatment, which will vary not only between different types of such ailments, but between different stages in the progress thereof. An adequate, effective, or reliable treatment for any kind of “arthritis” or “rheumatism” must, therefore, be predicated upon individual diagnosis, in order to determine whether the patient has arthritis or rheumatism, the particular kind of such ailment present, and whether it arose from a known or an unknown cause.

An adequate, effective, or reliable treatment for any of the various types of ailments included in the general terms “arthritis” and “rheumatism” may involve application of various therapeutic measures, including diet, rest or change of occupation, various types of physiotherapy such as orthopedic or thermal procedures, surgery, and medication; and delay of needed treatment may result in irreparable crippling, especially in those forms of arthritis and rheumatism known to be caused by specific infections. There is no drug, or combination of drugs, regardless of how administered, which will constitute an adequate, effective, or reliable treatment for any of the various forms of arthritis or rheumatism, nor is there any drug or combination of drugs which can restore to normal the pathological changes which result from any arthritic or rheumatic ailment. Where a corporation and the three individuals controlling it, engaged in the interstate sale and distribution of their medicinal preparation “Pruvo,” the only therapeutic, operative ingredient of which was acetylsalicylic acid, commonly known as aspirin; in advertising in newspapers and otherwise— (a) Represented falsely, directly and by implication, that said Pruvo, taken as directed by those suffering from all kinds of arthritis, rheumatism, and neuritis, would result in benefits in excess of those afforded by an analgesic and antipyretic, including reduction of swelling and freeing joints of stiffness; would quickly and completely relieve all pains of arthritis, rheumatism, and neuritis; and was a remarkable new medical discovery ; Complaint 49 F.T.C.

The facts being that the calcium succinate content of the preparation has no value in the treatment of said conditions for the reason that when administered orally, succinates, as such, never reach the bloodstream; and acetylsalicylic acid or aspirin, its only therapeutic operative ingredient, an analgesic and antipyretic; would afford only temporary relief from pain; (6) Falsely represented that, by taking said Pruvo as directed, persons afflicted with arthritis, rheumatism, and neuritis would be able to resume their normal living and usual occupations; and (c) Represented that said Pruvo was safe and might be taken by practically anyone without stomach upset or other unfavorable reactions; notwithstanding the fact that under certain circumstances, or when taken over prolonged periods of time, said product, by virtue of its aspirin content, might be harmful or toxic;

With effect of misleading a substantial portion of the purchasing public into the erroneous belief that such representations were true and thereby into the purchase of substantial quantities of said product; and with capacity and tendency so to mislead and deceive:

Held, That such representations constituted false advertisements, and that such acts and practices, under the circumstances set forth, were all to the prejudice and injury of the public and constituted unfair and deceptive acts and practices in commerce.

Before Mr. Abner E. Lipscomb, hearing examiner. Mr. Joseph Callaway for the Commission.

Mr. Charles H. Rowan, of Milwaukee, Wis., for respondents. ComMPpLaIntT Pursuant to the provisions of the Federal Trade Commission Act and by virtue of the authority vested in it by said Act the Federal Trade Commission, having reason to believe that Pruvo Pharmacal Company, a corporation and Harry L. Williams, Neal Wiliams, individually and as officers of Pruvo Pharmacal Company and M. Seibert, individually and as a director of said corporation, hereinafter referred to as respondents, have violated the provisions of said Act and it appearing to the Commission that a proceeding by it in respect thereof would be in the public interest hereby issues its complaint stating its charges in that respect as follows:

ParacrapPH 1. Respondent Pruvo Pharmacal Company is a corporation organized under the laws of the State of Wisconsin with its office and principal place of business located at 322 E. Michigan Street, Milwaukee, Wisconsin.

Respondents, Harry L. Williams, Neal Williams and M. Seibert are respectively the President, Vice-President and Director of Pruvo Pharmacal Company and have offices and place of business at 322 E. Michigan Street, Milwaukee, Wisconsin. The said individual re- PRUVO PHARMACAL CO. ET AL. 1367 1365, Complaint spondents are now, and at all times mentioned herein have been in control of the management, policy and operation of Pruvo Pharmacal Company, particularly in respect to the acts, practices, and methods herein alleged.

Par. 2. Respondents are now, and have been for more than six months last past, engaged in the business of selling and distributing a certain drug product as “drug” is defined in the Federal Trade Commission Act.

The designation used by respondents for the said product and the formula and directions for use thereof are as follows: Designation: Pruvo.

Formula: Each tablet contains 3 grains calcium succinate and 4 grains of acetylsalicylic acid, plus excipients. Directions: Dose: 2 to 4 tablets 4 times a day before meals and bed time with a glass of water until acute pairs are relieved, then 8 tablets a day (2 before meals and 2 at bed time) with water, for 2 or 38 months, or until pains disappear; then the dose can be reduced to one tablet 4 times a day as above for 2 or 8 months more. In severe cases of arthritis or rheumatism better relief may result if 6 tablets are taken 4 times a day.

Par. 8. Respondents cause their said product, when sold, to be transported from their place of business in the State of Wisconsin to purchasers thereof located in other States of the United States and in the District of Columbia. Respondents maintain and at all times mentioned herein have maintained a course of trade in the said product in commerce between and among the various States of the United States and in the District of Columbia. Respondents’ volume of business in such commerce is substantial.

Par. 4. In the course and conduct of their business the respondents, subsequent to March 21, 1938, have disseminated and caused the dissemination of certain advertisements concerning their product by the United States mails and by various means in commerce, as “commerce” is defined in the Federal Trade Commission Act, for the purpose of inducing and which were likely to induce directly or indirectly, its purchase, including but not limited to:

Advertisements inserted in the following newspapers: Milwaukee Sentinel, Milwaukee, Wisconsin—Issues of August 1, September 7, 1949, and January 9, 1950.

Grand Rapids Herald, Grand Rapids, Michigan—Issue of October 24, 1949.

Free Press, Detroit, Michigan—Issue of November 8, 1949. The Fargo Forum, Fargo, North Dakota, Issue of November 1, 1949. Complaint 49 F.T.C.

Rocky Mountain News, Denver, Colorado, Issue, November 8, 1949. Respondents have also disseminated and caused the dissemination of the advertisements referred to above for the purpose of inducing and which were likely to induce, directly or indirectly, the purchase of Pruvo in commerce as “commerce” is defined in the Federal Trade Commission Act.

Par. 5. Through the use of the said advertisements respondents have made, directly and by implication, the representations shown in the following subparagraphs identified as (a) to (e), inclusive. The said advertisements, by reason of said representations, are misleading in material respects and constitute false “advertisements” as that term is defined in the Federal Trade Commission Act by reason of the true facts which are set forth in subparagraphs (1) to (6), inclusive. (a) That Pruvo, taken as directed, by those suffering from all kinds of arthritis, rheumatism and neuritis will result in benefits in excess of those afforded by an analgesic and antipyretic, among these being reduction of swelling and freeing joints of stiffness. (1) Pruvo, however, taken, will not result in benefits to those suffering from arthritis, rheumatism and neuritis in excess of those afforded by an analgesic and antipyretic. Its use will not reduce swelling or free joints of stiffness.

(6) That Pruvo, taken as directed, will quickly and completely relieve all pains of arthritis, rheumatism and neuritis. (2) Pruvo, however taken, will not quickly or completely relieve all pains of arthritis, rheumatism or neuritis. The aches, pains and discomforts incident to these ailments may be of such a nature that they will be in no way alleviated by the use of Pruvo, however taken, and in other cases the relief afforded will be limited to such a degree of temporary and partial analgesic and antipyretic effects as its aspirin content may afford in the individual case. (8) The effect of Pruvo, when used in any of the ailments mentioned aforesaid, is limited to temporary and partial relief of minor aches and pains and fever.

(¢) That Pruvo is a remarkable new medical discovery. (4) Neither the composition or effects of Pruvo can be properly characterized as remarkable.

(d) That by taking Pruvo, as directed, persons afflicted with arthritis, rheumatism and neuritis will be able to resume their normal living and usual occupations.

(5) Persons afflicted with these ailments so severely as to interfere with either their normal habits of life or their ability to carry on their regular occupations will not be enabled to resume such habits or occupations by using said preparation.

PRUVO PHARMACAL CO. ET AL. 1369 1365 Decision (e) That Pruvo is safe and may be taken by practically anyone. without stomach upset or other unfavorable reactions. (6) Pruvo contains aspirin and cannot be taken with safety and impunity by persons who are adversely affected by said drug. Its use may cause stomach upset and other unfavorable reactions. Par. 6. The use by-respondents of the aforesaid false advertisements had the capacity and tendency to mislead and deceive a substantial portion of the purchasing ‘public into the erroneous and mistaken belief that the representations and statements contained therein were true and into the purchase of substantial quantities of Pruvo by reason of said erroneous and mistaken belief.

Par. 7. The aforesaid acts and practices of respondents, as herein alleged, are all to the prejudice and injury of the public and constitute unfair and deceptive acts and practices in commerce within the intent and meaning of the Federal Trade Commission Act. DECISION OF THE COMMISSION AND ORDER TO FILE REPORT OF COMPLIANCE Pursuant to the provisions of the Federal Trade Commission Act, the Federal Trade Commission, on May 19, 1950, issued and subsequently served its complaint in this proceeding upon the respondents named in the caption hereof, charging them with the use of unfair and deceptive practices in commerce in violation of the provisions of said Act. After the issuance of said complaint, counsel supporting the complaint and counsel for respondents, on July 28, 1950, entered into a stipulation, thereafter amended by a further stipulation on August 21, 1951, and subsequently supplemented by another stipulation on January 2, 1952, wherein it was agreed that the evidence in support of and in opposition to the complaint in the matter of Rhodes Pharmacal Company, Inc., et al., Docket No. 5691, and the testimony of Dr. Herman H. Tillis in the matter of Dolcin Corporation et al., Docket No. 5692, together with the statement of facts recorded in said stipulations, should constitute the record in the instant proceeding. It was further stipulated and agreed that when the Commission should have completed its adjudication in the two proceedings cited, the hearing examiner might, without any intervening procedure, issue his initial decision. Thereafter the hearing examiner, in accordance with the said stipulations, on December 18, 1952, filed his initial decision herein.

The Commission, having reason to believe that the initial decision did not constitute an adequate disposition of the matter, on January 29, 1953, issued and thereafter served upon the parties its order placing this case upon the Commission’s own docket for review. Thereafter Findings 49 F.T.C.

the Commission, having considered the entire record and having prepared a tentative decision, caused copies of said decision to be served upon respondents, together with its order, issued on March 24, 1953, granting leave to respondents to file within twenty days after service thereof, objections to the changes in the hearing examiner’s initial decision as shown by the said tentative decision. Thereafter the proceeding came on for final consideration by the Commission upon the record herein on review, including a memorandum of objections to the tentative decision filed on April 17, 1953, by counsel for respondents, and the Commission, having duly considered the matter, including the said memorandum of objections, and being now fully advised in the premises, finds that this proceeding is in the interest of the public and makes the following findings as to the facts, conclusion drawn therefrom, and order, the same to be in lieu of the initial decision of the hearing examiner.

FINDINGS AS TO FACTS Paracrary 1. Respondent Pruvo Pharmacal Company is a corporation organized under the laws of the State of Wisconsin, with its office and principal place of business located at 822 E. Michigan Street, Milwaukee, Wisconsin.

Respondents Harry L. Williams, Neal Williams, and M. Seibert, are, respectively, the President, Vice-President, and Director of Pruvo Pharmacal Company and have offices and place of business at 322 E. Michigan Street, Milwaukee, Wisconsin. The said individual respondents are now, and at all times mentioned herein have been, in control of the management, policy, and operation of Pruvo Pharmacal Company, particularly in respect to the acts, practices, and methods herein found.

Par. 2. Respondents are now, and have been for more than six months last past, engaged in the business of selling and distributing a certain drug product, as “drug” is defined in the Federal Trade Commission Act.

‘The designation used by respondents for the said product and the formula and directions for use thereof are as follows: Designation: “Pruvo.”

Formula: Each tablet contains 8 grains calcium succinate and 4 grains of acetylsalicyclic acid, plus excipients. Directions: Dose: 2 to 4 tablets four times a day before meals and bed time with a glass of water until acute pains are relieved, then 8 tablets a day (2 before meals and 2 at bed time) with water, for 2 or 3 months, or until pains disappear; then the dose can be reduced to one PRUVO PHARMACAL CO. ET AL. 1371 1365 Findings tablet 4 times a day as above for 2 or 3 months more. In severe cases of arthritis or rheumatism better relief may result if 6 tablets are taken 4 times a day. ;

Par. 3. Respondents cause their said product, when sold, to be transported from their place of business in the State of Wisconsin to purchasers located in other States of the United States and in the District of Columbia. Respondents maintain, and at all times mentioned herein have maintained, a course of trade in said product in commerce between and among the various States of the United States and in the District of Columbia. Respondents’ volume of business in such commerce is substantial.

Par. 4. In the course and conduct of their business, the respondents, subsequent to March 21, 1938, have disseminated and caused the dissemination of certain advertisements concerning their product by the United States mails and by various means in commerce, as “commerce” ‘ is defined in the Federal Trade Commission Act, for the purpose of inducing, and which were likely to induce, directly or indirectly, its purchase, including, but not limited to, advertisements inserted in the following newspapers:

Milwaukee Sentinel, Milwaukee, Wisconsin, Issues of August 1, September 7, 1949, and January 9, 1950.

Grand Rapids Herald, Grand Rapids, Michigan, Issue of October 24, 1949.

Free Press, Detroit, Michigan, Issue of November 8, 1949. The Fargo Forum, Fargo, North Dakota, Issue of November 1, 1949. Rocky Mountain News, Denver, Colorado, Issue of November 8, 1949.

Respondents have also disseminated and caused the dissemination of the advertisements referred to above for the purpose of inducing, and which were likely to induce, directly or indirectly, the purchase of Pruvo in commerce, as “commerce” is defined in the Federal Trade Commission Act.

Par. 5. Through the use of the said advertisements, respondents have made, directly and by implication, the representations shown in the following subparagraphs identified as (a) to (e) inclusive: (a) That Pruvo, taken as directed by those suffering from all kinds of arthritis, rheumatism and neuritis, will result in benefits in excess of those afforded by an analgesic and antipyretic, among these being reduction of swelling and freeing joints of stiffness ; (0) That Pruvo, taken as directed, will quickly and completely relieve all pains of arthritis, rheumatism, and neuritis; (ce) That Pruvo isa remarkable new medical discovery ; 1372 FEDERAL TRADE COMMISSION DECISIONS .

Findings | 49 F.T.C.

(d) That by taking Pruvo, as directed, persons afflicted with arthritis, rheumatism, and neuritis will be able to resume their normal living and usual occupations ;

(e) That Pruvo is safe and may be taken by practically anyone without stomach upset or other unfavorable reactions. Par. 6. The terms “arthritis” and “rheumatism” are general terms, sometimes used interchangeably, which refer to any of a number of diseases or pathological conditions including, among others, neuritis, sciatica, neuralgia, gout, fibrositis, bursitis, rheumatoid arthritis, osteoarthritis, rheumatic fever and infectious arthritis, all of which are characterized by one or more of such symptoms or manifestations as pain, stiffness, and inflammatory and destructive changes in the joints and tissues of the body.

The term “neuritis” means inflammation of a nerve, which may be attended by pain, paralysis and degeneration of the nerve substance. This condition is produced by many causes, such as localized infection, creating toxic substances in the system; toxic acidity from the use of various drugs; deprivation of certain chemical substances or vitamins; metabolic disturbances connected with diabetes; and infection of a nerve by various germs, such as that which causes syphilis. Par. 7. The various pathological conditions generally referred to as “arthritis” and “rheumatism” progress and develop differently. Likewise, they require different treatment, which will vary not only between different types of such ailments, but between different individuals suffering from the same ailment, and between different stages in the progress thereof. An adequate, effective, or reliable treatment for any kind of “arthritis” or “rheumatism” must, therefore, be predicated upon individual diagnosis, in order to determine whether the patient has arthritis or rheumatism, the particular kind of such ailment present, and whether it arose from a known or an unknown cause. Such a diagnosis may require any or all of the following determinations:

1. History of the patient, including information as to.age, sex, marital status, occupation, chronology of the present ailment; family history, such as age and cause of death of parents and relatives; any illnesses from which the patient may have suffered previously, particularly rheumatic fever, scarlet fever and streptococcus infections; 2. Detailed physical examination of every part of the patient’s anatomy; and 3. Laboratory examination, such as blood count, serological test for syphilis, urinalysis, and certain other tests as they may seem useful in the individual case, such as X-ray and analysis of fluids in individual joints.

PRUVO PHARMACAL CO. ET AL. 1373 1365 Findings Par. 8. An adequate, effective, or reliable treatment for any of the various types of ailments included in the general terms “arthritis” and “rheumatism” may involve application of various therapeutic measures, including diet; rest or change of occupation; various types of physiotherapy, such as orthopedic or thermal procedures; surgery ; and medication. Delay of needed treatment may result in irreparable crippling, especially in those forms of arthritis and rheumatism known to be caused by specific infections. There is no drug, or combination of drugs, regardless of how administered, which will constitute an adequate, effective, or reliable treatment for any of the various forms of arthritis or rheumatism, nor is there any drug or combination of drugs which can restore to normal the pathological changes which result from any arthritic or rheumatic ailment. Par. 9. The calcium succinate content of the drug preparation “Pruvo” has no significant therapeutic value in the treatment of arthritic or rheumatic conditions, for the reason that, when administered orally, as specified in the directions for taking Pruvo, succinates are converted to sugar by the liver, and, as succinates, never reach the bloodstream. The only ingredient contained in Pruvo which possesses active analgesic properties is acetylsalicyclic acid, the use and effect of which, as an analgesic and antipyretic, has been known for many years. Acetylsalicylic acid has for many years been sold throughout the United States as an analgesic under the name “aspirin.” Accordingly, the drug preparation “Pruvo” does not constitute a new medical discovery. The analgesic effect of this salicylate, in the amount contained in the drug preparation “Pruvo,” upon the aches, pains and discomforts of arthritic or rheumatic conditions is temporary. Accordingly, such drug preparation is neither a remarkable nor anew discovery.

Par. 10. Since the only therapeutically operative ingredient in the drug preparation “Pruvo” is acetylsalicylic acid, commonly known as aspirin, and since, under certain circumstances, or when taken over prolonged periods of time, aspirin may produce harmful effects upon the body, the drug preparation “Pruvo” may be toxic to the same extent, and cannot be taken over prolonged periods of time without the danger of such harmful effects, nor can such preparation be taken safely by persons adversely affected by aspirin. Par. 11. The drug preparation “Pruvo,” however taken, will not constitute an adequate, effective, or reliable treatment for any arthritic or rheumatic condition, including neuritis, nor will said preparation arrest the progress, correct the underlying causes, or effect a cure of any of such conditions. The drug preparation “Pruvo,” however taken, will not ameliorate the aches, pains and discomforts of any e 260133—S5 90 Order 49 F. T.C.

arthritic or rheumatic condition to any extent beyond the temporary relief thereof afforded by its salicylate content as an analgesic and antipyretic. The drug preparation “Pruvo,” however taken, will have no significant effect upon severe aches, pains and discomforts accompanying any arthritic or rheumatic condition, and will afford temporary relief of only minor aches, pains and discomforts. With the exception of such temporary relief, the drug preparation “Pruvo” cannot be depended upon to have any effect whatever upon the symptoms accompanying any arthritic or rheumatic condition, including neuritis. Persons forced by such ailments to discontinue their normal habits of living or their usual occupations will not be enabled, by taking the drug preparation “Pruvo,” to resume such habits or occupations.

Par. 12. Respondents’ representations concerning the drug preparation “Pruvo,” as hereinbefore found, are false and misleading in material respects, have had the capacity and tendency to mislead and deceive, and have misled and deceived a substantial portion of the purchasing public into the erroneous and mistaken belief that such representations were true, and into the purchase of substantial quantities of said drug preparation as a result thereof; and constitute false advertisements within the intent and meaning of the Federal Trade Commission Act.

CONCLUSION The acts and practices of respondents, as herein found, are all to the prejudice and injury of the public, and constitute unfair and deceptive acts and practices in commerce within the meaning of the Federal Trade Commission Act.

ORDER It is ordered, That the respondent Pruvo Pharmacal Company, a corporation, and its officers, and respondents Harry L. Williams and Neal Williams, individually and as officers, and respondent M. Seibert, individually and as a Director, of said corporation, and said respondents’ agents, representatives and employees, directly or through any corporate or other device, in connection with the offering for sale, sale and distribution of the drug preparation “Pruvo,” or any product of substantially similar composition or possessing substantially similar properties, whether sold under the same name or under any other name, do forthwith cease and desist from directly or indirectly: 1. Disseminating or causing to be disseminated, by means of the United States mails or by any means in commerce, as “commerce” is PRUVO PHARMACAL CO. ET AL. 1375 1365 : Order defined in the Federal Trade Commission Act, any advertisement which represents, directly or by implication : (a) That the taking of said preparation by those suffering from arthritis, rheumatism, neuritis, or any other kind of arthritic or rheumatic condition, will reduce swelling or free joints of stiffness, or will result in any therapeutic benefits in excess of those afforded by an analgesic or antipyretic;

(6) That the taking of said preparation will quickly or completely relieve all pains of arthritis, rheumatism, neuritis, or any other kind of arthritic or rheumatic condition, or have any therapeutic effect upon any of the symptoms or manifestations thereof, in excess of affording temporary relief of minor aches, pains, or fever; (c) That said preparation is a remarkable or new medical discovery ;

(d) That persons afflicted with arthritis, rheumatism or neuritis so severely that such afflictions interfere with their normal habits of living or their ability to carry on their usual occupations will be enabled, by taking the drug preparation “Pruvo,” to resume such normal living habits or usual occupations; (e) That the drug preparation “Pruvo” may safely be taken by persons adversely affected by aspirin.

2. Disseminating or causing to be disseminated any advertisement, by any means, for the purpose of inducing, or which is likely to induce, directly or indirectly, the purchase in commerce, as “commerce” is defined in the Federal Trade Commission Act, of said drug preparations, which advertisement contains any of the representations prohibited in Paragraph 1 hereof.

It is further ordered, That the respondents shall, within sixty (60) days after service upon them of this order, file with the Commission a report in writing setting forth in detail the manner and form in which they have complied with this order.

Commissioner Howrey not participating.

Sylabus 49 FLTC.