562 F.2d 749 (D.C. Cir. 1977), 76-1138, Warner-Lambert Co. v. F. T. C.
|Citation:||562 F.2d 749|
|Party Name:||1977-2 Trade Cases 61,563, 1977-2 Trade Cases WARNER-LAMBERT COMPANY, Petitioner, v. FEDERAL TRADE COMMISSION, Respondent.|
|Case Date:||August 02, 1977|
|Court:||United States Courts of Appeals, Court of Appeals for the District of Columbia Circuit|
Argued March 25, 1977.
Rehearing Denied Sept. 14, 1977.
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Herbert A. Bergson, Washington, D. C., with whom James H. Kelley, Donald L. Hardison, and Larry D. Sharp, Washington, D. C., were on the brief, for petitioner.
Jerold D. Cummins, Acting Asst. Gen. Counsel, F. T. C., Washington, D. C., with whom Gerald P. Norton, Acting Gen. Counsel, F. T. C., Washington, D. C., was on the brief, for respondent. Gerald Harwood, Asst. Gen. Counsel, F. T. C., Washington, D. C., at the time the record was filed, also entered an appearance for respondent.
Gilbert H. Weil, New York City, filed a brief on behalf of the Association of National Advertisers, Inc. as amicus curiae urging reversal.
William W. Rogal, Washington, D. C., filed a brief on behalf of the American Advertising Federation as amicus curiae urging reversal.
Before BAZELON, Chief Judge, and WRIGHT and ROBB, Circuit Judges.
Opinion for the court filed by Circuit Judge WRIGHT.
Dissenting opinion filed by ROBB, Circuit Judge.
J. SKELLY WRIGHT, Circuit Judge:
The Warner-Lambert Company petitions for review of an order of the Federal Trade Commission requiring it to cease and desist from advertising that its product, Listerine Antiseptic mouthwash, prevents, cures, or alleviates the common cold. The FTC order further requires Warner-Lambert to disclose in future Listerine advertisements that: "Contrary to prior advertising, Listerine will not help prevent colds or sore throats or lessen their severity." 1 We affirm but modify the order to delete from the required disclosure the phrase "Contrary to prior advertising."
The order under review represents the culmination of a proceeding begun in 1972, when the FTC issued a complaint charging petitioner with violation of Section 5(a)(1) of the Federal Trade Commission Act 2 by misrepresenting the efficacy of Listerine against the common cold.
Listerine has been on the market since 1879. Its formula has never changed. Ever since its introduction it has been represented as being beneficial in certain respects for colds, cold symptoms, and sore throats. Direct advertising to the consumer, including the cold claims as well as others, began in 1921.
Following the 1972 complaint, hearings were held before an administrative law judge (ALJ). The hearings consumed over four months and produced an evidentiary record consisting of approximately 4,000 pages of documentary exhibits and the testimony of 46 witnesses. In 1974 the ALJ issued an initial decision sustaining the allegations of the complaint. Petitioner appealed this decision to the Commission. On December 9, 1975 the Commission issued its decision essentially affirming the ALJ's
findings. It concluded that petitioner had made the challenged representations that Listerine will ameliorate, prevent, and cure colds and sore throats, and that these representations were false. Therefore the Commission ordered petitioner to:
(1) cease and desist from representing that Listerine will cure colds or sore throats, prevent colds or sore throats, or that users of Listerine will have fewer colds than non-users; 3
(2) cease and desist from representing that Listerine is a treatment for, or will lessen the severity of, colds or sore throats; that it will have any significant beneficial effect on the symptoms of sore throats or any beneficial effect on symptoms of colds; or that the ability of Listerine to kill germs is of medical significance in the treatment of colds or sore throats or their symptoms;
(3) cease and desist from disseminating any advertisement for Listerine unless it is clearly and conspicuously disclosed in each such advertisement, in the exact language below, that: "Contrary to prior advertising, Listerine will not help prevent colds or sore throats or lessen their severity." This requirement extends only to the next ten million dollars of Listerine advertising. 4
Petitioner seeks review of this order. The American Advertising Federation and the Association of National Advertisers have filed briefs as amici curiae.
II. SUBSTANTIAL EVIDENCE
The first issue on appeal is whether the Commission's conclusion that Listerine is not beneficial for colds or sore throats is supported by the evidence. The Commission's findings must be sustained if they are supported by substantial evidence on the record viewed as a whole. 5 We conclude that they are.
Both the ALJ and the Commission carefully analyzed the evidence. They gave full consideration to the studies submitted by petitioner. The ultimate conclusion that Listerine is not an effective cold remedy was based on six specific findings of fact.
First, the Commission found that the ingredients of Listerine are not present in sufficient quantities to have any therapeutic effect. This was the testimony of two leading pharmacologists called by Commission counsel. The Commission was justified in concluding that the testimony of Listerine's experts was not sufficiently persuasive to counter this testimony. 6
Second, the Commission found that in the process of gargling it is impossible for Listerine to reach the critical areas of the body in medically significant concentration. The liquid is confined to the mouth chamber. Such vapors as might reach the nasal passage would not be in therapeutic concentration. Petitioner did not offer any evidence that vapors reached the affected areas in significant concentration. 7
Third, the Commission found that even if significant quantities of the active ingredients of Listerine were to reach the critical sites where cold viruses enter and infect the body, they could not interfere with the activities of the virus because they could not penetrate the tissue cells. 8
Fourth, the Commission discounted the results of a clinical study conducted by petitioner on which petitioner heavily relies. Petitioner contends that in a four-year study schoolchildren who gargled with Listerine had fewer colds and cold symptoms than those who did not gargle with Listerine. The Commission found that the design and execution of the "St. Barnabas study" made its results unreliable. For the first two years of the four-year test no placebo was given to the control group. For the last two years the placebo was
inadequate: the control group was given colored water which did not resemble Listerine in smell or taste. There was also evidence that the physician who examined the test subjects was not blinded 9 from knowing which children were using Listerine and which were not, that his evaluation of the cold symptoms of each child each day may have been imprecise, and that he necessarily relied on the non-blinded child's subjective reporting. Both the ALJ and the Commission analyzed the St. Barnabas study and the expert testimony about it in depth and were justified in concluding that its results are unreliable. 10
Fifth, the Commission found that the ability of Listerine to kill germs by millions on contact is of no medical significance in the treatment of colds or sore throats. Expert testimony showed that bacteria in the oral cavity, the "germs" which Listerine purports to kill, do not cause colds and play no role in cold symptoms. Colds are caused by viruses. Further, "while Listerine kills millions of bacteria in the mouth, it also leaves millions. It is impossible to sterilize any area of the mouth, let alone the entire mouth." 11
Sixth, the Commission found that Listerine has no significant beneficial effect on the symptoms of sore throat. The Commission recognized that gargling with Listerine could provide temporary relief from a sore throat by removing accumulated debris irritating the throat. 12 But this type of relief can also be obtained by gargling with salt water or even warm water. 13 The Commission found that this is not the significant relief promised by petitioner's advertisements. It was reasonable to conclude that "such temporary relief does not 'lessen the severity' of a sore throat any more than expectorating or blowing one's nose 'lessens the severity' of a cold." 14
In its attack on the Commission's findings, petitioner relies heavily on a recent study of over-the-counter cold remedies by the Food and Drug Administration 15 which petitioner alleges found Listerine "likely to be effective." 16 Its argument is two-pronged: first, that the fact that the Commission's findings differ from the FDA's proves that the Commission's findings are wrong; and second, that it was error for the Commission to refuse to reopen its proceedings when the FDA study was released. We conclude that both of these arguments are without merit for the simple reason that the FDA study does not, to any significant degree, contradict the Commission's findings.
The FDA study is the product of an expert panel appointed in 1972 to study all over-the-counter cold, cough, allergy, bronchodilator, and anti-asthmatic drug products some 180 ingredients used in as many as 50,000 products. 17 The panel's draft report was issued in February 1976, two months after the FTC issued its order
against Listerine. The FTC refused to reopen its proceedings to consider the draft report. In September 1976 the expert panel's report was published, but it has not yet been adopted by the Commissioner of the FDA. 18
The only evidence pertinent to the effectiveness of Listerine that the FDA panel considered...
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