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Bristol-Myers Co. v. Federal Trade Commission

June 25, 1984

BRISTOL-MYERS COMPANY, PETITIONER,
v.
FEDERAL TRADE COMMISSION, RESPONDENT



Petition Seeking Review of an Order of the Federal Trade Commission which Required that Petitioner Cease and Desist Various Deception Advertisements for a Number of its Drug Products, Particularly its Over-the-counter Analgesics, Bufferin and Excedrin. Order enforced.

Feinberg, Chief Judge, Friendly and Oakes, Circuit Judges.

Author: Oakes

OAKES, Circuit Judge:

Bristol-Myers Company (Bristol) petitions for review of an order of the Federal Trade Commission (the Commission or FTC) made in respect to the advertising by Bristol of its well-known analgesics, Bufferin and Excedrin. The order represents over ten years of agency work formally commencing with the filing of complaints on February 23, 1973 by the Commission against Bristol and its advertising agencies, Ted Bates & Co., Inc. and Young & Rubicam, Inc., concerning alleged violations of sections 5 and 12 of the FTC Act, 15 U.S.C. §§ 45 and 52 (1982). On the same day the Commission also filed complaints challenging the advertising of certain competing non-prescription internal analgesic products, including Anacin (In re American Home Products Corp., 98 F.T.C. 136, 362 (1981), enforced as modified, American Home Products Corp. v. FTC, 695 F.2d 681 (3d Cir. 1983) (AHP)),*fn1 and Bayer Aspirin (In re Sterling Drug, Inc., No. 8919 (July 5, 1983), appeal pending, No. 83-7700 (9th Cir. filed Jan. 30, 1984)). We have considered each of Bristol's claims as to the remedial order and deny the petition for review and grant enforcement.

The Commission Decision and Order

The Commission's decision upheld fundings by its Administrative Law Judge (ALJ) that Bristol had engaged in a variety of deceptive practices in advertising Excedrin and Bufferin from 1960 to 1973, but dismissed the complaint allegations concerning Excedrin PM because it found that Bristol had not made the challenged claims as to that product. In concluding that Bristol and its advertising agencies had deceptively advertised Excedrin and Bufferin, the Commission found that Bristol had misrepresented that the analgesic superiority of Excedrin and Bufferin over competing products was scientifically proved, or "established," by the artful use of certain phrases such as "scientific tests" and "medically endorsed," as well as by the use of visual images. Bristol was found to have made seven false and deceptive claims of this nature, concerning both efficacy and the freedom-from-side-effects of its non-prescription internal analgesic products.*fn2 Part I of the Order prohibits Bristol from making comparative establishment claims asserting the superior effectiveness or freedom-from-side-effects of its OTC internal analgesics without proof consisting of "two or more adequate and well-controlled clinical investigations" conducted in accordance with procedures set forth in detail in the Order.

In addition the Commission found that Bristol had claimed, without a reasonable basis, that both Bufferin, which is a form of buffered aspirin, and Excedrin, a combination of aspirin, salicylamide, acetaminophen and caffeine, relieved tension and that physicians recommend Bufferin more frequently than they recommend any other OTC internal analgesic. Finding that such unsubstantiated claims were deceptive, the Commission in Part II of its Order requires Bristol not to make "any therapeutic performance or freedom-from-side-effects claim" for any OTC internal analgesic unless it has a "reasonable basis for making that claim [consisting of] competent and reliable scientific evidence supporting that claim." Part II, then, requires that all claims of this type be reasonable, while Part I imposes more rigorous requirements on similar comparative establishment claims.

The Commission also found that Bristol deceptively advertised that its products contained "unusual" or "special" ingredients even though the very same ingredients are commonly used in other OTC drug products intended for the same use or uses as the product advertised. These "special ingredient" claims were also found to have been made so as to conceal the fact that Bufferin and Excedrin were aspirin based, the deception operating by way of emphasis upon the unspecified analgesic ingredient. Part IIIA of the Order prohibits special ingredient advertising when the ingredient referred to is commonly used in other products for the same purpose. Noting that Bristol had previously signed stipulations in respect to special ingredient claims for a cold remedy and a facial cream, this part of the Order was applied across the board to all Bristol OTC products and not merely to OTC internal analgesics.

The Commission further found that Bristol falsely represented that doctors recommend Bufferin more than any other OTC internal analgesic. Part IIIB of the Order prohibits Bristol from representing "that any group, body or organization endorses or recommends [the use of a Bristol OTC drug] unless at the time such statement or representation is made, respondent has a reasonable basis for such statement or representation." This part of the Order was applied to all Bristol OTC drug products in the light of an earlier history of similar "doctors recommend" claims made by Bristol in connection with other products. See In re Bristol-Myers Co., 46 F.T.C. 162, 170 (1940) (order), aff'd, 185 F.2d 58 (4th Cir. 1950); 24 F.T.C. 1554 (1937) (stipulation).

On the other hand, the Commission declined to accept complaint counsel's recommendation that Bristol be required to run corrective advertising. See Warner-Lambert Co. v. FTC, 183 U.S. App. D.C. 230, 562 F.2d 749, 756-59 (D.C. Cir. 1977), cert. denied, 435 U.S. 950, 55 L. Ed. 2d 800, 98 S. Ct. 1575, 98 S. Ct. 1576 (1978). It also declined to uphold the ALJ insofar as his order would have applied to the labelling of Bristol products as well as to Bristol's advertising, in the light of the FTC's liaison agreement with the FDA as set forth in AHP, 98 F.T.C. at 411.

Discussion

Bristol makes a variety of objections to all three parts of the Order. As to Part I, Bristol contends that it should apply only to effectiveness claims, and that it should permit reliance on FDA studies. Part II is alleged to be unduly and unconstitutionally vague and overbroad, and is also said to reply on an "advertising substantiation" doctrine which violates the First Amendment. Part III is also allegedly overbroad. Moreover Part IIIA is said not to be reasonably related to any violation actually found by the FTC, and Part IIIB based upon fact-finding which is clearly erroneous.*fn3

A. Part I's applicability to freedom-from-side-effects claims. Bristol argues that the FTC had no basis for requiring two adequate, well-controlled clinical studies for freedom-from-side-effects comparative claims, so that Part I of the Order should be modified to apply solely to effectiveness claims. The Commission is said to have relied in formulating the two studies requirement upon FDA regulations which themselves distinguish between effectiveness claims, the validity of which should be proved by "controlled clinical investigations," and safety claims, proof of which "shall consist of adequate tests by methods reasonably applicable. . . ." 21 C.F.R. § 330.10(a)(4)(i) (safety), (ii) (effectiveness) (1983). The Commission is also said to have erred in stating that its clinical study requirement is consistent with the 1962 amendments to the Food, Drug and Cosmetic Act of 1938, 21 U.S.C. § 355(d) (1982). Under that statute, Bristol states, the "substantial evidence standard" applies only to product effectiveness claims and does not apply to safety claims. See E.R. Squibb & Sons, Inc. v. Weinberger, 483 F.2d 1382, 1385 (3d Cir. 1973). And pointing to the Commission's own opinion in AHP, Bristol notes that no freedom-from-side-effects claims were held subject to the two well-controlled clinical studies requirement in AHP. This is so because the only freedom-from-side-effects establishment allegation made in that case was dismissed because AHP was found not to have made the claim. 98 F.T.C. at 374 n.21. Bristol proposes that the correct test should be that product safety may be evaluated by "clinical or other experience, tests, or other scientific data." See E.R. Squibb & Sons, 483 F.2d at 1385 nn.18, 19. Under that standard Bristol states that it submitted four studies to support its claim that Bufferin upsets the stomach less frequently than aspirin.

We agree with the Commission, however, that the side-effects portion of Part I is premised on the Commission's factual determination supported by substantial evidence, that only two well-controlled clinical studies could establish Bristol's superior freedom-from-side-effects claim for Bufferin. Even assuming that Bristol is entitled to raise this question here for the first time, United States v. L.A. Tucker Trucklines, Inc., 344 U.S. 33, 36-37, 73 S. Ct. 67, 97 L. Ed. 54 (1952), the Commission found that Bristol claimed that Bufferin was proven to cause less stomach upset than aspirin without adequate substantiation. Dr. Grossman, an expert in the field of gastroenterology and gastrointestinal side-effects of aspirin, testified that only well-controlled clinical studies could establish that Bufferin causes less stomach upset than aspirin. His testimony amounts to substantial evidence on the record, which the Commission was entitled to rely upon in setting its standard. It should also be noted that the Third Circuit, in the context of reviewing the "substantial question" doctrine in that case,*fn4 concluded that both comparative safety (freedom-from-side-effects) and comparative effectiveness claims could appropriately be subjected to the two clinical test standard. See 695 F.2d at 695-98. Here as there the Order is upheld as supported by substantial evidence.

Insofar as FDA requirements and regulations are concerned, they simply do not govern this case. Not only is a different regulatory scheme involved, but generally speaking the FDA is concerned only with evaluating absolute safety and efficacy, and not with the questions of comparative safety and efficacy that arise in OTC drug advertising. Moreover, E.R. Squibb & Sons, 483 F.2d 1382, is wholly inapposite. That case involved withdrawal, not approval of a new drug application, and in providing that withdrawal may take place where "clinical or other experience, tests, or other scientific data show that such drug is unsafe," 21 U.S.C. § 355(e)(1) (1982), the FDA regulatory scheme simply provides a low threshold for withdrawal of a drug on safety grounds.

B. Part I and FDA approval as establishment evidence. Bristol seeks to modify Part I of the Commission Order to permit it to rely upon FDA regulations or other definitive FDA action approving claims for OTC internal analgesics as "establishing" such claims. Since the FDA is responsible under its Act, 21 U.S.C. §§ 301-392 (1982), to ensure that all OTC drugs are safe, effective and not misbranded, see 21 C.F.R. § 330.10 (1983), Bristol argues that the FTC should be satisfied by FDA approval. In this connection we note the existence of a liaison agreement between the two agencies, 36 Fed. Reg. 18,539 (1971), whereby the FTC defers to the FDA when allegedly deceptive claims appear on labelling for food, drugs or cosmetics. And we also note that the FDA has instituted an OTC Drug Review Program. See 21 C.F.R. § 330.1 (1983); see generally Cutler v. Kennedy, 475 F. Supp. 838, 844-45 (D.D.C. 1979).

Here too Bristol's contentions could be rejected on the ground that they were not previously raised before the Commission. Even on the merits, however, the modifications Bristol requests are unnecessary, if not undesirable.As we have indicated, the FDA's regulations are concerned almost exclusively with absolute claims. Part I of the Commission's Order here deals solely with comparative establishment claims. Therefore almost nothing would be gained by allowing the FDA's regulations to be used as requested by Bristol. Moreover FDA determinations are usually complex and subject to varying interpretations. To allow Bristol to rely on its evaluation of these determinations could conceivably lead to more deceptive advertisements and to more disputes with the FTC. The Commission is entitled to fashion its order to avoid such problems. There is nothing, however, to prevent Bristol from seeking modification from the Commission under section 5(b) of the Act, 15 U.S.C. § 45(b) (1982), and Commission regulations, 16 C.F.R. § 3.72 (1984) in the unlikely event that the FDA has occasion to consider a particular relevant comparative establishment claim and approves it without clinical testing.

C. Part II's alleged vagueness. Citing FTC v. Colgate-Palmolive Co., 380 U.S. 374, 392, 13 L. Ed. 2d 904, 85 S. Ct. 1035 (1965), Bristol argues that Part II of the Order is unduly vague insofar as it declines to specify "the amount and kinds of evidence necessary to constitute a reasonable basis for Bristol-Myers' future claims." The Commission has allegedly improperly left the determination of what constitutes a reasonable basis to case-by-case analysis. This is especially unfair, Bristol argues, because the only reasonable basis violation found in this case relates to a discontinued claim by Bristol that Excedrin, a drug containing caffein as one ingredient, is a "tension reliever." Finally, Bristol points to the Third Circuit's statement in AHP that "because the Commission has chosen not to bind itself in advance to rules as to the interpretation of the phrase 'reasonable basis,' any order which essentially relies upon 'reasonable basis' language will be imprecise, although not necessarily so." 695 F.2d at 710.

But absolute precision is not possible in certain FTC orders, and we have upheld reasonable basis provisions formulated in substantially identical terms. E.g., Jay Norris, Inc. v. FTC, 598 F.2d 1244, 1245-46, 1250-51 (2d Cir.), cert. denied, 444 U.S. 980, 62 L. Ed. 2d 406, 100 S. Ct. 481 (1979); see also our decision enforcing the FTC's order in In re Fedders Corp., 85 F.T.C. 38, 69 (1975) (performance claims for air conditioners must be substantiated by "competent scientific, engineering or other similar objective material"), order enforced, Fedders Corp. v. FTC, 529 F.2d 1398 (2d Cir.), cert. denied, 429 U.S. 818, 50 L. Ed. 2d 79, 97 S. Ct. 63 (1976). We note also that Part II of the Order is limited in scope to performance and side-effects claims for OTC internal analgesics and that it defines reasonable basis to consist of "competent and reliable scientific evidence." Moreover, the Commission has issued some 21 litigated orders and 126 consent orders involving advertising substantiation using equivalent language. If the Third Circuit decision in AHP may be read as holding that the reasonable basis standard of "competent and reliable scientific evidence" is excessively vague, with respect we decline to follow it since our own decisions require that we uphold the Order. But we note that the AHP court recognized that while reasonable basis language is "imprecise," it was careful to add the clause, "although not necessarily fatally so." 695 F.2d at 710. The part of the Order in that case was in fact vacated for the combined problems of overbreadth and vagueness.

D. Part II's alleged overbreadth and unreasonable relation to the violation. Every provision of the Order must bear a "reasonable relation" to the conduct of Bristol that was found unlawful. See ITT Continental Baking Co. v. FTC, 532 F.2d 207, 220-21 (2d Cir. 1976). Part II of the Order prohibits unsubstantiated claims concerning effectiveness and freedom-from-side-effects. Bristol argues that the only effectiveness claim it made that was found to be without a reasonable basis was the noncomparative claim that Bufferin and Excedrin relieved tension, and that this finding is too narrow a basis to justify Part II of the Order. The Third Circuit, in striking the "reasonable basis" provision in Part II-D of the AHP Order as ...


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