plaintiff's claims of literal and implicit falsity seriatim.
2. Literal or Explicit Falsity
"If advertisements are false on their face, a court may find a 'tendency to deceive' without looking to evidence of actual consumer response." Stiffel Co. v. Westwood Lighting Group, 658 F. Supp. 1103, 1111 (D.N.J. 1987). After a careful review of the evidence, the Court concludes that AHP has not successfully established a claim of literal falsehood in the instant action.
The burden of proof which plaintiff must satisfy in a false advertising action has been well articulated by the Third Circuit in Sandoz Pharmaceuticals Corp. v. Richardson-Vicks, Inc., 902 F.2d 222 (3d Cir. 1990), in which that court affirmed the district court's denial of a preliminary injunction in a Lanham Act dispute between two rival cough syrup manufacturers. In Sandoz, the plaintiff sought to prevail by showing simply that the defendant's advertising claims about its OTC drug's effectiveness were inadequately substantiated, without also showing that the claims were literally false or misleading to the public. Sandoz, 902 F.2d at 227. In rejecting plaintiff's contentions, the Third Circuit stated that a Lanham Act plaintiff "'bears the burden of showing that a challenged advertisement is false or misleading, not merely that it is unsubstantiated by acceptable tests or other proof.'" Sandoz, 902 F.2d at 228, quoting Procter & Gamble Co. v. Chesebrough-Pond's, Inc., 747 F.2d 114, 119 (2d Cir. 1984) (emphasis supplied). Thus, under Sandoz, a plaintiff relying on clinical data to demonstrate the literal falsity of a claim must affirmatively establish that that evidence demonstrates the patent falsity of the challenged claim, as opposed to simply failing to lend overwhelming credence to it.
When applied to the instant action, Sandoz clearly precludes a finding that AHP has met its burden of proof. A review of the testimony of Dr. Cooper reveals that he did not avow that the clinical evidence proved that ALEVE and ADVIl had the same duration. Dr. Cooper merely stated he did not see any differences between ALEVE and ADVIL (Tr. 2.76 Cooper)), but did not confirm that the tests proved that no differences existed. Indeed, Dr. Cooper testified that toward the end of the studies, "the preponderance of the data is kind of balanced whether differences exist or not." Tr. 2.77 (Cooper). Balance, however, is far from conclusive establishment. Moreover, in response to my own inquiry this witness acknowledged that "a trend appeared to be happening" favoring ALEVE with respect to the later hours of the studies. Tr. 2.146-47 (Cooper).
Thus, while it cannot be gainsaid that defendants have not proven their product lasts longer than plaintiff's, defendants do not have the burden of proof in this case. The plaintiff does. However, it is incontrovertible that plaintiff's evidence, in the form of their experts' testimony, is simply insufficient to sustain its burden of proof under Sandoz with regard to establishing literal falsity here.
In seeking to prove literal falsity by showing that there were no statistically significant differences between ALEVE and ADVIL with respect to the studies' primary variables (Tr. 6.196-97 ), plaintiff relies upon and urges this Court to follow the Second Circuit's decision in McNeil-P.C.C., Inc. v. Bristol-Myers Squibb Co., 938 F.2d 1544 (2d Cir. 1991). In McNeil, defendant Bristol-Myers advertised that its product, ASPIRIN FREE EXCEDRIN, "works better" than plaintiff's EXTRA-STRENGTH TYLENOL, a claim that was bottomed on the results of its own clinical studies. McNeil, 938 F.2d at 1549. The district court determined that a claim to superior efficacy could be proved or disproved only in clinical studies comparing the drugs at issue in comparable dosages. When properly analyzed, the court found relevant clinical tests showed no statistically significant differences between the drugs. In affirming the holding that the Bristol-Myers' ad was false and enjoining the EXCEDRIN advertising, the Second Circuit stated:
In the present case, McNeil has sustained its burden of proving Bristol-Myers' superiority claim to be false. Despite Bristol-Myers' arguments to the contrary, McNeil did more than merely critique and expose the methodological weaknesses of the AF EXCEDRIN studies. McNeil affirmatively demonstrated to the satisfaction of the district court that a proper analysis of the period one data -- which the court found to be the only relevant and reliable scientific data -- conclusively established that AF EXCEDRIN did not relieve pain better than ES TYLENOL to a statistically significant degree. Such proof was sufficient to establish that Bristol-Myers' superiority claim was false.
938 F.2d at 1549-50 (emphasis supplied). Thus, AHP essentially contends that to carry its burden with respect to proving the literal falsity of defendants' advertisements, it must only show that the probative clinical evidence fails to definitively or "conclusively" reveal statistically significant differences between the two OTC analgesics.
At the outset this Court notes that its decision is guided by Third Circuit precedent as set down in Sandoz. However, even if I were inclined to heed AHP's suggestion and follow McNeil, that case still does not carry the day for plaintiff, as an examination of the decision indicates that the Second Circuit predicated the holding on its finding that a reliable reinterpretation of the clinical data demonstrated conclusively that no significant differences existed between the products. But in this action, unlike McNeil, it cannot be said that the defendants' studies proved, let alone "conclusively established," that the two analgesics are the same. While the Syntex studies do not show that ALEVE has a duration of action superior to ADVIL, they do reveal certain trends favoring naproxen sodium over ibuprofen, especially with regard to PID and PAR scores, at the late hours of the study. In addition, with respect to the time to remedication scores, while there are no Statistically significant differences between the drugs, in two of the three studies ALEVE performed better than ADVIL on that measure. Indeed, as noted previously, the absence of a Statistically significant result on the time to remedication score does not conclusively establish that the drugs are the same, Since even AHP's clinical expert Dr. Cooper based a durational conclusion as to ibuprofen and acetaminophen in a prior study based on the differences in the drugs' PID and PAR Scores -- the same approach propounded here by Procter/Syntex, Thus, although the reliable data in this case do not prove with statistical certainty that ALEVE is longer lasting or better than ADVIl, the consistent trends favoring the former analgesic over the latter at the very least preclude any assertion by plaintiff that it has conclusively established the falsity of defendants' claim. Accordingly, the Court cannot say, based on the evidence before it, that the claim challenged here is literally false.
3. Implied Falsity
Because "public reaction is the measure of a commercial's impact," an implied falsity claim must be proven in a false advertising case via the use of a consumer survey. Rhone-Poulenc, 19 F.3d at 129-30. "'The probative value of a consumer survey is a highly fact-specific determination and a court may place such weight on survey evidence as it deems appropriate.'" Id. at 134, citing Weight Watchers Int'l, Inc. v. Stouffer Corp., 744 F. Supp. 1259, 1272 (S.D.N.Y. 1990). Surveys must have certain hallmarks of reliability. Pittsburgh Press Club v. United States, 579 F.2d 751, 758 (3d Cir. 1978). In rejecting a survey prepared for litigation use, the Third Circuit reviewed several factors which must be examined when determining the intrinsic reliability of a survey. Pittsburgh Press Club, 579 F.2d at 758. The court noted that:
A proper universe must be examined and a representative sample must be chosen; the persons conducting the survey must be experts; the data must be properly gathered and accurately reported. It is essential that the sample design, the questionnaires and the manner of interviewing meet the standards of objective surveying and statistical techniques. Just as important, the survey must be conducted independently of the attorneys involved in the litigation.
Id. For the reasons discussed below, AHP's surveys do not provide a reliable basis for determining whether any implied messages are being communicated by the ALEVE promotional campaign.
(a). Unreliability of the FSI Survey
The Court discounts the reliability of the FSI survey due to its use of two techniques that it deems coercive. First, the Court objects to AHP's repetition of four open-ended questions followed by a fifth query which specifically invited the participants to make a direct comparison between ALEVE and ADVIL. While this final question is troublesome given its suggestive nature alone, it becomes unacceptable given my finding that this question was used as a device to prompt the survey participants to continue to search for messages that they initially did not perceive to be conveyed by the FSI. This holding thus echoes the position taken by the Third Circuit in Johnson & Johnson-Merck v. Rhone-Poulenc Rorer, in which it affirmed the district court's rejection of a survey based on, inter alia, the fact that many of the responses were elicited only after repeated probes. Rhone-Poulenc Rorer, 19 F.3d at 133. In addition, the Court notes the opinion of the district court in Johnson & Johnson * Merck Consumer Pharmaceuticals Co. v. Smithkline Beecham Corp., 1991 WL 206312 (S.D.N.Y. Oct. 1, 1991), aff'd, 960 F.2d 294 (2d Cir. 1992), in which the court discounted as too leading a survey's use of several open-ended questions concerning an antacid commercial followed by two virtually identical questions asking participants to compare the products at issue because the comparison question was repeated two times. Smithkline, 1991 WL 206312, *8.
The second improper technique of the FSI survey was the extended time the participant was permitted to study the insert. As noted supra, each survey respondent had the opportunity to view and review the FSI during the course of the entire survey interview, which typically lasted from 10 to 15 minutes. This failure to simulate with any remote realism how consumers actually react to coupon inserts undercuts the reliability of the FSI survey, as the survey becomes more like an open-book test than a measure of realistic consumer reaction. See, e.g., Berkshire Fashions, Inc. v. Sara Lee Corp., 725 F. Supp. 790, 797-98 (S.D.N.Y.), aff'd, 904 F.2d 33 (2d Cir. 1990) (rejecting survey because side-by-side display of competing products did not replicate consumer behavior in the marketplace). Finally, the Court recognizes that since defendants will no longer publish the FSI in its present form, injunctive relief with respect to that insert is simply not required (even if the facts merited it), as precedent exists to support the conclusion that the need for injunctive relief is obviated where a defendant represents that an advertisement's transmission to the public will not be repeated. See, e.g., Consumers Union of United States, Inc. v. General Signal Corp., 724 F.2d 1044, 1052 n. 11 (2d Cir.), cert.denied, 469 U.S. 823, 83 L. Ed. 2d 45, 105 S. Ct. 100 (1984); American Express Travel Related Serv. v. Mastercard, 776 F. Supp. 787, 791 (S.D.N.Y. 1991); Tambrands, Inc. v. Warner-Lambert Co., 673 F. Supp. 1190, 1198 (S.D.N.Y. 1987).
(b). Unreliability of the Television Survey
It is clear that in a false advertising action survey results must be filtered via an adequate control mechanism to screen out those participants who took away no message from the advertisement as well as to account for those consumers who may have brought to the survey certain publicly held preconceptions regarding the product. Johnson & Johnson * Merck Consumer Pharmaceuticals Co. v. Smithkline Beecham Corp., 960 F.2d 294, 301 (2d Cir. 1992); Rhone-Poulenc Rorer, 19 F.3d at 134; American Home Products Corp. v. Johnson & Johnson, 654 F. Supp. 568, 590 (S.D.N.Y. 1987). In fact, the Second Circuit has held, in Johnson & Johnson * Merck Consumer Pharmaceuticals Co. v. Smithkline Beecham Corp., that where a portion of the survey population may have held extrinsic beliefs prior to viewing an advertisement, a control mechanism would likely be "indispensable." Smithkline Beecham Corp., 960 F.2d at 301.
In this case AHP's expert has conceded that the survey's built-in control mechanism could not in fact control for any preconceptions regarding analgesics that the survey population may have possessed, even though some type of "noise" filter was clearly demanded. The existence of OTC analgesic noise was confirmed by the fact that when the same survey was conducted substituting' an ADVIL commercial for the ALEVE spot, virtually the same results were obtained. Absent a valid noise filter, the Court is unable to discern if AHP's survey results are attributable to the advertisement or are instead attributable to consumers being bombarded with years of OTC advertising from which their pre- or misconceptions of these products have developed. Accordingly, the Court must discount plaintiff's television commercial survey.
(c). Inapplicability of AHP's Surveys to other ALEVE Advertising
The Court rejects AHP's contention that the FSI and television survey, even if probative, can be employed to assess whether other ALEVE print advertising (i.e., the New York Times advertisement) was false or misleading to the public. See American Express Travel Related Serv. v. Mastercard, 776 F. Supp. 787, 789-90 (S.D.N.Y. 1991) (holding that consumer survey performed on one television commercial had no bearing on a slightly revised version of the original ad). In addition, the Court is not persuaded that the testimony of AHP's witnesses as to whether untested ALEVE advertisements were misleading overcomes its failure to present reliable survey proof. The Third Circuit has made it patently clear that an expert's "personal opinion [as to what messages consumers received from an advertisement] is not the legal standard by which the courts must determine whether consumers were misled." Rhone-Poulenc Rorer, 19 F.3d at 136, citing Sandoz, 902 F.2d at 228-29. Absent "well-designed consumer surveys . . . . neither the district court nor this court can conclude that consumers were misled." Id.
Finally, the Court states that AHP cannot circumvent the survey requirement by pointing to an alleged intent on defendants' part to communicate a superior duration claim for ALEVE over ADVIL. While the Court did not make any explicit finding previously in this Opinion that defendants' overall marketing strategy demonstrated an intent to impart a superior duration message, it did note that such a finding is insufficient to merit an injunction since the proof did not establish that defendants' actions were in any way egregious. In the Third Circuit's recent Rhone-Poulenc Rorer decision, plaintiff Johnson-Merck maintained that Rorer's claim that its antacid product was "the strongest antacid there is" was false and/or misleading. Johnson-Merck contended it adduced evidence which showed Rorer clearly intended to convey a message of superior antacid relief by making its "strongest antacid" claim. Rhone-Poulenc Rorer, 19 F.3d at 130. After reviewing the extensive and rather probative evidence in question, the court held that the intended "halo effect" of Rorer's advertising was to impart a superior relief message. Id. at 131 ("we cannot see how the change of stated consumer promise in copy strategy documents and the addition of a claim of fast relief altered the halo effect of superior relief that attached to the phrase 'strongest antacid there is' . . ").
However, the court opined further that even if evidence of an intent to mislead had been presented, the plaintiff nevertheless was still obliged to show that the defendant engaged in "deliberate," "clear," and "egregious conduct" before it may avail itself of a presumption that misleading messages are being conveyed in an advertisement. Id. at 131-32. See also Smithkline Beecham Corp., 960 F.2d at 298-99; Resource Developers, Inc. v. Statue of Liberty-Ellis Island Foundation, Inc., 926 F.2d 134, 140 (2d Cir. 1991). Despite the great weight of the evidence demonstrating an intent to mislead, the court found that the actions of the defendant were simply not egregious. Since I have found that defendants did not engage in deliberately egregious conduct, my conclusion in this case mirrors the Court of Appeals's holding in Rhone-Poulenc Rorer that "even if we agree that [plaintiff has presented evidence of [defendants'] intent to mislead, this alone is insufficient to [establish that intent]." Id. at 131.
(d). The Over 65 Dosing and Prescription Heritage Claims
The only claims remaining for review by this Court are AHP's contentions that defendants falsely claimed that persons over age 65 can safely medicate using the dosing regimen permitted for younger individuals and its challenge to ALEVE's claimed prescription heritage in the ads directed to medical professionals. However, as the Court has previously stated, AHP has not come forward with the requisite consumer surveys, so that no claim of implicit falsity can be made out. Indeed, with respect to the professional ads, the Third Circuit has confirmed that a survey is required to see if the intended audience, even with its special knowledge of the product, was actually misled. Sandoz, 902 F.2d at 229-30. There is no such survey here. Additionally, a claim of literal falsity with respect to these claims also cannot stand since, as noted previously, there is clinical evidence in the record to support them.
As the foregoing illustrates, plaintiff cannot establish that it has a reasonable probability of success with its Lanham Act claims, as it cannot demonstrate that the advertisements at issue are either explicitly or implicitly false. Since plaintiff cannot establish the existence of this initial prong of the preliminary injunction inquiry, it is ineligible for such relief.
Accordingly, for the reasons stated herein, plaintiff's motion for a preliminary injunction is DENIED. In addition, with respect to plaintiff's 32 studies claim, the defendants are obligated, pursuant to the language contained in the parties' stipulation, to adjust this advertising claim to reflect the precise number of clinical tests and patients meeting the criterion which was outlined in the stipulation and adopted by this Court in its Opinion. An appropriate Order will issue with this Opinion.
Finally, the Court notes that before deciding the instant motion, it heard days of testimony and reviewed countless exhibits, including free-standing inserts, gravity-fed dispensers, clinical data and television commercials. It is thus not surprising that the Court presently finds itself in possession of a monumental headache, the alleviation of which is beyond the durational powers of any of the analgesics discussed herein. Accordingly, in an effort to achieve long lasting and efficacious relief, the Court will take them all.
NICHOLAS H. POLITAN
This matter having come before the Court on the application of plaintiff for a preliminary injunction, and the Court having conducted a hearing thereon, and having considered the matter and the submissions of the parties in support of and in opposition to the instant application, and for the reasons appearing more particularly in the Opinion of this Court in the above-captioned matter dated December 27, 1994, and good cause having been shown,
IT IS on this 27th day of December, 1994 hereby
ORDERED that plaintiff's application for a preliminary injunction be and the same hereby is DENIED, and it is further
ORDERED that defendants shall adjust their advertising claim that "The efficacy of ALEVE has been confirmed in 32 clinical trial involving 2,857 patients" to reflect the precise number of clinical tests and patients meeting the criterion outlined in the stipulation of the parties and adopted by this Court in its Opinion.
NICHOLAS H. POLITAN