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McNEIL-PPC, INC. v. PFIZER INC.

January 6, 2005.

McNEIL-PPC, INC., Plaintiff,
v.
PFIZER INC., Defendant.



The opinion of the court was delivered by: DENNY CHIN, District Judge

OPINION

[EDITORS' NOTE: PHOTOGRAPH IS ELECTRONICALLY NON-TRANSFERRABLE.]

  In June 2004, defendant Pfizer Inc. ("Pfizer") launched a consumer advertising campaign for its mouthwash, Listerine Antiseptic Mouthrinse. Print ads and hang tags featured an image of a Listerine bottle balanced on a scale against a white container of dental floss, as shown above. The campaign also featured a television commercial called the "Big Bang." In its third version, which is still running, the commercial announces that "Listerine's as effective as floss at fighting plaque and gingivitis. Clinical studies prove it." Although the commercial cautions that "[t]here's no replacement for flossing," the commercial repeats two more times the message that Listerine is "as effective as flossing against plaque and gingivitis." The commercial also shows a narrow stream of blue liquid flowing out of a Cool Mint Listerine bottle, then tracking a piece of dental floss being pulled from a white floss container, and then swirling around and between teeth — bringing to mind an image of liquid floss.

  In this case, plaintiff McNeil-PPC, Inc. ("PPC"), the market leader in sales of string dental floss and other interdental cleaning products, alleges that Pfizer has engaged in false advertising in violation of § 43(a) of the Lanham Act, 15 U.S.C. § 1125(a), and unfair competition in violation of state law. PPC contends that Pfizer's advertisements are false and misleading in two respects. First, PPC contends that Pfizer's literal (or explicit) claim that "[c]linical studies prove" that Listerine is "as effective as floss against plaque and gingivitis" is false. Second, PPC contends that Pfizer's advertisements also implicitly are claiming that Listerine is a replacement for floss — that all the benefits of flossing may be obtained by rinsing with Listerine — and that this implied message is false and misleading as well. Before the Court is PPC's motion for a preliminary injunction enjoining Pfizer from continuing to make these claims in its advertisements. For the reasons set forth below, I conclude that Pfizer's advertisements are false and misleading. PPC's motion is granted and a preliminary injunction will be issued. My findings of fact and conclusions of law follow.

  STATEMENT OF THE CASE

  A. The Facts

  1. The Parties and Their Products

  PPC, a wholly-owned subsidiary of Johnson & Johnson ("J&J"), manufactures and markets consumer oral health products. PPC is the market leader in the sales of interdental cleaning products (Tr. 286-87, 292-93),*fn1 including dental floss — waxed or unwaxed string used to mechanically remove food and debris from between the teeth and underneath the gumline. (See, e.g., DX 131). According to the label on J&J's Reach dental floss:
Dentists recommend regular flossing. Flossing has been clinically proven to remove plaque between teeth to help prevent gum disease.
(Id.). The label states that "Flossing is easy with the proper technique." It instructs users to "[g]ently slide floss between teeth" and "[m]ove floss up and down against tooth to clean both above and below the gum line, curving the floss around the tooth for best results." (Id.). The procedure is to be repeated for each tooth. (Id.).

  J&J invented floss nearly 100 years ago. (See Tr. 286). PPC's products include the Reach Access Daily Flosser (the "RADF"), a toothbrush-like device with a snap-on head (to be replaced after each use) containing a piece of string floss. (PX 172). The RADF was launched in August 2003. PPC also sells a battery-powered version of the RADF, called the Reach Access Power Flosser. (PX 173).

  Pfizer manufactures and markets consumer and pharmaceutical products, including Listerine, an essential oil-containing antimicrobial mouthrinse. (See, e.g., PX 162 (Cool Mint Listerine)). According to its label, Listerine:
Kills germs that cause Bad Breath, Plaque & the gum disease Gingivitis.
(Id.). Listerine has been "accepted" by the American Dental Association (the "ADA") and bears the ADA seal of acceptance on its label. (Id.). The label instructs users to rinse with Listerine full strength for 30 seconds, each morning and night. (Id.). Listerine also comes in several flavors, including Cool Mint, Fresh Burst, and Natural Citrus.

  2. Oral Hygiene and Oral Diseases

  Plaque is a biofilm comprised of a thin layer of bacteria that forms on teeth and other surfaces of the mouth. Food debris caught between teeth provides a source of nutrition for this bacteria and will help the bacteria multiply, grow, and persist. Plaque build-up may cause gingivitis, an inflammation of the superficial gum tissues surrounding the tooth. Gingivitis is common, affecting some two-thirds of the U.S. population. Its symptoms include red, inflamed, swollen, puffy, or bleeding gums. Periodontitis is inflammation that develops in deeper tissues, and involves the bone and connection to the tooth (the periodontal ligament). Periodontitis is less common, affecting some 10-15% (more or less) of the population, although it becomes more prevalent with age. It is a major cause of tooth loss. (Tr. 152-54, 160, 166; PXs 25, 56, 57, 178, 205 at 454; DX 408 at 100003039).

  Gingivitis is generally considered an early form of or precursor to periodontitis. (Tr. 152, 194; see, e.g., PX 228 at 1 ("gingival inflammation is thought to be a prerequisite to the development of periodontitis")). The ADA refers to mild or moderate gingivitis as "early gum disease" and periodontitis as "advanced gum disease." (PX 51). Gingivitis does not always progress to periodontitis, but "it is rare for periodontitis not to be preceded by gingivitis." (PX 213 at 16192; see Tr. 361).

  The removal of plaque and the prevention of plaque build-up are critical to addressing both gingivitis and periodontitis. (Tr. 154, 166).*fn2 In addition, although it is less clear, controlling plaque also helps prevent or reduce "caries" — cavities or dental decay. (Tr. 146, 153-54, 165-67).*fn3 The ADA recognizes that "[p]laque is responsible for both tooth decay and gum disease." (PX 51).

  The most common method of mechanically removing plaque is brushing, and today the use of toothbrushes and fluoridated toothpastes is "almost universal." (PX 205 at 450; see also PX 56 at 360 ("close to 100 percent . . . reported daily toothbrushing")).*fn4 Brushing, however, does not adequately remove plaque. In part, this is because many people do not brush properly or they brush less than the recommended two minutes twice a day. (PX 205 at 450). In part, it is also because for most people "toothbrushing alone cannot effectively control interproximal plaque," i.e., the plaque in the hard-to-reach places between the teeth. (Id. at 454). As a consequence, removal of plaque from the interproximal areas by additional methods is particularly important, for it is in these areas between the teeth that plaque deposits appear early and become more prevalent. (PX 205 at 454). The direct interproximal area is the area where there is "the most stagnation" and where "periodontal disease usually starts." (Tr. 193).

  Traditionally, the "most widely recommended" mechanical device for removing interproximal plaque is dental floss. (PX 56 at 360; see also PX 57 at 352; PX 205 at 454 ("Of all the methods for removing interproximal plaque, flossing is the most universal."); PX 214 at 876 ("Dental floss is still the most effective means we have to date for removing subgingival interproximal dental plaque."); Tr. 580 ("the gold standard"); Kumar Dep. 43 ("Brushing and flossing are standards for plaque control.")). The ADA recommends "brushing twice a day and cleaning between the teeth with floss or interdental cleaners once each day to remove plaque from all tooth surfaces." (PX 51). Flossing provides a number of benefits. It removes food debris and plaque interdentally and it also removes plaque subgingivally. As part of a regular oral hygiene program, flossing helps reduce and prevent not only gingivitis but also periodontitis and caries. (Tr. 151-52; see also Kumar Dep. 22; authorities cited in footnotes 2 and 3 supra).*fn5

  Some 87% of consumers, however, floss either infrequently or not at all. (Tr. 289). Although dentists and dental hygienists regularly tell their patients to floss (Tr. 289),*fn6 many consumers do not floss or rarely floss because it is a difficult and time-consuming process. (Tr. 289; see Schorr Dep. 129).*fn7

  As a consequence, a large consumer market exists to be tapped. If the 87% of consumers who never or rarely floss can be persuaded to floss more regularly, sales of floss would increase dramatically. PPC has endeavored, with products such as the RADF and the Power Flosser, to reach these consumers by trying to make flossing easier. (Tr. 289).

  At the same time, Pfizer has recognized that there is enormous potential here for greater sales of Listerine as well. Pfizer has come to realize that if it could convince consumers who were reluctant flossers that they could obtain the benefits of flossing by rinsing with Listerine, it would be in a position to see its sales of Listerine increase dramatically. (See Schorr Dep. 129 (Pfizer's associate product manager for Listerine agreeing that Pfizer's "as effective as floss" campaign is targeted towards people who do not floss or do not regularly floss because "[t]hey are consumers, and we want them to buy Listerine")).

  In the context of this case, therefore, Pfizer and PPC are competitors. (Tr. 291-92; PX 145; but see Tr. 667-68). 3. The Listerine Studies

  Pfizer sponsored two clinical studies involving Listerine and floss: the "Sharma Study" and the "Bauroth Study." (See PXs 56, 57). These studies purported to compare the efficacy of Listerine against dental floss in controlling plaque and gingivitis in subjects with mild to moderate gingivitis.

  a. The Sharma Study

  The Sharma Study resulted in an article entitled "Comparative effectiveness of an essential oil mouthrinse and dental floss in controlling interproximal gingivitis and plaque," published in the American Journal of Dentistry in December 2002. 15 Am. J. Dentistry 351 (2002) (PX 57). The Sharma study used 319 subjects, aged 18-63, who had mild to moderate gingivitis and dental plaque. (PX 57 at 352; PX 58 at 51907-08). The subjects were randomly placed into one of three groups, with each group following a different regimen: (i) daily toothbrushing plus rinsing with original Listerine Antiseptic mouthrinse twice a day (the "Listerine group"); (ii) daily toothbrushing plus flossing once a day (the "flossing group"); and (iii) daily toothbrushing plus rinsing with a placebo control rinse twice a day (the "control group"). (PX 57 at 352; PX 58 51908-11). At the outset, all subjects received baseline examinations and received scores for baseline levels of plaque and gingivitis, measured by three indices. (PX 57 at 352). Following these baseline examinations, all subjects received a complete dental prophylaxis to remove plaque, stain, and calculus. (Id.). The subjects then were started on their assigned regimen. The first rinsing or flossing was performed with instruction and supervision. Rinse subjects rinsed with 20 ml for 30 seconds and were provided with a supply of coded mouthrinse and plastic dosage cups for twice-daily use. Floss subjects received flossing instruction from a dental hygienist and were required to demonstrate their ability to floss all regions of the mouth, with additional instruction as needed. They were given written instructions and a supply of floss for once-daily home use. The article states that subjects were instructed "to continue their assigned regimen at home daily in addition to their usual oral hygiene procedures."*fn8 Subjects were provided with toothpaste and toothbrushes as needed. (Id.).

  The at-home use, which continued for six months, was unsupervised. Subjects were instructed to maintain diaries recording their compliance; rinsers were to initial twice a day when they rinsed and flossers were to initial once a day when they flossed. (See PX 57 at 352; PX 146). Subjects were to return to the clinical site once a month, bringing with them the unused rinse and floss, which were to be measured or weighed to check compliance. New supplies and diaries were to be issued for the next month. (PX 57 at 352). The subjects were re-instructed in their assigned regimens, as necessary. At three and six months, the subjects were examined and scored again, using the same indices for plaque and gingivitis. (PX 57 at 352). At the conclusion of the six months, 301 of the 319 subjects were deemed evaluable. (PX 57 at 353).

  The authors concluded that, for the Modified Gingival Index, both interproximally and whole mouth, both Listerine and flossing were significantly more effective than the control rinse at both three and six months. (PX 57 at 353). For the Quigley-Hein Plaque Index (Turesky modification), both interproximally and whole mouth, Listerine was significantly more effective than the control at both three and six months and flossing was significantly more effective than the control at three months but not at six months. Scores for the third index, the bleeding index, also showed that Listerine and flossing were significantly more effective than the control group at both three months and six months, but a low number of bleeding sites was noted. (Id. at 353). In general, the Listerine results were better than the floss results. (Id.).

  The authors noted that their study "was designed to simulate actual conditions under which flossing instruction might be employed in dental practice." (PX 57 at 354). The results, according to the authors, "indicated" that Listerine was "at least as good as" flossing in reducing interproximal gingivitis and "significantly more effective" than flossing in reducing interproximal plaque over the six-month period. (Id.). The authors recognized, however, a potential issue as to compliance. The plaque reductions in the flossing group "appeared to be somewhat lower than would be expected," and there was greater improvement at three months than at six months, suggesting "a deterioration of flossing technique with increased time following instruction." (Id.). As in real life, the subjects apparently flossed better immediately after they received instruction from a dental hygienist, but the quality of their flossing apparently diminished with the passage of time. The authors wrote:
It might be hypothesized that in the current study, subjects failed to consistently wrap the floss around the line angles of the teeth and this, coupled with scoring of the plaque index at six sites (including facial and lingual interproximal sites) per tooth, resulted in small percentage changes in mean plaque indices over time.
(Id.).

  The authors concluded that the study provided "additional support for the use of the essential oil mouthrinse as an adjunct to mechanical oral hygiene regimens." (Id. at 355). They cautioned that "[p]rofessional recommendations to floss daily should continue to be reinforced." (Id.).

  b. The Bauroth Study

  The Bauroth Study resulted in an article entitled "The efficacy of an essential oil antiseptic mouthrinse vs. dental floss in controlling interproximal gingivitis," published in March 2003 in the Journal of the American Dental Association. 134 J.A.D.A. 359 (2003) (PX 56). The Bauroth study was essentially identical to the Sharma Study, except that the Listerine group used Cool Mint Listerine rather than original Listerine.

  The Bauroth Study started with 362 subjects, randomly divided into the same three groups (Listerine, flossing, and control), and they followed the same regimens, respectively, as in the Sharma Study. (PX 360 at 360). In the end, 324 of the 362 subjects were evaluable. (Id. at 362). The results were consistent with the results of the Sharma Study, as the Bauroth authors concluded that Listerine was "at least as good as" dental floss in controlling interproximal gingivitis. (Id. at 364). As did the authors of the Sharma Study, however, the Bauroth authors gave a cautionary note:
[F]lossing was somewhat less effective in reducing interproximal plaque levels than might be expected. The reasons for this could not be determined from the design study. However, we might hypothesize that this could result from either behavioral or technical causes. It has been shown, for example, that flossing effectiveness decreases considerably in the absence of frequent reinforcement and instruction, and that the motivation to floss decreases as the time since the last dental visit increases. It also might be that in the current study, as time went by, the subjects failed to consistently wrap the floss around the line angles of the teeth. That would mean that the plaque that was visually accessible and scored in the interproximal areas from the line angle to the contact area was at higher levels in the floss group than in the antiseptic rinse group.
(Id.) (footnotes omitted). The Bauroth authors concluded: "[W]e do not wish to suggest that the mouthrinse should be used instead of dental floss or any other interproximal cleaning device." (Id.).

  Neither the Bauroth Study nor the Sharma Study purported to examine whether Listerine could replace floss (Kumar Dep. 10), and neither study examined the efficacy of Listerine with respect to severe gingivitis or periodontitis or tooth decay or the removal of food debris. (Id. 32). In addition, neither study considered the adjunctive effects of Listerine when used in addition to brushing and flossing. (See PXs 56, 57).

  4. The ADA Approval for Professional Advertising

  The ADA requires that all labeling and advertising bearing the ADA seal of acceptance be submitted to the ADA for review and approval prior to use. (See DX 10 at 15019; Tr. 585-86). Listerine carries the ADA seal. (PX 162). In March 2002, Pfizer asked the ADA Council on Scientific Affairs to approve advertising to professionals, based on the Sharma and Bauroth Studies, claiming that Listerine is "as effective as flossing" and "as essential as flossing." (DX 408 at 3034, 3051, 3052, 3054; Tr. at 585). Pfizer acknowledged to the ADA that "[w]e recognize that any comparison vs. flossing may send an unintended message to dental professionals that Listerine can replace flossing," and Pfizer assured the ADA that its advertising was "constructed" to "ensure that this does not happen." (Id. at 3034 (emphasis in original); see also Tr. at 584; PX 52 at 1655).

  Some consultants to the ADA expressed concerns about the Pfizer studies and the proposed professional advertising. One consultant noted:
It was a self-fulfilling prophecy . . . that the floss group would not be significantly better in six months over the other (brush only) control given the inappropriate preparation and follow through in the floss group. Because of floss' historically poor compliance record, a replacement for flossing [for] the regimen of daily plaque removal would be most welcome. However, in order for a substitute product to be "as good as" or "better" than flossing it must be compared against the data of a subject group who demonstrates they can and are flossing effectively, which the subjects in the flossing groups [in the two Pfizer studies] were not[,] based on the evidence presented.
(PX 60 at 10003126). Another consultant, who observed that the studies "appear to be well-done and controlled," nonetheless expressed concern regarding the measurement of compliance in the floss group and cautioned that "there is danger in misinterpretation of all of the potential draft ads proposed by Pfizer." (Id. at 100003128-29). Another consultant questioned whether the flossing subjects used proper flossing technique and warned that most readers of the ads "are likely to conclude what is most obvious from these ads, namely that floss and Listerine Antiseptic Mouthrinse are equally effective at inhibiting plaque and gingivitis and are, therefore, interchangeable." (Id. at 100003131-32). The same consultant also wrote:
If consumers conclude that floss and the mouthrinse are interchangeable and embark on the long-term use of the mouthrinse as a substitute for mechanical interdental cleansing, there is a risk that the mouthrinse regimen may not be as effective in preventing the onset of periodontitis as mechanical interdental hygiene. Furthermore, individuals who may already be affected by periodontitis may be worse off in the long run if the mouthrinse is substituted for mechanical interdental cleansing. Such subjects were intentionally excluded from these studies, but could be adversely affected by the existing ads.
(Id. at 100003133).
  Yet another consultant opined that the claims in the ads:
should not be allowed because they are too broad. The claims imply that the mouthrinse is as effective as floss without specifying that the populations studied only had `mild' or `slight' gingivitis. Certainly the data do not support the claim that the mouthrinse is as effective as flossing in patients with moderate to severe gingivitis or periodontitis. Such populations were not studied.
(Id. at 100003135).
  Pfizer responded to these criticisms in May 2002. (PXs 27, 60). In doing so, Pfizer assured the ADA:
We have [reinforced] and continue to reinforce that dentists should continue to encourage their patients to brush and floss in all professional materials including the current proposed advertisement (`when brushing and flossing are not enough'). Brushing and flossing remain the standard of plaque control and indispensable for both disease-free and periodontally affected individuals. Use of Listerine mouthrinse is not interchangeable with flossing.
(PX 27 at 100009904) (emphasis in original).
  By letter dated June 6, 2002, the ADA approved Pfizer's professional advertisements, as follows:
[T]he Council [on Scientific Affairs of the ADA] determined that Listerine . . . has been shown, in two 6-month clinical studies, to be as good as flossing at reducing interproximal plaque and gingivitis in subjects with mild to moderate gingivitis who brush twice a day with a fluoride dentifrice. . . .
The Council concurs with your request for the claim, "Now clinically proven as effective as flossing" for patients with mild to moderate gingivitis. Since study subjects with advanced gingivitis or periodontitis were not included in the studies, no claim can be made about such patients. The Council did not approve the claim, "Now proven equally essential as flossing," because it believes that "as essential as" implies that studies have shown that all consumers must both floss and rinse with Listerine.
(PX 40). The ADA also approved the claim "New clinical studies prove that the antimicrobial action of Listerine is as effective as flossing." (Id.). The claims were approved for use only with professionals "because of the potential to mislead consumers that they no longer need to floss." (Id.; see Kumar Dep. 186-87; Tr. 629-30). The ADA noted that Pfizer had agreed that it "does not wish to promote the message that consumers can stop daily flossing if they rinse twice a day with Listerine." (PX 40; see Lynch Dep. 36 (flossing "has a place in oral hygiene and it has a benefit")).

  The ADA reported on the Pfizer studies in its own website. The ADA wrote that "[w]hile some study results [referencing the Sharma and Bauroth Studies] indicate the use of a mouth rinse can be as effective as flossing for reducing plaque between the teeth," it continued to recommend "brushing twice a day and cleaning between the teeth with floss or interdental cleaners once each day." (PX 51). The ADA noted that the authors of the studies concluded that "in patients with mild to moderate gingivitis (early gum disease), rinsing twice a day with the antiseptic mouth rinse was as effective as flossing for reducing plaque and gingivitis between the teeth." (Id.). The ADA noted that the authors had not studied how the mouth rinse compared to floss in reducing tooth decay or periodontitis. (Id.).*fn9

  5. The Professional Advertising Campaign

  After the ADA approval, Pfizer began an advertising campaign directed at the professional dental community. (Tr. 588, 589-90). The campaign included as its "centerpiece" a journal ad and it also included other ads, direct mail, sales visits, ...


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