United States District Court, S.D. New York
January 6, 2005.
McNEIL-PPC, INC., Plaintiff,
PFIZER INC., Defendant.
The opinion of the court was delivered by: DENNY CHIN, District Judge
[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
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
(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
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
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
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.
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
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
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
(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
(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
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.
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, and reprints
of the two studies. (Tr. 589-90; PX 36 at 10012270).
One of the ads shows a bottle of Cool Mint Listerine balanced
equally on a scale opposite a container of dental floss. (DX
198; see Tr. 716-17). The ad proclaims: "Now Clinically Proven
As Effective as Floss Against Plaque and Gingivitis." (DX 198).
It further states that "[n]ew clinical studies prove that the
antimicrobial action of Listerine is as effective as flossing."
It further proclaims: "Significant reductions in plaque buildup
and clinically comparable reductions in gingivitis." (Id.). It
urges dentists to "Recommend Listerine." (Id.). In small print, it states: "When brushing
and flossing are not enough." (Id.). A similar ad, also showing
a Listerine bottle balanced on a scale against a floss container,
disclaims in fine print near the bottom of the page: "Floss
daily." (DX 199).
6. The ADA Approval for Consumer Advertising
In January 2004, Pfizer sought approval from the ADA to expand
its "as effective as flossing" advertising campaign to consumers.
(Tr. 590; PX 36). Pfizer emphasized in its submission that it had
spent the prior eighteen months "educating dental professionals."
(PX 36 at 10012270).*fn10 Pfizer stated: "We have now
reached the stage where professionals have been exposed to this
evidence-based claim more than 8.4 million times and we believe
it is time for us to be able to reach out directly to the
consumer." (Id.). Again Pfizer sought to assure the ADA that: we are taking appropriate, responsible and ethical
measures to convey an unambiguous, yet creative and
provocative, message to consumers that Listerine is
not a replacement for flossing and that it is an
adjunct to their usual mechanical oral care routine,
which should include flossing daily.
(Id. at 10012271-72; see Tr. 584 (Pfizer "reassured
[professionals] that once we went to the consumers we would not
communicate a substitution message."); PXs 44, 45, 46, 47, 48,
49, 50, 81; Schorr Dep. 90; Kumar Dep. 52 ("Pfizer has no
intention of telling people to stop flossing. We never have. We
never will.")). In its supporting materials, Pfizer acknowledged
that "flossing performed correctly and regularly remains the
standard for maintaining optimal interproximal gingival health,"
but it contended that "chemotherapeutic agents may also serve a
useful role especially in those patients whose brushing and
flossing are inadequate to prevent and control gingivitis." (PX
36 at 10012280).
On March 29, 2004, the ADA approved Pfizer's request to use the
"as effective as flossing" claim in advertising to consumers. (PX
66). The ADA provided, however, that the following language had
to be "clearly communicated" to consumers in any advertising:
Rinsing with Listerine is as effective as flossing in
removing interproximal plaque and in reducing
interproximal gingivitis in patients with mild to
moderate gingivitis when they brush twice a day with
a fluoride dentifrice.
(Id.). The ADA also instructed that "in all consumer
promotional materials using the Listerine is `as effective as
flossing' claim, Pfizer will need to inform consumers that they should
floss daily." (Id.).
Pfizer was concerned with the "very technical" nature of the
qualifying language (Tr. 598), and on April 27, 2004, it proposed
alternative language that it contended was "comprehensible at the
9-10th grade level":
Listerine is clinically proven as effective as floss
(at reducing plaque and gingivitis between teeth).
Ask your dentist.
(PX 89; see Tr. 598-99).
The ADA responded on May 19, 2004, approving the following
"Rinsing with Listerine is as effective as floss at
reducing plaque and gingivitis between teeth."
"Ask your dentist."
(DX 453; Tr. 599-600).
Thereafter, Pfizer submitted various pieces of proposed
promotional materials to the ADA for approval, including versions
of the Big Bang television commercial, and approval was
eventually received for advertisements that were eventually used
publicly. (See, e.g., DXs 415, 416, 418; Tr. 612-15, 620-21).
The ADA acknowledged that Pfizer had "increased the emphasis on
the importance of flossing." (PX 68 at 10048321). The ADA noted
that the Council on Scientific Affairs and ADA members had expressed reservation about the "Listerine is as effective as
floss" campaign, and noted that the ADA's advertising committee
was interested in receiving "any feedback" that Pfizer might
receive from consumers on the Big Bang commercial. (Id.). Prior
to the launch of the consumer campaign, the ADA expressed concern
about "the concept" that "if consumers don't have the time to
floss, they can use Listerine instead." (PX 123; see also PX
121). In another letter, the ADA wrote:
It is the [ADA Ad] Committee's opinion that [a
proposed] commercial is sending a mixed message to
consumers, and that they will believe that it won't
be a problem if they don't have time to brush or
floss because Listerine is just as effective.
As the Council on Scientific Affairs approved the
product as an adjunct for brushing and flossing for
patients who need extra help, it would not be
possible for the Ad Committee to approve the concept
of the commercial (if you don't have the time to
floss, then use Listerine instead). Disclaimers or
minor word changes do not alleviate the concerns the
Committee has about the basic premise of the
7. The Consumer Advertising Campaign
The consumer advertising campaign was launched in June 2004.
(See Tr. 646). Prior to the launch, Pfizer sent a letter to
150,000 dental professionals "practically the whole universe of
dental professionals" advising that Pfizer would be engaging in
a consumer advertising campaign conveying a "new message to
patients stating that `Listerine is as effective as floss.'" (Tr.
646; PX 44). The letter advised dentists that: "Rest assured, as with the professional campaign, we will promote
responsibly and emphasize to patients that rinsing with Listerine
cannot take the place of flossing." (PX 44; see also Kumar Dep.
26 (stating that Pfizer directs patients to floss and
professionals to teach patients to floss because flossing "is
extremely important to professionals")).
The first version of the Big Bang television commercial began
airing in June 2004. (Tr. 45; PXs 90, 93). The launch, however,
generated immediate concern among dental professionals. Pfizer
attended a convention of the American Dental Hygienists'
Association in Dallas in late June 2004. Its representatives
The hot topic of conversation was the new Listerine
commercial. Many professionals voiced concern over
the message conveyed. Approximately 85% of
professionals said patients would "get the wrong
idea" and stop flossing. Convention team members
[from Pfizer] stressed that Listerine is not a
replacement for flossing.
(PX 70 at 10013105).
Pfizer representatives also attended a convention of the
Academy of General Dentists in Anaheim in early July 2004 and
The new advertising campaign was the big concern at
this convention. The [Pfizer] convention team figures
that 75-85% of the Dental professionals that were
detailed had a negative reaction to the advertising;
they were and are concerned [that] Listerine is
sending the wrong message to their patients by saying
"Listerine is as effective as floss."
(PX 71 at 10013110; see also PXs 69, 72, 84 ("I'm growing tired of talking to cranky hygienists."), 87, 109, 125; but see also
PX 106 (Pfizer e-mail seeking to dispel "stories" that dentists
were angry about Pfizer's campaign)).
By letter dated June 23, 2004, J&J objected to the Pfizer "as
effective as floss" advertisements, including the Big Bang
commercial. J&J wrote that it was concerned that the advertising
contained "false and misleading claims" comparing rinsing to
flossing. (PX 129; see also PXs 130, 131, 132).*fn11
In part because of the concerns raised by the dental community,
Pfizer made changes to the advertisements, but Pfizer continued
to send the message that Listerine was "as effective as floss."
In the third version of the Big Bang, which continues to run, the
commercial announces that "Listerine's as effective as floss at
fighting plaque and gingivitis. Clinical studies prove it." (PX
95; see PX 92).*fn12 The commercial cautions that
"[t]here's no replacement for flossing," but states that "if you
don't floss like you should, you can get its plaque-fighting
benefits by rinsing." (PX 95; see PX 92). The commercial goes
on to repeat two more times the message that Listerine is "as
effective as flossing against plaque and gingivitis." (PX 95;
see PX 92).
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. (PX 95). In a superscript that
appears briefly on-screen, the commercial also tells viewers to
"[a]sk your dental professional." (PX 95; see PX 92).
Pfizer also published print ads, including a freestanding
circular with a manufacturer's discount coupon featuring a bottle
of Cool Mint Listerine balanced equally on a scale opposite a
floss container (similar to the image used in the professional
campaign). (PX 96).*fn13 The ad proclaims that Listerine "Is
Clinically Proven To Be As Effective as Floss at Reducing Plaque
& Gingivitis between the Teeth." (Id.). In small print near the
bottom of the page, the ad states: "Floss Daily." (Id.). There
is no instruction telling consumers to consult their dentists.
Pfizer also used a hang tag and shoulder labels on its bottles
of Listerine. (PXs 97, 98, 162; DX 432). The hang tag features
the scale image and is similar to the print ad just described.
(PX 97; see PX 96). The shoulder label has gone through three
versions. (See Tr. 616-20). The first version (which was red) stated: "Now Clinically Proven As Effective As
Floss," with the words in much smaller print "Against Plaque and
Gingivitis Between the Teeth." (PXs 98, 162). The second version
(which is blue) reads the same as the first, with the addition in
small print of the words: "Ask Your Dentist. Floss Daily." (PX
100). A third version (which is gold and red) is being or is
about to be distributed and reads: "As Effective As Floss Against
Plaque & Gingivitis Between Teeth," with the following words in
smaller print: "Ask Your Dentist. Not a Replacement for Floss."
Pfizer has also featured the "as effective as flossing" claim
on its website for Listerine. The first page of the website shows
the Cool Mint Listerine bottle shaking, with the stream of blue
liquid flowing out (as in the Big Bang commercial), and forming
the words "Listerine Antiseptic is as effective as flossing,"
with a footnote to the words: "Against plaque and gingivitis
between teeth. Use as directed. Ask your dentist. Not a
replacement for floss." (PX 41). The first page also states:
It's clinically proven.
A quick easy rinse with Listerine Antiseptic, twice a
day, is actually as effective as floss. Because
Listerine Antiseptic gets between teeth to kill the
germs that cause plaque and gingivitis. Ask your
dentist. You'll find out that Listerine Antiseptic
truly is the easy way to a healthy mouth.
(Id. at 090617; see also http://www.listerine.com ("Listerine
Antiseptic is as effective as flossing") (visited Jan. 3, 2005)). The website has an entire section entitled "Effective As Floss,"
spanning many pages. In a question-and-answer section, the
website addresses frequently asked questions, including the
Question 3 Most people don't like to floss/don't make
the time to floss. Isn't this new data telling people
that they don't have to floss?
Answer No, flossing is essential in preventing gum
disease because it helps remove food particles and
plaque from between the teeth, areas where the
toothbrush can't reach. However, optimal plaque
control through brushing and flossing alone can
sometimes be difficult to achieve. We believe that
the results [of the two studies] suggest the
importance of adding an antiseptic mouthwash to
patients' daily oral healthcare. . . .
(PX 41 at 090636-37).*fn14
In December 2004, Pfizer began running a fourth version of the
Big Bang. It is substantially similar to the third version, with
the exception that it makes reference to Pfizer's new Advanced
Listerine. (See Letter to Court from Kaye Scholer, dated
December 28, 2004 & Enc.).*fn15 8. The Surveys
In September and October 2004, at PPC's request, a consumer
research firm, Bruno and Ridgway Research Associates, conducted
three consumer surveys in connection with this case, in malls and
shopping centers in ten different locations throughout the United
States. (Tr. 30-33). The first was intended to determine the
message that consumers took away from the Big Bang commercial.
The second sought to determine the message that consumers took
away from the first of the three shoulder labels. The third
sought to measure the pre-existing beliefs of consumers regarding
the use of Listerine and floss. (Tr. 32-33; see PX 158).
In the first survey, consumers were shown the third version of
Big Bang twice and then asked a series of questions about the
ideas that were communicated to them by the commercial. The
survey found that 50% of the respondents took away the message
that "you can replace floss with Listerine." (Tr. 33; see PX
158 at 0012 ("one half (50%) of consumers who viewed the
Listerine commercial? take away a message that Listerine can be used instead of floss")).*fn16
In the second survey, eligible consumers were shown a Listerine
bottle with the first (or red) version of the shoulder label.
They were asked essentially the same questions as were asked in
the first survey. Some 45% of the consumers took away the message
that Listerine could be used instead of floss. (Tr. 32-33; see
PX 158 at 0017 ("just under one-half (45%) of consumers take away
a message from the bottle labeling that Listerine can be used
instead of floss")). Essentially the same methodology was
followed as was followed for the first survey. (Tr. 41-42,
In the third survey, a control survey, consumers were asked
their "pre-existing beliefs" regarding Listerine and floss; the
intent was to determine the number of people who did not recall
seeing the commercials but who still believed that Listerine
could be used instead of floss. A minority of those surveyed did
not recall seeing Big Bang, and of those 19% stated the opinion
that Listerine could be used in place of floss. (Tr. 33, 44-45;
PX 158 at 0022 ("Among the 209 consumers who could not recall
seeing the commercial, only 19% hold the opinion that you can use
Listerine instead of floss. This proportion is likely inflated because" the Big Bang commercial had been running for
The surveyors then took the three surveys together, subtracted
the 19% figure from the 50% and 45% figures, respectively, and
concluded that 31% of those who saw the commercial and 26% of
those who viewed the shoulder label took away a replacement
message. (Tr. 33, 49-50; see PX 158 at 0024 ("[I]f we use the
19% to adjust the communication levels reported in these surveys
for the potential influence of pre-conceived opinions, we are
still left with a substantial proportion of consumers who clearly
received the `can replace floss' message from the Listerine
commercial and its bottle label.")).
Pfizer commissioned its own survey, which was conducted by Dr.
Seymour Lieberman and his company, the Epsilon Group Inc., in
shopping malls in twelve markets throughout the United States in
August 2004. (Tr. 502-09, 543; see PX 164). Dr. Lieberman
sought to determine the impact that the Big Bang commercial (the
second version) was likely to have on sales of floss. (Tr. 503).
Dr. Lieberman concluded that the Big Bang had "no negative
impact" on consumers' expectations with respect to the purchase
or use of floss. (Tr. 504; see PX 164 at 12).
Dr. Lieberman also sought to determine whether the commercial
"created the idea that Listerine provides all of the benefits of
floss without reservation." (Tr. 503). He did so by showing half
the respondents the Big Bang commercial and half another Pfizer
commercial for Listerine called "Simple Solution." (Tr. 504-13; PX 164). The respondents were then asked a series of
questions, and the stated intent was to use Simple Solution as a
control to determine the number of people who took a replacement
message away from Big Bang. (Tr. 511-14). According to Dr.
Lieberman, Simple Solution was "a perfect control" because it did
not "either implicitly or explicitly [make] the claim that
Listerine is as effective as floss." (Tr. 514).
The storyboard for Simple Solution shows that the announcer
Do you always floss between all 32 teeth? You would
if you had the time.
Good thing there's Listerine.
In just 30 seconds, Listerine kills germs to fight
plaque build-up in places you may have missed with
brushing and flossing. . . .
(PX 164 at App. A, Simple Solution Storyboard).
Dr. Lieberman concluded that for both Big Bang and Simple
Solution, the percentage of respondents expecting to buy
mouthwash increased significantly after seeing the respective
commercial. (PX 164 at 12; see Tr. 518). Dr. Lieberman also
found that for both commercials, there were significant increases
23% for Big Bang and 19% for Simple Solutions in the number
of people who believed that Listerine provides all the benefits
of flossing. (PX 164 at 13 & Table B-7). Dr. Lieberman contended
that these numbers showed that Big Bang did not cause consumers
to take away a replacement message because the difference between
23% and 19% was not significant. (Tr. 521; PX 164 at 13). Dr. Lieberman also found that after they saw the commercials,
49% of those who saw Big Bang and 45% of those who saw Simple
Solution believed that "Listerine provides all of the benefits
of flossing." (PX 164 at Table B-7 (emphasis in original)).
Pfizer earlier commissioned, in the spring of 2004, Ipsos-ASI,
an advertising research company, to conduct quantitative or
large-scale market research into the message being conveyed by
several proposed advertisements or commercials using the
"clinically proven as effective as floss" claim. (PX 11; see
Tr. 653-55). In response to an earlier version of Big Bang, 27%
of the respondents took away the message that Listerine "can
substitute brushing/flossing." (PX 11 at 0003935). Some 10%
responded that they took away the message "[d]on't have to
floss/no need to floss." (Id. at 000397).*fn17
9. The Impact of the Ads
PPC's sales of string floss have been "relatively stable" from
a few months prior to the launch of Pfizer's advertising campaign
to the time of the preliminary injunction hearing. There were two
"peaks" in sales, which were likely the result of "buy one, get
one free" promotions. (Tr. 290-91; see Tr. 314-15). PPC's sales of the RADF and Power Flosser are down. There was a
drop in sales from the beginning of the year prior to the launch
of Pfizer's advertising campaign, which is likely the result of
introduction into the market of another power flosser by a
competitor. Sales of PPC's Power Flosser had actually increased
prior to June 2004. From the time Pfizer launched its advertising
campaign, sales of both the RADF and the Power Flosser have taken
a steep decline. (Tr. 291).
It is not surprising that sales of string floss have not
dropped while sales of the RADF and Power Flosser have. The
string floss category is comprised predominantly of "people who
are more loyal flossers," who would be less likely to replace
floss with Listerine. Consumers who use the RADF and Power
Flosser, in contrast, are predominantly "folks who don't like to
floss," who "would love to have a replacement for flossing."
These consumers "would be more susceptible to a message like the
Listerine advertising campaign." (Tr. 292).
The consumer advertising campaign launched in mid-June 2004,
and by July 2004 some 68 million people had already seen the Big
Bang. The Big Bang has continued to run since then and is running
currently as well. Since the ads began running, sales of
Listerine have increased by at least 10%. (Tr. 669).
B. Prior Proceedings
This action was filed on September 28, 2004. The complaint
asserts claims of 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. On October 1, 2004, PPC
moved by order to show cause for a preliminary injunction and
expedited discovery. On October 6, 2004, the parties consented to
a scheduling order and agreed to a schedule for expedited
discovery, including expert discovery, and the submission of
proposed findings of fact and conclusions of law. The Court
conducted an evidentiary hearing from December 13 to 17, 2004, at
the conclusion of which the Court reserved decision.
A. Applicable Legal Standards
1. Preliminary Injunctions
A party seeking a preliminary injunction must show that (1) it
is likely to suffer irreparable injury if relief is denied and
(2) there is either (a) a likelihood of success on the merits or
(b) sufficiently serious questions going to the merits to make
them a fair ground for litigation, with a balance of hardships
tipping decidedly in the movant's favor. Procter & Gamble Co. v.
Chesebrough-Pond's Inc., 747 F.2d 114, 118 (2d Cir. 1984);
SmithKline Beecham Consumer Healthcare, L.P. v. Johnson &
Johnson-Merck Consumer Pharms. Co., No. 01 Civ. 2775 (DAB), 2001
U.S. Dist. LEXIS 7061, *17 (S.D.N.Y.), aff'd, No. 01-7709, 2001
U.S. App. LEXIS 21472 (2d Cir. 2001). A preliminary injunction is
an "extraordinary remedy" that should not be routinely granted.
JSG Trading Corp. v. Tray-Wrap, Inc., 917 F.2d 75, 80 (2d Cir.
1990). 2. The Lanham Act
a. Irreparable Harm
In a Lanham Act false advertisement case,*fn18 the Second
Circuit has held that irreparable harm will be presumed where the
plaintiff demonstrates a likelihood of success in showing that a
comparative advertisement that mentions plaintiff's product by
name is literally false. Castrol, Inc. v. Quaker State Corp.,
977 F.2d 57, 62 (2d Cir. 1992); see also McNeilab Inc. v.
American Home Prods. Corp., 848 F.2d 34, 38 (2d Cir. 1988)
(making a distinction between false comparative advertising
claims and those involving "misleading, non-comparative
commercials which touted the benefits of the product advertised
but made no direct reference to any competitor's product").
When irreparable harm is not presumed but plaintiff's and
defendant's products are in head-to-head competition in the
relevant market, the Second Circuit does not require plaintiffs
to show an actual loss of sales. See Coca-Cola Co. v.
Tropicana Prods., Inc., 690 F.2d 312, 316 (2d Cir. 1982),
abrogated on other grounds by Fed.R.Civ.P. 52(a); Zeneca
Inc. v. Eli Lilly & Co., No. 99 Civ. 1452 (JGK), 1999 U.S. Dist.
LEXIS 10852, at *104 (S.D.N.Y. July 19, 1999). Section 43 of the
Lanham Act requires "only proof providing a reasonable basis for
the belief that the plaintiff is likely to be damaged as a result of the
false advertising." Johnson & Johnson v. Carter-Wallace, Inc.,
631 F.2d 186, 190 (2d Cir. 1980) ("The correct standard is
whether it is likely that [defendant's] advertising has caused or
will cause a loss of [plaintiff's] sales, not whether [plaintiff]
has come forward with specific evidence that [defendant's] ads
actually resulted in some definite loss of sales."). Proof that
sales of plaintiff's products would probably be harmed if
defendant's advertising tended to mislead consumers in the manner
alleged is sufficient to establish irreparable injury.
Coca-Cola, 690 F.2d at 316-17.
Requiring "more than a plaintiff's mere subjective belief" that
injury has occurred or is likely to occur, Johnson & Johnson,
631 F.2d at 189, the standard may be satisfied if the plaintiff
demonstrates that the parties are competitors in a relevant
market and shows "a logical causal connection between the alleged
false advertising and [plaintiff's] own sales position." Id. at
190-91 (finding that plaintiff satisfied this requirement with
specific evidence that consumers use plaintiff's product for
specific purposes and defendant's ad campaign affects those
markets, and that plaintiff supports its case with sales data, a
consumer witness' testimony that she changed products based on
defendant's false advertising, and survey evidence of consumer
confusion). Furthermore, injunctive relief is not barred just
because the possibility that the total pecuniary harm might be
relatively slight. See id. b. The Merits
Section 43(a) of the Lanham Act prohibits false advertising,
Any person who . . . uses in commerce any . . . false
or misleading description of fact, or false or
misleading representation of fact, which . . . in
commercial advertising or promotion, misrepresents
the nature, characteristics, qualities, or geographic
origin of his or her or another person's goods,
services, or commercial activities, shall be liable
in a civil action by any person who believes that he
or she is or is likely to be damaged by such act.
15 U.S.C. § 1125(a). Under the plain language of § 43(a), any
person who believes that he or she is or is likely to be damaged
by the false or misleading representations may bring suit under
the Lanham Act. See Societe de Hotels Meridien, S.A. v.
LaSalle Hotel Operating Partnership, L.P., 380 F.3d 126
, 130 (2d
Cir. 2004) ("We have consistently held that where the defendant
has drawn a direct comparison between its own product and that of
the plaintiff, we are inclined, without much more, to find
standing to bring Lanham Act claims.").
To prevail on a Lanham Act false advertising claim, a plaintiff
must demonstrate the falsity of the challenged advertisement, by
proving that it is either (1) literally false, as a factual
matter; or (2) implicitly false, i.e., although literally true,
still likely to mislead or confuse consumers. See Societe de
Hotels Meridien, 380 F.3d at 132; L&F Prods. v. Procter &
Gamble Co., 45 F.3d 709, 711 (2d Cir. 1995) (citing Johnson &
Johnson*Merck Consumer Pharms. Co. v. SmithKline Beecham Corp., 960 F.2d 294, 297 (2d Cir. 1992)); accord
Castrol, 977 F.2d at 62; McNeil-P.C.C., Inc. v. Bristol-Myers
Squibb Co., 938 F.2d 1544, 1549 (2d Cir. 1991).
The false or misleading statement must be material. S.C.
Johnson & Son, Inc. v. Clorox Co., 241 F.3d 232, 238 (2d Cir.
2001); National Basketball Assoc. v. Motorola, Inc.,
105 F.3d 841, 855 (2d Cir. 1997); see also 4 McCarthy on Trademarks &
Unfair Competition § 27:35 (there must be "some showing that the
defendant's misrepresentation was `material' in the sense that it
would have some effect on consumers' purchasing decisions"). In
considering the issue of falsity, the court should "`consider the
advertisement in its entirety and not . . . engage in
disputatious dissection. The entire mosaic should be viewed
rather than each tile separately.'" Avis Rent A Car Sys., Inc.
v. Hertz Corp., 782 F.2d 381, 385 (2d Cir. 1986) (quoting FTC
v. Sterling Drug, Inc., 317 F.2d 669, 674 (2d Cir. 1963)).
"[T]ext must yield to context." Avis, 782 F.2d at 385. Finally,
the "visual images in a commercial" must also be considered in
assessing falsity. S.C. Johnson, 241 F.3d at 238.
When the challenged statement is literally or explicitly false,
the court may grant relief "`without reference to the
advertisement's impact on the buying public.'" McNeil-P.C.C.,
938 F.2d at 1549 (quoting Coca-Cola, 690 F.2d at 317); see
also Castrol, 977 F.2d at 62 (finding that plaintiff bears the
burden of proving challenged advertising is literally false to a
"likelihood of success" standard). When a plaintiff relies upon the "impliedly false" theory, however, extrinsic evidence
must confirm that the advertising is likely to mislead or
confuse. L&F Prods., 45 F.3d at 711.
In proving an advertising claim literally false, a plaintiff
bears a different burden depending on whether the advertisement
purports to be based on test results. Hence, where a defendant's
advertisement contends that "clinical tests" prove the
superiority of its product (an "establishment claim"), the
plaintiff need only prove that "the tests referred to . . . were
not sufficiently reliable to permit one to conclude with
reasonable certainty that they established the proposition for
which they were cited." Castrol, 977 F.2d at 62-63 (citing
Procter & Gamble, 747 F.2d at 119). On the other hand, where a
superiority claim does not purport to rest on test results, the
plaintiff may prove falsity "`only upon adducing evidence' that
affirmatively show[s] [defendant's] claim . . . to be false."
Castrol, 977 F.2d at 62-63 (quoting Procter & Gamble,
747 F.2d at 116); accord McNeil-P.C.C., 938 F.2d at 1549.
Where a plaintiff proceeds on a claim of implied falsehood, the
plaintiff "must demonstrate, by extrinsic evidence, that the
challenged commercials tend to mislead or confuse consumers."
Johnson & Johnson*Merck, 960 F.2d at 298; accord L&F
Prods., 45 F.3d at 711. As the Second Circuit has explained, the
inquiry is: "what does the public perceive the message to be?"
Johnson & Johnson*Merck, 960 F.2d at 299. The trial judge may
not determine whether an advertisement is deceptive "based solely upon his or her own intuitive reaction."
Id. at 297. The trial judge must first determine "what message
was actually conveyed to the viewing audience," and then it must
determine the truth or falsity of the message. Id. at 298;
accord Clorox Co. Puerto Rico v. Proctor & Gamble Commercial
Co., 228 F.3d 24, 34 (1st Cir. 2000) (same).
Typically, an implied claim is proven through the use of a
consumer survey that shows a substantial percentage of consumers
are taking away the message that the plaintiff contends the
advertising is conveying. Johnson & Johnson*Merck,
960 F.2d at 298 ("the success of a plaintiff's implied falsity claim usually
turns on the persuasiveness of a consumer survey"); Cicle
Francesco Moser, S.R.L. v. Cannondale USA, Inc., 12 F. Supp. 2d 320,
324 (S.D.N.Y. 1998) (same). Cases have held that 20%
would constitute a substantial percentage of consumers. See Johnson
& Johnson-Merck Consumer Pharms. Co. v. Rhone-Poulenc Rorer
Pharms., Inc., 19 F.3d 125, 134 n. 14 (3d Cir. 1994) (citing
cases finding "deception rates" of 20% or more to be sufficient).
Survey results are useful and have "evidentiary value" if the
surveys are properly designed and objectively and fairly
conducted for example, they employ "filters" to screen out
individuals whose responses may distort the results; the
questions are directed to "the real issues"; and the questions
are not leading or suggestive. Johnson & Johnson*Merck Consumer
Pharms. Co. v. SmithKline Beecham Corp., 960 F.2d at 300; Universal City Studios, Inc. v. Nintendo Co., 746 F.2d 112, 118
(2d Cir. 1984).
After a plaintiff has established that a substantial number of
consumers have taken away the purported message, the district
court must then evaluate whether the message is false or likely
to mislead or confuse, and may consider factors such as the
commercial context, the defendant's prior advertising history,
and the sophistication of the advertising audience. See Johnson
& Johnson*Merck, 960 F.2d at 298. Of course, the court must also
consider the text and images used in the advertisement and the
evidence offered to prove or disprove the truth of the asserted
The plaintiff need not rely on consumer survey evidence to
prove an implied falsity claim if the plaintiff "`adequately
demonstrates that a defendant has intentionally set out to
deceive the public,' and the defendant's `deliberate conduct' in
this regard is of an `egregious nature.'" Johnson &
Johnson*Merck, 960 F.2d at 298-99 (quoting Resource Developers,
Inc. v. Statue of Liberty-Ellis Island Found., Inc.,
926 F.2d 134, 140 (2d Cir. 1991)). In these circumstances, "a presumption
arises `that consumers are, in fact, being deceived.'" Johnson &
Johnson*Merck, 960 F.2d at 298-99 (quoting Resource
Developers, 926 F.2d at 140).
I discuss first the issue of irreparable harm and second the
merits. 1. Irreparable Harm
I conclude that PPC has demonstrated that it is likely to
suffer irreparable harm if a preliminary injunction is not
granted. First, as I conclude below, PPC has demonstrated a
likelihood of success on its claim that Pfizer's ads are
literally false. Pfizer's ads are comparative ads, and although
they do not specifically mention PPC's product by name, PPC is
the market leader in sales of floss, with 40% or more of the
string floss category. (Tr. 286). As a PPC marketing executive
testified: "[PPC's] brand really is the floss category to many
consumers." (Tr. 293). In addition, the Pfizer ads feature a
white floss container similar to if not identical to J&J's white
floss container. (See, e.g., PX 92, 96, 97). Accordingly,
irreparable harm is presumed. See Castrol, 977 F.2d at 62.
Second, even assuming the presumption is inapplicable, in the
context of this case, where Pfizer is directly comparing
Listerine to floss, Pfizer and PPC are in head-to-head
competition for the same market non-flossers or reluctant
flossers. These individuals would be easily enticed by the notion
that they could obtain the benefits of flossing by rinsing with
Listerine. Moreover, there may very well be a future impact on
regular flossers as well. Hence, PPC is not required to show
actual loss of sales; it can prove irreparable harm by showing "a
logical causal connection between the alleged false advertising
and its own sales position." Johnson & Johnson v.
Carter-Wallace, Inc., 631 F.2d at 190. Such a logical causal
connection has been shown. In fact, by July 2004, when Pfizer's advertising
campaign was just a few weeks old, some 68 million people had
already seen Big Bang. Under all the circumstances, I conclude
that it is likely that Pfizer's ads will adversely affect PPC's
sales, if they have not done so already.
Third, it is likely that the ads already have adversely
affected PPC's sales. Although PPC's string floss sales have
remained stable, its sales of the RADF and Power Flosser which
employ pieces of string floss have sharply declined since
Pfizer launched its advertising campaign. It is here that PPC
will most readily be hurt, for it is the consumers who do not
floss or rarely floss who are more likely to replace floss if
they are persuaded they can obtain the same benefits by rinsing
with Listerine. Significantly, sales of Listerine have increased
at least 10% since Pfizer started its "as effective as floss"
Accordingly, I conclude that PPC has met the first prong of the
test for a preliminary injunction.
2. The Merits
I conclude that PPC has demonstrated a likelihood of success on
both its literal falsity claim and on its implied falsity claim.
I address each claim in turn.
a. Literal Falsity
Pfizer's advertisements make the explicit claim that "clinical
studies prove that Listerine is as effective as floss against
plaque and gingivitis." As Pfizer purports to rely on "clinical studies," this is an "establishment claim" and PPC need
only prove that "the [studies] referred to . . . were not
sufficiently reliable to permit one to conclude with reasonable
certainty that they established the proposition for which they
were cited." Castrol, 977 F.2d at 62-63. Two questions are
presented: first, whether the Sharma and Bauroth Studies stand
for the proposition that "Listerine is as effective as floss
against plaque and gingivitis"; and second, assuming they do,
whether the studies are sufficiently reliable to permit one to
draw that conclusion with "reasonable certainty."
First, even putting aside the issue of their reliability, the
two studies do not stand for the proposition that "Listerine is
as effective as floss against plaque and gingivitis." The two
studies included in their samples only individuals with mild to
moderate gingivitis. They excluded individuals with severe
gingivitis or with any degree of periodontitis, and they did not
purport to draw any conclusions with respect to these
individuals. Hence, the literal claim in Pfizer's advertisements
is overly broad, for the studies did not purport to prove that
Listerine is as effective as floss "against plaque and
gingivitis," but only against plaque and gingivitis in
individuals with mild to moderate gingivitis. The advertisements
do not specify that the "as effective as floss" claim is limited
to individuals with mild to moderate gingivitis. Consequently,
consumers who suffer from severe gingivitis or periodontitis
(including mild periodontitis) may be misled by the ads into believing that Listerine is just as effective as floss in helping
them fight plaque and gingivitis, when the studies simply do not
stand for that proposition.
Second, the two studies were not sufficiently reliable to
permit one to conclude with reasonable certainty that Listerine
is as effective as floss in fighting plaque and gingivitis, even
in individuals with mild to moderate gingivitis. What the two
studies showed was that Listerine is as effective as floss when
flossing is not done properly. The authors of both studies
recognized that the plaque reductions in the flossing groups were
lower than would be expected and hypothesized that "behavioral or
technical causes" were the reason. (PX 56 at 364; see also PX
57 at 354). Significantly, in some of the plaque reduction scores
for the flossing groups there was greater improvement at three
months than at six months, suggesting a deterioration in flossing
technique with the passage of time. (PX 57 at 354).*fn19 Hence, the studies did not "prove" that Listerine is "as
effective as floss." Rather, they proved only that Listerine is
"as effective as improperly-used floss." The studies showed only
that Listerine is as effective as floss when the flossing is not
performed properly. As one of the ADA consultants observed in
objecting to the advertising when it was proposed, "for a
substitute product to be `as good as' or `better' than flossing
it must be compared against the data of . . . subject[s] who
demonstrate they can and are flossing effectively." (PX 60 at
100003126; see also Tr. 182-83).
Pfizer and its experts argue that the two studies are reliable,
notwithstanding the indications that the participants in the
flossing group did not floss properly, because these conditions
reflect "real-world settings." (Tr. 439; see Tr. 441, 459-60).
But the ads do not say that "in the real world," where most
people floss rarely or not at all and even those who do floss
have difficulty flossing properly, Listerine is "as effective as
floss." Rather, the ads make the blanket assertion that Listerine works just as well as floss, an assertion the two
studies simply do not prove. Although it is important to
determine how a product works in the real world, it is probably
more important to first determine how a product will work when it
is used properly.
Not surprisingly, Pfizer relies heavily on the ADA's approval
of its "as effective as floss" campaign as well as the ads
themselves. Although this is a significant fact, the ADA's
approval is not controlling. First, it is clear that the ADA's
endorsement was hardly unanimous. Second, the ADA itself
repeatedly emphasized to Pfizer that consumers were not to be
misled into believing "they no longer need to floss." (PX 40).
Third, the ADA also noted that the studies did not address
individuals with severe gingivitis or periodontitis or consider
the impact on tooth decay. (Id.; PX 51). Finally, based on the
extensive record presented on this motion, I believe the ADA was
simply wrong in approving the message that "clinical studies
prove" that Listerine is as effective as floss in fighting plaque
Accordingly, I hold that PPC is likely to succeed on its claim
of literal false advertisement.
b. Implied Falsity
In considering the claim of implied falsity, in accordance with
Second Circuit law, I determine first the message that consumers
take away from the advertisements and second whether that message
is false. (i) The Implicit Message
Pfizer argues that its advertisements do not implicitly send
the message that Listerine is a replacement for floss. I
disagree. Rather, I find that Pfizer's advertisements do send the
message, implicitly, that Listerine is a replacement for floss
that the benefits of flossing may be obtained by rinsing with
Listerine, and that, in particular, those consumers who do not
have the time or desire to floss can switch to Listerine instead.
First, the words and images used in the advertisements confirm
that this is the message being sent. The words ("as effective as
floss") and images (a stream of blue liquid tracking floss as it
is removed from a floss container and then swirling between and
around teeth; a bottle of Listerine balanced equally on a scale
against a container of floss) convey the impression that
Listerine is the equal to floss.
Second, the Ridgway survey is convincing and was conducted in a
generally objective and fair manner. I accept its findings as
well as the testimony of Mr. Ridgway. Pfizer's objections to his
conclusions are rejected.*fn20 The Ridgway surveys show that 31% and 26% of the consumers who saw Big Bang
and the shoulder label, respectively, took away the message that
"you can replace floss with Listerine." (Tr. 33). Hence, a
substantial percentage of the consumers who saw the
advertisements took away a replacement message.
Third, even Pfizer's survey expert, Dr. Lieberman, made
findings corroborating Mr. Ridgway's conclusions. Dr. Lieberman
found that 49% of those who saw Big Bang believed "Listerine
provides all of the benefits of flossing." (PX 164 at Table B-7
(emphasis in original)).*fn21 Even Dr. Lieberman's results,
then, show that a substantial percentage of consumers took away a
Fourth, Pfizer's own documents, including the Ipsos study, the
Sabena report, internal reports of feedback from the dental
community (including the overwhelming reactions at the two dental
conventions), and internal documents showing that Pfizer
anticipated and prepared responses to deal with complaints that
it was sending a message that consumers could rinse instead of
floss, further confirm that consumers were and are taking away a
replacement message. (See, e.g., PXs 10, 11, 27, 36, 69, 70,
72, 84, 87, 109, 125).
Pfizer argues that the ads contained cautionary language and
disclaimers telling consumers to "floss daily," urging them to
consult their dentists, and noting that "[t]here's no replacement
for flossing." Hence, Pfizer argues, its ads are not conveying a
replacement message. The argument is rejected. Notwithstanding
the disclaimer language, Pfizer's ads are clearly suggesting to
consumers, through its overall words and images, that if they do
not have the time or desire to floss, they can rinse with Listerine instead, for Listerine is just "as effective
as floss." The few words of disclaimer are lost when the ads are
considered as a whole. After all, the point of an implied falsity
claim is that even though an advertisement "is literally true it
is nevertheless likely to mislead or confuse consumers." Johnson
& Johnson*Merck, 960 F.2d at 297.*fn22
Finally, Pfizer relies heavily on the Seventh Circuit's
decision in Mead Johnson & Co. v. Abbott Lab., 201 F.3d 883
(7th Cir. 2000). There, Judge Easterbrook wrote that:
interpreting "misleading" [in § 43(a)(1) of the
Lanham Act] to include factual propositions that are
susceptible to misunderstanding would make consumers
as a whole worse off by suppressing truthful
statements that will help many of them find superior
products. A "misunderstood" statement is not the same
as one designed to mislead.
201 F.3d at 886. The Mead Johnson decision, however, is of
little assistance in this case. The issue there was whether the
statement "1st Choice of Doctors" on infant formula containers
was misleading and constituted false advertisement. The plaintiff
argued that "1st" meant more than 50% and that a simple plurality
would not suffice. Understandably, the Seventh Circuit rejected
the argument. Here, the advertised claim is much less nebulous
it is a claim based on purported proof provided by "clinical
tests." Moreover, the court in Mead Johnson was concerned that surveys were being used in that case "to determine
the meaning of words." Id. at 886. The court observed that
"[i]t would be a bad idea to replace the work of these
professionals [philologists and others who contribute to
dictionaries] with the first impressions of people on the
street." Id. In this case, the Ridgway surveys were used in the
manner in which surveys are traditionally used in false
advertisement cases. The Mead Johnson decision does not dictate
a different result here.
Accordingly, I conclude that the Pfizer ads send an implicit
message that Listerine is a replacement for floss.
The final inquiry, then, is whether the implicit message sent
by the Pfizer ads is false. Pfizer argues that even assuming the
advertisements do send a replacement message, the message is
true: Listerine provides all the benefits of flossing.
Pfizer's position is based on two premises. First, Pfizer
contends, the Sharma and Bauroth Studies prove that Listerine is
as effective as floss in fighting plaque and gingivitis. Second,
Pfizer contends, no clinical proof exists to show that flossing
provides any benefit other than fighting plaque and gingivitis
there is no clinical proof that flossing reduces tooth decay or
periodontitis. Indeed, Pfizer asserts, this notion is a "myth,"
and goes so far as to argue that there is no proof that reducing
plaque will reduce caries or periodontitis. (See, e.g., Tr. 349-51 (Pfizer's expert, Dr.
Hujoel, arguing that there is no connection between plaque and
periodontitis)). Hence, Pfizer continues, because Listerine does
everything that floss can do, Listerine therefore provides all
the benefits of floss and consumers can "toss the floss" and
replace it with Listerine.
These arguments are rejected. I conclude that the implicit
message sent by Pfizer's advertisements is false, for Listerine
is not a replacement for floss.
First, as discussed above, Pfizer's initial premise is wrong.
The Sharma and Bauroth Studies do not prove that Listerine is
just as effective as floss in fighting plaque and gingivitis.
They prove only that Listerine is just as effective in fighting
plaque and gingivitis as improperly-used floss. One simply cannot
conclude from the two studies that Listerine is just as effective
as flossing when the flossing is performed properly.
Second, Pfizer's second premise is wrong as well: there is
substantial, convincing clinical, medical, and other proof to
show that flossing does fight tooth decay and periodontitis and
that Listerine is not a replacement for flossing.
Flossing provides certain benefits that Listerine does not.
Floss penetrates subgingivally to remove plaque and biofilm below
the gumline. Flossing, as part of a regular oral prevention
program, also can reduce periodontitis. Flossing also reduces tooth decay and has an anti-caries effect. Finally,
flossing removes food debris interdentally, including pieces of
food trapped between the teeth that rinsing cannot dislodge.
(See generally Tr. 151-67 (testimony of Dr. Paquette); PX 51
Numerous articles confirm that tooth decay and periodontitis
can be reduced or prevented through interdental plaque control
methods, including flossing. (See, e.g., articles cited in
footnotes 2 and 3 supra). One study in particular the
Dorchester study is instructive in this respect. (PX 215 (G.Z.
Wright et al., "The Dorchester Dental Flossing Study: Final
Report," 1 Clinical Preventive Dentistry 23 (1979)). This was a
20-month clinical trial conducted with children to determine
whether flossing done regularly and properly had any effect
on the incidence of new caries. (Id. at 26). This was a
"split-mouth" study: each child had one side of his or her mouth
flossed each school day by a dental assistant; the other half of
the mouth was not flossed. (Id. at 23). Hence, the design
provided for both test and control surfaces in the same mouth and
there was no issue about compliance. In the end, there was a
striking difference there was more than a 50% reduction in the
number of new caries on the flossed side relative to the
unflossed side. (Id. at 24, 26; see generally Tr. 161-62).
As Pfizer's experts pointed out, there were some limitations to
the Dorchester study. The sample size was small (only 88
children); the study was conducted many years ago (in the mid-1970's); the study was conducted only with children (no
adults were included); the study was conducted in a
"fluoride-deficient town" in Ontario, Canada; and the study does
not reflect real-world conditions, as the flossing was performed
by dental assistants on almost a daily basis. (PX 23, 26).
Nonetheless, the study demonstrates the benefits of flossing when
flossing is performed properly, and those benefits include
reducing the incidence of caries. Moreover, the Dorchester study
is corroborated by other studies. (See, e.g., PXs 210, 211, and
other articles cited in footnotes 2 and 3 supra). Again,
although real-world usage is important, it is also important to
study the efficacy of a product when it is used correctly.
Other substantial evidence also demonstrates, overwhelmingly,
that flossing is important in reducing tooth decay and
periodontitis and that it cannot be replaced by rinsing with a
mouthwash. The ADA continues to say on its website that "[p]laque
is responsible for both tooth decay and gum disease." (PX 51).
Even in discussing the two Pfizer Listerine studies, the ADA
continued to proclaim to consumers: "FLOSSING RECOMMENDED FOR
GOOD ORAL HEALTH CARE." (Id. see also PXs 40, 66, 68, 122)).
In the very articles upon which Pfizer based its advertising
campaign, the authors emphasized that dental professionals should
continue to recommend daily flossing and cautioned that they were
not suggesting that mouthrinse be used instead of floss. (PX 57
at 354; PX 56 at 364). Pfizer itself continues to recognize on
its own website that "flossing is essential in preventing gum disease." (PX 41 at 090636). It also
repeatedly acknowledged to the ADA that Listerine was "not
interchangeable with flossing" (PX 27 at 100009904) and it
repeatedly reassured both the ADA and the professional dental
community that it was not intending to send a replacement
message. (See, e.g., PXs 27, 36, 44-50, 70, 81). Yet, after
telling the ADA and dental professionals for two years that it
was not suggesting that floss can be replaced by Listerine, it
takes that position in this lawsuit. Pfizer's complete
turn-around is highly troubling.*fn23
Finally, of course, dentists and hygienists have been telling
their patients for decades to floss daily. They have been doing
so for good reason. The benefits of flossing are real they are
not a "myth." Pfizer's implicit message that Listerine can
replace floss is false and misleading.
In sum, I find that PPC has demonstrated that it will suffer
irreparable harm if a preliminary injunction is not issued, and I
find further that PPC has demonstrated a likelihood of success on
both its literal falsity claim and on its implied falsity claim.
In addition, although I do not reach the "serious issues" prong of the test for a preliminary injunction and
therefore am not required to weigh the equities, I find that the
equities tip decidedly in favor of PPC. In addition, I find that
Pfizer's false and misleading advertising also poses a public
health risk, as the advertisements present a danger of
undermining the efforts of dental professionals and the ADA
to convince consumers to floss on a daily basis.*fn24
PPC's motion for a preliminary injunction is granted to the
extent that I will issue an order enjoining Pfizer, during the
pendency of this lawsuit, from communicating, in its advertising
or promotional materials or activities, the claims that: (1)
clinical studies prove that Listerine is as effective as floss
(in any respects), provides the same benefits as floss, or can
replace floss; (2) Listerine is as effective as, or can be used
instead of, floss; (3) flossing provides no health benefits
beyond reducing plaque and gingivitis; and (4) the Sharma and
Bauroth Studies prove anything concerning the comparative oral
health benefits of Listerine versus flossing. Pfizer is not
enjoined from using the Sharma and Bauroth Studies to support the
claim that Listerine fights plaque and gingivitis, as long as it
does not invoke a comparison to floss.
PPC's request for an order directing Pfizer to engage in
corrective advertising is denied, without prejudice to renewal
following a trial on the merits. The parties shall promptly discuss the issues of (i) PPC's
request for a recall of Listerine bottles that feature a hang tag
or shoulder label containing the "as effective as floss" claim;
(ii) the amount of a bond pursuant to Fed.R.Civ.P. 65(c); and
(iii) the language of a proposed order. I note that PPC submitted
a proposed order with its proposed findings of fact and
conclusions of law.
As for a stay pending appeal, I am not inclined to grant a stay
pending appeal, but I would consider a brief stay to permit
Pfizer to seek immediate relief from the Second Circuit.
Counsel for the parties shall appear for a conference on
January 10, 2005, at 2 p.m. In the meantime, the preliminary
injunction is not yet in effect.