Novartis Consumer Health, Inc v. Johnson & Johnson-Merck Consumer Pharmaceuticals Co

PRECEDENTIAL
Filed May 14, 2002
UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT
No. 01-1154
NOVARTIS CONSUMER HEALTH, INC.
v.
JOHNSON & JOHNSON-MERCK CONSUMER
PHARMACEUTICALS CO.,
Appellant
Appeal from the United States District Court
for the District of New Jersey
D.C. No. 00-cv-05361
District Judge: Honorable William G. Bassler
Argued: March 14, 2001
Before: RENDELL, AMBRO, and BRIGHT,*
Circuit Judges
(Opinion filed: May 14, 2002)
Steven A. Zalesin (Argued)
Patterson, Belknap, Webb & Tyler
1133 Avenue of the Americas
New York, NY 10036
Counsel for Appellant
_________________________________________________________________
* The Honorable Myron H. Bright, Senior Circuit Judge, United States
Court of Appeals for the Eighth Circuit, sitting by designation.
Bruce P. Keller (Argued)
Debevoise & Plimpton
919 Third Avenue
New York, NY 10022
Counsel for Appellee
OPINION OF THE COURT
AMBRO, Circuit Judge:
This is an appeal from a preliminary injunction entered
by the United States District Court for the District of New
Jersey against the Appellant, Johnson & Johnson-Merck
Consumer Pharmaceuticals Co. ("J&J"). The Appellee,
Novartis Consumer Health, Inc. ("Novartis"), moved the
District Court for a preliminary injunction pending a trial

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on the merits of its claim that J&J engaged in false
advertising in violation of section 43(a) of the Lanham Act,
15 U.S.C. S 1125(a). The District Court granted the motion
and enjoined J&J from using "Mylanta Night Time
Strength" as the designation for its over-the-counter liquid
heartburn medicine that competes directly with the Maalox
line of liquid antacid products marketed by Novartis. The
District Court had jurisdiction to enter the injunction
pursuant to 28 U.S.C. S 1331. We have appellate
jurisdiction pursuant to 28 U.S.C. S 1292(a)(1). For the
reasons noted below, we affirm the District Court’s decision
to enter the preliminary injunction.
I. Background Facts & Procedural History
The parties produce over-the-counter drugs that treat
heartburn. Heartburn is caused by stomach acid that
backs up ("refluxes") into the esophagus. This acid reflux is
likely to occur shortly after a meal, when the stomach
produces high volumes of acid to begin the digestion
process. Heartburn also occurs more frequently at night
because acid more easily refluxes into the esophagus when
a person is lying down and because, during sleep, the body
naturally secretes acid that raises the stomach pH levels.
According to a Gallup Organization Study for the American
2
Gastroenterological Association entitled "Understanding
Heartburn In America," of the 60 million Americans who
experience heartburn, almost 80% experience symptoms at
night. With this market, producers of heartburn remedies
vigorously compete to capture sales among nighttime
heartburn sufferers.
There are three types of heartburn remedies currently on
the over-the-counter market. Stomach acid "blockers" such
as Pepcid AC and Zantac 75 treat heartburn by reducing
the production of stomach acid for approximately eight to
twelve hours. "Rafting agents" such as Gaviscon form a
foam layer on top of the stomach contents so that, when
reflux occurs, the foam backs up into the esophagus rather
than the acidic gastric contents. The foam barrier lasts for
about three to four hours. Finally, there are "antacids" that
work by neutralizing excess acid already present in the
stomach. Antacids provide fast relief, but the effects wear
off within thirty to sixty minutes because antacids have no
effect on the production of new stomach acid. Novartis
produces and markets the Maalox brand of antacids while
J&J produces and markets the Mylanta brand.
The strength of an antacid is measured by the product’s
ability to neutralize acid in a beaker (i.e.,"in vitro") over a
fifteen minute period. This acid neutralization capacity
("ANC") does not, however, represent an antacid’s
effectiveness in the human body (i.e., "in vivo"), or its ability
to relieve the symptoms of acid reflux, because other
factors -- such as rate of gastric emptying, rate of secretion
of acid, and degree of mixing between the antacid and

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gastric contents -- all bear on the antacid’s efficacy. See
Johnson & Johnson-Merck Consumer Pharm. Co. v. Rhone-
Poulenc Rorer Pharm., Inc., 19 F.3d 125, 127 (3d Cir. 1994)
(hereinafter "Rorer"). Although ANC ratings may be provided
to physicians, the FDA prohibits manufacturers of antacid
products from listing ANC scores on their product labels
because it believes that consumers might mistake the ANC
rating as a measure of effectiveness in vivo. See 38 Fed.
Reg. 31264 (Nov. 12, 1973). However, under Rorer
manufacturers are permitted to categorize and label
antacids by comparative strengths. Rorer, 19 F.3d at 136.
3
J&J announced the introduction of "Mylanta Night Time
Strength" ("MNTS") in March 2000 and began shipping in
June. After its introduction, the two brands of antacids
were available in the following strengths:
MAALOX: MYLANTA:
Regular Strength Regular Strength
Extra Strength Extra Strength
Maximum Strength Night Time Strength
MNTS has more active ingredients per teaspoon than other
antacids. It has 500 milligrams of each of aluminum
hydroxide and magnesium hydroxide while Maximum
Strength Maalox has 500 milligrams of aluminum
hydroxide and 450 milligrams of magnesium hydroxide.
MNTS’s ANC rating is also higher than all other antacid
products. Its ANC rating is roughly 7% higher than
Maximum Strength Maalox and 25% higher than Extra
Strength Mylanta.1
In August 2000, J&J launched a national advertising
campaign in support of MNTS. In nationally disseminated
television commercials, J&J claimed that MNTS was"made
just for" nighttime heartburn, that it was "the strongest
antacid you can get," and that it was "something strong
enough to get rid of even your toughest nighttime
heartburn." The announcer then stated, "Go ahead, enjoy
your night," while the words "New Mylanta Nighttime"
appeared on the screen. The disclaimer "does not contain
sleep aid" also briefly appeared on the screen, allegedly in
letters that were minuscule relative to the size of the phrase
"The Strongest Antacid."
J&J disseminated other promotional materials as well. In
August 2000, J&J published a "free standing insert" print
advertisement in Sunday newspapers nationwide that
advertised MNTS as the "solution for heartburn at its
worst," and as having been "specially formulated for Night
Time heartburn." In small letters, the lower left-corner of
_________________________________________________________________
1. MNTS’s price is commensurately higher than that of Extra Strength
Mylanta (as indeed is Maalox Maximum Strength compared to its Extra
Strength antacid) though, as noted above, the duration of effective relief
in each product is essentially the same.

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4
the advertisement stated "does not contain a sleep aid."
J&J’s website purportedly boasted that MNTS "is the first
and only antacid formulated specifically to relieve your
toughest nighttime heartburn," and promised that the
product would deliver a restful night’s sleep because "you
may know you have to be up early the next day, but your
stomach doesn’t."
Shortly after the national advertising campaign began,
Novartis expressed its objections to J&J over the MNTS
name and the advertising claims made in the campaign. In
response, J&J decided to revise its television commercial
and website to eliminate many of the disputed claims. The
revised television commercial for MNTS pictured a woman
sitting down on a couch after dinner. The announcer
stated: "What a time for really tough heartburn. Good thing
there’s something just as tough." MNTS was then described
as "the strongest antacid you can get" that is"made strong
to work on even tough nighttime heartburn . . . fast." As
the commercial closed, the woman had her eyes closed and
her head tilted back on the sofa.
The revised website stated, "Do you experience your
heartburn at night? 76% of heartburn sufferers say they
do. If you do, here is great news for you! Introducing
MYLANTA Nighttime Strength. MYLANTA Nighttime
Strength begins neutralizing acid on contact. In fact, no
other antacid is faster or stronger. And MYLANTA does not
contain a sleep aid so you can sleep naturally at night.
MYLANTA Nighttime Strength works on even your tough
nighttime heartburn."
On October 31, 2000, Novartis filed a complaint pursuant
to section 43(a) of the Lanham Act, 15 U.S.C. S 1125(a),
and the New Jersey Consumer Fraud Act, N.J.S.A.S 56:8-1,
et seq., alleging that J&J’s advertisements regarding MNTS
and the name and packaging of the product itself are false
and misleading. On December 8, 2000, Novartis filed a
motion for a preliminary injunction pending the outcome of
its Lanham Act claims.2 In both its complaint and its
_________________________________________________________________
2. Novartis did not argue for a preliminary injunction pending the
outcome of its claims under the New Jersey Consumer Fraud Act. See
Novartis Consumer Health, Inc. v. Johnson & Johnson-Merck Consumer
Pharm. Co., 129 F. Supp. 2d 351, 355 n.2 (D.N.J. 2000).
5
motion for preliminary injunction, Novartis alleged that the
MNTS name and associated packaging and advertisements
were false because, inter alia, they communicated, either
explicitly or implicitly, the following false or misleading
claims:

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(1) MNTS is "specially formulated," and therefore
better than other antacids, at relieving night time
heartburn; and
(2) MNTS provides heartburn relief throughout the
night.
Novartis Consumer Health, Inc. v. Johnson & Johnson-Merck
Consumer Pharm. Co., 129 F. Supp. 2d 351, 358 (D.N.J.
2000).
Neither party requested discovery. The District Court held
oral argument on December 18 and 19, 2000. The Court
then issued an opinion and order on December 22, 2000,
granting Novartis’ motion and enjoining J&J from:"(1)
marketing and disseminating Mylanta Night Time Strength
under that name; (2) using the designation ‘Night Time’ or
‘Night Time Strength’ on any antacid product;[and] (3)
otherwise claiming, either explicitly or implicitly, in any
packaging, advertising, or other promotional materials, that
Mylanta Night Time Strength is specially formulated for
night time heartburn, provides all night relief, and/or
possesses a strength that correlates with its efficacy." 129
F. Supp. 2d at 369. The District Court further ordered that
Novartis post a security bond in the amount of $1,000,000
by December 29, 2000.3 Id. J&J filed a timely notice of
appeal.4
_________________________________________________________________
3. The bond amount was later increased to $9,180,000 by order of the
District Court entered on February 22, 2001.
4. Novartis urges us to conclude that the appeal is moot because, when
applying to this Court for an emergency stay of the preliminary
injunction, J&J unequivocally swore that it would have to abandon the
MNTS product line if the injunction remained in place for as much as six
weeks, a period that expired on February 2, 2001. By order entered on
January 22, 2001, a panel of this Court denied the stay because, inter
alia, it did not credit J&J’s assertion that it would suffer irreparable
harm before it could complete the appeal process. It would be
6
II. Discussion
We review the District Court’s ultimate decision to grant
a preliminary injunction for abuse of discretion. See, e.g.,
Sandoz Pharm. Corp. v. Richardson-Vicks, Inc., 902 F.2d
222, 226 (3d Cir. 1990). However, an injunction is"an
extraordinary remedy, which should be granted only in
limited circumstances." Instant Air Freight Co. v. C.F. Air
Freight, Inc., 882 F.2d 797, 800 (3d Cir. 1989). In exercising
its discretion, the District Court must be convinced that the
following factors favor granting preliminary relief: (1) the
likelihood that the moving party will succeed on the merits;
(2) the extent to which the moving party will suffer
irreparable harm without injunctive relief; (3) the extent to
which the nonmoving party will suffer irreparable harm if
the injunction is issued; and (4) the public interest. Clean

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Ocean Action v. York, 57 F.3d 328, 331 (3d Cir. 1995). The
District Court’s predicate findings of fact are reviewed for
clear error, and its conclusions of law receive plenary
review. Sandoz, 902 F.2d at 226.
On appeal, the parties have made arguments pertaining
to the District Court’s findings on all four factors above.
Additionally, J&J has argued that the injunction issued by
the District Court violates the First Amendment because it
is overbroad. We address first whether the District Court
properly found that Novartis would be likely to succeed on
the merits. We then turn to the Court’s findings regarding
irreparable harm, balancing of harms, and the public
interest. Finally, we focus on whether the injunction issued
is overbroad.
A. Likelihood of Success on the Merits
Novartis brought its underlying claim against J&J
pursuant to S 43(a) of the Lanham Act, which prohibits
_________________________________________________________________
inequitable now to find the appeal moot based on that estimation of
irreparable harm that had previously been rejected. We therefore decline
to apply a doctrine of judicial estoppel to find this appeal moot. See
SunAmerica Corp. v. Sun Life Assur. Co. of Canada , 77 F.3d 1325, 1332
(11th Cir. 1996) (declining to apply doctrine of judicial estoppel because
"the District Court was not fooled" by defendant’s representations in its
application for a stay of preliminary injunction).
7
false advertising in interstate commerce. Section 43(a)
provides in pertinent part:
(1) Any person who, on or in connection with any goods
or services, or any container for goods, uses in
commerce any word, term, name, symbol, or device, or
any combination thereof, or any false designation of
origin, false or misleading description of fact, or false or
misleading representation of fact which . . . (B) 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. S 1125(a). Liability arises if the commercial
message or statement is either (1) literally false or (2)
literally true or ambiguous, but has the tendency to deceive
consumers. Castrol Inc. v. Pennzoil Co., 987 F.2d 939, 943
(3d Cir. 1993) ("a plaintiff must prove either literal falsity or
consumer confusion, but not both") (emphasis in original).
We will address Novartis’ allegations under each theory.
1. Did J&J Disseminate Literally False Claims Re
"Mylanta Night Time Strength"?

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If a plaintiff proves that the challenged commercial claims
are "literally false," a court may grant relief without
considering whether the buying public was actually misled.
Rorer, 19 F.3d at 129. In analyzing whether an
advertisement or product name is literally false, a court
must determine, first, the unambiguous claims made by
the advertisement or product name, and second, whether
those claims are false. Clorox Co. v. Proctor & Gamble
Commercial Co., 228 F.3d 24, 34 (1st Cir. 2000). A "literally
false" message may be either explicit or "conveyed by
necessary implication when, considering the advertisement
in its entirety, the audience would recognize the claim as
readily as if it had been explicitly stated." Id. at 35.
Regardless, only an unambiguous message can be literally
false. "The greater the degree to which a message relies
upon the viewer or consumer to integrate its components
and draw the apparent conclusion, however, the less likely
8
it is that a finding of literal falsity will be supported." United
Indus. Corp. v. Clorox Co., 140 F.3d 1175, 1181 (8th Cir.
1998); see Warner-Lambert Co. v. BreathAsure, Inc., 204
F.3d 87, 96 (3d Cir. 2000); Castrol, 987 F.2d at 946; see
also Cuisinarts, Inc. v. Robot-Coupe Int’l Corp., 1982 WL
121559, at *2 (S.D.N.Y. June 9, 1982).
The District Court found that the MNTS product name
and/or advertising conveyed two messages that are literally
false by necessary implication: (1) that the MNTS product is
superior to other products in providing nighttime relief, 129
F. Supp. 2d at 360-61; and (2) that the product is specially
formulated for nighttime relief, id. at 364. We will discuss
each of these messages in turn after briefly reviewing the
cases where courts have found a false message necessarily
implied from a product’s name or advertisement.
The common theme in these cases is a finding, based on
a facial analysis of the product name or advertising, that
the consumer will unavoidably receive a false message from
the product’s name or advertising. When consumer
deception can be determined by examining the challenged
name or advertising on its face, the plaintiff is excused from
the burden of demonstrating actual deception through the
use of a consumer survey.
For example, in BreathAsure, the defendant claimed that
its capsules would freshen breath when swallowed, and
that they were more effective at freshening breath than
other products like gum, mints, and mouthwash because
the capsule would "[f]ight the problem at its source."
BreathAsure, 204 F.3d at 89. During the course of litigation
it became clear that the capsules had no effect on bad
breath because in fact bad breath originates in the mouth,
not in the stomach. See id. at 90. The District Court found
that the BreathAsure product claim was therefore
misleading because it "implie[d] assurance where there
[was] no basis for it," and we concurred. Id. at 96. In
addition, because "[t]he name [BreathAsure] falsely tells the

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consumer that he or she has assurance of fresher breath
. . .," id. at 97, we enjoined use of that name.
In Castrol, the defendant’s advertisements claimed that
motor oil viscosity breakdown leads to engine failure. The
9
advertising also claimed that the defendant’s brand of
motor oil outperformed any leading motor oil against
viscosity breakdown. We affirmed the District Court’s
conclusion that these two claims taken together necessarily
implied that "Pennzoil outperforms the other leading brands
with respect to protecting against engine failure, because it
outperforms them in protecting against viscosity
breakdown, the cause of engine failure." Castrol, 987 F.2d
at 947. Because this implied message of superior protection
against engine failure was false, the defendant, Pennzoil,
was permanently enjoined from using these challenged
advertisements. See id. at 948.
In Cuisinart, the defendant’s advertisement stated:
"Robot-Coupe: 21, Cuisinart: 0. WHEN ALL 21 OF THE
THREE-STAR RESTAURANTS IN FRANCE’S MICHELIN
GUIDE CHOOSE THE SAME PROFESSIONAL MODEL
FOOD PROCESSOR, SOMEBODY KNOWS THE SCORE-
SHOULDN’T YOU?" Cuisinart, 1982 WL 121559, at *2. The
District Court for the Southern District of New York found
that the advertisement necessarily implied a message that
both Robot-Coupe and Cuisinart built professional model
food processors and that restauranteurs presented with two
existing alternatives had chosen the Robot-Coupe model.
This implied message was false because Cuisinart did not
in fact make a professional model food processor. The
Court therefore issued a preliminary injunction prohibiting
the use of this advertisement. See id. at *2-3.
As noted already, the District Court here found that the
MNTS name and advertising necessarily imply a claim that
MNTS provides superior relief for nighttime heartburn. 129
F. Supp. 2d at 359-60. It provided the following reasons for
this determination:
While night time sufferers may indeed be likely to opt
for a higher strength antacid, the "Night Time
Strength" designation does more than simply promise
a "higher" strength; it claims that its strength
corresponds to effectiveness such that it can even
remedy night time heartburn, the symptoms of which
tend to be "severe" or "moderate."
Consistent with the label, the television commercial
promises that MNTS is "made strong to work on even
10
tough nighttime heartburn." J&J’s website also
provides that MNTS "works on even your tough

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nighttime heartburn." Despite the FDA conclusion that
the ANC rating might confuse the public, the MNTS
product name and advertising play upon and reinforce
the perception that greater strength provides relief for
more severe heartburn, which often can occur at night.
In other words, MNTS is named and advertised to
suggest that its strength gives it the ability to fight
greater heartburn. Therefore, J&J’s advertisements
necessarily imply a claim of superior relief.
Id. at 360.
In short, the District Court found that the MNTS name
and advertising would "play upon" and "reinforce"
consumer perceptions and "suggest" that its strength
correlates to greater efficacy. The very use of these verbs is
instructive. When a Court considers whether a product’s
name and advertising are misleading, it may examine
consumer survey evidence demonstrating that they"play
upon" or "reinforce" consumer perceptions, or otherwise
"suggest" false messages. By contrast, when a Court
considers whether a message is necessarily implied from
the product’s name and advertising, it must determine
whether the false message will necessarily and unavoidably
be received by the consumer.
In this case, consumers will only receive a message of
superior relief from the MNTS name and advertising if they
assume that a product that provides "Night Time" relief is
more effective than a product that provides "Extra
Strength" or "Maximum" relief. The MNTS name and
advertising alone do not require that this inference will be
made. The District Court therefore clearly erred in finding
that a message of superior efficacy is necessarily implied
from the MNTS name and advertising. Instead, Novartis
should have been required to prove through a consumer
survey that the name and advertising actually misled or
had a tendency to mislead consumers into believing that
the product provided nighttime heartburn relief superior to
any other product in the market.5
_________________________________________________________________
5. Because we hold that a message of superior relief is not necessarily
implied from the MNTS name and advertising, we need not address
11
Although the District Court erred in finding that a
message of superior efficacy is necessarily implied from the
MNTS name and advertising, it did not err when it found
that the MNTS name is literally false by necessary
implication because it conveys the unambiguous message
that the product is specially formulated to relieve nighttime
heartburn. The Court found that "the product name
Mylanta ‘Night Time Strength’ necessarily implies a false
message . . . that it possesses a quality that is particularly
efficacious for those suffering from heartburn at night." 129
F. Supp. 2d at 364. It reasoned as follows:

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Here, by naming its product "Night Time Strength,"
J&J maintains that its goal was to emphasize the
strength of the product, rather than its duration.
Clearly, the designations such as "regular,""extra," or
"maximum" would have sufficiently described the level
of strength of MNTS. The use of "nighttime," however,
is as Novartis points out, a temporal designation
communicating that the product is effective in
remedying "nighttime" heartburn. Cf. Bristol-Myers
Squibb Co. v. McNeil-P.P.C., Inc., 973 F.2d 1033, 1040-
41 (2d Cir. 1992) ("PM" designation immediately
conveys night time use). Indeed J&J admits that MNTS
is "targeted exclusively to the needs of nighttime
sufferers." Miller Decl., at P 17.
Id. We agree with the District Court that the term
"nighttime" conveys a different meaning than the terms
"regular," "extra," and "maximum." The latter terms
describe different degrees of strength and are descriptions
that are arguably supported by evidence of different ANC
ratings.6 By contrast, the "nighttime" designation describes
_________________________________________________________________
whether that message is a false one. Were we to have reached this issue,
however, we would have agreed with the District Court that a message
of superior relief is false. Declarations from experts in both Rorer and the
current litigation explain that a slightly higher ANC rating cannot
support a message of superior efficacy. See Castell Decl. PP 6-11;
Albrecht Decl. PP 10-11.
6. As we noted supra n.5, we do not mean to say that differences in ANC
rating can support claims of greater efficacy. From our holding in Rorer,
however, it appears that sufficient differences in ANC rating may support
a claim of greater strength, i.e., regular, extra, and maximum strengths.
Rorer, 19 F.3d at 136-37.
12
not a degree of strength, but rather a time when the
product will be effective. The phrase "nighttime strength"
therefore necessarily conveys a message that the MNTS
product is specially made to work at night. We cannot say
that the District Court’s finding to that effect is clearly
erroneous.
We also cannot say that the District Court clearly erred
in finding that this message is false. J&J argues that the
Court improperly shifted the burden of proof from Novartis
to J&J when considering this question. It points out that
the plaintiff, Novartis, "bears the burden of showing that a
challenged advertisement is false or misleading, not merely
that it is unsubstantiated by acceptable tests or other
proof." Sandoz, 902 F.2d at 228. While this is generally the
case, in Sandoz we specifically declined to answer "whether
completely unsubstantiated advertising claims violate the
Lanham Act absent proof that consumers are actually
misled by this lack of substantiation." Id. at 228 n.7
(emphasis in original). We explained that

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[i]n such a case, there is a plausible argument that the
claim is literally false because the advertiser has
absolutely no grounds for believing that its claim is
true. A Lanham Act plaintiff may be permitted to
presume that consumers expect advertisers to have at
least some semblance of support for their publicly-
disseminated claims. However, since that is not the
question before us, we do not decide whether a
completely unsubstantiated claim is per se false or
whether a Lanham Act plaintiff can presume that a
defendant must have some substantiation for its
advertising claims.
Id.
Today we decide what we left open in Sandoz. We hold
that, although the plaintiff normally has the burden to
demonstrate that the defendant’s advertising claim is false,
a court may find that a completely unsubstantiated
advertising claim by the defendant is per se false without
additional evidence from the plaintiff to that effect.
Here, the District Court observed that "J&J does not
argue or present any evidence to show that MNTS was
13
specifically formulated for night time heartburn or that its
product actually remedies heartburn at night more
effectively than heartburn during the daytime." 129 F.
Supp. 2d at 363. On appeal, J&J has not directed our
attention to any evidence in the record that was overlooked
by the District Court. We therefore conclude that the
message of special formulation for nighttime relief that is
necessarily implied from the MNTS name is a completely
unsubstantiated advertising claim, and that the District
Court did not clearly err by concluding that this claim is
per se false.
2. Did J&J Disseminate Misleading Claims Re"Mylanta
Night Time Strength"?
Absent a finding that an advertising claim is literally
false, a plaintiff may still allege a successful Lanham Act
cause of action by proving the following five elements by a
preponderance of evidence:
(1) that the defendant has made false or misleading
statements as to his own product [or another’s]; (2)
that there is actual deception or at least a tendency to
deceive a substantial portion of the intended audience;
(3) that the deception is material in that it is likely to
influence purchasing decisions; (4) that the advertised
goods traveled in interstate commerce; and (5) that
there is a likelihood of injury to the plaintiff in terms of
declining sales, loss of good will, etc.
Rorer, 19 F.3d at 129 (alteration in original). The burden,
as we pointed out already, rests with the plaintiff. Sandoz,

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902 F.2d at 228.
As noted above, we believe the District Court properly
concluded that Novartis is likely to succeed on the merits of
its Lanham Act claim because the MNTS name necessarily
implies the literally false message that the product is
specially formulated for nighttime use. Alternatively, we
would still affirm the determination that Novartis is likely to
succeed on the merits because we agree that Novartis will
likely be able to prove, through the use of a consumer
survey, that the MNTS name and label mislead consumers
into believing that the product provides all-night relief. See
Rorer, 19 F.3d at 129-30; Sandoz, 902 F.2d at 228-29.
14
The District Court gave significant weight to the results
of a consumer survey designed by Dr. Gerald L. Ford. See
129 F. Supp. 2d at 364-67. The Ford survey was conducted
in what is called a "double blind" fashion during which
both the respondents and the interviewers are unaware of
the purpose of the survey or its sponsor. According to Dr.
Ford, 432 respondents were split into two groups known as
"cells." The first cell was asked to focus on the MNTS
product line as it would likely appear in retail stores. The
second cell served as a control group that was asked to
focus on the Mylanta Extra Strength product. In the MNTS
cell, approximately 30% of the respondents expressed their
belief that MNTS provided relief that lasted the whole night.
By contrast, less than 5% of the respondents in the control
cell believed that Mylanta Extra Strength provides relief
that lasts all night. After netting out this "noise,"7 the
survey results indicated that a total of 25% of respondents
received a message that the MNTS product provides all-
night relief.
The District Court accepted this 25% figure as sufficient
proof that the MNTS product name "deceive[s] a substantial
portion of the intended audience." 129 F. Supp. 2d at 367.
Indeed, this figure is higher than others that have been
found sufficient to support a Lanham Act violation. See
Rorer, 19 F.3d at 129, 134 n.14 (assuming without deciding
that "[w]ith regard to what constitutes a substantial or
significant number of consumers who are misled[,] . . . 20%
would be sufficient"); see also Church & Dwight Co. v. S.C.
Johnson & Son, 873 F. Supp. 893, 911 (D.N.J. 1994)
(acknowledging that 21% to 34% would be sufficient);
McNeilab, Inc. v. Am. Home Prods. Corp., 501 F. Supp. 517,
525, 527 (S.D.N.Y. 1980) (holding that 23% was sufficient).
J&J argues that the survey results were not credible
because the survey contained leading or suggestive
questions.8 The evidentiary value of a survey depends on its
_________________________________________________________________
7. The responses of the control cell are called"noise." They represent the
percentage of people that would have found a message of "all-night
relief " irrespective of the labeling claim.

-- 12 of 27 --

8. The Ford survey contained, in part, the following questions:
15
underlying objectivity as determined through many factors,
such as "whether [the survey] is properly‘filtered’ to screen
out those who got no message from the advertisement,
whether the questions are directed to the real issues, and
whether the questions are leading or suggestive." Johnson
& Johnson-Merck Consumer Pharm. Co. v. SmithKline
Beecham Corp., 960 F.2d 294, 300 (2d Cir. 1992). A survey
is "not credible if it relies on leading questions which are
‘inherently suggestive and invite guessing by those who did
not get any clear message at all.’ " Rorer , 19 F.3d at 134.
Dr. Ford’s declaration states that the survey is objective
because a full filter question was used (Q7.0) that asked:
"[B]ased just upon your review, does the labeling on this
product communicate anything . . . about how long this
product will provide relief?" He declares that"[o]nly
_________________________________________________________________
Q6.0: Based just upon your view, what is the main message
communicated by the labeling on this product?
Q6.1: (asked only if "yes" to question Q6.0): What other messages,
if any, are communicated by the labeling on this product?
Q6.2: What other messages, if any, are communicated by the
labeling on this product? (same as question Q6.1)
Q7.0: Again, based just upon your review, does the labeling on this
product communicate anything to you about how long this
product will provide relief?
Q7.1 (asked only if "yes" to question Q7.0): What does the labeling
communicate to you with regard to how long this product will
provide relief?
Q7.2: Why do you say that?
Q7.3: Again, based just on your review, does the labeling on this
product communicate anything to you about how long, in
hours, this product will provide relief?
Q7.4 (asked only if "yes" to question Q7.3): What does the labeling
communicate to you with regard to how long, in hours, this
product will provide relief? Why do you say that?
Q7.5: Why do you say that?
129 F. Supp. 2d at 365.
16
respondents who received such a message were asked
follow-up questions to determine precisely what message
about duration they received." The follow-up questions were

-- 13 of 27 --

therefore, in his view, not misleading.
However, J&J argues that the Ford survey is improper
because the filter question itself was suggestive and
misleading. It maintains that the survey presented
respondents with a leading question about the product’s
duration of relief when the subject’s responses to the first
three questions (Q6.0, Q6.1, Q6.2) demonstrated that they
had been left with no impression about how long the
product would work. In short, J&J is arguing that the
filtering was applied too late, and should have occurred
after Q6.2, not after Q7.0.
In Rorer, we affirmed the District Court’s decision to
ignore survey results that "suffered from repetitive and
leading questions and no filter mechanism." 19 F.3d at 135
(internal quotations omitted). The questions asked in that
survey were as follows:
2a. What ideas did the advertiser try to get across
about Maalox tablets in the commercial?
2b. What other ideas did they try to get across?
2c. What did they show in this commercial about
Maalox tablets? What else? Anything else?
3a. In the commercial you just saw, they said Maalox
tablets are the strongest. What does that mean to
you?
3b. What is the commercial saying that Maalox
tablets are strongest at doing?
5a. The commercial you just saw contained the
statement, "Your doctor will tell you they’re the
strongest," referring to Maalox tablets. What does
that statement mean to you?
Id. at 133 n.12. The District Court rejected results from
questions 3a, 3b and 5a for the following reasons:
The first "communication" questions [2a, 2b and 2c]
were most probative. For the second series of
17
questions, the survey failed to filter out those
respondents who recorded a message of superiority on
first viewing. By flagging Rorer’s "strongest claim" ("in
the commercial you just saw, they said Maalox is the
strongest antacid there is. What does that mean to
you?"), the "comprehension" question colored the
answers. The next questions9 . . . were even more
suggestive. By asking what ESMP [Extra Strength
Maalox Plus] was strongest at doing, they called for the
answer "relief." The technique of punctuating open-
ended questions with repeated probes is questionable
but did not discredit the responses to questions (2a),

-- 14 of 27 --

(2b), and (2c).
Id. at 135. Thus, the District Court found that 2a, 2b, and
2c were not leading questions, but 3a, 3b and 5a were
leading because a proper filter had not been applied to
"screen out those respondents who recorded a message of
superiority on first viewing." The comprehension question
that should have served as a filter (question 3a) was itself
a leading question.
We believe the filter in this case is qualitatively different
from the one in Rorer. In Rorer, the comprehension
question asked: "In the commercial you just saw, they said
Maalox tablets are the strongest. What does that mean to
you?" It was clearly flagging for the attention of the survey
respondent the specific message in the commercial that the
plaintiff alleged to be misleading (namely, that Maalox
tablets are the strongest) and leading the respondent to
answer that strength means something other than what it
says. Respondents then answered that the strongest tablets
would provide good relief or better relief, which is not true
because strength does not correlate to efficacy. The
respondents were led to convey that they had received this
message of efficacy because, had they responded that
"strongest means strongest" (the only answer that would
_________________________________________________________________
9. Although the District Court referred to these"next questions" as "(3a)
in the ‘Minty Tablets’ survey and (4) in the‘Firefighter’ survey," we
believe that it meant to say (3b), not (3a), in the Minty Tablets survey.
The Court was referring to the question that asked what Extra Strength
Maalox Plus was strongest at doing, which was question (3b).
18
have been true), they would have believed that they were
being unresponsive to the question.
By contrast, the comprehension question in the Ford
survey (Q7.0) asked generally whether the product label
communicated anything about how long the product would
provide relief. It did not ask respondents to focus on the
MNTS name before answering this question. Moreover, it
did not lead them to respond that the product provides all-
night relief. Although the question prompted respondents to
comment on duration of relief, the respondents were free to
say that the label communicated that the product provides
fast-acting, short-term relief. To do so would not have been
unresponsive to the question. The District Court therefore
did not abuse its discretion by concluding that the Ford
survey met a proper filter question threshold and could be
accorded significant weight. Rorer, 19 F.3d at 134 ("the
probative value of a consumer survey is a highly fact-
specific determination and a court may place such weight
on survey evidence as it deems appropriate"); see also
Havana Club Holding, S.A. v. Galleon S.A., 203 F.3d 116,
131 (2d Cir. 2000) ("A district court has broad discretion
concerning the weight of particular evidence, including
consumer surveys such as those proffered here . . . ."), cert.

-- 15 of 27 --

denied, 531 U.S. 918 (2000).10
In addition to challenging the objectivity of the Ford
survey, J&J disputes the District Court’s use of its results.
J&J argues that the District Court’s finding can only be
supported by respondents who answered that the product
name implied that there was all-night relief. However, only
questions Q8.0, Q8.1, and Q8.211 ask the respondent to
_________________________________________________________________
10. After rejecting J&J’s argument that the survey was improper because
it lacked proper filtering questions, the District Court stated that, in any
event, any "bias that may have resulted from any leading questions was
eliminated by the use of the control group." 129 F. Supp. 2d at 365
(citing Volkswagen Aktiengesellschaft v. Uptown Motors, No. 91 Civ. 3447
(DLC), 1995 WL 605605, at *4 (S.D.N.Y. May 11, 1995)). We refrain from
adopting this position because we are uncertain whether the effects of
asking leading questions without proper filtering may be greater on the
MNTS test cell than the control cell.
11. Questions Q8.0, Q8.1, and Q8.2 of the Ford Survey read as follows:
19
evaluate the product name, whereas questions Q6.0
through Q7.5 ask the respondent to evaluate the product’s
label. Taking only the answers to questions Q8.0 through
Q8.2 into account, less than 5% of respondents indicated
that the product name communicates a message of all-
night relief.
Nevertheless, we agree with Novartis that excluding all
answers to questions Q6.0 through Q7.5 is too restrictive.
Counting responses to all survey questions, 60% of the
persons finding an ‘all night’ message referred to the name.
It has already been established that 25% of respondents
reported that they had received a message of all-night relief.
If 60% of those respondents referenced the product name in
their answers, it is fair to conclude that at least 15% of the
total number of respondents (60% of 25% = 15%) derived a
message of all-night relief from the product name, not the
entire product label.
Assuming arguendo that only 15% of respondents
received a message of all-night relief from the MNTS name,
we need not vacate the injunction. Relying upon Coca-Cola
Co. v. Tropicana Prods., Inc., 690 F.2d 312, 317 (2d Cir.
1982), the District Court observed that even a 15.5% figure
would be sufficient to demonstrate a likelihood of
substantial consumer confusion.12 129 F. Supp. 2d at 367.
In Coca-Cola the consumer survey evidence demonstrated
only 7.5% consumer deception. Coca-Cola Co. v. Tropicana
Prods., Inc., 538 F. Supp. 1091, 1096 (S.D.N.Y.), rev’d, 690
F.2d 312 (2d Cir. 1982). There, the District Court denied
_________________________________________________________________
Q8.0: Again, based upon your review, does the name on this
product communicate anything to you about the product?

-- 16 of 27 --

Q8.1: (asked only if "yes" to question Q8.0): What does the name
on this product communicate to you about the product?
Q8.2: Why do you say that?
12. Although the 15.5% figure that the District Court considered was
proferred by J&J under a different rationale than the one used on
appeal, the District Court did find that 15.5% would be sufficient to
support a finding of substantial consumer confusion. 129 F. Supp. 2d at
367.
20
the injunction sought by the plaintiff because, inter alia, "a
level of consumer confusion significantly below 15% does
not indicate plaintiff ’s probable success on the merits." Id.
On appeal, the Second Circuit reversed, finding that"a
significant number of consumers would be likely to be
misled." Coca-Cola, 690 F.2d at 317. 13
In an analogous context involving trademark cases under
the Lanham Act, courts have held that survey evidence of
15% confusion is sufficient to demonstrate actual
confusion. See Sara Lee Corp. v. Kayser-Roth Corp., 81 F.3d
455, 466-67 & n.15 (4th Cir. 1996) (15-20% confusion was
sufficient to establish "actual confusion . . . to a significant
degree"); Goya Foods, Inc. v. Condal Distribs., Inc., 732 F.
Supp. 453, 457 n.7 (S.D.N.Y. 1990) (9-10% confusion was
sufficient to demonstrate "meaningful evidence of actual
confusion"). Likewise we believe that survey evidence
demonstrating that 15% of the respondents were misled by
the MNTS name is sufficient to establish the "actual
deception or at least a tendency to deceive a substantial
portion of the intended audience," Rorer, 19 F.3d at 129,
necessary to establish a Lanham Act claim for false or
misleading advertising under section 43(a). The District
Court therefore did not clearly err when it found that
Novartis would likely be able to establish this element of its
Lanham Act claim.
To summarize, we affirm the District Court’s conclusion
that Novartis would likely be able to succeed on the merits.
Novartis will likely be able to prove that the MNTS name
necessarily implies a false message that the product is
specially formulated for nighttime relief, or alternatively
that the MNTS name and label mislead a substantial
portion of consumers to believe that the product provides
all-night relief.
_________________________________________________________________
13. Although the Second Circuit’s holding was made before Federal Rule
of Civil Procedure 52(a) was amended to provide that a district court’s
findings of fact cannot be set aside unless clearly erroneous, its holding
nevertheless supports the view that a 7.5% figure could sustain a finding
of substantial consumer confusion.
21

-- 17 of 27 --

B. Irreparable Harm, Balance of Harms, and the Public
Interest
Before granting a preliminary injunction, a district court
must consider the extent to which the moving party will
suffer irreparable harm without injunctive relief. Clean
Ocean, 57 F.3d at 331. Here, the District Court found that
Novartis would likely suffer irreparable harm if a
preliminary injunction did not issue. See 129 F. Supp. 2d
at 367-68. The Court further concluded that the balance of
harms and the public interest weighed in favor of issuing
the injunction. See id. at 368-69. J&J objects to each of
these findings. All are reviewed for clear error, and the
ultimate decision to grant the injunction is reviewed for
abuse of discretion. See Sandoz, 902 F.2d at 226.
J&J argues that the District Court applied the wrong
standard when evaluating whether Novartis had
demonstrated irreparable injury. The District Court stated
that "although the plaintiff need not come forward with
specific evidence that the challenged claims actually
resulted in some definite loss of sales, the plaintiff must
establish that it has a reasonable basis for believing that it
is likely to suffer injury as a result of the false advertising."
129 F. Supp. 2d at 367 (citing Johnson & Johnson v.
Carter-Wallace, Inc., 631 F.2d 186, 190 (2d Cir. 1980), and
BreathAsure, 204 F.3d at 95-96). J&J argues that whether
the plaintiff has a "reasonable basis for believing that it is
likely to suffer injury" is the standard for determining
whether the plaintiff has standing to bring a false
advertising claim seeking, as an ultimate remedy, that a
permanent injunction be imposed against the defendant. It
maintains that to satisfy the irreparable injury requirement
for obtaining a preliminary injunction, Novartis was
required to satisfy the additional burden of demonstrating
"potential harm which cannot be redressed by a legal or an
equitable remedy following a trial." Instant Air Freight, 882
F.2d at 801.
We agree that the cases relied upon by the District Court,
Carter-Wallace and BreathAsure, discussed the standing
requirement for a Lanham Act claim rather than the
irreparable injury requirement for obtaining a preliminary
injunction. Carter-Wallace, 631 F.2d at 190; BreathAsure,
22
204 F.3d at 95-96. In those cases, we reviewed district
court decisions denying and granting, respectively,
permanent injunctions after bench trials on the merits. See
Carter-Wallace, 631 F.2d at 187-88; BreathAsure, 204 F.3d
at 90-91. In both, we concluded that, as a matter of
standing and as a substantive element of a Lanham Act
violation, the plaintiff must demonstrate "a reasonable
basis for the belief that the plaintiff is likely to be damaged
as a result of the false advertising." Carter-Wallace, 631
F.2d at 189-90; accord BreathAsure, 204 F.3d at 93. Carter-
Wallace and BreathAsure did not discuss, however, the
standard for evaluating whether a plaintiff seeking a

-- 18 of 27 --

preliminary injunction will suffer irreparable harm if the
injunction is not issued. We agree that this standard -- i.e.,
potential harm that cannot be redressed following trial --
differs from the standing requirement and injury element
for a Lanham Act claim -- i.e., a reasonable basis for
believing that a plaintiff is likely to suffer injury.
Nonetheless, we conclude that the District Court’s error
in citing the wrong standard was harmless because there is
sufficient evidence in the record to support a finding of
irreparable harm necessary to issue a preliminary
injunction. The District Court observed that the promotion
and sale of MNTS had already had a measurable effect on
Maalox’s market share as reflected by a decrease in sales of
Maalox that corresponds to the increased sales for MNTS.
129 F. Supp. 2d at 369. We are satisfied that this loss of
market share constitutes irreparable harm. See Moltan Co.
v. Eagle-Picher Indus., Inc., 55 F.3d 1171, 1175 (6th Cir.
1995) (affirming decision to grant preliminary injunction
where manufacturer’s false claims were causing irreparable
injury to a competitor in the form of lost sales and market
share); Cordis Corp. v. Medtronic, Inc., 835 F.2d 859, 864
(Fed. Cir. 1987) ("a loss in market share caused by an
injunction could result in irreparable harm"); see also
Pappan Enters., Inc. v. Hardee’s Food Sys., Inc., 143 F. 3d
800, 805 (3d Cir. 1998) ("Grounds for irreparable injury
include loss of control of reputation, loss of trade, and loss
of goodwill."); Opticians Ass’n v. Indep. Opticians, 920 F.2d
187, 195 (3d Cir. 1990) (same). In a competitive industry
where consumers are brand-loyal, we believe that loss of
market share is a "potential harm which cannot be
23
redressed by a legal or an equitable remedy following a
trial." Instant Air Freight, 882 F.2d at 801.
Before granting an injunction, a district court must
balance the relative harm to the parties, i.e. , the potential
injury to the plaintiff if an injunction does not issue versus
the potential injury to the defendant if the injunction is
issued. Sandoz, 902 F.2d at 226. In this case, the Court
concluded that the balance of harms favored issuing the
injunction. 129 F. Supp. 2d at 368-69. We agree.
J&J argued before the District Court that it would suffer
substantial injury if a preliminary injunction were to issue
because, after a certain period of time, it would be unable
to relaunch the MNTS product. It maintains that if that
were to occur it would lose the value of its substantial
investment and goodwill in the MNTS product name.
The District Court discounted J&J’s claims of potential
injury, in part because "any financial loss that will be
suffered by J&J as a result of its decision to name its
product ‘Night Time Strength’ is self-imposed." 129 F.
Supp. 2d at 369. We reject J&J’s assertion that it was error
for the Court to have done so. As we have previously ruled,
the injury a defendant might suffer if an injunction were

-- 19 of 27 --

imposed may be discounted by the fact that the defendant
brought that injury upon itself. See Pappan, 143 F.3d at
806 ("The self-inflicted nature of any harm suffered by [the
party opposing the injunction] also weighs in favor of
granting preliminary injunctive relief."); Opticians Ass’n,
920 F.2d at 197 ("By virtue of this recalcitrant behavior, the
[party opposing the injunction] can hardly claim to be
harmed, since it brought any and all difficulties occasioned
by the issuance of an injunction upon itself.").
Moreover, we disagree with J&J’s assertion that the
potential harm to it from losing the MNTS product line if
the injunction were issued outweighs the potential harm to
Novartis from losing market share if the injunction were not
issued. A case relied upon by J&J, Genovese Drug Stores,
Inc. v. TGC Stores, Inc., 939 F. Supp. 340, 350-51 (D.N.J.
1996), does not persuade us otherwise. There, the District
Court was persuaded that an injunction would have put
the defendant out of business by forcing it to change the
24
name of its two, new health care stores. It noted that "if
defendant were forced to preliminarily change its name and
then succeed in this lawsuit, it would be economically
unsound and, most likely, financially unfeasible for
defendant to return to its original name." Id. at 350-51. The
Court found that "[s]uch harm is irreparable, and more
devastating than the possibility of harm to plaintiff ’s
reputation and good will [if the injunction did not issue]."
Id. Because of this, and because the plaintiff had failed to
demonstrate a likelihood of success on the merits, the
Court denied injunctive relief.
By contrast, the preliminary injunction issued against
J&J does not require that it abandon its entire brand name.14
The preliminary injunction also does not require J&J to
abandon its product name forever; it only requires that the
company cease shipping the MNTS product under that
name until the end of litigation on the merits. If the District
Court rules for J&J on the merits, shipping the MNTS
product currently in inventory may continue. Like the
District Court, we are not persuaded by J&J’s assertion
that it would be unable to relaunch the product under the
MNTS name after a short period of time. See discussion
supra n.4. Moreover, the injunction does not prohibit J&J
from shipping the product currently in inventory under a
different name, label, and advertising that is not literally
false and/or misleading, such as "Maximum Strength
Mylanta." Finally, we observe that, unlike the plaintiff in
Genovese, Novartis has demonstrated a likelihood of
success on the merits. As other circuit courts have
observed, "[t]he more likely the plaintiff is to win, the less
heavily need the balance of harms weigh in his favor."
NLRB v. Electro-Voice, Inc., 83 F.3d 1559, 1568 (7th Cir.
1996); accord Abbott Labs. v. Mead Johnson & Co. , 971
F.2d 6, 12 (7th Cir. 1992). We therefore agree that the
_________________________________________________________________

-- 20 of 27 --

14. We think it fair to say that, even if J&J were to lose its entire
investment in the MNTS product line to date (estimated at approximately
$9 million based on the bond amount imposed by the District Court,
discussed supra n.3), it would not, as one of the largest companies in
America, go out of business. See "Fortune 500 list" (Apr. 15, 2002),
available at http://www.fortune.com/lists/F500/index.html (listing J&J
47th on the Fortune 500 list).
25
balance of harms weighs in favor of granting the
preliminary injunction.
Finally, we find no error in the District Court’s finding
that the public interest favors issuing the injunction. 129 F.
Supp. 2d at 369. We agree with those district courts that
have found that "[t]here is a strong public interest in the
prevention of misleading advertisements, and this interest
is particularly strong where over-the-counter drugs are
concerned." American Home Prods. Corp. v. Johnson &
Johnson, 654 F. Supp. 568, 590 (S.D.N.Y. 1987) (citing
Upjohn Co. v. American Home Prods. Corp., 598 F. Supp.
550, 557 (S.D.N.Y. 1984)); accord Church & Dwight, 873 F.
Supp. at 912; W.L. Gore & Assoc., Inc. v. Totes, Inc., 788 F.
Supp. 800, 814 (D. Del. 1992). Moreover, we believe that
where the plaintiff has demonstrated a likelihood of success
on the merits, the public interest leans even more toward
granting the injunction.
All told, the District Court did not clearly err when it
found that Novartis would suffer irreparable harm if the
injunction were not issued, and the equities, including the
balance of harms and the public interest, weigh in favor of
granting the preliminary injunction. Because we are also
affirming the District Court’s finding that Novartis will likely
be able to succeed on the merits of its Lanham Act claim,
we find no abuse of discretion in the Court’s decision to
grant a preliminary injunction pending the outcome of a
trial on the merits.
C. Is The Injunction Overbroad?
J&J argues that the preliminary injunction imposed by
the District Court violates the First Amendment because it
enjoins all use of the MNTS name instead of ordering as a
narrower remedy that a disclaimer be added to the label
explaining that the product provides only short-term relief.15
_________________________________________________________________
15. Novartis argues that the issue of overbreadth is waived because
plaintiff failed to raise it before the District Court. We disagree. The
cases relied upon by Novartis held that a plaintiff ’s claim that the
defendant had violated his First Amendment rights was waived on
appeal when it was not presented properly to the District Court in the
first instance. See Hopkins v. Saunders, 199 F.3d 968, 974 (8th Cir.
26

-- 21 of 27 --

It is true that injunctive relief should be "no more
burdensome to the defendant than necessary to provide
complete relief to plaintiffs." Califano v. Yamasaki, 442 U.S.
682, 702 (1979); accord Ameron, Inc. v. U.S. Army Corps of
Eng’rs, 787 F.2d 875, 887-88 (3d Cir. 1986), adopted in
part on reh’g by 809 F.2d 979, 981 (1987). Moreover,
because commercial speech is entitled to appropriate
protection under the First Amendment, an injunction
restraining allegedly false or misleading speech must be
narrowly tailored to "cover only the speech most likely to
deceive consumers and harm [the plaintiff]." ALPO
PetFoods, Inc. v. Ralston Purina Co., 913 F.2d 958, 972
(D.C. Cir. 1990); see also Mobius Mgmt. Sys., Inc. v. Fourth
Dimension Software, Inc., 880 F. Supp. 1005, 1024-25
(S.D.N.Y. 1994).
The preliminary injunction in this case prohibits J&J
from: "(1) marketing and disseminating Mylanta Night Time
Strength under that name; (2) using the designation‘Night
Time’ or ‘Night Time Strength’ on any antacid product;
[and] (3) otherwise claiming, either explicitly or implicitly, in
any packaging, advertising, or other promotional materials,
that Mylanta Night Time Strength is specifically formulated
for night time heartburn, provides all-night relief, and/or
possesses a strength that correlates with its efficacy." 129
F. Supp. 2d at 369. We think this injunction is not
overbroad, for it only reaches claims that are false. See
Castrol, 987 F.2d at 949 (injunction was "not overbroad
because it only reache[d] the specific claims that the
district court found to be literally false").
The District Court concluded, and we agree, that Novartis
will likely prove that the MNTS name, inter alia , necessarily
implies a false message that the product is specially
_________________________________________________________________
1999), cert. denied, 531 U.S. 873 (2000); Ferrill v. Parker Group, Inc., 168
F.3d 468, 475 (11th Cir. 1999); Moulton v. Vigo County, 150 F.3d 801,
803 (7th Cir. 1998). This situation is distinguished from the current case
where the defendant is arguing that an injunction issued by the District
Court violates the First Amendment because it is overbroad. J&J
correctly points out that the first real opportunity to comment on the
overbreadth of an injunction issued by the District Court is on direct
appeal to this Court.
27
formulated for nighttime relief. We do not believe that a
disclaimer can rectify a product name that necessarily
conveys a false message to the consumer. The Court
therefore did not violate the First Amendment by
prohibiting J&J from using the MNTS designation.
However, the injunction does more than prohibit the use
of the MNTS name. It also prohibits J&J from "otherwise
claiming" in its packaging, advertising, or promotional
materials that MNTS is specially formulated for nighttime
heartburn, provides all-night relief, or possesses a strength
that correlates with greater efficacy. We conclude that the

-- 22 of 27 --

injunction does not violate the First Amendment in doing so
because each of these messages is false. As discussed
above, the message that MNTS is specially formulated for
nighttime heartburn is false. Moreover, J&J does not
dispute that a message of all-night relief would be false. It
merely argues that this message is not received from the
product’s name. Finally, it is well settled that a product’s
strength, as demonstrated in vitro, does not correlate to
greater efficacy at relieving symptoms in the body. See
Rorer, 19 F.3d at 128. Because each of these messages is
false, the injunction may outright prohibit J&J from
making them, either explicitly or implicitly, in its
packaging, advertising, or promotional materials.
We note that had we limited our holding to affirm only
the District Court’s finding that the MNTS product name is
misleading (and not literally false or necessarily implying
any false message), the issue of whether the injunction
could prohibit all use of that product name, as opposed to
requiring a disclaimer, would have been a closer question.
At one time the Second Circuit held that "[d]isclaimers are
a favored way of alleviating consumer confusion."
Consumers Union of United States, Inc. v. Gen. Signal Corp.,
724 F.2d 1044, 1053 (2d Cir. 1983). It did so because it
observed that "[a]bsolute prohibitions of speech as provided
for in the instant preliminary injunction are improper
where there is any possibility that an explanation or
disclaimer will suffice." Id. The Second Circuit has since
retreated from the position taken in Consumers Union and
shifted the burden to the defendant to demonstrate that a
disclaimer would suffice to protect consumers. See Home
28
Box Office, Inc. v. Showtime/The Movie Channel Inc. , 832
F.2d 1311, 1316 (2d Cir. 1987); Charles of the Ritz Group
Ltd. v. Quality King Distrib., Inc., 832 F.2d 1317, 1324 (2d
Cir. 1987) ("In [Home Box Office], this court considered and
rejected appellants’ claim that disclaimers are a favored
way of alleviating substantial consumer confusion."). Even
so, the District Court’s "determination of whether to grant
relief in the form of an absolute injunction or through the
use of a disclaimer will not be disturbed on appeal . . .
unless there has been an abuse of discretion." Soltex
Polymer Corp. v. Fortex Indus., Inc., 832 F.2d 1325, 1329-
1330 (2d Cir. 1987).
Likewise, we believe that district courts should consider
ordering the narrowest remedy possible to protect the
public from misleading product names or advertising. This
may include using disclaimers rather than absolute
prohibitions on speech. Although we are skeptical whether
disclaimers can cure false advertising claims (made literally
or by necessary implication), they may be able to dispel
misleading messages implied by a product’s name. If a
district court is not persuaded that the defendant’s
proposed disclaimer would protect consumers fully, it may
take the more significant measure of entering a complete
prohibition on false speech.

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III. Conclusion
To summarize our holding, we conclude that the District
Court did not abuse its discretion by preliminarily enjoining
J&J, pending the outcome of a trial on the merits, from
marketing and distributing the MNTS product under that
name and from otherwise claiming that the product is
specifically formulated to relieve nighttime heartburn,
provides all-night relief, or possesses a strength that
correlates with greater efficacy. We affirm the Court’s
finding that Novartis will likely succeed on the merits of its
Lanham Act claims. Although we do not agree that the
MNTS name and advertising necessarily imply a message of
superior efficacy, we affirm the Court’s rulings that (1) the
MNTS name necessarily implies a false message of special
formulation for nighttime relief and that (2) the MNTS name
and label mislead a substantial portion of consumers to
29
believe that the product provides all-night relief. We also
affirm the Court’s findings that Novartis is likely to suffer
irreparable harm, and that the balancing of harms and the
public interest favor issuing the preliminary injunction.
Finally, we conclude that the injunction is not overbroad
because it merely prohibits J&J from disseminating false
speech. We therefore affirm the judgment of the District
Court.
30
BRIGHT, Circuit Judge, dissenting:
In its decision today, the majority creates a new rule that
allows a district court to conclude that a completely
unsubstantiated advertising claim can be per se false,
despite the fact that, under FDA regulations, no antacid
manufacturer can substantiate its efficacy claims in any
meaningful way. I believe that the majority goes too far
when it states that, as a matter of law, "Night Time
Strength" necessarily conveys a claim of special formulation
for nighttime relief that implies falsity. I reject the claim of
false advertising against Johnson & Johnson-Merck. I
therefore dissent.
The Food and Drug Administration’s regulations
recognize that greater strength does not mean greater
effectiveness. FDA rules prohibit any antacid manufacturer
from claiming that its product is more effective than
another antacid at relieving the symptoms of heartburn.
However, under FDA regulations and Johnson & Johnson-
Merck Consumer Pharms. Co. v. Rhone-Poulenc Rorer
Pharms., 19 F.3d 125, 127-28 (3rd Cir. 1994), antacid
manufacturers can rely on differences in ANC ratings to
support claims of greater strength. As a result, the antacid
industry has the "unfortunately common" advertising
practice of touting ANC ratings, promising symptom relief,

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and inviting consumers to correlate strength with effective
relief. Rorer, 19 F.3d at 132. This may fool the consumer,
but it is permissible advertising.
The makers of Mylanta Night Time Strength targeted
consumers’ concerns about relief of nighttime heartburn.
Mylanta gave its product a clever name and stated that the
product works at night. This is not false. MNTS does work
at night and provides relief. Indeed, all the antacid products
of both companies work in the morning, at noon, and at
night.
The majority’s factual and legal examination of the name1
Mylanta Night Time Strength tracks the following logic: (1)
_________________________________________________________________
1. It is important to note that the majority’s holding focuses solely on the
name of the product, not the advertising. The falsity is, therefore, derived
entirely from the name, Mylanta Night Time Strength.
31
because the "nighttime" designation describes a time2 when
the product will be effective, the phrase "nighttime
strength" necessarily conveys a message that MNTS is
specially formulated to work at night; (2) it is completely
unsubstantiated that MNTS is specially formulated to work
at night; (3) therefore, the message conveyed by the"Night
Time" designation is per se false.
The majority’s first premise is flawed. The majority claims
that the phrase "Night Time Strength" necessarily and
unavoidably conveys the message that the product is
specially formulated to work at night. Despite the majority’s
best efforts to the contrary, this message is not
unambiguously conveyed. MNTS’s name may suggest that
the product is specially formulated for nighttime heartburn,
but the words "Night Time" no more necessarily imply
special formulation for nighttime relief than the words
"Extra Strength" necessarily imply special formulation for
greater effectiveness. Both phrases are suggestive and
neither are literally false, see United Indus. Corp. v. The
Clorox Co., 140 F.3d 1175, 1181 (8th Cir. 1998) (a merely
suggestive conclusion "relies upon the viewer or consumer
to integrate its components"), but the majority characterizes
the former implication as necessary, but the latter merely
suggestive.
The majority recognized this difficulty when it rejected
the district court’s finding that the name MNTS necessarily
implies a message of superior efficacy:
In this case, consumers will only receive a message of
superior relief from the MNTS name and advertising if
they assume that a product that provides "Night Time"
relief is more effective than a product that provides
"Extra Strength" or "Maximum" relief. The MNTS name
and advertising alone do not require that this inference
will be made.

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Maj. Op. at 11. The same logic applies to the message of
special formulation; consumers will only receive a message
that MNTS is specially made for heartburn if they assume
_________________________________________________________________
2. The district court refers to the adjective"nighttime" as conveying "a
temporal designation."
32
that the name "Night Time" indicates how the product is
chemically composed.
Furthermore, in its oral argument to the district court,
Novartis recognized there were "four possible
communications" that the name Mylanta Night Time
Strength could convey.3 If the plaintiff can identify four
distinct messages in the name, how can the majority
conclude there is only one inescapable message? J&J also
points out that none of the respondents in Novartis’s
consumer survey identified the "unambiguous" message
that MNTS was specially formulated to work at night. Only
the district court was able to discern this message. As the
Second Circuit has noted, "It is not for the judge to
determine, based solely upon his or her own intuitive
reaction, whether the advertisement is deceptive. Rather, as
we have reiterated in the past, ’[t]he question in such cases
is - what does the person to whom the advertisement is
addressed find to be the message?’" Johnson & Johnson-
Merck Consumer Pharms. Co. v. SmithKline Beecham Corp.,
960 F.2d 294, 297-98 (2d Cir. 1992) (emphasis in original)
(citations omitted).
As an alternative holding, the majority contends that
Novartis is likely to succeed on the merits because it will be
able to prove, through use of a consumer survey, that the
MNTS name and advertising mislead consumers into
believing that the product provides all-night relief. I
disagree.
An injunction is an "extraordinary remedy" and the hotly
contested results of the consumer survey do not provide the
requisite likelihood that Novartis will succeed on the merits.
The Ford Survey contained only three truly open-ended
questions, which resulted in about seven percent of
respondents stating that the MNTS label conveys anything
about all-night relief. The next series of questions relied on
a leading question: "how long" the product would provide
relief. Such questions are "inherently suggestive and invite
_________________________________________________________________
3. The four communications the name could convey are: (1) that it lasts
all night; (2) that it is specially formulated; (3) that it is the most
effective; or (4) that it is a sleep aid. Novartis refers to these options as
"the universe of necessary implications." App. at A66-68.
33

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guessing by those who did not get any clear message at all"
and surveys that rely on them are not credible. Rorer, 19
F.3d at 134.
J&J argues that the suggestiveness of the questions is
borne out by the fact that when the survey questions
directed the consumer’s attention to the name, Mylanta
Night Time Strength, and asked if the name communicated
anything, less than five percent responded that the name
communicated that the product lasts all night or
"overnight."
The consumer survey results indicate, at most, borderline
levels of consumer confusion. They do not support the
district court’s decision to implement a sweeping injunction
against MNTS.
Finally, I believe that the public interest concerns
expressed by the majority and the district court are entirely
misplaced. Essentially, both parties use marketing
techniques to increase their market share of different
strengths of antacid even though there is no provable
difference in terms of effectiveness. Mylanta, knowing that
people are most concerned with nighttime heartburn,
focused its advertising on that concern. The majority
appears to hold that, as a matter of law, antacid
manufacturers can only label their products with terms
that describe different degrees of strength such as regular,
extra, and maximum. All other words, such as nighttime,
necessarily convey a false message. If we were truly
concerned about the public interest, both companies would
be forced to label their products with the following:
GREATER STRENGTH AND GREATER PRICE DO NOT
EQUAL GREATER RELIEF.
Because a preliminary injunction should not have been
granted in this case, I dissent.
A True Copy:
Teste:
Clerk of the United States Court of Appeals
for the Third Circuit
34

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