The opinion of the court was delivered by: Cannella, District Judge:
Plaintiff's request for injunctive relief under the Lanham Act
is granted. 15 U.S.C. § 1125(a) (1988).
Defendant Bristol-Myers Squibb Company, Inc. ["Bristol-Myers"]
is one of the leading sellers of over-the-counter ["OTC"]
internal analgesics. For approximately thirty years, the
company has been marketing Excedrin, an analgesic containing
250 milligrams ["mg."] aspirin, 250 mg. acetaminophen ["APAP"]
and 65 mg. of caffeine per tablet. In May 1990, Bristol-Myers
introduced Aspirin Free Excedrin ["AF Excedrin"], an OTC
analgesic containing 1000 mg. APAP and 130 mg. caffeine in a
two tablet dose.
McNeil-P.P.C., Inc. ["McNeil"] manufactures Tylenol and is the
market leader in OTC analgesics. In 1989, McNeil's adult
Tylenol products had a 22.9% share of the market, while its
closest competitor, Advil, had only a 10.2% share of the
market. Extra-Strength Tylenol ["ES Tylenol"] contains 1000 mg.
APAP in a two tablet dose. The only difference between AF
and ES Tylenol is that AF Excedrin contains caffeine.
On August 30, 1990, Bristol-Myers launched an aggressive
television advertising campaign for AF Excedrin. The
advertising directly compares AF Excedrin with ES Tylenol and
asserts that AF Excedrin works better than ES Tylenol. Before
Bristol-Myers began its television advertising campaign, it
distributed promotional materials to drug retailers which also
asserted AF Excedrin's superiority over ES Tylenol.
Bristol-Myers plans to spend approximately $10 million on its
commercial advertising for AF Excedrin. A story-board of one
commercial currently appearing on a national television network
is reprinted below:
McNeil commenced the instant action on September 4, 1990,
alleging that Bristol-Myers' advertising for AF Excedrin is
false. McNeil amended its complaint to add an allegation that
the advertising conveys a false message to consumers as to the
magnitude of difference between AF Excedrin and ES Tylenol.
McNeil contends that Bristol-Myers' advertisements and
promotional materials for AF Excedrin violate section 43(a) of
the Lanham Act, 15 U.S.C. § 1125(a) (1988) and sections 349 and
350 of the New York General Business Law, N.Y.Gen.Bus.Law §§
349, 350 (McKinney 1988).*fn1 McNeil seeks a preliminary and
permanent injunction (1) enjoining Bristol-Myers from claiming
in its advertisements that (A) AF Excedrin relieves headache or
other pain better than ES Tylenol or (B) scientific tests
establish that AF Excedrin relieves headache or other pain
better than ES Tylenol and (2) directing Bristol-Myers to
recall advertisements or promotional materials which claim that
AF Excedrin is superior to ES Tylenol.
Pursuant to Rule 65(a)(2) of the Federal Rules of Civil
Procedure, the Court consolidated a hearing on McNeil's motion
for a preliminary injunction with a trial on the merits.*fn2
The following opinion constitutes the Court's findings of fact
and conclusions of law on plaintiff's motion for injunctive
I. Standards Governing Injunctive Relief Under Section 43(a)
of the Lanham Act
Section 43(a) of the Lanham Act provides in pertinent part:
Any person who shall affix, apply, or annex, or use in
connection with any goods or services, . . . any false
description or representation . . . and shall cause such goods
or services to enter into commerce . . . shall be liable to a
civil action . . . by any person who believes that he is or is
likely to be damaged by the use of any such false description
15 U.S.C. § 1125(a) (1988). To establish a violation of section
43(a) the plaintiff has the burden of proving by a
preponderance of the evidence that an advertisement is
literally false, or that it has a tendency to mislead or
deceive. See Coca-Colä Co. v. Tropicana Prods., Inc.,
690 F.2d 312, 314-15, 317-18 (2d Cir. 1982); Johnson & Johnson v.
Carter-Wallace, Inc., 631 F.2d 186, 192 (2d Cir. 1980);
American Home Prods. Corp. v. Johnson & Johnson,
577 F.2d 160, 165-66 (2d Cir. 1978). A merchant's description of its
product may be false or misleading in either the description of
the product itself or in its comparison to a product
manufactured by a competitor. See McNeilab, Inc. v. American
Home Prods. Corp., 848 F.2d 34, 38 (2d Cir. 1988).
When an advertising claim is alleged to be false, the court may
grant relief based on its own findings without reference to the
consumer's reaction to the advertisement. See Coca-Cola Co.,
690 F.2d at 317; American Home Prods. Corp., 577 F.2d at 165.
Plaintiff is not entitled to relief merely by showing that the
clinical tests or other evidence relied on by the defendant to
support its superiority claim are unpersuasive. See Procter &
Gamble Co. v. Chesebrough-Pond's Inc., 747 F.2d 114, 119 (2d
Cir. 1984). Rather,
plaintiff must adduce evidence that the advertisement is false.
See id. A claim of test proven superiority may be deemed
false if it is shown that the clinical research purportedly
supporting the representation was not sufficiently reliable to
permit the reasonable conclusion that the research established
the claim made. See id. Similarly, "representations found to
be unsupported by accepted research or which are contradicted
by prevailing authority or research, may be deemed false on
their face and actionable under section 43(a) of the Lanham
Act." Alpo Petfoods, Inc. v. Ralston Purina Co., 720 F. Supp. 194,
213 (D.D.C. 1989), aff'd in part, rev'd in part on other
grounds; 913 F.2d 958 (D.C.Cir. 1990).
It is well settled that section 43(a) of the Lanham Act
encompasses more than literal falsehoods. See, e.g., American
Home Prods. Corp., 577 F.2d at 165. To determine whether a
statement that is literally true is misleading the court's
reaction is not determinative; rather, the court must consider
whether the message that is conveyed to the public is beyond
its literal meaning and misleading or deceptive. See Avis Rent
A Car System, Inc. v. Hertz Corp., 782 F.2d 381, 386 (2d Cir.
1986); American Home Prods. Corp., 577 F.2d at 165-66. In
making its decision, the court first considers the literal
meaning of the advertisement and then as the finder of fact
decides whether the evidence shows that the public is likely to
be mislead. See American Home Prods. Corp. v. Johnson &
Johnson, 654 F. Supp. 568, 590 (S.D.N.Y. 1987); McNeilab, Inc.
v. American Home Prods. Corp., 501 F. Supp. 517, 525 (S.D.N Y
1980). The extent to which consumers are deceived need not be
established to support the finding that an advertisement tends
to mislead, all that is required is a "qualitative showing [to]
establish that a not insubstantial number of consumers received
a false or misleading impression from it." McNeilab, Inc.,
501 F. Supp. at 528. Surveys may be used to demonstrate the
meaning an advertisement has to the target audience, but
whether the survey is of probative value depends on its
fundamental fairness and objectivity. See American Home Prods.
Corp., 654 F. Supp. at 590.
To obtain injunctive relief under the Lanham Act, a party must
demonstrate a "likelihood of deception or confusion on the part
of the buying public" as a result of the product's false or
misleading description. See Burndy Corp. v. Teledyne Indus.
Inc., 748 F.2d 767, 772 (2d Cir. 1984). It is well settled
that such a likelihood of confusion sufficiently establishes
both the requisite irreparable harm and likelihood of success
on the merits typically required for the issuance of injunctive
relief. See, e.g., Hasbro, Inc. v. Lanard Toys, Ltd.,
858 F.2d 70, 73 (2d Cir. 1988); Home Box Office, Inc. v.
Showtime/Movie Channel, Inc., 832 F.2d 1311, 1314 (2d Cir.
1987); Standard & Poor's Corp. v. Commodity Exchange, Inc.,
683 F.2d 704, 708 (2d Cir. 1982). Irreparable harm is generally
presumed for Lanham Act violations because a false comparison
to a specific product reduces the consumers' incentive to
purchase that product. Thus, a competitor in the relevant
market may obtain permanent injunctive relief by showing a
likelihood of competitive injury resulting from the false
advertising. See Johnson & Johnson, 631 F.2d at 190-91.
McNeil's entitlement to injunctive relief depends on whether
McNeil is able to show by a preponderance of the evidence that
AF Excedrin does not relieve headache pain better than ES
Tylenol. More specifically, since both AF Excedrin and ES
Tylenol contain the same amount of APAP, McNeil must
demonstrate that the presence of caffeine in AF Excedrin fails
to make AF Excedrin superior to ES Tylenol in relieving
II. The Food and Drug Administration's Review of Caffeine's
Effectiveness as an Analgesic Adjuvant
The Food and Drug Administration [the "FDA"] reviews OTC drugs
for safety and effectiveness. The FDA recognizes that APAP is
an effective analgesic. In addition, it is well settled by the
FDA that caffeine acting alone is not effective in
relieving headache pain. See 42 Fed.Reg. 35482 (1977).
However, the FDA has not reached a conclusive determination
regarding caffeine's effectiveness as an analgesic
adjuvant.*fn3 The FDA's review of OTC drugs is conducted in
four stages. In the first stage, the FDA appoints an advisory
panel of independent scientists who analyze existing data and
make recommendations to the FDA in the form of monographs,
which set forth the drug's safety and effectiveness. See
21 C.F.R. § 330.10(a)(1)-(5) (1990). Next, the FDA reviews the
monographs and makes them available for public comment. See
id. § 330.10(a)(6). In the third stage the FDA publishes a
tentative final monograph and affords the public an opportunity
to object to its findings. See id. ...