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