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Pharmacia Corp. v. Glaxosmithkline Consumer Healthcare

November 24, 2003


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



This matter comes before the Court on the motion by plaintiff Pharmacia Corporation ("Pharmacia") pursuant to Federal Rule of Civil Procedure ("Rule") 65(a) for a preliminary injunction enjoining defendant GlaxoSmithKline Consumer Healthcare, L.P. ("GSKCH") from broadcasting two television commercials. Pharmacia contends that certain of the claims made by GSKCH's commercials violate Section 43(a) of the Lanham Act, codified at 15 U.S.C. § 1125(a) ("the Lanham Act"). The Court will grant in part and deny in part Pharmacia's motion.

This case involves a dispute between distributors of over-the-counter ("OTC") products designed to help purchasers stop smoking cigarettes. Pharmacia and GSKCH market competing brands of nicotine replacement therapy ("NRT") products in the United States. (Pharm. Proposed Findings of Fact and Conclusions of Law ("PFFCL") at 6.) Pharmacia sells a nicotine transdermal patch under the brand name Nicotrol ("Nicotrol"). (GSKCH PFFCL at 1.) GSKCH markets a competing nicotine transdermal patch under the brand name NicoDerm CQ ("NicoDerm"). (Id.) GSKCH also sells a nicotine gum under the brand name Nicorette ("Nicorette"). (Id.)

GSKCH began airing two commercials on December 22, 2002, which the parties refer to as "Revised Tough Decision" and "Revised Smart Choice." (Pharm. PFFCL at 12.) "Revised Tough Decision" features an actor portraying a consumer deciding whether to buy Nicorette or Nicotrol. (GSKCH PFFCL at 9.) A voice-over asks: "Trying to quit smoking? According to the labels, Nicorette gum can be used whenever you need it, day or night. Nicotrol's patch can only be worn for 16 hours." (Id.; Pharm. PFFCL at 12.) Superimposed text at the bottom of the screen reads: "Used anytime. Use as directed." (GSKCH PFFCL at 9.) The announcer then states: "So much for flexibility," after which the actor chooses Nicorette. (Id.)

"Revised Smart Choice" is a commercial contrasting NicoDerm and Nicotrol. An announcer compares the two products on four criteria, as an animated checklist appears on the screen depicting the features being described. (Id. at 15.) The announcer states that: (1) both products feature a three-step program; (2) NicoDerm alone offers a program for lighter smokers; (3) users can wear NicoDerm for "the day or 24 hours," while Nicotrol may only be worn for 16 hours; and (4) "more doctors prefer the patch that gives you the choice." (Id. at 15-16.) The commercial concludes with the announcer telling viewers: "NicoDerm CQ. The power of choice." (Id. at 16.)

Pharmacia asks the Court to enjoin GSKCH from showing "Revised Tough Decision" because the "claim that `according to the labels,' the Nicorette gum may be `used whenever you need it, day or night' is expressly false." (Pharm. PFFCL at 13.) Pharmacia also requests that GSKCH be enjoined from airing "Revised Smart Choice" because "(i) it implie[s] the false message that the use of NicoDerm CQ result[s] in superior quitting efficacy as compared Nicotrol, and (ii) the express claim that `doctors prefer' NicoDerm CQ because it gives the user a 16 or 24 hour `choice' [is] not established by GlaxoSmithKline's data." (Id.) The Court held an evidentiary hearing on February 3 & 4, 2003, April 23, 2003 and June 4, 2003, to determine whether an injunction should issue.


"[A]n injunction is an extraordinary remedy, which should be granted only in limited circumstances." Novartis Consumer Health, Inc. v. Johnson & Johnson-Merck Consumer Pharms. Co., 290 F.3d 578, 586 (3d Cir. 2002) (quotations omitted). The Court will only issue a preliminary injunction if we are 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.

Id. See also AT&T v. Winback & Conserve Program, Inc., 42 F.3d 1421, 1427 (3d Cir. 1994) ("The injunction should issue only if the plaintiff produces evidence sufficient to convince the district court that all four factors favor preliminary relief.").

I. Likelihood of Success on the Merits

a. The Lanham Act

Pharmacia must first show that at trial it is likely to succeed in proving that GSKCH's ads violate the Lanham Act. The Lanham Act reads, in pertinent part,

(1) Any person who . . . in connection with any goods or services . . . uses in commerce any word, term, name, symbol, or device, or any combination thereof, or . . . false or misleading description of fact, or false or misleading representation of fact, which- -

(A) is likely to cause confusion, or to cause mistake, or to deceive as to the affiliation, connection, or association of such person with another person, or as to the origin, sponsorship, or approval of his or her goods, services, or commercial activities by another person, or

(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. § 1125(a). To prove a Lanham Act violation, the complaining party must show:

(1) the defendant made false or misleading statements about the plaintiff's [or his own] product; (2) there is actual deception or a tendency to deceive a substantial portion of the intended audience; (3) the deception is material in that it is likely to influence purchasing decisions; (4) the advertised goods traveled in interstate commerce; and (5) there is a likelihood of injury to the plaintiff.

Highmark, Inc. v. UPMC Health Plan, Inc., 276 F.3d 160, 171 (3d Cir. 2001). Here, neither party contests the existence of the latter three elements: materiality, travel in interstate commerce, or likelihood of injury. Accordingly, we will focus our inquiry on the first two showings: the false or misleading claim that deceives or has a tendency to deceive consumers.

A Lanham Act false or misleading statement may be proved in one of two ways. The plaintiff must show that "the commercial message or statement is either (1) literally false or (2) literally true or ambiguous, but has the tendency to deceive consumers." Novartis, 290 F.3d at 586. If the plaintiff can show literal falsity, "the court may grant relief without reference to the advertisement's impact on the buying public." Castrol Inc. v. Pennzoil Co., 987 F.2d 939, 943 (3d Cir. 1993).

In analyzing whether an advertisement or product name is literally false, a court must determine, first, the unambiguous claims made by the advertisement . . . , and second, whether those claims are false. 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.

Novartis, 290 F.3d at 586-87 (quotations and citations omitted). However, "only an unambiguous message can be literally false"; if the message is susceptible of more than one meaning, the plaintiff cannot assert literal falsity. See id. at 587.

Where the plaintiff is unable to demonstrate that the complained-of statement is literally false, a Lanham Act violation may still be established by proving that the commercial makes a false or misleading claim and that a substantial portion of consumers actually understand the ad to be making that claim. See Johnson & Johnson-Merck Consumer Pharms. Co. v. Rhone-Poulenc Rorer Pharms., Inc., 19 F.3d 125, 129 (3d Cir. 1994) ("Rorer"); Dentsply Int'l, Inc. v. Great White, Inc., 132 F. Supp. 2d 310, 324 (M.D. Pa. 2000). When the plaintiff chooses this evidentiary route because literal falsity cannot be shown, the plaintiff "must prove that [the statement] is deceptive or misleading, which depends on the message that is conveyed to consumers." Rorer, 19 F.3d at 129. The plaintiff must therefore produce evidence that consumers are actually misled by the defendant's statements; speculation as to how consumers could react is insufficient. See Highmark, 276 F.3d at 171. "[T]he success of [the plaintiff's] claim usually turns on the persuasiveness of a consumer survey." Rorer, 19 F.3d at 129-30.

b. "According to the Labels, Nicorette Gum Can Be Used Whenever You Need It, Day or Night"

Pharmacia contends that GSKCH's statement in "Revised Tough Decision" that "According to the labels, Nicorette gum can be used whenever you need it, day or night" violates the Lanham Act because it is literally false. While the ad tells viewers that the label states Nicorette may be used any time the consumer needs it, ...

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