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GLAXO WARNER-LAMBERT OTC G.P. v. JOHNSON & JOHNSON

July 22, 1996

GLAXO WARNER-LAMBERT OTC G.P., Plaintiff,
v.
JOHNSON & JOHNSON MERCK CONSUMER PHARMACEUTICALS CO., Defendant.



The opinion of the court was delivered by: BATTS

 At the outset, I want to state that I have been particularly impressed by the ingenuity, intelligence and tenacity of counsel for both parties in this action before me. It has been clear to me that the intensity displayed on the phone, and in hearings over the last several weeks comes from the caliber of counsel as well as the fervor with which they advanced their clients' positions. The same is true of the witnesses called by both sides.

 Unfortunately, these are not the standards or considerations that I must apply in determining whether or not to issue a preliminary injunction in an alleged false advertising claim under the Lanham Act.

 A party seeking preliminary injunctive relief must show (a) that it will suffer irreparable harm if relief is denied, and (b) either (i) a likelihood of the success of the merits, or (ii) sufficiently serious questions going to the merits to make them fair ground for litigation, and (c) a balance of the hardships tipping decidedly in plaintiff's favor. Castrol, Inc. v. Quaker State Corporation, 977 F.2d 57, 62 (2d Cir. 1992). Irreparable harm is presumed when the plaintiff can demonstrate a likelihood of success in showing defendant's advertisement was literally false. Id.

 In order to recover damages or to obtain equitable relief, a plaintiff must demonstrate either (1) the challenged advertisement is literally false, or (2) while the advertisement is literally true it is nevertheless likely to mislead or confuse consumers. Johnson & Johnson-Merck Consumer Pharmaceuticals Company v. Smith Kline Beechman Corporation, 960 F.2d 294, 297 (2d Cir. 1992). McNeil-P.C.C., Inc. v. Bristol-Myers Squibb Co., 938 F.2d 1544, 1549 (2d Cir. 1991).

 Turning to the duration claim, the ad here states, in its entirety, "If you're considering Zantac 75 for heartburn, consider this first, Pepcid AC. Both Pepcid AC and Zantac 75 can be taken after dinner to relieve heartburn. And 12 hours later both are still controlling acid so you can sleep. But read the labels. Here's the difference, you can take Pepcid AC to stop heartburn before it starts. Zantac 75 can't claim that. Before or after, you can be heartburn free with Pepcid AC."

 Plaintiff argues that defendant's claim in the contested advertisement -- "12 hours later both are still controlling acid so you can sleep," is literally false. "Where the advertising claim is shown to be literally false, the court may enjoin the use of the claim 'without reference to the advertisement's impact on the buying public,'" McNeil, 938 F.2d at 1549, quoting Coca-Cola Co. v. Tropicana Products, Inc., 690 F.2d 312, 317 (2d Cir. 1982). To show falsity one must do more than show the tests that support the claim are unpersuasive. McNeil, 938 F.2d at 1549.

 Furthermore, the standard the Court will apply depends on the language of the advertisement. When the ad relies on scientific studies, whether implicitly by making a claim while showing a graph or diagram, or explicitly, by stating, for example, "that studies show," the standard to apply is stricter.

 To prove a claim literally false, that mentions scientific evidence, the plaintiff bears the burden of showing that "the tests referred to...[are] not sufficiently reliable to permit one to conclude with reasonable certainty that they established the proposition for which they were cited," again citing McNeil, 938 F.2d at 1549 (quoting Procter & Gamble Co. v. Cheesebrough-Pond's Inc., 747 F.2d 114, 119 (2d Cir. 1984)); see also Castrol, 977 F.2d at 62. When no mention of scientific studies is made in an advertisement, then falsity is proven upon adducing evidence that affirmatively shows the claim to be false. Castrol, 977 F.2d at 62. This second standard is the plaintiff's burden. Plaintiff would argue that Dr. Ross testified that any statement made in an advertisement, claiming equivalency, represents to a consumer that there are tests to support the statement. The Court finds that this attempt to apply the less stringent standard to the facts here fails. The less stringent standard is meant to apply to those commercials that mention "studies" or "tests," or make statements while pointing to graphs or similar items. This ad had none of those implications. (Tr. at 4-6; 7/18/96) Although the consumer survey offered by the plaintiff was offered for the prevention claim only, it is curious to note that, at least one respondent, No. 0615, stated in response to the question about the main ideas of the ad, "Household mother commending Pepcid AC, rather than a doctor."

 Defendant does not have the burden of proving that its advertisement is true.

 Here, plaintiff claims that the advertisement is literally false because Pepcid AC cannot control acid for 12 hours. However, the Court finds that the advertisement does not claim that the medicine controls acid for 12 hours, rather, the ad claims that Pepcid AC is controlling acid at the twelfth hour, or twelve hours after dosage. Indeed, plaintiffs cannot affirmatively prove that Pepcid AC does not control acid twelve hours after dosage. In fact, there is evidence before the Court that shows that Pepcid AC does control acid twelve hours after dosage.

 Six studies have been advanced to prove the claims at issue. Four of those studies involve Pepcid AC. However, only two of the four are nighttime studies. The ad here states that Pepcid AC, "can be taken after dinner to relieve heartburn. And 12 hours later both are still controlling acid so you can sleep." The advertisement refers to the nighttime relief of heartburn. The Court will first address, therefore, the nighttime studies.

 Defendant's Exhibit study 066, evidenced in Plaintiff's Trial Exhibits 31 and 32, and J&J Merck's study 076, evidenced in Plaintiff's 35 and 35.1, are nighttime studies. (Tr. at 67, 7/18/96.) In each, it is shown that Pepcid AC controls acid to a statistically significant degree, a p-value that is less than 0.05, 12 hours after dosage. (Tr. at 45, 7/18/96.) Plaintiff's expert, Professor Charles A. Rohde, a biostatistician, agrees. Referring to study 066, Professor Rohde states, "we had acid duration from one hour post-dosing to twelve hours post-dosing." (Tr. at 59, 7/18/96.) Referring to the 076 study, Professor Rohde states, "we still see an effect...at 12 hours post-dose." (Tr. at 68, 7/18/96.) Later in the testimony, the Court asks, "It will control acid 12 hours after dosage?" Professor Rohde responds, "That's correct...In fact, we have seen ...


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