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

290 F.3d 578, 62 U.S.P.Q. 2d (BNA) 1757, 2002 U.S. App. LEXIS 9447, 2002 WL 987438
CourtCourt of Appeals for the Third Circuit
DecidedMay 14, 2002
Docket01-1154
StatusPublished
Cited by345 cases

This text of 290 F.3d 578 (Novartis Consumer Health, Inc. v. Johnson & Johnson-Merck Consumer Pharmaceuticals Co.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Third Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Novartis Consumer Health, Inc. v. Johnson & Johnson-Merck Consumer Pharmaceuticals Co., 290 F.3d 578, 62 U.S.P.Q. 2d (BNA) 1757, 2002 U.S. App. LEXIS 9447, 2002 WL 987438 (3d Cir. 2002).

Opinion

*583 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 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. § 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. § 1331. We have appellate jurisdiction pursuant to 28 U.S.C. § 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 (“re-fluxes”) 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 Gas-troenterological 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 (ie., “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 gastric contents — all bear on the antacid’s efficacy. See Johnson & Johnson-Merck Consumer Pharm. Co. v. Rhone-Poulenc Rorer Pharms., Inc., 19 F.3d 125, 127 (3d *584 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.

J&J announced the introduction of “My-lanta 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 My-lanta. 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 Mylan-ta 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 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 *585

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290 F.3d 578, 62 U.S.P.Q. 2d (BNA) 1757, 2002 U.S. App. LEXIS 9447, 2002 WL 987438, Counsel Stack Legal Research, https://law.counselstack.com/opinion/novartis-consumer-health-inc-v-johnson-johnson-merck-consumer-ca3-2002.