Novartis Consumer Health v. Johnson & Johnson
| Decision Date | 14 May 2002 |
| Docket Number | No. 01-1154.,01-1154. |
| Citation | 290 F.3d 578 |
| Parties | NOVARTIS CONSUMER HEALTH, INC. v. JOHNSON & JOHNSON-MERCK CONSUMER PHARMACEUTICALS CO., Appellant. |
| Court | U.S. Court of Appeals — Third Circuit |
Steven A. Zalesin (Argued), Patterson, Belknap, Webb & Tyler, New York City, for appellant.
Bruce P. Keller (Argued), Debevoise & Plimpton, New York City, for appellee.
Before: RENDELL, AMBRO, and BRIGHT,* Circuit Judges.
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.
The parties produce over-the-counter drugs that treat heartburn. Heartburn is caused by stomach acid that backs up ("refluxes") 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 (i.e., "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 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 "Mylanta 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 Mylanta.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 Mylanta 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: 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 eyes closed and her head tilted back on the sofa.
The revised website stated,
On October 31, 2000, Novartis filed a complaint pursuant to section 43(a) of the Lanham Act, 15 U.S.C. § 1125(a), and the New Jersey Consumer Fraud Act, N.J.S.A. § 56:8-1, et seq., alleging that J & J's advertisements regarding MNTS and the name and packaging of the product itself are false and misleading. On December 8, 2000, Novartis filed a motion for a preliminary injunction pending the outcome of its Lanham Act claims.2 In both its complaint and its motion for preliminary injunction, Novartis alleged that the MNTS name and associated packaging and advertisements were false because, inter alia, they communicated, either explicitly or implicitly, the following false or misleading claims:
(1) MNTS is "specially formulated," and therefore better than other antacids, at relieving night time heartburn; and
(2) MNTS provides heartburn relief throughout the night.
Neither party requested discovery. The District Court held oral argument on December 18 and 19, 2000. The Court then issued an opinion and order on December 22, 2000, granting Novartis' motion and enjoining J & J from: "(1) marketing and disseminating Mylanta Night Time Strength under that name; (2) using the designation `Night Time' or `Night Time Strength' on any antacid product; [and] (3) otherwise claiming, either explicitly or implicitly, in any packaging, advertising, or other promotional materials, that Mylanta Night Time Strength is specially formulated for night time heartburn, provides all night relief, and/or possesses a strength that correlates with its efficacy." 129 F.Supp.2d at 369. The District Court further ordered that Novartis post a security bond in the amount of $1,000,000 by December 29, 2000.3 Id. J&J filed a timely notice of appeal.4
We review the District Court's ultimate decision to grant a preliminary injunction for abuse of discretion. See, e.g., Sandoz Pharm. Corp. v. Richardson-Vicks, Inc., 902 F.2d 222, 226 (3d Cir.1990). However, an injunction is "an extraordinary remedy, which should be granted only in limited circumstances." Instant Air Freight Co. v. C.F. Air Freight, Inc., 882 F.2d 797, 800 (3d Cir.1989). In...
To continue reading
Request your trial
-
Nekrilov v. City of Jersey City
...Pharms., Inc. v. Watson Pharms., Inc. , 765 F.3d 205, 210 (3d Cir. 2014) (quoting Novartis Consumer Health, Inc. v. Johnson & Johnson-Merck Consumer Pharms. Co. , 290 F.3d 578, 586 (3d Cir. 2002) ). The decision to grant or deny a preliminary injunction is within the Court's discretion. See......
-
In re Depomed Patent Litig.
...will sustain by losing significant market share and revenue on its flagship product. Novartis Consumer Health, Inc. v. Johnson & Johnson-Merck Consumer Pharms. Co., 290 F.3d 578, 596 (3d Cir. 2002); Lazzaroni USA Corp. v. Steiner Foods, 2006 U.S. Dist. LEXIS 20962, at *21 (D.N.J. Apr. 10, 2......
-
Doe v. Boyertown Area Sch. Dist.
...not issue versus the potential injury to the defendant if the injunction is issued." Novartis Consumer Health, Inc. v. Johnson & Johnson—Merck Consumer Pharm. Co. , 290 F.3d 578, 596 (3d Cir. 2002). As the plaintiffs have failed to establish a likelihood of success on the merits of those cl......
-
Reese v. Pook & Pook, LLC.
...false or (2) literally true or ambiguous, but has the tendency to deceive consumers.” Novartis Consumer Health, Inc. v. Johnson & Johnson–Merck Consumer Pharm. Co. , 290 F.3d 578, 586 (3d Cir.2002) citing Castrol Inc. v. Pennzoil Co. , 987 F.2d 939, 943 (3d Cir.1993) (“a plaintiff must prov......
-
Federal Law of Unfair Competition
...TRADEMARKS & UNFAIR COMPETITION ¶ 27:7B (2d ed. 1984)). 104. Novartis Consumer Health v. Johnson & Johnson-Merck Consumer Pharms. Co., 290 F.3d 578, 590 (3d Cir. 2002). 105. AT&T v. Winback & Conserve Program, Inc., 42 F.3d 1421, 1428 n.9 (3d Cir. 1994); see also Pizza Hut, Inc. v. Papa Joh......
-
Table of Cases
...580 (1996), aff’d , 223 F.3d 783 (D.C. Cir. 1996), 14 Novartis Consumer Health, Inc. v. Johnson & Johnson-Merck Consumer Pharm. Co., 290 F.3d 578 (3d Cir. 2002), 1229, 1239, 1244, 1247, 1251, 1253, 1265, 1266, 1277, 1298, 1302, 1306, 1307, 1319 Novartis Corp., 127 F.T.C. 580 (1999), aff’d ,......
-
Private Remedies for False or Misleading Advertising: Lanham Act Section 43(a)
...v. United Indus. Corp., 315 F.3d 264, 274 (4th Cir. 2002); Novartis Consumer Health, Inc. v. Johnson & Johnson-Merck Consumer Pharm. Co., 290 F.3d 578, 586-87 (3d Cir. 2002). 120. See Am. Home Prods. Corp. v. Johnson & Johnson, 436 F. Supp. 785, 797 (S.D.N.Y. 1977). 121. See, e.g., Scotts C......
-
Table of cases
...156 Novartis Consumer Health, v. Johnson & Johnson-Merck Consumer Pharm., 290 F.3d 578 (3d Cir. 2002) .................................... 26, 29, 106 Outdoor Technologies v. Vinyl Visions, LLC, 2006 WL 2849782 (S.D. Ohio 2006) .................................................. 49 Palm, Inc......