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In a court battle between the makers of two popular heartburn remedies — Maalox and Mylanta — a federal appeals court has upheld an injunction that prohibits Johnson & Johnson-Merck from using the name “Mylanta Night Time Strength” because it falsely suggests that the product was specially formulated for nighttime use. But a dissenting judge complained that his colleagues were announcing a new rule of law that allows courts to treat any unsubstantiated advertising claim as a false claim. The decision by the 3rd U.S. Circuit Court of Appeals in Novartis Consumer Health Inc. v. Johnson & Johnson-Merck Consumer Pharmaceuticals Co. is legally significant because it answers a question about the burdens of proof in a Lanham Act case that the court had dodged in a previous decision. In its 1990 decision in Sandoz Pharmaceuticals Corp. v. Richardson-Vicks Inc., the 3rd Circuit specifically declined to decide whether the plaintiff in a false advertising claim must prove that consumers are actually misled by advertising claims that are “completely unsubstantiated.” Now the 3rd Circuit has answered that question in a way that makes it easier for plaintiffs to win injunctions. “Today we decide what we left open in Sandoz. We hold that, although the plaintiff normally has the burden to demonstrate that the defendant’s advertising claim is false, a court may find that a completely unsubstantiated advertising claim by the defendant is per se false without additional evidence from the plaintiff to that effect,” U.S. Circuit Judge Thomas L. Ambro wrote. The decision upholds a preliminary injunction issued by U.S. District Judge William G. Bassler of the District of New Jersey that enjoined J&J from using the name “Mylanta Night Time Strength” for the strongest version of its over-the-counter liquid heartburn medicine that competes directly with the Maalox line of liquid antacid products marketed by Novartis. Ambro’s decision begins with a brief description of heartburn — a malady suffered by an estimated 60 million Americans — and the three types of drugs used to combat it. Heartburn is caused by stomach acid that backs up or “refluxes” into the esophagus. Reflux most often occurs soon after a meal when the stomach produces high volumes of acid to begin the digestion process. It 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 pH levels in the stomach. There are currently three types of heartburn remedies on the over-the-counter market. Stomach acid “blockers” such as Pepcid AC and Zantac treat heartburn by reducing the production of stomach acid for approximately eight to 12 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. Maalox and Mylanta are “antacids” that work by neutralizing excess acid already present in the stomach. Antacids provide fast relief, but the effects wear off within 30 to 60 minutes because antacids have no effect on the production of new stomach acid. The U.S. Food and Drug Administration prohibits antacid makers from touting the “acid neutralization capacity” of their products because consumers might mistake the rating as a measure of effectiveness. But the courts have ruled that the products can be marketed under categories of varying strengths. Maalox is marketed in three strengths — “regular,” “extra” and “maximum.” Mylanta is also sold in “regular” and “extra” strengths, and in March 2000, J&J began selling the strongest version as “Mylanta Night Time Strength.” In television commercials, J&J claimed that the new product 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.” J&J’s Internet Web site also boasted that the new product “is the first and only antacid formulated specifically to relieve your toughest nighttime heartburn,” and promised that it 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.” Novartis objected to J&J over the name and the advertising claims. As a result, J&J revised the campaign to eliminate many of the disputed claims. But Novartis wasn’t satisfied and filed suit in U.S. District Court citing claims under the Lanham Act and the New Jersey Consumer Fraud Act, alleging that J&J’s advertisements, and the name and packaging of the new product were false and misleading. The suit alleged that J&J was falsely claiming that its product was “specially formulated,” and therefore better than other antacids, at relieving night-time heartburn; and that it provides heartburn relief throughout the night. Judge Bassler agreed and issued an injunction in December 2000 that barred the use of the term “Night Time” in the product name and “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.” J&J urged the 3rd Circuit to lift the injunction, arguing that the irreparable harm it was suffering by pulling the product outweighed any harm that Novartis might suffer in the form of decreased market share for Maalox. The appellate court disagreed and voted 2-1 to keep the injunction in place. Judge Ambro, in an opinion joined by U.S. Circuit Judge Marjorie O. Rendell, held that Bassler was correct in finding that the product name is “literally false” because it “conveys the unambiguous message that the product is specially formulated to relieve nighttime heartburn.” “We agree with the district court that the term ‘nighttime’ conveys a different meaning than the terms ‘regular,’ ‘extra,’ and ‘maximum.’ The latter terms describe different degrees of strength and are descriptions that are arguably supported by evidence of different [acid neutralization capacity] ratings,” Ambro wrote. “By contrast, the ‘nighttime’ designation describes not a degree of strength, but rather a time when the product will be effective. The phrase ‘nighttime strength’ therefore necessarily conveys a message that the MNTS product is specially made to work at night,” Ambro wrote. Since J&J had no evidence that the product is specially formulated for nighttime use, Ambro concluded that “the message of special formulation for nighttime relief that is necessarily implied from the … name is a completely unsubstantiated advertising claim.” In dissent, visiting 8th Circuit Senior Judge Myron H. Bright said he would have lifted the injunction because J&J’s claims are not false. “Mylanta gave its product a clever name and stated that the product works at night. This is not false. [The product] does work at night and provides relief. Indeed, all the antacid products of both companies work in the morning, at noon, and at night,” Bright wrote. Bright complained that the majority had created “a new rule that allows a district court to conclude that a completely unsubstantiated advertising claim can be per se false, despite the fact that, under FDA regulations, no antacid manufacturer can substantiate its efficacy claims in any meaningful way.” The flaw in the majority’s logic, Bright said, was in its first premise — that the use of the term “Night Time” in the product name conveyed the message to consumers that it was specially formulated for nighttime use. “[The] name may suggest that the product is specially formulated for nighttime heartburn, but the words ‘Night Time’ no more necessarily imply special formulation for nighttime relief than the words ‘Extra Strength’ necessarily imply special formulation for greater effectiveness. Both phrases are suggestive and neither are literally false,” Bright wrote. Bright also took issue with the majority’s finding that the injunction was in the public interest. “Essentially, both parties use marketing techniques to increase their market share of different strengths of antacid even though there is no provable difference in terms of effectiveness. Mylanta, knowing that people are most concerned with nighttime heartburn, focused its advertising on that concern,” Bright wrote. “The majority appears to hold that, as a matter of law, antacid manufacturers can only label their products with terms that describe different degrees of strength such as regular, extra, and maximum. All other words, such as nighttime, necessarily convey a false message. “If we were truly concerned about the public interest, both companies would be forced to label their products with the following: GREATER STRENGTH AND GREATER PRICE DO NOT EQUAL GREATER RELIEF.” Novartis was represented in the appeal by attorney Bruce P. Keller of Debevoise & Plimpton in New York. J&J was represented by attorney Steven A. Zalesin of Patterson, Belknap, Webb & Tyler in New York.

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