Johnson & Johnson-Merck Consumer Pharmaceuticals Company v. Rhone-Poulenc Rorer Pharmaceuticals, Inc

19 F.3d 125, 30 U.S.P.Q. 2d (BNA) 1112, 1994 U.S. App. LEXIS 4538
CourtCourt of Appeals for the Third Circuit
DecidedMarch 15, 1994
Docket93-1349
StatusPublished
Cited by133 cases

This text of 19 F.3d 125 (Johnson & Johnson-Merck Consumer Pharmaceuticals Company v. Rhone-Poulenc Rorer Pharmaceuticals, Inc) 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
Johnson & Johnson-Merck Consumer Pharmaceuticals Company v. Rhone-Poulenc Rorer Pharmaceuticals, Inc, 19 F.3d 125, 30 U.S.P.Q. 2d (BNA) 1112, 1994 U.S. App. LEXIS 4538 (3d Cir. 1994).

Opinions

OPINION OF THE COURT

SCIRICA, Circuit Judge.

This dispute arises from an advertising war between major competing producers of over-the-counter antacid remedies. Plaintiff/appellant Johnson & Johnson-Merck Consumer Pharmaceuticals Company (“Johnson-Merck”) alleges that television commercials by defendanVappellee Rhone-Poulenc Rorer Pharmaceuticals, Inc. (“Rorer”), about ■ its product Extra Strength Maalox Plus (“ESMP”), are misleading advertising in violation of section 43(a) of the Lanham Act, 15 U.S.C. § 1125(a) (1988). Johnson-Merck produces and markets a competing product, Mylanta Double-Strength (“Mylanta II”), and claims its sales suffered as a result of the misleading advertising.

Key to the controversy is Rorer’s description of ESMP as “the strongest antacid there is” in television commercials promoting ESMP tablets and liquid. Johnson-Merck contends the claim misleads consumers into thinking that ESMP is superior as a treatment for acid indigestion.

The district court held a five-day evidentia-ry hearing on Johnson-Merck’s motion for a preliminary injunction. Because the record developed in the hearing was so extensive, the court, with the agreement of the parties, converted its Memorandum and Order on the motion into one on the merits of the case and entered final judgment.1 The district court found Johnson-Merck failed to meet its burden of proof with respect to claims that the [127]*127advertising was false or misleading and with respect to damages.2

Johnson-Merck appeals, contending the advertisements should have been enjoined if it showed that Rorer either intended to or in fact did mislead consumers. Johnson-Merck claims it proved both at the hearing. Specifically, Johnson-Merck maintains the trial court erred in failing to evaluate its evidence of Rorer’s intent to mislead and in misevalu-ating its key evidence that the commercials did mislead consumers.

The district court had jurisdiction based on a federal question arising under the Lanham Act. 28 U.S.C. § 1331. We have jurisdiction under 28 U.S.C. § 1291. We review the district court’s conclusions of law in a plenary fashion, its findings of fact under a clearly erroneous standard, and its decision to grant or deny an injunction for abuse of discretion. Castrol Inc. v. Pennzoil Co., 987 F.2d 939, 943 (3d Cir.1993); Sandoz Pharmaceuticals Corp. v. Richardson-Vicks, Inc., 902 F.2d 222, 226 (3d Cir.1990).

I.

A. Acid Neutralizing Capacity and Effectiveness of Antacids

Over-the-counter (“OTC”) antacids are designed to provide symptomatic relief from acid indigestion by neutralizing excess acid in the stomach or esophagus. However, the test on which advertisers rely for claims of strength does not measure the operation of antacids in the human body (in vivo testing); rather, it measures their operation in glass beakers of acid in the laboratory (in vitro testing).

In the 1970’s, the Food and Drug Administration adopted a laboratory test for acid neutralizing capacity (“ANC”) which defines OTC antacids for purposes of labeling and measures their strength. The test determines how much acid is neutralized in a glass beaker by a single dose of antacid over a fifteen-minute period. The ANC test does not measure an antacid’s capacity to neutralize acid in vivo, which depends on other factors in addition to ANC,3 nor does it provide information on an antacid’s ability to relieve the symptoms of acid indigestion. Such information would be more useful to consumers than the results of laboratory studies, but the FDA concluded human testing would be too laborious. ANC information is provided to physicians, but because the FDA thought the consuming public might mistakenly take the ANC rating as a measure of effectiveness, it decided to exclude such information from product labels. It concluded that this “technical information on the consumer label could result more in confusion than enlightenment and could result in unwarranted consumer reliance solely upon this information as an indication of relative effectiveness.” 38 Fed.Reg. 31264 (11/12/73). Ironically, the very information the FDA feared would mislead consumers has become the basis of advertising claims and is called upon to support such claims when they are challenged as false or misleading.

When liquid ESMP and Mylanta II are compared in vitro, ESMP has a higher ANC rating; when they are compared in tablet form, Mylanta IPs ANC rating is higher. However, in vivo tests, conducted by both parties to demonstrate the relative effectiveness of the two brands of antacid, show no advantage for either brand in the human body. The district court found that “[n]ot one of the in vivo studies, performed by either side, demonstrated any statistically or clinically significant difference in the ability of Mylanta II or ESMP to relieve symptoms of acid indigestion.”

[128]*128The district court’s conclusion that neither in vitro nor in vivo tests provides any basis for either antacid manufacturer to claim that its product is more effective at relieving symptoms is well supported, and neither party contests it. The dispute is over whether Rorer caused consumers to think that ESMP was more effective at relieving symptoms by making misleading claims of superior relief in its commercials, thereby violating the Lan-ham Act.

B. Commercial Claims

Rorer began airing television commercials in July 1989, claiming that ESMP is “the strongest antacid there is,” or “the strongest antacid I can [could] buy.” 4 Some commercials included the statements, “The doctor told me it was strongest,” or ‘Tour doctor will tell you they’re strongest.” Others contained weaker medical claims, such as “My doctor recommended it,” or “Its doctor recommended formula neutralizes more, more than any leading antacid.” The district court focused on two television commercials, first aired in 1991, the “Firefighter” commercial, which advertised ESMP liquid, and the “Minty Tablets” commercial, which advertised ESMP tablets. Although there were minor differences in these and other commercials aired at different times, the versions described below are typical of the advertisements objected to by Johnson-Merck.

The Firefighter commercial which aired on NBC and CBS in the summer of 1991 showed a fireman saying, “To survive in today’s world, you have to follow certain basics. You have to work, and you have to eat. And both play havoc with your stomach. That’s why I take Maalox.” The screen then showed liquid ESMP, with the voice saying, “Maalox is the strongest antacid there is.” Superimposed on the screen was the text, “Dose for Dose Based on Lab Tests.” The screen showed the fireman again, who went on to say, “And who knows more about stomach problems than Maalox? You know it’s a funny thing.

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19 F.3d 125, 30 U.S.P.Q. 2d (BNA) 1112, 1994 U.S. App. LEXIS 4538, Counsel Stack Legal Research, https://law.counselstack.com/opinion/johnson-johnson-merck-consumer-pharmaceuticals-company-v-rhone-poulenc-ca3-1994.