1. What are the limitations of the studies on which Pfizer relied?

2. Why are mouthwash and floss competitors?

3. Describe the standards the court uses for stopping a misleading or false ad.

In June 2004, Pfizer Inc. (“Pfizer”) launched a consumer advertising campaign for its mouthwash, Listerine Antiseptic Mouthrinse. Print ads and hang tags on the bottles in the stores featured an image of a Listerine bottle balanced on a scale against a white container of dental floss.

The campaign also featured a television commercial called the “Big Bang.” The commercial announced that “Listerine’s as effective as floss at fighting plaque and gingivitis. Clinical studies prove it.” There had been two studies on floss vs. mouthwash, but the studies concluded that flossing was still necessary in addition to mouthwash. The studies were suggesting that mouthwash with no flossing is better than nothing at all but still concluded that there was no substitute that brought the same results as flossing.

McNeil-PPC, Inc. (“PPC”) (and a division of Johnson & Johnson), the market leader in sales of string dental floss and other interdental cleaning products, brought suit alleging that Pfizer had engaged in false advertising in its conclusions about the studies and the use of floss and asked for an injunction halting the ads.

JUDICIAL OPINION

CHIN, District Judge … Traditionally, the “most widely recommended” mechanical device for removing interproximal plaque is dental floss. The ADA recommends “brushing twice a day and cleaning between the teeth with floss or interdental cleaners once each day to remove plaque from all tooth surfaces.” Flossing provides a number of benefits. It removes food debris and plaque interdentally and it also removes plaque subgingivally. As part of a regular oral hygiene program, flossing helps reduce and prevent not only gingivitis but also periodontitis and caries. Some 87 percent of consumers, however, floss either infrequently or not at all. Although dentists and dental hygienists regularly tell their patients to floss, many consumers do not floss or rarely floss because it is a difficult and time-consuming process.

As a consequence, a large consumer market exists to be tapped. If the 87 percent of consumers who never or rarely floss can be persuaded to floss more regularly, sales of floss would increase dramatically. PPC has endeavored, with products such as the RADF and the Power Flosser, to reach these consumers by trying to make flossing easier. Pfizer has come to realize that if it could convince consumers who were reluctant flossers that they could obtain the benefits of flossing by rinsing with Listerine, it would be in a position to see its sales of Listerine increase dramatically….

[T]herefore, Pfizer and PPC are competitors. Pfizer sponsored two clinical studies involving Listerine and floss: the “Sharma Study” and the “Bauroth Study.” These studies purported to compare the efficacy of Listerine against dental floss in controlling plaque and gingivitis in subjects with mild to moderate gingivitis.

The authors (of the Sharma study) concluded that the study provided “additional support for the use of the essential oil mouth rinse as an adjunct to mechanical oral hygiene regimens.” They cautioned that “[professional recommendations to floss daily should continue to be reinforced.”

The Bauroth Study authors concluded: “[W]e do not wish to suggest that the mouth rinse should be used instead of dental floss or any other interproximal cleaning device.” The ADA reported on the Pfizer studies in its own Web site. The ADA wrote that “[w]hile some study results [referencing the Sharma and Bauroth Studies] indicate the use of a mouth rinse can be as effective as flossing for reducing plaque between the teeth,” it continued to recommend “brushing twice a day and cleaning between the teeth with floss or interdental cleaners once each day.” ……………………