Immediately after the Food and Drug Administration (FDA) issued a warning letter to Johnson & Johnson Consumer Products, Inc. to challenge the company’s promotion of Listerine Total Care Anticavity Mouthwash® as an anti-plaque product, putative class actions alleging consumer fraud were filed against the company in California and Florida. Britton v. Johnson & Johnson, McNeil PPC Inc., No. 10-04450 (U.S. Dist. Ct., N.D. Cal., filed October 1, 2010); Pelkey v. McNeil Consumer Healthcare, No. 10-61853 (U.S. Dist. Ct., S.D. Fla., filed October 5, 2010).
The California plaintiff reportedly seeks to certify a nationwide class of consumers and asks the court for compensatory and punitive damages. The Florida plaintiff seeks to certify a statewide class of consumers and seeks restitution and disgorgement as well as an injunction to stop the alleged unlawful practices.
The FDA warning letter refers to the claims appearing on the product label and asserts that its disease prevention text (“Helps prevent cavities”) makes the product a drug. The letter also contends that because the mouthwash “is not generally recognized as safe and effective for the antiplaque indications in its labeling, … it is, therefore, a new drug [which] may not be introduced or delivered for introduction into interstate commerce unless it is the subject of an FDA-approved application.” According to the letter, the marketing of the product without an FDA-approved application violates the Federal Food, Drug, and Cosmetic Act. FDA gives the company 15 working days from receipt of the letter to correct the identified violations. See Mealey’s Class Actions, October 7, 2010.
It has become increasingly common in the United States for consumer fraud lawsuits to follow regulatory action against a product manufacturer. These cases are part of the trend, and both refer to the FDA action to bolster their allegations.