• Court Orders Maker of Cold Sore Medication to Change Ads
  • December 6, 2005
  • Law Firm: Reed Smith LLP - Pittsburgh Office
  • A federal court has ordered the maker of RELEEV cold sore medicine to change its advertising and packaging. The ruling is a win for pharmaceutical giant GlaxoSmithKline, which manufactures the competing product, Abreva.

    The Merix Pharmaceutical Corp. has been ordered to remove from RELEEV packaging the statement "1 Day Cold Sore Treatment," and "before" and "after" photographs. The company has ceased to make other claims objected to by Glaxo, such as that RELEEV can prevent cold sores, and cure them in a day.

    Merix had contended the injunctive relief sought by Glaxo would destroy the life work of Merix founder Meryl Squires, a single mother who put herself through community college at night and created the company after concocting a remedy to treat her own cold sores.

    The U.S. District Court for the District of New Jersey was unmoved. "None of these factors...can justify the sale and advertising of RELEEV by means of claims that are not true," the court stated in GlaxoSmithKline Consumer Healthcare, L.P. v. Merix Pharmaceutical Corp., No. 05-898 (DRD) (D.N.J. Sept. 13, 2005).

    Merix's gross profits for the year of 2004 alone could exceed $4 million, the court noted.

    "In light of RELEEV's existing market penetration and in light of its substantial profit margin, the court does not find that a preliminary injunction will destroy Ms. Squire's life work. Whatever adverse effect it may have is a price that must be paid for failing to take curative action voluntarily for such a long period of time."

    Ms. Squires founded Merix after discovering that benzalkonium chloride, a common topical antiseptic, combined with the natural remedy Echinacea, provided her and her friends with relief from cold sores.

    Glaxo's nonprescription product, Abreva, is the only over-the-counter product approved by the Food and Drug Administration to shorten the healing time for cold sores.

    Both products sell for between $15 and $20 a tube.

    From the time Merix launched RELEEV, the company made "extravagant claims" about the product on the Internet, on its packaging and in its advertising, the court stated.

    In 2003, Glaxo alerted the FDA to what it considered to be unfounded claims by Merix and the FDA sent a warning letter to Merix. In response, Ms. Squires modified some of her claims. Glaxo then brought a complaint before the National Advertising Division of the Better Business Bureau, which found in Glaxo's favor. Merix appealed, upon which Glaxo instigated the New Jersey case.

    The New Jersey court rejected claims that RELEEV can prevent cold sores and heal them in one day, noting "[t]here is no clinical evidence to support these claims." Similarly, the court sided with Glaxo on the issue of clinical testing, finding flaws in all of the tests and studies cited by Merix.

    The court also criticized Merix for marketing RELEEV as FDA-approved when its main ingredient was approved as an antiseptic for cuts and wounds rather than as a cold sore healer.

    In addition, the company's claims that RELEEV was highly rated by consumers was based on anecdotal evidence rather than on consumer research, the court stated.

    "The claims that Merix has made for RELEEV ... have been found to be literally false or false in a variety of other ways," the court concluded. The court did support Merix's claim that RELEEV provides relief of symptoms within 24 hours, and refused Glaxo's request to enjoin that claim.

    Why This Matters: Advertisers must be able to substantiate the claims they make in ads. Regulators pay particular attention to claims made in advertisements of health care products.