Plaintiffs sued Colgate over Softsoap Antibacterial soap, alleging state law false advertising claims. Colgate argued that the primary jurisdiction doctrine should justify dismissal or a stay; the court disagreed.
The active ingredient in Softsoap Antibacterial is triclosan, whose safety and effectiveness in hand soaps the FDA has been studying since the 1970s. In 1994, the FDA announced that it lacked sufficient evidence to determine whether triclosan was safe and effective for consumer hand soaps. Its review is ongoing.
Plaintiffs alleged that many scientific studies over the past 15 years raised doubts about triclosan, including evidence that its use can produce resistant bacteria, that it’s a member of a class of chemicals suspected of causing cancer in humans, and that triclosan hand soaps are no more effective at killing bacteria than regular soap and water. Thus, plaintiffs alleged, Colgate falsely or misleadingly implied that antibacterial triclosan soaps were more effective than non-triclosan liquid soaps or regular soap and water; falsely/misleadingly claimed to have clinical proof of its claims; etc. Colgate stopped making consumer products containing triclosan, so plaintiffs voluntarily abandoned their requests for injunctive relief, but still pursued other remedies.
The primary jurisdiction doctrine applies when a claim requires the resolution of issues which have been placed within the special competence of an administrative body, even if the courts have concurrent jurisdiction. This helps promote national uniformity in the interpretation and application of a federal regulatory regime, and it allows courts to use agencies’ expertise in deciding technical factual questions. Thus, a court may suspend the judicial process in order to allow an agency to give its views. The First Circuit considers (1) whether an important issue in the case lies “at the heart of an administrative agency's task”; (2) whether the issue requires the agency's technical expertise; and (3) whether, “though perhaps not determinative, the agency determination would materially aid the court.” These three factors “must be balanced against the potential for delay inherent in the decision to refer an issue to an administrative agency.”
On the first factor: triclosan hand soaps were already over-the-counter in 1972, when the FDA announced the monograph process, by which it would identify conditions under which drugs would be considered safe, effective, and not misbranded. It was grandfathered in, and the FDA still hasn’t completed its review. It issued a proposed monograph on topical antimicrobial products in 1974, finding that there was insufficient data on safety and effectiveness for triclosan in daily, at-home hand washing. In 1978, it issued its first tentative final monograph covering triclosan products. In 1991, it reopened the record and issued an amended tentative final monograph, proposing barring, among other things, triclosan in consumer hand soaps, one year after the final monograph’s publication. In 2003, it reopened the record again. In 2005, a representative of DHHS stated that the “FDA was not aware of any evidence that antibacterial washes were superior to plain soap and water for reducing transmission of or preventing infection for consumers.” In 2009, the FDA announced that it would reissue the tentative final monograph in multiple segments separately covering topical antimicrobial drug products intended for use by consumers, health care professionals, and food handlers separately. It has been unable to provide “a detailed timeline for completion of this process,” but claims to be “working diligently to publish the proposed rule.” It’s not clear whether the final monograph will ban the use of triclosan in consumer hand soaps or limit its use; it will establish labeling requirements, and would be subject to challenge in court.
The court concluded that the task in this case would be backward-looking and historical—were Colgate’s claims misleading and unsubstantiated when made? How would a reasonable consumer have understood those claims? By contrast, the monograph process is forward-looking and wouldn’t involve factual conclusions about Colgate’s past conduct, not its substantiation or what Colgate knew or should have known. Thus, the present case didn’t turn on factual disputes that lie at the heart of the FDA's regulatory authority.
As for the need for agency expertise, “the central issues that will have to be answered to resolve plaintiffs' damage claims do not require the expertise of the FDA.” Again, historical fact determinations about substantiation were well within judicial competence, and the FDA doesn’t have technical expertise “related to questions of fraud and deceit. Courts, by contrast, routinely determine whether past conduct or statements were false or misleading.” In addition, when marketing claims relate to comparative safety or efficacy, the FTC generally takes the lead. “Since both federal courts and the FTC are competent to decide whether labeling and advertising statements were false or misleading, the FDA's special expertise is not required to resolve these issues.”
Nor would an FDA decision materially aid the court in resolving the case. Colgate argued that the allegedly forthcoming monograph could provide “some data that might be useful to one side or the other.” That’s not enough.
On the other side, “[a]ny minimal value that an FDA ruling might have on the resolution of this case is greatly outweighed by the harm that the plaintiffs will suffer if the action is delayed, potentially for several years, until the FDA makes a determination.” Forty years after the FDA began investigating triclosan products, the agency has made several runs at the question, missing “multiple self-imposed deadlines …, most recently in February 2013.” Even after a tentative final monograph issues, 14 more months at minimum will pass before the final monograph, which could still be appealed and stayed. This long, unavoidable delay weighed strongly against applying the primary jurisdiction doctrine.