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.
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