By Kurt R. Karst –
Earlier this week, the U.S. Court of Appeals for the Second Circuit issued a decision that paves the way for the Natural Resources Defense Council (“NRDC”) to pursue its action to compel FDA to finalize the Agency’s review and regulation of topical antimicrobial drug products (e.g., hand soaps) containing triclosan, but not triclocarban, under the Over-the-Counter (“OTC”) Drug Review. In vacating a January 2011 decision from the U.S. District Court for the Southern District of New York granting FDA’s Motion to Dismiss for lack of standing, the Second Circuit gave new life to some of the merits arguments raised in the NRDC’s Motion for Summary Judgment filed in the district court. Interestingly, the district court granted FDA’s Motion to Dismiss orally after an 8-minute hearing on the basis that the NRDC lacked standing because its members could avoid their workplace exposure to triclosan by purchasing antimicrobial-free soap for use at work.
As we previously reported, the NRDC alleges in its lawsuit that FDA has unreasonably delayed the publication of a final OTC drug monograph with respect to triclosan and triclocarban in violation of the Administrative Procedure Act. According to the NRDC, “both recent and older studies associat[e] triclosan and triclocarban with significant health risks,” and as such, immediate action by FDA is needed. In support of its standing to bring the lawsuit, the NDRC submitted, among other things, the declarations of two members – Ms. Diana Owens, a veterinary technician, and Dr. Megan Schwarzman, a physician – “both of whom fear health harms from their repeated workplace exposure to triclosan and from the development of antibiotic-resistant bacteria through ubiquitous use of both triclosan and triclocarban.”
In tentative final monographs in the OTC Drug Review in 1978 and 1994, FDA designated both triclosan and triclocarban as “Category III” ingredients. (“Category III” ingredients are excluded from a monograph on the basis that there are insufficient data for FDA to determine their status as generally recognized as safe and effective.) In May 2003, FDA reopened the administrative record to accept comments and data on OTC healthcare antiseptic drug products, but the Agency has not taken further action on triclosan and triclocarban under the OTC Drug Review to date. (For the latest FDA update, see here.) Frustrated with FDA’s glacial pace at completing the OTC Drug review for these ingredients, the NRDC decided to sue FDA to compel Agency action.
FDA challenged the NRDC’s standing to sue in this matter, citing the Second Circuit’s decision in Baur v. Veneman, 352 F.3d 625 (2d Cir. 2003). FDA argued in its brief that the Court should affirm the district court’s decision because the NRDC failed to establish injury-in-fact (i.e., that there is an actual and sufficiently serious risk of harm to human health from exposure to topical antimicrobial drug products containing triclosan and triclocarban). Moreover, argued FDA, even if the NRDC did make such a showing, it failed to show involuntary exposure to such products by its members, or that they they suffered a cognizable harm in their efforts to avoid such exposure.
The NDRC argued in its briefs (here and here) that the organization has a clear case for associational standing to bring the lawsuit against FDA, because reasonable apprehension of harm from direct exposure to a chemical, such as triclosan or triclocarban, is a cognizable injury in fact sufficient for standing under Article III of the U.S. Constitution. The NDRC’s efforts were also supported by several public interest organizations in an amicus brief. The amici expressed a common concern that “unduly restrictive decisions concerning standing to sue . . . impair the protection of the public against unlawful action by both public officials and private entities.”
After reviewing the New York district court’s grant of summary judgment and its determination of standing de novo, the Second Circuit vacated the district court decision and remanded it for further proceedings. According to the Court, the NRDC’s evidence is sufficient to satisfy the injury-in-fact requirement to establish standing with respect to triclosan, even though there is scientific uncertainty as to the harmfulness of the ingredient to humans. Moreover, the injury of triclosan exposure is “fairly traceable” to the alleged delay in FDA’s finalizing its regulation of topical antiseptic antimicrobial ingredients under the OTC Drug Review, and “neither the availability of triclosan-free soap for purchase nor the possibility that NRDC members’ employers might be willing to supply triclosan-free soap prevents NRDC from establishing that the triclosan exposure is fairly traceable to FDA’s alleged unreasonable delay in regulating triclosan.”
Moving on the triclocarban, however, the Court found that the injury-in-fact requirement to establish standing was not met. The “NRDC provided no evidence that its members were directly exposed to triclocarban. . . . [Rather, the] NRDC argues that its members suffer injury in fact due to FDA’s alleged delay in finalizing its regulation of triclocarban because the proliferation of triclocarban, together with other antimicrobial antiseptic chemicals, may lead to the development of antibiotic-resistant bacteria.” This, said the Court, is more of a contingent and far-off threatened injury rather than an iminent injury, and does not support standing.
The Court’s decision could increase congressional interest in the outcome of the case. Over the past couple of years, Representatives Ed Markey (D-MA) and Louise Slaughter (D-NY) have doggedly pursued an FDA ban on the use of triclosan in consumer products (see here and here).