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Natural Resources Defense Council v. FDA

In this case, a federal district court ruled that NRDC lacked standing to challenge the FDA’s failure to regulate antibacterial soaps because NRDC’s members, who faced a threat of injury from exposure to antibacterial soap in their workplaces, could just buy their own soap and take it to work with them. The court’s holding that a person lacks standing to sue if she can avoid an injury by making an otherwise unnecessary expenditure of money, or changing her behavior in some other undesired way, is contrary to many court decisions and would severely restrict the circumstances in which plaintiffs in environmental, consumer health and safety, and many other types of cases could bring suit. Public Citizen, on behalf of itself and several other organizations, filed an amicus curiae brief in support of NRDC’s appeal to the U.S. Court of Appeals for the Second Circuit challenging the dismissal of the case.

The Second Circuit held that NRDC had presented evidence of standing sufficient to withstand summary judgment as to the regulation of one of the antibiotics at issue but not the other. The court explained that standing may be based on exposure to a potentially dangerous product, and NRDC’s evidence established that triclosan is potentially dangerous and that at least one of its members is frequently exposed to soap that contained triclosan. As to triclocarban, the court explained that NRDC presented no evidence of members’ direct exposure but relied on evidence that the proliferation of triclocarban may contribute to the development of antibiotic-resistant bacteria. The court held that this evidence does not establish an injury sufficiently particularized to satisfy the injury-in-fact requirement of Article III standing. The court vacated the district court’s grant of summary judgment and remanded for further proceedings.

On remand, FDA and NRDC agreed to timetables for publishing tentative final monographs and final monographs for antiseptic hand wash products, health care antiseptic products, and consumer antiseptic hand rub products. The district court entered the agreement as a consent decree.