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recognized” exceptions applies. Wash. Ass’n for Television & Child., 712 F.2d at 681–82. Two exceptions are relevant here: futility and administrative abuse of process.
Start with futility. Plaintiffs need not exhaust claims where they can demonstrate “the futility or inadequacy of administrative review.” Gardner v. Sch. Bd. Caddo. Par., 958 F.2d 108, 112 (5th Cir. 1992); see also Honig v. Doe, 484 U.S. 305, 327 (1988). The futility exception applies when exhaustion would be “clearly useless” and “it is certain [a] claim will be denied.” Tesoro Refin. & Mktg. Co. v. FERC, 552 F.3d 868, 874 (D.C. Cir. 2009) (quotation omitted); see also Carr v. Saul, 141 S. Ct. 1352, 1361 (2021) (“[T]his Court has consistently recognized a futility exception to exhaustion requirements.”).
Given FDA’s 2016 Petition Denial and its 2021 Petition Denial, it would have been futile for plaintiffs to include a challenge to the 2000 Approval in their 2019 Citizen Petition. FDA rejected this exact challenge in its 2016 Petition Denial. So it would have been “clearly useless” to raise the precise challenge again in the 2019 Citizen Petition. Further, this exact reasoning applies with equal force to plaintiffs’ challenge to the 2019 Generic Approval because it’s entirely dependent on the underlying 2000 Approval. Thus, plaintiffs’ challenges to the 2000 Approval and the 2019 Generic Approval are not barred by exhaustion.
Next, administrative abuse of process. It’s well-established that where an agency fails to follow its own regulations, exhaustion may not be required. See Way of Life Television Network, Inc. v. FCC, 593 F.2d 1356, 1359–60 (D.C. Cir. 1979); see also Wash. Ass’n for Television & Child., 712 F.2d at 681. That’s especially true “where the obvious result would be a plain miscarriage of justice.” Hormel v. Helvering, 312 U.S. 552, 558 (1941). Here, FDA was required by its own regulations to respond to citizen petitions within 180
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