Neither Safe, Nor Legal, Nor Rare: The D.C. Circuit’s Use of the Doctrine of Ratification to Shield Agency Action from Appointments Clause Challenges

Key to the constitutional design of the federal government is the separation of powers. An important support for that separation is the Appointments Clause, which governs how officers of the United States are installed in their positions. Although the separation of powers generally, and the Appointments Clause specifically, support democratically accountable government, they also protect individual citizens against abusive government power. But without a judicial remedy, such protection is ineffectual—a mere parchment barrier. Such has become the fate of the Appointments Clause in the D.C. Circuit, thanks to that court’s adoption—and zealous employment—of the rule that agency action, otherwise unconstitutional under the clause, may be “ratified” by a constitutionally competent officer. This ratification precludes a court from addressing a plaintiff’s constitutional claims against the original agency action. It is deemed effective regardless of whether it comports with the procedural and substantive limitations applicable to the original action. It is effective as well even if the ratifying federal actor makes no effort to abandon the decision-making procedures that led to the alleged constitutional violation. The D.C. Circuit’s ratification defense should be abandoned. It cannot be squared with United States Supreme Court ratification jurisprudence in analogous contexts, the doctrine of ratification as traditionally understood at common law, or an appropriately vigorous judicial enforcement of the separation of the powers. But if the D.C. Circuit (or the Supreme Court, once it has the opportunity to address the question) does not wish to discard the doctrine altogether, at the very least it should limit the doctrine’s application to cases where the official’s ratification adheres to all of the substantive and significant procedural requirements that typically govern the type of action being ratified

The Hallmarks of a Good Test: A Proposal for Applying the Functional Equivalent Rule From County of Maui v. Hawaii Wildlife Fund

The Clean Water Act generally requires a federal permit for the discharge of pollutants “from any point source” to navigable waters. It is undisputed that permits are required for discharges of pollutants from point sources that proceed “directly” to regulated waters. But there is much disagreement over the extent to which indirect point-source discharges are regulated. In an attempt to clarify, the United States Supreme Court in County of Maui v. Hawaii Wildlife Fund ruled that permits are required not just for direct point-source discharges, but also for any point-source discharge that is the “functional equivalent” of a direct point-source discharge. Unfortunately, the Court did not define the term “functional equivalent,” other than to offer a non-exhaustive list of seven factors to consider (emphasizing time and distance), and to admonish lower courts to both respect the states’ traditional authority over water pollution and be mindful of avoiding decisions that would encourage evasion of the Act’s permitting requirements. To pick up where County of Maui left off, this Article proposes the “hallmark” interpretation of the functional equivalent test. According to this approach, a pollutant discharge is the “functional equivalent” of a direct discharge (and therefore requires a permit) if it bears the hallmarks of a direct discharge—in other words, if the discharged pollutants still betray the traces of having been emitted from a “discernible, confined and discrete conveyance” (the statutory definition of “point source”). In contrast, if the pollutants lack those hallmarks, and thus are indistinguishable from pollutants added by nonpoint sources, then their discharge is not a regulated “functional equivalent.” This “hallmark” approach is consistent not only with County of Maui’s articulation of the functional equivalent rule, but also with the Court’s expectation of how that rule should be implemented. In support of the proposed hallmark analysis, the Article defines the reference point (“direct discharge”) and its functions, then explains how to determine whether the hallmarks of the pollutants at issue are equivalent to the hallmarks of a direct discharge. Finally, it cautions that, consistent with County of Maui’s admonition, the functional equivalent analysis must include a “perspective” check to prevent the Act from being used to undercut the states’ traditional authority over water quality, while also respecting Congress’ intent that certain point-source discharges be federally regulated

Excitability in autonomous Boolean networks

We demonstrate theoretically and experimentally that excitable systems can be built with autonomous Boolean networks. Their experimental implementation is realized with asynchronous logic gates on a reconfigurabe chip. When these excitable systems are assembled into time-delay networks, their dynamics display nanosecond time-scale spike synchronization patterns that are controllable in period and phase.Comment: 6 pages, 5 figures, accepted in Europhysics Letters (epljournal.edpsciences.org

Bone Marrow Transplant

Mucopolysaccharidosis type I-H (MPS I-H) is a rare lysosomal storage disorder caused by α-L-Iduronidase deficiency. Early haematopoietic stem cell transplantation (HSCT) is the sole available therapeutic option to preserve neurocognitive functions. We report long-term follow-up (median 9 years, interquartile range 8-16.5) for 51 MPS I-H patients who underwent HSCT between 1986 and 2018 in France. 4 patients died from complications of HSCT and one from disease progression. Complete chimerism and normal α-L-Iduronidase activity were obtained in 84% and 71% of patients respectively. No difference of outcomes was observed between bone marrow and cord blood stem cell sources. All patients acquired independent walking and 91% and 78% acquired intelligible language or reading and writing. Intelligence Quotient evaluation (n = 23) showed that 69% had IQ ≥ 70 at last follow-up. 58% of patients had normal or remedial schooling and 62% of the 13 adults had good socio-professional insertion. Skeletal dysplasia as well as vision and hearing impairments progressed despite HSCT, with significant disability. These results provide a long-term assessment of HSCT efficacy in MPS I-H and could be useful in the evaluation of novel promising treatments such as gene therapy

Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial

Background Non-alcoholic steatohepatitis (NASH) is a common type of chronic liver disease that can lead to cirrhosis. Obeticholic acid, a farnesoid X receptor agonist, has been shown to improve the histological features of NASH. Here we report results from a planned interim analysis of an ongoing, phase 3 study of obeticholic acid for NASH. Methods In this multicentre, randomised, double-blind, placebo-controlled study, adult patients with definite NASH,non-alcoholic fatty liver disease (NAFLD) activity score of at least 4, and fibrosis stages F2–F3, or F1 with at least oneaccompanying comorbidity, were randomly assigned using an interactive web response system in a 1:1:1 ratio to receive oral placebo, obeticholic acid 10 mg, or obeticholic acid 25 mg daily. Patients were excluded if cirrhosis, other chronic liver disease, elevated alcohol consumption, or confounding conditions were present. The primary endpointsfor the month-18 interim analysis were fibrosis improvement (≥1 stage) with no worsening of NASH, or NASH resolution with no worsening of fibrosis, with the study considered successful if either primary endpoint was met. Primary analyses were done by intention to treat, in patients with fibrosis stage F2–F3 who received at least one dose of treatment and reached, or would have reached, the month 18 visit by the prespecified interim analysis cutoff date. The study also evaluated other histological and biochemical markers of NASH and fibrosis, and safety. This study is ongoing, and registered with ClinicalTrials.gov, NCT02548351, and EudraCT, 20150-025601-6. Findings Between Dec 9, 2015, and Oct 26, 2018, 1968 patients with stage F1–F3 fibrosis were enrolled and received at least one dose of study treatment; 931 patients with stage F2–F3 fibrosis were included in the primary analysis (311 in the placebo group, 312 in the obeticholic acid 10 mg group, and 308 in the obeticholic acid 25 mg group). The fibrosis improvement endpoint was achieved by 37 (12%) patients in the placebo group, 55 (18%) in the obeticholic acid 10 mg group (p=0·045), and 71 (23%) in the obeticholic acid 25 mg group (p=0·0002). The NASH resolution endpoint was not met (25 [8%] patients in the placebo group, 35 [11%] in the obeticholic acid 10 mg group [p=0·18], and 36 [12%] in the obeticholic acid 25 mg group [p=0·13]). In the safety population (1968 patients with fibrosis stages F1–F3), the most common adverse event was pruritus (123 [19%] in the placebo group, 183 [28%] in the obeticholic acid 10 mg group, and 336 [51%] in the obeticholic acid 25 mg group); incidence was generally mild to moderate in severity. The overall safety profile was similar to that in previous studies, and incidence of serious adverse events was similar across treatment groups (75 [11%] patients in the placebo group, 72 [11%] in the obeticholic acid 10 mg group, and 93 [14%] in the obeticholic acid 25 mg group). Interpretation Obeticholic acid 25 mg significantly improved fibrosis and key components of NASH disease activity among patients with NASH. The results from this planned interim analysis show clinically significant histological improvement that is reasonably likely to predict clinical benefit. This study is ongoing to assess clinical outcomes