Justia Government & Administrative Law Opinion Summaries

The Food and Drug Administration (“FDA”) approved mifepristone to be marketed with the brand name Mifeprex under Subpart H (the “2000 Approval”). In January 2023, FDA approved a modified REMS for mifepristone, lifting the in-person dispensing requirement.  Plaintiffs (physicians and physician organizations) filed a suit against FDA, HHS, and a several agency heads in the official capacities. Plaintiffs challenged FDA’s 2000 Approval of the drug and also requested multiple grounds of alternative relief for FDA’s subsequent actions. Plaintiffs moved for a preliminary injunction ordering FDA to withdraw or suspend (1) FDA’s 2000 Approval and 2019 Generic Approval, (2) FDA’s 2016 Major REMS Changes, and (3) FDA’s 2021 Mail-Order Decision and its 2021 Petition Denial of the 2019 Citizen Petition. The district court entered an order staying the effective date of the 2000 Approval and each of the subsequent challenged actions.   The Fifth Circuit granted Defendants’ motions for a stay pending appeal. The court wrote that at this preliminary stage, and based on the court’s necessarily abbreviated review, it appears that the statute of limitations bars Plaintiffs’ challenges to the Food and Drug Administration’s approval of mifepristone in 2000. However, Plaintiffs brought a series of alternative arguments regarding FDA’s actions in 2016 and subsequent years. And the district court emphasized that its order separately applied to prohibit FDA’s actions in and after 2016 in accordance with Plaintiffs’ alternative arguments. As to those alternative arguments, Plaintiffs’ claims are timely. Defendants have not shown that Plaintiffs are unlikely to succeed on the merits of their timely challenges. For that reason, Defendants’ motions for a stay pending appeal are denied in part. View "Alliance Hippocratic Medicine v. FDA" on Justia Law

Plaintiff was on active duty with the United States Army. He bought a car from Select Cars of Thornburg in Fredericksburg, Virginia, and financed his purchase with a loan from United Auto Credit Corporation. The loan financed not only the car’s cost but also the cost of Guaranteed Asset Protection. Guaranteed Asset Protection is like extra insurance, covering any amount still due on the car loan after auto insurance is paid out if the car is totaled or stolen. Plaintiff’s claims arise from this single loan. This loan, Plaintiff alleged, violated the Military Lending Act because the loan agreement mandated arbitration and failed to disclose certain information. The district court dismissed the case, holding that the loan was not covered by the Act at all.   The Fourth Circuit affirmed. The court explained that a statutory provision must be given the ordinary meaning it had when it was enacted. Relevant dictionaries, carefully considered, sometimes shed light on that ordinary meaning. Yet here, dueling dictionaries provide more than one linguistically permissible meaning.  But by examining the relevant phrase in its statutory context. This context shows that while “the express purpose” can be used in different senses, it is best read in Section 987(i)(6) to mean the specific purpose. This loan was offered for the specific purpose of financing Plaintiff’s car purchase. And that satisfies Section 987(i)(6)’s relevant condition and the Act is inapplicable. View "Jerry Davidson v. United Auto Credit Corporation" on Justia Law

The Federal Communications Commission (“FCC”) has long monitored local telephone companies’ “access stimulation.” In 2011, the FCC issued rules to address this phenomenon, defining when carriers engage in access stimulation and restricting the rates that they could charge. After local carriers found loopholes in this regulatory system, the FCC revisited and updated these rules, issuing the Updating the Intercarrier Compensation Regime to Eliminate Access Arbitrage (“Access Arbitrage Order”), 34 FCC Rcd. 9035 (2019). Wide Voice, LLC (“Wide Voice”), rearranged its business model and call traffic path in coordination with closely related entities, HD Carrier and Free Conferencing. Wide Voice petitions for review of the FCC’s order, specifically arguing that the FCC unreasonably concluded that it violated Section 201(b) by restructuring its business operations to continue imposing charges that were otherwise prohibited.   The Ninth Circuit denied the petition for review. The panel held that the FCC properly exercised its authority under § 201(b) to hold Wide Voice liable for circumventing its newly adopted rule in the Access Arbitrage Order when the company devised a workaround. Contrary to Wide Voice’s assertions, the FCC need not establish new rules prohibiting the evasion of its existing rules to find a Section 201(b) violation. The panel rejected Wide Voice’s contention that it restructured its business to comply with, rather than evade, the FCC’s new rules. Finally, the panel rejected Wide Voice’s contention that even if the FCC was permitted to find its conduct “unjust and unreasonable,” it did not have fair notice that its practices were unlawful, and therefore the FCC violated its right to due process. View "WIDE VOICE, LLC V. FCC, ET AL" on Justia Law

Schwab Multimedia received a construction permit from the Federal Communications Commission (FCC). But Schwab never built its station. Though the FCC granted Schwab’s first three requests for more time, it denied Schwab’s fourth. Schwab appealed the FCC’s decision, claiming that it was arbitrary and capricious.   The DC Circuit affirmed. The court held that the FCC based its denial of Schwab’s tolling request on three underlying determinations, and those determinations were reasonable. First, the FCC reasonably found that Schwab had no construction site. Indeed, Schwab admitted as much. It told the Media Bureau that the landlord of the original site had “rescinded [its] verbal agreement . . . to use the site.” And it offered no evidence to suggest that it had since secured the landlord’s permission. Second, it was reasonable for the FCC to conclude that site loss was the real reason Schwab could not build. Third, the FCC reasonably held that site loss is not a legitimate basis for tolling. Further, Schwab produced no evidence to show that good cause would support a waiver. View "Levine/Schwab Partnership v. FCC" on Justia Law

Securus Technologies, LLC (Securus), is one of six telecommunications companies providing incarcerated persons calling services (IPCS) in California. In this original proceeding, Securus challenges the decision of the California Public Utilities Commission (PUC) adopting interim rate relief for IPCS in the first phase of a two-phase rulemaking proceeding. Among other things, the PUC’s decision: (1) found IPCS providers operate as locational monopolies within the incarceration facilities they serve and exercise market power; (2) adopted an interim cap on intrastate IPCS rates of $0.07 per minute for all debit, prepaid, and collect calls; and (3) prohibited providers from charging various ancillary fees associated with intrastate and jurisdictionally mixed IPCS.   The Second Appellate District affirmed the PUC’s decision. The court concluded Securus has not shown the PUC erred by finding providers operate locational monopolies and exercise market power. The court held that facts do not—as Securus contends—demonstrate Securus “cannot recover its costs (including a reasonable rate of return)” under the interim rate cap and do not amount to a “clear showing” that a rate of $0.07 per minute “is so unreasonably low” that “it will threaten Securus’s financial integrity.” Thus, Securus has failed to satisfy its “burden of proving . . . prejudicial error” on constitutional grounds. View "Securus Technologies v. Public Utilities Com." on Justia Law

The Bureau of Consumer Financial Protection (“the CFPB”) promulgated the Prepaid Rule, which regulates digital wallets and other prepaid accounts. As relevant here, the Rule requires financial institutions to make certain disclosures by using model language or other “substantially similar” wording. Challenging the Rule on statutory, administrative, and constitutional grounds, PayPal sued the CFPB. The district court reached only PayPal’s statutory claims, vacating part of the Rule because it mandated a “model clause” in violation of the Electronic Fund Transfer Act (“EFTA”). In this case, PayPal and the CFPB proceed on the assumption that EFTA prohibits mandatory model clauses, and so the DC Circuit considered only whether the Prepaid Rule mandates such a clause.   The DC Circuit reversed. The court concluded the CFPB’s Prepaid Rule does not mandate a “model clause” in contravention of EFTA. That the Rule’s content and formatting requirements do not fall within the meaning of “model clause” does not necessarily mean the CFPB can impose whatever content and formatting requirements it chooses. The court directed that on remand, the district court may consider PayPal’s other challenges to the Rule, including the APA and constitutional claims, which remain to be addressed. View "PayPal, Inc. v. CFPB" on Justia Law

In 2019, the Department of Justice announced that it would resume federal executions using a new lethal agent: the drug pentobarbital. Shortly thereafter, Citizens for Responsibility and Ethics in Washington submitted a Freedom of Information Act (FOIA) request for the Bureau of Prisons’ records related to its procurement of pentobarbital. The Bureau of Prisons supplied some records but withheld any information that could identify companies in the government’s pentobarbital supply chain. The Bureau invoked FOIA Exemption 4, which protects, among other things, trade secrets and confidential commercial information. The district court sustained those withholdings and entered judgment for the Bureau.   The DC Circuit reversed. The court concluded that on de novo review that the Bureau of Prisons has not met its burden to justify the challenged nondisclosures. In particular, the Bureau has not provided the detailed and specific explanation required to justify withholding the information as “commercial” and “confidential” under Exemption 4. The court remanded to the district court to determine in the first instance whether and to what extent any information in the public domain is the basis on which the government seeks to withhold any records or reasonably segregable portions thereof under Exemption 4. View "CREW v. DOJ" on Justia Law

The Public Utilities Commission (the Commission or PUC) oversees the California High-Cost Fund A program (CHCF-A), which provides subsidies to small, rural, independent telephone companies that provide local telephone service in rural and remote areas of California. The subsidies defray the high cost of providing service in such areas. Ten small rural telephone companies that participate in CHCF-A subsidies filed this writ proceeding to nullify the Commission’s broadband imputation order. They contend broadband imputation (1) is not authorized by section 275.6, (2) exceeds the authority granted to the Commission by other statutes and the California Constitution, (3) is preempted by federal law, and (4) is an unconstitutional taking of private property.   The Fifth Appellate District denied the telephone companies’ petition for a writ. The court reasoned that to implement broadband imputation in a general rate case, the Commission will be required to conduct several reasonableness inquiries before reaching a decision about a telephone company’s rates. At this point, the “total effect” of broadband imputation on the telephone companies’ rates cannot be determined because the Commission has not made the foregoing reasonableness determinations and established a telephone company’s rate design and CHCF-A subsidy. Consequently, the court wrote it cannot determine that the rates will be so unreasonably low as to be confiscatory in violation of the telephone companies’ constitutional rights. View "Calaveras Telephone Co. v. Public Utilities Commission" on Justia Law

Under the Hatch-Waxman Act, a drug may receive “new chemical entity exclusivity” if no active ingredient in the drug was previously “approved.” The drug Aubagio was awarded this exclusivity because the Food & Drug Administration (“FDA”) determined that Aubagio’s only active ingredient, teriflunomide, had never previously been approved. This case concerns a challenge to Aubagio’s exclusivity period, which Sandoz Inc. raises to secure a solo period of marketing exclusivity for its generic equivalent. Sandoz maintains that teriflunomide was previously “approved” as an impurity in the drug Arava. In the alternative, Sandoz argued that teriflunomide was in fact approved as an active ingredient in Arava. The district court granted summary judgment for the FDA, agreeing with the agency that Aubagio was entitled to exclusivity because teriflunomide had never previously been approved.   The DC Circuit affirmed the district court’s judgment. The court held that while Sandoz did not exhaust its statutory argument before the FDA, in the absence of a statutory or regulatory exhaustion requirement, the court found it appropriate to decide Sandoz’s challenge. When the FDA approves a new drug, it does not also “approve” known impurities in that drug for the purpose of new chemical entity exclusivity. And the record is clear the FDA did not approve teriflunomide as an active ingredient when it approved Arava. Aubagio was therefore entitled to new chemical entity exclusivity, and Sandoz cannot benefit from a solo exclusivity period for its generic equivalent. View "Sandoz Inc. v. Xavier Becerra" on Justia Law

Plaintiff appealed the district court’s dismissal of her putative class action against the West Virginia Parkways Authority, in which she alleges that the Parkways Authority improperly collected fees. And the Parkways Authority appeals the district court’s holding that it was not entitled to sovereign immunity under the United States or West Virginia Constitutions.   Plaintiff relied on the Class Action Fairness Act for jurisdiction. The Fourth Circuit vacated the district court’s judgment and remanded the case remanded to the district court with directions to dismiss without prejudice. The court concluded that here, Section 1332(d)(5)(A) bars jurisdiction under Section 1332(d)(2) of the Class Action Fairness Act. The court explained that the Parkways Authority is the only, and thus “primary,” defendant. And it is a “governmental entity.” The Parkways Authority’s sovereign-immunity claim is strong enough to conclude that the district court “may be foreclosed from ordering relief” against it. So Section 1332(d)(2)’s jurisdictional grant “shall not apply.” Since that is the only provision that Plaintiff relies on to establish jurisdiction over her putative class action, the district court lacked jurisdiction to hear it. View "Blazine Monaco v. WV Parkways Authority" on Justia Law