Justia Government & Administrative Law Opinion Summaries

A biotechnology company developed a gene therapy for two hereditary blood disorders, which may negatively affect patients’ fertility. To address potential deterrence due to fertility concerns, the company created a program offering up to $70,000 for fertility services to patients receiving the therapy. The program was initially limited to privately insured patients, as the company was concerned it might violate federal healthcare statutes if extended to federally insured patients. To clarify the legality, the company requested an advisory opinion from the Department of Health and Human Services (HHS), arguing that the program did not violate relevant statutes and, alternatively, qualified for statutory exceptions.After significant delays and exchanges, HHS issued an unfavorable advisory opinion, concluding the program violated both the Anti-Kickback Statute (AKS) and the Beneficiary Inducement Statute (BIS), and denied immunity from enforcement. The company sued HHS and its officials in the United States District Court for the District of Columbia, challenging both the advisory opinion and the regulations governing timing for advisory opinions. The district court granted summary judgment to HHS, finding that the program violated the AKS and deferring to HHS’s reasoning regarding the BIS exception, while dismissing the challenge to the timing regulations as moot after the opinion was issued.On appeal, the United States Court of Appeals for the District of Columbia Circuit reviewed the district court’s decision de novo. The court affirmed summary judgment for HHS regarding the AKS, holding that the program constituted prohibited remuneration intended to induce patients to purchase the therapy. However, it reversed as to the BIS, finding HHS’s determination arbitrary and capricious due to its failure to explain why the statutory exception did not apply. The court also held that the company had standing to challenge HHS’s timing regulations and that those regulations unlawfully evaded the statutory deadline. The judgment was affirmed in part, reversed in part, and remanded. View "Vertex Pharmaceuticals Inc. v. HHS" on Justia Law

Manufacturers of medical and digital devices, represented by two trade associations, challenged a regulation enacted by the Librarian of Congress under the Digital Millennium Copyright Act (DMCA). The regulation, known as the medical device repair exemption, allows certain third parties to circumvent technological protection measures on medical equipment software for the purpose of diagnosis, maintenance, or repair. The associations contended that this exemption threatened their copyrights by enabling independent service organizations to access and use software that, they argued, was primarily intended for repair and maintenance.The United States District Court for the District of Columbia initially dismissed some of the associations’ claims, including those under the Administrative Procedure Act (APA), on sovereign immunity grounds and found the rulemaking was within the Librarian’s authority and not unconstitutional. On appeal, the United States Court of Appeals for the District of Columbia Circuit reversed in part, directing the district court to evaluate the APA claims. After further rulemaking and additional arguments, including discussion of Supreme Court precedent and the renewal of the exemption, the district court granted summary judgment for the Librarian and Library of Congress. The court concluded that the exemption was consistent with the DMCA, the fair use doctrine, and was supported by the administrative record.On further appeal, the United States Court of Appeals for the District of Columbia Circuit affirmed the district court’s judgment. It held that the Librarian’s adoption and renewal of the medical device repair exemption were not arbitrary or capricious under the APA. The court found the Librarian’s application of the statutory fair use factors reasonable, including determinations that the use was transformative, the software was primarily functional, the amount of use was justified, and the exemption did not harm the market for the original works. The judgment for the Librarian and Library of Congress was affirmed. View "Medical Imaging & Technology Alliance v. Library of Congress" on Justia Law

A natural gas company operating in multiple states applied to the Federal Energy Regulatory Commission (FERC) for permission to build new pipeline facilities and abandon some existing ones, requesting that the costs of these improvements be included in future customer rates. The company’s customers, a group of retail natural gas distributors, challenged the application, arguing that less costly alternatives existed, that the improvements were not justified by customer needs, and that FERC should not pre-determine the rate treatment for the project. The core dispute arose when the customers requested access to specific pipeline flow data, designated as sensitive Critical Energy Infrastructure Information, which was withheld from the public docket. FERC eventually released the requested data, but the customers claimed that the delay impaired their ability to participate meaningfully in the proceedings.FERC granted the company’s application, issuing a Certificate of Public Convenience and Necessity and permitting facility abandonment. The Commission found that the evidence, including flow data, demonstrated the necessity of the project and justified the proposed rate treatment, noting that objections to rates could be addressed in future proceedings. The customers filed a rehearing request, alleging that FERC’s decision was premature and unsupported by substantial evidence due to delayed data access. FERC denied rehearing, later provided the requested data, and solicited comments, but the customers maintained that the timing was inadequate and refused to comment.The United States Court of Appeals for the District of Columbia Circuit reviewed the consolidated petitions. The court found the customers had standing, the case was not moot, and limited its review to arguments raised in the rehearing request. Applying the arbitrary and capricious standard, the court held that FERC’s procedures and consideration of the record, including flow data, were sufficient and did not violate due process. The petitions for review were denied. View "East Tennessee Group v. FERC" on Justia Law

In 2022, Soohyung Kim and his company, through an affiliate, secured a winning bid to purchase TEGNA, a large broadcast television company. The transaction required regulatory approval from the Federal Communications Commission (FCC) within 450 days, as specified in the merger agreement. The proposal drew objections from several organizations and individuals, including labor unions, public interest groups, and a rival bidder. Amid ongoing objections and extended public comment periods, the FCC’s Media Bureau ultimately failed to approve the license transfer within the required timeframe, resulting in the expiration of the merger agreement and obligating Kim’s group to pay significant break-up fees.After the collapse of the merger, the appellants filed suit in the United States District Court for the District of Columbia against both the FCC and various private parties. They alleged constitutional and statutory violations, including Equal Protection claims, Communications Act violations, federal civil rights and conspiracy claims, and D.C.-law tort claims, asserting that the FCC and private parties conspired to prevent the merger based on race. The District Court dismissed all claims. Regarding the FCC, the court found the appellants lacked standing for prospective relief, as they failed to allege a substantial risk of future injury. The court also dismissed the Communications Act claims for lack of jurisdiction. As to the claims against private parties, the court applied Noerr-Pennington immunity and found no plausible basis for the civil rights or tort claims.On appeal, the United States Court of Appeals for the District of Columbia Circuit affirmed the District Court’s dismissal. The court held that the appellants lacked standing against the FCC due to insufficient allegations of likely future injury. The court further held that the claims against private appellees failed because the complaint did not plausibly allege intentional race discrimination or actionable tortious interference, and thus did not state a claim upon which relief could be granted. View "SGCI Holdings III LLC v. FCC" on Justia Law

A group of commercial fishers and buyers of South Atlantic red snapper challenged a regulation issued by the National Marine Fisheries Service. This regulation, under the South Atlantic Snapper-Grouper Fishery Management Plan, established an annual catch limit for red snapper based solely on “landings” (fish brought ashore), without including “dead discards” (fish that die after being caught and thrown back). The fishers argued that this approach failed to prevent overfishing as required by federal law, since dead discards represent a significant and increasing portion of total red snapper mortality.The United States District Court for the District of Columbia granted summary judgment in favor of the Service. The district court concluded that the D.C. Circuit’s recent decision in A.P. Bell Fish Co. v. Raimondo largely resolved the main legal issues. That precedent had determined that federal law does not require the annual catch limit to directly restrict bycatch, such as dead discards, so long as the regulatory mechanism is designed to prevent overfishing. The district court also found no basis to conclude that excluding dead discards from the enforceable limit made it impossible to address overfishing.The United States Court of Appeals for the District of Columbia Circuit reviewed the case. It first rejected the Service’s argument that the case was moot due to a superseding rule (Amendment 59), finding that the fundamental regulatory approach remained unchanged. On the merits, the court concluded that its prior decision in A.P. Bell Fish Co. controlled: the Service’s landings-only annual catch limit does not violate the statutory requirement to specify catch limits at a level that prevents overfishing. The court affirmed the judgment of the district court. View "Slash Creek Waterworks, Inc. v. Lutnick" on Justia Law

Venture Global CP2 LNG and Venture Global CP Express sought authorization from the Federal Energy Regulatory Commission (FERC) to construct and operate a liquefied natural gas (LNG) export terminal and an 85-mile pipeline in Louisiana. FERC’s review included extensive environmental analysis in compliance with the National Environmental Policy Act (NEPA), resulting in an Environmental Impact Statement (EIS) and a Supplemental EIS (SEIS). Both assessments concluded that, with recommended mitigation measures, the project’s environmental impacts, including those on air quality and the commercial fishing industry, would not be significant.Individuals and advocacy groups challenged FERC’s authorization, raising eleven alleged errors under the Natural Gas Act (NGA) and NEPA. After FERC’s initial order in 2024, the challengers sought rehearing. FERC partially granted rehearing to address concerns raised by recent D.C. Circuit decisions and directed additional environmental review, which led to the SEIS. The SEIS found no exceedances of relevant air quality standards for the terminal and compressor station. FERC reaffirmed its authorization in 2025, and subsequent rehearing requests were denied. The challengers then petitioned the United States Court of Appeals for the District of Columbia Circuit for review.The United States Court of Appeals for the District of Columbia Circuit held that FERC’s interpretation and application of the NGA was lawful and not arbitrary, emphasizing the presumption in favor of terminal authorization under Section 3, absent an affirmative showing of inconsistency with the public interest. The court found FERC’s NEPA analysis reasonable, deferring to FERC’s use of established air quality standards and its reliance on expert agency data. The court also upheld FERC’s treatment of cumulative impacts and harm to commercial fisheries as sufficiently addressed and explained. The petitions for review were denied in full. View "For a Better Bayou v. FERC" on Justia Law

Several nonprofit organizations and associations that receive federal funding challenged a memorandum issued by the Office of Management and Budget (OMB) shortly after President Trump’s return to office in 2025. The memorandum, M-25-13, directed federal agencies to temporarily pause the obligation and disbursement of all federal financial assistance to analyze compliance with recent executive orders. Plaintiffs argued that the memorandum called for a sweeping freeze on virtually all federal funding, which they alleged would have catastrophic consequences for federally funded programs.The United States District Court for the District of Columbia initially responded to plaintiffs’ request for emergency relief by issuing a temporary restraining order, and later a preliminary injunction, barring OMB from implementing the memorandum. The district court found that the memorandum was likely to be arbitrary and capricious and possibly beyond OMB’s statutory authority. The court rejected the government’s argument that the case was moot after OMB rescinded the memorandum, relying in part on statements from the White House Press Secretary and ongoing funding disruptions.The United States Court of Appeals for the District of Columbia Circuit reviewed the preliminary injunction. It did not address the merits of the plaintiffs’ legal arguments or the district court’s interpretation of the memorandum. Instead, it concluded that the plaintiffs’ challenge was likely moot because OMB had rescinded the memorandum before the government knew of the lawsuit and had clarified, in guidance issued the day after the memorandum, that a global funding freeze was not intended. The court found that there was no reasonable expectation the government would reissue the challenged action. As a result, the court vacated the preliminary injunction. View "National Council of Nonprofits v. OMB" on Justia Law

Two companies competed for a Federal Aviation Administration (FAA) hardware contract related to air traffic control tower simulators. Adacel, having already secured a related software contract, knew that its own software would be used, giving it an informational advantage over Adsync, which was unaware of the software selection. Adacel’s bid was lower, and it initially won the hardware contract. Adsync protested, and the FAA’s Office of Dispute Resolution for Acquisition (ODRA) found Adacel’s advantage unfair. The FAA allowed Adsync to revise its bid with knowledge of the software, but restricted changes to those attributable to the new information and barred Adacel from revising its bid.After Adsync revised its proposal with significant price reductions, the FAA’s contracting team accepted most, but rejected about $734,000 in reductions pertaining to basic hardware, finding Adsync had failed to justify their connection to the software selection. As a result, Adacel’s bid remained lower, and it again won the contract. Adsync filed a second protest with ODRA, challenging the FAA’s rejection of some price reductions, the technical evaluation, and the best value determination. ODRA concluded that the FAA had a rational basis for its decisions and recommended denial of the protest. The FAA adopted ODRA’s recommendations.Adsync sought review in the United States Court of Appeals for the District of Columbia Circuit. The court held that the FAA did not violate its Acquisition Management System Guidance’s “price realism” provision, as it was not applicable to the remedial rebid context. The court further found substantial evidence supported the FAA’s rejection of certain price reductions and concluded that ODRA did not abuse its discretion in denying bid and proposal costs. Accordingly, the petition was denied. View "Adsync Technologies, Inc. v. FAA" on Justia Law

A pharmaceutical company that manufactures both branded and generic drugs challenged the federal agency rules implementing the Medicare Drug Price Negotiation Program created under the Inflation Reduction Act of 2022. Specifically, the company objected to two rules: first, the agency’s grouping of two drugs with the same active ingredient and manufacturer, but approved under separate applications, as one “qualifying single source drug” for price negotiation; and second, the agency’s requirement that a generic drug must be engaged in “bona fide marketing” to be considered as marketed, which affects when a branded drug exits the negotiation program. The company argued that these rules exceeded the agency’s statutory authority and that the program deprived it of protected property interests without due process.The United States District Court for the District of Columbia reviewed the case. It found that the statutory bar on judicial review did not prevent the company’s challenges to generally applicable agency guidance. On the merits, the district court upheld the agency’s definition of a qualifying single source drug, ruled that the challenge to the “bona fide marketing” standard was not yet ripe, and rejected the due process claim due to lack of a protected property interest. The company appealed.The United States Court of Appeals for the District of Columbia Circuit reviewed the case de novo. The appellate court held that the statutory review bar precludes review only of drug-specific determinations, not generally applicable legal standards. On the merits, it concluded that the statute permits the agency to treat drugs with the same active ingredient and manufacturer as one statutory drug. The court found that the due process challenge failed because the company lacked a protected property interest. However, it determined that the challenge to the “bona fide marketing” requirement was ripe and remanded that issue to the district court for further proceedings. The court thus affirmed in part, reversed in part, and remanded. View "Teva Pharmaceuticals USA, Inc. v. Kennedy" on Justia Law

The Export-Import Bank of the United States (Eximbank) agreed to lend up to $5 billion to support the development of a major liquefied natural gas project in Mozambique. After insurgent attacks in the project area halted operations, Eximbank approved an amendment in 2025 to allow disbursement of funds on a revised schedule. Two environmental organizations, Friends of the Earth U.S. and Justiça Ambiental, argued that Eximbank’s actions violated statutory requirements by failing to provide a notice-and-comment period or disclose certain economic and environmental analyses before approving the amendment. The organizations claimed the project’s restart would intensify local conflict, cause environmental harm, and impair their ability to serve affected communities.The United States District Court for the District of Columbia denied the plaintiffs’ motion for a preliminary injunction. The court found that the plaintiffs were unlikely to show standing for most of their claims, including lack of a notice-and-comment period and diversion of organizational resources. However, the district court concluded they had a substantial likelihood of standing on an informational injury theory relating to Eximbank’s failure to provide environmental information, but determined the plaintiffs had not shown a likelihood of success on the merits for any of their claims.The United States Court of Appeals for the District of Columbia Circuit reviewed the denial of the preliminary injunction. The court affirmed the district court’s decision. It held that the plaintiffs failed to establish organizational standing because their alleged injuries were either not particularized or too attenuated. The court concluded the plaintiffs demonstrated a substantial likelihood of informational standing for environmental information but failed to show a likelihood of success on the merits, because NEPA does not apply to projects with effects entirely outside U.S. jurisdiction and Eximbank’s disclosure obligations were not triggered. The denial of the preliminary injunction was therefore affirmed. View "Friends of the Earth v. Export-Import Bank" on Justia Law