Justia Government & Administrative Law Opinion Summaries

Novartis Pharmaceuticals Corporation manufactures Entresto, a drug used to treat chronic heart failure. MSN Pharmaceuticals, Inc. sought approval from the Food and Drug Administration (FDA) to market a generic version of Entresto by submitting an abbreviated new drug application (ANDA). MSN’s application excluded certain methods of use protected by Novartis’s patents and claimed that the generic drug contained the same active ingredients as Entresto. The FDA approved MSN’s application, prompting Novartis to challenge the approval, arguing that the generic’s labeling and composition were unlawfully different from Entresto.The United States District Court for the District of Columbia reviewed Novartis’s claims under the Administrative Procedure Act. Novartis argued that the FDA’s approval of MSN’s ANDA and denial of Novartis’s citizen petitions were arbitrary and capricious, particularly regarding the omission of patented dosing regimens and indications from the generic’s label, and the determination that the generic contained the same active ingredients as Entresto. The district court granted summary judgment in favor of the FDA, finding that the agency’s actions were reasonable and consistent with statutory and regulatory requirements. Novartis appealed this decision.The United States Court of Appeals for the District of Columbia Circuit affirmed the district court’s judgment. The appellate court held that the FDA reasonably concluded the generic drug’s labeling changes were permissible to avoid patent infringement and did not render the generic less safe or effective for non-patented uses. The court also found that the FDA’s determination that the generic and Entresto shared the same active ingredients was supported by scientific evidence and regulatory guidance. The court applied de novo review to legal questions and deferred to the FDA’s scientific expertise, ultimately upholding the agency’s approval of MSN’s ANDA. View "Novartis Pharmaceuticals Corp. v. Kennedy" on Justia Law

Two individuals brought a lawsuit under the False Claims Act, alleging that a telecommunications company, through a controlled shell entity, fraudulently obtained nearly $113 million in bidding credits during a Federal Communications Commission (FCC) spectrum license auction. The core claim was that the shell entity misrepresented its independence and concealed its relationship with the larger company, which, if disclosed, would have disqualified it from receiving small business credits. The relators asserted that the shell entity never operated as a genuine business and had an undisclosed agreement to transfer licenses to the larger company after a regulatory waiting period.The United States District Court for the District of Columbia twice dismissed the case, first without prejudice and then with prejudice, finding that the public-disclosure bar of the False Claims Act applied. The court concluded that the alleged fraud had already been publicly disclosed through the shell entity’s FCC filings, and that the relators’ complaint did not materially add to the information already available.The United States Court of Appeals for the District of Columbia Circuit reviewed the dismissal de novo. The appellate court held that, even assuming the prior FCC filings constituted public disclosures of substantially the same fraud, the relators qualified as “original sources” because their allegations materially added to the publicly disclosed information. Specifically, the relators provided new evidence that the shell entity never functioned as an independent business and plausibly alleged an undisclosed agreement to transfer licenses, both of which were not revealed in the public filings. The court found that these additions were significant enough to potentially influence the government’s decision to pursue the case. Accordingly, the appellate court reversed the district court’s dismissal and remanded the case for further proceedings. View "United States v. U.S. Cellular Corp." on Justia Law

An instrumentality of Iran attempted to wire nearly $10 million through an American bank, but the funds were blocked by the U.S. government under the International Emergency Economic Powers Act (IEEPA) due to Iran’s designation as a state sponsor of terrorism. Two groups of plaintiffs, each holding substantial judgments against Iran for its support of terrorist acts, sought to attach these blocked funds to satisfy their judgments. The funds had been frozen by the Office of Foreign Assets Control (OFAC) and were the subject of a pending civil-forfeiture action initiated by the United States.The United States District Court for the District of Columbia initially quashed the plaintiffs’ writs of attachment. The court reasoned, first, that the funds were not “blocked assets” as defined by the Terrorism Risk Insurance Act (TRIA) and thus were immune from attachment. Second, it held that the government’s earlier-filed civil-forfeiture action invoked the prior exclusive jurisdiction doctrine, barring any subsequent in rem proceedings against the same property. The district court also noted that the existence of the Victims of State Sponsored Terrorism Fund suggested Congress did not intend to encourage individual attachment actions.On appeal, the United States Court of Appeals for the District of Columbia Circuit reversed. The court held that the funds in question are “blocked assets” under TRIA, as they remain frozen by OFAC and are not subject to a license required by a statute other than IEEPA. The court further held that the prior exclusive jurisdiction doctrine does not bar multiple in rem proceedings filed in the same court. Accordingly, the court concluded that neither sovereign immunity nor the prior exclusive jurisdiction doctrine prevented the plaintiffs from seeking attachment of the funds and reversed the district court’s order quashing the writs of attachment. View "Estate of Levin v. Wells Fargo Bank, N.A." on Justia Law

Several electricity generators challenged a change in how they are compensated for producing reactive power, a component of electricity necessary for grid stability but not directly consumed by end users. For many years, the Midcontinent Independent System Operator (MISO) provided generators with cost-based compensation for reactive power, in addition to market-based payments for real power. In 2022, MISO amended its tariff to eliminate separate compensation for reactive power, meaning neither transmission owners nor independent generators would receive payment for producing it within a standard range. This change was approved by the Federal Energy Regulatory Commission (FERC) and given immediate effect, despite objections from generators who argued they had made investments and entered contracts in reliance on the prior compensation structure.FERC approved MISO’s tariff amendment and denied requests for rehearing, concluding that the comparability standard justified the change and that generators’ reliance interests were either unsupported or outweighed by other considerations. FERC reasoned that generators should not have expected compensation for reactive power to continue indefinitely, especially since prior orders had made such compensation contingent on similar treatment for transmission owners. Generators petitioned the United States Court of Appeals for the District of Columbia Circuit for review, arguing that FERC failed to adequately consider their short-term financial reliance on the previous compensation scheme.The United States Court of Appeals for the District of Columbia Circuit held that FERC acted arbitrarily and capriciously by failing to adequately consider the generators’ short-term reliance interests before allowing the tariff change to take immediate effect. The court did not address the substantive validity of the tariff amendment itself but found that FERC’s explanation was insufficient regarding the abrupt elimination of compensation. The court granted the petitions for review, set aside FERC’s orders, and remanded the matter for further proceedings. View "Capital Power Corp. v. Federal Energy Regulatory Commission" on Justia Law

The case concerns a rule issued by the Federal Maritime Commission in 2024 to address concerns about demurrage and detention charges in maritime shipping. These charges are imposed by ocean carriers and marine terminal operators on shippers, truckers, and other entities for delays in the movement or return of shipping containers. The rule sought to clarify which parties could be billed for these charges, limiting invoices to those in a contractual relationship with the billing party—typically shippers or consignees. However, the rule categorically excluded motor carriers from being billed, even when they had a direct contract with the ocean carrier.Prior to review by the United States Court of Appeals for the District of Columbia Circuit, the Federal Maritime Commission promulgated the rule and responded to public comments. Initially, the Commission suggested that motor carriers in contractual privity could be billed, but later issued a correction stating that motor carriers could not be billed under any circumstances, regardless of contractual relationship. The World Shipping Council, representing ocean carriers, petitioned for review, arguing that the rule was arbitrary and capricious, among other challenges.The United States Court of Appeals for the District of Columbia Circuit found that the Commission’s rule was arbitrary and capricious under the Administrative Procedure Act. The court held that the Commission failed to reasonably explain its exclusion of motor carriers from the set of billable parties, despite its stated rationale of limiting billing to those in contractual privity. The court granted the petition for review, severed and set aside the portion of the rule (46 C.F.R. § 541.4) that confined billing to shippers or consignees, and left the remainder of the rule intact. View "World Shipping Council v. FMC" on Justia Law

A Swiss healthcare company entered into a contract with the Republic of Equatorial Guinea to modernize and operate a medical clinic. After the relationship deteriorated, with Equatorial Guinea refusing to allow the company to run the clinic, the company initiated arbitration in Switzerland and was awarded damages. The parties settled the first arbitration, but the company later sought further damages in a second arbitration. Equatorial Guinea challenged the arbitrators’ jurisdiction, arguing that the contract’s dispute-resolution clause required the company to first seek relief in Equatoguinean courts before pursuing international arbitration. The arbitral panel found the clause ambiguous but ultimately concluded that exhaustion of local remedies was not required and awarded the company over $9 million.The United States District Court for the District of Columbia reviewed the company’s petition to confirm the arbitral award. The court found it had subject-matter jurisdiction under the Foreign Sovereign Immunities Act’s arbitration exception. On the merits, the court deferred to the arbitrators’ interpretation of the dispute-resolution clause, relying on the Supreme Court’s decision in BG Group, PLC v. Republic of Argentina, and confirmed the award.On appeal, the United States Court of Appeals for the District of Columbia Circuit agreed that the district court had jurisdiction but disagreed with its deferential approach to the arbitrators’ interpretation of the dispute-resolution clause. The appellate court held that, in this context, the question of whether exhaustion of local remedies was required is a substantive arbitrability issue for courts, not arbitrators, to decide. The court vacated the district court’s judgment and remanded the case for further proceedings to resolve the proper interpretation of the dispute-resolution clause. View "Marseille-Kliniken AG v. Republic of Equatorial Guinea" on Justia Law

The Environmental Protection Agency (EPA) awarded $16 billion in grants to five nonprofit organizations to support the reduction of greenhouse gas emissions, as part of a larger $27 billion congressional appropriation under the Inflation Reduction Act. The grants were structured through agreements between the nonprofits and EPA, with Citibank acting as a financial agent to hold and disburse the funds. After concerns arose regarding conflicts of interest, lack of oversight, and last-minute amendments to the grant agreements, EPA terminated the grants in early 2025. Citibank, following an FBI recommendation, froze the accounts associated with the grants. The nonprofits sued, seeking to prevent the termination and to restore access to the funds.The United States District Court for the District of Columbia granted a preliminary injunction, ordering EPA and Citibank to continue funding the grants. The district court found it had jurisdiction, concluding the plaintiffs’ claims were not essentially contractual and thus did not need to be brought in the Court of Federal Claims. The court determined the plaintiffs were likely to succeed on their constitutional, regulatory, and arbitrary and capricious claims, and that the balance of harms and public interest favored the injunction.On appeal, the United States Court of Appeals for the District of Columbia Circuit held that the district court abused its discretion in issuing the injunction. The appellate court found that the plaintiffs’ regulatory and arbitrary and capricious claims were essentially contractual, meaning jurisdiction lay exclusively in the Court of Federal Claims, not the district court. The court also held that the constitutional claim was meritless. The equities and public interest, the appellate court concluded, favored the government’s need for oversight and management of public funds. Accordingly, the D.C. Circuit vacated the preliminary injunction and remanded the case for further proceedings. View "Climate United Fund v. Citibank, N.A." on Justia Law

The case concerns a challenge to the United States Department of the Interior’s approval of the 2024–2029 National Outer Continental Shelf Oil and Gas Leasing Program, which authorizes up to three lease sales in the Gulf of Mexico region. Environmental organizations argued that the Department failed to adequately assess the risks to vulnerable coastal communities, did not properly consider the endangered Rice’s whale in its environmental sensitivity analysis, overlooked potential conflicts with other ocean uses, and did not sufficiently balance the program’s projected benefits against its environmental costs. The Department, in coordination with the Bureau of Ocean Energy Management, had developed the program through a multi-year process involving public comment and environmental review.After the Department finalized the program, the environmental groups and the American Petroleum Institute (API) each petitioned for review in the United States Court of Appeals for the District of Columbia Circuit. API later withdrew its petition but remained as an intervenor. The environmental petitioners sought to have the program remanded for further consideration, arguing violations of the Outer Continental Shelf Lands Act (OCSLA). The Department and API contested the petitioners’ standing and the merits of their claims.The United States Court of Appeals for the District of Columbia Circuit held that the environmental petitioners had associational standing to pursue their claims. On the merits, the court found that the Department of the Interior had satisfied OCSLA’s requirements by reasonably evaluating environmental justice concerns, the selection of representative species for environmental sensitivity analysis, and potential conflicts with other uses of the Gulf. The court concluded that the Department’s decision-making process was reasoned and not arbitrary or capricious. Accordingly, the court denied the petition for review, leaving the 2024–2029 leasing program in effect. View "Healthy Gulf v. Department of the Interior" on Justia Law

Judge Pauline Newman, a sitting judge on the United States Court of Appeals for the Federal Circuit, was investigated by a Special Committee of her circuit under the Judicial Councils Reform and Judicial Conduct and Disability Act of 1980. The investigation was initiated after the Chief Judge of the Federal Circuit raised concerns about Judge Newman’s ability to manage her workload due to alleged health and age-related impairments. The Special Committee requested that Judge Newman undergo medical examinations and provide medical records, which she refused, arguing the requests and investigation were unlawful. As a result, the Federal Circuit’s Judicial Council suspended Judge Newman from receiving new case assignments for one year, with the suspension subsequently renewed.Judge Newman filed suit in the United States District Court for the District of Columbia, challenging her suspension on statutory and constitutional grounds. She argued that the Judicial Council exceeded its statutory authority, violated her due process rights by not transferring the matter to another circuit, and that the Act’s case-suspension provision was unconstitutional both facially and as applied. The district court dismissed her statutory and as-applied constitutional claims for lack of jurisdiction, relying on circuit precedent, and rejected her facial constitutional challenge on the merits.On appeal, the United States Court of Appeals for the District of Columbia Circuit affirmed the district court’s judgment. The court held that, under binding precedent from McBryde v. Committee to Review Circuit Council Conduct & Disability Orders of the Judicial Conference of the United States, it lacked jurisdiction to review Judge Newman’s statutory and as-applied constitutional claims. The court further held that Judge Newman’s facial constitutional challenge to the Act’s case-suspension provision failed because the provision has many constitutional applications. The judgment of the district court was affirmed. View "Newman v. Moore" on Justia Law

The case centers on the southwestern willow flycatcher, a bird listed as an endangered subspecies by the United States Fish and Wildlife Service since 1995. The New Mexico Cattle Growers’ Association petitioned the Service to remove the bird from the endangered species list, arguing that it is not a valid subspecies and thus does not qualify for protection under the Endangered Species Act. Their petition relied heavily on a 2015 scientific article by Robert Zink, which critiqued previous studies supporting the subspecies classification. The Service conducted a thorough review, including public comment and expert consultation, and ultimately reaffirmed the subspecies designation, finding that the best available scientific evidence supported its continued listing.The United States District Court for the District of Columbia reviewed the Service’s decision after the Cattle Growers filed suit, claiming the agency’s determination was arbitrary and capricious under the Administrative Procedure Act. The district court granted summary judgment in favor of the Service and its intervenors, the Center for Biological Diversity and the Maricopa Audubon Society, finding that the Service had reasonably explained its reliance on scientific studies and its application of the non-clinal geographic variation standard to determine subspecies validity.On appeal, the United States Court of Appeals for the District of Columbia Circuit reviewed the district court’s summary judgment de novo. The appellate court held that the Service’s decision was neither arbitrary nor capricious, as it was based on a reasonable and well-explained evaluation of scientific evidence. The court rejected the Cattle Growers’ arguments regarding the indeterminacy of the non-clinal geographic variation standard and found no merit in claims of constitutional or procedural deficiencies. The judgment of the district court was affirmed. View "New Mexico Cattle Growers' Association v. FWS" on Justia Law