Justia Government & Administrative Law Opinion Summaries

A pharmaceutical company sought approval from the Food and Drug Administration (FDA) to market tasimelteon, a drug previously approved for a rare sleep disorder, as a treatment for jet lag. The company submitted results from several clinical trials, focusing on both objective sleep measures and subjective assessments of alertness and next-day functioning. The FDA’s Center for Drug Evaluation and Research issued a complete response letter indicating that the application did not provide substantial evidence of efficacy, particularly criticizing the measurement of next-day impairment and the tools used for subjective endpoints. The company engaged in further discussions and dispute resolution with the FDA, including proposing a narrower indication for approval, but these efforts were unsuccessful.After the FDA issued a formal notice of opportunity for a hearing (NOOH), the company requested a hearing and submitted expert declarations supporting the adequacy of its clinical evidence. The FDA ultimately denied both the application and the hearing request, finding no genuine and substantial issue of fact warranting a hearing. The company then petitioned the United States Court of Appeals for the District of Columbia Circuit for review, arguing that the FDA was required to hold a hearing, that material factual disputes existed, that the FDA’s decision-making was arbitrary and capricious, and that the final decision violated the Appointments Clause.The United States Court of Appeals for the District of Columbia Circuit held that the Food, Drug, and Cosmetic Act does not require the FDA to hold a hearing before denying every new drug application, but the agency must grant a hearing if there are material factual disputes. The court found that, in this case, the FDA’s refusal to hold a hearing was arbitrary and capricious because the company’s expert evidence created genuine disputes over the adequacy of the clinical trials. The court remanded the case to the FDA for further proceedings consistent with its opinion. View "Vanda Pharmaceuticals, Inc. v. FDA" on Justia Law

The case concerns the executive branch’s decision to freeze foreign aid funds that Congress had appropriated for fiscal year 2024. On January 20, 2025, the President issued an executive order directing the State Department and USAID to pause foreign assistance spending, pending a review of those programs. This led to the suspension or termination of thousands of grant awards and significant restructuring within the agencies. Organizations that were recipients of these funds, many of which relied heavily on such funding, challenged the executive order, arguing that the freeze unlawfully impounded funds that Congress had directed to be spent.The United States District Court for the District of Columbia initially granted a temporary restraining order, and later a preliminary injunction, against the executive branch (excluding the President personally). The district court found that the plaintiffs had standing due to financial harm, and that they were likely to succeed on their claims that the executive branch’s actions violated the separation of powers, the Take Care Clause, the Impoundment Control Act (ICA), the Anti-Deficiency Act, and the Administrative Procedure Act (APA). The court ordered the government to make available the full amount of appropriated funds.The United States Court of Appeals for the District of Columbia Circuit reviewed the case and vacated the district court’s preliminary injunction. The appellate court held that the plaintiffs lacked a cause of action to pursue their claims. Specifically, it found that the plaintiffs could not bring a freestanding constitutional claim when the alleged violations were statutory in nature, that the ICA precludes APA review by private parties (reserving enforcement to the Comptroller General), and that the plaintiffs could not reframe their claims as ultra vires actions. The court concluded that, although the plaintiffs had standing, they were not entitled to the preliminary injunction because they were unlikely to succeed on the merits. View "Global Health Council v. Trump" on Justia Law

Terri R. Winnon, a former executive assistant and controller for a group of skilled nursing facilities (SNFs) in Texas, alleged that her former employers and associated entities engaged in fraudulent schemes to obtain improper reimbursements from Medicare and Texas Medicaid. She claimed that the defendants paid unlawful kickbacks to doctors and hospital discharge planners for patient referrals and inflated therapy service bills to maximize government reimbursements. Winnon’s allegations included specific practices such as employee bonuses tied to Medicare census targets, “sham” medical directorships, and “marketing gifts” to hospital staff, as well as systematic upcoding of therapy services by a contracted provider, RehabCare.After Winnon filed her qui tam action under the False Claims Act (FCA) and related Texas statutes, the United States District Court for the District of Columbia dismissed her claims. The court found that her allegations against RehabCare were barred by the FCA’s public disclosure provision, as similar claims had already been made public in a prior lawsuit, United States ex rel. Halpin & Fahey v. Kindred Healthcare, Inc. The district court also determined that Winnon’s claims against the SNF Defendants did not meet the heightened pleading requirements of Federal Rule of Civil Procedure 9(b), as they lacked sufficient particularity regarding the alleged fraudulent conduct.On appeal, the United States Court of Appeals for the District of Columbia Circuit affirmed the district court’s dismissals. The appellate court held that Winnon’s claims against RehabCare were precluded by the public disclosure bar because her allegations were substantially similar to those previously disclosed and she did not qualify as an “original source” under the FCA. Regarding the SNF Defendants, the court concluded that Winnon’s allegations failed to satisfy Rule 9(b)’s requirement for particularity, as she did not provide enough specific details to support a strong inference that false claims were actually submitted. The court affirmed the district court’s judgments in full. View "USA v. Lozano" on Justia Law

After Georgia enacted the Election Integrity Act (SB 202) following the 2020 elections, several organizations and the United States Department of Justice (DOJ) filed lawsuits in the U.S. District Court for the Northern District of Georgia, challenging the law on various grounds, including race discrimination. The DOJ and several plaintiff organizations entered into a common-interest agreement to coordinate their litigation efforts and share privileged attorney work product. Georgia, suspecting improper coordination, submitted a Freedom of Information Act (FOIA) request to the DOJ seeking all communications between the DOJ and the aligned non-governmental plaintiffs. The DOJ produced many documents but withheld or redacted others, citing FOIA Exemption 5, which protects privileged attorney work product from disclosure.The United States District Court for the District of Columbia reviewed Georgia’s suit to enforce its FOIA request. The district court granted summary judgment in favor of Georgia, holding that the communications between the DOJ and non-governmental parties were not “intra-agency” records under Exemption 5 and that the DOJ had waived any work-product privilege by sharing the materials with third parties, even under a common-interest agreement.The United States Court of Appeals for the District of Columbia Circuit reviewed the case de novo. The court held that when the government shares attorney work product with aligned parties under a common-interest agreement, those communications qualify as “intra-agency” materials for purposes of FOIA Exemption 5. The court further held that such sharing does not waive the attorney work-product privilege, provided the parties are aligned and the sharing is pursuant to a common-interest agreement. The court affirmed the district court’s judgment only as to two emails predating the agreement but reversed the remainder of the district court’s decision, allowing the DOJ to withhold the other documents. View "State of Georgia v. DOJ" on Justia Law

Several companies incorporated in Cyprus and the Isle of Man, who were shareholders of OAO Yukos Oil Company, alleged that the Russian Federation unlawfully expropriated Yukos’s assets between 2003 and 2004. The shareholders initiated arbitration proceedings under the Energy Charter Treaty, which Russia had signed but not ratified, claiming that Russia’s actions violated the Treaty’s protections against expropriation. The arbitral tribunal in The Hague found in favor of the shareholders, awarding them over $50 billion in damages. Russia contested the tribunal’s jurisdiction, arguing that it was not bound to arbitrate under the Treaty because provisional application of the arbitration clause was inconsistent with Russian law, and that the shareholders were not proper investors under the Treaty.After the tribunal’s decision, Russia sought to set aside the awards in Dutch courts. The Dutch Supreme Court ultimately upheld the tribunal’s jurisdiction and the awards, finding that Russia was provisionally bound by the Treaty’s arbitration clause and that the shareholders qualified as investors. Meanwhile, the shareholders sought to enforce the arbitral awards in the United States District Court for the District of Columbia. Russia moved to dismiss, asserting sovereign immunity under the Foreign Sovereign Immunities Act (FSIA) and arguing that the arbitration exception did not apply because there was no valid arbitration agreement. The district court denied Russia’s motion, holding that it had jurisdiction under the FSIA’s arbitration exception, and deferred to the arbitral tribunal’s determination that an arbitration agreement existed.On appeal, the United States Court of Appeals for the District of Columbia Circuit held that the existence of an arbitration agreement is a jurisdictional fact under the FSIA that must be independently determined by the district court, rather than deferred to the arbitral tribunal. The court vacated the district court’s judgment and remanded for independent consideration of whether the FSIA’s arbitration exception applies, including whether the Dutch courts’ judgments should have preclusive effect. View "Hulley Enterprises Ltd. v. Russian Federation" on Justia Law

The appellant, a Slovenian-born U.S. permanent resident, claimed to have discovered billions of dollars dispersed across Africa after the death of Muammar Gaddafi. He sought to repatriate these funds to the United States and enlisted the help of a Washington, D.C. lawyer. The appellant alleged that, during his efforts in Kenya and Côte d'Ivoire, he was unable to complete the repatriation due to issues with verifying the legitimacy of Treasury Department letters. He further claimed that, while detained in Côte d'Ivoire, the funds were stolen and replaced with counterfeit cash, and that he was later arrested for alleged money laundering and misrepresentation of U.S. documents. Upon returning to the United States, the lawyer withdrew representation due to the criminal allegations against the appellant.The United States District Court for the District of Columbia dismissed the appellant’s fraud claims in two parts. First, it found that the complaint failed to allege any actionable misrepresentation by the lawyer, noting that the lawyer had provided legal services as agreed. Second, for the claims against three federal employees, the court allowed the United States to substitute itself as defendant under the Westfall Act, as the employees were acting within the scope of their employment. The court then dismissed the claim against the United States on the basis of sovereign immunity.The United States Court of Appeals for the District of Columbia Circuit affirmed the district court’s decision. It held that the appellant’s complaint did not allege with particularity any fraudulent misrepresentation by the lawyer at the time of contract formation. Regarding the federal employees, the court found that the appellant failed to rebut the government’s certification that the employees acted within the scope of their employment, and thus sovereign immunity barred the claim. The court also denied the appellant’s request for leave to amend and for jurisdictional discovery. View "Plevnik v. Sullivan" on Justia Law

A dispute arose between the National Association of Broadcasters (NAB) and the Federal Communications Commission (FCC) regarding a rule requiring broadcasters to disclose if any programming was paid for by a foreign governmental entity. The FCC's 2021 Rule mandated such disclosures and included specific diligence steps for broadcasters to follow. NAB challenged the rule, leading to a court decision that vacated part of the rule requiring broadcasters to search federal databases.The FCC then issued a revised rule in 2024, which retained the core disclosure requirements but modified the diligence steps. The new rule exempted commercial ads and political candidate ads from the disclosure requirement but included paid public service announcements (PSAs) and issue advertisements. NAB challenged the 2024 Rule, arguing it violated the Administrative Procedure Act (APA) and the First Amendment, and exceeded the FCC's statutory authority.The United States Court of Appeals for the District of Columbia Circuit reviewed the case. The court found that the 2024 Rule complied with the APA's notice-and-comment requirements and was neither arbitrary nor capricious. The court also held that the rule did not violate the First Amendment, as it was narrowly tailored to serve a significant governmental interest in preventing foreign influence in U.S. broadcasting. The court further determined that the FCC did not exceed its statutory authority with the reasonable diligence requirements, as the rule did not directly regulate lessees but required broadcasters to seek information from them.Ultimately, the court denied NAB's petition for review, upholding the FCC's 2024 Rule. View "National Association of Broadcasters v. FCC" on Justia Law

The Red Lake Band of Chippewa Indians, a federally recognized tribe, operates several substance-abuse health programs funded by the federal government. To support these programs, the Tribe built the Obaashiing Chemical Health Treatment Center, costing $5.8 million, financed through a $4.95 million loan from the Department of Agriculture and $850,000 of the Tribe's own funds. The Tribe sought compensation from the Indian Health Service (IHS) for both the facility's depreciation and the loan payments under a § 105(l) lease.The United States District Court for the District of Columbia reviewed the case. The Government had compensated the Tribe for depreciation in 2020 and 2021 and for loan payments in 2022 but refused to compensate for both costs each year, citing 25 C.F.R. § 900.70, which prohibits duplicative compensation. The district court upheld the Government's decision, agreeing that compensating for both depreciation and loan payments would be duplicative.The United States Court of Appeals for the District of Columbia Circuit reviewed the case. The court held that the Government correctly declined to compensate the Tribe for both depreciation and loan payments, as doing so would result in duplicative compensation. The court affirmed the district court's judgment regarding the 2022 decision but reversed the judgment for 2020 and 2021. The court instructed the district court to vacate the Government's decision for those years and remand the matter to the agency for further proceedings, allowing the Government to apply its anti-duplication rationale consistently across all years. View "Red Lake Band of Chippewa Indians v. HHS" on Justia Law

The Federal Energy Regulatory Commission (FERC) approved a 1,000-foot natural-gas pipeline crossing the U.S.-Mexico border. The Sierra Club and Public Citizen challenged this approval, arguing that FERC should have exercised jurisdiction over a longer 157-mile pipeline extending into Texas, considered the environmental impact of the entire pipeline, and evaluated alternatives to the border-crossing segment. They also claimed that FERC's approval of the border-crossing pipeline was arbitrary and capricious.The lower court, FERC, concluded that it did not have jurisdiction over the 157-mile Connector Pipeline because it did not cross state lines or carry interstate gas upon entering service. FERC conducted an Environmental Assessment for the 1,000-foot Border Facility, found minimal environmental impact, and deemed it in the public interest. After FERC reaffirmed its conclusions on rehearing, the petitioners sought judicial review.The United States Court of Appeals for the District of Columbia Circuit reviewed the case. The court held that FERC reasonably declined to exercise jurisdiction over the Connector Pipeline under Section 3 of the Natural Gas Act, respecting state regulatory authority. The court also found substantial evidence supporting FERC's conclusion that the Connector Pipeline would not transport interstate gas initially, thus not subjecting it to Section 7 jurisdiction. The court rejected the petitioners' claims that FERC's approval of the Border Facility was arbitrary and capricious, noting the presumption favoring authorization under the Natural Gas Act.Regarding the National Environmental Policy Act (NEPA), the court found that FERC reasonably defined the project's purpose and need, appropriately limited its environmental review to the Border Facility, and did not need to consider the upstream Connector Pipeline's impacts. The court denied the petition, affirming FERC's decisions. View "Sierra Club v. FERC" on Justia Law

The American Burying Beetle, the largest carrion beetle in North America, was listed as an endangered species by the Fish and Wildlife Service in 1989. In 2015, the Service began reevaluating the Beetle's status, prompted by a petition from private entities. The Service's Species Status Assessment Report revealed that the Beetle's current range is larger than initially thought, with several large, resilient populations across the United States. The Service concluded that the Beetle faces a relatively low near-term risk of extinction but is likely to become endangered in the foreseeable future due to future land-use changes and climate change. Consequently, in 2020, the Service downlisted the Beetle from "endangered" to "threatened" and established a Section 4(d) Rule for its conservation.The Center for Biological Diversity challenged the downlisting and the sufficiency of the protections for the Beetle as a threatened species. The United States District Court for the District of Columbia granted summary judgment for the Service, concluding that the Downlisting Rule did not violate the Endangered Species Act, was supported by the administrative record, and was reasonably explained. The court also found that the Center failed to establish standing for its challenges to the Section 4(d) Rule.The United States Court of Appeals for the District of Columbia Circuit affirmed the district court's judgment. The court held that the Service's conclusion that the Beetle was not endangered at the time of the decision in 2020 was reasonable and consistent with the record evidence. The court also found that the Center lacked standing to challenge the Section 4(d) Rule on appeal. The Service's decision to downlist the Beetle to threatened status was based on the best available scientific and commercial data, and the Service's predictions about the Beetle's future viability were adequately explained and supported by the record. View "Center for Biological Diversity v. FWS" on Justia Law