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 involves a dispute between the operator of a day-care center and various officials and employees of the Alabama Department of Human Resources (ADHR) and the Elmore County Department of Human Resources (EDHR). The operator applied to renew the day-care’s license, but a background check revealed that one employee, V.F., had a prior indicated report for child abuse. ADHR officials informed the operator that the license could not be renewed unless V.F. was terminated or cleared. After V.F. was terminated, further disputes arose regarding documentation and access to the facility. ADHR officials subsequently reported alleged deficiencies, leading to the temporary suspension and eventual revocation of the day-care’s license, as well as the operator’s arrest. The criminal charges were later dismissed, and after an administrative hearing, the day-care was relicensed.Previously, the administrative law judge (ALJ) conditionally affirmed ADHR’s decision to revoke the license but allowed for relicensing if the facility met standards. The Montgomery Circuit Court affirmed the ALJ’s decision, and the Alabama Court of Civil Appeals dismissed a further appeal as moot after the license was reissued. The operator and the day-care then filed a new lawsuit in circuit court against the DHR employees, alleging various torts and seeking declaratory relief. The DHR employees moved to dismiss, arguing collateral estoppel based on the prior administrative proceedings. The circuit court granted the motion, dismissing the claims.The Supreme Court of Alabama reviewed whether the circuit court properly dismissed the claims on collateral estoppel grounds. The Court held that, because the circuit court considered materials outside the complaint, the motion to dismiss was converted to a summary judgment motion. The Court found that the plaintiffs failed to adequately argue that collateral estoppel did not apply and affirmed the circuit court’s judgment. The Supreme Court of Alabama thus affirmed the dismissal of the claims. View "Williams v. Dodd" on Justia Law

The petitioner was convicted in 2016 of conspiracy to commit robbery, burglary, robbery, and first-degree kidnapping, receiving concurrent sentences including 8 to 20 years for robbery and 5 years to life for kidnapping. In November 2022, the Nevada Board of Parole Commissioners assessed him as a high risk to reoffend, denied parole, and scheduled his next hearing for January 2025. The petitioner requested a reassessment, arguing the risk level was incorrect. The Board found an error, reassessed him as moderate risk, and held a new hearing in April 2023, but again denied parole and rescheduled the next hearing for November 2025, nine months later than originally set.The petitioner sought a writ of mandamus from the Supreme Court of the State of Nevada, arguing that the Board unlawfully punished him for seeking reconsideration by delaying his next parole hearing. He claimed this delay was vindictive and violated his due process rights, relying on the presumption of vindictiveness established in North Carolina v. Pearce, 395 U.S. 711 (1969), and its progeny.The Supreme Court of the State of Nevada held that the presumption of vindictiveness may generally arise in parole proceedings if the Board, upon reconsideration, extends the time before a prisoner may be considered for parole again. However, the court concluded that the presumption does not apply when the Board corrects its own error without prompting from an outside tribunal. The court further found that the petitioner failed to demonstrate actual vindictiveness. The Board acted within its statutory discretion in scheduling the next hearing, and the petition for writ relief was denied. View "Stewart v. Board of Parole Commissioners" on Justia Law

Dakota Bay, LLC owns property adjacent to McCook Lake in Union County, South Dakota, and planned to construct a canal connecting its land to the lake. To facilitate this, Dakota Bay’s owner, Michael Chicoine, applied for a shoreline alteration permit and a water permit to use an existing irrigation well to fill and maintain the canal. The McCook Lake Recreation Area Association, which holds a permit to pump water from the Missouri River into McCook Lake, opposed the project. The Association argued that constructing the canal would require a permit to appropriate water from McCook Lake and that the canal would increase water loss from the lake, potentially impairing the Association’s ability to maintain lake levels.The South Dakota Department of Agriculture and Natural Resources Water Management Board held hearings and ultimately denied the Association’s petition for a declaratory ruling, finding that the canal’s construction would not constitute an appropriation of water from McCook Lake. The Board also granted Dakota Bay’s application to use well water for the canal, finding that unappropriated water was available, the use was beneficial and in the public interest, and that it would not unlawfully impair existing water rights. The Association appealed both decisions to the Circuit Court of the First Judicial Circuit, which affirmed the Board’s rulings and also upheld the Board’s decision to quash subpoenas issued by the Association.On further appeal, the Supreme Court of the State of South Dakota affirmed the circuit court’s decisions. The Court held that constructing the canal would not result in an appropriation of water from McCook Lake and thus did not require a water appropriation permit. The Court also held that Dakota Bay’s proposed use of well water for the canal was a beneficial use in the public interest and that the Board did not abuse its discretion in quashing the subpoenas, clarifying that administrative proceedings are governed by the Administrative Procedures Act, not the rules of civil procedure. View "Mccook Lake Recreation Area V. Dakota Bay, LLC" on Justia Law

Several U.S. companies that import products from China challenged the imposition of tariffs on certain Chinese goods, known as List 3 and List 4A tariffs. These tariffs were implemented by the Office of the United States Trade Representative (USTR) after an investigation found that China engaged in unreasonable or discriminatory practices that burdened U.S. commerce. The initial tariffs, covering $50 billion in imports (Lists 1 and 2), were not contested. However, after China retaliated with its own tariffs, USTR expanded the tariffs to cover an additional $200 billion (List 3) and later $120 billion (List 4A) in Chinese imports. The plaintiffs argued that these expanded tariffs exceeded USTR’s statutory authority and violated the Administrative Procedure Act (APA) by failing to properly consider public comments.The United States Court of International Trade reviewed the case first. It found that USTR acted within its authority under Section 307(a)(1)(B) of the Trade Act of 1974, which allows modification of trade actions when the burden on U.S. commerce increases or decreases. However, the court also determined that USTR had not adequately responded to significant public comments as required by the APA. The court ordered a limited remand for USTR to further explain its reasoning and how it considered public input. After USTR provided a more detailed explanation, the trial court sustained the List 3 and List 4A tariffs.On appeal, the United States Court of Appeals for the Federal Circuit affirmed the trial court’s judgment. The appellate court held that Section 307(a)(1)(C) independently authorized USTR’s modifications, allowing escalatory trade actions when the original action was no longer appropriate. The court also found that USTR’s remand redetermination satisfied the APA’s notice-and-comment requirements. Thus, the Federal Circuit affirmed and sustained the challenged tariffs. View "HMTX Industries LLC v. United States" on Justia Law

Several companies that supply electricity generation services in Pennsylvania challenged a billing practice used by a regional electric distribution company (EDC), FirstEnergy. FirstEnergy, which is responsible for delivering electricity to customers, offered its own customers the option to pay for non-commodity goods and services—such as smart thermostats and surge protection—through their regular utility bills, a practice known as “on-bill billing.” However, FirstEnergy did not allow competing electric generation suppliers (EGSs) to use this billing method for their own non-commodity goods and services. The EGSs argued that this practice was unlawfully discriminatory under Section 1502 of the Public Utility Code and Section 2804(6) of the Electricity Generation Customer Choice and Competition Act, which prohibit unreasonable preferences or advantages in utility service.An administrative law judge initially found in favor of the EGSs, concluding that FirstEnergy’s practice gave it a significant competitive advantage and violated the anti-discrimination provisions. However, the Pennsylvania Public Utility Commission (PUC) reversed this decision, reasoning that discrimination only occurs if the EDC provides the billing service to third parties but not to EGSs, which was not the case here. The PUC also determined that the relevant statutes did not require EDCs to offer on-bill billing for non-commodity goods and services to EGSs.The Commonwealth Court of Pennsylvania affirmed the PUC’s decision, holding that the statutory provisions at issue did not obligate EDCs to provide on-bill billing for non-commodity goods and services to EGSs. The Supreme Court of Pennsylvania reviewed the case and agreed with the lower courts. The Court held that EDCs have no statutory duty to provide on-bill billing for non-commodity goods and services to EGSs, and that such billing does not constitute “service,” “electric services,” or “transmission and distribution service” under the relevant statutes. The Court affirmed the order of the Commonwealth Court. View "Interstate Gas Supply, Inc. v. Public Utility Commission" on Justia Law

Entities approved to grow, process, or test medical marijuana in Pennsylvania challenged a regulation issued by the Pennsylvania Department of Health. The Department required that growers and processors use one independent laboratory to test marijuana at harvest and a different independent laboratory to test the product after processing, a rule known as the “two-lab requirement.” The challengers argued that this regulation exceeded the Department’s authority under the Medical Marijuana Act, which states that growers and processors must contract with “one or more independent laboratories” for testing.The Commonwealth Court of Pennsylvania, sitting en banc, reviewed the challenge. It focused on the statutory language in Section 704 of the Act, interpreting the phrase “one or more independent laboratories” to mean that growers and processors could choose to use only one laboratory if they wished. The court concluded that the Department’s two-lab requirement conflicted with the Act and declared the regulation unenforceable. A dissenting opinion argued that the Department had broad regulatory authority under the Act, including the power to require multiple laboratories to ensure patient safety.The Supreme Court of Pennsylvania reviewed the case on direct appeal. It held that the Medical Marijuana Act grants the Department of Health discretion to determine the number of laboratories required for testing, in order to fulfill the Act’s explicit goals, including patient safety and high-quality research. The Court found that the Commonwealth Court erred by interpreting Section 704 in isolation and failing to consider the broader context and policy objectives of the Act. The Supreme Court reversed the Commonwealth Court’s order and remanded the case for further proceedings to address the remaining issues, including whether the two-lab requirement is reasonable. View "Green Analytics North, LLC v. Department of Health" on Justia Law