Justia U.S. D.C. Circuit Court of Appeals Opinion Summaries

Jazz Pharmaceuticals, Inc. (Jazz) challenged the FDA's approval of Avadel CNS Pharmaceuticals Inc.'s (Avadel) drug Lumryz, which contains the same active ingredient, oxybate, as Jazz's drug Xywav. Jazz argued that the FDA's approval violated its seven-year marketing exclusivity under the Orphan Drug Act (ODA). The key issue was whether Lumryz and Xywav are considered the "same drug" under the ODA, which would bar the FDA from approving Lumryz during Xywav's exclusivity period.The United States District Court for the District of Columbia granted summary judgment in favor of the FDA and Avadel, concluding that the FDA's approval of Lumryz did not violate the ODA. The court reasoned that the statutory text, history, and purpose indicated that Congress intended to incorporate the FDA's regulatory definition of "same drug," which includes a clinical superiority requirement. The court found that Lumryz, being clinically superior to Xywav due to its once-nightly dosing regimen, was not the "same drug" as Xywav.The United States Court of Appeals for the District of Columbia Circuit affirmed the district court's decision. The appellate court held that the FDA did not act beyond its statutory authority in approving Lumryz. The court concluded that Congress, by amending the ODA in 2017, intended to incorporate the FDA's longstanding regulatory definition of "same drug," which includes the concept of clinical superiority. Since Lumryz was found to be clinically superior to Xywav, it was not considered the "same drug," and thus, the FDA's approval of Lumryz during Xywav's exclusivity period was lawful. View "Jazz Pharmaceuticals, Inc. v. Kennedy" on Justia Law

A group of entities managing a university hospital and a union representing the hospital’s service workers have been negotiating a successor agreement since 2016. The hospital proposed three key changes: granting itself unilateral control over employment terms, imposing a no-strike clause, and eliminating binding arbitration. The National Labor Relations Board (NLRB) found that these proposals collectively constituted bad faith bargaining, as they would leave union employees worse off than if no contract existed.An Administrative Law Judge (ALJ) initially sustained the complaint against the hospital, concluding that the hospital violated Sections 8(a)(1) and 8(a)(5) of the National Labor Relations Act (NLRA) by bargaining in bad faith. The ALJ found that the hospital’s proposals, including a restrictive grievance-arbitration procedure and a broad management rights clause, indicated an intent to undermine the bargaining process. The hospital’s regressive bargaining tactics further supported this conclusion.The United States Court of Appeals for the District of Columbia Circuit reviewed the case. The court upheld the NLRB’s findings, agreeing that the hospital’s conduct amounted to bad faith surface bargaining. The court found substantial evidence supporting the NLRB’s conclusion that the hospital’s proposals, taken together, would strip the union of its representational role and leave employees with fewer rights than they would have without a contract. The court also upheld the NLRB’s procedural decisions, including vacating an earlier decision due to a board member’s financial conflict of interest and seating a new member for the final decision.The court denied the hospital’s petition for review and granted the NLRB’s cross-application for enforcement, affirming the NLRB’s order for the hospital to recognize and bargain with the union, rescind unilateral changes, compensate affected employees, and submit periodic reports on bargaining progress. View "District Hospital Partners, L.P. v. NLRB" on Justia Law

Michael Solondz, a commercial airline pilot, was diagnosed with anxiety and prescribed mirtazapine after experiencing side effects from another medication. Mirtazapine effectively managed his anxiety without significant side effects. Solondz sought medical clearance from the Federal Aviation Administration (FAA) to resume flying, but the FAA categorically disallows pilots from flying while taking mirtazapine, despite allowing conditional approvals for other antidepressants.The FAA denied Solondz's request for a Special Issuance medical certificate multiple times, citing his use of mirtazapine, anxiety, sleep apnea, optic neuritis, and a history of atrial fibrillation. Solondz provided evidence that his conditions were well-managed and that mirtazapine did not cause significant side effects. The FAA's final denial letter reiterated these reasons and added a concern about a potential malignant melanoma diagnosis, which Solondz disputed.The United States Court of Appeals for the District of Columbia Circuit reviewed the case. The court found that the FAA failed to provide a reasonable explanation for categorically disallowing pilots taking mirtazapine from obtaining medical certification. The court noted that the FAA's process for conditionally approving other antidepressants involves a six-month waiting period and individualized medical assessments, which could also apply to mirtazapine.The court vacated the FAA's final denial letter and remanded the case for further explanation. The court emphasized that the FAA must articulate a clear rationale for its policy and avoid offering explanations that contradict the evidence. The petition for review was granted, and the case was remanded to the FAA for further proceedings consistent with the court's opinion. View "Solondz v. FAA" on Justia Law

Radio Communications Corporation (RCC), a telecommunications and media company, petitioned for review of a final order issued by the Federal Communications Commission (FCC) implementing the Low Power Protection Act (LPPA). The LPPA allows low power television (LPTV) stations to apply for an upgrade to a Class A license if they meet certain criteria, including operating in a Designated Market Area (DMA) with not more than 95,000 television households. The FCC's order adopted this limitation and used Nielsen’s Local TV Report to determine a station’s DMA.RCC operates an LPTV station, W24EZ-D, in Connecticut, which is licensed to serve Allingtown, a neighborhood of West Haven with fewer than 15,000 television households. However, the station is part of the Hartford-New Haven DMA, which has approximately one million television households. RCC challenged the FCC's order, arguing that the size limitation should apply to a station’s community of license, not its DMA. RCC also raised other statutory and constitutional arguments, including claims that the order contravenes section 307(b) of the Communications Act, violates the Commerce Clause, improperly delegates legislative authority to Nielsen, and restricts programming content in violation of the First Amendment.The United States Court of Appeals for the District of Columbia Circuit reviewed the case. The court held that the FCC's order adheres to the best reading of the LPPA, which clearly limits Class A license eligibility to LPTV stations operating in a DMA with not more than 95,000 television households. The court found that the FCC properly defined DMA according to Nielsen’s data, as authorized by Congress, and that the statute does not reference "community of license." The court also rejected RCC's constitutional arguments, finding that the FCC's interpretation did not violate the Commerce Clause or the nondelegation doctrine. Consequently, the court denied RCC's petition for review. View "Radio Communications Corporation v. FCC" on Justia Law

The case involves two organizations, Doc Society and International Documentary Association (IDA), which promote documentary filmmaking globally. They challenged a policy by the Secretary of State requiring visa applicants to disclose their social media information from the past five years. The plaintiffs argued that this policy violated the First Amendment and the Administrative Procedure Act, claiming it impeded their core activities and harmed their members.The United States District Court for the District of Columbia found that the plaintiffs had organizational standing but dismissed their claims on the merits, stating they failed to state a claim under the First Amendment or the Administrative Procedure Act. The district court dismissed the complaint with prejudice.The United States Court of Appeals for the District of Columbia Circuit reviewed the case. The court concluded that the plaintiffs did not adequately allege that a favorable decision would redress their claimed injuries. The court found that the plaintiffs lacked standing because they did not provide specific allegations showing that their partners and members would return to their prior use of social media or reconsider their willingness to travel to the United States if the policy were vacated. The court reversed the district court's determination that the plaintiffs had standing, vacated the remainder of the district court's order, and remanded the case for further proceedings, including whether the plaintiffs should be granted leave to amend their complaint. View "Doc Society v. Rubio" on Justia Law

N.S. was arrested for robbery and destruction of property and was released on his own recognizance by a Magistrate Judge. However, before he could leave the courthouse, U.S. Marshals detained him based on an ICE detainer. N.S. filed a class complaint alleging that the Marshals acted beyond their statutory authority by making a civil immigration arrest, violating the Administrative Procedure Act.The United States District Court for the District of Columbia certified the proposed class and granted N.S.'s request for a permanent injunction, prohibiting Marshal Dixon and his agents from arresting and detaining criminal defendants in the Superior Court for suspected civil immigration violations. The court held that the Marshals were not authorized to make civil immigration arrests as they had not undergone the required training. The court also found that the 2002 Order delegating authority to the Marshals lacked sufficient legal support.The United States Court of Appeals for the District of Columbia Circuit reviewed the case. The court held that the Marshals were not authorized to make civil immigration arrests due to the lack of required training. However, the court found that the class-wide injunction issued by the district court was barred by 8 U.S.C. § 1252(f)(1), which prohibits lower courts from enjoining the operation of certain immigration provisions. The court vacated the injunction and remanded the case to the district court to reconsider the appropriate remedy. View "N.S. v. Dixon" on Justia Law

In 2013, the Metropolitan Municipality of Lima (Lima) and Rutas de Lima S.A.C. (Rutas) entered into a Concession Contract for the construction and operation of urban roads in Lima, Peru. Rutas agreed to finance and manage the project in exchange for toll revenue, while Lima was responsible for preliminary infrastructure activities. Subsequent agreements transferred these preliminary responsibilities to Rutas in exchange for toll rate increases. Social protests erupted in response to these increases, leading Lima to close a toll unit and refuse further rate hikes. Rutas initiated two international arbitrations, claiming Lima breached the contract. Lima argued the contract was void due to bribery by Rutas’s parent company, Odebrecht S.A.The District Court for the District of Columbia reviewed the case after two arbitration tribunals ruled in favor of Rutas, finding insufficient evidence of corruption linked to the Concession Contract. Lima sought to vacate the arbitration awards, citing violations of U.S. public policy against corruption, fraud by Rutas in discovery, and misconduct by the second tribunal in excluding evidence. The District Court denied Lima’s petitions and confirmed the awards, concluding that Lima failed to prove the contract was obtained through bribery and that any alleged discovery misconduct did not prejudice Lima’s case.The United States Court of Appeals for the District of Columbia Circuit affirmed the District Court’s judgment. The court held that the arbitration tribunals’ findings were supported by the record and that there was no sufficient evidence linking Odebrecht’s bribes to the Concession Contract. The court also found no merit in Lima’s claims of discovery fraud and tribunal misconduct, noting that Lima suffered no prejudice from the exclusion of evidence. The court concluded that enforcing the arbitration awards did not violate U.S. public policy. View "Metropolitan Municipality of Lima v. Rutas De Lima S.A.C." on Justia Law

MCS Industries, Inc. (MCS), a shipper, filed a complaint with the Federal Maritime Commission (FMC) against MSC Mediterranean Shipping Company S.A. (Mediterranean), alleging violations of the Shipping Act of 1984. MCS claimed that Mediterranean failed to provide agreed cargo space, forced MCS to pay higher rates on the spot market during the Covid-19 pandemic, refused to deal with MCS, discriminated against shippers at certain ports, and engaged in unreasonable business practices. Mediterranean initially provided some discovery material but later refused further requests, citing jurisdictional issues and Swiss law restrictions on document production.The Administrative Law Judge (ALJ) ordered Mediterranean to comply with discovery requests, but Mediterranean continued to resist, arguing that the FMC lacked jurisdiction and that Swiss law precluded compliance. After multiple warnings and attempts to resolve the discovery issue, including a failed Hague Convention request, the ALJ issued a default judgment against Mediterranean, ordering it to pay reparations to MCS. The FMC affirmed the default judgment, remanding only to recalculate reparations and consider sanctions for delay.The United States Court of Appeals for the District of Columbia Circuit reviewed the case. The court held that the FMC had jurisdiction over the complaint, as the allegations involved violations of the Shipping Act, not merely breach of contract claims. The court also found that the FMC did not abuse its discretion in issuing a default judgment. The court noted that Mediterranean's refusal to comply with discovery orders prejudiced MCS, burdened the FMC, and undermined the authority of the Commission. The court denied Mediterranean's petitions for review, affirming the FMC's decision. View "MSC Mediterranean Shipping Company S.A. v. Federal Maritime Commission" on Justia Law

Junius Joyner, III, an African-American male, was hired by a legal staffing agency, Mestel & Company (Hire Counsel), and assigned to work at Morrison & Foerster LLP in Washington, D.C. He worked on the merger of Sprint Corporation with T-Mobile U.S., Inc. from July to December 2019. Joyner alleged several incidents of racial discrimination and a hostile work environment, including delayed work assignments, derogatory comments, and harassment by coworkers. He also claimed wrongful discharge under D.C. law, asserting he was terminated after reporting potential antitrust violations.The United States District Court for the District of Columbia dismissed Joyner’s complaint for failure to state a claim. The court found that Joyner did not provide sufficient facts to support his claims of racial discrimination and a hostile work environment under 42 U.S.C. § 1981 and Title VII. The court also dismissed his wrongful discharge claim under D.C. law, concluding that it lacked supplemental jurisdiction over this state law claim.The United States Court of Appeals for the District of Columbia Circuit reviewed the case de novo. The court affirmed the district court’s dismissal of Joyner’s federal claims, agreeing that Joyner failed to plausibly allege that his treatment was racially motivated or that the work environment was sufficiently hostile. The court found that Joyner’s allegations did not meet the necessary standard to infer racial discrimination or a hostile work environment. However, the appellate court vacated the district court’s judgment on the wrongful discharge claim, holding that the district court lacked jurisdiction over this claim and remanded it with instructions to dismiss for lack of jurisdiction. View "Joyner v. Morrison and Foerster LLP" on Justia Law

Seven District of Columbia citizen-voters filed a complaint challenging the constitutionality of the Local Resident Voting Rights Amendment Act of 2022, which allows noncitizens to vote in municipal elections. The plaintiffs argued that this law dilutes their votes, discriminates against U.S. citizens, and violates the constitutional right to citizen self-government. The District of Columbia Board of Elections, responsible for implementing the law, was named as the defendant.The case was initially brought in D.C. Superior Court, but the Board removed it to the United States District Court for the District of Columbia. The Board then moved to dismiss the case, arguing that the plaintiffs lacked standing and failed to state a claim. The district court agreed with the Board, holding that the plaintiffs did not demonstrate any individual disadvantage and thus lacked standing. The court dismissed the complaint, characterizing the plaintiffs' grievances as generalized and insufficient to confer standing.The United States Court of Appeals for the District of Columbia Circuit reviewed the case. The court held that the plaintiffs had standing to sue because they alleged a concrete and particularized injury: the dilution of their votes due to the expansion of the electorate to include noncitizens. The court distinguished this case from others where plaintiffs failed to show individualized harm. The court found that the plaintiffs' claims were specific to their voting power in D.C. local elections and not merely a generalized grievance. Consequently, the court reversed the district court's dismissal and remanded the case for further proceedings. The Board's cross-appeal was dismissed as moot. View "Hall v. District of Columbia Board of Elections" on Justia Law