Vanda Pharmaceuticals, Inc. sought fast track designation from the FDA for its investigational drug, tradipitant, intended to treat gastroparesis. The FDA denied the request, citing a partial clinical hold on the drug due to the lack of long-term animal studies to assess its toxicological effects. Vanda argued that the FDA's denial was arbitrary, capricious, and contrary to law.The United States District Court for the District of Columbia granted summary judgment in favor of the FDA, upholding the agency's decision. Vanda then appealed to the United States Court of Appeals for the District of Columbia Circuit.The Court of Appeals affirmed the District Court's decision, holding that the FDA's denial of Vanda's fast track application was neither contrary to law nor arbitrary and capricious. The court found that the FDA properly considered the drug's development plan, including the clinical hold, in assessing whether tradipitant demonstrated the potential to address unmet medical needs. The court also noted that the FDA's definition of the unmet medical need as long-term treatment of gastroparesis symptoms was reasonable, given the chronic nature of the condition and the existing short-term treatment options. The court rejected Vanda's arguments that the FDA's decision was inconsistent with its prior positions and that the agency improperly considered the clinical hold. The court concluded that the FDA's decision was supported by a rational connection between the facts found and the choice made. View "Vanda Pharmaceuticals, Inc. v. FDA" on Justia Law

Dr. Susan Neese and Dr. James Hurly, both doctors in Amarillo, Texas, filed a pre-enforcement challenge against the Department of Health and Human Services (HHS) regarding the Notification of Interpretation and Enforcement of Section 1557 of the Affordable Care Act and Title IX of the Education Amendments of 1972. The Notification, issued in May 2021, interprets the prohibition on sex discrimination to include discrimination based on sexual orientation and gender identity. The plaintiffs, who are unwilling to provide certain gender-affirming care, feared that their medical practices might be viewed as discriminatory under the Notification, potentially leading to enforcement actions and loss of federal funding.The United States District Court for the Northern District of Texas granted summary judgment in favor of the plaintiffs. The district court found that the plaintiffs had standing to challenge the Notification and ruled in their favor.The United States Court of Appeals for the Fifth Circuit reviewed the case and determined that the plaintiffs lacked Article III standing. The court found that the plaintiffs had not demonstrated how their conduct constituted gender-identity discrimination under any plausible interpretation of the Notification. The plaintiffs did not view their own practices as discriminatory, nor did they provide evidence that HHS would view them as such. Additionally, there was no indication that an enforcement proceeding was imminent. As a result, the Fifth Circuit vacated the district court's judgment and remanded the case with instructions to dismiss the plaintiffs' claims for lack of jurisdiction. View "Neese v. Becerra" on Justia Law

Randell Shepherd, a career coal miner, filed a claim for benefits under the Black Lung Benefits Act (BLBA), invoking the Act’s presumption that he was entitled to benefits due to his over fifteen years of mining and total disability from chronic obstructive pulmonary disease (COPD), bronchitis, and emphysema. Incoal, Inc., Shepherd’s most recent employer, contested his entitlement, arguing that his disability was caused by smoking, not mining. An administrative law judge (ALJ) found Incoal’s expert opinions unpersuasive and inconsistent with the Act’s regulations and preamble, which recognize pneumoconiosis as a latent and progressive disease. The ALJ ruled that Incoal failed to rebut the presumption that Shepherd was entitled to benefits. The Benefits Review Board (BRB) affirmed the ALJ’s decision.Incoal petitioned the United States Court of Appeals for the Sixth Circuit for review, arguing that the ALJ improperly relied on the regulatory preamble over their evidence and that the presumption was effectively irrebuttable, violating the Constitution and the Administrative Procedure Act (APA). The court reviewed the case de novo, focusing on whether the ALJ’s decision was supported by substantial evidence and correctly applied the law.The Sixth Circuit held that the ALJ was entitled to reference the preamble to assess the credibility of expert opinions and found that the ALJ’s decision was supported by substantial evidence. The court noted that the BLBA’s rebuttable presumption is constitutional, as it is based on a rational relationship between the length of a miner’s career and the risk of pneumoconiosis. The court concluded that Incoal’s arguments were unpersuasive and that the ALJ applied the correct legal principles. Consequently, the court denied Incoal’s petition for review. View "Incoal, Inc. v. OWCP" on Justia Law

The case involves the Pennsylvania Professional Liability Joint Underwriting Association (JUA), which was established by the General Assembly of the Commonwealth of Pennsylvania nearly fifty years ago to address a medical malpractice insurance crisis. The JUA acts as a professional liability insurer of last resort for high-risk medical providers and is funded solely by premiums paid by its policyholders. Over the years, the JUA has accumulated a surplus of about $300 million through investments. From 2016 to 2019, the Commonwealth attempted to transfer the JUA’s surplus to the General Fund or assume control of the JUA through legislative actions.The United States District Court for the Middle District of Pennsylvania reviewed the case multiple times. In 2017, the JUA sued the Governor after the enactment of Act 44, which mandated the transfer of $200 million from the JUA to the General Fund. The District Court granted a preliminary injunction and later summary judgment in favor of the JUA, holding that the JUA was a private entity and that the Act violated the Takings Clause. In 2018, after the enactment of Act 41, which placed the JUA under the control of the Insurance Department and mandated the transfer of all its assets, the JUA again sued. The District Court ruled in favor of the JUA, reiterating its earlier decision. In 2019, the JUA challenged Act 15, which required the JUA to be funded by the Commonwealth and categorized it as a Commonwealth agency. The District Court granted partial summary judgment for the JUA, holding that certain provisions of Act 15 constituted a regulatory taking and violated the First Amendment.The United States Court of Appeals for the Third Circuit reviewed the case and applied the principles from Trustees of Dartmouth College v. Woodward to determine whether the JUA is a public or private entity. The Court concluded that the JUA is a public entity because it was created to serve a public purpose, exercises the Commonwealth’s coercive power, and only the Commonwealth has a legally protectable interest in the JUA. Consequently, the JUA cannot assert constitutional claims against the Commonwealth. The Court reversed the District Court’s rulings in part, affirmed in part, and remanded for further proceedings. View "Pennsylvania Professional Liability Joint Underwriting Association v. Governor of Pennsylvania" on Justia Law

The United States Department of the Navy issued a solicitation requesting technical support for its electromagnetic spectrum resources, requiring proposals to be submitted via email by a specified deadline. eSimplicity, Inc. submitted its proposal before the deadline, but it was not received by the Contracting Officer due to the email exceeding the maximum file size and being bounced back. The Navy deemed eSimplicity's proposal untimely and did not consider it.eSimplicity filed a pre-award bid protest with the United States Court of Federal Claims. The Claims Court ruled in favor of eSimplicity, concluding that the file size was an unstated evaluation criterion and that the government control exception could apply to electronically submitted proposals. The court remanded the case for the Navy to reconsider its decision or to take other actions consistent with the court's opinion. Subsequently, the Navy issued an amended solicitation and awarded the contract to eSimplicity.The United States Court of Appeals for the Federal Circuit reviewed the case. The court determined that the appeal was moot because the original solicitation had expired, and the contract had been awarded under a new solicitation. The court found that there was no longer a live controversy, as the issues presented on appeal concerned the now-expired solicitation. The court also rejected the government's argument that the case fell under the "capable of repetition yet evading review" exception to mootness, noting that the government had other opportunities to appeal similar issues in the past but chose not to do so. Consequently, the appeal was dismissed. View "ESIMPLICITY, INC. v. US " on Justia Law

The case involves a dispute between the municipality of Anchorage and the United States regarding two agreements related to the improvement of the Port of Alaska. In 2003, Anchorage and the United States, through the Maritime Administration (MARAD), signed a Memorandum of Understanding (2003 Memorandum) to upgrade and expand the port. In 2011, they signed a Memorandum of Agreement (2011 Memorandum) to address issues that arose during the project, including large-scale damage discovered in 2010.The United States Court of Federal Claims held that the United States breached the 2003 Memorandum by failing to deliver a defect-free port and the 2011 Memorandum by settling subcontractor claims without consulting Anchorage. The court awarded Anchorage $367,446,809 in damages, including $11,279,059 related to the settlement of subcontractor claims.The United States Court of Appeals for the Federal Circuit reviewed the case. The court found that the 2003 Memorandum did not require the United States to deliver a defect-free port, as it lacked specific terms such as what was to be built, where, dimensions, deadlines, and costs. The court vacated the Court of Federal Claims' decision regarding the 2003 Memorandum and remanded for further proceedings.However, the Federal Circuit affirmed the Court of Federal Claims' decision that the United States breached the 2011 Memorandum by settling subcontractor claims without conferring with Anchorage. The court upheld the award of $11,279,059 in damages to Anchorage for this breach. The case was vacated in part, affirmed in part, and remanded for further consideration consistent with the Federal Circuit's opinion. View "ANCHORAGE v. US " on Justia Law

Malcolm Pipes, a former reservist in the United States Air Force, sought disability-retirement pay and benefits after suffering a stroke while participating in the Air Force’s Self-paced Fitness Improvement Program (SFIP). Pipes argued that he was in inactive-duty training (IDT) status at the time of his injury, which would entitle him to the benefits under 10 U.S.C. § 1204. The Air Force Board for Correction of Military Records (AFBCMR) and the United States Court of Federal Claims (Claims Court) previously denied his claim, leading to this appeal.In the first appeal, the United States Court of Appeals for the Federal Circuit reversed the lower court's decision, holding that Pipes was in a duty status when ordered to participate in the SFIP. However, the court did not address whether Pipes was in IDT status when performing the SFIP. On remand, the AFBCMR and the Claims Court again denied relief, concluding that Pipes did not have the necessary advance authorization for IDT status as required by Air Force Manual (AFMAN) 36-8001.The United States Court of Appeals for the Federal Circuit reviewed the case and upheld the Claims Court's decision. The court found that the AFMAN applies to all IDT and requires advance authorization for such status. Pipes failed to provide evidence of receiving this authorization. The court also rejected Pipes's argument that the lawful order to participate in the SFIP automatically placed him in IDT status. The court noted that the Department of Veterans Affairs' grant of service connection for Pipes's stroke did not impact the determination of his duty status under the AFMAN.The court affirmed the Claims Court's judgment, concluding that the AFBCMR's decision was not arbitrary, capricious, contrary to law, or unsupported by substantial evidence. View "PIPES v. US " on Justia Law

Enriqueta Diaz, a former county judge and resident of Maverick County, opposed the issuance of certificates of obligation for water and sewer improvements by the Maverick County Commissioners Court. She collected signatures on a petition to force an election on the issue. Despite her petition, the commissioners decided to issue the certificates without holding an election. During the meeting, Diaz heckled the commissioners, leading County Judge English Cantu to hold her in contempt and order her removal. Diaz was detained outside in the rain for several hours and later sentenced to 24 hours in jail, though she was released without being confined.Diaz filed a lawsuit under 42 U.S.C. § 1983 in the United States District Court for the Western District of Texas, seeking damages for false imprisonment and bystander liability against County Judge English Cantu and three county commissioners. The district court denied the defendants' motion to dismiss, rejecting their claims of state sovereign immunity, judicial immunity, and qualified immunity. The defendants appealed the decision.The United States Court of Appeals for the Fifth Circuit reviewed the case. The court held that constitutional county judges in Texas are not entitled to state sovereign immunity as they are considered local rather than state officers. The court also determined that English Cantu was not entitled to judicial immunity because he was acting in an administrative capacity, not a judicial one, during the commissioners court meeting. Additionally, the court found that English Cantu was not entitled to qualified immunity because he acted without discretionary authority in holding Diaz in contempt. However, the court reversed the district court's denial of qualified immunity for the commissioners on the bystander liability claims, as the law was not clearly established that they had a duty to intervene. The case was remanded for further proceedings. View "Diaz v. Cantu" on Justia Law

The United States Army Corps of Engineers partnered with the City of Dallas on the Dallas Floodway Extension (DFE) project, which began in 1999. Plaintiffs Timpy Ondrusek and Barbara Ann Ondrusek Wolfe own property that Dallas attempted to condemn for the DFE. They sued the Corps and the City in federal district court, seeking declaratory and injunctive relief under the Administrative Procedure Act (APA), claiming the Corps failed to prepare a supplemental environmental impact statement (SEIS) to account for new information, violating the National Environmental Policy Act (NEPA) and the Clean Water Act (CWA).The United States District Court for the Northern District of Texas dismissed the claims, determining the case was not justiciable. The court found the plaintiffs had not shown Article III standing and dismissed the complaint without prejudice. The plaintiffs filed an amended complaint, but the district court again concluded the case was not justiciable, noting the levee design phase was only 35 percent complete, and dismissed the case as unripe without prejudice, denying leave to amend.The United States Court of Appeals for the Fifth Circuit reviewed the case. The court found the claims against the Army Corps of Engineers were ripe for decision, as the Corps' failure to comply with NEPA presented a present controversy. The court determined the plaintiffs had standing, as they alleged a concrete and particularized risk of environmental harm to their property due to the Corps' failure to prepare an SEIS. The court reversed the district court's dismissal of the suit with respect to the Army Corps of Engineers, affirmed the dismissal with respect to the City of Dallas, and remanded for further proceedings. View "Ondrusek v. United States Army Corps of Engineers" on Justia Law

Patricia Burnette Chastain was appointed as the clerk of superior court in Franklin County in May 2013 and was subsequently elected to the position in November 2013 and reelected in 2017. In July 2020, an attorney named Jeffrey Thompson filed an affidavit requesting an inquiry into Ms. Chastain's conduct, alleging various instances of misconduct, including distributing gift certificates to jurors, allowing a judicial candidate to address a jury, and acting unprofessionally with correctional officers, among other allegations.Judge John M. Dunlow initially suspended Ms. Chastain and set a hearing date. However, due to a conflict of interest, Judge Dunlow and another judge were recused, and Judge Thomas H. Lock was appointed to preside over the removal inquiry. After an evidentiary hearing, Judge Lock issued an order in October 2020 permanently removing Ms. Chastain from her position based on findings of willful misconduct. Ms. Chastain appealed, and the Court of Appeals vacated the order, holding that Judge Lock lacked authority under Article IV of the North Carolina Constitution to remove her and remanded the case for reconsideration under Article VI.The Supreme Court of North Carolina reviewed the case and held that Judge Lock had the authority to preside over the removal proceeding as a replacement for the recused senior regular resident superior court judge. The court also held that procedural due process requires that removal be based only on conduct identified in the initiating affidavit. Furthermore, the court clarified that the standard for removal under Article IV is "misconduct," not "willful misconduct." The Supreme Court vacated the Court of Appeals' decision and remanded the case for reconsideration of removal under the proper standards. The court also noted that discretionary review was improvidently allowed regarding the procedure for disqualification under Article VI. View "In re Chastain" on Justia Law