Justia Government & Administrative Law Opinion Summaries

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

A group of 53 California hospitals challenged the Secretary of Health and Human Services' (HHS) 2020 low-wage-index policy, which adjusted Medicare payment rates by inflating the rates for the lowest quartile of hospitals and reducing payments to all hospitals by a small percentage. The hospitals argued that the policy violated statutory provisions, was arbitrary and capricious, resulted from a faulty administrative procedure, and was unsupported by evidence.The United States District Court for the Central District of California denied HHS's motion for summary judgment, granted the hospitals' motion for summary judgment, and remanded the matter to the Secretary without vacating the policy. The court held that HHS lacked authority to implement the low-wage-index policy under either the Wage Index Provision or the Exceptions and Adjustments Provision and found procedural defects in the policy's implementation.The United States Court of Appeals for the Ninth Circuit affirmed the district court's holding that the Secretary exceeded his statutory authority in establishing the 2020 wage index. The court held that the low-wage-index policy did not "reflect" area differences in hospital wage levels as required by the statute and that the Exceptions and Adjustments Provision could not independently authorize the policy. The court also vacated the district court's decision to remand the case without vacating the policy, stating that when an agency cannot issue the challenged policy in another way, the only appropriate remedy is vacatur. Judge Nguyen dissented, arguing that the low-wage-index policy was consistent with the statutory text and that the majority's decision would have negative repercussions for vulnerable communities. View "Kaweah Delta Health Care District v. Becerra" on Justia Law

Plaintiffs Luther C. Parente and Eric L. Stewart sued the Rhode Island Department of Corrections (RIDOC) and its staff for failing to properly treat their preexisting medical conditions. They alleged various federal and state constitutional, statutory, and common law bases for relief, including a claim under the Rhode Island Civil Rights Act of 1990 (RICRA). The plaintiffs claimed that RIDOC's medical and correctional staff failed to meet their medical needs, resulting in harm and discrimination.The United States District Court for the District of Rhode Island denied RIDOC's motion for summary judgment on Eleventh Amendment grounds as to the RICRA claim. The district court held that Rhode Island's general waiver of sovereign immunity under the State Tort Claims Act applied to RICRA claims, reasoning that discrimination actions under RICRA sounded in tort. RIDOC appealed this decision, arguing that the district court erred in holding that violations of civil rights under RICRA were subject to the general waiver of Eleventh Amendment immunity.The United States Court of Appeals for the First Circuit reviewed the case and determined that there was a "special reason" to certify the underlying state-law issue to the Rhode Island Supreme Court. The appellate court noted that the question of whether RICRA claims are "actions of tort" under the State Tort Claims Act is a matter of state law that has not been definitively resolved by the Rhode Island Supreme Court. Therefore, the First Circuit certified the question to the Rhode Island Supreme Court to determine whether discrimination claims under RICRA are covered by the general waiver of sovereign immunity under the State Tort Claims Act. The First Circuit retained jurisdiction over the issue pending resolution of the certified question. View "Parente v. Lefebvre" on Justia Law

James Lowe appealed a decision by Workforce Safety and Insurance (WSI) regarding the denial of his request for continued opioid medication exceeding 90 Morphine Milligram Equivalents (MME) daily. Lowe argued that WSI abused its discretion in denying his request for approval of the medication.The District Court of McKenzie County, Northwest Judicial District, reviewed the case and affirmed WSI's decision. The court found that WSI had not acted arbitrarily, unreasonably, or capriciously in its decision-making process. The court also noted that Lowe's medical provider had not provided sufficient documentation to support the medical necessity for exceeding the 90 MME limit, as required by the new law effective July 1, 2022.The Supreme Court of North Dakota reviewed the case and upheld the lower court's decision. The court found that WSI had conducted a full review of Lowe's request and had properly applied the guidelines governing long-term opioid pain management. The court concluded that WSI did not abuse its discretion in denying Lowe's request for continued opioid medication in excess of 90 MME daily. The court affirmed the district court judgment affirming the managed care binding dispute resolution decision by WSI. View "Lowe v. Workforce Safety and Insurance" on Justia Law

Dr. Fares Jeries Rabadi, a licensed physician in California, had his certificate of registration to dispense controlled substances revoked by the Drug Enforcement Administration (DEA). The DEA initiated an investigation into Rabadi in April 2018 due to his high-risk prescribing practices. In March 2020, the DEA issued an Order to Show Cause and Immediate Suspension of Registration, alleging that Rabadi issued numerous prescriptions for controlled substances outside the usual course of professional practice and not for a legitimate medical purpose to seven individuals. Rabadi requested a hearing before an administrative law judge (ALJ), which took place in September 2020. The ALJ found Rabadi's testimony not credible and recommended revoking his registration. The DEA Administrator adopted the ALJ's recommendations with minor modifications and revoked Rabadi's registration.Rabadi petitioned for review, arguing that the DEA's revocation was invalid because DEA ALJs are unconstitutionally insulated from removal by two layers of "for-cause" protections. The United States Court of Appeals for the Ninth Circuit reviewed the case. The court held that Rabadi's argument failed under Decker Coal Co. v. Pehringer, which found similar ALJ removal protections constitutional. The court noted that DEA ALJs perform purely adjudicatory functions, Congress does not mandate the use of ALJs for DEA hearings, and DEA ALJ decisions are reviewed de novo by the DEA Administrator, who is removable at will by the President.Rabadi also argued that the DEA Administrator's order was arbitrary and capricious. The court rejected this argument, finding that the Administrator properly ignored Rabadi's unsupported defense regarding high dosages of prescribed drugs and appropriately analyzed the public interest factors, including Rabadi's lack of a conviction record. The Ninth Circuit denied Rabadi's petition for review, upholding the DEA Administrator's order. View "RABADI V. USDEA" on Justia Law

A federal inmate, Dustin Rowland, developed a hernia after a pretrial detention fight. A physician deemed the hernia "reducible and stable," recommending non-surgical treatments. Rowland, desiring surgery, utilized the Bureau of Prisons' (BOP) Administrative Remedial Program, which involves a four-step grievance process. His initial requests were denied, but a later appeal led to approval for a surgical consultation. However, Rowland's final appeal was denied for procedural reasons, and he did not correct the deficiency. He eventually received surgery but filed a lawsuit claiming deliberate indifference to his medical needs, seeking damages under Bivens, injunctive relief for post-operative care, and a negligence claim under the Federal Tort Claims Act (FTCA).The United States District Court for the District of Colorado dismissed Rowland's Bivens claim, granted summary judgment against his injunctive relief claim for failure to exhaust administrative remedies, and dismissed the FTCA claim for lack of subject matter jurisdiction due to non-exhaustion. Rowland's motion for reconsideration was also denied.The United States Court of Appeals for the Tenth Circuit reviewed the case. The court affirmed the district court's dismissal of the Bivens claim, noting that Rowland's case presented a new context not covered by previous Bivens cases and that the BOP's Administrative Remedial Program provided an adequate alternative remedy. The court also upheld the summary judgment on the injunctive relief claim, as Rowland failed to exhaust administrative remedies specifically for post-operative care. Lastly, the court affirmed the dismissal of the FTCA claim, emphasizing the jurisdictional requirement of exhausting administrative remedies before filing suit. The court found no abuse of discretion in the district court's denial of Rowland's Rule 60(b) motion for reconsideration. View "Rowland v. Matevousian" on Justia Law

Richard Shreves, while incarcerated at the Montana State Prison, received medical care and subsequently filed a complaint against Dr. Paul Rees with the Board of Medical Examiners at the Montana Department of Labor and Industry (DLI). The Correctional Health Care Review Team (CHCRT) reviewed the complaint and found no violation of law or practice rules by Dr. Rees, leading to the closure of the complaint without forwarding it to the Board of Medical Examiners. Shreves then petitioned for judicial review, challenging the CHCRT's decision and the lack of detailed findings in their response.The First Judicial District Court dismissed Shreves's petition, concluding that he lacked standing. The court reasoned that the CHCRT process did not implicate Shreves's legal rights, as it was designed to screen complaints for potential disciplinary action against the healthcare provider, not to adjudicate the complainant's rights.The Supreme Court of the State of Montana affirmed the District Court's dismissal. The court held that Shreves did not have standing to petition for judicial review because the statute governing the CHCRT process did not authorize judicial review at the behest of the complainant. The court also found that Shreves's constitutional challenge to the CHCRT's authority did not confer standing, as he lacked a personal stake in the outcome. Additionally, the court determined that any alleged mishandling of filings by the District Court did not affect the outcome, as the legal conclusions regarding standing were correct. View "Shreves v. Montana Dept. of Labor" on Justia Law

A group of healthcare and air-ambulance providers challenged certain agency rules regarding the No Surprises Act, which aims to protect patients from unexpected medical bills. The key issues involved the calculation of the "qualifying payment amount" (QPA), deadlines for insurers to respond to provider bills, and disclosure requirements for insurers.The United States District Court for the Eastern District of Texas reviewed the case and held several provisions of the rules unlawful, vacating them. The court found that the rules conflicted with the Act's terms and were arbitrary and capricious. The defendant agencies appealed the decision regarding certain provisions, while the plaintiffs cross-appealed the court's upholding of the disclosure requirements.The United States Court of Appeals for the Fifth Circuit reviewed the case. The court reversed the district court's vacatur of the QPA calculation provisions, holding that the rules did not conflict with the Act and were not arbitrary and capricious. The court affirmed the district court's vacatur of the deadline provision, agreeing that it conflicted with the Act's unambiguous terms. The court also affirmed the district court's decision upholding the disclosure requirements, finding them reasonable and adequately explained.In summary, the Fifth Circuit reversed the district court's decision on the QPA calculation provisions, affirmed the vacatur of the deadline provision, and upheld the disclosure requirements. The court concluded that the proper remedy for the unlawful deadline provision was vacatur, not remand, and rejected the idea of party-specific vacatur. View "Texas Medical Association v. Health and Human Services" on Justia Law