Justia Government & Administrative Law Opinion Summaries

The Supreme Court reversed the decision of the court of appeals affirming the final order of the Commissioner of the Department of Human Services' (DHS) concluding that Trinity had engaged in the abuse outlined in DHS's notices and spreadsheets, holding that the first report of the administrative law judge (ALJ) was the binding decision in this matter.Trinity Home Health Care, which provided nursing and personal care assistant services, received reimbursement from DHS for services that it provided to Medicaid-eligible people with disabilities. After an investigation, DHS sent Trinity notices of termination from the program and demanding return of overpayments and payment-withholding. Both before and after remand by the Commissioner, the ALJ found that terminating Trinity's participation in the Minnesota Health Care Programs was an inappropriate sanction for Trinity's failure to provide certain records. The Commissioner modified the report, concluding that Trinity had engaged in the abuse alleged by the DHS. The court of appeals affirmed. The Supreme Court reversed, holding (1) the Commissioner did not have the authority to remand the case due to the DHS's general authority to administer and supervise Medicaid; and (2) the Commissioner did not have implied authority to remand the case to the ALJ under case law. View "In re Surveillance & Integrity Review Appeals by Trinity Home Health Care Services" on Justia Law

The Family Smoking Prevention and Tobacco Control Act requires any tobacco product not on the market before February 15, 2007, to receive FDA approval, 21 U.S.C. 387j(a)(1)–(2). Only if the FDA concludes that “permitting such tobacco product to be marketed would be appropriate for the protection of the public health” can the product be approved. Manufacturers seeking advance permission to market new products. In 2020, the FDA began taking aggressive action to remove fruit- and dessert-flavored e-cigarettes (electronic nicotine delivery systems (ENDS)) from the market, leaving aside tobacco- and menthol-flavored ENDS. More recently, based on additional studies and market data, the FDA has denied the applications of importers and manufacturers to market menthol-flavored ENDS.An importer challenged that denial, arguing that it was arbitrary and capricious for the FDA to apply the same regulatory framework to menthol that it used to assess the appropriateness of sweeter flavors, to ultimately reject its applications for its menthol-flavored ENDS to remain on the market, and to do so without granting a transition period. The Third Circuit denied a petition for review. The FDA applied a regulatory framework consistent with its statutory mandate, provided a reasoned explanation for its denial, and based its decision on scientific judgments that courts may not second-guess. View "Logic Technology Development LLC v. United States Food and Drug Administration" on Justia Law

The Idaho Department of Health and Welfare’s (“the Department”) cited Grace at Fairview Lakes, LLC (“Grace”), a residential assisted living and memory care facility, for failing to provide a safe living environment for residents and for inadequate training in relation to COVID-19 infection control measures. Grace requested administrative review of the enforcement action, which was affirmed by a Department administrator. Grace then filed an administrative appeal challenging the action, which was affirmed by a hearing officer. Grace then filed a petition for judicial review to the district court. The district court denied all the relief sought by Grace. On appeal to the Idaho Supreme Court, Grace argued the district court erred because the hearing officer’s decision was not supported by substantial evidence in the record as a whole. The Supreme Court found no error in the district court’s decision because there was substantial evidence in the record to support the hearing officer’s order. View "Grace at Fairview Lakes, LLC v. IDHW" on Justia Law

Plaintiffs-Appellants Santa Paula Animal Rescue Center, Inc. (SPARC) and Lucky Pup Dog Rescue (Lucky Pup) (collectively Appellants) appealed a judgment of dismissal following the trial court’s order sustaining, without leave to amend, Defendant County of Los Angeles’s (the County) demurrer to Appellants’ petition for writ of mandate. Appellants contend that the Hayden Act and, more specifically, Food and Agriculture Code section 31108 and similar provisions impose on the County a ministerial duty to (1) release a dog or other shelter animal to a requesting animal adoption or rescue organization with Internal Revenue Code section 501(c)(3) status prior to euthanasia without first determining whether the animal has behavioral problems or is adoptable or treatable, and (2) release the aforementioned animal to the requesting animal rescue or adoption organization without requiring the organization to meet qualifications additional to having Internal Revenue Code section 501(c)(3) status.   The Second Appellate District reversed the trial court’s judgment and directed the trial court to vacate its order sustaining the demurrer without leave to amend. The court concluded that the demurrer was improperly granted because the County lacks discretion to withhold and euthanize a dog based upon its determination that the animal has a behavioral problem or is not adoptable or treatable. However, the County has discretion to determine whether and how a nonprofit organization qualifies as an animal adoption or rescue organization. View "Santa Paula Animal Rescue Center, Inc. v. County of L.A." on Justia Law

A group of Doctors sued the FDA and the Department of Health and Human Services (together, the “Agencies”), claiming an FDA ad intended to deter people from off-label use of ivermectin to treat COVID-19. Each Doctor says that FDA’s messaging interfered with their own individual medical practice.The Doctors argue that FDA’s ad and similar public statements violated FDA’s enabling act (“Act”) and the Administrative Procedure Act (“APA”). The district court held that sovereign immunity protects the Agencies and the Officials, and it dismissed the suit. The Fifth Circuit reversed.The Fifth Circuit held that the Doctors can use the APA to bypass sovereign immunity and assert their ultra vires claims against the Agencies and the Officials. The ad was plausibly agency action, because it publicly announced the general principle that consumers should not use ivermectin to treat the coronavirus, and the Doctors fall within the Act’s zone of interests.The Doctors’ pure APA claim cannot go forward because the ad does not determine legal rights and thus lacks the finality. However, the Fifth Circuit held that the Doctors’ first theory was enough to allow this suit to proceed. View "Apter v. Dept of Health & Human Svc" on Justia Law

Hospitals receive greater payment if their Medicare patients are disproportionately low-income individuals entitled to federal supplemental security income benefits. Pomona Valley Hospital Medical Center contends that the Department of Health and Human Services undercounted the number of its Medicare patients who were entitled to SSI benefits and thus undercompensated the hospital for treating them. Pomona sought to prove the undercount through data from state benefit programs that piggyback on SSI. In an administrative proceeding, Pomona introduced expert testimony explaining how the state data derives from and overlaps with the federal SSI data. The Provider Reimbursement Review Board held that Pomona failed to prove the undercount, but the district court set aside its decision and remanded the case to the Board for further proceedings.   The DC Circuit affirmed. The court explained that using statewide statistics, Pomona estimated that fewer than 10 such patients would likely show up in its SSI-fraction calculations in any given year. And neither the Board nor the Contractor countered these estimates. Given the lack of contrary evidence in the record, such discrepancies appear immaterial and suggest no substantial flaw in Pomona’s methodology. Further, the court explained that Pomona provided uncontroverted evidence that two potential difficulties with its approach amounted to little more than rounding errors. It proffered creditable testimony from two experts indicating that the only explanation for the discrepancy was some error in CMS’s collection or matching of data. By contrast, the Contractor remained silent. Given the strength of the hospital’s showing, and the absence of any countervailing evidence, the Board’s conclusion that Pomona had failed to prove an undercount was unreasonable View "Pomona Valley Hospital Med v. Xavier Becerra" on Justia Law

The Supreme Court denied Petitioner's petition for a writ of certiorari or mandamus in this matter arising from district court orders holding Petitioner, the Nevada Division of Public and Behavioral Health, in contempt for vacating competency court orders, holding that Petitioner failed to meet its burden of demonstrating the need for extraordinary relief.The competency orders were issued in relation to eleven criminal defendants in Nevada who were all deemed incompetent to assist in their own defense and ordered to psychiatric treatment (collectively, Defendants). Defendants moved to dismiss their cases or, alternatively, for Petitioner to show cause as to why it should not be held in contempt after significant delays in accepting Defendants for treatment. The district court found Petitioner in contempt for failing to comply with the court orders and issued sanctions. Petitioner then filed the instant petition. The Supreme Court denied relief, holding that the district court had jurisdiction to hold Petitioner in contempt and did not manifestly or capriciously abuse its discretion in doing so. View "State, Dep't of Health v. District Court" on Justia Law

After the FDA promulgated regulations applying the Act to vaping products, Fontem US, LLC, submitted numerous applications to market its flavored and unflavored vaping products. The FDA denied all of them, concluding Fontem had not shown its products were “appropriate for the protection of the public health.” Fontem petitioned for review, arguing the denial was unlawful.   The DC Circuit denied the petition for review as to Fontem’s flavored products and granted the petition for review with respect to the unflavored products. The court explained that as to Fontem’s flavored products, the FDA reasonably found a lack of evidence that the benefits of such products to adult smokers sufficiently outweighed the potential risks to young non-smokers. The court wrote that as to Fontem’s unflavored products, however, the FDA acted unlawfully by failing to engage in the holistic public health analysis required by the statute. The court concluded that the agency did not take into account the potential benefits of unflavored products or weigh those benefits against risks to public health. Instead, the agency identified highly granular deficiencies but failed to evaluate the potential effects of such deficiencies on public health or to weigh these deficiencies against the potential benefits of Fontem’s products. View "Fontem US, LLC v. FDA" on Justia Law

The United States Food and Drug Administration approved mifepristone for use in 2000 under the brand name Mifeprex. FDA approved a generic version in 2019, and in 2021, FDA announced that it would not enforce an agency regulation requiring mifepristone to be prescribed and dispensed in person. The agency moved that requirement from mifepristone’s conditions for use. The subject of this appeal is those four actions: the 2000 Approval, the 2016 Amendments, the 2019 Generic Approval, and the 2021 Non-Enforcement Decision. Plaintiffs, Medical Organizations and Doctors contend that FDA overlooked important safety risks in approving mifepristone and amending its restrictions. The Medical Organizations and Doctors moved for preliminary injunctive relief. The district court granted the motion but stayed the effective date of each of the challenged actions under 5 U.S.C. Section 705. FDA appealed, as did Intervenor Danco Laboratories, LLC.     The Fifth Circuit vacated in part and affirmed in part. The court vacated in part and concluded that the Medical Organizations and Doctors’ claim as to the 2000 Approval is likely barred by the statute of limitations. Thus, until final judgment, Mifeprex will remain available to the public under the conditions for use that existed in 2016. The court also vacated the portion of the order relating to the 2019 Generic Approval because Plaintiffs have not shown that they are injured by that particular action. The generic version of mifepristone will also be available under the same conditions as Mifeprex. The court affirmed the components of the stay order that concern the 2016 Amendments and the 2021 Non-Enforcement Decision. View "Alliance Hippocratic Medicine v. FDA" on Justia Law

In this declaratory judgment action, the Supreme Court vacated the judgment of the circuit court overruling the motion to intervene as a matter of right filed by St. Louis and Jackson counties (the Counties), holding that the circuit court erred in overruling the Counties' motion to intervene as a matter of right.Plaintiffs brought this suit against the Department of Health and Senior Services. The circuit court ultimately declared that 19 C.S.R. 20-20.050(3) was constitutionally invalid. Several entities filed motions to intervene, including the Counties. The circuit court overruled all motions to intervene. The Supreme Court vacated the order below, holding that the circuit court erred in denying intervention where the motions were timely filed, the counties had an interest in the subject matter of the action, disposition of the action would impede their interests, and the existing parties no longer adequately represented their interest. View "Robinson v. Mo. Dep't of Health & Senior Services" on Justia Law