Justia Government & Administrative Law Opinion Summaries
Articles Posted in Health Law
Santa Paula Animal Rescue Center, Inc. v. County of L.A.
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
Apter v. Dept of Health & Human Svc
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
Pomona Valley Hospital Med v. Xavier Becerra
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
State, Dep’t of Health v. District Court
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
Fontem US, LLC v. FDA
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
Alliance Hippocratic Medicine v. FDA
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
Robinson v. Mo. Dep’t of Health & Senior Services
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
Conforti v. County of Ocean, et al.
In summer 2010, plaintiff Carol Conforti obtained a restraining order against her husband. On September 8, he was arrested for violating the restraining order by returning to the marital home to see his son. Conforti was taken to the OCJ, where he was evaluated by a staff member of Correctional Health Services (CHS). A CHS staff member wrote on the “Intake Receiving and Screening” form that Conforti reported: (1) drinking half a gallon of vodka each day; (2) major surgery that left him with rods and screws in his back; (3) feeling “hopeless or helpless”; and (4) the “[r]ecent significant loss” of his marriage. A physician prescribed him one extra mattress and medicine for back pain and alcohol dependence, and instructed that he not be assigned work or a top bunk. After 27 days, Conforti was released. Just over a week later, Conforti was arrested for again returning to the marital home to see his son. He arrived at OCJ on October 13, 2010. A document from Conforti’s file acknowledged his previous incarceration and history of binge drinking but stated he had “[n]o current mental health issues/concerns” and was cleared for OCJ’s general population. On October 16, he requested medical attention for back pain. On October 20, Conforti wrote a suicide note to his parents, closed the door to his cell, covered the cell door window with a sheet, and hung himself. During discover, plaintiff submitted an expert report who opined that defendants the County of Ocean and the Ocean County Jail acted negligently by failing to adequately train and supervise OCJ staff to prevent inmate suicide. The County defendants moved for summary judgment on immunity grounds under the New Jersey Tort Claims Act (TCA). A jury found defendant negligent and apportioned liability 60% against the County and 40% against Correctional Health Services (CHS). Defendants moved for JNOV, reasserting their medical-facility-immunity argument. The New Jersey Supreme Court found no reversible error in the trial court’s refusal to dismiss plaintiff’s negligence count at the summary judgment stage, and no error in refusing to overturn the jury’s verdict after trial. View "Conforti v. County of Ocean, et al." on Justia Law
Optimal Wireless LLC v. IRS
The Affordable Care Act obligates large employers to provide their full-time employees with health insurance coverage meeting certain requirements. If an employer fails to provide coverage or provides noncomplying coverage, it is liable for an exaction under 26 U.S.C. Section 4980H. In 2019, the Internal Revenue Service sent two letters proposing exactions under Section 4980H to appellant Optimal Wireless, a wireless communications company. Optimal then filed an action against the IRS and the Department of Health and Human Services, claiming that the agencies had failed to satisfy certain procedural requirements before imposing the proposed exactions. Optimal sought a declaratory judgment and an injunction barring the IRS from collecting any money without complying with those procedures. The district court dismissed Optimal’s suit for lack of jurisdiction.
The DC Circuit affirmed. The court explained that the Anti-Injunction Act provides that, with certain exceptions, “no suit for the purpose of restraining the assessment or collection of any tax shall be maintained in any court by any person, whether or not such person is the person against whom such tax was assessed.” The court explained that because Congress repeatedly called the Section 4980H exaction a tax, Optimal’s suit is barred by the Anti-Injunction Act. The court further wrote that Congress’s use of the phrase “assessable payment” does not conflict with—or otherwise detract from the import of—its choice to label the Section 4980H exaction a “tax” in multiple provisions. The terms are not mutually exclusive. View "Optimal Wireless LLC v. IRS" on Justia Law
We The Patriots USA, Inc. et al. v. Conn. Office of Early Childhood Dev.
Plaintiffs appealed the district court’s judgment dismissing claims against Defendants, challenging Public Act 21-6, which revised the Connecticut General Statutes to repeal religious exemptions from state immunization requirements for schoolchildren, college and university students, and childcare participants. Plaintiffs are two organizations and three individuals who allege that the Act violates the Free Exercise Clause of the First Amendment of the U.S. Constitution and other federal constitutional and statutory guarantees. The district court granted the motions of Defendants to dismiss certain of Plaintiffs’ claims against the state agencies as barred by the Eleventh Amendment, to dismiss the organizational Plaintiffs' claims for lack of standing, and to dismiss all counts of the complaint for failure to state a claim.
The Second Circuit affirmed in part and vacated and remanded in part. The court explained the district court's distinction between "special services" and "special education" was overly strict. The IDEA and its associated regulations do not use the phrase "special services." A reasonable inference from the allegation that Plaintiff’s son suffers from "a speech and learning disorder for which he now receives special services," combined with the allegation that he "is disabled within the meaning of the IDEA," is that the "special services" the complaint mentions constitute "special education" rather than "related services." Therefore, the court concluded that because the district court parsed the complaint too restrictively, failing to draw reasonable inferences in Plaintiff’s favor, the court erred when it found Plaintiff had not stated a plausible claim for relief under the IDEA. The court, therefore, vacated this portion of the judgment. View "We The Patriots USA, Inc. et al. v. Conn. Office of Early Childhood Dev." on Justia Law