Justia Health Law Opinion Summaries

Articles Posted in US Court of Appeals for the Fifth Circuit
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In a case involving the State of Texas, the American Association of Pro-Life Obstetricians & Gynecologists, and the Christian Medical & Dental Associations as plaintiffs, and the United States Department of Health and Human Services (HHS), its Secretary Xavier Becerra, the Centers for Medicare and Medicaid Services (CMS), and other officials as defendants, the United States Court of Appeals for the Fifth Circuit affirmed the district court's decision. The plaintiffs challenged HHS's guidance on the Emergency Medical Treatment and Active Labor Act (EMTALA), which they alleged mandated providers to perform elective abortions beyond HHS's authority and contrary to state law. The plaintiffs sought to enjoin the enforcement of this guidance. The district court granted the injunction within Texas or against any member of a plaintiff organization, and HHS appealed.The Court of Appeals held that the HHS guidance constituted a final agency action as it binds HHS to a particular legal position and has clear legal consequences should a physician or hospital violate it. The court found that HHS's guidance exceeds the statutory language of EMTALA, which does not mandate any specific type of medical treatment, let alone abortion care. The court also held that HHS was required to subject the guidance to notice and comment as it "establishes or changes a substantive legal standard." The court affirmed the injunction, finding it not overbroad, but rather tailored based on the parties, issues, and evidence before it. View "Texas v. Becerra" on Justia Law

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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

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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

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A company providing crane services, TNT Crane & Rigging, Inc., petitioned the Fifth Circuit to overturn the final orders of the Occupational Safety and Health Review Commission. Those orders reversed decisions by an administrative law judge that were favorable to the company. The principal dispute is whether regulations applicable to the disassembly of a crane apply to the tragic accident that occurred here.   The Fifth Circuit denied the petition. The court held that substantial e supports the Commission’s determination that TNT did not have a work rule designed to prevent violations of Section 1926.1407(b)(3). Second, substantial evidence supports the Commission’s determination that TNT did not adequately monitor employee compliance with its power line safety rules. Finally, substantial evidence supports the Commission’s determination that TNT did not prove it effectively enforced its power line safety rules when it discovered violations. View "TNT Crane & Rigging v. OSHC" on Justia Law

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President Biden issued Executive Order 14043, which generally required all federal employees to be vaccinated. Employees who didn’t comply would face termination. He also issued Executive Order 14042, imposing the same requirements and punishments for federal contractors. Plaintiffs, Feds for Medical Freedom, raised several constitutional and statutory claims. First, they asserted constitutional objections. They claimed both mandates were arbitrary, capricious, and otherwise not in accordance with law under the Administrative Procedure Act (“APA”). And the contractor mandate violated the APA because it was not in accordance with law. Finally, they sought relief under the Declaratory Judgment Act (“DJA”). Plaintiffs sought preliminary injunctions against both mandates. The district court declined to enjoin the contractor mandate because it was already the subject of a nationwide injunction. But it enjoined the employee mandate on January 21, 2022. On an expedited appeal, the Fifth Circuit majority held that the Civil Service Reform Act of 1978 (“CSRA”) precluded the district court’s jurisdiction. The Government timely appealed that injunction. The Government’s contention is that the CSRA implicitly repeals Section1331 jurisdiction over Plaintiffs’ claims.   The Fifth Circuit affirmed the district court’s decision and held that it has jurisdiction over pre-enforcement challenges to President Biden’s vaccine mandate for federal employees. The court explained that the text and structure of the CSRA create a decades-old, well-established, bright-line rule: Federal employees must bring challenges to CSRA-covered personnel actions through the CSRA, but they remain free to bring other, non-CSRA challenges under the district courts’ general Section 1331 jurisdiction. View "Feds for Medical Freedom v. Biden" on Justia Law

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The Food and Drug Administration denied Petitioner R.J. Reynolds Vapor Company’s (“RJRV”) application to market menthol-flavored e-cigarettes. Petitioners so ughta stay pending review of the denial order on the merits. RJRV petitioned the FDA for a stay, which was denied. RJRV and three other companies then petitioned the Fifth Circuit for review and moved to stay the Denial Order.   The Fifth Circuit entered a full stay pending resolution of RJRV’s petition on the merits. The court explained that the FDA’s disregard for the principles of fair notice and consideration of reliance interests is exacerbated by its failure to consider alternatives to denial. When an agency changes course, as the FDA did here, it must take into account “alternatives that are within the ambit of the existing policy.” Here, the court wrote, the FDA gave RJRV no such opportunity for its menthol PMTA. Further, the court explained that the FDA did not adequately address RJRV’s evidence that substantial health benefits would accrue to adult and youth cigarette smokers alike who switched to menthol Vuse, while popularity among youth would remain low overall. Moreover, the court found that RJRV has adduced evidence that the FDA has effectively banned all non-tobacco-flavored e-cigarettes, pursuant to its new and secret heightened evidentiary standard, without affording affected persons any notice or the opportunity for public comment. The court also held that given RJRV’s uncontested allegations and legal arguments, RJRV has met its burden of showing irreparable harm if denied a stay pending appeal. View "R.J. Reynolds v. FDA" on Justia Law

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An individual and an advocacy group seek to appeal from the denial of a motion to quash two grand jury subpoenas and an order compelling compliance with one of them. There is no jurisdiction for appeals challenging a grand jury subpoena for production of documents unless (1) the appellant has been held in contempt, or (2) a client-intervenor asserts that documents in the possession of a subpoenaed, disinterested third party are protected by attorney-client privilege.   The Fifth Circuit dismissed the appeal explaining that neither exception applied. The court explained that the subpoenaed documents are in the hands of Appellants. They are interested third parties in that they are being investigated for witness tampering. They have a direct and personal interest in suppressing the documents that could potentially corroborate the witness tampering accusation. Consequently, Appellants obviously have “a sufficient stake in the proceeding to risk contempt by refusing compliance.” Accordingly, the court wrote it lacks jurisdiction over the appeal, and Appellants must either comply with the subpoena or be held in contempt to seek the court’s review. View "In re: Grand Jury Subpoena" on Justia Law

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Section 1557 of the Patient Protection and Affordable Care Act prohibits health care programs that receive federal funds from discriminating against patients on the basis of sex. Section 1557 incorporates Title IX’s definition of prohibited sex discrimination. The Secretary of HHS has authority to issue regulations to implement Section 1557.In May 2016, HHS issued a rule interpreting Section 1557’s prohibition of “discrimination on the basis of sex.” Plaintiffs claimed the rule violated the Administrative Procedure Act (APA) by defining “sex discrimination” inconsistently with Title IX. Initially, the district court issued a nationwide preliminary injunction and ultimately granted summary judgment to Plaintiffs but denied permanent injunctive relief. Significant litigation followed.In this case, HHS argues that any challenge to the 2016 Rule is now moot because the district court already vacated the parts of the rule that violated the APA, and because the 2020 Rule rescinded the 2016 Rule. The Fifth Circuit agreed. View "Franciscan Alliance v. Becerra" on Justia Law

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Defendant owned and operated a healthcare clinic. Along with another provider, Defendant engaged in a scheme to fraudulently bill Medicare for home health services that were not properly authorized, not medically necessary, and, in some cases, not provided. Insiders testified to Defendant's role in the conspiracy, indicating she knew the home healthcare agencies were paying marketers to recruit patients. Defendant also told an undercover FBI agent she could show him how to make money by recruiting patients. Defendant was convicted and sentenced to 300 months in federal prison.Defendant appealed, challenging the sufficiency of the evidence against her. However, the Fifth Circuit affirmed her conviction, finding that a rational jury could have concluded that Defendant knew about and willfully joined the conspiracy. Additionally, the court rejected Defendant's challenges to her sentence, finding that the district court did not commit a procedural error and that her sentence was not substantively unreasonable. View "USA v. Rodriguez" on Justia Law

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The Louisiana Independent Pharmacies Association (“LIPA”) sued Express Scripts on behalf of its members, seeking a declaratory judgment on whether La. Rev. Stat. Ann. Sections 22:1860.1 and 46:2625 are preempted by Medicare Part D.1 Express Scripts moved to dismiss LIPA’s request for declaratory judgment regarding the reimbursement provision for failure to state a claim, see Fed. R. Civ. P. 12(b)(6), on the basis that Medicare Part D preempts the reimbursement provision for prescriptions covered by Part D plans The district court concluded, however, that Express Scripts failed “to meet its burden of showing preemption or any other basis for dismissal.” Express Scripts moved to certify the order denying its motion to dismiss for interlocutory appeal under 28 U.S.C. Section1292(b). The district court granted certification,   The Fifth Circuit vacated the district court’s order concluding that the court lacks both federal question and diversity jurisdiction. The court explained that here, LIPA seeks a declaration that Express Scripts’ state law and related contractual obligation to reimburse LIPA’s member pharmacies for the provider fee is not preempted by federal law. Applying the well-pleaded complaint rule requires the court to imagine a hypothetical coercive lawsuit brought by Express Scripts against LIPA’s member pharmacies. But none is conceivable, thus, because Express Scripts has no possible ground for a coercive lawsuit, no federal question arises for purposes of jurisdiction in LIPA’s declaratory judgment case. Accordingly, the court concluded that LIPA must make the same showing to satisfy the amount in controversy requirement. View "LA Indep Pharmacies v. Express Scripts" on Justia Law