Justia Health Law Opinion Summaries

The 1949 Federal Property and Administrative Services Act concerns the purchase of goods and services on behalf of the federal government, 40 U.S.C. 101. In November 2021, the Safer Federal Workforce Task Force, citing the Act, issued a “Guidance” mandating that employees of federal contractors in covered contracts with the federal government become fully vaccinated against COVID-19. Ohio, Kentucky, and Tennessee and Ohio sheriffs’ offices challenged the mandate. The district court enjoined its enforcement in the three states and denied the government’s request to stay the injunction pending appeal.The Sixth Circuit denied relief in January 2022 and, a year later, affirmed. The Property Act does not authorize the President to issue directives that simply “improve the efficiency of contractors and subcontractors.” The plaintiffs are likely to succeed in showing that the President exceeded his authority in issuing the mandate. The plaintiffs are likely to lose valuable government contracts and incur unrecoverable compliance costs if the mandate is not enjoined. The public interest “lies in a correct application” of the law. Because an injunction limited to the parties can adequately protect the plaintiffs’ interests while the case is pending, the district court abused its discretion in extending the preliminary injunction’s protection to non-party contractors in the plaintiff states. View "Commonwealth of Kentucky v. Biden" on Justia Law

The Washington State Health Care Authority (“HCA”) and the Swinomish Indian Tribal Community petition for review of a Center for Medicare and Medicaid Services (“CMS”) decision denying Washington’s request to amend Apple Health, the Washington State Medicaid plan (the “State Plan”). HCA petitioned CMS to amend the State Plan to include dental health aide therapists (“DHATs”) on the list of licensed providers who can be reimbursed through Medicaid. CMS rejected the Amended State Plan on the basis that it violates the Medicaid free choice of providers statute and regulation guaranteeing all Medicaid beneficiaries equal access to qualified healthcare professionals willing to treat them. Petitioners challenged this denial.   The Ninth Circuit granted the petition of review. The panel rejected CMS’s reasoning on the ground that the underlying Washington statute—Wash. Rev. Code Section 70.350.020—did not violate Section 1396(a)(23) because it merely authorized where and how DHATs can practice and did not in any way restrict Medicaid recipients’ ability to obtain service from DHATs relative to non-Medicaid recipients. CMS’s rejection of the Amended State Plan was “not in accordance with law.” 5 U.S.C. Section 706(2)(A). Accordingly, the panel granted the petition for review and remanded to the agency with instructions to approve the Amended State Plan. View "WASHINGTON STATE HEALTH CARE A, ET AL V. CENTERS FOR MEDICARE & MEDICAI, ET AL" on Justia Law

Under the Hatch-Waxman Act, a drug may receive “new chemical entity exclusivity” if no active ingredient in the drug was previously “approved.” The drug Aubagio was awarded this exclusivity because the Food & Drug Administration (“FDA”) determined that Aubagio’s only active ingredient, teriflunomide, had never previously been approved. This case concerns a challenge to Aubagio’s exclusivity period, which Sandoz Inc. raises to secure a solo period of marketing exclusivity for its generic equivalent. Sandoz maintains that teriflunomide was previously “approved” as an impurity in the drug Arava. In the alternative, Sandoz argued that teriflunomide was in fact approved as an active ingredient in Arava. The district court granted summary judgment for the FDA, agreeing with the agency that Aubagio was entitled to exclusivity because teriflunomide had never previously been approved.   The DC Circuit affirmed the district court’s judgment. The court held that while Sandoz did not exhaust its statutory argument before the FDA, in the absence of a statutory or regulatory exhaustion requirement, the court found it appropriate to decide Sandoz’s challenge. When the FDA approves a new drug, it does not also “approve” known impurities in that drug for the purpose of new chemical entity exclusivity. And the record is clear the FDA did not approve teriflunomide as an active ingredient when it approved Arava. Aubagio was therefore entitled to new chemical entity exclusivity, and Sandoz cannot benefit from a solo exclusivity period for its generic equivalent. View "Sandoz Inc. v. Xavier Becerra" on Justia Law

In this interlocutory appeal, the Supreme Court held that when a person requests an electronic copy of a public electronic record under the Kansas Open Records Act (KORA) a public agency must provide that copy in electronic format.Plaintiff filed a petition to enforce her rights under KORA after Defendant - a hospital - refused to produce for Plaintiff requested electronic records in "electronic" format rather than "paper" format. The district court ordered Defendant to provide Plaintiff with electronic copies of the records. The court of appeals reversed, holding that KORA gives an agency discretion over how it provides records. The Supreme Court reversed, holding (1) the court of appeals missed the critical implication that any "accurate reproduction" of a public record must mirror the content of that record, unless specifically exempted; and (2) the only accurate reproduction of an electronic file is a copy of the electronic file. View "Roe v. Phillips County Hospital" on Justia Law

The issue this case presented for the Idaho Supreme Court's review centered on whether the Idaho Constitution protects abortion from the legislature's broad power to enact laws concerning the public’s health, welfare, and safety. Planned Parenthood Great Northwest, Hawaii, Alaska, Indiana, Kentucky, and Caitlin Gustafson, M.D., on behalf of herself and her patients (collectively “Petitioners”), brought three petitions, each seeking a writ of prohibition and declaratory relief blocking implementation and enforcement of recently enacted laws in Idaho. Petitioners also raised various facial challenges, claiming these laws offend important constitutional principles, such as equal protection, due process, the special laws provision, the separation of powers doctrine, and purported “informational privacy” protections under the Idaho Constitution. Petitioners further claimed that the Idaho Human Rights Act limited the legislature’s ability to regulate abortion through the Total Abortion Ban and 6-Week Ban. After careful consideration of the issued raised, the Idaho Supreme Court denied Petitioners’ requests for extraordinary writs of prohibition and declaratory relief. View "Planned Parenthood Great Northwest, et al. v. Idaho" on Justia Law

In November 2015, while hospitalized at Fremont, an acute psychiatric facility, McGovern was assaulted by another patient. In March 2016, McGovern’s attorney sent Fremont a letter, requesting that Fremont preserve evidence, and stating that counsel would be gathering more information and would present Fremont’s insurance carrier with a pre-litigation demand. It requested that Fremont place its carrier on notice. On October 27, 2016, McGovern’s counsel sent Fremont a Notice of Intent to Commence Action For Medical Negligence Pursuant to Code of Civil Procedure 364, which requires that a plaintiff give a healthcare provider 90 days’ notice before commencing an action for professional negligence. Subsection (d) tolls the limitations period for 90 days if the notice is served on the defendant within the last 90 days of the applicable statute of limitations. which expired on November 7, 2016, in McGovern's case.McGovern filed suit on January 20, 2017. The trial court granted Fremont summary adjudication, finding that the March letter constituted a section 364 notice. so the complaint was not timely filed, and McGovern failed to establish a triable issue of fact as to neglect under Welfare & Institutions Code 15610.57. The court of appeal reversed. The March letter lacked the requisite elements for section 364 compliance and was not a notice of intent. McGovern’s professional negligence causes of action are not time-barred, The court also reversed an order quashing a subpoena for the assailant’s mental health records. View "McGovern v. BHC Fremont Hospital, Inc." on Justia Law

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

An elementary school nurse who unsuccessfully attempted to save the life of a choking child sought workers’ compensation benefits for mental health problems she attributed to the incident. She argued that she suffered post-traumatic stress disorder (PTSD) due to exposure to the child’s bodily fluids and resulting risk of disease and to the mental stress of the incident. The Alaska Workers’ Compensation Board denied her claims, concluding that her exposure to bodily fluids was not a sufficient physical injury to trigger a presumption of compensability and that the mental stress of the incident was not sufficiently extraordinary or unusual to merit compensation. The Board was most persuaded by the opinion of the employer’s medical expert that the nurse’s mental health problems were the result of a pre-existing mental health condition and were not caused by the incident. The Alaska Workers’ Compensation Appeals Commission affirmed. After review, the Alaska Supreme Court found: (1) the Board failed to recognize the link between exposure to bodily fluids and mental distress over the risk of serious disease, which under Alaska precedent was enough to establish a presumption that the mental distress is compensable; and (2) the Board failed to consider the particular details of the child’s death and the nurse’s involvement when it concluded as a general matter that the stress of responding to a choking incident at school was not sufficiently extraordinary to merit compensation for mental injury. However, because the Board found in the alternative that the incident was not the cause of the nurse’s mental health problems, and because both the Commission and the Alaska Supreme Court had to respect the Board’s credibility determinations and the weight it gave conflicting evidence, the denial of benefits was affirmed. View "Patterson v. Matanuska-Susitna Borough School District" on Justia Law

Plaintiff Vermont Human Rights Commission, on behalf of plaintiff Latonia Congress, appealed a trial court’s decision granting summary judgment to defendant Centurion of Vermont LLC on the Commission’s claims of discrimination under the Vermont Public Accommodations Act (VPAA). Congress was incarcerated at a prison owned and operated by the Vermont Department of Corrections (DOC). The DOC contracted with Centurion to provide all medical services for inmates at the prison. Under the previous provider, Congress was seen by an audiologist, who determined that she had substantial bilateral hearing loss, and she was given hearing aids for both ears. In December 2016, Congress reported that the hearing aids were not working, and Centurion planned to send them “to Audiology for check of functioning.” Later in December 2016, a doctor examined Congress’s ears and did not find any indication of an obstruction or other problem that might be affecting her hearing. Congress delivered her hearing aids to the medical unit to be sent out for testing. They were returned to her without having been tested. The record established that no one knew what happened to the hearing aids during that time; they were apparently misplaced. Through 2017 and early 2018, Congress attempted numerous times to obtain functioning hearing aids. Because Congress was deemed “functional” for some period of time despite her reported difficulty in hearing conversations, she was not eligible for hearing aids under Centurion’s policies. Eventually, in March 2018, an audiologist concluded Congress had moderate to severe bilateral hearing loss, which was worse in one ear, and recommended hearing aids. She was provided with one hearing aid in April 2018, which improved her hearing in that ear. Congress was released from prison in October 2019. In March 2020, the Commission filed a complaint against Centurion, the DOC, and other state defendants, alleging, as relevant here, that they discriminated against Congress in violation of the VPAA by failing to provide her with functioning hearing aids and thereby denying her equal access to certain benefits and services offered at the prison. Finding no reversible error in the grant of summary judgment in favor of Centurion, the Vermont Supreme Court affirmed. View "Human Rights Commission v. Vermont, et al." on Justia Law

In these two different qui tam cases in which the United States executed a settlement agreement with AthenaHealth, Inc. and multiple relators, the First Circuit affirmed the judgment of the district court denying Relators' denial of their claims for attorneys' fees, holding that the district court did not err.Relators Cheryl Lovell and William McKusick appealed from the district court's denial of their entire claim for attorneys' fees under the False Claims Act (FCA), 31 U.S.C. 3729 et seq., and relator Georgie Sandborn appealed from the omission of certain claimed fees from his attorneys' fees award. The First Circuit (1) affirmed as to Lovell and McKusick, holding that these relators did not receive a relator's share and so were not entitled to attorneys' fees; and (2) affirmed as to Sanborn, thus rejecting his argument that he may be allowed fees associated with his claim, in which the government did not intervene. View "United States, ex rel. Lovell v. AthenaHealth, Inc." on Justia Law