Justia Health Law Opinion Summaries

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Amiodarone was developed in the 1960s for the treatment of angina and was released in other countries. Amiodarone is associated with side effects, including pulmonary fibrosis, blindness, thyroid cancer, and death. In the 1970s, U.S. physicians began obtaining amiodarone from other countries for use in patients with life-threatening ventricular fibrillation or ventricular tachycardia who did not respond to other drugs. In 1985, the FDA approved Wyeth’s formulation of amiodarone, Cordarone, as a drug of last resort for patients suffering from recurring life-threatening ventricular fibrillation and ventricular tachycardia. The FDA’s “special needs” approval issued without randomized clinical trials. In 1989, the FDA described Wyeth’s promotional activities as promoting an unapproved use of the drug. In 1992, the FDA objected to promotional labeling pieces for Cordarone. Other manufacturers developed generic amiodarone, which has been available since 1998.Consolidated lawsuits alleged that plaintiffs suffered unnecessary, serious side effects when they took amiodarone, as prescribed by their doctors, for off-label use to treat atrial fibrillation, a more common, less serious, condition than ventricular fibrillation. The FDA never approved amiodarone for the treatment of atrial fibrillation, even on a special-needs basis. The court of appeal affirmed the dismissal of the lawsuits. The claims are preempted as attempts to privately enforce the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301, regulations governing medication guides and labeling and have no independent basis in state law. The court also rejected fraud claims under California’s unfair competition law and Consumers Legal Remedy Act. View "Amiodarone Cases" on Justia Law

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This appeal arose from an Idaho district court decision affirming a declaratory ruling issued by Respondent Dave Jeppesen (the Director) in his capacity as Director of the Idaho Department of Health and Welfare (the Department). Appellant Grace at Twin Falls, LLC (Grace), a residential assisted living and memory care facility, partnered with a preferred pharmacy to offset costs associated with a software system that coordinated the tracking and delivery of residents’ prescription medications. Because residents who failed to choose the preferred pharmacy did not receive the offset, Grace sought to charge those residents an additional $10.00 each month to cover the difference. Grace brought a petition for declaratory ruling to the Department, asking the Director to declare that Idaho Code section 39-3316(12)(b) and IDAPA 16.03.22.550.12.b did not prohibit Grace from charging the $10.00 fee to those residents who did not choose the preferred pharmacy. The Director denied the petition, declaring that Grace would not “be permitted to assess a non-preferred-pharmacy fee as such fee violates residents’ right to choose their pharmacy or pharmacist . . . .” Grace sought judicial review before the district court, which affirmed the Director’s declaratory ruling. Grace then appealed to the Idaho Supreme Court. Finding no reversible error, the Supreme Court affirmed the district court. View "Grace at Twin Falls, LLC v. Jeppesen" on Justia Law

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The First Circuit affirmed Defendant's sentence of twenty-four months' imprisonment imposed in connection with his plea of guilty to health care fraud, holding that the sentence was neither procedurally nor substantively unreasonable.Defendant pleaded guilty to health care fraud for his multiyear scheme to defraud MaineCare, a state-run program that administers Medicaid benefits in the state of Maine and reimburses Maine health care providers for MaineCare services. After a hearing, the court varied downward and imposed a sentence of twenty-four months' imprisonment. The First Circuit affirmed Defendant's sentence, holding (1) the district court did not err in its loss calculations or in imposing a four-level leader/organizer enhancement; and (2) Defendant's downward variant sentence satisfied the substantive reasonableness standard. View "United States v. Ahmed" on Justia Law

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The First Circuit affirmed the judgment of the district court dismissing Calvary Chapel of Bangor's (Calvary) complaint against Maine Governor Janet Mills raising several facial and as-applied constitutional and statutory challenges to the Governor's executive orders seeking to slow the spread of the COVID-19 outbreak in early 2020, holding that the complaint was moot and that no mootness exception could save it.Calvary sued the Governor in federal court claiming that the Governor's orders at issue discriminated against Calvary by treating religious gatherings less favorably than other gatherings. Calvary requested a temporary restraining order, a preliminary injunction, a permanent injunction, and a declaratory judgment. The district court denied relief and dismissed the complaint. The First Circuit affirmed, holding that this case was moot and that no exception to mootness applied. View "Calvary Chapel of Bangor v. Mills" on Justia Law

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Eight named inmates and two nonprofit organizations (collectively, plaintiffs) filed an amended complaint in district court seeking a mixture of a classwide writ of habeas corpus and classwide injunctive and declaratory relief. Plaintiffs alleged that the State’s management of COVID-19 in New Mexico prisons violated inmates’ rights under the New Mexico Constitution. The district court dismissed the amended complaint, concluding that it lacked subject-matter jurisdiction because the individual inmate-plaintiffs failed to exhaust the internal grievance procedures of the New Mexico Corrections Department (NMCD) before seeking relief, as required by NMSA 1978, Section 33-2-11(B) (1990). Agreeing with the result, but not all of its reasoning, the New Mexico Supreme Court affirmed the district court: "to satisfy the habeas corpus exhaustion requirement under Rule 5-802(C) for an entire plaintiff class, one or more named class members must exhaust administrative remedies for each claim. Because no Named Plaintiff exhausted or sought to exhaust NMCD’s internal grievance procedures, we affirm." View "Anderson, et al. v. New Mexico" on Justia Law

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The Mississippi Division of Medicaid (DOM) and Yalobusha County Nursing Home (YNH) dispute four costs submitted for reimbursement by YNH in its fiscal year 2013 Medicaid cost report. The DOM appeals the Hinds County Chancery Court’s judgment ordering the DOM to reverse the four adjustments at issue. Because the DOM correctly interpreted the appropriate statutes and because its decisions were supported by substantial evidence, the Mississippi Supreme Court reversed the chancery court’s order and rendered judgment reinstating the decisions of the DOM. View "Mississippi Division of Medicaid v. Yalobusha County Nursing Home" on Justia Law

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Neurosurgeon Donald Blaskiewicz, M.D. went to work for the Spine Institute of Idaho (the “Spine Institute” or the “Institute”) in 2018. The Spine Institute entered into a Professional Services Agreement (the PSA) with Blaskiewicz containing a non-compete clause, contractually proscribing Blaskiewicz from practicing medicine within fifty miles of the Spine Institute’s office (with an explicit exception for Caldwell) for a period of eighteen months, should his employment with the Spine Institute be terminated for any reason. Pursuant to the PSA, Blaskiewicz had two ways to avoid the non-compete clause: he could either get permission from the Spine Institute to practice medicine within the proscribed area, or he could pay the Spine Institute $350,000 in “liquidated damages.” The PSA also required any disputes to be resolved by arbitration. Less than a year and a half after hiring Blaskiewicz, the Spine Institute terminated his employment. Blaskiewicz filed suit in district court, seeking a declaratory judgment that the non-compete clause was unenforceable. The district court concluded that the non-compete clause was against public policy and void as a matter of law, and granted summary judgment in favor of Blaskiewicz. The Idaho Supreme Court reversed, finding the district court did not cite or analyze the statutes governing non-compete agreements in Idaho. The Court concluded there were genuine issues of material fact such that summary judgment was inappropriate as to whether the non-compete provision was void as a matter of public policy or otherwise enforceable. View "Blaskiewicz v. Spine Institute of Idaho" on Justia Law

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Liquid Labs manufactures and sells e-liquids that generally contain nicotine and flavoring for use in e-cigarettes. The e-liquids qualify as “new tobacco product[s]” under the Family Smoking Prevention and Tobacco Control Act, 21 U.S.C. 387-387u, and may not be introduced into interstate commerce without the FDA’s authorization. The FDA must deny a premarket tobacco product application (PMTA) if the applicant fails to “show[] that permitting such tobacco product to be marketed would be appropriate for the protection of public health,” as determined with respect to the risks and benefits to the population as a whole, including users and non-users of the tobacco product.” FDA Guidelines have highlighted that flavored e-liquids’ had a “disproportionate appeal to children.”Liquid Labs submitted PMTAs covering 20 e-liquid products and submitted a marketing plan setting forth plans to discourage youths from using its products. The FDA denied the PMTAs, concluding that Liquid Labs had not shown that the benefits of the products sufficiently outweighed the risks they posed to youths. The documents indicated that evidence could have been provided through “randomized controlled trial[s] and/or longitudinal cohort stud[ies],” or other evidence that reliably and robustly evaluated the impact of the new flavored vs. tobacco-flavored products on adult smokers’ switching or cigarette reduction over time.” The Third Circuit denied a petition for review. The FDA’s order was within its statutory authorities and the Administrative Procedure Act. View "Liquid Labs LLC v. United States Food and Drug Administration" on Justia Law

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The Supreme Judicial Court affirmed the judgment entered by the probate court appointing the Department of Health and Human Services as T.'s adult guardian and conservator pursuant to Me. Rev. Stat. 5-301, 5-401(2), holding that the probate court did not err in determining that the emergency and final hearings on the Department's petition constituted a unified proceeding.The Department filed a petition for appointment of a full guardian and conservator for T., age eighty-six, in the probate court, and also requesting the appointment of an emergency guardian and conservator. The court held an evidentiary emergency review hearing, after which the court ordered that an emergency appointment continue pending a final hearing. The court then held a final hearing and granted the Department's petition. T. appealed, arguing that the court should not have considered certain testimony given at the emergency hearing because the court's conclusion that the two proceedings were part of a unified proceeding was erroneous. The Supreme Judicial Court affirmed, holding that when the trial judge in a guardianship and conservatorship proceeding has heard the evidence presented in prior stages of the proceeding, that judge may consider the evidence in later stages because the process is a unified proceeding. View "In re Adult Guardianship & Conservatorship of T." on Justia Law

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R.A.C. Rolling Hills LP, dba ActivCare at Rolling Hills Ranch, and ActivCare Living, Inc. (together, ActivCare), appealed an order denying their petition to compel arbitration in the elder abuse lawsuit filed by Mary Leger. ActivCare contended the trial court erred in concluding that it had waived its right to arbitration because it sought to compel arbitration less than 30 days after filing its answer. Under the unique facts of this case, the Court of Appeal concluded substantial evidence supported the trial court’s waiver finding and affirmed the order. View "Leger v. R.A.C. Rolling Hills" on Justia Law