Justia Health Law Opinion Summaries

Brad Acy Holley, who was serving a 127-month federal sentence after pleading guilty to methamphetamine conspiracy, suffered from significant health issues, including polycystic kidney disease and end-stage renal disease requiring dialysis. Following his declining health and ongoing treatments in a federal medical facility, Holley sought compassionate release, arguing that his condition constituted an extraordinary and compelling reason for a sentence reduction. He also asserted that he was not receiving necessary specialized medical care in prison, particularly a kidney transplant, and requested appointment of counsel and an expert witness to assist with his motion.The United States District Court for the Southern District of West Virginia denied Holley’s requests, finding that his medical condition, while serious, was being adequately managed in prison and did not qualify as a terminal illness or otherwise meet the threshold for extraordinary and compelling reasons for compassionate release. The court also declined to appoint counsel or an expert, determining that neither was warranted under the circumstances. Holley appealed these decisions.The United States Court of Appeals for the Fourth Circuit reviewed the district court’s decisions for abuse of discretion. The appellate court held that the district court did not abuse its discretion in denying compassionate release, finding the court properly relied on Holley’s individualized medical records rather than generalized statistics, and reasonably concluded Holley was not suffering from a terminal illness with an end-of-life trajectory. The Fourth Circuit also held that Holley was not legally entitled to appointed counsel or an expert witness for his compassionate release motion, as there were no exceptional circumstances justifying such appointments. Accordingly, the Fourth Circuit affirmed the district court’s judgment in all respects. View "US v. Holley" on Justia Law

A pharmaceutical manufacturer participating in the federal 340B Drug Pricing Program challenged a Missouri law that prohibits manufacturers from restricting the delivery of discounted 340B drugs to contract pharmacies associated with covered entities. The manufacturer argued that its policy of limiting deliveries to only one contract pharmacy conflicted with Missouri’s statute, which requires delivery to all contract pharmacies designated by covered entities. The manufacturer sought declaratory and injunctive relief, claiming the Missouri statute violated the dormant Commerce Clause and was preempted by federal law.The United States District Court for the Western District of Missouri granted a motion to dismiss the manufacturer’s preemption claims, finding Missouri’s statute did not conflict with federal patent or drug exclusivity laws or the 340B Program, and that Eighth Circuit precedent foreclosed the field preemption argument. The court denied the motion to dismiss the dormant Commerce Clause claim, but ultimately denied the manufacturer’s motion for a preliminary injunction, concluding the manufacturer was unlikely to succeed on the merits of its claims, had not shown irreparable harm, and that the balance of equities and public interest weighed against preliminary relief.The United States Court of Appeals for the Eighth Circuit reviewed the district court’s denial of preliminary injunction under the abuse of discretion standard. The appellate court affirmed the district court’s decision, holding that the Missouri statute regulates only in-state delivery of 340B drugs and does not impermissibly control extraterritorial commerce, discriminate against interstate commerce, or impose excessive burdens in relation to local benefits. The court also found the manufacturer’s preemption claims foreclosed by Eighth Circuit precedent and concluded the statute is neither field nor conflict preempted. The district court’s denial of preliminary injunctive relief was affirmed. View "Novartis Pharmaceuticals Corp. v. Hanaway" on Justia Law

Texas Tobacco Barn operated a laboratory and retail shop in Lubbock, Texas, manufacturing and selling e-liquids and vape products. After applying for authorization to sell over 2,200 vape products, including Barn Brewed Beetle Juice e-liquids, the FDA denied approval and warned that these products were considered “adulterated” and “misbranded.” Despite assurances from Texas Tobacco Barn that it would cease sales, a subsequent FDA inspection revealed continued sale of unauthorized products. The FDA initiated proceedings seeking a civil penalty of $19,192 for violations.The enforcement action began with an administrative hearing before an HHS administrative law judge (ALJ), who reviewed evidence including inspection photos and testimony from an FDA inspector. Texas Tobacco Barn admitted that the e-liquids lacked FDA authorization but disputed the inspector’s findings and challenged the FDA’s regulatory authority. The ALJ concluded that the FDA proved its case by a preponderance of the evidence and imposed the civil penalty. On appeal, the HHS Departmental Appeals Board affirmed the ALJ’s ruling, agreeing the ALJ lacked jurisdiction to address constitutional challenges but offering advisory comments on those defenses.Reviewing the agency’s final decision, the United States Court of Appeals for the Fifth Circuit considered Texas Tobacco Barn’s statutory and constitutional arguments. The court rejected the nondelegation challenge, citing its own precedent and Supreme Court guidance clarifying FDA’s explicit authority to regulate vape products. However, the Fifth Circuit held that the administrative process violated Texas Tobacco Barn’s Seventh Amendment right to a jury trial. The court determined that civil penalties for FDCA violations are legal in nature and do not fall under the public-rights exception that would permit agency adjudication without a jury. As a result, the Fifth Circuit granted the petition and vacated the agency’s decision. View "Texas Tobacco Barn v. HHS" on Justia Law

A private health insurer that participates in the Medicare Advantage program consolidated two of its contracts in 2024. One of the pre-existing contracts (“consumed contract”) had provided a Special Needs Plan (SNP) and received a star rating for that measure in 2023, while the other (“surviving contract”) did not. After consolidation, the insurer’s new contract offered an SNP for 2025. The Centers for Medicare and Medicaid Services (CMS) calculates star ratings for consolidated contracts by taking the enrollment-weighted mean of measure scores from the consumed and surviving contracts. Initially, CMS excluded the consumed contract’s SNP data for the 2025 star rating, but after the insurer’s request, CMS included the data, resulting in the same overall rating as before.The insurer challenged this calculation in the United States District Court for the District of Columbia, arguing that including the consumed contract’s SNP data violated the statute, regulations, and agency guidance, and that CMS failed to adequately explain a change in calculation methodology. The district court granted summary judgment in favor of CMS, finding that the agency’s actions complied with applicable law and guidance, and that no further explanation for the calculation was required.On appeal, the United States Court of Appeals for the District of Columbia Circuit affirmed the district court’s judgment. The appellate court held that CMS properly applied its regulations and guidance by including the consumed contract’s SNP measure score in the calculation. The court also found that the methodology provided accurate information to beneficiaries, as required by statute, and that CMS did not make a policy change triggering a requirement for further explanation. The district court’s entry of summary judgment in favor of CMS was affirmed. View "HMO Louisiana, Inc. v. Department of Health and Human Services" on Justia Law

A pharmaceutical company, together with a healthcare research organization and a kidney patient advocacy group, challenged regulatory actions by the Centers for Medicare & Medicaid Services (CMS) concerning the Medicare payment system for end-stage renal disease (ESRD). The dispute arose after CMS included oral-only drugs, specifically XPHOZAH—a drug manufactured by the company for treating hyperphosphatemia in dialysis patients—within the bundled payment for renal dialysis services under Medicare, effective January 1, 2025. Previously, such oral drugs were reimbursed separately under Medicare Part D.The plaintiffs filed suit in the United States District Court for the District of Columbia, contesting both the inclusion of oral-only drugs in the bundled payment regulation and the specific identification of XPHOZAH as a renal dialysis service. They asserted these actions were arbitrary, exceeded statutory authority, and violated the Administrative Procedure Act. CMS moved to dismiss the complaint, arguing that federal law expressly bars judicial review of the Secretary’s “identification of renal dialysis services included in the bundled payment.” The district court agreed, finding that both the regulation and the identification of XPHOZAH fell within the statutory bar to judicial review because they constituted “identifications” as defined by the statute and were within the agency’s delegated authority. The court dismissed the action for lack of jurisdiction.On appeal, the United States Court of Appeals for the District of Columbia Circuit reviewed the district court’s dismissal de novo. The appellate court affirmed, holding that the relevant statute, 42 U.S.C. § 1395rr(b)(14)(G), clearly precludes judicial review of the Secretary’s identification of renal dialysis services, including oral-only drugs and XPHOZAH. The court found that CMS acted within its statutory authority, and therefore, further judicial review was barred. The district court’s dismissal was affirmed. View "Ardelyx, Inc. v. Kennedy" on Justia Law

Norwich Pharmaceuticals sought to market a generic version of Xifaxan, a drug invented by Salix Pharmaceuticals for treating irritable bowel syndrome with diarrhea and hepatic encephalopathy. Norwich submitted an Abbreviated New Drug Application (ANDA) to the FDA, identified as number 214369. Salix believed this ANDA infringed its patents and sued Norwich in the United States District Court for the District of Delaware. That court found Norwich’s ANDA infringed Salix’s patents related to hepatic encephalopathy, while the patents for irritable bowel syndrome were invalid as obvious. The court’s final judgment barred FDA approval of Norwich’s ’369 ANDA until Salix’s hepatic encephalopathy patents expired in October 2029.Following the judgment, Norwich amended its ’369 ANDA to remove the indication for hepatic encephalopathy and requested the Delaware District Court modify its judgment to allow immediate FDA approval of the amended ANDA. The court denied this motion, reasoning that Norwich could not change its ANDA after final judgment to circumvent the prior ruling. Norwich appealed to the United States Court of Appeals for the Federal Circuit, which agreed the judgment restricted approval of the entire ANDA, including non-infringing indications, until 2029, and affirmed the Delaware District Court’s decision.After the FDA declined to grant final approval of Norwich’s amended ANDA, instead issuing only tentative approval, Norwich sued in the United States District Court for the District of Columbia, arguing the FDA acted arbitrarily and capriciously. The court granted summary judgment to the FDA and Salix. On appeal, the United States Court of Appeals for the District of Columbia Circuit held that the Delaware District Court’s judgment applied to Norwich’s ANDA as amended, so the FDA correctly delayed final approval until October 2029. The appellate court affirmed the district court’s judgment. View "Norwich Pharmaceuticals, Inc. v. Kennedy" on Justia Law

After experiencing ongoing struggles with gender identity, a young adult sought a double mastectomy and was informed by the surgical clinic that a letter from a mental health practitioner was required to proceed. The petitioner requested this letter from her therapist, who had previously counseled her on unrelated matters. The therapist provided a letter recommending the surgery on February 22, 2021. Their therapeutic relationship ended on May 14, 2021. The petitioner underwent surgery on June 11, 2021, subsequently suffered medical complications, and later regretted the procedure. In 2023, she filed suit against the therapist and the therapist’s employer, alleging negligence and fraud in the issuance of the recommendation letter, and sought to hold the employer vicariously and directly liable.The case was first adjudicated in a Texas district court, where the respondents sought summary judgment, arguing that the petitioner’s claims were time-barred by the two-year statute of limitations for health care liability claims under Section 74.251(a) of the Texas Civil Practice and Remedies Code. The district court granted summary judgment and severed the claims, making the decision final as to the therapist and her employer. On appeal, the Court of Appeals for the Second District of Texas affirmed, holding that the statute of limitations began to run on the date the recommendation letter was provided.The Supreme Court of Texas reviewed the case and concluded that the lower courts erred in their interpretation of the statute of limitations. The Court held that, under Section 74.251(a), a claim is timely if filed within two years of the completion of the relevant health care treatment or the occurrence of the tort. Here, treatment concluded on May 14, 2021, and the alleged injury occurred on June 11, 2021, when the surgery was performed. Because the petitioner gave notice of her claims within two years of these events, her suit was not time-barred. The judgment of the court of appeals was reversed and remanded for further proceedings. View "ALDACO v. WOOD" on Justia Law

A woman, referred to as Naomi, was charged with felony battery by a prisoner after slapping a nurse while incarcerated in the Milwaukee County jail. At her initial court appearance, concerns were raised about her competency to stand trial, and the Milwaukee County Circuit Court ordered a competency evaluation. Upon finding Naomi incompetent but likely to regain competence with treatment, the court committed her to the Department of Health Services (DHS) for treatment. The court originally found her incompetent to refuse medication and, after applying the standards from Sell v. United States, ordered involuntary medication to restore competency. Naomi appealed, and the court stayed the order. Subsequently, after DHS raised concerns about Naomi’s dangerousness, the court vacated its earlier order and issued a new involuntary medication order based solely on Naomi’s dangerousness, relying on WIS. STAT. § 51.61(1)(g)3.Naomi challenged the legal authority for this order, arguing that someone committed only under WIS. STAT. § 971.14 for competency restoration could not be involuntarily medicated on dangerousness grounds under § 51.61(1)(g)3. The Wisconsin Court of Appeals agreed with Naomi, rejecting the State’s arguments that various statutory and case law authorities permitted the order.The Supreme Court of Wisconsin reviewed the matter and affirmed the Court of Appeals. The court held that WIS. STAT. § 51.61(1)(g)3. does not authorize a court to order involuntary medication for an individual committed exclusively under WIS. STAT. § 971.14. The court based its decision on statutory language, context, and history, finding that § 971.14 provides a separate, more stringent process for involuntary medication orders in the context of competency restoration, and that § 51.61(1)(g)3. cannot be used as an alternative basis for such orders. View "State v. N. K. B." on Justia Law

In this case, an individual referred to as Mark was detained following property damage allegations and later underwent an inpatient psychiatric evaluation to assess his competency for trial. As his mental health concerns continued, Outagamie County initiated involuntary civil commitment proceedings under Wisconsin law. After his emergency detention, two examiners were appointed to assess Mark and submit written reports. One examiner’s report was not made accessible to Mark’s counsel until less than 48 hours before the final hearing, because the filing was delayed due to a holiday.The Outagamie County Circuit Court determined that, despite the delayed access to the report by Mark’s counsel, the court retained competency to proceed. Neither party intended to rely on the late report, and Mark’s counsel declined to seek a postponement. The court found the statutory violation did not affect Mark’s substantial rights and entered orders for involuntary commitment and involuntary medication and treatment. Mark appealed, and the Wisconsin Court of Appeals reversed, concluding that the failure to provide timely access to the examiner’s report deprived the circuit court of competency.The Supreme Court of Wisconsin reviewed the case. It held that the statutory requirement for counsel to have access to the examiners’ reports at least 48 hours before the final hearing is not central to Chapter 51’s statutory scheme governing involuntary commitment, and thus, noncompliance does not strip the circuit court of competency. The court further held that any error in failing to meet the 48-hour requirement was subject to harmless error review. Because the delay in access did not affect Mark’s substantial rights or the outcome, the error was harmless. The Supreme Court of Wisconsin reversed the decision of the Court of Appeals and affirmed the circuit court’s orders. View "Outagamie County v. M.J.B." on Justia Law

A company that manufactures menthol-flavored e-cigarette products applied to the United States Food & Drug Administration (FDA) for marketing authorization, as required under the Family Smoking Prevention and Tobacco Control Act (TCA). The FDA, concerned about the appeal of non-tobacco-flavored e-cigarettes to minors, especially menthol varieties, evaluated whether the benefits of these products for adult smokers outweighed the risks to youth. After reviewing the evidence and applying its “comparative-efficacy standard,” which requires proof that non-tobacco-flavored e-cigarettes encourage more adult smokers to switch or quit compared to tobacco-flavored versions, the FDA denied the application.The petitioners challenged the FDA’s denial through a petition for review to the United States Court of Appeals for the Fifth Circuit. They raised four main arguments: that the FDA’s authority under the TCA violated the major questions and nondelegation doctrines; that the TCA’s “appropriate for the protection of the public health” (APPH) standard is unconstitutionally vague; that the FDA’s comparative-efficacy standard was an unlawfully adopted tobacco product standard; and that the FDA’s application of the APPH standard to their application was arbitrary and capricious. The petitioners also argued that the FDA improperly disregarded recent data and failed to consider their proposed marketing plan.The United States Court of Appeals for the Fifth Circuit reviewed the FDA’s decision under the Administrative Procedure Act’s arbitrary and capricious standard. The court held that Congress’s delegation of authority to the FDA was constitutional, the APPH standard was not unconstitutionally vague, and the comparative-efficacy standard was not a tobacco product standard requiring notice-and-comment rulemaking. The court further found that the FDA reasonably explained its decision and did not act arbitrarily or capriciously in denying the application. The petition for review was denied. View "VDX Distro v. FDA" on Justia Law