Justia Government & Administrative Law Opinion Summaries

A company that manufactures flavored e-liquids for use in electronic nicotine delivery systems (ENDS), including fruit and candy flavors, submitted premarket applications to the Food and Drug Administration (FDA) seeking authorization to sell 64 such products. The FDA’s regulatory authority under the Family Smoking Prevention and Tobacco Control Act (TCA) requires that new tobacco products be shown to be “appropriate for the protection of the public health” before they can be marketed. The FDA denied the company’s applications, citing the failure to provide robust comparative evidence demonstrating that its flavored products offer a public health benefit for adult smokers that outweighs the risks to youth, compared to tobacco-flavored ENDS.Following the FDA’s marketing denial order, the company petitioned for review in the United States Court of Appeals for the Ninth Circuit. The company argued that the FDA acted arbitrarily and capriciously by requiring comparative efficacy evidence, failed to adequately consider its marketing and sales restriction plans, and improperly denied authorization for “zero nicotine” products. It also argued that the FDA could only impose a comparative efficacy requirement through notice-and-comment rulemaking under the TCA and the Administrative Procedure Act (APA).The United States Court of Appeals for the Ninth Circuit denied the petition for review. The court held that the FDA’s denial based on the absence of comparative efficacy evidence was neither arbitrary nor capricious, especially since the applicant offered no evidence distinguishing its products’ youth risks from those of other flavored ENDS. The court also found that any error in declining to consider marketing or access restriction plans was harmless. Additionally, the court ruled that the FDA was not required to undertake notice-and-comment rulemaking before applying the comparative efficacy requirement, and the inclusion of “zero nicotine” products in the denial order was proper based on the company’s own representations. View "DRIP MORE LLC V. FDA" on Justia Law

In 2024, Iowa enacted legislation (HF 2677) prohibiting the manufacture and sale of electronic nicotine delivery systems (ENDS) that had not received marketing authorization from the United States Food and Drug Administration (FDA). The law required manufacturers to certify their compliance with federal premarket approval requirements or demonstrate that their products were pending FDA review. Several manufacturers, retailers, and consumers challenged the law, contending it was preempted by federal law, specifically the Family Smoking Prevention and Tobacco Control Act, and that it violated constitutional equal protection guarantees.The United States District Court for the Southern District of Iowa granted a preliminary injunction, halting enforcement of the law. The district court found that at least one plaintiff had standing, was likely to succeed on the merits of the preemption claim, and was not required to post a security bond. It dismissed claims against the Iowa Department of Revenue based on Eleventh Amendment immunity but allowed the case to proceed against the Director in her official capacity. The Department voluntarily stayed enforcement while the litigation continued.The United States Court of Appeals for the Eighth Circuit reviewed the district court’s order. The Eighth Circuit held that at least one retailer plaintiff had Article III standing, as they plausibly alleged injury from the credible threat of enforcement. However, the appellate court concluded the plaintiffs were not likely to succeed on the merits of their preemption claim. The court determined that HF 2677 was not preempted by federal law, as it fell within the scope of the Tobacco Control Act’s savings clause, which permits state requirements relating to the sale and distribution of tobacco products. The Eighth Circuit vacated the preliminary injunction and remanded the case for further proceedings. View "Iowans for Alternatives v. Mosiman" on Justia Law

The plaintiff participated in a clinical trial for an experimental COVID-19 vaccine manufactured by AstraZeneca in November 2020. Before receiving the vaccine, she signed an informed-consent form stating that AstraZeneca would compensate her for injuries caused by the vaccine, including providing medical care and reimbursement, and that the company had an insurance policy to cover such costs. The form also disclosed that federal law may limit her right to sue for vaccine-related injuries, referencing the Public Readiness and Emergency Preparedness Act (PREP Act), which provides broad immunity to vaccine manufacturers during a public health emergency.After suffering debilitating medical injuries from the vaccine, the plaintiff requested compensation and care from AstraZeneca, which was denied. She then filed suit in the United States District Court for the District of Utah, alleging breach of contract and breach of the contractual duty of good faith and fair dealing. AstraZeneca moved to dismiss the complaint, arguing that the PREP Act immunized it from liability. The district court denied the motion, holding that the PREP Act’s immunity provision applies only to tort claims, not to contract-based claims. The court further reserved judgment on whether AstraZeneca had waived its statutory immunity in the informed-consent form.The United States Court of Appeals for the Tenth Circuit reviewed the case and reversed the district court’s ruling. The appellate court held that the PREP Act’s immunity provision applies to “all claims for loss,” including those arising from breach of contract, provided they bear a causal relationship to the administration or use of a covered countermeasure like a vaccine. The court remanded the case for the district court to consider whether AstraZeneca waived immunity in the informed-consent form. View "Dressen v. AstraZeneca AB" on Justia Law

The plaintiff, an advocacy organization representing nurse anesthetists, filed suit against the Secretary and Department of Health and Human Services (HHS) after several private insurers reduced reimbursement rates for nurse anesthetists practicing independently, compared to physician anesthesiologists. The plaintiff alleged these lower rates violated a nondiscrimination provision in the Affordable Care Act (ACA), which prohibits insurers from discriminating against healthcare providers acting within the scope of their license. The ACA assigns primary enforcement of this provision to the states, but allows HHS to intervene if a state fails to enforce it. The plaintiff sought a writ of mandamus compelling HHS to enforce the provision and also asserted a claim under the Administrative Procedure Act for agency action unlawfully withheld or unreasonably delayed.The United States District Court for the Northern District of Ohio granted HHS’s motion to dismiss, concluding that the plaintiff lacked standing. The court found the plaintiff had not adequately established that its members had suffered a cognizable injury or that any alleged injury was traceable to HHS’s conduct.On appeal, the United States Court of Appeals for the Sixth Circuit reviewed the district court’s dismissal de novo. The Sixth Circuit determined that even if the plaintiff’s members had experienced monetary harm, they failed to show that the harm was caused by HHS’s alleged nonenforcement, as it was the insurers—not HHS—that set the reimbursement rates. The court found the causal link between government inaction and insurers’ decisions too speculative. Additionally, the court held that any relief ordered by the court would not likely redress the alleged injuries, given the discretionary nature of enforcement and uncertainty about how insurers would respond. Therefore, the Sixth Circuit affirmed the district court’s dismissal for lack of standing. View "Am. Ass'n of Nurse Anesthesiology v. Kennedy" on Justia Law

Several pharmaceutical manufacturers participating in the federal 340B program, which requires them to provide discounted drugs to qualifying healthcare providers, proposed changing how they fulfill this obligation. Historically, these manufacturers complied by offering upfront discounts on eligible drug purchases. In 2024, they sought to implement a new rebate model, where providers would purchase drugs at full price and receive a post-purchase rebate to reach the required discounted price. The Secretary of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), responded that such rebate mechanisms had not been approved for these entities, requested further information, and stated that the manufacturers could not move forward with the new models without official approval.The manufacturers sued the Secretary in the United States District Court for the District of Columbia, arguing that the statute allowed them to unilaterally implement rebate models unless expressly disapproved by the Secretary. Advocacy groups and hospitals intervened, contending that rebate models were not permitted at all. The district court granted summary judgment for the Secretary, concluding that manufacturers could not implement such rebate systems without prior approval.Upon review, the United States Court of Appeals for the District of Columbia Circuit affirmed the district court’s judgment. The appellate court held that the statutory text of Section 340B permits rebate models but requires the Secretary to affirmatively provide for such mechanisms before manufacturers may implement them. The court found that the statute vests authority in the Secretary to determine acceptable pricing mechanisms and that manufacturers cannot act unilaterally in this regard. Because the Secretary had not approved the proposed rebate models, the court concluded that the manufacturers’ intended implementation was properly blocked. The appellate court therefore affirmed the district court’s decision in favor of the Secretary. View "Novartis Pharmaceuticals Corporation v. Kennedy" on Justia Law

Alignment Healthcare, a private health insurer offering Medicare Advantage plans, challenged the accuracy of its star ratings issued by the Centers for Medicare & Medicaid Services (CMS) for two of its contracts. The ratings are partly determined by an annual survey of enrollees, and Alignment claimed that a significant drop in Spanish-language responses resulted from errors in survey administration—specifically, that some Spanish-speaking enrollees received the survey in English despite indicating a preference for Spanish. Alignment argued that this error negatively affected its ratings, as its internal data showed higher satisfaction among Spanish-speaking enrollees.After receiving preliminary survey results in September 2024, Alignment raised these concerns with CMS, requesting a review of the sampling methodology and suppression of the disputed survey data. CMS reviewed the sampling and response data, consulted with the survey vendor, and ultimately found no evidence of a survey administration error. CMS noted that Spanish-speaking enrollees had access to Spanish-language surveys and that the rates of Spanish responses were higher than average. CMS denied Alignment’s requests for data suppression or further validation, stating it had no authority to remove the results absent evidence of protocol violations.Alignment then filed suit under the Administrative Procedure Act in the United States District Court for the District of Columbia, which granted summary judgment for CMS. On appeal, the United States Court of Appeals for the District of Columbia Circuit reviewed the district court’s decision de novo. The appellate court held that Alignment failed to demonstrate that CMS’s actions were arbitrary or capricious or that survey protocols had been violated. The court found CMS’s investigation and explanation adequate, rejected Alignment’s contentions regarding unequal treatment and nondelegation, and affirmed the district court’s grant of summary judgment to CMS. View "Alignment Healthcare Inc. v. HHS" 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