Justia Government & Administrative Law Opinion Summaries

After the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization returned abortion regulation to the states, the Food and Drug Administration (FDA) changed its rules to allow the abortion drug mifepristone to be prescribed online and sent by mail, eliminating the prior requirement for in-person doctor visits. The State of Louisiana, joined by an individual plaintiff, challenged this 2023 regulation (the “2023 REMS”) under the Administrative Procedure Act (APA), arguing that the FDA’s decision was not supported by sufficient data and resulted in illegal abortions and increased Medicaid costs within the state.The United States District Court for the Western District of Louisiana found that Louisiana had standing, was likely to succeed on the merits, and was suffering irreparable harm. However, the district court declined to stay the regulation, reasoning that the balance of equities and public interest favored denying immediate relief. Instead, the district court stayed the litigation to allow the FDA to complete its ongoing review of mifepristone’s safety protocols, which the FDA admitted had previously lacked adequate consideration.On appeal, the United States Court of Appeals for the Fifth Circuit reviewed whether a stay of the 2023 REMS pending appeal was warranted under 5 U.S.C. § 705. The Fifth Circuit concluded that Louisiana was strongly likely to succeed on the merits because the FDA’s removal of the in-person dispensing requirement was arbitrary and capricious, relied on insufficient data, and was inadequately explained. The court further found that Louisiana faced ongoing irreparable harm to its sovereign interests and financial losses. The appellate court determined that neither the FDA’s nor the manufacturers’ interests outweighed Louisiana’s injuries or the public interest, and that a stay of the regulation was appropriate. The court therefore granted Louisiana’s motion for a stay pending appeal. View "Louisiana v. FDA" on Justia Law

A group of businesses and consumers involved in the sale and manufacture of consumable hemp products containing manufactured delta-8 THC challenged actions taken by the Texas Department of State Health Services and its commissioner. Following federal and state legislative changes in 2018 and 2019 that removed “hemp” and certain tetrahydrocannabinols (THC) in hemp from the definition of controlled substances, the Texas commissioner objected to a federal rule that would have further decontrolled hemp-derived extracts, including delta-8 THC. The commissioner then amended the state schedules to clarify that manufactured delta-8 THC remained a Schedule I controlled substance, leading to substantial business disruption for the vendors who had entered the delta-8 market.The vendors sued in district court, arguing that the commissioner exceeded her authority both procedurally and substantively under Texas law by modifying the schedules in a way that contradicted the Texas Farm Bill, and that the Department’s website statement about delta-8 THC was an invalid rule under the Texas Administrative Procedure Act (APA). The trial court denied the Department’s plea to the jurisdiction (challenging standing and sovereign immunity) and issued a temporary injunction against enforcement of the amended schedules and the website statement. The Court of Appeals for the Third District of Texas affirmed, concluding that the vendors had standing, the claims were justiciable, and a temporary injunction was appropriate.The Supreme Court of Texas held that the vendors had standing and their claims were ripe for review. However, it concluded that the commissioner acted within her broad statutory discretion and followed proper procedures under Health & Safety Code § 481.034(g) in objecting to the federal rule and amending the schedules. The court also held that the website statement was not an APA “rule.” Accordingly, it reversed the injunction and rendered judgment for the Department, with the only affirmed portion being the finding of standing. View "TEXAS DEPARTMENT OF STATE HEALTH SERVICES v. SKY MARKETING CORP." on Justia Law

Metro Treatment of New Hampshire, L.P. operates outpatient opioid treatment clinics licensed by the New Hampshire Department of Health and Human Services (DHHS). AmeriHealth Caritas New Hampshire is a Medicaid Managed Care Organization (MCO) responsible for arranging healthcare services for Medicaid-eligible patients, including some treated by Metro. The parties’ relationship was governed by an ancillary services agreement. Following an audit of Metro’s patient records, AmeriHealth determined that Metro had violated certain state administrative rules and sought to recoup $36,722.27 in alleged Medicaid overpayments. After Metro appealed through the contractual process, AmeriHealth reduced the recoupment amount and advised Metro it could seek further review through a State Fair Hearing as provided by statute.Metro then filed an appeal with the Administrative Appeals Unit (AAU) of DHHS, but argued that the AAU lacked jurisdiction over payment disputes between MCOs and providers. The AAU issued a written decision concluding that it has subject matter jurisdiction under RSA 126-A:5, VIII to hear appeals arising from determinations that Medicaid payments were inappropriately made and should be recouped. The AAU denied Metro’s motion for reconsideration and stayed further proceedings pending Metro’s petition for a writ of certiorari to the Supreme Court of New Hampshire.The Supreme Court of New Hampshire reviewed whether the AAU has jurisdiction in this dispute. The court held that the AAU does possess jurisdiction under RSA 126-A:5, VIII because Metro is a provider licensed by DHHS and the statute provides for appeals by such providers. The court rejected Metro’s argument that the statute or administrative rules limited jurisdiction only to disputes involving direct departmental actions. The decision of the AAU was affirmed and the matter was remanded for further proceedings. View "Petition of Metro Treatment of N.H." on Justia Law

This case involves several dialysis providers, a nonprofit organization, and individual patients challenging a California law (AB 290) aimed at regulating relationships between dialysis providers and nonprofits that assist patients with health insurance premiums. The law was enacted due to concerns that providers were donating to nonprofits to help keep patients on private insurance, which led to higher reimbursements for providers compared to public insurance. Key provisions of the law included capping provider reimbursements if they had a financial relationship with a nonprofit offering patient assistance, requiring disclosure of patients receiving such assistance, restricting nonprofits from conditioning assistance on patient treatment choices, mandating disclosure to patients of all insurance options, and a safe harbor for seeking federal advisory opinions.The United States District Court for the Central District of California granted in part and denied in part motions for summary judgment. It upheld the constitutionality of the reimbursement cap, coverage disclosure requirement, and safe harbor provision, but found the anti-steering, patient disclosure, and financial assistance restriction provisions unconstitutional. The district court also ruled that the unconstitutional parts were severable from the remainder of the statute and rejected claims that federal law preempted the state law.The United States Court of Appeals for the Ninth Circuit reviewed the case. It held that the reimbursement cap, patient disclosure requirement, and financial assistance restriction violated the First Amendment because they burdened the rights of expressive association and were not narrowly tailored to serve the state’s interests. The court found the coverage disclosure requirement constitutional under the standard for compelled commercial speech, as it required only factual, uncontroversial information reasonably related to a state interest. However, it concluded that the unconstitutional provisions were not severable from the coverage disclosure requirement. The court also held challenges to the safe harbor provision moot. The court affirmed in part, reversed in part, and each party was ordered to bear its own costs. View "DOE V. BONTA" on Justia Law

A group of pharmaceutical manufacturers that participate in the federal 340B drug pricing program challenged a new West Virginia law, S.B. 325, which imposed restrictions and penalties on manufacturers regarding the delivery of discounted drugs to contract pharmacies. The 340B program is a federal scheme where drug manufacturers provide discounts to designated health care providers (“covered entities”) in exchange for access to the Medicaid market. Dissatisfied with the federal program’s scope, West Virginia enacted S.B. 325, which specifically barred manufacturers from restricting delivery of 340B drugs to any location authorized by a covered entity (including contract pharmacies), and from requiring data submission as a condition for delivery, with significant penalties for violations.The manufacturers sued in the United States District Court for the Southern District of West Virginia seeking to enjoin enforcement of S.B. 325, arguing that it was preempted by federal law. The district court found that the manufacturers were likely to succeed on the merits of their preemption claim, that they faced irreparable harm, and that the balance of equities and public interest favored injunctive relief. The court granted a preliminary injunction against enforcement of the statute.On appeal, the United States Court of Appeals for the Fourth Circuit addressed whether S.B. 325 was preempted by federal law. The Fourth Circuit held that S.B. 325 likely interferes with the federal 340B program by imposing additional conditions on manufacturers solely because of their participation in a federal program, thereby intruding into a domain reserved for federal regulation. The court found that Congress had struck a careful bargain in the 340B program and that West Virginia’s law sought to alter that bargain in a way that conflicted with federal objectives and the enforcement scheme administered by the Department of Health and Human Services. The Fourth Circuit affirmed the district court’s preliminary injunction, barring enforcement of S.B. 325. View "Pharmaceutical Research & Manufacturers of America v. McCuskey" on Justia Law

A class of inmates at the Louisiana State Penitentiary alleged that the prison’s medical care was constitutionally inadequate and that the facility failed to comply with the Americans with Disabilities Act and the Rehabilitation Act. The lawsuit began in 2015, and evidence was introduced at trial in 2018. In 2021, the United States District Court for the Middle District of Louisiana issued a lengthy opinion finding systemic Eighth Amendment violations and ADA/RA noncompliance. While prison officials began making improvements ahead of a scheduled remedial trial, the district court later issued a Remedial Opinion and Order, prescribing detailed institutional changes and appointing special masters to oversee compliance.The district court’s Remedial Order required the state to bear the costs of three special masters, directed broad institutional reforms, and did not expressly adhere to the limitations imposed by the Prison Litigation Reform Act (PLRA). The court entered final judgment in favor of the plaintiffs, retaining jurisdiction only for compliance procedures. After entry of judgment, the defendants appealed. During the appeal, a panel of the United States Court of Appeals for the Fifth Circuit stayed the Remedial Order. The Fifth Circuit, sitting en banc, subsequently reviewed whether it had appellate jurisdiction and the validity of the district court’s orders.The United States Court of Appeals for the Fifth Circuit held that it had appellate jurisdiction under 28 U.S.C. § 1291 or, alternatively, § 1292(a)(1). The Fifth Circuit found that the district court’s Remedial Order violated the PLRA by failing to apply the statutory needs-narrowness-intrusiveness standard, improperly appointing multiple special masters, and requiring the state to pay their fees. The Fifth Circuit also concluded that the district court erred by disregarding ongoing improvements to prison medical care and by misapplying the standards for injunctive relief under the Eighth Amendment and the ADA/RA. The court vacated the district court’s judgment and remanded for further proceedings. View "Parker v. Hooper" on Justia Law

Four women incarcerated at the Huron Valley Correctional Facility in Michigan suffered from persistent, painful rashes between 2016 and 2019. Despite repeated complaints, medical staff—contracted through Corizon Health—failed to diagnose scabies, instead providing ineffective treatments and attributing the condition to environmental factors like improper laundering. It was only after an outside dermatologist intervened that scabies was correctly identified, prompting prison-wide treatment efforts. However, these efforts were delayed and, in some cases, inadequate, resulting in prolonged suffering for the affected inmates.After their experiences, the four women filed suit in the United States District Court for the Eastern District of Michigan against multiple defendants, including high-level Michigan Department of Corrections officials and Wayne State University medical officers, alleging Eighth Amendment violations and state-law negligence. The district court found that the women’s complaint plausibly alleged “clearly established” Eighth Amendment violations by all defendants and denied the officials’ request for qualified immunity. The court also rejected a claim of state-law immunity, finding that the officials could be the proximate cause of the inmates’ injuries under Michigan law.On appeal, the United States Court of Appeals for the Sixth Circuit reviewed the district court’s denials. The Sixth Circuit held that existing precedent did not “clearly establish” that the non-treating prison officials’ reliance on contracted medical providers was so unreasonable as to violate the Eighth Amendment. Thus, it reversed the district court’s denial of qualified immunity on the federal damages claims. However, the appellate court affirmed the denial of state-law immunity, finding the plaintiffs adequately pleaded proximate cause under Michigan law. The case was remanded for further proceedings consistent with these holdings. View "Machelle Pearson v. MDOC" on Justia Law

A California-based company that produces lab-grown chicken sought to distribute and sell its product in Florida. After the company received federal approval from the USDA and FDA to market its lab-grown chicken, Florida enacted SB 1084, a law banning the manufacture, sale, and distribution of all lab-grown meat within the state. The company had previously held tasting events and developed business relationships in Florida but had no plans to manufacture its product there.Following the enactment of SB 1084, the company filed suit in the U.S. District Court for the Northern District of Florida against state officials, seeking declaratory and injunctive relief. The company argued that the federal Poultry Products Inspection Act (PPIA) preempted Florida’s ban, claiming the state’s law imposed “additional or different” ingredient or facilities requirements in violation of the PPIA. The district court denied the company’s motion for a preliminary injunction, finding the company unlikely to succeed on its preemption claims because SB 1084 did not regulate the company’s ingredients, premises, facilities, or operations. The court also addressed standing and procedural questions, ultimately dismissing the preemption claims after the company amended its complaint.On appeal, the United States Court of Appeals for the Eleventh Circuit reviewed whether the filing of an amended complaint or the district court’s dismissal order rendered the appeal moot and whether the company could challenge the Florida law as preempted. The Eleventh Circuit held the appeal was not moot and that the company could bring a preemption action in equity. However, the court concluded the company was unlikely to succeed on the merits. The court held that Florida’s ban did not impose ingredient or facilities requirements preempted by the PPIA, as it simply banned the product’s sale and manufacture. Therefore, the district court’s denial of a preliminary injunction was affirmed. View "Upside Foods Inc v. Commissioner, Florida Department of Agriculture" on Justia Law

A healthcare provider operating as a covered entity under the federal Section 340B Drug Pricing Program purchased pharmaceuticals from several drug manufacturers. The provider alleged that these manufacturers engaged in a fraudulent scheme by knowingly charging prices for drugs that exceeded the statutory ceiling, resulting in inflated reimbursement claims submitted to Medicaid, Medicare, and other government-funded programs. The provider did not seek compensation for its own overcharges, but instead brought a qui tam action under the False Claims Act (FCA), seeking to recover losses on behalf of the federal and state governments.The United States District Court for the Central District of California dismissed the complaint with prejudice. It reasoned that, under the Supreme Court’s holding in Astra USA, Inc. v. Santa Clara County, Section 340B does not confer a private right of action for covered entities to sue drug manufacturers over pricing disputes; such claims must instead be pursued through the Section 340B Administrative Dispute Resolution process. The district court concluded that the provider’s FCA claims were essentially attempts to enforce Section 340B and should therefore be barred.On appeal, the United States Court of Appeals for the Ninth Circuit reversed the district court’s dismissal. The appellate court held that the provider’s FCA claims were not barred by the absence of a private right of action under Section 340B or by the Astra decision, because the action was brought to remediate fraud against the government and not to recover personal losses or enforce Section 340B directly. The court further found that the provider had plausibly pleaded falsity under the FCA. The Ninth Circuit remanded the case for further proceedings. View "ADVENTIST HEALTH SYSTEM OF WEST V. ABBVIE INC." on Justia Law

A former employee of a pharmaceutical manufacturer brought a qui tam lawsuit under the False Claims Act, alleging that the company improperly calculated and reported its “Best Price” for certain drugs to the Centers for Medicare and Medicaid Services (CMS), as required under the Medicaid Rebate Statute. The plaintiff claimed that, during a period from 2005 to 2014, the company failed to aggregate multiple rebates and discounts given to different entities on the same drug, resulting in inflated “Best Price” reports and underpayment of rebates owed to Medicaid. The complaint asserted that the company was subjectively aware that CMS interpreted the statute to require aggregation of all such discounts, especially after the company’s communications with CMS during a 2006–2007 rulemaking process and the company’s subsequent internal audit.After the government and several states declined to intervene, the United States District Court for the District of Maryland dismissed the amended complaint, finding that, even under the subjective scienter standard established in United States ex rel. Schutte v. SuperValu Inc., the plaintiff had not plausibly alleged that the company acted with actual knowledge, deliberate ignorance, or reckless disregard as to the truth or falsity of its reports. The district court also suggested that ambiguity in the statute precluded a finding of falsity.On appeal, the United States Court of Appeals for the Fourth Circuit reviewed the dismissal de novo. The Fourth Circuit held that the plaintiff’s allegations—including the company’s awareness of CMS’s interpretation of the rule, its targeted audit and compliance efforts, and its continued use of non-aggregated reporting—plausibly alleged the requisite subjective scienter under the False Claims Act. The court clarified that statutory ambiguity does not, at the pleading stage, negate scienter or falsity, and remanded for the district court to address other elements, including falsity, in the first instance. The Fourth Circuit reversed the dismissal and remanded for further proceedings. View "United States ex rel. Sheldon v. Allergan Sales, LLC" on Justia Law