Justia Health Law Opinion Summaries

A pharmaceutical company sought approval from the Food and Drug Administration (FDA) to market tasimelteon, a drug previously approved for a rare sleep disorder, as a treatment for jet lag. The company submitted results from several clinical trials, focusing on both objective sleep measures and subjective assessments of alertness and next-day functioning. The FDA’s Center for Drug Evaluation and Research issued a complete response letter indicating that the application did not provide substantial evidence of efficacy, particularly criticizing the measurement of next-day impairment and the tools used for subjective endpoints. The company engaged in further discussions and dispute resolution with the FDA, including proposing a narrower indication for approval, but these efforts were unsuccessful.After the FDA issued a formal notice of opportunity for a hearing (NOOH), the company requested a hearing and submitted expert declarations supporting the adequacy of its clinical evidence. The FDA ultimately denied both the application and the hearing request, finding no genuine and substantial issue of fact warranting a hearing. The company then petitioned the United States Court of Appeals for the District of Columbia Circuit for review, arguing that the FDA was required to hold a hearing, that material factual disputes existed, that the FDA’s decision-making was arbitrary and capricious, and that the final decision violated the Appointments Clause.The United States Court of Appeals for the District of Columbia Circuit held that the Food, Drug, and Cosmetic Act does not require the FDA to hold a hearing before denying every new drug application, but the agency must grant a hearing if there are material factual disputes. The court found that, in this case, the FDA’s refusal to hold a hearing was arbitrary and capricious because the company’s expert evidence created genuine disputes over the adequacy of the clinical trials. The court remanded the case to the FDA for further proceedings consistent with its opinion. View "Vanda Pharmaceuticals, Inc. v. FDA" on Justia Law

A hospital submitted its proposed budget for the upcoming fiscal year, requesting a 6.1% increase in net patient revenue (NPR) and a 2.8% increase in commercial negotiated rates. The hospital justified its request by citing increased patient volume and efforts to reduce wait times. The Green Mountain Care Board, which regulates hospital budgets in Vermont, had previously issued guidance setting a 3.5% benchmark for NPR growth and a 3.4% benchmark for commercial rate increases, requiring hospitals to justify any requests above these benchmarks.After reviewing the hospital’s proposal, the Green Mountain Care Board approved a 5.0% NPR increase—higher than the benchmark but lower than requested—citing the hospital’s strong financial health and the need to balance access to care with cost containment. The Board also approved the requested 2.8% commercial rate increase but included a footnote reducing this increase to 1.2% due to a prior budget overage, referencing a separate budget-enforcement order. The hospital appealed the Board’s decision to the Vermont Supreme Court, arguing that the Board’s NPR decision was arbitrary and that the reduction in the commercial rate increase violated procedural requirements under the Vermont Administrative Procedure Act (VAPA).The Vermont Supreme Court held that the Board had adequately explained its decision to approve a 5.0% NPR increase and acted within its discretion, given the statutory mandate to balance cost control and access to care. However, the Court struck the footnote reducing the commercial rate increase to 1.2%, because the underlying budget-enforcement order had been reversed by the Vermont Superior Court for failure to follow VAPA procedures and was no longer valid. The Supreme Court otherwise affirmed the Board’s decision. View "In re Rutland Regional Medical Center Fiscal Year 2025" on Justia Law

Several individuals who allegedly owed debts to Kentucky public institutions—either for medical services at the University of Kentucky or for educational services at the University of Kentucky, Morehead State University, or the Kentucky Community & Technical College System—challenged the referral of their debts to the Kentucky Department of Revenue for collection. The plaintiffs argued that the statutes used to justify these referrals did not apply to their debts and that the Department unlawfully collected the debts, sometimes without prior court judgments or adequate notice. The Department used its tax collection powers, including garnishments and liens, to recover these debts, and in some cases, added interest and collection fees.In the Franklin Circuit Court, the plaintiffs sought declaratory and monetary relief, including refunds of funds collected. The Circuit Court ruled that the Department was not authorized by statute to collect these debts and held that sovereign immunity did not protect the defendants from the plaintiffs’ claims. The court also certified the medical debt case as a class action. The Court of Appeals reviewed these interlocutory appeals and held that while sovereign immunity did not bar claims for purely declaratory relief, it did bar all claims for monetary relief, including those disguised as declaratory relief.The Supreme Court of Kentucky reviewed the consolidated appeals. It held that sovereign immunity does not bar claims for purely declaratory relief or for a refund of funds that were never due to the state, nor does it bar constitutional takings claims. However, the court held that sovereign immunity does bar claims for a refund of funds that were actually due to the state, even if those funds were unlawfully or improperly collected. The court affirmed in part, reversed in part, and remanded for further proceedings to determine which funds, if any, were never due to the state and thus subject to refund. The court also found that statutory changes rendered prospective declaratory relief in the medical debt case moot, but not retrospective relief. View "LONG V. COMMONWEALTH OF KENTUCKY" on Justia Law

An individual diagnosed with Alzheimer’s disease was admitted to a personal care facility in Kentucky after his spouse, who had been appointed his conservator by a Tennessee court, signed a mandatory arbitration agreement required for admission. The spouse did not specify her capacity when signing. The patient later suffered injuries and died, leading his spouse, as administratrix of his estate, to file suit alleging negligence, wrongful death, and other claims against the facility and its operators.The defendants moved to compel arbitration, arguing that the spouse had authority to sign the agreement under the Tennessee conservatorship order or, alternatively, under Kentucky’s Living Will Directive Act, which allows a spouse to make “health care decisions” for an incapacitated person. The Fayette Circuit Court denied the motion, finding that signing an arbitration agreement was not a health care decision under the Act and that the spouse lacked authority to bind the patient. The court did not rule on unconscionability. The Kentucky Court of Appeals affirmed, distinguishing prior cases involving powers of attorney and holding that the Act’s definition of “health care decision” did not include entering arbitration agreements.The Supreme Court of Kentucky reviewed whether a spouse may bind an incapacitated person to arbitration for facility admission under the Living Will Directive Act. The Court held that signing an arbitration agreement is not a “health care decision” as defined by Kentucky law, which limits such decisions to consenting to or withdrawing consent for medical procedures, treatments, or interventions. The Court affirmed the Court of Appeals’ decision, upholding the denial of the motion to compel arbitration, and remanded the case for further proceedings. View "LEXINGTON ALZHEIMER'S INVESTORS, LLC V. NORRIS" on Justia Law

Terri R. Winnon, a former executive assistant and controller for a group of skilled nursing facilities (SNFs) in Texas, alleged that her former employers and associated entities engaged in fraudulent schemes to obtain improper reimbursements from Medicare and Texas Medicaid. She claimed that the defendants paid unlawful kickbacks to doctors and hospital discharge planners for patient referrals and inflated therapy service bills to maximize government reimbursements. Winnon’s allegations included specific practices such as employee bonuses tied to Medicare census targets, “sham” medical directorships, and “marketing gifts” to hospital staff, as well as systematic upcoding of therapy services by a contracted provider, RehabCare.After Winnon filed her qui tam action under the False Claims Act (FCA) and related Texas statutes, the United States District Court for the District of Columbia dismissed her claims. The court found that her allegations against RehabCare were barred by the FCA’s public disclosure provision, as similar claims had already been made public in a prior lawsuit, United States ex rel. Halpin & Fahey v. Kindred Healthcare, Inc. The district court also determined that Winnon’s claims against the SNF Defendants did not meet the heightened pleading requirements of Federal Rule of Civil Procedure 9(b), as they lacked sufficient particularity regarding the alleged fraudulent conduct.On appeal, the United States Court of Appeals for the District of Columbia Circuit affirmed the district court’s dismissals. The appellate court held that Winnon’s claims against RehabCare were precluded by the public disclosure bar because her allegations were substantially similar to those previously disclosed and she did not qualify as an “original source” under the FCA. Regarding the SNF Defendants, the court concluded that Winnon’s allegations failed to satisfy Rule 9(b)’s requirement for particularity, as she did not provide enough specific details to support a strong inference that false claims were actually submitted. The court affirmed the district court’s judgments in full. View "USA v. Lozano" on Justia Law

Arkansas enacted a law in 2021 that prohibits healthcare professionals from providing or referring minors for gender transition procedures, which include certain medical and surgical interventions intended to alter a minor’s physical characteristics to those of a different sex. Four minors, their parents, and two healthcare professionals challenged the law, arguing it violated their constitutional rights. The law was passed over the governor’s veto and defined violations as unprofessional conduct subject to disciplinary action.The United States District Court for the Eastern District of Arkansas initially granted a preliminary injunction, and a panel of the Eighth Circuit affirmed, finding a likelihood of success on the Equal Protection claim. After a bench trial, the district court permanently enjoined enforcement of the law, holding that it violated the Equal Protection Clause, the Due Process Clause, and the First Amendment.The United States Court of Appeals for the Eighth Circuit, sitting en banc, reversed the district court’s decision. The appellate court held that the law does not classify based on sex or transgender status, but rather on age and medical procedure, and is therefore subject to rational basis review. The court found that the state’s interest in protecting the health and safety of minors provided a rational basis for the law. The court also concluded that there is no deeply rooted constitutional right for parents to obtain gender transition procedures for their children over a state prohibition. Regarding the First Amendment, the court determined that the law’s restriction on referrals regulates professional conduct with only incidental effects on speech and survives intermediate scrutiny. The permanent injunction was reversed and the case remanded. View "Brandt v. Griffin" on Justia Law

Two children, E.R. and G.S., have severe, complex medical conditions that require constant, skilled care. Their mothers, who are their primary caregivers and sole financial supporters, have been trained by medical professionals to provide the necessary care at home. For years, Indiana’s Medicaid program reimbursed these mothers for providing “attendant care services” under a waiver program designed to keep individuals out of institutions. In July 2024, the Indiana Family and Social Services Administration (FSSA) implemented a policy change that would make parents ineligible to be paid providers of attendant care for their children, threatening to force E.R. and G.S. into institutional care due to the lack of available in-home nurses.The Indiana Protection and Advocacy Services Commission, along with E.R. and G.S., sued to block the policy change and require FSSA to secure in-home nursing. The United States District Court for the Southern District of Indiana initially granted a preliminary injunction requiring FSSA to take steps to obtain in-home nurses and to pay the mothers for a different, lower-paid service. After further proceedings, the court modified its order, ultimately requiring FSSA to pay the mothers for attendant care at the previous rate until in-home nursing could be secured.The United States Court of Appeals for the Seventh Circuit affirmed the district court’s October 1 injunction. The court held that the plaintiffs are likely to succeed on their claims under the Americans with Disabilities Act’s integration mandate, which requires states to provide services in the most integrated setting appropriate. The court found that prohibiting the mothers from providing paid attendant care placed the children at serious risk of institutionalization and that FSSA had not shown that allowing such care would fundamentally alter the Medicaid program or violate federal law. The case was remanded for further proceedings. View "Indiana Protection and Advocacy Services Comm'n v Indiana Family and Social Services Administration" on Justia Law

An employee of the Department of Veterans Affairs began experiencing respiratory issues at work, which she attributed to the building environment. Over several years, she requested various accommodations, including changes to her work schedule, relocation of her workstation, and the use of air purifiers. The Department provided some accommodations, but the employee found them ineffective. In 2012, she was diagnosed with breast cancer and submitted a Family and Medical Leave Act (FMLA) form to request leave for treatment. Later, she learned that a union steward had been informed of her cancer diagnosis by a human resources manager, which she had not expected. After returning to work, she continued to request further accommodations, eventually being allowed to work from home full-time.The United States District Court for the Middle District of Florida granted summary judgment in favor of the Department on all claims, including disability discrimination, failure to accommodate, unlawful disclosure of medical information, and retaliation or hostile work environment. The court found that the Department had provided reasonable accommodations, that there was no evidence of discrimination or retaliation, and that the employee had not shown a tangible injury from the alleged disclosure of her medical information.On appeal, the United States Court of Appeals for the Eleventh Circuit affirmed the district court’s summary judgment on the claims of disability discrimination, failure to accommodate, retaliation, and hostile work environment. The appellate court agreed that the Department had made reasonable efforts to accommodate the employee and that her dissatisfaction with the accommodations did not amount to a legal violation. However, the Eleventh Circuit reversed the summary judgment on the unlawful disclosure claim, holding that requiring medical information for FMLA leave constituted an employer inquiry under the Rehabilitation Act, and that there were genuine issues of fact as to whether confidential medical information was improperly disclosed and whether the employee suffered a tangible injury as a result. The case was remanded for further proceedings on the unlawful disclosure claim. View "Mullin v. Secretary, Department of Veterans Affairs" on Justia Law

A pharmaceutical company challenged the federal government’s implementation of a new program created by the Inflation Reduction Act of 2022, which authorizes the Centers for Medicare and Medicaid Services (CMS) to negotiate prices for certain high-expenditure prescription drugs under Medicare. The company’s drug was selected for the program, and it signed an agreement to participate “under protest” while filing suit. The company alleged that the program violated its constitutional rights under the First, Fifth, and Eighth Amendments, and that CMS failed to follow required notice-and-comment procedures under the Administrative Procedure Act (APA) when issuing the standard agreement for participation.The United States District Court for the District of Connecticut granted summary judgment to the government on all claims. The district court found that participation in the program was voluntary, so there was no unlawful deprivation of rights. It also held that the program did not impose unconstitutional conditions on participation in Medicare and Medicaid, and that the Inflation Reduction Act expressly allowed CMS to implement the program for its first three years without notice-and-comment rulemaking.The United States Court of Appeals for the Second Circuit reviewed the case and affirmed the district court’s judgment. The Second Circuit held that, under its precedent in Garelick v. Sullivan, participation in the Medicare Drug Price Negotiation Program is voluntary, and thus the program does not effect a taking, deprive the company of property without due process, or compel speech in violation of the First Amendment. The court further held that the program does not impose unconstitutional conditions because it is designed to control Medicare spending and does not regulate the company’s private market conduct. Finally, the court concluded that the Inflation Reduction Act expressly exempted CMS from the APA’s notice-and-comment requirement for the program’s initial years. View "Boehringer Ingelheim Pharms., Inc. v. Dep't of Health & Hum. Servs." on Justia Law

A Chinese manufacturer of electronic nicotine delivery systems (ENDS) sought authorization from the Food and Drug Administration (FDA) to market its refillable e-cigarette device in the United States. The device, sold without e-liquid, allows consumers to use a wide range of nicotine concentrations. The manufacturer submitted a premarket tobacco product application (PMTA) in August 2020, asserting that its product was appropriate for the protection of public health. After a preliminary assessment, the FDA identified deficiencies in the application and issued a deficiency letter in March 2023, requesting additional information. The manufacturer responded to some, but not all, of the deficiencies and requested an extension, which the FDA later denied. In January 2024, the FDA issued a final order denying the application, citing insufficient data to evaluate the product’s risks and benefits.The United States Court of Appeals for the Fifth Circuit reviewed the case after the manufacturer and a retailer based in Texas, who was also affected by the denial, petitioned for review. The court determined that venue was proper because the retailer had its principal place of business in the circuit. The petitioners argued that the FDA’s denial was arbitrary and capricious, claiming the agency failed to weigh the public health benefits of the product and improperly limited applicants to a single deficiency letter.The Fifth Circuit held that the FDA’s decision was reasonable and reasonably explained. The court found that the FDA had considered the potential benefits and risks of the product, explained the deficiencies in the application, and did not impose new evidentiary requirements without notice. The court also concluded that the FDA’s policy of issuing only one deficiency letter was adequately justified and not arbitrary. The petition for review was denied. View "Shenzhen Youme v. FDA" on Justia Law