Justia Health Law Opinion Summaries

The plaintiffs in this case are minor patients who had been receiving gender-affirming medical care at the TRUE Center for Gender Diversity, a specialized department at a major pediatric hospital serving the Rocky Mountain Region. Following a December 2025 declaration by the U.S. Secretary of Health and Human Services stating that medical gender-affirming care for minors was unsafe and could result in exclusion from federal health care payment programs, the hospital suspended such care for transgender patients under eighteen. The hospital continued to provide hormone therapy and puberty blockers to cisgender youth for other medical reasons. The plaintiffs, representing a class of similarly situated individuals, experienced immediate and significant emotional and physical harm as a result.The plaintiffs filed a class action in the District Court for the City and County of Denver seeking a preliminary injunction under the Colorado Anti-Discrimination Act (CADA) to require the hospital to resume medically necessary gender-affirming care. The trial court found that the plaintiffs were likely to succeed on the merits, faced irreparable harm, and lacked an adequate remedy at law, but denied the injunction. The court reasoned that granting the injunction was contrary to the public interest, the balance of equities favored the hospital, and the injunction was not sufficiently specific to preserve the status quo.The Supreme Court of Colorado, en banc, reviewed the trial court's denial for abuse of discretion. It concluded that the trial court misapplied the legal standards governing preliminary injunctions in discrimination cases, particularly regarding the public interest and balance of equities. The Supreme Court held that the plaintiffs satisfied all six required factors, including a reasonable probability of success on their CADA claim, and that the injunction would preserve the pre-suspension status quo. The trial court’s order was reversed, and the case was remanded with instructions to grant the preliminary injunction. View "Boe v. Children's Hosp. Colo." on Justia Law

A three-year-old child, L.W., who has a rare metabolic condition that can cause life-threatening hypoglycemia, moved from Virginia to Georgia. In Virginia, he had received 96 hours per week of care through Medicaid, including private nursing and support provided by his mother. After his family relocated to Georgia, L.W.'s mother applied for comparable nursing services under the Georgia Pediatric Program (GAPP), but the state approved only 21 hours per week. Requests for increased hours were denied by the state’s contractor, Alliant Health Solutions, which relied on a policy requiring evidence of a change in medical condition to justify increasing hours. L.W.’s family and physician argued that the approved hours were insufficient and unsustainable, risking L.W.’s health and placing heavy burdens on his parents.The United States District Court for the Northern District of Georgia reviewed the case after L.W.’s mother filed suit under 42 U.S.C. § 1983, alleging that Georgia’s Medicaid program was failing to provide services required by federal law. The court found that 21 hours of nursing care per week was insufficient to meet L.W.'s medical needs, based on evidence from his mother and physician. It granted a preliminary injunction requiring Georgia to provide at least 100 hours of private nursing care per week and to evaluate future requests under the correct legal standard, without requiring a bond from the plaintiffs.The United States Court of Appeals for the Eleventh Circuit affirmed the district court’s order. It held that, regardless of the reasonableness of the state’s general policy, Georgia Medicaid must provide care sufficient to correct or ameliorate an individual patient’s medical condition as required by federal law. The Eleventh Circuit concluded that the district court did not clearly err in its factual findings, and that the injunction was proper under the applicable legal standards. View "L.W. v. Commissioner of the Georgia Department of Community Health" on Justia Law

An educational technology company was contracted by a county office of education to provide software and technology services to school districts, which involved collecting and storing various types of student data, including medical information. In 2022, the company experienced a data breach that resulted in unauthorized access to student medical records, including those of a minor plaintiff. The minor, through a guardian, filed a class action lawsuit alleging violations of both the Confidentiality of Medical Information Act (CMIA) and the Customer Records Act (CRA), claiming the company was negligent in protecting confidential medical information and failed to provide timely disclosure of the breach.The Superior Court of Ventura County granted the company’s demurrer and dismissed the case, concluding that the plaintiff failed to state a claim under either statute, as the company was not a covered entity under the CMIA or CRA and the plaintiff was not a “customer” under the CRA. The California Court of Appeal, Second Appellate District, Division Six, reversed, finding that the company fell within the scope of both statutes and that the plaintiff had alleged sufficient facts to support both claims. The appellate court also determined that the trial court erred by denying leave to amend the complaint.The Supreme Court of California reversed the appellate decision. The Court held that the plaintiff did not sufficiently allege the company was a “provider of health care” under the CMIA, nor that he was the company’s “customer” under the CRA, so no claim was stated under either statute. However, the Court clarified that under the CMIA, a breach of confidentiality occurs when medical information is exposed to a significant risk of unauthorized access or use, and actual viewing by an unauthorized party is not required. The judgment was reversed and remanded for further proceedings. View "J.M. v. Illuminate Education, Inc." on Justia Law

A group of pharmacy benefit managers and related companies, including both benefit managers and mail-order pharmacies, were sued by the State of Arkansas in state court. The State alleged that these companies contributed to the opioid epidemic by facilitating and encouraging the misuse, abuse, and over-prescription of opioids, particularly through their negotiations with drug manufacturers for placement of opioid drugs on insurance formularies in exchange for rebates and fees. The State’s complaint asserted claims for public nuisance, negligence, and unjust enrichment under state law, and included allegations that the companies prioritized profits from rebates over public health concerns.After being sued, the defendant companies removed the case to the United States District Court for the Eastern District of Arkansas, citing the federal officer removal statute, 28 U.S.C. § 1442(a)(1), as well as the general removal statute. They argued that their actions were taken under the direction of federal officers, particularly in their roles administering federal health care programs, such as those governed by the Federal Employees Health Benefits Act (FEHBA). The State moved to remand, asserting that the complaint disclaimed any claims against federal officers or persons acting under them. The district court found the disclaimers sufficient and remanded the case to state court.On appeal, the United States Court of Appeals for the Eighth Circuit held that removal was proper under the federal officer removal statute. The court concluded that the defendant companies acted under the direction of federal officers when administering federal health plans and negotiating drug rebates, and that these actions were sufficiently related to the claims in the complaint. The court determined that the State’s disclaimers could not sever the connection between the challenged conduct and federal duties, given the indivisibility of negotiations on behalf of both federal and private clients. The Eighth Circuit therefore reversed the district court’s remand order. View "Griffin v. OptumRx, Inc." on Justia Law

Three individuals suffering from opioid use disorder (OUD) alleged that while incarcerated in facilities where a private medical contractor provided care, they were denied medically accepted screening and treatment for their condition. They claimed that the medical contractor excluded opioid dependence screening and treatment from its otherwise comprehensive services, forcing affected individuals to undergo withdrawal, even when arriving with a valid prescription for medication-assisted treatment. The plaintiffs asserted that these policies were motivated by cost-saving considerations and persisted even after the contractor was aware of the prevailing medical standards and associated constitutional risks.The United States District Court for the Southern District of West Virginia reviewed the case, which was filed as a class action under 42 U.S.C. § 1983. The plaintiffs sought to certify two classes: one requesting injunctive relief to require the contractor to provide proper screening and treatment, and another seeking damages for past deprivation of such care. The district court certified both classes after narrowing their definitions to ensure ascertainability and found that the requirements of Federal Rule of Civil Procedure 23 were met. Wexford Health Sources, Inc., the defendant, challenged the certification, particularly arguing against the validity, typicality, and commonality of the classes, as well as the predominance and superiority requirements for the damages class.The United States Court of Appeals for the Fourth Circuit reviewed the district court's decision. The Fourth Circuit remanded the case to the district court to determine, in the first instance, whether the named plaintiffs had standing to represent the class seeking injunctive relief, given that standing was first raised on appeal and required fact-specific findings. The Fourth Circuit affirmed the district court’s certification of the damages class, finding no abuse of discretion in its conclusions regarding ascertainability, the Rule 23(a) requirements, predominance, and superiority. View "Spurlock v. Wexford Health Sources, Inc." on Justia Law

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

Matthew and Jamie Skipper obtained health insurance from CareFirst BlueChoice, Inc. through the Maryland Health Benefit Exchange. After experiencing infertility, they underwent in-vitro fertilization (IVF), which included freezing embryos. When they later sought coverage for the medically necessary procedure of embryo thawing as part of a subsequent IVF cycle, CareFirst denied coverage, citing a policy exclusion. The Skippers paid for the thawing themselves and later sought reimbursement. CareFirst denied their appeal as untimely. The Skippers filed a complaint with the Maryland Insurance Administration and, while that was pending, brought a putative class action in the United States District Court for the District of Maryland. Shortly after the federal suit was filed, CareFirst reversed its denial and paid the claim. The federal court then dismissed the Skippers’ complaint for lack of jurisdiction due to the amount-in-controversy requirement. The Skippers promptly refiled their class action in the Circuit Court for Prince George’s County.CareFirst moved to dismiss in the Circuit Court, arguing the case was moot because it had paid the Skippers’ claim and that the policy did not cover embryo thawing. The Circuit Court granted the motion based on mootness. The Appellate Court of Maryland reversed, holding that the payment did not moot the class claims and that the complaint adequately stated a claim.The Supreme Court of Maryland affirmed the Appellate Court’s judgment. The Court held that when a putative class action is first filed in another court and the defendant tenders individual relief to the named representative before dismissal for lack of jurisdiction, a substantially similar complaint promptly refiled in state court is not moot until the representative has a reasonable opportunity to seek class certification. Additionally, the Court held that the relevant policy exclusion does not authorize CareFirst to deny coverage for medically necessary expenses arising from IVF procedures, including embryo thawing, and that Maryland law requires such coverage. The case was remanded for further proceedings. View "Carefirst Bluechoice v. Skipper" on Justia Law

The case involves a Massachusetts psychiatrist who owned and operated a clinic providing treatment for addiction with imported drugs. The drugs included naltrexone and disulfiram in forms not approved by the FDA for use in the United States. The shipments were brought in from Hong Kong and falsely described on import documents as “plastic beads in plastic tubes,” with their value understated. The government charged the defendant with several crimes, including international money laundering, unlawful importation of merchandise, and receipt and delivery of misbranded drugs. The jury found the defendant guilty on some counts but acquitted him on others, including all counts against his wife.The United States District Court for the District of Massachusetts conducted the trial. After the jury’s verdict, the court sentenced the defendant to 36 months’ imprisonment on each count, to be served concurrently, and calculated the sentence using the fraud guideline in the United States Sentencing Guidelines. The defendant appealed, arguing that the district court erred in its evidentiary rulings, in admitting or excluding certain testimony, and in its application of the Sentencing Guidelines.The United States Court of Appeals for the First Circuit reviewed the case. It affirmed the defendant’s convictions, finding no reversible error in the district court’s evidentiary decisions or in its exclusion of expert testimony. The appellate court vacated the sentence for the misdemeanor misbranding conviction because it exceeded the statutory maximum. The court retained jurisdiction over the appeal and remanded to the district court for clarification regarding the application of the fraud guideline, specifically instructing the lower court to explain the basis for its use of that guideline and to address the impact of recent amendments related to acquitted conduct. View "US v. Shafa" on Justia Law