Justia Health Law Opinion Summaries

Two individuals, Solano and Maxilin, brought a qui tam action under the False Claims Act (FCA), alleging that Barton Associates, Inc., a temporary medical staffing agency, orchestrated a scheme to induce the submission of fraudulent claims to Medicare and other government healthcare programs. Solano, who owns a mobility device business, described being solicited by a Barton employee to participate in a scheme where Barton-recruited clients would create call centers to solicit medical service requests from patients eligible for government programs. Barton would then assign physicians to prescribe services, and charge clients an assessment fee for each prescription, allegedly leading to clients submitting claims to the government. Maxilin, a certified coding associate, alleged that his employer, Medtech, was one of Barton's clients and participated by channeling patients to Barton physicians for “unnecessary” prescriptions. The complaint described large numbers of prescriptions and claims, but Solano did not participate in the scheme and neither plaintiff provided specific details of actual false claims submitted.The United States District Court for the District of Massachusetts dismissed the complaint with prejudice, finding that Solano and Maxilin failed to plead fraud with the particularity required by Federal Rule of Civil Procedure 9(b). The court determined that the complaint only outlined the alleged scheme in general terms and lacked reliable indicia or specific details—such as time periods, locations, amounts, or identification of government programs—to support a strong inference that false claims were actually submitted. The court also denied the plaintiffs’ motion for reconsideration or, alternatively, for leave to amend the complaint.Upon appeal, the United States Court of Appeals for the First Circuit affirmed the district court’s decisions. The appellate court held that the complaint did not meet the Rule 9(b) standard, even under the more flexible approach applicable to inducement-based FCA claims, and found no abuse of discretion in the denial of reconsideration or leave to amend. View "USA, ex rel. Solano v. Barton Associates, Inc." on Justia Law

A California nonprofit organization that operates health centers in Nevada, along with a physician, challenged the enforcement of a Nevada law, originally enacted in 1985, that imposed parental notification and judicial bypass requirements on minors seeking abortions. The law had never taken effect due to a long-standing federal injunction, but after Dobbs v. Jackson Women’s Health Organization overruled Roe v. Wade, the federal court vacated the injunction in 2025, allowing the law to become enforceable for the first time. The challengers argued that the law was unconstitutionally vague, exceeded legislative authority, and violated procedural due process rights, particularly focusing on the requirements for parental notification and the process for judicial bypass.When the plaintiffs sought a temporary restraining order and preliminary injunction in the Eighth Judicial District Court, the district court found standing and ripeness only as to certain aspects but held that the plaintiffs had not shown a likelihood of success on the merits or sufficient injury. As a result, the district court denied the motion for a preliminary injunction.On appeal, the Supreme Court of Nevada reviewed de novo the questions of standing, ripeness, and the legal standards for a preliminary injunction. The Supreme Court of Nevada held that the plaintiffs had standing and that the case was ripe for review. The court found that the parental notification and judicial bypass provisions were unconstitutionally vague under the higher standard applicable to statutes involving criminal penalties and constitutional rights, as they failed to provide clear guidance to physicians and allowed for arbitrary enforcement. The court concluded that the plaintiffs demonstrated a reasonable likelihood of success on the merits, irreparable harm, and that the balance of hardships and public interest favored granting relief. Accordingly, the Supreme Court of Nevada reversed the district court’s order and remanded with instructions to grant the preliminary injunction. View "PLANNED PARENTHOOD MAR MONTE, INC. VS. STATE" on Justia Law

A plaintiff alleged that she suffered serious eye injuries, including blindness in one eye, after receiving an injection of a pharmaceutical product manufactured by the defendant. The specific unit used was from a lot later recalled due to the possible presence of silicone particulates. The plaintiff had a history of eye conditions and prior treatments but argued that her injuries followed the use of the recalled product. She presented two experts on causation: a retained ophthalmologist who provided a report and deposition, and her treating physician, who did not provide a written expert report.The Superior Court, Law Division, denied the defendant’s motions to bar the experts’ testimony and for summary judgment. The court did not conduct the “gatekeeping” inquiry regarding expert reliability required by New Jersey law. The defendant appealed, and the Appellate Division reversed. It found the experts’ opinions to be inadmissible net opinions, lacking evidentiary support for the proposed theory of causation and methodology. The Appellate Division thus also reversed the denial of summary judgment, holding the plaintiff had not established causation.The Supreme Court of New Jersey reviewed the case and held that its decision in In re Accutane Litigation requires trial courts to resolve disputes about the reliability of expert testimony by undertaking a “rigorous” gatekeeping analysis, potentially including a hearing under N.J.R.E. 104. The Supreme Court found the record insufficient for this determination and ordered a remand so the trial court could conduct the proper reliability inquiry. The Court held the retained expert’s report was not a net opinion but left open whether the treating physician’s testimony could be admitted, depending on whether a proper expert report is served. The Supreme Court reversed the Appellate Division’s judgment and remanded the matter to the trial court for proceedings consistent with its opinion. View "Beavan v. Allergan U.S.A., Inc." on Justia Law

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