Justia Health 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

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

After being found not guilty of a crime by reason of insanity, C.F. was admitted to a state hospital, where he was treated with antipsychotic medication under a court order. When the Department of State Hospitals sought to renew the order authorizing involuntary medication, the trial court held an evidentiary hearing. C.F.’s counsel did not request a court reporter, though one could have been provided at no cost by simply submitting a form. Consequently, no verbatim record of the hearing was made, and C.F. did not attend, with his counsel waiving his appearance.The Superior Court of Napa County heard from the Department’s expert witness and found, by clear and convincing evidence, that C.F. lacked capacity to refuse treatment, granting the renewal for up to one year. C.F. appealed, arguing that he was denied effective assistance of counsel because his lawyer did not secure a record of the hearing. When C.F. later applied for a settled statement to reconstruct the hearing for appellate review, the trial court denied the request, finding he had waived his right to a record by not requesting a reporter.The Court of Appeal of the State of California, First Appellate District, Division Five, found that C.F.’s counsel’s failure to request a reporter constituted deficient performance, with no tactical explanation and resulting prejudice. The absence of a hearing record rendered meaningful appellate review impossible, amounting to a denial of due process and effective assistance of counsel. The appellate court reversed the trial court’s order and remanded for a new hearing, noting that if the Department seeks to renew the order after its expiration, the new hearing may be combined with any future renewal petition. View "People v. C.F." on Justia Law

A hospital employee discovered that someone had posted on social media a screenshot from the hospital’s internal system, revealing Supreme Court Justice Ruth Bader Ginsburg’s name, dates of ten medical visits, and the types of services she received. The post, which first appeared on an anonymous online forum, fueled conspiracy theories regarding the Justice’s health. The hospital investigated and identified two employees who had inappropriately searched for the Justice’s information, ultimately focusing on Trent Russell, who worked for a non-profit with access to patient records. Forensic analysis linked Russell’s home computer to the search, and evidence showed he formatted his hard drive after his access was revoked. He was charged with unlawfully obtaining health information, unlawfully destroying records, and disclosing health information.The United States District Court for the Eastern District of Virginia denied Russell’s motion to suppress statements made to federal agents during an interview at his workplace. The court found no coercion despite the presence of his employer’s CEO. The court also limited cross-examination of an agent regarding Russell’s explanations for the search, sustaining a hearsay objection but allowing other avenues to explore bias. At trial, the jury convicted Russell of obtaining individually identifiable health information and destroying records, but acquitted him of disclosing health information. The district court sentenced him to 24 months’ imprisonment.The United States Court of Appeals for the Fourth Circuit reviewed the case. It held that Russell’s interview statements were voluntary, as there was no evidence of coercion or threats. The court found no abuse of discretion in the district court’s limitation of cross-examination, and any error was harmless given the other evidence of bias. It also held that the information Russell obtained qualified as “individually identifiable health information” under federal law. The Fourth Circuit affirmed the judgment in full. View "US v. Russell" on Justia Law

The case involves a dispute between two biopharmaceutical companies over the distribution of a biosimilar drug following the expiration of a key patent. After Janssen’s patent for the composition of its biologic drug expired, Samsung sought to introduce its biosimilar product. Janssen and Samsung had previously settled related patent litigation through an agreement that granted Samsung a limited license to enter the market at a set date and restricted Samsung’s ability to sublicense, except to certain commercialization partners. Samsung subsequently entered into agreements with both Sandoz and Quallent, a subsidiary of the Cigna Group, allowing Quallent to distribute the biosimilar under its own label. Janssen argued that the sublicense to Quallent violated the settlement agreement and would cause it irreparable harm by altering market dynamics, reducing its market share and negotiation leverage, and sought a preliminary injunction to prevent Samsung from supplying Quallent during the litigation.The United States District Court for the District of New Jersey denied Janssen’s motion for a preliminary injunction. The court found that while Janssen was likely to succeed on the merits of its breach-of-contract claim, it had not demonstrated irreparable harm because any injury could be measured and compensated by monetary damages. The court credited Samsung’s expert's view that harm to Janssen would be quantifiable, did not find persuasive evidence of brand loyalty or reputational harm, and concluded that Janssen’s asserted loss of negotiation leverage was too speculative.On appeal, the United States Court of Appeals for the Third Circuit reviewed the District Court’s denial for abuse of discretion and affirmed. The Court held that loss of market share in a complex market does not categorically constitute irreparable harm in contract cases, and that mere difficulty in calculating damages does not meet the threshold for irreparable harm. The Court concluded that Janssen had not shown the requisite irreparable harm to justify preliminary injunctive relief. View "Johnson & Johnson v. Samsung Bioepis Co Ltd" on Justia Law

A Tennessee-based commercial bakery, which provides a self-funded health benefits plan governed by ERISA for its employees, structured its prescription drug benefits through a pharmacy benefit manager (PBM) and created an in-house pharmacy offering lower copays to employees. Tennessee enacted laws targeting PBMs, requiring pharmacy network access for any willing provider and prohibiting cost-sharing incentives to steer participants to certain pharmacies, including those owned by the plan sponsor. The bakery and its PBM excluded a pharmacy from their network after an audit, and after the pharmacy filed administrative complaints under the new Tennessee law, the bakery sought declaratory and injunctive relief in federal court, claiming ERISA preempted these PBM-focused state laws.The United States District Court for the Eastern District of Tennessee found that the bakery, as plan fiduciary, had standing to bring a pre-enforcement challenge. The court concluded that the Tennessee PBM laws were preempted by ERISA because they required specific plan structures, governed central aspects of plan administration, and interfered with uniform national plan administration. The district court granted summary judgment in favor of the bakery, permanently enjoining the Tennessee Commissioner from enforcing the PBM laws against the bakery’s health plan or its PBM.On appeal, the United States Court of Appeals for the Sixth Circuit reviewed the case de novo. The court agreed with the district court’s analysis, holding that the challenged Tennessee PBM statutes have an impermissible connection with ERISA plans and are therefore preempted. The court found that the laws mandated network structure and cost-sharing provisions, interfering directly with ERISA plan administration. The Sixth Circuit also held that the ERISA saving clause did not preserve these laws from preemption due to the deemer clause’s application to self-funded plans. The judgment of the district court was affirmed. View "McKee Foods Corp. v. BFP Inc." 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