Justia Health Law Opinion Summaries

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

The defendant, a patient at a community mental health center, was informed by his career counselor that he had been dismissed from classes at UNH Manchester and would be removed by security if he returned to campus. Distressed by this news, he insisted he would still attend his evening class. In communications with his counselor and later his therapist, he reiterated his plan to attend, culminating in a statement asking if “doing a mass shooting” would be required for him to get what he wanted. When told his statement would be reported, he claimed it was a figure of speech. The counselor reported his comments to the treatment team and local police, in accordance with center policy. Law enforcement notified UNH Manchester, which took security precautions, and later apprehended the defendant. He was indicted for criminal threatening based on his statements.Prior to trial in the Superior Court, the defendant sought to exclude the testimony of his counselor and therapist regarding his statements, asserting the therapist-patient privilege, and also moved to dismiss for insufficiency of the evidence. The Superior Court denied both motions, finding an “essential need” for the privileged communications and concluding that a reasonable jury could find the defendant guilty. The jury convicted the defendant of criminal threatening.On appeal, the Supreme Court of New Hampshire reviewed whether the trial court properly allowed admission of the privileged communications and whether the evidence was sufficient for conviction. The court held that the State demonstrated an “essential need” to pierce the therapist-patient privilege due to the centrality of the communications to the charged offense and the compelling public safety interest in investigating threats of mass violence. The court also found the evidence sufficient for a rational jury to conclude beyond a reasonable doubt that the defendant acted in reckless disregard for causing fear, terror, or public inconvenience. The conviction was affirmed. View "State v. Stewart" on Justia Law

The defendant, a pharmacist and owner of a retail pharmacy, was implicated in a federal investigation after concerns arose about the prescribing patterns of a local physician whose patients often filled prescriptions at the defendant’s pharmacy. The government alleged that the defendant improperly filled prescriptions for controlled substances and fraudulently billed Medicaid and Medicare by instituting a policy requiring customers to fill three non-controlled prescriptions for every controlled substance prescription (the “3:1 Policy”), thereby submitting claims for prescriptions that were not medically necessary.Following indictment, the United States District Court for the District of Kansas presided over the defendant’s trial. The jury convicted the defendant on two counts related to the unlawful distribution of controlled substances and two counts of healthcare fraud. On direct appeal, the convictions were affirmed. After the Supreme Court clarified the intent requirement for drug distribution offenses in Ruan v. United States, the defendant filed a motion under 28 U.S.C. § 2255 claiming ineffective assistance of trial counsel for failing to object to a jury instruction about the scienter requirement for distributing controlled substances. The district court vacated the distribution counts but denied relief on the healthcare fraud counts, finding no prejudice as to those.The United States Court of Appeals for the Tenth Circuit reviewed whether the challenged jury instruction affected the convictions for healthcare fraud. The court held that the instruction at issue pertained only to the distribution counts and did not impact the fraud counts, which were based on separate conduct and legal standards. The court affirmed the district court’s denial of relief on the healthcare fraud counts, concluding that any error in the jury instruction did not prejudice the defendant regarding those convictions. View "United States v. Otuonye" 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

While incarcerated at Augusta Correctional Center in Virginia, Daniel Jackson, proceeding without an attorney, filed a complaint using a standard prisoner form. He named the prison’s medical department and two healthcare providers as defendants, describing his medical condition and alleging a series of events: the confiscation of his prescribed ankle sleeve, the denial of a lower bunk assignment despite his medical needs, and pain caused by required work footwear. Jackson also claimed he was denied proper physical therapy and pain medication, and asserted that one nurse suggested he acquire drugs illicitly. His complaint sought compensation for lost wages, treatment for his pain, and damages for suffering.The United States District Court for the Western District of Virginia screened the complaint under 28 U.S.C. § 1915A. It construed the action as asserting Eighth Amendment deliberate indifference claims against the individual healthcare providers, dismissing the prison medical department as an improper defendant under § 1983. After allowing Jackson to supplement his complaint with additional allegations—such as retaliation by one nurse—the district court recognized both deliberate indifference and First Amendment retaliation claims. The retaliation claim was dismissed for lack of plausible causation. Ultimately, the district court granted summary judgment for the defendants on the deliberate indifference claims, finding no genuine disputes of material fact regarding the adequacy of medical care provided.Jackson, now represented by counsel, appealed to the United States Court of Appeals for the Fourth Circuit. He argued that the district court should have construed his complaint to assert a claim under the Americans with Disabilities Act (ADA). The Fourth Circuit held that the district court did not err in construing Jackson’s complaint as presenting only an Eighth Amendment claim, emphasizing that courts must liberally construe pro se pleadings but are not required to identify every conceivable claim. The judgment in favor of the defendants was affirmed. View "Jackson v. Dameron" on Justia Law

An employee of the Falmouth Public Schools in Maine, enrolled in a health insurance plan administered by Anthem Health Plans of Maine, Inc., challenged the plan’s exclusion of coverage for weight-loss medications. After being diagnosed with obesity and prescribed FDA-approved weight-loss drugs, the employee’s requests for coverage were repeatedly denied. Her medical providers appealed to Anthem, supporting the necessity of the medication, but Anthem maintained its denial, citing the plan’s explicit exclusion of weight-loss medications regardless of obesity diagnosis.The employee, on behalf of herself and a proposed class, sued Anthem’s parent company, Elevance Health, Inc., in the United States District Court for the District of Maine. She alleged that the exclusion constituted disability discrimination under Section 1557 of the Patient Protection and Affordable Care Act, which incorporates the nondiscrimination requirements of Section 504 of the Rehabilitation Act. Elevance moved to dismiss, arguing the complaint failed to plausibly allege disability discrimination. The district court granted the motion, reasoning that the exclusion applied to all enrollees, regardless of disability status, and did not target disabled individuals for discriminatory treatment. The court found the allegations of discrimination to be conclusory and insufficient to support claims of intentional, proxy, or disparate impact discrimination.On appeal, the United States Court of Appeals for the First Circuit affirmed the district court’s dismissal. The appellate court held that the plaintiff failed to plausibly allege that the exclusion of weight-loss medication coverage constituted discrimination under Section 1557. The court concluded that the exclusion was facially neutral, did not serve as a proxy for disability discrimination, and did not result in a lack of meaningful access to plan benefits for disabled individuals. Accordingly, the dismissal of the complaint was affirmed. View "Holland v. Elevance Health, Inc." 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

Two pharmaceutical companies developing treatments for achondroplasia, a genetic disorder, became involved in litigation after one company (Ascendis) filed a New Drug Application (NDA) for its product. The other company (BioMarin), holding a relevant patent, filed a complaint with the United States International Trade Commission (ITC) alleging patent infringement by Ascendis’s product. Shortly afterward, Ascendis filed a declaratory judgment action in the United States District Court for the Northern District of California, seeking a judgment of non-infringement and arguing that its activities were protected under the statutory “safe harbor” for regulatory approval.More than thirty days after filing its district court complaint, Ascendis moved for an expedited hearing. BioMarin responded by seeking to dismiss or stay the district court action pending the ITC’s investigation. Ascendis voluntarily dismissed its complaint without prejudice and promptly refiled a nearly identical complaint, this time moving for a mandatory stay under 28 U.S.C. § 1659(a)(2), which requires a district court to stay its proceedings if requested within thirty days of the action’s filing or of being named as a respondent in the ITC. BioMarin opposed, contending Ascendis’s request was untimely, and sought a discretionary stay instead.The United States District Court for the Northern District of California granted BioMarin’s motion for a discretionary stay and denied Ascendis’s motion for a mandatory stay as moot. On appeal, the United States Court of Appeals for the Federal Circuit held that § 1659(a)(2) does not permit a litigant to restart the thirty-day period for a mandatory stay by voluntarily dismissing and refiling a substantially identical action. The court reasoned that the statutory deadline applies to the original action and that allowing refiling would circumvent the statute’s purpose. The Federal Circuit affirmed the district court’s decision. View "ASCENDIS PHARMA A/S v. BIOMARIN PHARMACEUTICAL INC. " on Justia Law