Justia Health Law Opinion Summaries

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

An orthopedic surgeon partnered with a medical supply businessman to form a durable medical equipment company. The company was formally listed under the surgeon’s mother’s name, even though she had no actual ownership or management role. The surgeon provided his mother’s personal information to his partner, who submitted Medicare enrollment forms on the company’s behalf. In January 2019, the company submitted a Medicare form notifying a change in business hours, but it falsely listed the mother as the sole owner and manager. The company ceased operations after Medicare began to suspect fraud.A federal grand jury in the Southern District of Florida indicted the surgeon on charges of conspiracy to defraud the United States and pay health care kickbacks, and making a false statement relating to health care matters. The jury acquitted him of conspiracy but convicted him of making a false statement. The United States District Court for the Southern District of Florida sentenced him to thirty-three months in prison, imposed three years of supervised release, and ordered him to pay $315,704.52 in restitution and to forfeit $125,000. The defendant challenged several aspects of his conviction and sentence, including venue, the sufficiency of the indictment, the sufficiency of the evidence, jury instructions, forfeiture, and restitution.The United States Court of Appeals for the Eleventh Circuit affirmed the district court’s rulings on all grounds except restitution. The court held that the evidence was sufficient to support the false statement conviction and found no error in the jury instructions or the forfeiture order. However, the court determined that the government had not shown by a preponderance of the evidence that the false statement actually caused the losses for which restitution was ordered. The restitution order was vacated and the case remanded for further proceedings on that issue. View "United States v. Alexander" on Justia Law

A California-based company that produces lab-grown chicken sought to distribute and sell its product in Florida. After the company received federal approval from the USDA and FDA to market its lab-grown chicken, Florida enacted SB 1084, a law banning the manufacture, sale, and distribution of all lab-grown meat within the state. The company had previously held tasting events and developed business relationships in Florida but had no plans to manufacture its product there.Following the enactment of SB 1084, the company filed suit in the U.S. District Court for the Northern District of Florida against state officials, seeking declaratory and injunctive relief. The company argued that the federal Poultry Products Inspection Act (PPIA) preempted Florida’s ban, claiming the state’s law imposed “additional or different” ingredient or facilities requirements in violation of the PPIA. The district court denied the company’s motion for a preliminary injunction, finding the company unlikely to succeed on its preemption claims because SB 1084 did not regulate the company’s ingredients, premises, facilities, or operations. The court also addressed standing and procedural questions, ultimately dismissing the preemption claims after the company amended its complaint.On appeal, the United States Court of Appeals for the Eleventh Circuit reviewed whether the filing of an amended complaint or the district court’s dismissal order rendered the appeal moot and whether the company could challenge the Florida law as preempted. The Eleventh Circuit held the appeal was not moot and that the company could bring a preemption action in equity. However, the court concluded the company was unlikely to succeed on the merits. The court held that Florida’s ban did not impose ingredient or facilities requirements preempted by the PPIA, as it simply banned the product’s sale and manufacture. Therefore, the district court’s denial of a preliminary injunction was affirmed. View "Upside Foods Inc v. Commissioner, Florida Department of Agriculture" on Justia Law

An elderly man, Jerome, experienced significant health decline and was moved into a nursing home, prompting his wife, Janet, to petition the Saginaw Probate Court for a protective order under Michigan law. She requested the transfer of all of Jerome’s assets and most of his income to her, citing her increased financial needs and Jerome’s inability to manage his affairs due to physical and mental health issues. Janet’s petition was filed before Jerome’s application for Medicaid was resolved, and the probate court granted the transfer and set a monthly support payment for Janet.The Department of Health and Human Services (DHHS) appealed. The Michigan Court of Appeals affirmed in part but vacated the probate court’s order, relying on its earlier precedent in In re Estate of Schroeder, which prohibited consideration of Medicaid eligibility before a formal determination. The case was remanded for a new assessment of need and current valuation of assets. On remand, the probate court again ordered the transfer and support, applied retroactively, but the Court of Appeals vacated this order as well, citing reliance on outdated asset information and the same legal standard regarding Medicaid eligibility.The Michigan Supreme Court reviewed the case after Jerome’s death, holding that the appeal was not moot because Medicaid benefits can be awarded retroactively, even to a deceased individual’s estate. The Supreme Court ruled that probate courts may consider the likely availability of Medicaid benefits before a final eligibility determination when assessing the needs of an individual and their dependents under MCL 700.5401(3)(b). The Court expressly overruled the contrary rule announced in In re Estate of Schroeder, reinstated the probate court’s 2022 protective order, and remanded the case for further proceedings. View "In Re Estate Of Sizick" on Justia Law