Justia U.S. 8th Circuit Court of Appeals Opinion Summaries

The dispute centers on allegations by a Minnesota-based health insurer that several related pharmaceutical companies carried out an unlawful scheme involving the distribution and sale of repackaged and adulterated oncology drugs. The scheme allegedly involved breaking sterile seals on medication vials, pooling overfill amounts—which were not intended for patient use—and creating pre-filled syringes that were then sold to healthcare providers. These syringes were ultimately administered to cancer patients, including many insured under programs operated by the plaintiff. The defendants did not themselves submit claims for reimbursement, but the plaintiff asserts it paid for treatments using these adulterated drugs, unaware of their compromised quality.Prior to this lawsuit, the scheme was the subject of other civil actions and federal investigations, including qui tam actions and a federal criminal prosecution. The defendants disclosed these investigations in annual reports filed with the Securities and Exchange Commission and the events received media attention beginning in 2012. In 2017, a related company pleaded guilty to federal charges, admitting to the repackaging scheme, and paid significant fines and settlements. The plaintiff filed suit in 2023, asserting claims for common-law fraud, unjust enrichment, and violations of several Minnesota consumer protection statutes. The United States District Court for the District of Minnesota dismissed the complaint, finding the claims were barred by the applicable six-year statute of limitations, and that the plaintiff had failed to sufficiently plead fraudulent concealment to toll the limitations period.The United States Court of Appeals for the Eighth Circuit reviewed the district court’s dismissal de novo. It concluded that publicly available disclosures and the plaintiff’s own allegations established that the plaintiff should have discovered its causes of action no later than 2016. Because the plaintiff did not file suit until 2023, its claims were untimely. The court affirmed the district court’s judgment, holding that all claims were barred by the statute of limitations. View "United HealthCare Services, Inc. v. AmerisourceBergen Corporation" on Justia Law

In 2024, Iowa enacted legislation (HF 2677) prohibiting the manufacture and sale of electronic nicotine delivery systems (ENDS) that had not received marketing authorization from the United States Food and Drug Administration (FDA). The law required manufacturers to certify their compliance with federal premarket approval requirements or demonstrate that their products were pending FDA review. Several manufacturers, retailers, and consumers challenged the law, contending it was preempted by federal law, specifically the Family Smoking Prevention and Tobacco Control Act, and that it violated constitutional equal protection guarantees.The United States District Court for the Southern District of Iowa granted a preliminary injunction, halting enforcement of the law. The district court found that at least one plaintiff had standing, was likely to succeed on the merits of the preemption claim, and was not required to post a security bond. It dismissed claims against the Iowa Department of Revenue based on Eleventh Amendment immunity but allowed the case to proceed against the Director in her official capacity. The Department voluntarily stayed enforcement while the litigation continued.The United States Court of Appeals for the Eighth Circuit reviewed the district court’s order. The Eighth Circuit held that at least one retailer plaintiff had Article III standing, as they plausibly alleged injury from the credible threat of enforcement. However, the appellate court concluded the plaintiffs were not likely to succeed on the merits of their preemption claim. The court determined that HF 2677 was not preempted by federal law, as it fell within the scope of the Tobacco Control Act’s savings clause, which permits state requirements relating to the sale and distribution of tobacco products. The Eighth Circuit vacated the preliminary injunction and remanded the case for further proceedings. View "Iowans for Alternatives v. Mosiman" on Justia Law

A pharmaceutical manufacturer participating in the federal 340B Drug Pricing Program challenged a Missouri law that prohibits manufacturers from restricting the delivery of discounted 340B drugs to contract pharmacies associated with covered entities. The manufacturer argued that its policy of limiting deliveries to only one contract pharmacy conflicted with Missouri’s statute, which requires delivery to all contract pharmacies designated by covered entities. The manufacturer sought declaratory and injunctive relief, claiming the Missouri statute violated the dormant Commerce Clause and was preempted by federal law.The United States District Court for the Western District of Missouri granted a motion to dismiss the manufacturer’s preemption claims, finding Missouri’s statute did not conflict with federal patent or drug exclusivity laws or the 340B Program, and that Eighth Circuit precedent foreclosed the field preemption argument. The court denied the motion to dismiss the dormant Commerce Clause claim, but ultimately denied the manufacturer’s motion for a preliminary injunction, concluding the manufacturer was unlikely to succeed on the merits of its claims, had not shown irreparable harm, and that the balance of equities and public interest weighed against preliminary relief.The United States Court of Appeals for the Eighth Circuit reviewed the district court’s denial of preliminary injunction under the abuse of discretion standard. The appellate court affirmed the district court’s decision, holding that the Missouri statute regulates only in-state delivery of 340B drugs and does not impermissibly control extraterritorial commerce, discriminate against interstate commerce, or impose excessive burdens in relation to local benefits. The court also found the manufacturer’s preemption claims foreclosed by Eighth Circuit precedent and concluded the statute is neither field nor conflict preempted. The district court’s denial of preliminary injunctive relief was affirmed. View "Novartis Pharmaceuticals Corp. v. Hanaway" 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

ARcare, Inc., a nonprofit community health center receiving federal funding, suffered a data breach in early 2022 when an unauthorized third party accessed confidential patient information, including names, social security numbers, and medical treatment details. After ARcare notified affected individuals, several patients filed lawsuits alleging that ARcare failed to adequately safeguard their information as required under federal law. Plaintiffs reported fraudulent invoices and that their information was found for sale on the dark web.The actions were removed to the United States District Court for the Eastern District of Arkansas, where six class actions were consolidated. ARcare sought to invoke absolute immunity under 42 U.S.C. § 233(a) of the Federally Supported Health Centers Assistance Act (FSHCAA), which provides immunity for damages resulting from the performance of “medical, surgical, dental, or related functions.” ARcare moved to substitute the United States as defendant under the Federal Tort Claims Act, arguing the data breach arose from a “related function.” The district court denied the motion, finding that protecting patient information from cyberattacks was not sufficiently linked to the provision of health care to qualify as a “related function” under the statute.On appeal, the United States Court of Appeals for the Eighth Circuit reviewed the statutory immunity issue de novo. The court affirmed the district court’s denial of immunity, holding that the FSHCAA’s language does not extend statutory immunity to claims arising from a health center’s data security practices. The court reasoned that “related functions” must be activities closely connected to the provision of health care, and data security is not such a function. Therefore, ARcare is not entitled to substitute the United States as defendant, and the denial of statutory immunity was affirmed. View "Hale v. ARcare, Inc" on Justia Law

A certified nurse midwife in Nebraska sought to provide home birth services but was prevented from doing so by state law. The Nebraska Certified Nurse Midwifery Practice Act requires midwives to work under a supervising physician through a practice agreement and prohibits them from attending home births outside authorized medical facilities. The midwife alleged that these restrictions forced her to turn away women seeking home births and sued state officials, claiming the law violated her constitutional rights and the rights of her prospective patients.The United States District Court for the District of Nebraska dismissed the midwife’s claims. The court found that she failed to state a claim for violation of her own rights under the Due Process Clause and lacked standing to assert claims on behalf of her prospective patients. The district court concluded that the statutory requirements were rationally related to legitimate state interests in health and safety and that the midwife did not have a sufficiently close relationship with prospective patients nor could she show that those patients were hindered from bringing their own suits.On appeal, the United States Court of Appeals for the Eighth Circuit reviewed the district court’s dismissal de novo. The appellate court held that the Nebraska law regulating midwifery is subject to rational basis review and that the legislature could rationally believe the restrictions serve legitimate interests in public health and safety. The court also held that the midwife lacked third-party standing to assert the rights of prospective patients because she did not have a close relationship with them and they were not hindered from bringing their own claims. The Eighth Circuit affirmed the district court’s judgment, upholding the dismissal of all claims. View "Swanson v. Hilgers" on Justia Law

Arkansas enacted a law in 2021 that prohibits healthcare professionals from providing or referring minors for gender transition procedures, which include certain medical and surgical interventions intended to alter a minor’s physical characteristics to those of a different sex. Four minors, their parents, and two healthcare professionals challenged the law, arguing it violated their constitutional rights. The law was passed over the governor’s veto and defined violations as unprofessional conduct subject to disciplinary action.The United States District Court for the Eastern District of Arkansas initially granted a preliminary injunction, and a panel of the Eighth Circuit affirmed, finding a likelihood of success on the Equal Protection claim. After a bench trial, the district court permanently enjoined enforcement of the law, holding that it violated the Equal Protection Clause, the Due Process Clause, and the First Amendment.The United States Court of Appeals for the Eighth Circuit, sitting en banc, reversed the district court’s decision. The appellate court held that the law does not classify based on sex or transgender status, but rather on age and medical procedure, and is therefore subject to rational basis review. The court found that the state’s interest in protecting the health and safety of minors provided a rational basis for the law. The court also concluded that there is no deeply rooted constitutional right for parents to obtain gender transition procedures for their children over a state prohibition. Regarding the First Amendment, the court determined that the law’s restriction on referrals regulates professional conduct with only incidental effects on speech and survives intermediate scrutiny. The permanent injunction was reversed and the case remanded. View "Brandt v. Griffin" on Justia Law

Lonnie Parker, a licensed medical practitioner, was found guilty by a jury of distributing oxycodone and promethazine HCl with codeine solution in a manner unauthorized by the Controlled Substances Act. The case began when an individual named N.C. was pulled over for reckless driving, found impaired, and later died in custody. The DEA suspected Parker of operating a "pill mill" and seized patient records from his clinic. An expert reviewed these records and found that Parker had prescribed controlled substances inappropriately.The United States District Court for the Western District of Arkansas sentenced Parker to 87 months’ imprisonment. Parker appealed, arguing that the evidence was insufficient to support his convictions, the jury instructions were improper, and the district court committed procedural error in sentencing. The district court had calculated Parker’s base offense level by including uncharged prescriptions as relevant conduct, resulting in a total offense level of 30 and an advisory sentencing guidelines range of 108 to 135 months. The court varied downwards to 87 months.The United States Court of Appeals for the Eighth Circuit reviewed the case. The court found that the evidence was sufficient to support Parker’s convictions, as the expert testimony provided enough basis for the jury to conclude that Parker prescribed controlled substances without a legitimate medical purpose. The court also found no plain error in the jury instructions, noting that the instructions as a whole clarified the requirements for criminal conduct. Finally, the court determined that any potential error in calculating the quantity of controlled substances for sentencing was harmless, as the district court stated it would have imposed the same sentence regardless. The Eighth Circuit affirmed the judgment of the district court. View "United States v. Parker" on Justia Law

Laguerre Payen, a federal inmate, was convicted in 2010 of multiple terrorism-related charges and sentenced to 25 years imprisonment. During his incarceration, Payen exhibited disruptive and dangerous behavior, including numerous assaults, threats, and other violations. He was diagnosed with schizophrenia and mild intellectual disability and was committed twice under 18 U.S.C. § 4245 for mental health treatment. Despite some improvement, Payen's behavior remained inconsistent, and he refused medication after his commitments ended.The United States District Court for the Western District of Missouri committed Payen under 18 U.S.C. § 4246, finding by clear and convincing evidence that his release would pose a substantial risk of bodily injury or serious property damage due to his mental illness. Payen appealed, arguing that the district court relied on erroneous facts and that the government failed to prove his dangerousness by clear and convincing evidence.The United States Court of Appeals for the Eighth Circuit reviewed the district court's finding of dangerousness for clear error. The court noted that the district court had relied on the unanimous opinions of experts, including an independent evaluator, who diagnosed Payen with schizophrenia and intellectual disability and concluded that his release would pose a substantial risk. The court also considered Payen's extensive history of violent and disruptive behavior, his refusal to take medication voluntarily, and the lack of a suitable release plan.The Eighth Circuit affirmed the district court's decision, finding no clear error in the determination that Payen's release would create a substantial risk of harm to others or their property. The court emphasized that the district court had properly focused on the expert reports and Payen's history of dangerous behavior in making its decision. View "United States v. Payen" on Justia Law

The Association for Accessible Medicines (AAM), representing generic drug manufacturers, challenged a Minnesota law regulating drug prices, Minn. Stat. § 62J.842, arguing it violated the dormant Commerce Clause. The law prohibits manufacturers from imposing excessive price increases on generic or off-patent drugs sold in Minnesota. The district court granted AAM's motion for a preliminary injunction, finding the law likely violated the dormant Commerce Clause.The United States District Court for the District of Minnesota concluded that AAM was likely to succeed on the merits of its claim, faced a threat of irreparable harm, and that the balance of harms and public interest factors were neutral. Minnesota appealed, contesting the likelihood of success on the merits and the balance of harms/public interest.The United States Court of Appeals for the Eighth Circuit reviewed the district court’s ruling for abuse of discretion and its legal conclusions de novo. The court found that the Minnesota law had the impermissible extraterritorial effect of controlling prices outside the state, similar to laws previously struck down by the Supreme Court. The court rejected Minnesota's argument that the law did not control out-of-state prices, noting that it effectively regulated out-of-state transactions if the drugs ended up in Minnesota.The Eighth Circuit affirmed the district court’s decision, agreeing that AAM was likely to succeed on the merits of its dormant Commerce Clause claim. The court also found no abuse of discretion in the district court’s assessment of the balance of harms and public interest, noting that protecting constitutional rights is always in the public interest. The preliminary injunction against the Minnesota law was upheld. View "Ass'n for Accessible Medicines v. Ellison" on Justia Law