Justia Health Law Opinion Summaries

Articles Posted in US Court of Appeals for the Eighth Circuit
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Plaintiff saw Cognium, a “nutraceutical” manufactured by Natrol, on sale. Cognium, according to Natrol’s advertising, improves memory and concentration. Its packaging stated that Cognium is “powered by Cera-Q, a natural protein from silkworm cocoons,” and can improve “Memory Recall Efficiency” by 90% when taken twice daily for four weeks. The box claimed that “nine clinical studies in adults, seniors and children showed statistically significant improvements in memory and cognition in 4 weeks or less when taken as directed.”   Plaintiff filed a putative class action complaint against Natrol, seeking damages for herself and establishment of a National Class and Missouri Consumer Subclass. Plaintiff alleged that, prior to her purchases of Cognium, two of the nine clinical studies noted on its packaging had been retracted, including one for “data fabrication and falsification.”   With Plaintiff’s individual claims dismissed, the court determined the sole named plaintiff could not represent the purported class and dismissed the entire action. On appeal, Plaintiff argued the district court erred in granting summary judgment dismissing her MMPA and unjust enrichment claims.   The Eighth Circuit affirmed. The court explained that here Plaintiff purchased a product that expressly stated on the label it was “not intended to” do what she stated she purchased it for, serve as a substitute treatment for her prescription medication. Thus, for Plaintiff the actual value of the Cognium she purchased, and the value of Cognium without Natrol’s alleged marketing misrepresentations was “zero.” The benefit of the bargain rule does not apply in this situation, so Plaintiff cannot prove that she suffered ascertainable loss “as a result of” Natrol’s unlawful practice. View "Christine Vitello v. Natrol, LLC" on Justia Law

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Plaintiffs, a transgender youth, their parents, and two healthcare professionals, sought to enjoin Arkansas Act 626, which prohibits healthcare professionals from providing gender transition procedures to any individual under the age of 18 or from referring any such individual to any healthcare professional for gender transition procedures. The district court enjoined the Act, and the State appealed.The Eighth Circuit held that because a minor's sex at birth determines whether or not the minor can receive certain types of medical care under the law, Act 626 discriminates on the basis of sex. Thus, to be valid, the Act must be supported by an exceedingly persuasive justification. The Eighth Circuit determined that the Act prohibits medical treatment that conforms with the recognized standard of care for adolescent gender dysphoria and that the purpose of the Act is not to ban a treatment but to ban an outcome the State deems undesirable. Thus, the district court did not err in granting an injunction. View "Dylan Brandt v. Leslie Rutledge" on Justia Law

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Defendant, a neurosurgeon, chose to use implants distributed by DS Medical, a company wholly owned by his fiancée. Physicians in other practices grew suspicious and filed various claims under the False Claims Act. The jury returned a verdict for the government on two of the three claims. The district court then awarded treble damages and statutory penalties in the amount of $5,495,931.22. Following the verdict, the government moved to dismiss its two remaining claims without prejudice, see Fed. R. Civ. P. 41(a)(2), on the ground that any recovery would be “smaller and duplicative of what the [c]ourt ha[d] already awarded.”   The Eighth Circuit reversed and remanded for a new trial. The court explained that are several ways to prove that a claim is “false or fraudulent” under the False Claims Act. One of them is to show that it “includes items or services resulting from a violation” of the anti-kickback statute. This case required the court to determine what the words “resulting from” mean. The court concluded that it creates a but-for causal requirement between an anti-kickback violation and the “items or services” included in the claim. Thus, the court reversed and remanded because district court did not instruct the jury along these lines. View "United States v. Midwest Neurosurgeons, LLC, et al" on Justia Law

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Defendants Kim Reynolds, Governor of Iowa, and Ann Lebo, Director of the Iowa Department of Education, appealed the district court’s entry of a preliminary injunction completely barring enforcement of Iowa’s facial covering statute, Code Section 280.31. The Eighth Circuit vacated the district court’s entry of preliminary injunction completely barring enforcement of Iowa Code Section 280.31 as moot.   The court reasoned that the issue surrounding the preliminary injunction is moot because the current conditions differ vastly from those prevailing when the district court addressed it. The court reasoned that COVID-19 vaccines are now available to children and adolescents over the age of four, greatly decreasing Plaintiffs’ children’s risk of serious bodily injury or death from contracting COVID-19 at school. Further, when Plaintiffs sought a preliminary injunction, delta was the dominant variant, producing high transmission rates and caseloads throughout the country. Now, omicron has become dominant and subsided, leaving markedly lower transmission rates and caseloads throughout Iowa and the country. The court noted that to the extent that the case continues, the Court emphasized that the parties and district court should pay particular attention to Section 280.31’s exception for “any other provision of law.” Iowa Code Section 280.31. This exception unambiguously states that Section 280.31 does not apply where “any other provision of law” requires masks. The word "any” makes the term “provision of law” a broad category that does not distinguish between state or federal law. View "The Arc of Iowa v. Kimberly Reynolds" on Justia Law

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Under Michigan abortion law, a minor may bypass the parental-consent requirement by obtaining a court order granting the right to self-consent (for mature minors) or judicial consent (for “best interests” minors). When the plaintiff sought to apply for judicial bypass, the defendant hadn’t heard of the process and told the plaintiff to come back later. Plaintiff sued the defendant in her individual and official capacities under 42 U.S.C. § 1983, alleging that defendant’s refusal to allow her to apply for a judicial bypass without parental notification violated her Fourteenth Amendment rights. The district court denied the motion when the defendant moved for summary judgment, invoking quasi-judicial and qualified immunity.Before the Eighth Circuit, the defendant claimed she acted at the direction of the Associate Circuit Judge (“Judge”). The Judge testified that he did not recall telling the defendant not to accept the application without parental consent. The circuit court concluded there was a genuine issue of material fact regarding the Judge’s practice of giving pre-filing directions. Further, the is a clearly established right to apply for a judicial bypass. Thus the circuit court declined to address the defendant’s other arguments regarding qualified immunity. View "Jane Doe v. Michelle Chapman" on Justia Law

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The Eighth Circuit affirmed the district court's dismissal of Regional's declaratory judgment claims alleging that defendants' procedures in suspending Regional's Medicare payments and forcing it out of business without notice, a hearing, or an opportunity to appeal violated its Fifth Amendment rights to procedural and substantive due process. The court concluded that no actual controversy exists between Regional and defendants within the meaning of the Declaratory Judgment Act. The court explained that, having abandoned any claim for damages, Regional seeks nothing more than a judicial pronouncement that its constitutional rights were violated. Therefore, the possibility of Regional re-establishing a business that is certified to receive Medicare reimbursements, again submitting documentation insufficient to meet Medicare requirements for billed services, and again having Medicare payments suspended is too conjectural or hypothetical to pose a real and immediate threat of injury sufficient to confer subject matter jurisdiction in federal court. View "Regional Home Health Care, Inc. v. Becerra" on Justia Law

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The Hospitals filed suit to enjoin the OPTN's new policy, which significantly changes the method for allocating donated kidneys to kidney transplant patients, as unlawful under the Transplant Act and the Administrative Procedure Act (APA).The Eighth Circuit affirmed the district court's denial of the Hospitals' motion for a temporary restraining order and preliminary injunction. Examining the district court's balancing of the Dataphase factors, the court concluded that the district court did not err in concluding that the Hospitals failed to show that their procedural APA claim is likely to succeed on the merits. The court also agreed with the district court that the Hospitals failed to demonstrate that they are likely to succeed on the merits of their claim that adoption of the Fixed Circle Policy was arbitrary and capricious agency action. Furthermore, the district court did not abuse its discretion in concluding that the Hospitals' one-year delay refuted their allegations of irreparable harm, and the balance of the equities and public interest weigh in favor of denying the requested preliminary injunction. View "Adventist Health System v. U.S. Department of Health and Human Services" on Justia Law

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The Eighth Circuit affirmed the district court's grant of summary judgment in favor of HHS and CMS in an action brought by Northport, alleging that a regulation promulgated by CMS through notice and comment rulemaking is unlawful and should be set aside for violating the Administrative Procedure Act (APA), the Federal Arbitration Act (FAA), and the Regulatory Flexibility Act (RFA). The revised HHS regulations (Revised Rule) prohibits long-term care facilities from conditioning the admission of Medicare and Medicaid residents on their agreement to pre-dispute, binding arbitration and gives the residents the right to rescind the binding arbitration agreements, as well as certain other rights.The court concluded that the Revised Rule does not, in words or effect, render arbitration agreements entered into in violation thereof invalid or unenforceable, and thus it does not conflict with the FAA. Furthermore, the Revised Rule represents a reasonable accommodation of manifestly competing interests and is entitled to deference, and thus the district court properly concluded that it is not ultra vires. The court also concluded that the Revised Rule reflects CMS's reasoned judgment in light of competing considerations, and is not arbitrary or capricious. Finally, although CMS failed to provide a factual basis in support of its section 605(b) certification in the Revised Rule, the court concluded that failing to do so was harmless error. View "Northport Health Services of Arkansas, LLC v. U.S. Department of Health and Human Services" on Justia Law

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After a Tessier's employee was modifying a hole cover on the roof of an unfinished building when the cover collapsed and he fell 22 feet to the floor below, OSHA issued a citation against Tessier's under 29 C.F.R. 1926.501(b)(4)(i), for failing to protect its employees from falling through holes.The Eighth Circuit denied the petition for review filed by Tessier's, concluding that substantial evidence supported the ALJ's conclusion that the employees had removed a one-foot-by-three-foot section of the cover before it collapsed and, in doing so, exposed a hole. Because this hole was not covered and was more than six feet above the second floor, Tessier's was required to protect its employees from falling by means of an alternative form of fall protection, which it had not done. Therefore, the ALJ did not err in concluding that Tessier's had committed the violation. View "Tessier's, Inc. v. Secretary of Labor" on Justia Law

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PCMA filed suit claiming that the Employee Retirement Income Security Act of 1974 (ERISA) and the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Medicare Part D), preempt two sections of the North Dakota Century Code regulating the relationship between pharmacies, pharmacy benefits managers (PBMs), and other third parties that finance personal health services. The district court determined that only one provision in the legislation was preempted by Medicare Part D and entered judgment in favor of North Dakota on the remainder of PCMA's claims.The Eighth Circuit held that it need not address the "connection with" element of the analysis because the legislation is preempted due to its impermissible "reference to" ERISA plans. In this case, the legislation is preempted because its references to "third-party payers" and "plan sponsors" impermissibly relate to ERISA benefit plans. Therefore, the court held that the North Dakota legislation is preempted because it "relates to" ERISA plans "by regulating the conduct of PBMs administering or managing pharmacy benefits." Finally, the court held that North Dakota waived its savings clause argument. Accordingly, the court affirmed in part, reversed in part, and remanded. View "Pharmaceutical Care Management Ass'n v. Tufte" on Justia Law