Justia Health Law Opinion Summaries

In the case of Wages and White Lion Investments, L.L.C., doing business as Triton Distribution; Vapetasia, L.L.C., versus the Food & Drug Administration, the court found that the FDA acted arbitrarily and capriciously in its denial of Premarket Tobacco Product Applications (PMTAs) for flavored e-cigarette products.The petitioners, Triton Distribution and Vapetasia, are manufacturers of flavored e-cigarette liquids. They filed PMTAs for their products, as required by the Family Smoking Prevention and Tobacco Control Act, which prohibits the sale of any “new tobacco product” without authorization from the FDA. The FDA, after issuing detailed guidance on the information it required for approval of e-cigarette products, subsequently denied all flavored e-cigarette applications, including those of the petitioners, on the grounds that they failed to predict new testing requirements imposed by the FDA without notice.The court found that the FDA had failed to provide the manufacturers with fair notice of the rules, had not acknowledged or explained its change in position, and had ignored the reasonable and serious reliance interests that manufacturers had in the pre-denial guidance. Furthermore, the FDA attempted to cover up its mistakes with post hoc justifications at oral argument.As a result, the court granted the petitions for review, set aside the FDA's marketing denial orders, and remanded the matters to the FDA. The court rejected FDA's argument that even if it arbitrarily and capriciously denied petitioners’ applications, that error was harmless, stating that the harmless error doctrine is narrow and does not apply to discretionary administrative decisions. The court also rejected FDA's contention that it gave manufacturers fair notice of their obligations to perform long-term scientific studies in its pre-denial guidance documents. View "Wages and White Lion Invest v. FDA" on Justia Law

In this appeal, Marcus Raper contested the Social Security Administration’s (SSA) 2020 denial of his claim for disability insurance benefits. Raper raised three arguments: (1) that the administrative law judge's (ALJ) initial lack of constitutional appointment under the Appointments Clause tainted his later constitutionally appointed review of his case, (2) that the ALJ failed to clearly articulate good cause for not fully crediting his treating physician’s medical opinion, and (3) that the ALJ wrongly discredited his subjective complaints of pain by not properly considering evidence other than objective medical evidence.The United States Court of Appeals for the Eleventh Circuit affirmed the lower court’s decision. First, the court found no Appointments Clause violation as the ALJ's initial decision, made when he was unconstitutionally appointed, had been vacated on the merits and the case was remanded to the same ALJ who was then constitutionally appointed. Second, the court held that the ALJ articulated good cause for discounting Raper's treating physician’s opinion, finding the opinion inconsistent with the record. Lastly, the court found that the ALJ had properly considered Raper’s subjective complaints in light of the record as a whole and adequately explained his decision not to fully credit Raper’s alleged limitations on his ability to work. View "Raper v. Commissioner of Social Security" on Justia Law

In a case involving the State of Texas, the American Association of Pro-Life Obstetricians & Gynecologists, and the Christian Medical & Dental Associations as plaintiffs, and the United States Department of Health and Human Services (HHS), its Secretary Xavier Becerra, the Centers for Medicare and Medicaid Services (CMS), and other officials as defendants, the United States Court of Appeals for the Fifth Circuit affirmed the district court's decision. The plaintiffs challenged HHS's guidance on the Emergency Medical Treatment and Active Labor Act (EMTALA), which they alleged mandated providers to perform elective abortions beyond HHS's authority and contrary to state law. The plaintiffs sought to enjoin the enforcement of this guidance. The district court granted the injunction within Texas or against any member of a plaintiff organization, and HHS appealed.The Court of Appeals held that the HHS guidance constituted a final agency action as it binds HHS to a particular legal position and has clear legal consequences should a physician or hospital violate it. The court found that HHS's guidance exceeds the statutory language of EMTALA, which does not mandate any specific type of medical treatment, let alone abortion care. The court also held that HHS was required to subject the guidance to notice and comment as it "establishes or changes a substantive legal standard." The court affirmed the injunction, finding it not overbroad, but rather tailored based on the parties, issues, and evidence before it. View "Texas v. Becerra" on Justia Law

The Supreme Court of Iowa ruled that the State University of Iowa, Iowa State University of Science and Technology, and the University of Northern Iowa were required to be members of the Iowa Individual Health Benefit Reinsurance Association (IIHBRA) and therefore had to pay assessments to the association. The universities had argued that they were not members of IIHBRA and that the statute requiring them to pay assessments violated the Iowa Constitution, which prohibits the state from acting as a surety for another. The court rejected these arguments, finding that the statutory scheme did not violate the constitution and that the universities, as providers of health benefit plans, were indeed members of IIHBRA. The court also ruled that IIHBRA was statutorily authorized to impose late payment fees against its members. However, the court denied IIHBRA's request for attorney fees and costs. The court affirmed in part, reversed in part, and remanded the case for further proceedings. View "Iowa Individual Health Benefit Reinsurance Ass’n v. State University of Iowa" on Justia Law

In the case at hand, the Court of Appeals of the State of Nevada reversed and remanded a district court order that had dismissed a professional negligence action for being time-barred. The case was brought by Gina Engelson, as the special administrator of the estate of Lenore Meyer, against Dignity Health (doing business as St. Rose Dominican Hospital-Siena Campus) and Grape Holdings LLC (doing business as Sage Creek Post-Acute). Lenore Meyer had developed a severe bedsore while being treated at these facilities. Meyer's family alleged that the care provided by the facilities fell below the standard of care in multiple ways, including failing to timely and adequately treat the bedsore. Meyer eventually died, and exactly one year after her death, Engelson filed a professional negligence complaint against the facilities. The district court dismissed the complaint as time-barred, finding that the complaint was filed more than a year after the estate and its special administrator knew or should have known about the relevant legal injury.Upon review, the Court of Appeals found that the district court erred in dismissing the complaint as time-barred. The Court of Appeals clarified that an affidavit of merit, which is required to support a professional negligence-based wrongful death claim, need not opine as to the element of causation. The Court of Appeals concluded that the evidence did not irrefutably demonstrate that the estate or its special administrator discovered or should have discovered the legal injury more than a year before the filing of the complaint. Therefore, the Court of Appeals reversed the district court's order and remanded for further proceedings. View "Engelson v. Dignity Health" on Justia Law

In a case before the United States Court of Appeals For the Eighth Circuit, the plaintiffs, a group of patients, sued BJC Health System (BJC) alleging that BJC had violated their medical privacy rights under Missouri state law. Specifically, the plaintiffs claimed that when they accessed their electronic health records (EHRs) through BJC’s online patient portal, their protected health information was shared with third-party marketing services. BJC removed the case to federal court under the federal officer removal statute, arguing that they acted under the United States Department of Health and Human Services (HHS) when creating and operating the online patient portal. BJC's argument was rejected by the district court which ordered the case to be remanded back to Missouri state court. BJC appealed this decision.The United States Court of Appeals For the Eighth Circuit affirmed the decision of the district court to remand the case to the Missouri state court. The appellate court held that BJC, while receiving federal incentive payments from HHS for creating and operating the online patient portal, was not essentially performing a basic governmental task or duty. Therefore, BJC was not acting under a federal officer in terms of the federal officer removal statute. The court concluded that the creation and operation of an online patient portal was not a basic governmental task, and BJC was not a government contractor or functioning as a federal instrumentality. View "Doe v. BJC Health System" on Justia Law

The United States Court of Appeals for the Ninth Circuit upheld the drug-trafficking and money-laundering convictions of Benjamin Galecki and Charles Burton Ritchie for their distribution of "spice," a synthetic cannabinoid product. The defendants were found guilty of manufacturing and distributing spice through their company, Zencense Incenseworks, LLC. The drug-trafficking charges were based on the premise that the cannabinoid used, XLR-11, was treated as a controlled substance because it was an "analogue" of a listed substance. The court rejected the defendants' arguments that their convictions should be set aside due to Fourth Amendment violations, insufficient evidence, and vagueness of the Controlled Substance Analogue Enforcement Act of 1986. However, the court reversed their mail and wire fraud convictions due to insufficient evidence. The case was remanded for further proceedings. View "USA V. GALECKI" on Justia Law

In this case, Virginia Cora Ward, as the administratrix of the estate of Edmund Edward Ward, brought a case against AlphaCore Pharma, LLC (ACP) and Bruce Auerbach. The decedent, Edmund Ward, was a participant in a clinical trial for a drug known as ACP-501, which was developed by ACP and administered by the National Institutes of Health (NIH). The trial took place in Maryland, where Ward traveled from his home in Massachusetts to receive treatment. Ward later withdrew from the trial due to deteriorating kidney function.In 2016, Ward filed a complaint against ACP, Auerbach, and several others, alleging fraudulent inducement to participate in the clinical trial. ACP and Auerbach moved to dismiss the case for lack of personal jurisdiction, arguing that they lacked sufficient contacts with Massachusetts. The United States District Court for the District of Massachusetts agreed with them and dismissed the case. Ward appealed to the United States Court of Appeals for the First Circuit.The First Circuit affirmed the district court's decision. The court held that neither ACP nor Auerbach had sufficient related and purposeful contacts in and with Massachusetts to establish personal jurisdiction. The court rejected Ward's claims that ACP and Auerbach had contacts with Massachusetts through their interactions with Ward's Massachusetts-based doctor, their alleged shipment of the drug to Massachusetts, their involvement in drafting the clinical trial protocol, and their alleged reimbursement of Ward's travel expenses. The court found that these claims were either unsupported by evidence or were not sufficient to establish personal jurisdiction. As a result, the court affirmed the district court's dismissal of the case against ACP and Auerbach for lack of personal jurisdiction. View "Ward v. Schaefer" on Justia Law

In a case before the Supreme Court of the State of Alaska, the court was asked to determine the deadline for filing a claim against a decedent’s estate for reimbursement for Medicaid services provided to the decedent while alive. The probate code of Alaska provides that for claims arising “before the death of the decedent,” the creditor must file within four months after the estate's representative first published notice to creditors. For claims arising “at or after the death of the decedent,” the creditor must file within four months after the claim arose. The court held that Medicaid estate recovery claims arise before death and therefore must be filed within four months after notice to creditors. The court reasoned that although the state may not pursue these claims until after the Medicaid beneficiary has died, these claims arise when Medicaid services are provided, not when the claims become enforceable. The court's decision was based on the interpretation of the probate code, the underlying legislative purpose of the Medicaid estate recovery statute, and the weight of precedent from other jurisdictions. View "In the Matter of the Estate of Fe Perez Abad" on Justia Law

The Supreme Court of Texas handled a case in which a nurse claimed her employer, Scott & White Memorial Hospital, wrongfully terminated her employment in retaliation for reporting potential child abuse or neglect to the Texas Child Protective Services (CPS), which is considered a protected conduct under Section 261.110(b) of the Texas Family Code.The nurse, Dawn Thompson, had previously received two written reprimands for violating the hospital's personal-conduct policy. On the third occasion, she disclosed a child patient's protected health information to a school nurse without the parents' authorization. This was considered by the hospital as a violation of the Health Insurance Portability and Accountability Act (HIPAA) and a breach of the patient's rights. Consequently, Thompson was terminated.Thompson filed a lawsuit against the hospital, asserting that her termination was in violation of Family Code Section 261.110(b), which protects professionals who report child abuse or neglect in good faith from adverse employment actions.The Supreme Court of Texas ruled that Section 261.110 imposes a "but-for causation" requirement, which means that the protected conduct must be such that without it, the adverse employment action would not have occurred when it did. In this case, the court found that Thompson would have been terminated when she was due to her HIPAA violation, regardless of her report to CPS. Therefore, the court rejected Thompson's retaliation claim and reinstated the trial court's summary judgment in favor of the hospital. View "SCOTT & WHITE MEMORIAL HOSPITAL v. THOMPSON" on Justia Law