Justia Government & Administrative Law Opinion Summaries

The case involves the West Virginia Department of Health, Office of the Chief Medical Examiner, and Dr. Allen R. Mock (collectively "Petitioners") and Dr. Patsy Cipoletti, Jr., administrator of the estate of his deceased wife, June Cipoletti ("Respondent"). The Respondent filed a complaint against the Petitioners, alleging that they violated the West Virginia Medical Professional Liability Act (MPLA) by negligently determining Mrs. Cipoletti’s cause of death. The Petitioners filed a motion to dismiss, arguing that the Respondent had not asserted a proper cause of action under the MPLA. The circuit court denied the motion to dismiss, determining that the MPLA applied and that Petitioners were not entitled to qualified immunity.The Circuit Court of Kanawha County denied the Petitioners' motion to dismiss. The court determined that the MPLA applied and that Petitioners were not entitled to qualified immunity. The court found that Dr. Mock’s conduct fell under and was governed by the MPLA, thus depriving Petitioners of qualified immunity.The Supreme Court of Appeals of West Virginia reversed the circuit court's decision. The court found that the Petitioners' actions were discretionary and not in violation of any "clearly established statutory or constitutional rights or laws" and were not "otherwise fraudulent, malicious, or oppressive." Therefore, the court concluded that the Petitioners were entitled to qualified immunity from the lawsuit. The court also found that the Respondent had failed to plead a viable MPLA cause of action against the Petitioners. The court remanded the case to the circuit court with directions to grant the Petitioners' motion to dismiss. View "West Virginia Department of Health v. Cipoletti" on Justia Law

The case involves Novartis Pharmaceuticals Corporation and United Therapeutics Corporation, both drug manufacturers, and the Health Resources and Service Administration (HRSA). The dispute centers around Section 340B of the Public Health Service Act, which mandates drug manufacturers to sell certain drugs at discounted prices to select healthcare providers. These providers often contract with outside pharmacies for distribution. The manufacturers argued that these partnerships have left the Section 340B program vulnerable to abuse, leading them to impose their own contractual terms on providers, such as limits on the number of pharmacies to which they will make shipments. The government contended that these restrictions violate the statute.The case was initially heard in the United States District Court for the District of Columbia. The district court ruled that Section 340B does not prohibit manufacturers from limiting the distribution of discounted drugs by contract.The case was then reviewed by the United States Court of Appeals for the District of Columbia Circuit. The court agreed with the district court's ruling, stating that Section 340B does not categorically prohibit manufacturers from imposing conditions on the distribution of covered drugs to covered entities. The court further held that the conditions at issue in this case do not violate Section 340B on their face. The court did not rule out the possibility that other, more onerous conditions might violate the statute or that these conditions may violate Section 340B as applied in particular circumstances. The court affirmed the district court's decision to set aside the enforcement letters under review, while reserving the possibility of future enforcement under theories of liability narrower than the one pressed here. View "Novartis Pharmaceuticals Corporation v. Johnson" on Justia Law

The case involves D.K., a patient diagnosed with an unspecified schizophrenia spectrum and other psychotic disorders, who was found incompetent to stand trial and committed to the Department of State Hospitals (DSH) by the Orange County Superior Court. After D.K.'s transfer to Napa State Hospital, DSH filed a petition for an interim order to compel involuntary medication of D.K. with antipsychotic medication. An administrative law judge (ALJ) conducted an evidentiary hearing and ordered D.K. involuntarily medicated from January 17, 2023, to February 7, 2023. D.K. filed a petition for a writ of administrative mandate with the Napa County Superior Court, challenging the medication order. The superior court denied her petition, concluding D.K. was not entitled to writ review.The Court of Appeal of the State of California First Appellate District Division Three found that D.K.'s appeal was moot because the order had expired and no meaningful relief could be effectuated through review of that order. However, the court exercised its discretion to address D.K.'s appeal of the superior court's finding that the statutory scheme of section 1370 precluded her from filing a writ of administrative mandamus to challenge the medication order. The court concluded that both the significant liberty interests at issue and the language of section 1370 support D.K.'s right to seek writ review. The court reversed the superior court's holding that D.K. was not entitled to writ review. However, it dismissed as moot D.K.'s challenge to the court's finding that substantial evidence supported the involuntary medication order, so it did not remand the case for further proceedings. View "D.K. v. Office of Admin. Hearings" on Justia Law

The case involves the family of Todd Kerchen, who died from a lethal dose of fentanyl. The family filed a complaint against the University of Michigan and Dr. James Woods, alleging violations under 42 U.S.C. § 1983 and Michigan state law. The family claimed that the fentanyl that killed Todd originated from a University of Michigan pharmacology lab where Christian Raphalides, the person who allegedly provided the drug to Todd, worked. The lab was overseen by Dr. Woods. The family argued that the lab's lax policies surrounding the use of controlled substances led to Todd's death.The district court denied the defendants' motion to dismiss and ordered limited discovery on whether the action was barred by the statutes of limitations applicable to the plaintiffs' claims. The defendants appealed this decision.The United States Court of Appeals for the Sixth Circuit reversed the district court's decision. The court found that the University of Michigan and Dr. Woods in his official capacity were entitled to sovereign immunity, barring all claims against them. The court also found that Dr. Woods in his individual capacity was entitled to qualified immunity, barring the § 1983 claim against him. Furthermore, the court found that the wrongful death claim against Dr. Woods in his individual capacity should be dismissed as it was barred by governmental immunity. The court dismissed the remainder of the defendants' appeal for lack of jurisdiction. View "Kerchen v. University of Michigan" on Justia Law

A Mexican national, J.R., who worked seasonally in Sully County, South Dakota, required emergency medical treatment for appendicitis. He was taken to Avera St. Mary’s Hospital in Hughes County, where he received treatment and incurred medical bills totaling over $75,000. J.R. had no health insurance, few assets, and returned to Mexico without paying the bills. Avera sought reimbursement from Sully County under county poor-relief statutes.The Sully County Board of Commissioners denied Avera's application for reimbursement, citing J.R.'s status as a nonresident of Sully County. Avera appealed this decision to the circuit court, which remanded the case back to the Commission for a more detailed factual record. After a hearing, the Commission again denied Avera's claim, determining that J.R. was indigent by design and was not in distress in Sully County at the time the county was notified. Avera appealed this decision to the circuit court, which affirmed the Commission's decision.The Supreme Court of the State of South Dakota affirmed the lower court's decision. The court found that the county's obligation to support poor persons is statutory, not common law. The court interpreted the poor-relief statutes to require every county to support all poor and indigent persons who have established residency therein. However, the parties agreed that J.R. was not a resident of Sully County. The court found that the county had no statutory obligation to reimburse Avera for J.R.'s emergency medical services, as he was a nonresident indigent who had left Sully County before the Commission learned he was in distress. The court concluded that in these circumstances, where temporary relief had already been administered to the nonresident indigent by a third party in another county, Sully County had no statutory obligation to reimburse Avera for J.R.'s emergency medical services. View "Avera St. Mary’s Hospital V. Sully County" on Justia Law

The case involves Asif Sayeed and three associated healthcare companies who were found liable for violating the Anti-Kickback Statute and False Claims Act, resulting in a nearly $6 million judgment. Sayeed owned a healthcare management company, Management Principles, Inc. (MPI), which managed two smaller companies that provided home-based medical services to Medicare recipients in Illinois. Sayeed's companies received a significant amount of their business from the Healthcare Consortium of Illinois. In December 2010, Sayeed devised a scheme to bypass the Consortium’s referral process by directly soliciting its clients for additional services. MPI signed a Management Services Agreement with the Consortium, which gave MPI full access to its clients’ healthcare data. MPI used this information to identify and directly solicit Medicare-eligible seniors who might want or need additional healthcare services.The district court held a bench trial in July 2019 and found that Sayeed and his companies had not violated the Anti-Kickback Statute or False Claims Act because they had paid the Consortium with the intent to obtain information, not patient referrals. The plaintiff appealed, and the court of appeals reversed the decision, concluding that the defendants' conduct qualified as a form of indirect referral giving rise to an unlawful kickback scheme.On remand, the district court found the defendants liable under both the Anti-Kickback Statute and False Claims Act. The court imposed $5,940,972.16 in damages, which it calculated by trebling the value of the Medicare claims it deemed false and then adding a per-claim penalty of $5,500. The defendants appealed, challenging both the damages award and the underlying finding of liability. The United States Court of Appeals for the Seventh Circuit affirmed the judgment of liability but reversed in part to permit the district court to clarify which Medicare claims, all or some, resulted from the defendants’ illegal kickback scheme. View "Stop Illinois Health Care Fraud, LLC v. Sayeed" on Justia Law

The case revolves around Gracie and Jeff Richardson, the legal guardians of their adult son, JMR, who suffers from severe developmental and intellectual disabilities. JMR requires full-time care and receives the highest level of Medicaid benefits offered through the Home and Community Based Services Waiver Program (HCBS Program) administered by the Wyoming Department of Health. The HCBS Program offers numerous services to participants like JMR to meet their individually assessed needs. In 2017, the Department entered into a settlement agreement with the Richardsons to establish an individual plan of care for JMR that permitted him to spend his individual budget amount on adult day services, residential habilitation services (community living services), and respite services.In 2021, the Department reviewed JMR’s individual plan of care pursuant to a quality improvement review. The Department discovered JMR’s providers had been billing for respite services at the same time JMR had been receiving community living services. Under the Department’s Comprehensive and Supports Waiver Service Index (the Index), providers are not authorized to bill for both the daily rate of community living services and the fifteen-minute units of respite services. The Department, relying on the Index, notified the Richardsons that it was required to remove respite services from JMR’s individual plan of care. The Richardsons requested an administrative hearing, which upheld the Department’s decision. The Richardsons appealed to the district court, which affirmed the decision. The Richardsons then appealed to the Supreme Court of Wyoming.The Supreme Court of Wyoming affirmed the lower court's decision. The court found that the Department acted in accordance with law when it removed respite services from JMR’s individual plan of care. The court held that the Index, which was incorporated by reference in the Department’s Medicaid regulations, constituted a rule with the force and effect of law. The court also found that the Department’s quality improvement review, which was used to identify the billing deemed erroneous under the Index, was not considered a “rule” under the Wyoming Administrative Procedure Act and therefore did not require the rulemaking process before implementation. Finally, the court concluded that the Department’s removal of respite services from JMR’s individual plan of care did not violate the parties’ 2017 Settlement Agreement. View "Richardson v. State of Wyoming, Ex Rel. Wyoming Department of Health" on Justia Law

The case involves a group of plaintiffs, led by Chris Calnan, who challenged a rule implemented by Maine Emergency Medical Services (Maine EMS) requiring emergency medical service (EMS) workers to be fully vaccinated against COVID-19 and influenza. The plaintiffs sought a declaratory judgment that Maine EMS lacked statutory authority to implement such a rule.The Superior Court (Kennebec County) dismissed the plaintiffs' complaint. The court concluded that the plaintiffs had named the correct defendants, that it had jurisdiction to consider the challenge to the rulemaking, and that the EMS Board acted within its authority in implementing the immunization rule. The court also dismissed the plaintiffs' motion for summary judgment as moot.On appeal, the Maine Supreme Judicial Court affirmed the lower court's decision. The court found that the EMS Board did not exceed its statutory authority in issuing the immunization rule. The court also concluded that the rule aligns with the purpose of the Maine Emergency Medical Services Act of 1982, which is to ensure optimum patient care and the safe handling and transportation of patients. Lastly, the court determined that the EMS Board followed the applicable rulemaking process for the promulgation of the immunization rule. View "Calnan v. Hurley" on Justia Law

In September 2020, George Fluitt was indicted on three counts of fraud and offering kickbacks related to genetic testing services that his company, Specialty Drug Testing LLC, provided to Medicare beneficiaries. As part of a nationwide investigation into genetic testing fraud, the Government executed search warrants at laboratories referred to as the Hurricane Shoals Entities (“HSE”), allegedly operated by Khalid Satary. The Government copied several terabytes of data from HSE, some of which were later determined to be material to Fluitt’s defense.In the lower courts, the Government established a “Filter Team” to review materials seized in its investigation and identify any that might be privileged. The Filter Team’s review was governed in part by a Protocol Order, which established a multi-step process for notifying a third party that it might have a claim of privilege and then adjudicating that claim. HSE and Satary provided privilege logs to the Filter Team, asserting thousands of claims of privilege. Both Fluitt and the Filter Team found these privilege logs to be facially deficient as they made only threadbare assertions of privilege, without any accompanying explanation.In the United States Court of Appeals Fifth Circuit, the court affirmed the lower court's decision. The court found that the appellants failed to establish their claims of privilege. The court also found that the appellants' argument that they are not bound by the Protocol Order was a red herring, as the magistrate judge evaluated the appellants’ privilege logs under the standards established by federal caselaw. The court also rejected the appellants' argument that Fluitt “has not shown a need for the documents” and has not “demonstrated any kind of relevancy.” The court found that the record suggests that Fluitt “has a need” for the potentially privileged documents, as the Government determined that the potentially privileged materials were material to preparing Fluitt’s defense. View "United States v. Fluitt" on Justia Law

The case involves a dispute over the adjusted Medicaid reimbursement rates for for-profit residential health care facilities in New York. The New York State Department of Health and its Commissioner, in response to a legislative mandate, eliminated a component known as the "residual equity reimbursement factor" from the computation formula used to set these rates. This change was part of a broader effort to reduce Medicaid costs in the state. The petitioners, 116 for-profit nursing homes, challenged this adjustment, arguing that it was retroactively applied and violated their rights under the Public Health Law and the Equal Protection Clause.The Supreme Court partially granted the petitioners' motion for a preliminary injunction against enforcement of the clause pending a final determination of the proceeding. It also partially granted the respondents' motion for summary judgment, dismissing the petitioners' claims that the adjusted rates were not "reasonable and adequate to meet costs" under the Public Health Law and violated their equal protection rights. However, the court found that the adjusted rates were improperly applied retroactively. The Appellate Division affirmed the Supreme Court's decision.The New York Court of Appeals, in its review, held that the Department of Health did not violate the legislature's intent when it announced the recalculated rates for services provided on or after April 2, 2020. The court found that the legislature clearly expressed its intent for the elimination clause to be applied without delay, and that the initial implementing ratemaking was not subject to the usual 60-day advance notice requirement. The court also rejected the petitioners' claims that the adjusted rates were not "reasonable and adequate to meet costs" and violated their equal protection rights. The court modified the order of the Appellate Division in accordance with its opinion and, as so modified, affirmed it. View "In re Aaron Manor Rehabilitation & Nursing Ctr., LLC v Zucker" on Justia Law