Justia Government & Administrative Law Opinion Summaries
Articles Posted in Health Law
Legato Vapors, LLC v. Cook
Indiana’s 2015 Vapor Pens and E-Liquid Act regulates the manufacture and distribution of vapor pens and the liquids used in e-cigarettes, Ind. Code 7.1-7- 1-1. The Act has extraterritorial reach and imposed detailed requirements of Indiana law on out-of-state manufacturing operations. It purported to regulate the design and operation of out-of-state production facilities, including requirements for sinks, cleaning products, and even the details of contracts with outside security firms and the qualifications of those firms’ personnel. The Seventh Circuit reversed dismissal of a challenge to the Act. Imposing these Indiana laws on out-of-state manufacturers violates the dormant Commerce Clause. Indiana has ample authority to regulate in-state commerce in vapor pens, e-liquids, and e-cigarettes to protect the health and safety of its residents, by prohibiting sales to minors and requiring child-proof packaging, ingredient labeling, and purity. The requirements for in-state production facilities pose no inherent constitutional problems. Indiana may not, however, try to achieve its health and safety goals by directly regulating out-of-state factories and commercial transactions. View "Legato Vapors, LLC v. Cook" on Justia Law
Delek Refining, Ltd. v. OSHC
Delek petitions for review of OSHA citations for violations of its process safety management rules, which govern an employer’s responsibility to inspect, and to develop inspection and recording regimes for, machinery that handles large volumes of hazardous chemicals. Item 4 alleges a failure to resolve open findings and recommendations identified during process hazard analyses that occurred in 1994, 1998, 1999, 2004, and 2005—prior to Delek purchasing and taking possession of the refinery. Item 8 alleges an inadequate monitoring and inspection regime for certain equipment involved in process safety management. Item 12 alleges that Delek failed to determine and document a response to the findings of a 2005 compliance audit in a timely manner. Item 12 was also conducted before Delek took possession of the refinery. The court concluded that citations for Items 4 and 12 are barred by the six-month statute of limitations in 29 U.S.C. 658(c). Accordingly, the court vacated those items. The court also concluded that the regulations relevant to the citation for Item 8 are ambiguous and the Secretary's interpretation is reasonable. The court affirmed the citation for Item 8. View "Delek Refining, Ltd. v. OSHC" on Justia Law
Dyous v. Commissioner of Mental Health & Addiction Services
Petitioner was charged with several criminal offenses. Petitioner pleaded not guilty by reason of mental disease or defect. After a nonadversarial proceeding, the court rendered a judgment acquitting Petitioner of all offenses on the basis of mental disease or defect and committed Petitioner to the custody of the Commissioner of Mental Health and Addiction Services (Respondent) for a period not to exceed twenty-five years. Respondent later transferred custody of Petitioner to the jurisdiction of the Psychiatric Security Review Board. Petitioner remained committed to the custody of the Board for more than twenty-five years. Petitioner then filed a petition for habeas corpus challenging his extended confinement. The habeas court denied Petitioner’s petition. The Supreme Court affirmed, holding (1) the habeas court properly denied Petitioner relief on his claim regarding the knowing and voluntary nature of his plea; and (2) the habeas court correctly determined that Petitioner did not receive ineffective assistance of counsel. View "Dyous v. Commissioner of Mental Health & Addiction Services" on Justia Law
West Texas LTC Partners, Inc. v. Dept. of Health & Hum. Svcs.
West Texas LTC Partners, Inc., doing business as Cedar Manor Nursing & Rehabilitation Center ("Cedar Manor"), appealed a Departmental Appeals Board ("DAB") of the U.S. Department of Health and Human Services ("HHS") decision. In 2013, Cedar Manor was surveyed by the Texas Department of Aging and Disability Services ("DADS"). The surveyor found Cedar Manor out of compliance with three regulations after observing the care provided to two wheelchair-bound residents, Resident #1 and Resident #4. Early the next year, DADS found additional violations of several regulations. The surveys were conducted by a designated state agency on behalf of the Centers for Medicare & Medicaid Services ("CMS") of HHS. The findings were reviewed by CMS, and civil money penalties ("CMPs") or other remedies may be imposed by the Secretary of HHS if the facility was found noncompliant. For the two sets of violations, CMS recommended two CMPs: $6,050 per day for three days, and $350 per day for forty-two days, to run consecutively from the end of an "immediate hazard" penalty. Cedar Manor appealed the findings and CMPs and requested a hearing before an administrative law judge ("ALJ"). CMS moved for summary judgment on all of the violations after the briefing and evidence were submitted. The ALJ granted summary judgment and upheld the CMPs. On de novo review, the DAB affirmed. The Fifth Circuit found that the DAB decision was neither arbitrary and capricious nor unsupported by substantial evidence, it denied Cedar Manor's petition for review. View "West Texas LTC Partners, Inc. v. Dept. of Health & Hum. Svcs." on Justia Law
Borgess Medical Center v. Burwell
In 1973, two Kalamazoo, Michigan hospitals formed a consortium to manage their health education programs and to train interns and residents. In the 1980s, they joined Michigan State University to form the Michigan State University Kalamazoo Center for Medical Studies (KCMS). KCMS administered graduate medical programs for residency programs for the hospitals. The hospitals agreed to incur “joint and equal responsibility for providing [KCMS] with sufficient financing to carry out its programs as negotiated on a yearly basis.” KCMS also received patient-care revenue, support from Michigan State University, and funds from contracts and grants. The hospitals sought reimbursement on their Medicare cost reports (42 U.S.C. 1395ww(h)) during fiscal years 2000–2004 for costs incurred for residents’ training at KCMS’s nonhospital clinics. The Centers for Medicare and Medicaid Services found that the hospitals failed to show they incurred all or substantially all of the costs of their residency programs and that they failed to comply with a requirement of a written agreement detailing the financing of their offsite programs. The district court and D.C. Circuit affirmed the denials of reimbursement, rejecting an argument that the “written agreement” requirement was satisfied by a collection of documents executed over the years. None of the documents met the regulatory criteria. View "Borgess Medical Center v. Burwell" on Justia Law
Seaside Farm, Inc. v. United States
Seaside filed suit under the Federal Tort Claims Act (FTCA), 28 U.S.C. 1346(b), 2671-2680, alleging that the FDA negligently issued a contamination warning in response to an outbreak of Salmonella Saintpaul that devalued Seaside’s tomato crop by $15,036,293.95. The court affirmed the district court's holding that the FDA was exercising a discretionary function in connection with the contamination warning. The court explained that the ruling was essential to protect the FDA’s vital role in safeguarding the public food supply. Accordingly, the court affirmed the judgment. View "Seaside Farm, Inc. v. United States" on Justia Law
Maine Medical Center v. Burwell
The consolidated appeals in this case involved a dispute between the Secretary of Health and Human Services and a group of Maine hospitals about certain payments - called disproportionate share payments (DSH payments) - the hospitals had received in reimbursement from the federal government for charity care for fiscal years dating as far back as 1993. Generally speaking, the more low-income patients a hospital services, the higher the hospital’s DSH payment. In this case, the Secretary maintained that the Hospitals were overinclusive in their DSH payment calculations. An intermediary reassessed the DSH payments and recouped from the Hospitals approximately $22 million in alleged overpayments. The Provider Reimbursement Review Board, in turn, ordered the intermediary to restore approximately $17 million to the Hospitals. The Secretary reversed. The Hospitals sought judicial review, but neither side was satisfied with the district court’s ruling. On appeal, the First Circuit reversed in part and affirmed in part, holding (1) the Secretary properly reopened the disputed years and adequately demonstrated that the Hospitals had received substantial overpayments of DSH funds; and (2) the Hospitals’ defenses to repayment were unavailing. View "Maine Medical Center v. Burwell" on Justia Law
Billeaudeau v. Opelousas General Hospital Authority
The issue this case presented for the Louisiana Supreme Court's review was a res nova issue of whether a claim for negligent credentialing fell within the purview of the Louisiana Medical Malpractice Act (LMMA) and was, therefore, subject to its statutory cap on damages. After completion of the medical review process, plaintiffs Brandi, Veronica, and Joseph Billeaudeau proceeded in their suit against Opelousas General Hospital Authority (OGH), among other defendants, for injuries Brandi sustained allegedly arising from the medical malpractice of Dr. Kondilo Skirlis-Zavala, an independent contractor working in the OGH’s emergency department (ED). Along with their medical malpractice claims, plaintiffs specifically alleged OGH was negligent in credentialing Dr. Zavala and subsequently moved for partial summary judgment, seeking a determination that their negligent credentialing claim was not subject to the LMMA’s cap on damages. The District Court granted the motion and ultimately certified the judgment as final. The Court of Appeal affirmed on appeal. The Supreme Court found plaintiffs’ negligent credentialing claim did not fall within the provisions of the LMMA. Accordingly, the Court affirmed the Court of Appeal. View "Billeaudeau v. Opelousas General Hospital Authority" on Justia Law
Union of Med. Marijuana Patients v. City of San Diego
Union of Medical Marijuana Patients, Inc. (UMMP) appealed a trial court judgment denying its petition for writ of mandate, which challenged the City of San Diego's enactment of an ordinance adopting regulations for the establishment and location of medical marijuana consumer cooperatives in the City. UMMP argued that the City did not comply with the California Environmental Quality Act (CEQA) when enacting the ordinance. After review, the Court of Appeals concluded that the ordinance did not constitute a "project" within the meaning of CEQA, and accordingly the City was not required to conduct an environmental analysis prior to enacting the ordinance. View "Union of Med. Marijuana Patients v. City of San Diego" on Justia Law
In re I.G.
In involuntarily hospitalized patient diagnosed with schizophrenia appealed a trial court’s order allowing for his involuntary medication. Patient argued that the court erred by: (1) incorrectly applying the competency standard under 18 V.S.A. 7625; and (2) failing to address whether a previously prepared document reflecting his desire not to be given psychiatric medication was a “competently expressed written . . . preference[] regarding medication” under 18 V.S.A. 7627(b). After review, the Supreme Court concluded that the trial court’s findings supported its conclusion under section 7625, but agreed that the trial court did not squarely address patient’s argument under section 7627 in its findings. Accordingly, the Court reversed on that issue and remanded for the trial court to issue findings addressing the applicability of section 7627(b). View "In re I.G." on Justia Law