Justia Government & Administrative Law Opinion Summaries

Articles Posted in Health Law
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Appellants, researchers in the field of adult stem cells who oppose the use of federal funding for the development of embryonic stem cell (ESC) research, filed a complaint seeking declaratory and injunctive relief against the Secretary's implementation of regulations allowing federal funding of such research. The court, applying Chevron analysis, held that the NIH had reasonably interpreted the Dickey-Wicker Amendment's ban on funding "research in which . . . embryos are destroyed" to allow federal funding of ESC research. Further, the preliminary-injunction exception was not applicable to the law-of-the-case preclusion. The court also held that the NIH's interpretation of the Dickey-Wicker Amendment's actual language was reasonable and the NIH's decision to dismiss the comments categorically objecting to ESC was not arbitrary or capricious. Accordingly, the court affirmed summary judgment in favor of the government. View "Sherley, et al. v. Sebelius, et al." on Justia Law

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In this appeal, the question presented to the Supreme Court based on the facts of this case was: "[w]hen a physician is alleged to have acted as an apparent agent of a hospital, does the Maine Health Security Act require that the alleged negligent acts or omissions of that physician be evaluated by the mandatory prelitigation screening and mediation panel before a claim may be brought in court against the hospital based on that physician’s conduct? The Court answered that question in the affirmative: "[b]ecause Maine law requires that a prelitigation screening panel evaluate a physician's alleged professional negligence before consideration at trial, and because that did not occur in the instant case," the Court vacated the judgment and remanded the case for further proceedings. View "Levesque v. Central Maine Medical Center" on Justia Law

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A trade group and a physician-owned hospital sued the Secretary of the Department of Health and Human Services. They sought injunctive relief to remedy multiple alleged constitutional infirmities with Section 6001 of the Patient Protection and Affordable Care Act. Section 6001 limits Medicare reimbursement for services furnished to a patient referred by a physician owner. Although it denied the Secretary's motion to dismiss for lack of jurisdiction, the district court granted summary judgment to the Secretary, concluding that Congress had a rational basis for enacting Section 6001, the new law did not constitute a real or regulatory taking, and the law's requirements were not unconstitutionally vague. The plaintiffs appealed. The Fifth Circuit Court of Appeals vacated the district court's decision and dismissed the appeal, holding that the district court lacked subject matter jurisdiction over this case. View "Physician Hosps. of Am. v. Sebelius" on Justia Law

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Applicants for and recipients of Medicaid home health Services claimed that the New York State Office of Temporary and Disability Assistance and the New York State Department of Health, violated their statutory right, enforceable under 42 U.S.C.1983, to an opportunity for Medicaid fair hearings. They claimed that this right, as construed by federal regulation, entitles them to “final administrative action” within 90 days of their fair hearing requests. The district court declared that “final administrative action” includes the holding of Medicaid fair hearings, the issuance of fair hearing decisions, and the implementation of any relief ordered in those decisions and permanently enjoined the state agencies to ensure that “final administrative action” implemented within 90 days of fair hearing requests. The Second Circuit affirmed in part, holding that the plaintiffs have a right to a Medicaid hearing and decision ordinarily within 90 days of their fair hearing requests, and that such right is enforceable under section 1983. The permanent injunction was, however, overbroad because “final administrative action” refers not to the implementation of relief ordered in fair hearing decisions, but to the holding of fair hearings and to the issuance of fair hearing decisions.

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Appellants were executives at the Purdue Frederick Company when it misbranded the painkiller OxyContin a schedule II controlled substance. The Company was convicted of fraudulent misbranding, and the executives were convicted under the "responsible corporate officer" doctrine of the misdemeanor of misbranding a drug. Based upon their convictions, the Secretary of Health and Human Services later excluded the individuals from participation in federal health care programs for twelve years under 42 U.S.C. 1320a-7(b). Appellants sought review, arguing that the statute did not authorize their exclusion and the Secretary's decision was unsupported by substantial evidence and was arbitrary and capricious. The district court granted summary judgment for the Secretary. The D.C. Circuit Court of Appeals reversed, holding (1) the statute authorized the Secretary's exclusion of Appellants, but (2) the Secretary's decision was arbitrary and capricious for want of a reasoned explanation for the length of the exclusions.

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Plaintiff sought to develop a rapid, self-administered test to determine a person’s HIV status. The development process included collection of human blood and saliva samples. Plaintiff sued the United States under the Federal Tort Claims Act for the destruction of its blood and saliva specimens by the Food and Drug Administration. The specimens had been seized during a criminal investigation and the freezer in which they were stored broke down. The district court entered summary judgment that the suit arose from a law enforcement officer’s detention of property, excepting the claims from the FTCA waiver of sovereign immunity, 28 U.S.C. 2680(c). The Seventh Circuit affirmed. The government presented uncontroverted evidence that the officer detained the specimens as a law enforcement officer

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The Secretary of the Department of Health and Human Services (HHS) imposed a civil money penalty on Greenbrier Nursing and Rehabilitation Center, a skilled nursing facility in Arkansas, for noncompliance with Medicare participation requirements. The Eighth Circuit Court of Appeals denied Greenbrier's petition for review, holding (1) substantial evidence supported HHS's finding that Greenbrier was not in substantial compliance with 42 C.F.R. 483.25; (2) the finding that Greenbrier's noncompliance with section 483.25 rose to the level of immediate jeopardy was not erroneous; and (3) judicial review of two of Greenbrier's objections to the monetary penalty was barred, and Greenbrier received adequate notice of its noncompliance.

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Locane, born in 1983, was adopted and does not know her family medical history. She suffered her first symptoms within two weeks of being vaccinated in 1997 and was diagnosed with Crohn’s Disease. She sought compensation under the National Childhood Vaccine Injury Act, 42 U.S.C. 300aa-1 to -34, alleging that she suffered Crohn’s disease as a result of hepatitis B vaccination. A special master denied the claim, finding Locane’s disease began before her vaccination and that Locane failed to prove by a preponderance of the evidence that the vaccine caused or significantly aggravated her disease. The Federal Circuit affirmed.

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In 2009, the Board of Health of the City of New York adopted a resolution requiring all tobacco retailers to display signs bearing graphic images showing certain adverse health effects of smoking. The district court held that the resolution is preempted by federal labeling laws. The Second Circuit affirmed, citing the Federal Cigarette Labeling and Advertising Act, 15 U.S.C. 1331-41, a comprehensive program to deal with cigarette labeling and advertising, which includes a preemption provision, limiting the extent to which states may regulate the labeling, advertising, and promotion of cigarettes.

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Miramar Lodge Nursing Home (Miramar) was destroyed by Hurricane Katrina. Miramar at the time was located in Pass Christian, Harrison County, Mississippi. On January 5, 2010, Harrison County Properties, LLC, d/b/a Gulfport Care Center (GCC,) filed a certificate of need (CON) application with the Mississippi Department of Health (DOH). GCC requested the CON for the construction of a replacement facility and relocation of ninety nursing-home beds from Miramar to an area located in central Harrison County, approximately twenty miles from Pass Christian. Sixty of Miramar’s 180 beds were relocated in 2006 to Boyington Health Care Facility in Gulfport, Harrison County, Mississippi. The remaining thirty Miramar beds were the subject of a separate CON application, which proposed to relocate those thirty beds to Hattiesburg, Mississippi. Several nursing homes from Harrison County and Jackson County contested GCC’s CON application and requested a public hearing. On August 26, 2010, the State Health Officer (SHO), concurring with the findings, conclusions, and recommendations of the DOH staff and the hearing officer, granted GCC a CON for the construction of a ninety-bed replacement nursing home in Harrison County. The contestants appealed to the Hinds County Chancery Court, which affirmed the SHO’s decision. The contestants the appealed to the Supreme Court arguing that: 1) DOH failed to comply with Mississippi law in granting the CON to GCC, as "GCC did not act in sufficient time to re-open Miramar under CON law"; 2) no actual need was demonstrated for the project; 3) no economic viability was demonstrated for the project; and 4) DOH failed to follow its own rules and regulations in granting the CON. Having found that the SHO’s decision to grant GCC a CON for the construction of a ninety-bed replacement nursing home in Harrison County is supported by substantial evidence, the Supreme Court affirmed the decision of the Hinds County Chancery Court.