Justia Health Law Opinion Summaries

In this case involving a facility that operated under the protection of a thirty-six-year-old consent decree the Supreme Judicial Court held that the trial judge did not abuse her discretion in concluding that the Department of Developmental Services failed to establish that the consent decree should be terminated based on the evidentiary record before the probate court.In question was the treatment and welfare of individuals who suffered from severe developmental and intellectual disabilities that caused them to engage in grievous self-harm and other life-threatening behaviors. The individuals lived in group homes under the care of Judge Rotenberg Educational Center, Inc. (JRC), a facility that employed the use of aversive interventions such as electric skin shock as part of its treatment approach. In the 1980s and 1990s State agencies disrupted JRC's operations, after which the consent decree was issued. Years later, the agencies bound by the decree moved for its termination, but the probate and family court denied the motion. The Supreme Judicial Court affirmed, holding that the Department's arguments against continued enforcement of the consent decree were unavailing. View "Judge Rotenberg Educational Center, Inc. v. Commissioner of Dep't of Developmental Services" on Justia Law

A group of Doctors sued the FDA and the Department of Health and Human Services (together, the “Agencies”), claiming an FDA ad intended to deter people from off-label use of ivermectin to treat COVID-19. Each Doctor says that FDA’s messaging interfered with their own individual medical practice.The Doctors argue that FDA’s ad and similar public statements violated FDA’s enabling act (“Act”) and the Administrative Procedure Act (“APA”). The district court held that sovereign immunity protects the Agencies and the Officials, and it dismissed the suit. The Fifth Circuit reversed.The Fifth Circuit held that the Doctors can use the APA to bypass sovereign immunity and assert their ultra vires claims against the Agencies and the Officials. The ad was plausibly agency action, because it publicly announced the general principle that consumers should not use ivermectin to treat the coronavirus, and the Doctors fall within the Act’s zone of interests.The Doctors’ pure APA claim cannot go forward because the ad does not determine legal rights and thus lacks the finality. However, the Fifth Circuit held that the Doctors’ first theory was enough to allow this suit to proceed. View "Apter v. Dept of Health & Human Svc" on Justia Law

Hospitals receive greater payment if their Medicare patients are disproportionately low-income individuals entitled to federal supplemental security income benefits. Pomona Valley Hospital Medical Center contends that the Department of Health and Human Services undercounted the number of its Medicare patients who were entitled to SSI benefits and thus undercompensated the hospital for treating them. Pomona sought to prove the undercount through data from state benefit programs that piggyback on SSI. In an administrative proceeding, Pomona introduced expert testimony explaining how the state data derives from and overlaps with the federal SSI data. The Provider Reimbursement Review Board held that Pomona failed to prove the undercount, but the district court set aside its decision and remanded the case to the Board for further proceedings.   The DC Circuit affirmed. The court explained that using statewide statistics, Pomona estimated that fewer than 10 such patients would likely show up in its SSI-fraction calculations in any given year. And neither the Board nor the Contractor countered these estimates. Given the lack of contrary evidence in the record, such discrepancies appear immaterial and suggest no substantial flaw in Pomona’s methodology. Further, the court explained that Pomona provided uncontroverted evidence that two potential difficulties with its approach amounted to little more than rounding errors. It proffered creditable testimony from two experts indicating that the only explanation for the discrepancy was some error in CMS’s collection or matching of data. By contrast, the Contractor remained silent. Given the strength of the hospital’s showing, and the absence of any countervailing evidence, the Board’s conclusion that Pomona had failed to prove an undercount was unreasonable View "Pomona Valley Hospital Med v. Xavier Becerra" on Justia Law

On appeal from the trial court's denial of a motion to compel arbitration in this wrongful death lawsuit brought against Defendant, a nursing home, the Supreme Court held that Defendant did not meet the requirements for limited statutory immunity from civil liability under either Tennessee's Durable Power of Attorney for Health Care Act, Tenn. Code Ann. 34-6-201 to -218, or the Health Care Decisions Act, Tenn. Code Ann. 68-11-1801 to -1815.After a resident of the nursing home died his estate brought the underlying wrongful death suit. Defendant moved to compel arbitration based on an arbitration agreement executed by Plaintiff on the decedent's behalf pursuant to a durable power of attorney for health care (POA) form. Plaintiff objected, arguing that the decedent did not have the mental capacity to appoint an agent when he executed the POA. The trial court concluded that the POA was invalid. The court of appeals reversed, concluding that the trial court erred in looking beyond the face of the POA to determine whether Defendant had the mental capacity to execute it. The Supreme Court reversed and affirmed the trial court, holding that the trial court did not err in considering evidence on whether the principal had the requisite mental capacity to execute the POA. View "Welch v. Oaktree Health & Rehabilitation Center LLC" on Justia Law

The Supreme Court denied Petitioner's petition for a writ of certiorari or mandamus in this matter arising from district court orders holding Petitioner, the Nevada Division of Public and Behavioral Health, in contempt for vacating competency court orders, holding that Petitioner failed to meet its burden of demonstrating the need for extraordinary relief.The competency orders were issued in relation to eleven criminal defendants in Nevada who were all deemed incompetent to assist in their own defense and ordered to psychiatric treatment (collectively, Defendants). Defendants moved to dismiss their cases or, alternatively, for Petitioner to show cause as to why it should not be held in contempt after significant delays in accepting Defendants for treatment. The district court found Petitioner in contempt for failing to comply with the court orders and issued sanctions. Petitioner then filed the instant petition. The Supreme Court denied relief, holding that the district court had jurisdiction to hold Petitioner in contempt and did not manifestly or capriciously abuse its discretion in doing so. View "State, Dep't of Health v. District Court" on Justia Law

The Supreme Court held that persons facing involuntary commitment under the Sexually Violent Predator Act (SVP Act), Cal. Welf. & Inst. Code 6600 et seq., have a due process right to a timely trial but that whether pretrial delay violates that right depends in the first instance on the reasons for the delay. See Barker v. Wingo (1972), 407 U.S. 514, 531.In 2005, Petitioner was determined to be an SVP and committed to the state hospital for two years. The next year, the applicable statute was amended to provide for indefinite commitment instead of renewable two-year terms. Before Petitioner's term ended, the State filed a recommitment petition seeking indefinite commitment under the new version of the statute. Petitioner later filed a motion to dismiss the petition to extend commitment, arguing that the "excessive delay" in his case violated his due process right to a timely trial. The trial court denied the motion to dismiss, after which Petitioner filed an original petition for a writ of mandate. The court of appeal denied the writ petition. The Supreme Court affirmed, holding that Petitioner failed to establish a violation of his due process rights. View "Camacho v. Superior Court" on Justia Law

After the FDA promulgated regulations applying the Act to vaping products, Fontem US, LLC, submitted numerous applications to market its flavored and unflavored vaping products. The FDA denied all of them, concluding Fontem had not shown its products were “appropriate for the protection of the public health.” Fontem petitioned for review, arguing the denial was unlawful.   The DC Circuit denied the petition for review as to Fontem’s flavored products and granted the petition for review with respect to the unflavored products. The court explained that as to Fontem’s flavored products, the FDA reasonably found a lack of evidence that the benefits of such products to adult smokers sufficiently outweighed the potential risks to young non-smokers. The court wrote that as to Fontem’s unflavored products, however, the FDA acted unlawfully by failing to engage in the holistic public health analysis required by the statute. The court concluded that the agency did not take into account the potential benefits of unflavored products or weigh those benefits against risks to public health. Instead, the agency identified highly granular deficiencies but failed to evaluate the potential effects of such deficiencies on public health or to weigh these deficiencies against the potential benefits of Fontem’s products. View "Fontem US, LLC v. FDA" on Justia Law

Plaintiff was placed on unpaid administrative leave and then terminated from her employment with defendant Sequoia Union Elementary School District (the School District) after refusing to either provide verification of her COVID-19 vaccination status or undergo weekly testing as required by a then-operative order of the State Public Health Officer.Plaintiff brought suit under the Confidentiality of Medical Information Act against defendants the School District; Sequoia Union Elementary School (the School); and the School principal and superintendent, alleging (1) discrimination due to her refusal to authorize release of her medical information and (2) unauthorized use of her medical information.The trial court sustained defendants’ demurrer without leave to amend, finding each claim failed as a matter of law due to certain statutory exceptions.Without any factual allegations that defendants received any “medical information,” such as medical records, a medical certification, or other information in “electronic or physical form... derived from a provider of health care” (section 56.05, subd.(i)), the Fifth Appellate District found that the complaint fails to state a cause of action for unauthorized use of such information under section 56.20(c). View "Rossi v. Sequoia Union Elementary School" on Justia Law

Former employees of Alternatives, a for-profit hospice provider, sued under the False Claims Act, 31 U.S.C. 3729, alleging that Alternatives submitted claims for Medicare reimbursement despite inadequate documentation in the patients’ medical records supporting hospice eligibility, under 42 C.F.R. 418.22(b)(2). For a patient to be eligible for Medicare hospice benefits, and for a hospice provider to be entitled to reimbursement, a patient must be certified as “terminally ill.” The district court granted Alternatives summary judgment based on lack of materiality, finding “no evidence” that Alternatives’ insufficiently documented certifications "were material to the Government’s decision to pay.” The court reasoned that “[t]he Government could see what was or was not submitted” yet never refused any of Alternatives’ claims, despite the inadequacy or missing supporting documentation or where compliance was otherwise lacking.The Third Circuit vacated. When a government contractor submits a claim for payment but fails to disclose a statutory, regulatory, or contractual violation, that claim does not automatically trigger liability. The Act requires that the alleged violation be “material” to the government’s decision to pay. The Supreme Court has identified factors to assist courts in evaluating materiality. In this case, the court based its decision principally on the government’s continued payments after being made aware of its deficient documentation, overlooking factors that could have weighed in favor of materiality— and despite an open dispute over the government’s “actual knowledge.” View "Druding v. Care Alternatives" on Justia Law

Defendant ended up at a Twin Cities chiropractic clinic after an automobile accident. The visit resulted in a job: the clinic hired him to recruit patients. And then another one did too. Defendant’s role was to bring in as many accident victims as possible. Each new patient could undergo treatment up to $20,000, the limit of basic economic benefits available under most Minnesota automobile insurance policies. After a jury trial, the district court ordered Defendant to pay $187,277 in restitution to the insurance companies he defrauded. On remand, the amount of restitution decreased. This time, the district court concluded that Defendant qualified as a runner for only 53 of the 65 victims, which dropped the award to $155,864. Defendant, for his part, has adopted an all-or-nothing strategy: he does not believe he owes a single penny of restitution.   The Eighth Circuit affirmed. The court explained that Defendant received up to $1,500 per patient he recruited, which satisfies the pecuniary-gain requirement. A series of text messages establishes the remaining elements. When the clinic owner later said she was “praying for some ice and snow” to bring in more clients, Defendant replied that he had “been praying for [the] last four weeks.” It was reasonable to conclude from these messages that Hussein “directly procure[d]” these patients with at least a “reason to know,” if not actual knowledge, that the provider’s purpose was to obtain benefits under an automobile-insurance contract. View "United States v. Abdisalan Hussein" on Justia Law