Justia Health Law Opinion Summaries

Plaintiffs-Appellants Santa Paula Animal Rescue Center, Inc. (SPARC) and Lucky Pup Dog Rescue (Lucky Pup) (collectively Appellants) appealed a judgment of dismissal following the trial court’s order sustaining, without leave to amend, Defendant County of Los Angeles’s (the County) demurrer to Appellants’ petition for writ of mandate. Appellants contend that the Hayden Act and, more specifically, Food and Agriculture Code section 31108 and similar provisions impose on the County a ministerial duty to (1) release a dog or other shelter animal to a requesting animal adoption or rescue organization with Internal Revenue Code section 501(c)(3) status prior to euthanasia without first determining whether the animal has behavioral problems or is adoptable or treatable, and (2) release the aforementioned animal to the requesting animal rescue or adoption organization without requiring the organization to meet qualifications additional to having Internal Revenue Code section 501(c)(3) status.   The Second Appellate District reversed the trial court’s judgment and directed the trial court to vacate its order sustaining the demurrer without leave to amend. The court concluded that the demurrer was improperly granted because the County lacks discretion to withhold and euthanize a dog based upon its determination that the animal has a behavioral problem or is not adoptable or treatable. However, the County has discretion to determine whether and how a nonprofit organization qualifies as an animal adoption or rescue organization. View "Santa Paula Animal Rescue Center, Inc. v. County of L.A." on Justia Law

During the COVID-19 pandemic, Twitter broadened its definition of censorable, harmful information to include “content that goes directly against guidance from authoritative sources of global and local public health information.” Twitter began permanently suspending any user who received five or more infractions for violating its COVID-19 policy. The plaintiffs,Twitter users who used their accounts to question responses to the COVID-19 pandemic, suffered multiple temporary suspensions. They claim the Biden administration became involved, announcing that “[t]he President’s view is that the major [social-media] platforms have a responsibility ... to stop amplifying untrustworthy content, disinformation, and misinformation, especially related to COVID-19 vaccinations.” Later, the Surgeon General released an advisory statement related to COVID-19 misinformation and (according to Plaintiffs) “command[ed] technology platforms” to take several steps. President Biden stated that social media platforms are “killing people” with COVID-19 misinformation. Days later, USA Today reported that the “[t]he White House is assessing whether social media platforms are legally liable for misinformation.”Plaintiffs sued the Department of Health and Human Services (HHS), asserting claims under the First Amendment, Fourth Amendment, and Administrative Procedure Act, citing HHS’s unlawful efforts to “instrumentalize[] Twitter” to “silenc[e] opinions that diverge from the White House’s messaging on COVID-19.” The Sixth Circuit affirmed the dismissal of the complaint. The plaintiffs have not adequately pleaded that HHS compelled Twitter’s chosen course of conduct, leaving a “highly attenuated chain of possibilities” that is too speculative to establish a traceable harm View "Changizi v. Department of Health and Human Services" on Justia Law

Waters was born with homocystinuria and diagnosed with that condition at the age of six. Homocystinuria is a genetic attribute that causes metabolic issues that prevent Waters’s liver from metabolizing methionine, an amino acid, that produces L-cysteine, another amino acid. Her physician prescribed HCU coolers–a medical food containing a methionine-free protein formula. Waters ingests HCU coolers orally; she has a fully functioning gastrointestinal tract. Waters sought reimbursement for HCU coolers purchased during 2018-2019, under the prosthetic-device benefit of Medicare Part B, 42 U.S.C. 1395k(a)(2)(I); 1395x(s)(8). The National Coverage Determinations Manual explains that, as part of the prosthetic-device benefit, enteral nutrition is considered reasonable and necessary when a patient “cannot maintain weight and strength commensurate with his” “general condition” because food does not reach the digestive tract and specifies that “[e]nteral therapy may be given by nasogastric [nose], jejunostomy [small intestine], or gastrostomy [stomach] tubes.” The NCD acknowledges “[s]ome patients require supplementation of their daily protein and caloric intake,” but “[n]utritional supplementation is not covered under Medicare Part B.”The Sixth Circuit affirmed several levels of denial of Waters’s claim, acknowledging the difficult circumstances of Waters and her family. An HCU cooler is not a stand-alone prosthetic device based on the plain meaning of prosthetic “device” and because an HCU cooler is a medical food according to the FDA. View "Waters v. Becerra" on Justia Law

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