Justia Health Law Opinion Summaries

The Family Smoking Prevention and Tobacco Control Act requires any tobacco product not on the market before February 15, 2007, to receive FDA approval, 21 U.S.C. 387j(a)(1)–(2). Only if the FDA concludes that “permitting such tobacco product to be marketed would be appropriate for the protection of the public health” can the product be approved. Manufacturers seeking advance permission to market new products. In 2020, the FDA began taking aggressive action to remove fruit- and dessert-flavored e-cigarettes (electronic nicotine delivery systems (ENDS)) from the market, leaving aside tobacco- and menthol-flavored ENDS. More recently, based on additional studies and market data, the FDA has denied the applications of importers and manufacturers to market menthol-flavored ENDS.An importer challenged that denial, arguing that it was arbitrary and capricious for the FDA to apply the same regulatory framework to menthol that it used to assess the appropriateness of sweeter flavors, to ultimately reject its applications for its menthol-flavored ENDS to remain on the market, and to do so without granting a transition period. The Third Circuit denied a petition for review. The FDA applied a regulatory framework consistent with its statutory mandate, provided a reasoned explanation for its denial, and based its decision on scientific judgments that courts may not second-guess. View "Logic Technology Development LLC v. United States Food and Drug Administration" on Justia Law

In this action arising out of the curtailment of classes and services at the University of Rhode Island (URI) during the COVID-19 pandemic, the First Circuit affirmed the judgment of the district court dismissing some of Plaintiffs' claims early in the litigation and granting summary judgment in favor of Defendant on the remaining claims, holding that the district court did not err.Plaintiffs, students who remained enrolled at URI during the pandemic, filed separate putative class actions against URI alleging breach of contract and unjust enrichment. Specifically, Plaintiffs argued that URI had breached its contract when it stopped providing in-person, on-campus instruction. The district court dismissed certain claims and then, following the completion of discovery, granted summary judgment on the remaining claims. The First Circuit affirmed, holding that Plaintiffs failed to make out a genuine issue of material fact as to whether URI had either an express or implied contract to provide in-person services and activities. View "Burt v. Bd. of Trustees of University of R.I." on Justia Law

The Supreme Court affirmed the judgment of the district court ordering Respondent's continued hospitalization following his court-ordered psychiatric treatment, holding that respondents in proceedings brought under Iowa Code chapter 229 do not have a federal constitutional right to represent themselves and forego the legal representation required by the statute.Respondent, who had a history of self-harm, suicide threats, and refusal to take his medications, was ordered to be involuntarily hospitalized under chapter 229. A series of subsequent court orders left Respondent's commitment in place for the next two years. Thereafter, Respondent moved to terminate his commitment and asked to proceed pro se. The district court denied Respondent's motion to proceed pro se and ordered his continued hospitalization. The Supreme Court affirmed, holding (1) the Sixth Amendment right to counsel and right to self-representation in criminal cases do not apply to Chapter 229 proceedings; and (2) the district court's factual findings were supported by substantial evidence and binding on appeal. View "In re V.H." on Justia Law

The First Circuit affirmed in part and vacated in part the judgment of the district court denying Appellants' request for preliminary injunctive relief from the COVID-19 vaccine policy of Woods Hole, Martha's Vineyard and Nantucket Steamship Authority, holding that remand was required.At issue was Executive Order No. 595, which the Governor of the Commonwealth of Massachusetts issued in response to the COVID-19 pandemic. In response to the order, the Authority issued its own vaccine policy requiring all Authority employees to be fully vaccinated. Appellants, Authority employees, submitted timely requests for religious exemptions from the policy, but the requests were denied. Appellants brought this action under 42 U.S.C. 1983 claiming Appellees denied their rights under the Free Exercise Clause of the First Amendment and also pleading state-law claims. The district court denied relief. The First Circuit affirmed in part and vacated in part, holding that the district court's "likelihood of success" ruling was erroneous. View "Brox v. Woods Hole" on Justia Law

At issue before the Colorado Supreme Court in this matter was a trial court’s order denying immunity to Defendant New Century Hospice, Inc. and its subsidiaries, Defendants Legacy Hospice, LLC, d/b/a New Century Hospice of Denver, LLC, and Legacy Hospice of Colorado Springs, LLC (collectively, “New Century”). New Century argued it was entitled to immunity under four different statutes. Tana Edwards filed suit against New Century (her former employer) and Kathleen Johnson, the Director of Operations for New Century Castle Rock (collectively, “Defendants”). As part of her employment with New Century, Edwards provided in-home care to an elderly patient. In December 2019, Johnson began to suspect that Edwards was diverting pain medications from the patient. Defendants reported the suspected drug diversion to the Castle Rock Police Department and the Colorado Department of Public Health and Environment (“CDPHE”). Defendants also lodged a complaint against Edwards’s nursing license with the Colorado Board of Nursing (“the Board”). After investigations, no criminal charges were filed and no formal disciplinary actions were taken against Edwards. Edwards subsequently brought this action against Defendants, alleging claims for negligent supervision and negligent hiring against New Century, as well as claims for defamation and intentional infliction of emotional distress against New Century and Johnson. Defendants moved for summary judgment. The trial court granted the motion as to Edwards’s claims for negligent hiring, defamation, and intentional infliction of emotional distress, finding that the claims were either time-barred or could not be proven. Three of the statutes New Century cited for its immunity claim, 12-20-402(1), C.R.S. (2022) (“the Professions Act”), 12-255-123(2), C.R.S. (2022) (“the Nurse Practice Act”), and 18-6.5-108(3), C.R.S. (2022) (“the Mandatory Reporter statute”), only authorized immunity for a “person.” Relying on the plain meaning of “person,” the Supreme Court held that New Century was not entitled to immunity under these three statutes because it was a corporation, not a person. The fourth statute, 18-8-115, C.R.S. (2022) (“the Duty to Report statute”), explicitly entitled corporations to immunity, but only if certain conditions were met. Applying the plain language of the statute, the Supreme Court held that New Century was not entitled to summary judgment on the issue of immunity under this statute because it did not carry its burden of demonstrating that all such conditions were met. View "In re Edwards v. New Century Hospice" on Justia Law

The Idaho Department of Health and Welfare’s (“the Department”) cited Grace at Fairview Lakes, LLC (“Grace”), a residential assisted living and memory care facility, for failing to provide a safe living environment for residents and for inadequate training in relation to COVID-19 infection control measures. Grace requested administrative review of the enforcement action, which was affirmed by a Department administrator. Grace then filed an administrative appeal challenging the action, which was affirmed by a hearing officer. Grace then filed a petition for judicial review to the district court. The district court denied all the relief sought by Grace. On appeal to the Idaho Supreme Court, Grace argued the district court erred because the hearing officer’s decision was not supported by substantial evidence in the record as a whole. The Supreme Court found no error in the district court’s decision because there was substantial evidence in the record to support the hearing officer’s order. View "Grace at Fairview Lakes, LLC v. IDHW" on Justia Law

The insurer, in this case, had notice of the hospital’s lien for treatment provided to the patient and, pursuant to a settlement agreement with the patient, gave him a check for the lien amount made payable to both him and the hospital. The hospital, Long Beach Memorial Medical Center, claims this action did not comply with the Hospital Lien Act (HLA) and sued the insurer who wrote the check, Allstate Insurance Company, for violating the HLA. The trial court granted Allstate’s motion for summary judgment, ruling Allstate’s two-payee check, which was never cashed, satisfied its obligation under the HLA.   The Second Appellate District reversed. The court concluded that merely delivering to the patient (or, in this case, his attorney) a check for the lien amount, made payable to both the patient and the hospital, is not a payment in satisfaction of the hospital’s lien under the HLA. The court explained Allstate maintains that it made this payment to the Medical Center concurrent with payment to the patient and that, therefore, the Medical Center cannot establish Allstate made a settlement payment to the patient without paying the Medical Center the amount of its lien. The court explained that Allstate declined to specify which check made payable to the Medical Center as copayee—the February 2020 check or the March 2021 check— Allstate claims satisfied its payment obligation to the Medical Center. However, neither check was a payment to the Medical Center. Moreover, Allstate does not invoke the exception to the general rule here. View "Long Beach Memorial Medical Center v. Allstate Ins. Co." on Justia Law

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