Justia Health Law Opinion Summaries

A patient sued a hospital, arguing the hospital violated the Alaska Health Care Decisions Act (HCDA) when it temporarily assumed decision-making authority over his medical care while he was incapacitated and treated him without his consent or that of his parents, whom he had previously authorized to make medical decisions on his behalf if he were rendered incompetent or incapacitated. The hospital argued it was entitled to immunity under the HCDA because it held a good faith belief that the patient’s parents lacked authority to make medical decisions for him, based on conduct that convinced health care providers at the hospital that the parents were not acting in the patient’s best interest. The superior court agreed with the hospital and granted its summary judgment motion, concluding that the immunity provisions applied. The superior court concluded the hospital was entitled to immunity because its doctors had acted in good faith and in accordance with generally accepted medical standards. In a matter of first impression for the Alaska Supreme Court, it determined the superior court overlooked the requirement for specific good faith as to the authority or lack thereof of the patient’s surrogate or agent. The grant of summary judgment was reversed and the matter remanded for further proceedings. View "Bohn v. Providence Health & Srvs - Washington" on Justia Law

The Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 301, sets forth separate and detailed regimes for the regulation of medical products classified as drugs or devices. Since 2017, the U.S. Food and Drug Administration (FDA) has exercised its claimed discretion to classify Genus’s “Vanilla SilQ” line of diagnostic contrast agents as drugs, notwithstanding the FDA’s recognition that the products “appear” to satisfy the statutory definition for devices. Contrast agents are used in medical imaging to improve the visualization of tissues, organs and physiological processes. The FDA claims that, if a medical product satisfies the statutory definitions of both a “drug” and a “device,” the Act’s overlapping definitions grant by implication the FDA broad discretion to regulate the product under either regime. Genus challenged the FDA’s classification decision as inconsistent with the Administrative Procedure Act (APA), 5 U.S.C. 706(2), and the FDCA.The D.C. Circuit affirmed summary judgment in favor of Genus. The FDCA unambiguously forecloses the FDA’s interpretation. “It would make little sense, then, for the Congress to have constructed such elaborate regulatory regimes—carefully calibrated to products’ relative risk levels—only for the FDA to possess the authority to upend the statutory scheme by reclassifying any device as a drug, no matter its relative risk level.” View "Genus Medical Technologies LLC v. United States Food and Drug Administration" on Justia Law

The Supreme Court affirmed the decision of the court of appeals reversing the judgment of the circuit court denying The Mix Up's motion for temporary injunctive relief challenging Emergency Order 3 issued by the Department of Health Services (DHS) Secretary-designee, Andrea Palm, holding that the order met the definition of a rule and should have been promulgated according to statutory rulemaking procedures.Emergency Order 3 was issued as a response to the COVID-19 pandemic and limited the size of indoor public gatherings. Plaintiffs initiated this lawsuit, alleging that the order was a rule and that DHS did not undertake proper rulemaking procedures. The circuit court granted Plaintiffs' motion for an ex parte temporary injunction. The Mix Up was granted intervention and moved for a temporary injunction. The circuit court vacated the ex part order denying The Mix Up's motion for temporary injunctive relief. The court of appeals reversed, holding that the order was invalid and unenforceable as a matter of law. The Supreme Court affirmed, holding (1) Emergency Order 3 met the definition of a rule, and therefore, the order should have been promulgated according to rule making procedures set forth in Wis. Stat. ch. 227; and (2) therefore, Emergency Order 3 was not validly enacted and was unenforceable. View "Tavern League of Wisconsin, Inc. v. Palm" on Justia Law

After the Indian Health Service agreed to pay the Swinomish Indian Tribal Community to run a health program on the Swinomish Reservation, Swinomish filed suit under the Contract Disputes Act and Declaratory Judgment Act, claiming that it was owed additional sums in direct and indirect contract support for costs calculated as percentages of the money it received from insurers and spent on health services. The DC Circuit affirmed the district court's grant of the government's motion for summary judgment, holding that the Indian Self-Determination and Education Assistance Act does not require Indian Health Service to pay for contract support costs on insurance money received by Swinomish. Neither does Swinomish's contract with Indian Health Service. View "Swinomish Indian Tribal Community v. Becerra" on Justia Law

Plaintiffs, consisting of the estate of decedent Edward William Kuntz (decedent), his wife, and his three children, sued, among others, the Kaiser Foundation Hospital and the Permanente Medical Group, Inc. (collectively Kaiser), asserting causes of action sounding in elder abuse, negligent infliction of emotional distress, and wrongful death. Kaiser filed a petition to stay the action and compel arbitration. The trial court granted the petition as to the elder abuse cause of action, staying the other causes of action. Ultimately, the trial court entered judgment in favor of Kaiser. Plaintiffs appealed, arguing: (1) Kaiser failed to satisfy its burden of producing a valid agreement to arbitrate; and (2) Kaiser failed to comply with the mandatory requirements of Health and Safety Code section 1363.1 concerning the disclosure of arbitration requirements. Finding no reversible error, the Court of Appeal affirmed. View "Kuntz v. Kaiser Foundation Hospital" on Justia Law

The First Circuit vacated the ruling of the district court denying Plaintiffs' motion for a preliminary injunction in this case, holding that record lacked necessary findings and that remand was required.This case arose from a decision by the Speaker of the New Hampshire House of Representatives to enforce a House rule precluding any representative from participating in proceedings involving the full House, including House matters, other than in person. Plaintiffs, including seven members of the House who claimed to suffer from medical conditions making them vulnerable to COVID-19, brought this action arguing that the Speaker was required to allow them to participate remotely under Title II of the Americans with Disabilities Act, 42 U.S.C. 12132, and section 504 of the Rehabiliation Act, 29 U.S. 794. The district court denied Plaintiffs' motion for a preliminary injunction. The First Circuit vacated the district court's decision, holding that the court erred in finding that the doctrine of legislative immunity shielded the Speaker from having to comply with the ADA and/or Section 504. View "Cushing v. Packard" on Justia Law

The Ninth Circuit's order denied appellants' emergency motion for injunctive relief, which sought to prohibit the enforcement of California's COVID-19 restrictions on private "gatherings" and various limitations on businesses as applied to appellants' in-home Bible studies, political activities, and business operations. The court concluded that appellants have not demonstrated a likelihood of success on the merits for their free exercise, due process, or equal protection claims, nor have they demonstrated that injunctive relief is necessary for their free speech claims.In regard to the free exercise claim, the court concluded that, when compared to analogous secular in-home private gatherings, the State's restrictions on in-home private religious gatherings are neutral and generally applicable and thus subject to rational basis review. The court believed that the best interpretation of Roman Catholic Diocese v. Cuomo, South Bay United Pentecostal Church v. Newsom, and Gateway City Church v. Newson is that rational basis review should apply to the State's gatherings restrictions because in-home secular and religious gatherings are treated the same, and because appellants' underinclusivity argument fails as they have not provided any support for the conclusion that private gatherings are comparable to commercial activities in public venues in terms of threats to public health or the safety measures that reasonably may be implemented. Therefore, appellants have not shown that gatherings in private homes and public businesses "similarly threaten the government's interest," and they have not shown that strict scrutiny applies.The court also denied as unnecessary appellants' request for an injunction on their free speech and assembly claims. Based on the district court's ruling, the State's gatherings restrictions do not apply to Appellant Tandon's requested political activities, and given the State's failure to define rallies or distinguish Tandon's political activities from Appellant Gannons' political activities, the court concluded that, on the record before it, the State's restrictions do not apply to the Gannons' political activities.Finally, the court concluded that the business owner appellants have not established a likelihood of success on their claims. The court has never held that the right to pursue work is a fundamental right and the district court did not err by applying rational basis review to the due process claims. Likewise, business owners are not a suspect class, and the district court correctly applied rational basis review to their equal protection claims. View "Tandon v. Newsom" on Justia Law

The Ninth Circuit vacated the district court's judgment in favor of defendant in an action brought by plaintiff, seeking injunctive relief under Title III of the Americans with Disabilities Act (ADA). Plaintiff, who survived years of abuse, obtained Aspen as a service dog to help her cope with her post-traumatic stress disorder (PTSD), dissociative identity disorder (DID), anxiety, and depression. Because enrolling in a full training course to provide Aspen with formal certification was not a viable option for plaintiff, she began self-training Aspen to perform specific tasks she thought would ameliorate her disability and decrease her isolation. In the underlying suit, plaintiff challenged Del Amo's practice of denying admission to Aspen as a violation of Title III of the ADA and California's Unruh Civil Rights Act.The panel held that the district court erred by effectively imposing a certification requirement for plaintiff's dog to be qualified as a service animal under the ADA. The panel held that the ADA prohibits certification requirements for qualifying service dogs for three reasons: (1) the ADA defines a service dog functionally, without reference to specific training requirements; (2) Department of Justice regulations, rulemaking commentary, and guidance have consistently rejected a formal certification requirement; and (3) allowing a person with a disability to self-train a service animal furthers the stated goals of the ADA, for other training could be prohibitively expensive. The panel remanded for the district court to reconsider whether Aspen was a qualified service dog at the time of trial, and if Aspen is a service dog, whether Del Amo has proved its affirmative defense of fundamental alteration. View "C. L. v. Del Amo Hospital, Inc." on Justia Law

Shortly after COVID-19 struck the Wallace Pack Unit, plaintiffs filed suit seeking injunctive relief on behalf of three certified classes of inmate for violations of the Eighth Amendment, the Americans with Disabilities Act (ADA), and the Rehabilitation Act. Specifically, plaintiffs alleged that defendants acted with deliberate indifference to their health and safety in violation of the Eighth Amendment in light of the dangers of COVID-19 for a geriatric prison population, and that defendants violated the ADA and Rehabilitation Act by failing to accommodate for specific risks to wheelchair-bound and other mobility-impaired inmates.On April 16, 2020, the district court entered a preliminary injunction which was stayed by the Fifth Circuit on April 22 and then vacated on June 5. On September 29, 2020, the district court issued a permanent injunction, concluding that plaintiffs did not need to exhaust administrative remedies; defendants were deliberately indifferent; and defendants violated the ADA and the Rehabilitation Act.The Fifth Circuit reversed the district court's permanent injunction and rendered judgment for defendants. The court concluded that the prison officials were not deliberately indifferent based on a lack of a systemic approach. After considering Policy B-14.52, its unwritten additions, and its administration, the court explained that the record does not support a finding of deliberate indifference in the way the officials considered and adopted a response to COVID-19. The court also concluded that the prison officials were not deliberately indifferent based on a failure to abide by basic public health guidance regarding testing, social distancing, mask use, handwashing, sanitation, and cleaning. Finally, the court concluded that the mobility-impaired inmates failed to establish their prima facie ADA claim, and consequently their Rehabilitation Act claim. View "Valentine v. Collier" on Justia Law

The Supreme Court affirmed in part and dismissed part the judgment of the district court denying summary judgment in favor of the Wyoming State Hospital on Plaintiffs' claims asserting various claims of negligence under the Wyoming governmental Claims Act, Wyo. Stat. Ann. 1-39-101 - 120, holding that section 1-30-110's waiver of governmental immunity is not limited to medical malpractice claims.In denying the Hospital's motion for summary judgment, the district court concluded (1) the Hospital had waived its immunity under section 1-39-110, and (2) genuine issues of material fact precluded summary judgment. The Supreme Court affirmed in part and dismissed in part, holding (1) because it did not involve the purely legal issue of whether the Hospital was immune from suit under the Claims Act, the Hospital's appeal with respect to section 1-39-118 and proximate cause is dismissed for lack of jurisdiction; and (2) the district court did not err in concluding that the Hospital had waived its immunity under section 1-39-110. View "Wyoming State Hospital v. Romine" on Justia Law