Justia U.S. 9th Circuit Court of Appeals Opinion Summaries

The FDA issued marketing denial orders for Petitioners’ flavored products, finding that Petitioners’ applications lacked sufficient evidence showing that their flavored products would provide a benefit to adult use.   The Ninth Circuit denied petitions for review challenging the denial of Petitioners’ premarket tobacco product applications seeking FDA authorization to sell nicotine-containing e-liquids in the United States. The panel held that the text of the Family Smoking Prevention and Tobacco Control Act (the “Tobacco Control) Act”) plainly authorizes the FDA to require that manufacturers submit comparative health risk data, which necessarily includes comparisons of flavored e-liquids to tobacco-flavored e-liquids. The panel also held that the FDA did not arbitrarily or capriciously deny Petitioners’ applications and that any error the agency committed by failing to consider Petitioners’ marketing plans was harmless.   The panel held that the FDA did not introduce a new evidentiary standard; rather, it consistently required evidence that evaluated the impacts of flavored versus non-flavored products on initiation and cessation. Further,the panel concluded that, even if the agency erred by failing to consider Petitioners’ marketing plans, any error was harmless, and it would not remand on this basis. Finally, the panel addressed Petitioners’ post-argument motions to supplement the administrative record and file supplemental briefing, seeking judicial notice of a premarket tobacco product application deficiency letter, FDA internal memoranda, and FDA press releases. View "NUDE NICOTINE INC. V. FDA" on Justia Law

The Federally Supported Health Centers Assistance Act (“FSHCAA”) provides that health centers receiving funding under Section 330 of the Public Health Service Act (“PHSA”) may be deemed Public Health Service (“PHS”) employees. Plaintiffs alleged that Defendants violated their duty to report a court-ordered Lane County Mental Health patient’s refusal to comply with the terms of his probation. Plaintiffs alleged they were injured as a result of Defendants’ failure to report a patient’s repeated failures to comply with his mental health treatment plan. Defendants contended that they were entitled to Section 233 immunity. The district court held that Section 233 immunity did not apply to Defendants and remanded to state court.   The Ninth Circuit reversed the district court’s order remanding to state court Plaintiffs’ action alleging negligence and wrongful death claims against federally funded community health centers and their employees (“Defendants”), and remanded to the district court to enter an order substituting the United States as the defendant and deeming the action as one brought under the Federal Tort Claims Act. The panel first addressed whether there was jurisdiction to review the district court’s remand order. Ordinarily, a remand order is not reviewable on appeal, except for cases removed pursuant to 28 U.S.C. Section 1442. The panel agreed with Defendants that Section 233 immunity did not turn on who brings the claim, but rather on whether the conduct giving rose to the claim arose out of the Defendants’ performance of “medical, surgical, dental or related functions.” View "SAM FRIEDENBERG, ET AL V. LANE COUNTY, ET AL" on Justia Law

President Biden invoked his authority under the Federal Property and Administrative Services Act of 1949 (“Procurement Act”) to direct federal agencies to include in certain contracts a clause requiring covered contractor employees to follow COVID-19 safety protocols, including vaccination requirements, in order for employees to be eligible to work on federal government projects. Plaintiffs sued to enjoin the vaccination mandate. This lawsuit revolved around four documents that comprise the Contractor Mandate: the Executive Order, the Task Force Guidance, the Office of Management and Budget Determination, and the Federal Acquisition Regulatory Council Guidance. The district court granted a permanent injunction against the Contractor Mandate, effective in any contract that either involved a party domiciled or headquartered in Arizona and/or was performed “principally” in Arizona.   The Ninth Circuit reversed the district court’s order granting a permanent injunction and dissolved the injunction. First, the panel held the Major Questions Doctrine—which requires that Congress speak clearly if it wishes to assign to an agency decisions of vast economic and political significance—did not apply. Second, the panel held that even if the Major Questions Doctrine applied, it would not bar the Contractor Mandate because the Mandate is not a transformative expansion of the President’s authority under the Procurement Act. Third, the panel held that the Contractor Mandate fell within the President’s authority under the Procurement Act. Fourth, the panel held that the nondelegation doctrine and state sovereignty concerns did not invalidate the Contractor Mandate. Finally, the panel held that the Contractor Mandate satisfied the Office of Federal Procurement Policy Act’s procedural requirements. View "KRISTIN MAYES, ET AL V. JOSEPH BIDEN, ET AL" on Justia Law

This case involved a Washington licensing scheme that disciplines healthcare providers for practicing conversion therapy on minors. The 9th Circuit denied a petition for rehearing en banc.Judge O'Scannlain, joined by Judges Ikuta, Nelson and Vandyke, issued a statement respecting from the court's decision to deny rehearing en banc because the decision correctly applied existing precedent. However, Judge Scannlain noted that the court should have used this case as an opportunity to resolve a circuit split and to "clarify that regulation of the medical profession is not a First-Amendment-free zone."Dissenting from the denial of rehearing en banc, Judge Bumatay wrote that because the speech underpinning conversion therapy is overwhelmingly—if not exclusively— religious, the court should have granted Plaintiff's petition for en banc review to evaluate his Free Speech claim under a more exacting standard. View "BRIAN TINGLEY V. ROBERT FERGUSON, ET AL" on Justia Law

The Washington State Health Care Authority (“HCA”) and the Swinomish Indian Tribal Community petition for review of a Center for Medicare and Medicaid Services (“CMS”) decision denying Washington’s request to amend Apple Health, the Washington State Medicaid plan (the “State Plan”). HCA petitioned CMS to amend the State Plan to include dental health aide therapists (“DHATs”) on the list of licensed providers who can be reimbursed through Medicaid. CMS rejected the Amended State Plan on the basis that it violates the Medicaid free choice of providers statute and regulation guaranteeing all Medicaid beneficiaries equal access to qualified healthcare professionals willing to treat them. Petitioners challenged this denial.   The Ninth Circuit granted the petition of review. The panel rejected CMS’s reasoning on the ground that the underlying Washington statute—Wash. Rev. Code Section 70.350.020—did not violate Section 1396(a)(23) because it merely authorized where and how DHATs can practice and did not in any way restrict Medicaid recipients’ ability to obtain service from DHATs relative to non-Medicaid recipients. CMS’s rejection of the Amended State Plan was “not in accordance with law.” 5 U.S.C. Section 706(2)(A). Accordingly, the panel granted the petition for review and remanded to the agency with instructions to approve the Amended State Plan. View "WASHINGTON STATE HEALTH CARE A, ET AL V. CENTERS FOR MEDICARE & MEDICAI, ET AL" on Justia Law

Nexus Pharmaceuticals, Inc. (Nexus) developed the trademarked and FDA-approved drug Emerphed, ready-to-use ephedrine sulfate in a vial. Drug compounding by “outsourcing facilities” is permitted without FDA approval, but 21 U.S.C. Section  353b, a part of the Food, Drug, and Cosmetic Act, excludes from this exception compounded drugs that are “essentially a copy of one or more approved drugs.” To avoid the Act’s bar on private enforcement, Nexus alleged violation of state laws that prohibit the sale of drugs not approved by the FDA.   The Ninth Circuit affirmed the district court’s dismissal, for failure to state a claim, of state law claims brought by Nexus against Central Admixture Pharmacy Services, Inc., operator of a network of compounding pharmacies that sold the drug ephedrine sulfate pre-loaded into ready-to-use syringes without FDA approval.   The panel affirmed the district court’s conclusion that, under the implied preemption doctrine, Nexus’s state law claims were barred because they were contrary to the Food, Drug, and Cosmetic Act’s exclusive enforcement provision, which states that proceedings to enforce or restrain violations of the Act, including the compounding statute, must be by and in the name of the United States, not a private party. The panel held that all of Nexus’s claims depended on a determination of whether Central Admixture’s ephedrine sulphate was “essentially a copy” of Nexus’s Emerphed, and the plain text of the Food, Drug, and Cosmetic Act left that determination in the first instance to the FDA and its enforcement process. View "NEXUS PHARMACEUTICALS, INC. V. CAPS, ET AL" on Justia Law

Plaintiffs are a married couple who have each been deaf since early childhood. They appealed the district court’s judgment, entered following a three-day bench trial, on their claims under (1) the Americans with Disabilities Act (ADA), (2) Section 504 of the Rehabilitation Act (Section 504), (3) Section 1557 of the Affordable Care Act (ACA), and (4) California’s Unruh Civil Rights Act (Unruh Act) against Defendant Doctors Medical Center of Modesto, Inc. (DMC), an acute care hospital. Plaintiffs alleged that DMC failed to afford them effective communication during a series of hospital stays between 2015 and 2017.   The Ninth Circuit affirmed the district court’s judgment, after a bench trial, in favor of Defendants. The panel affirmed the district court’s dismissal as moot of plaintiffs’ ADA claims for injunctive relief.   As to the Section 504 Rehabilitation Act claims, the panel held that the district court properly ruled that Plaintiffs failed to show that they were denied program benefits on the basis of their disabilities because they did not show that the hospital failed in its affirmative obligation to provide the auxiliary aids necessary to afford them effective communication. The panel held that the district court did not err by failing to apply “primary consideration,” an ADA Title II rule, to the Section 504 claims, because there is no evidence that Section 504 contains an implicit requirement that a covered entity give primary consideration to the requests of the individual with disabilities when determining what types of auxiliary aids to use. Because Plaintiffs did not establish that the hospital engaged in any disability discrimination, their California Unruh Act claims also failed. View "MARK BAX, ET AL V. DOCTORS MED. CTR. OF MODESTO, ET AL" on Justia Law

The Ninth Circuit reversed in part and vacated in part the district court’s grant of Defendants’ motion to dismiss, and remanded for further proceedings, in an action in which federally-qualified health centers operating in Arizona and their membership organization alleged that the Arizona Health Care Cost Containment System, which administers Arizona’s Medicaid program, and its director violated 42 U.S.C. Section 1396a(bb) and binding Ninth Circuit precedent by failing or refusing to reimburse Plaintiffs for the services of dentists, podiatrists, optometrists, and chiropractors.   First, the panel held that the court’s precedent in California Ass’n of Rural Health Clinics v. Douglas (“Douglas”), 738 F.3d 1007 (9th Cir. 2013), established that FQHC services are a mandatory benefit under Section 1396d(a)(2)(C) for which Plaintiffs have a right to reimbursement under Section 1396a(bb) that is enforceable under 42 U.S.C. Section 1983. The panel rejected Defendants’ interpretation of Section 1396d(a)(2)(C)’s phrase “which are otherwise included in the plan” as applying to both the phrases “FQHC services” and “other ambulatory services offered by a [FQHC.]” The panel, therefore, rejected Defendants’ assertion that Section 1396d(a)(2)(C) only required states to cover FQHC services that are included in the state Medicaid plan.   The panel recognized that Douglas held that the mandatory benefit of “FQHC services” under § 1396d(a)(2)(C) includes “services furnished by . . . dentists, podiatrists, optometrists, and chiropractors” as well as doctors of medicine and osteopathy. The panel held that Arizona’s categorical exclusion of adult chiropractic services violated the unambiguous text of the Medicaid Act as interpreted in Douglas. View "AACHC V. AHCCCS" on Justia Law

Plaintiff alleged that Defendants Kinetic Concepts, Inc., and its indirect subsidiary KCI USA, Inc. (collectively, “KCI”) submitted claims to Medicare in which KCI falsely certified compliance with certain criteria governing Medicare payment for the use of KCI’s medical device for treating wounds. The district court granted summary judgment to KCI, concluding that Plaintiff failed to establish a genuine issue of material fact as to the False Claims Act elements of materiality and scienter.   The Ninth Circuit reversed the district court’s summary judgment. The court agreed that compliance with the specific criterion that there be no stalled cycle would not be material if, upon case-specific review, the Government routinely paid stalled-cycle claims. In other words, if stalled-cycle claims were consistently paid when subject to case-specific scrutiny, then a false statement that avoided that scrutiny and instead resulted in automatic payment would not be material to the payment decision. The court concluded, however, that the record did not show this to be the case. The court considered administrative rulings concerning claims that were initially denied, post-payment and pre-payment audits of particular claims, and a 2007 report by the Office of Inspector General of the U.S. Department of Health and Human Services. The court concluded that none of these forms of evidence supported the district court’s summary judgment ruling.   The court held that the district court further erred in ruling that there was insufficient evidence that KCI acted with the requisite scienter and that the remainder of the district court’s reasoning concerning scienter rested on a clear failure to view the evidence in the light most favorable to Plaintiff. View "STEVEN HARTPENCE V. KINETIC CONCEPTS, INC." on Justia Law

Plaintiff filed a lawsuit alleging state law claims arising from SelectHealth’s administration of her deceased husband’s MA plan and his death. Under Part C of the Medicare Act, beneficiaries can enroll in an MA plan and receive Medicare benefits through private MA organizations instead of the government. SelectHealth removed the action to federal court on the basis of diversity jurisdiction.   The Ninth Circuit affirmed the district court’s summary judgment in favor of SelectHealth, Inc. because the Medicare Act’s express preemption provision, 42 U.S.C. Section 1395w-26(b)(3), barred Plaintiff’s state law claims.   The court held that Section 1872 of Title XVIII of the SSA provides that Section 205(h) is applicable to cases under the Medicare Act to the same extent as in cases under Title II. The court concluded that enrollees in an MA plan must likewise first exhaust their administrative remedies before seeking judicial review of a claim for benefits.   Next, the court concluded that Plaintiff’s claims were not subject to the SSA’s exhaustion requirement because the dispute was not whether Plaintiff’s husband received a favorable outcome from the internal benefits determination process but rather whether he should have received the services earlier.   Further, the court held that Plaintiff’s claim that SelectHealth breached a duty to process timely her husband’s October 7, 2016, appeal was expressly preempted. Because the standards established under Part C supersede any state law duty that would impose obligations of MA plans on the same subject. View "NAOMI AYLWARD V. SELECTHEALTH, INC." on Justia Law