Justia Health Law Opinion SummariesArticles Posted in US Court of Appeals for the Eleventh Circuit
State of Florida v. Department of Health and Human Services
In November 2021, the Secretary of Health and Human Services issued an interim rule that requires facilities that provide health care to Medicare and Medicaid beneficiaries to ensure that their staff, unless exempt for medical or religious reasons, are fully vaccinated against COVID-19, 86 Fed. Reg. 61,555. Under the rule, covered staff must request an exemption or receive their first dose of a two-dose vaccine or a single-dose vaccine by December 6, 2021. Florida unsuccessfully sought a preliminary injunction to bar the interim rule’s enforcement.The Eleventh Circuit upheld the denial of the motion, first deciding not to apply the mootness doctrine and to exercise jurisdiction despite another district court’s issuance of a nationwide injunction. Florida failed to demonstrate a substantial likelihood that it will prevail on the merits, that it will suffer irreparable injury absent an injunction, or that the balance of the equities favors an injunction. The Secretary has express statutory authority to require facilities voluntarily participating in the Medicare or Medicaid programs to meet health and safety standards to protect patients. The Secretary provided a detailed explanation for why there was good cause for dispensing with the notice-and-comment requirement. Ample evidence supports the Secretary’s determination that facility staff vaccination will provide important protection for patients. View "State of Florida v. Department of Health and Human Services" on Justia Law
Callahan v. United Network for Organ Sharing
Liver-transplant candidates and transplant hospitals challenged HHS's adoption of a new policy for allocating donated livers. In 2019, the Eleventh Circuit held that the plaintiffs had not shown a substantial likelihood of success on the merits of their claim that the Secretary failed to follow procedures under 42 C.F.R. 121.4(b) during the new liver-allocation policy's development. Section 121.4(b) does not require the Secretary to refer the new liver allocation policy to an Advisory Committee on Organ Transplantation or to publish the new policy in the Federal Register for public comment. The court remanded for the district court to consider the remaining Administrative Procedure Act and Fifth Amendment claims.The district court ordered limited discovery on remand. The defendants ultimately produced requested communications between its top-level personnel and outside policymakers that, according to the plaintiffs, exposed “bad faith and improper behavior.” The district court ultimately excluded the documents from the administrative record for the APA claim, while noting that the documents included “colorable evidence of animosity and even some measure of regional bias.” The hospitals moved to unseal the documents. In 2021, the Eleventh Circuit affirmed an order unsealing the documents. The documents here are “plainly judicial records” and the appellants have not shown good cause to keep them sealed. View "Callahan v. United Network for Organ Sharing" on Justia Law
Turner v. Costa Crociere S.P.A.
Turner, a Wisconsin resident, filed a putative class action against Costa, an Italian cruise operator, and its American subsidiary, alleging that their negligence contributed to an outbreak of COVID-19 aboard the Costa Luminosa during his transatlantic voyage beginning on March 5, 2020. The Luminosa had evacuated a passenger, who subsequently died of COVID-19, from a cruise immediately preceding Turner’s cruise. Costa told passengers that the ship was safe. It did not hire any experts to verify that the ship had been sufficiently cleaned and allegedly failed to refuse boarding to individuals who had COVID-19 symptoms or had traveled to high-risk areas. On March 8, the Luminosa had docked to transport passengers with COVID-19 symptoms to the hospital but did not inform passengers of those circumstances, When passengers disembarked on March 19, 36 of the 75 passengers tested positive for COVID-19. The Eleventh Circuit affirmed the dismissal of Turner’s complaint on forum non conveniens grounds. Turner's passage ticket contract included a forum selection clause requiring that all claims associated with his cruise be litigated in Genoa, Italy. Forum selection clauses are presumptively valid and enforceable; Turner failed to defeat the presumption by showing that the clause was induced by fraud or overreaching, that he would be deprived of his day in court because of inconvenience or unfairness, the chosen law would deprive him of a remedy or enforcement of the clause would contravene public policy.’ View "Turner v. Costa Crociere S.P.A." on Justia Law
Smith v. Crisp Regional Hospital, Inc.
The Eleventh Circuit affirmed the district court's dismissal of the complaint brought by plaintiff, alleging that the Hospital's delay in transferring his son constitutes a violation of the Emergency Medical Treatment and Active Labor Act. The court concluded that there is no provision of the Act suggesting that Congress intended to impose time restrictions with respect to a hospital’s decision to transfer a patient to another hospital. The court explained that the only time restriction in the statute relates not to the transfer decision, but rather to the screening and stabilization requirements. Therefore, plaintiff's claim that the Hospital unreasonably delayed the transfer of his son does not state a claim of violation of the Act. The court noted that plaintiff's claim is the kind of claim contemplated by state medical malpractice laws. Finally, the court rejected plaintiff's contention that the Hospital's delay in transferring the child violated the Act's requirement of an "appropriate transfer." View "Smith v. Crisp Regional Hospital, Inc." on Justia Law
Hubbard v. Bayer Healthcare Pharmaceuticals Inc.
In 2012, 41-year-old Karen Hubbard suffered a catastrophic stroke caused by a blood clot to her brain--a venous sinus thrombosis, a type of venous thromboembolism (VTE). She had been taking Beyaz, a birth control pill manufactured by Bayer. While she first received a prescription for Beyaz on December 27, 2011, Karen had been taking similar Bayer birth control products since 2001. The pills are associated with an increased risk of blood clots. The Beyaz warning label in place at the time of Karen’s Beyaz prescription warned of a risk of VTEs and summarized studies.The Eleventh Circuit affirmed summary judgment in favor of Bayer. Georgia’s learned intermediary doctrine controls this diversity jurisdiction case. That doctrine imposes on prescription drug manufacturers a duty to adequately warn physicians, rather than patients, of the risks their products pose. A plaintiff claiming a manufacturer’s warning was inadequate bears the burden of establishing that an improved warning would have caused her doctor not to prescribe her the drug in question. The Hubbards have not met this burden. The prescribing physician testified unambiguously that even with the benefit of the most up-to-date risk information about Beyaz, he considers his decision to prescribe Beyaz to Karen to be sound and appropriate. View "Hubbard v. Bayer Healthcare Pharmaceuticals Inc." on Justia Law
MSP Recovery Claims, Series LLC v. Ace American Insurance Co.
Plaintiffs, collection agencies, appealed the district court's dismissals with prejudice of their claims against defendants, seeking double damages against defendants under the Medicare Secondary Payer Act and alleging that actors within the Medicare Advantage system, including Medicare Advantage Organizations (MAOs) and various "downstream actors" that contracted with MAOs, had assigned their Medicare Secondary Payer Act claims to plaintiffs for collection.The Eleventh Circuit vacated the dismissals of plaintiffs' claims based on assignments from downstream actors, holding that the district court erred by narrowly construing 42 U.S.C. 1395y(b)(3)(A) to categorically exclude claims by downstream actors. The court explained that both the text and the objective of section 1395y(b)(3)(A) support allowing downstream actors to bring suit, or assign their right to bring suit, against primary payers. Therefore, the court remanded these claims for further proceedings.The court found that the district court erred insofar as it dismissed MSPRC's HFAP claims with prejudice, and ordered that the district court's dismissal be without prejudice. The court also found that the district court erred in dismissing MSPA's FHCP and IMC claims based on the purported cancellation and validity of MSPA's assignments. Finally, defendants' alternative claims are without merit. The court vacated the dismissal of plaintiffs' remaining claims in case number 18-12149. In case number 18-13049, the court affirmed the dismissal of plaintiffs' claims but modified the dismissal of these claims to be without prejudice. View "MSP Recovery Claims, Series LLC v. Ace American Insurance Co." on Justia Law
Hoffer v. Secretary, Florida Department Corrections
Hepatitis C (HCV) is a bloodborne virus. Only about 1% of the general population suffers from HCV; its prevalence among prison inmates is much higher. HCV primarily attacks the liver, causing scarring, or “fibrosis,” which is measured from F0 (no fibrosis) to F4 (cirrhosis). Many people “spontaneously clear” HCV without treatment. HCV patients were previously prescribed weekly injections of Interferon, which caused unpleasant side effects, and succeeded in eradicating HCV only about 30% of the time. In 2013, a new HCV treatment became available—direct-acting antiviral (DAA) pills, with few side effects and a 95% cure rate. DAAs are very expensive.Chronic-HCV inmates incarcerated in Florida prisons filed a class action under 42 U.S.C. 1983, alleging deliberate indifference to inmates’ serious medical needs. Florida then hired Dr. Dewsnup, who had developed and implemented an HCV-treatment plan for the Oregon prison system. Florida adopted Dewsnup's proposal of providing DAAs for all inmates at level F2 and above and monitoring F0- and F1-level inmates and treating them with DAAs under certain circumstances. Ultimately, the court ordered DAA treatment of all F0s and F1s within two years of their initial staging. The Eleventh Circuit reversed. The state’s plan to monitor all HCV-positive inmates, including those who have not exhibited serious symptoms, and provide DAAs to anyone with an exacerbating condition, showing signs of rapid progression, or developing even moderate fibrosis, satisfies constitutional requirements. View "Hoffer v. Secretary, Florida Department Corrections" on Justia Law
SmileDirectClub, LLC v. Battle
SmileDirect filed suit against the Georgia Board of Dentistry, including the Board’s members in their individual capacities, alleging inter alia, antitrust, Equal Protection, and Due Process violations related to the amendment of Ga. Bd. of Dentistry R. 150-9-.02. On appeal, the Board members challenged the denial of their motion to dismiss the complaint with respect to the alleged antitrust violations.After determining that it does have appellate jurisdiction under the collateral order doctrine, the Eleventh Circuit affirmed, holding that, based on the facts alleged in SmileDirect's complaint, the Board members are not entitled to state-action immunity under Parker v. Brown, 317 U.S. 341 (1943), at this point in the litigation, and the district court properly denied their motion to dismiss. In this case, the Board members have failed to satisfy the Midcal test by failing to meet the "active supervision" prong of the test and both prongs are necessary to satisfy the test. Furthermore, the court rejected the Board members' argument that ipso facto state-action immunity is available merely because of the Governor's power and duty, and without regard to his actual exercise thereof. The court explained that the Board members have established no more than the mere potential for active supervision on the part of the Governor, and thus they have fallen far short of establishing that the amended rule was "in reality" the action of the Governor. View "SmileDirectClub, LLC v. Battle" on Justia Law
Patel v. Hamilton Medical Center, Inc.
After the Medical Center suspended plaintiff's medical privileges, plaintiff filed suit against the Medical Center, an injunction against the suspension, and a declaration that the Health Care Quality Improvement Act provided no immunity from damages to the Medical Center.The Eleventh Circuit vacated the district court's judgment and remanded with instructions to dismiss plaintiff's complaint for lack of subject matter jurisdiction. Plaintiff contends only that federal question jurisdiction exists over his suit, but a request for declaratory relief that a federal law does not entitle the opposing party to a defense ordinarily does not raise a federal question under 28 U.S.C.1331. The court explained that, because the Declaratory Judgment Act does not enlarge the court's jurisdiction, plaintiff must still assert an underlying ground for federal court jurisdiction. In this case, plaintiff's complaint does not establish that the Medical Center could file a coercive action under federal law. Furthermore, a plaintiff cannot create federal question jurisdiction by seeking a declaration that a federal defense does not protect the defendant. Therefore, plaintiff's request for declaratory judgment does not establish federal question jurisdiction. View "Patel v. Hamilton Medical Center, Inc." on Justia Law
MSP Recovery Claims, Series LLC v. QBE Holdings, Inc.
The Eleventh Circuit affirmed the district court's dismissal based on lack of standing of this action for damages under the Medicare Secondary Payer Act and remanded with instructions for the district court to dismiss the complaint with prejudice. The court held that the Addendum (but not the Nunc Pro Tunc Assignment) is impermissible parol evidence; although the Nunc Pro Tunc Assignment could create standing on the basis of retroactive assignment of claims, plaintiffs did not receive any rights under it; and the court declined to consider whether the Recovery Agreement by itself equitably assigned plaintiffs HFHP's rights under the Act because plaintiffs did not assert this argument before the district court. View "MSP Recovery Claims, Series LLC v. QBE Holdings, Inc." on Justia Law