Justia U.S. 11th Circuit Court of Appeals Opinion Summaries

Articles Posted in Health Law
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Defendant was convicted of conspiracy and substantive health care fraud for fraudulently billing Medicare and Medicaid for millions of dollars for visits to nursing home patients that he never made. He challenged the convictions, sentence, restitution amount, and forfeiture amount on appeal. In an April 12, 2022 opinion, the Eleventh Circuit affirmed Defendant's convictions and sentence.Following the court's initial opinion, Defendant filed a petition for rehearing en banc. The Eleventh Circuit considered Defendant's petition as a petition for a panel rehearing. The court granted Defendant's petition, vacated its previous opinion and issued a revised opinion that did not change the court's judgment or Defendant's sentence. Defendant was given 21 days to file a supplemental brief. View "USA v. Douglas Moss" on Justia Law

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Relators brought qui tam claims against dozens of defendants alleging healthcare fraud against the federal government in April 2017. H.I.G. Capital, LLC and H.I.G. Surgery Centers, LLC (“H.I.G.”) were among the defendants. Plaintiffs amended their complaint in January 2019.Previously, another group of relators filed qui tam claims against several of the same defendants; however, they did not name H.I.G. in their initial complaint. The federal government intervened, resulting in a $41 million settlement which included the defendants and both sets of relators. The settlement agreement released H.I.G. insofar as any independent conduct outside their status as investors in or owners of the defendants included in the settlement. Relators then amended their complaint a second time, narrowing their allegations to focus only on H.I.G.The district court granted H.I.G.’s motion to dismiss based on the first-to-file rule. The district court determined that, because the settled claim was pending at the time Relators filed their initial complaint, Relators’ complaint was barred if the actions were related. The district court found the cases were related and dismissed Relators’ claims.The Eleventh Circuit affirmed. Relators filed their complaints while the action that was eventually settled was pending. Thus, Relators’ case must be dismissed if the actions were related. The court then adopted the “same material elements” test relied upon by other circuit courts. Finding that the two cases contained the same material elements of fraud, the court concluded the district court properly dismissed Relators’ claims. View "Sheldon Cho, et al v. H.I.G. Capital, LLC, et al" on Justia Law

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In this qui tam action, after the jury found that Pinellas violated the False Claims Act and that the United States sustained damages, the district court trebled the damages and imposed statutory minimum penalties of $1,177,000 ($5,500 for each of the 214 violations).The Eleventh Circuit affirmed in part and reversed in part. The court upheld the district court's admission of Exhibit 24 where Pinellas failed to argue that the admission of the evidence constituted plain error. The court concluded that there was sufficient evidence for the jury to have found that, had Medicare known of Pinellas's misrepresentations, it would not have paid the refiled reimbursement claims. Furthermore, viewed in the light most favorable to the verdict, the evidence on scienter is not overwhelmingly in favor of Pinellas. Therefore, the jury's decision stands. The court also upheld the jury's findings on damages where the court concluded that the proper measure of damages in this case is the difference between what the United States paid and what it would have paid had Pinellas' claims been truthful. The court rejected the remaining challenges to the jury's verdict. The court further concluded that the monetary award imposed does not violate the Excessive Fines Clause. Finally, the court dismissed Pinellas' appeal as to the allocation of the monetary award between Ms. Yates and the United States. View "Yates v. Pinellas Hematology & Oncology, P.A." on Justia Law

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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

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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

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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

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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

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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

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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

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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