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

Bidi Vapor LLC filed a premarket tobacco product application (PMTA) with the U.S. Food and Drug Administration (FDA) in 2020 for its tobacco-flavored electronic nicotine delivery system (ENDS) product, the Bidi Stick – Classic. The FDA identified several deficiencies in the application, and despite Bidi Vapor submitting supplemental information, the FDA found the evidence insufficient. On January 22, 2024, the FDA issued a Marketing Denial Order (MDO) based on three independent grounds: high abuse liability of the product, incomplete study on leachable compounds, and lack of adequate comparison data on harmful constituents. This order prevented Bidi Vapor from marketing the Bidi Classic.Bidi Vapor appealed the FDA’s decision, arguing that the FDA violated the Tobacco Control Act and the Administrative Procedure Act, and acted in an arbitrary and capricious manner. The company contended that the FDA failed to conduct a balanced analysis of the product’s benefits and deficiencies, imposed product standards without proper rulemaking, and did not conduct a second cycle of toxicological review.The United States Court of Appeals for the Eleventh Circuit reviewed the case. The court held that the FDA’s decision was reasonable and not arbitrary or capricious. The court found that the FDA had appropriately considered the relevant data and provided a satisfactory explanation for its actions, particularly regarding the high abuse liability of the Bidi Classic. The court noted that this deficiency alone was sufficient to support the MDO, and therefore did not address the other two grounds. The court denied Bidi Vapor’s petition for review, upholding the FDA’s Marketing Denial Order. View "Bidi Vapor LLC v. Food and Drug Administration" on Justia Law

Jaime Vargas and Francis R. Alvarez, former employees of medical supplier Lincare, Inc., and its subsidiary Optigen, Inc., filed a qui tam complaint under the False Claims Act (FCA). They alleged that Optigen engaged in fraudulent practices, including systematic upcoding of durable medical equipment, improper kickback arrangements, waiver of co-pays, and shipment of unordered supplies. The relators claimed that Optigen billed CPAP batteries and accessories under codes designated for ventilator accessories, waived patient co-pays without assessing financial hardship, shipped CPAP supplies automatically without patient requests, and paid kickbacks to healthcare providers for referrals.The case was initially filed in the Eastern District of Virginia and later transferred to the Middle District of Florida. The United States declined to intervene, and the District Court unsealed the complaint. The relators filed multiple amended complaints, each of which was dismissed by the District Court for failing to meet the heightened pleading standard of Federal Rule of Civil Procedure 9(b). The District Court dismissed the fourth amended complaint, holding that it still failed to plead sufficient facts with the requisite specificity.The United States Court of Appeals for the Eleventh Circuit reviewed the case. The court affirmed the District Court's dismissal of the relators' claims regarding improper kickback arrangements, waiver of co-pays, and automatic shipment of supplies, finding that these allegations lacked the necessary specificity and failed to identify any actual false claims submitted to the government. However, the court reversed the dismissal of the upcoding claim, holding that the relators had pleaded sufficient facts with particularity to withstand a motion to dismiss. The court remanded the case for further proceedings limited to the upcoding issue. View "Vargas v. Lincare, Inc." on Justia Law

Dr. Jeffery D. Milner, a physician, brought a qui tam action under the False Claims Act (FCA) against Baptist Health Montgomery, Prattville Baptist, and Team Health. Milner alleged that while working at a hospital owned by the defendants, he discovered that they were overprescribing opioids and fraudulently billing the government for them. He claimed that he was terminated in retaliation for whistleblowing after reporting the overprescription practices to his superiors.Previously, Milner filed an FCA retaliation lawsuit against the same defendants in the U.S. District Court for the Northern District of Alabama, which was dismissed with prejudice for failure to state a claim. The court found that Milner did not sufficiently allege that he engaged in protected conduct under the FCA or that his termination was due to such conduct. Following this dismissal, Milner filed the current qui tam action in the U.S. District Court for the Middle District of Alabama. The district court dismissed this action as barred by res judicata, relying on the Eleventh Circuit's decisions in Ragsdale v. Rubbermaid, Inc. and Shurick v. Boeing Co.The United States Court of Appeals for the Eleventh Circuit reviewed the case and affirmed the district court's dismissal. The court held that Milner's qui tam action was barred by res judicata because it involved the same parties and the same cause of action as his earlier retaliation lawsuit. The court found that both lawsuits arose from a common nucleus of operative fact: the defendants' alleged illegal conduct and Milner's discovery of that conduct leading to his discharge. The court also noted that the United States, which did not intervene in the qui tam action, was not barred from pursuing its own action in the future. View "Milner v. Baptist Health Montgomery" on Justia Law

Michael Chapman, an Alabama inmate, sued prison officials and staff for deliberate indifference to his medical needs, violating the Eighth Amendment. Chapman alleged that an untreated ear infection led to severe injuries, including mastoiditis, a ruptured eardrum, and a brain abscess. He also claimed that the prison's refusal to perform cataract surgery on his right eye constituted deliberate indifference. The district court granted summary judgment for all defendants except the prison’s medical contractor, which had filed for bankruptcy.The United States District Court for the Middle District of Alabama found Chapman’s claim against nurse Charlie Waugh time-barred and ruled against Chapman on other claims, including his request for injunctive relief against Commissioner John Hamm, citing sovereign immunity. The court also concluded that Chapman’s claims against other defendants failed on the merits and dismissed his state-law claims without prejudice.The United States Court of Appeals for the Eleventh Circuit reviewed the case. The court reversed the district court’s determination that Chapman’s claim against Waugh was time-barred, finding that Chapman’s cause of action accrued within the limitations period. The court vacated the district court’s judgment for Waugh and remanded for reconsideration in light of the recent en banc decision in Wade, which clarified the standard for deliberate indifference claims. The court also vacated the judgment for Hamm on Chapman’s cataract-related claim for injunctive relief, as sovereign immunity does not bar such claims. Additionally, the court vacated the summary judgment for all other defendants due to procedural errors, including inadequate notice and time for Chapman to respond, and remanded for further consideration. View "Chapman v. Dunn" on Justia Law

Troy Olhausen, a former Senior Vice President of Business Development and Marketing at Arriva Medical, LLC, filed a qui tam action under the False Claims Act against his former employers, Arriva, Alere, Inc., and Abbott Laboratories, Inc. He alleged that the defendants submitted fraudulent claims to the Center for Medicare and Medicaid Services (CMS) for reimbursement. Specifically, Olhausen claimed that Arriva submitted claims without obtaining required assignment-of-benefits signatures and failed to disclose or accredit certain call-center locations that processed claims.The United States District Court for the Southern District of Florida dismissed Olhausen’s third amended complaint, holding that he failed to plead with the particularity required under Federal Rule of Civil Procedure 9(b) that any fraudulent claims were actually submitted to the government. The district court found that Olhausen did not provide sufficient details to establish that false claims had been submitted, as he did not work in the billing department and lacked firsthand knowledge of the claim submissions.On appeal, the United States Court of Appeals for the Eleventh Circuit reviewed the case. The court concluded that Olhausen adequately pled with particularity that allegedly false claims were submitted under Count II, which involved claims for heating pads that lacked assignment-of-benefits signatures. The court found that the internal audit allegations provided sufficient indicia of reliability to satisfy Rule 9(b). However, the court upheld the dismissal of Count IV, which alleged that Arriva failed to disclose or accredit certain call-center locations, as Olhausen did not adequately allege that any claims involving these locations were actually submitted. Consequently, the court vacated the dismissal of Counts II and VI (conspiracy) and remanded them for further proceedings, while affirming the dismissal of Count IV. View "Olhausen v. Arriva Medical, LLC" on Justia Law

The plaintiffs, co-personal representatives of the estate of Sara Schleider, filed a lawsuit in Florida state court against GVDB Operations, LLC, and JSMGV Management Company, LLC. They alleged that the defendants failed to prevent the spread of COVID-19 at their assisted living facility, resulting in Sara Schleider contracting the virus and subsequently dying. The plaintiffs asserted state-law claims for survival and wrongful death under Florida Statute § 429.28, alleging negligence and, alternatively, willful misconduct or gross negligence.The defendants removed the case to the United States District Court for the Southern District of Florida, claiming federal subject matter jurisdiction on three grounds: acting under a federal officer, complete preemption by the Public Readiness and Emergency Preparedness (PREP) Act, and an embedded federal question concerning the PREP Act. The district court concluded it lacked subject matter jurisdiction and remanded the case to state court, finding that the defendants' arguments did not establish federal jurisdiction.The United States Court of Appeals for the Eleventh Circuit reviewed the district court's decision. The appellate court affirmed the remand, holding that the defendants did not act under a federal officer, as their compliance with federal guidelines did not equate to acting under federal authority. The court also determined that the PREP Act did not completely preempt the plaintiffs' state-law claims, as the Act's willful misconduct provision did not wholly displace state-law causes of action for negligence. Lastly, the court found that the plaintiffs' claims did not raise a substantial federal question under the Grable doctrine, as the federal issues were not necessarily raised by the plaintiffs' well-pleaded complaint. Thus, the district court's remand to state court was affirmed. View "Howard Schleider v. GVDB Operations, LLC" on Justia Law

The case involves John Holland, William Moore, and Ed Cota, who were accused of participating in an illegal healthcare kickback scheme. The government alleged that Holland and Moore, hospital executives for Tenet Healthcare, paid the Cotas to refer Medicaid or Medicare-covered pregnant women to Tenet hospitals. The payments were purportedly disguised as contracts for translation services. Tracey Cota, Ed Cota's wife, pleaded guilty to violating the Anti-Kickback Statute (AKS) by participating in this scheme. However, the other defendants argued that their business relationship did not violate the AKS because they lacked the requisite mental state or mens rea.The United States District Court for the Northern District of Georgia held a pretrial "paper" hearing to determine the admissibility of out-of-court statements made by the defendants' alleged coconspirators. The district court concluded that the government needed to prove by a preponderance of the evidence that the defendants' conduct was illegal to admit the statements under Rule 801(d)(2)(E). The court found that the government failed to prove the defendants' knowledge of illegality and thus excluded the coconspirator statements.The United States Court of Appeals for the Eleventh Circuit reviewed the district court's decision. The appellate court held that the district court erred in requiring proof of an illegal conspiracy to admit coconspirator statements. The court clarified that under Rule 801(d)(2)(E), it is sufficient to show that the statements were made during and in furtherance of a joint venture, regardless of the venture's legality. The Eleventh Circuit reversed the district court's decision and remanded the case for further proceedings consistent with this opinion. View "United States v. Holland" on Justia Law

The case involves a class action lawsuit brought by several minor children, through their legal guardians, against the Commissioner of the Georgia Department of Community Health. The plaintiffs challenged the Department's practices regarding the provision of skilled nursing services under the Medicaid Act. Specifically, they contested the Department's use of a scoresheet to determine the number of skilled nursing hours and the practice of reducing those hours as caregivers learn to perform skilled tasks.The United States District Court for the Northern District of Georgia granted summary judgment in favor of the plaintiffs. The court ruled that the Department's review process did not give appropriate weight to the recommendations of treating physicians and that the practice of reducing skilled nursing hours as caregivers learn skilled tasks violated the Medicaid Act. The district court issued permanent injunctions requiring the Department to approve the skilled nursing hours prescribed by the patients' treating physicians.The United States Court of Appeals for the Eleventh Circuit reviewed the case and reversed the district court's decision. The appellate court held that the Department's review process, which includes the use of a scoresheet to determine a presumptive range of skilled nursing hours, complies with the Medicaid Act. The court also found that the practice of reducing skilled nursing hours as caregivers learn skilled tasks is reasonable and does not violate the Act. The court vacated the permanent injunctions and remanded the case for further proceedings. The appellate court did not address the plaintiffs' challenge regarding the consideration of caregiver capacity, as the district court had ruled that issue moot. The appeal of the preliminary injunctions was deemed moot following the vacatur of the permanent injunctions. View "M.H. v. Commissioner, Georgia Dept. of Community Health" on Justia Law

Elizabeth Peters Young was convicted of conspiring to pay and receive kickbacks from federal reimbursements for medical creams and lotions dispensed by pharmacies she worked with. The district court sentenced her to 57 months in prison and ordered her to pay $1.5 million in restitution and forfeiture, representing the gross proceeds she controlled during the conspiracy.The United States District Court for the Southern District of Florida initially reviewed the case. Young challenged her conviction, restitution order, and forfeiture judgment, arguing insufficient evidence for her conspiracy conviction, improper calculation of restitution, and errors in the forfeiture amount. The district court denied her motion to set aside the verdict and sentenced her, including the contested financial penalties.The United States Court of Appeals for the Eleventh Circuit reviewed the case. The court affirmed Young’s conspiracy conviction, finding sufficient evidence that she conspired with others, including a pharmacy, to receive kickbacks. The court also upheld the forfeiture judgment, ruling that Young was liable for the gross proceeds she controlled, even if she distributed some to co-conspirators. However, the court vacated the restitution order, agreeing with Young that the government did not prove the amount of loss it experienced due to her conduct. The court remanded the case for further proceedings to determine the correct restitution amount. View "USA v. Young" on Justia Law

The case revolves around an employment discrimination suit filed by Dr. Tara Loux against her former employers, BayCare Medical Group and St. Joseph’s Hospital. Dr. Loux sought to discover BayCare’s internal documents about the performance of other doctors who were not fired despite also committing errors. BayCare objected to disclosing certain documents, such as its “quality files” and “referral logs,” arguing that they were privileged under the Patient Safety and Quality Improvement Act of 2005. The Act creates a statutory privilege for work product prepared for or reported to patient safety organizations.The district court ordered BayCare to produce the disputed documents, concluding that the Act does not privilege documents if they have a “dual purpose,” only one of which relates to making reports to a patient safety organization. The court held that these documents were not privileged because BayCare used information in the documents for other purposes, such as internal safety analysis and peer review.The United States Court of Appeals for the Eleventh Circuit disagreed with the district court's interpretation of the Act. The appellate court found that the district court had applied an incorrect "sole purpose" standard to assess whether BayCare’s quality files and referral logs fell under the privilege. The court held that the Act does not require that privileged information be kept solely for provision to a Patient Safety Organization. The court granted BayCare's petition for a writ of mandamus, directing the district court to vacate its orders compelling the disclosure of the privileged documents and reconsider BayCare’s assertion of privilege consistent with the appellate court's opinion. View "In re: Baycare Medical Group, Inc." on Justia Law