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

Several plaintiffs, including United States Sugar Corporation, Okeelanta Corporation, and Sugar Cane Growers Cooperative of Florida, challenged the United States Army Corps of Engineers' approval of the Everglades Agricultural Area Project (EAA Project). The plaintiffs argued that the Corps violated the Administrative Procedure Act by using the wrong water supply baseline in its Savings Clause analysis and by failing to conduct a separate analysis for the standalone operation of the storm water treatment area (STA). They also claimed that the Corps violated the National Environmental Policy Act (NEPA) by not evaluating the effects of the standalone STA operation in its Environmental Impact Statement (EIS).The Southern District of Florida granted summary judgment in favor of the Corps. The district court held that the Corps did not violate the Savings Clause by using the LORS 2008 baseline instead of the year 2000 baseline, as the water supply loss reflected in LORS 2008 was due to structural integrity issues with the Herbert Hoover Dike, not an implementation of the Plan. The court also found that the Corps' decision to use LORS 2008 was reasonable and that the plaintiffs had standing to bring their claims.The United States Court of Appeals for the Eleventh Circuit affirmed the district court's decision on the plaintiffs' first claim, agreeing that the Corps did not violate the Savings Clause. The court also affirmed the district court's decision on the plaintiffs' third claim, holding that the Corps did not violate NEPA by failing to include the standalone STA operation in its EIS, as the standalone STA had independent utility and could be evaluated in a supplemental EIS.However, the Eleventh Circuit reversed the district court's decision on the plaintiffs' second claim, finding that it was not ripe for review because the Corps had not made a final decision authorizing the standalone operation of the STA. The court remanded the case with instructions to dismiss the second claim for lack of finality and ripeness. View "United States Sugar Corp. v. Army Corps of Engineers" on Justia Law

The case involves the Organization of Professional Aviculturists, Inc. and the Lineolated Parakeet Society, who sought to import two captive-bred parrot species, the Cactus conure and the green form of the Lineolated parakeet, from certain European countries. The Wild Exotic Bird Conservation Act of 1992 prohibits the importation of these species unless they are added to a list of approved species. The plaintiffs petitioned the U.S. Fish and Wildlife Service to add these species to the list but only those bred in specific European countries. The Service denied the petitions, stating that the Act and its regulations do not allow for species to be approved on a country-by-country basis.The plaintiffs then filed a lawsuit, arguing that the Service's denial violated the Act and the Administrative Procedure Act (APA). The U.S. District Court for the Southern District of Florida dismissed the claims with prejudice, reasoning that the Act requires the Service to consider species as a whole, not on a country-by-country basis. The court found that this interpretation aligned with the agency's long-standing interpretation and the statute's structure.The United States Court of Appeals for the Eleventh Circuit reviewed the case and affirmed the district court's judgment. The appellate court held that the text, structure, and purpose of the Act require the Service to determine whether to exempt a species as a whole from the importation moratorium, not on a country-by-country basis. The court found that the Act's language and structure, including the requirement to consider regulatory and enforcement mechanisms in all countries of origin, support this interpretation. The court also noted that the Service's consistent interpretation since 1994 further supports this conclusion. Therefore, the Service's denial of the petitions did not violate the APA. The judgment of the district court was affirmed. View "Organization of Professional Aviculturists, Inc. v. U.S. Fish and Wildlife Service" on Justia Law

Gray Television, a broadcaster in Alaska, sought review of a final forfeiture order by the Federal Communications Commission (FCC). The FCC had imposed the maximum forfeiture penalty on Gray for violating the prohibition on owning two top-four stations in a single designated market area (DMA). Gray acquired the CBS network affiliation of KTVA-TV for its own station, KYES-TV, which resulted in Gray owning two top-four stations in the Anchorage DMA. Gray did not seek a waiver from the FCC for this transaction.The FCC issued a Notice of Apparent Liability for Forfeiture (NAL) against Gray, proposing a penalty of $518,283, the statutory maximum. Gray responded, arguing that the transaction did not violate the rule because KYES was already a top-four station according to Comscore ratings data. Gray also contended that the FCC failed to provide fair notice of its interpretation of the rule and that the enforcement action violated the First Amendment and the Communications Act.The United States Court of Appeals for the Eleventh Circuit reviewed the case. The court affirmed the FCC's determination that Gray violated the rule, finding that the FCC reasonably relied on Nielsen ratings data, which showed that KYES was not a top-four station at the time of the transaction. The court also held that the FCC's interpretation of the rule was reasonable and that Gray had fair notice of the rule's application to its transaction.However, the court vacated the forfeiture penalty and remanded for further proceedings. The court found that the FCC failed to provide adequate notice to Gray that the proposed penalty was based on a finding of egregiousness, which violated due process. Additionally, the court held that the FCC did not adequately explain its consideration of Gray's good faith in determining the penalty amount. View "Gray Television, Inc. v. Federal Communications Commission" 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

Tim Daniels, a commercial fisherman in Florida, challenged the constitutionality of regulations by Florida’s Fish and Wildlife Conservation Commission (FWC) that restrict where and how Florida-registered vessels can harvest Florida pompano in federal waters. Daniels argued that federal law preempts state regulations affecting fishing in federal waters and that Florida’s regulations violate the Equal Protection Clause by only restricting Florida-registered vessels.The United States District Court for the Southern District of Florida granted summary judgment for the FWC, concluding that Florida’s regulations do not violate the Privileges and Immunities Clause, the Supremacy Clause, the Commerce Clause, or the Equal Protection Clause. The court also determined that Daniels lacked standing to sue.The United States Court of Appeals for the Eleventh Circuit reviewed the case and concluded that Daniels has standing to sue because he faces a credible threat of prosecution under Florida’s regulations, which affects his commercial fishing activities. The court found that Daniels’s injury is directly traceable to Florida’s regulations and can be redressed by a favorable judicial decision.On the merits, the Eleventh Circuit held that the Magnuson-Stevens Fishery Conservation and Management Act does not preempt Florida’s regulations. The court reasoned that the Act allows states to regulate fishing vessels registered under their laws in federal waters when there is no federal fishery management plan or regulations in place. The court also held that Florida’s regulations do not violate the Equal Protection Clause because they are rationally related to the legitimate governmental purpose of conserving and managing pompano stock, and the regulations only apply to Florida-registered vessels, which are within the state’s jurisdiction.The Eleventh Circuit affirmed the District Court’s decision, upholding Florida’s pompano regulations. View "Daniels v. Executive Director of the Florida Fish and Wildlife Conservation Commission" on Justia Law

Rhonda Fleming, an inmate at Federal Correctional Institution Tallahassee (FCIT), filed a pro se lawsuit against Warden Erica Strong and the United States, alleging Eighth Amendment violations due to her exposure to mold, asbestos, and COVID-19, which she claimed caused severe health issues. Fleming sought injunctive relief and damages under Bivens and the Federal Tort Claims Act (FTCA). She alleged that despite her complaints, the prison officials, including Warden Strong, failed to address the hazardous conditions, leading to her contracting COVID-19 twice and requiring hospitalization.The United States District Court for the Northern District of Florida partially granted and partially denied the defendants' motion to dismiss. The magistrate judge recommended dismissing most of Fleming's claims, including all claims against Strong, citing that Bivens did not provide a remedy for her Eighth Amendment claim. However, the district court disagreed, finding that Fleming's Eighth Amendment claim was similar to a previously recognized Bivens claim and allowed it to proceed. The district court did not address the issue of qualified immunity.The United States Court of Appeals for the Eleventh Circuit reviewed the case. The court had to determine whether it had jurisdiction to hear an interlocutory appeal from the district court's order recognizing a Bivens cause of action. The Eleventh Circuit joined four other circuits in holding that the collateral-order doctrine does not extend to Bivens-extension orders that do not address qualified immunity. The court emphasized that qualified immunity adequately protects government officials from the burdens of litigation and that separation-of-powers concerns with Bivens extensions do not justify immediate appeal. Consequently, the Eleventh Circuit dismissed the appeal for lack of jurisdiction. View "Fleming v. FCI Tallahassee Warden" on Justia Law

Kristie Williams, a former employee of the University of Alabama at Birmingham, requested leave under the Family and Medical Leave Act (FMLA) to care for her daughter, who was allegedly sexually assaulted while serving in the Marine Corps. The University approved her leave, but Williams claimed she continued to receive work-related communications and criticism from her supervisors during her leave. This led to her resignation, and she subsequently sued the University, alleging interference with her FMLA rights and retaliation.The United States District Court for the Northern District of Alabama denied the University’s motion to dismiss, which argued that the suit was barred by state sovereign immunity. The court reasoned that Williams might have been seeking family-care leave under the FMLA, for which the Supreme Court had previously held that Congress validly abrogated state sovereign immunity.The United States Court of Appeals for the Eleventh Circuit reviewed the case and affirmed the district court’s decision. The court held that Williams’s suit could proceed regardless of whether she sought family-care leave, active-duty leave, or servicemember-family leave. For family-care leave, the Supreme Court’s decision in Hibbs confirmed that Congress had abrogated state sovereign immunity. For active-duty and servicemember-family leave, the court concluded that Alabama waived its sovereign immunity under the plan-of-the-Convention doctrine when it joined the Union, as these provisions were enacted pursuant to Congress’s constitutional authority to raise and support the military. Thus, the Eleventh Circuit affirmed the district court’s denial of the University’s motion to dismiss and remanded the case for further proceedings. View "Williams v. Board of Trustees of The University of Alabama" on Justia Law