Justia Health Law Opinion Summaries

In 2008, Santiago Alirio Gomez Rivera began working with co-conspirators in Latin America to obtain and transport cocaine for importation into the United States. Rafael Segundo Castro Diaz joined the conspiracy later, helping transport 1,200 kilos of cocaine in April 2013. The United States Coast Guard intercepted the boat carrying the cocaine, and the men aboard were arrested. Years later, a federal grand jury returned three indictments against Gomez Rivera and Castro Diaz, with the second superseding indictment expanding the conspiracy period from January 2008 to September 2013.The United States District Court for the Southern District of Florida denied the defendants' motions to dismiss the second superseding indictment, which they argued was untimely and broadened the original charges. The defendants then negotiated a stipulated bench trial, preserving their right to appeal the denial of their motions to dismiss. The district court adjudicated them guilty, but there were clerical errors in Castro Diaz's judgment documentation.The United States Court of Appeals for the Eleventh Circuit reviewed the case. The court held that a superseding indictment can satisfy the statute of limitations if it is independently timely or relates back to a timely prior indictment. The second superseding indictment was independently timely, as it was returned within five years of the alleged conspiracy period. The court also found sufficient evidence to support the convictions, as both defendants stipulated to facts indicating their involvement in the conspiracy until September 2013. The court affirmed the convictions and sentences but remanded for the correction of clerical errors in Castro Diaz's judgment. View "USA v. Santiago Alirio Gomez Rivera" on Justia Law

State Farm Mutual Automobile Insurance Company and others filed a lawsuit against Michael LaRocca and his associated chiropractic clinics, alleging that the clinics submitted fraudulent insurance claims for services that were not medically necessary. The clinics, owned by LaRocca, were operating under an exemption from Florida's Health Care Clinic Act, which requires clinics to be licensed unless they are wholly owned by licensed health care practitioners who are legally responsible for compliance with all federal and state laws.The United States District Court for the Middle District of Florida denied State Farm's motion for partial summary judgment, rejecting the argument that LaRocca's failure to ensure compliance with all laws invalidated the clinics' exemption and rendered their charges noncompensable. The court found that the term "legally responsible" did not impose an affirmative duty on LaRocca to ensure compliance with all laws but rather indicated accountability for violations.The United States Court of Appeals for the Eleventh Circuit reviewed the case and determined that the interpretation of "legally responsible" within the context of Florida's Health Care Clinic Act was a matter best decided by the Florida Supreme Court. The Eleventh Circuit certified the question to the Florida Supreme Court, seeking clarification on whether the term imposes an affirmative duty on clinic owners to ensure compliance with all federal and state laws to maintain their exemption status. The Eleventh Circuit deferred its decision pending the Florida Supreme Court's interpretation. View "State Farm Mutual Automobile Insurance Company v. LaRocca" on Justia Law

Detectives with the Fort Myers Police Department observed Alphonso Lataurean James engaging in suspected drug transactions at a gas station. James was seen wearing a cross-body bag, which he later took into a vehicle. After stopping the vehicle, detectives found the bag containing a handgun and ammunition. They also discovered drugs in the car, including fentanyl and cocaine. James admitted to possessing the bag but denied knowledge of the firearm. DNA testing linked James and others to the gun. James, a convicted felon, was charged with possession of a firearm by a convicted felon.The United States District Court for the Middle District of Florida sentenced James to ninety-two months in prison, applying a four-level enhancement under U.S.S.G. § 2K2.1(b)(6)(B) for possessing a firearm in connection with another felony offense. James objected, arguing that the enhancement was improperly applied based on the Sentencing Guidelines' commentary. The district court overruled his objections, finding that the firearm was in close proximity to the drugs, thus meeting the "in connection with" requirement.The United States Court of Appeals for the Eleventh Circuit reviewed the case. The court held that the phrase "in connection with" in U.S.S.G. § 2K2.1(b)(6)(B) is unambiguous and does not require deference to the Sentencing Guidelines' commentary. Despite the district court's error in relying on the commentary, the appellate court found that the district court's factual findings were sufficient to support the enhancement. The court affirmed James's sentence, concluding that he possessed the firearm in connection with drug trafficking. View "USA v. James" on Justia Law

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

The Eleventh Circuit reversed the grant of summary judgment to defendants on plaintiff's suit alleging unlawful discrimination because plaintiffs could not effectively communicate with hospital staff in the absence of auxiliary aids or services. The Eleventh Circuit held that plaintiffs had Article III standing to seek prospective injunctive relief; rejected the district court's substantive standard for liability; and concluded that for an effective-communication claim brought under the Americans with Disabilities Act (ADA), 42 U.S.C. 12101 et seq., and Section 504 of the Rehabilitation Act of 1973 (RA), 29 U.S.C. 794, there is no requirement that a plaintiff show actual deficient treatment or to recount exactly what plaintiff did not understand. Rather, the relevant inquiry is whether the hospitals' failure to offer an appropriate auxiliary aid impaired the patient's ability to exchange medically relevant information with hospital staff. In this case, plaintiffs have offered sufficient evidence to survive summary judgment where the record demonstrated that plaintiffs' ability to exchange medically relevant information was impaired. On remand, the district court was directed to consider the deliberate-indifference issue in regards to monetary damages. View "Silva v. Baptist Health South Florida" on Justia Law

The seven consolidated cases in this appeal all involve attempts by assignees of a health maintenance organization (HMO) to recover conditional payments via the Medicare Secondary Payer Act's (MSP Act), 42 U.S.C. 1395y(b)(2)(B)(ii), (b)(3)(A), private cause of action. At issue is whether a contractual obligation, without more (specifically, without a judgment or settlement agreement from a separate proceeding), can satisfy the “demonstrated responsibility” requirement of the private cause of action provided for by the MSP Act. The court held that a plaintiff suing a primary plan under the private cause of action in the MSP Act may satisfy the demonstrated responsibility prerequisite by alleging the existence of a contractual obligation to pay. A judgment or settlement from a separate proceeding is not necessary. Therefore, the court vacated the district courts' judgments and remanded for further proceedings. View "MSP Recovery LLC v. AllState Ins. Co." on Justia Law

Humana filed suit against Western, alleging claims for double damages pursuant to the Medicare Secondary Payer Act (MSP), 42 U.S.C. 1395y(b)(3)(A), private cause of action and for a declaratory judgment regarding Western’s obligation to reimburse Humana for Medicare benefits that Humana paid on behalf of its Medicare Advantage plan enrollee. The district court granted summary judgment to Humana. At issue, as a matter of first impression, is whether the MSP private cause of action permits a Medicare Advantage Organization (MAO) to sue a primary payer that refuses to reimburse the MAO for a secondary payment. The court joined the Third Circuit and held that an MAO may sue a primary payer under the MSP private cause of action. Accordingly, the court affirmed the judgment. View "Humana Medical Plan v. Western Heritage Ins. Co." on Justia Law