Justia Health Law Opinion Summaries

A provider of air ambulance services transported a patient insured by a health maintenance organization, but the provider was not part of the insurer’s network. After the transport, the provider and insurer could not agree on the payment amount. The dispute was submitted to the Independent Dispute Resolution (IDR) process established by the federal No Surprises Act, which requires each party to submit a payment offer and supporting rationale to an arbitrator. The arbitrator, a certified IDR entity, selected the insurer’s lower payment offer. The provider alleged that the insurer had misrepresented its “Qualifying Payment Amount” (QPA) by submitting a lower QPA to the arbitrator than it had previously provided to the provider, and claimed this constituted fraud.The United States District Court for the Middle District of Florida dismissed the provider’s complaint, finding that judicial review of IDR awards is limited to the grounds set forth in the Federal Arbitration Act (FAA), and that the provider’s allegations did not meet the heightened pleading requirements for fraud. The court also dismissed the arbitrator from the case with prejudice, holding that the No Surprises Act does not create a cause of action against IDR entities.On appeal, the United States Court of Appeals for the Eleventh Circuit affirmed the district court’s dismissal. The Eleventh Circuit held that the No Surprises Act incorporates the FAA’s limited grounds for vacating arbitration awards and that the provider failed to adequately plead fraud or undue means under those standards. The court also found that the arbitrator did not exceed its authority and that it was not necessary to name the arbitrator as a defendant to challenge the award. The judgment of the district court was affirmed in full. View "REACH Air Medical Services LLC v. Kaiser Foundation Health Plan Inc." on Justia Law

A patient with a long history of severe depression and multiple suicide attempts underwent 95 electroconvulsive therapy (ECT) treatments at a Nebraska hospital between 2014 and 2016. The ECT was administered using a device manufactured by Somatics, LLC. After the treatments, the patient experienced significant memory loss and was diagnosed with a neurocognitive disorder. In 2020, he filed suit against Somatics in the United States District Court for the Middle District of Florida, alleging negligence, strict product liability, breach of warranties, violation of Nebraska’s Consumer Protection Act, and fraudulent misrepresentation, primarily claiming that Somatics failed to adequately warn of the risks associated with ECT.The district court dismissed the claims under Nebraska’s Consumer Protection Act and for fraudulent misrepresentation, merged the strict liability and breach of implied warranty claims, and granted summary judgment to Somatics on the design defect, manufacturing defect, and breach of express warranty claims. The remaining claims for negligence and strict liability, both based on failure to warn, were merged for trial. The jury found that while Somatics failed to provide adequate warnings, this failure was not the proximate cause of the plaintiff’s injuries, and awarded no damages. The district court denied the plaintiff’s post-trial motions, including for a new trial.On appeal, the United States Court of Appeals for the Eleventh Circuit reviewed the district court’s decisions de novo for summary judgment and for abuse of discretion on evidentiary and procedural rulings. The Eleventh Circuit held that the district court properly granted summary judgment on the design defect claim, correctly merged the negligence and strict liability claims, gave an appropriate jury instruction on proximate cause, and did not abuse its discretion in excluding certain evidence and expert testimony. The judgment of the district court was affirmed. View "Thelen v. Somatics, LLC" on Justia Law

A physician licensed in Florida worked at a weight management clinic, where he was responsible for maintaining a federal registration to dispense controlled substances. After a report of missing controlled substances at the clinic, local police and the Drug Enforcement Administration (DEA) began investigating. The investigation revealed that the physician had issued numerous prescriptions for controlled substances without proper documentation of a doctor-patient relationship, failed to maintain required records, did not properly report or store controlled substances, and dispensed medication in violation of labeling requirements. The physician claimed that another clinic employee had forged his signature on some prescriptions and denied personal wrongdoing.The DEA issued an Order to Show Cause, notifying the physician of its intent to revoke his registration and deny pending applications, citing violations of federal and state law. The physician submitted a Corrective Action Plan but did not request a hearing. The DEA Administrator reviewed the evidence, including expert testimony and the physician’s admissions, and found that the physician’s continued registration would be inconsistent with the public interest. The Administrator revoked the registration and denied all pending applications, emphasizing the physician’s failure to accept responsibility and the inadequacy of his proposed corrective measures.The United States Court of Appeals for the Eleventh Circuit reviewed the DEA’s final order under an abuse of discretion standard, deferring to the agency’s factual findings if supported by substantial evidence. The court held that the physician received adequate procedural due process, as he was given notice and an opportunity for a hearing, which he declined. The court also rejected the argument that the DEA was required to find knowing or intentional misconduct under Ruan v. United States, holding that such a mens rea requirement does not apply to administrative revocation proceedings under 21 U.S.C. § 824. The petition for review was denied. View "Ashraf v. Drug Enforcement Administration" on Justia Law

An employee of the Department of Veterans Affairs began experiencing respiratory issues at work, which she attributed to the building environment. Over several years, she requested various accommodations, including changes to her work schedule, relocation of her workstation, and the use of air purifiers. The Department provided some accommodations, but the employee found them ineffective. In 2012, she was diagnosed with breast cancer and submitted a Family and Medical Leave Act (FMLA) form to request leave for treatment. Later, she learned that a union steward had been informed of her cancer diagnosis by a human resources manager, which she had not expected. After returning to work, she continued to request further accommodations, eventually being allowed to work from home full-time.The United States District Court for the Middle District of Florida granted summary judgment in favor of the Department on all claims, including disability discrimination, failure to accommodate, unlawful disclosure of medical information, and retaliation or hostile work environment. The court found that the Department had provided reasonable accommodations, that there was no evidence of discrimination or retaliation, and that the employee had not shown a tangible injury from the alleged disclosure of her medical information.On appeal, the United States Court of Appeals for the Eleventh Circuit affirmed the district court’s summary judgment on the claims of disability discrimination, failure to accommodate, retaliation, and hostile work environment. The appellate court agreed that the Department had made reasonable efforts to accommodate the employee and that her dissatisfaction with the accommodations did not amount to a legal violation. However, the Eleventh Circuit reversed the summary judgment on the unlawful disclosure claim, holding that requiring medical information for FMLA leave constituted an employer inquiry under the Rehabilitation Act, and that there were genuine issues of fact as to whether confidential medical information was improperly disclosed and whether the employee suffered a tangible injury as a result. The case was remanded for further proceedings on the unlawful disclosure claim. View "Mullin v. Secretary, Department of Veterans Affairs" on Justia Law

Robert Kennedy was convicted of possessing a firearm as a convicted felon, possessing heroin with the intent to distribute, and possessing a firearm in furtherance of a drug trafficking crime. The convictions were based on evidence found during a search of his apartment, including drugs, scales, and a firearm. Kennedy's prior convictions for burglary and drug offenses led to his classification as an armed career criminal and a career offender, resulting in a guidelines range of 420 months to life imprisonment. He received a below-guidelines sentence of 360 months.The United States District Court for the Middle District of Georgia admitted text messages and expert testimony over Kennedy's objections and found sufficient evidence to support his convictions. The court also determined that Kennedy's prior convictions qualified him for the ACCA and career offender enhancements, despite his arguments to the contrary.The United States Court of Appeals for the Eleventh Circuit reviewed the case and affirmed the district court's decisions. The appellate court held that the text messages were admissible as they were directly related to the charged offense and not subject to Rule 404(b). The expert testimony was also deemed appropriate as it did not violate Rule 704(b). The court found sufficient evidence to support Kennedy's convictions, including testimony linking him to the drugs and firearm.The appellate court also upheld the ACCA enhancement, finding that Kennedy's prior burglary convictions qualified as predicate offenses. The court rejected Kennedy's arguments against the career offender enhancement, affirming that his prior drug convictions met the criteria. Finally, the court found Kennedy's sentence to be both procedurally and substantively reasonable, given the circumstances and the guidelines range. The sentence was affirmed. View "United States v. Kennedy" on Justia Law

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