Justia Health Law Opinion Summaries

Dr. William Partin filed a lawsuit against Baptist Healthcare System, Inc. and Dr. Daniel Eichenberger after he resigned from his position. Partin alleged that Baptist and Eichenberger retaliated against him in violation of the Emergency Medical Treatment and Active Labor Act (EMTALA) and brought claims under Indiana law for breach of contract, tortious interference with contractual relations, and defamation. The dispute arose from Partin's treatment of a suicidal patient, J.C., in Baptist's emergency department, where Partin ordered procedures against J.C.'s will, leading to complaints from hospital staff.The United States District Court for the Southern District of Indiana granted summary judgment in favor of Baptist and Eichenberger. The court found that no reasonable jury could conclude that Partin engaged in EMTALA-protected activity or that he was retaliated against for such activity. The court also determined that Partin's breach of contract claim failed because the bylaws did not create a contractual relationship between Partin and Baptist, and his resignation was not under duress. Additionally, the court found no evidence to support Partin's claims of tortious interference with contract or defamation.The United States Court of Appeals for the Seventh Circuit reviewed the case and affirmed the district court's decision. The appellate court held that Partin did not engage in EMTALA-protected activity and that his belief in reporting a potential EMTALA violation was not objectively reasonable. The court also agreed that the bylaws did not create a contract between Partin and Baptist and that Partin's resignation was voluntary. Furthermore, the court found that Baptist's actions were justified and not malicious, and that the statements made by Eichenberger and Marksbury were protected by qualified privilege and not made in bad faith. View "Partin v Baptist Healthcare System, Inc." 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

Robert Saint, an attorney representing a whistleblower in a False Claims Act case, requested a legal memorandum (White Paper) from the Family & Social Services Administration (FSSA) under Indiana’s Access to Public Records Act (APRA). The White Paper was created by HealthNet, a private entity, and given to FSSA for use during Medicaid settlement negotiations. FSSA denied the request, claiming the document was protected by attorney-client privilege and the deliberative material exception.The Marion Superior Court ordered FSSA to disclose the White Paper, finding that FSSA failed to demonstrate an attorney-client relationship or that the document was deliberative material prepared for FSSA’s decision-making. The court also found that any privilege was waived when the document was tendered to FSSA. FSSA appealed, reasserting the deliberative material exception and arguing that the document was used for decision-making within the agency.The Indiana Court of Appeals affirmed the trial court’s decision, rejecting FSSA’s arguments and finding that the White Paper was neither intra-agency nor interagency material. The court also found that FSSA waived its private contractor and confidentiality arguments by not raising them earlier.The Indiana Supreme Court reviewed the case and affirmed the trial court’s order. The court held that the deliberative material exception did not apply because the White Paper was not intra-agency material. The court emphasized that intra-agency material must originate from and be communicated between employees of the same agency. Since the White Paper was created by HealthNet and not generated within FSSA, it did not qualify for the exception. The court concluded that FSSA failed to meet its burden of proof and ordered the disclosure of the White Paper. View "Family & Social Services Administration v. Saint" on Justia Law

The buyers of a pharmaceutical business appealed the Superior Court’s dismissal of their fraudulent-inducement and indemnification claims against the sellers. The trial court determined that the buyers had waived their fraudulent-inducement claims and that the indemnification claim was time-barred. The court’s waiver determination was based on its interpretation of a letter agreement between the parties, executed after the buyers’ acquisition of the business and following governmental proceedings involving FDA and Department of Justice investigations. The sellers argued that the letter agreement precluded further litigation, including the buyers’ claims. The buyers contended that the letter agreement only limited the size and scope of claims for losses attributable to the governmental proceedings. The Superior Court agreed with the sellers and dismissed the buyers’ fraudulent-inducement claims.The Superior Court found that the buyers’ indemnification claim was untimely because it was filed more than 60 months after the acquisition closed, as required by the Purchase Agreement. The court rejected the buyers’ argument that the survival period was tolled due to the sellers’ fraudulent concealment, reasoning that the buyers were on inquiry notice of the alleged breaches well within the limitations period.The Supreme Court of Delaware reviewed the case and held that the buyers’ interpretation of the letter agreement was reasonable, as was the sellers’ and the trial court’s. The court found the relevant provision of the letter agreement to be ambiguous, making it inappropriate to dismiss the buyers’ fraudulent-inducement claim. The court also concluded that the buyers adequately pleaded that the sellers had fraudulently concealed the facts giving rise to the indemnification claim, potentially tolling the survival period. Consequently, the court reversed the Superior Court’s judgment and remanded the case for further proceedings. View "LGM Holdings, LLC v. Gideon Schurder" on Justia Law

The case involves Early Willard Woodmore, III, who was convicted for his role in a methamphetamine distribution enterprise in eastern Oklahoma. The Drug Enforcement Administration (DEA) began investigating the Woodmore organization in 2018 after receiving a tip about methamphetamine shipments. Early Woodmore, along with his siblings Calvin and Amber, led the organization. They received methamphetamine from Kimberly Noel in California, who shipped the drugs concealed in everyday objects. The organization distributed the drugs in smaller quantities throughout eastern Oklahoma. Early Woodmore was arrested in April 2019 and continued to communicate with his sister Amber, who took over operations. The DEA intercepted a significant methamphetamine shipment in August 2019, leading to further charges.The United States District Court for the Eastern District of Oklahoma indicted Early Woodmore on five counts, including conspiracy to distribute methamphetamine and money laundering. He proceeded to a joint trial with his brother Calvin in April 2022. The jury convicted Early Woodmore on all counts, and he was sentenced to life imprisonment for the drug charges and 240 months for the money laundering charges, to run concurrently.The United States Court of Appeals for the Tenth Circuit reviewed the case. Early Woodmore raised three main challenges: judicial bias due to the district court's handling of a custody dispute during the trial, an erroneous jury instruction regarding the right of attorneys to interview witnesses, and the lack of a definitional instruction for "methamphetamine (actual)." The Tenth Circuit rejected all three challenges. The court found no judicial bias, upheld the jury instruction on attorney interviews, and determined that the term "methamphetamine (actual)" was sufficiently clear based on the evidence presented at trial. Consequently, the Tenth Circuit affirmed the district court's judgment of conviction. View "United States v. Woodmore" on Justia Law

Dr. Blake Vanderlan, a physician at a hospital operated by Jackson HMA, LLC, alleged that the hospital systematically violated the Emergency Medical Treatment and Labor Act (EMTALA). He reported these violations to the Department of Health and Human Services, prompting an investigation by the Center for Medicare and Medicaid Services (CMS). CMS confirmed the violations and referred the matter to the Office of Inspector General (OIG) for potential civil monetary penalties. Vanderlan then filed a qui tam lawsuit under the False Claims Act (FCA) against Jackson HMA, alleging five FCA violations, including a retaliation claim.The United States District Court for the Southern District of Mississippi handled the case initially. The government investigated Vanderlan’s claims but declined to intervene. The case continued for six and a half years, during which the district court severed Vanderlan’s retaliation claims. The government eventually moved to dismiss the qui tam claims, arguing that the lawsuit interfered with administrative settlement negotiations and lacked merit. The district court granted the dismissal based on written filings and reaffirmed its decision after reconsideration.The United States Court of Appeals for the Fifth Circuit reviewed the case. The court held that the district court did not err in denying Vanderlan an evidentiary hearing, as the FCA only requires a hearing on the briefs. The court also determined that the government’s motion to dismiss fell under Rule 41(a)(1), which allows for dismissal without a court order, and thus, the district court had no discretion to deny the dismissal. The Fifth Circuit affirmed the district court’s judgment, concluding that the government’s decision to dismiss the case was justified and that the district court applied the correct standard. View "Vanderlan v. Jackson HMA" 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

Richard Hall and his partners established a pharmacy business to capitalize on the market for compounded drugs, targeting federal insurers for high reimbursements. They created two pharmacies, Rxpress and Xpress Compounding, to handle private and federal insurance claims, respectively. The business model involved paying marketers commissions to secure prescriptions from physicians, which led to over $59 million in federal healthcare reimbursements. Hall and his partners were indicted for conspiracy to defraud the United States, paying and receiving illegal kickbacks, and money laundering.The United States District Court for the Northern District of Texas tried the case. The jury found Hall guilty on multiple counts, including conspiracy to defraud the United States and paying illegal kickbacks. The district court sentenced Hall to 52 months in prison, three years of supervised release, and ordered him to pay over $59 million in restitution. Hall's motion for release pending appeal was denied by both the district court and the appellate court.The United States Court of Appeals for the Fifth Circuit reviewed the case. Hall raised four arguments on appeal: improper jury instructions regarding the burden of proof for the safe-harbor defense under the Anti-Kickback Statute (AKS), the definition of "employee" in the jury instructions, the exclusion of his proposed jury instruction on kickback recipients, and the imposition of restitution. The Fifth Circuit held that the district court correctly placed the burden of persuasion for the safe-harbor defense on Hall, properly defined "employee" in the jury instructions, and did not err in excluding Hall's proposed instruction on kickback recipients. The court also upheld the restitution order, finding it appropriate based on the total loss to the government. Consequently, the Fifth Circuit affirmed Hall's convictions and the district court's restitution order. View "United States v. Hall" on Justia Law

Mark Sorensen, owner of SyMed Inc., a Medicare-registered distributor of durable medical equipment, was involved in a business arrangement with PakMed LLC, Byte Success Marketing, and Dynamic Medical Management. They advertised orthopedic braces, obtained signed prescriptions from patients' doctors, distributed the braces, and collected Medicare reimbursements. Byte and KPN, another marketing firm, advertised the braces, and interested patients provided their information, which was forwarded to call centers. Sales agents then contacted patients, generated prescription forms, and faxed them to physicians for approval. Physicians retained discretion to sign and return the forms, with many choosing not to.A federal grand jury indicted Sorensen on four counts: one count of conspiracy and three counts of offering and paying kickbacks for Medicare referrals. The jury found Sorensen guilty on all counts. Sorensen moved for acquittal, arguing insufficient evidence and lack of awareness of the scheme's illegality. The district court denied his motions, finding the evidence sufficient for the jury to conclude Sorensen knew the fee structure and purchase of doctors' orders were illegal. Sorensen was sentenced to 42 months in prison but was released on bond pending appeal.The United States Court of Appeals for the Seventh Circuit reviewed the case and reversed the district court's judgment due to insufficient evidence. The court found that Sorensen's payments to PakMed, KPN, and Byte were for advertising, manufacturing, and shipping services, not for patient referrals. The court emphasized that the Anti-Kickback Statute targets payments to individuals with influence over healthcare decisions, which was not the case here. The court concluded that Sorensen's actions did not violate the statute, as there was no evidence of improper influence over physicians' independent medical judgment. View "USA v Sorensen" on Justia Law

A nurse at a medical clinic where Dr. George P. Naum, III worked prescribed controlled substances without a doctor's supervision. The government prosecuted Naum for conspiracy and aiding and abetting the distribution of controlled substances outside the usual course of his professional practice, alleging he knew about the nurse’s conduct but did not stop it. A federal jury convicted Naum on these counts.The United States District Court for the Northern District of West Virginia handled the initial trial. Naum was found guilty of one count of conspiracy to distribute controlled substances outside the bounds of professional medical practice and four counts of aiding and abetting in the distribution of controlled substances outside the bounds of professional medical practice. Naum's motion for a new trial was denied, and he appealed. The Fourth Circuit initially affirmed the district court's decision.The United States Supreme Court later clarified in Ruan v. United States that to convict a defendant under 21 U.S.C. § 841(a), the government must prove the defendant knew or intended that their conduct was unauthorized. Naum argued that the district court failed to instruct the jury on this requirement. The Fourth Circuit agreed that the jury instructions misstated the law post-Ruan but applied plain error review. The court concluded that Naum did not meet his burden of showing that the outcome of his trial would have been different with proper instructions. Therefore, the Fourth Circuit affirmed Naum's conviction. View "United States v. Naum" on Justia Law