Justia Health Law Opinion Summaries

In a healthcare fraud case involving Medicare kickbacks, defendants Lindell King and Ynedra Diggs appealed their convictions and sentences. They challenged the United States District Court for the Southern District of Texas's decision to admit recordings involving them and other co-conspirators, and disputed the court's calculation of the improper benefit received for the purpose of their sentence, as well as the restitution award. The United States Court of Appeals for the Fifth Circuit examined these arguments and ruled in favor of the lower court.The defendants were accused of receiving bribes from a Medicare provider, Dr. Paulo Bettega, for referring Medicare beneficiaries to him for unnecessary treatment or non-provided treatment. The Court of Appeals rejected the defendants' Confrontation Clause arguments, stating the recordings were not testimonial and did not violate the Confrontation Clause. It further dismissed the defendants' assertion that the recordings were impermissible hearsay.Regarding the calculation of the improper benefit, the court concluded that the government had proved by a preponderance of the evidence that the entire operation was fraudulent. The defendants failed to provide rebuttal evidence of any legitimate medical expenses that should offset the amount paid to Bettega for treatment provided to residents of their group homes.The Court of Appeals also upheld the restitution award. It rejected the defendants' argument that their maximum restitution was limited to the $70,000 they received in kickbacks. The court held the defendants jointly and severally liable for all foreseeable losses within the scope of their conspiracy.In conclusion, the Court of Appeals affirmed the judgment and sentence of the district court, finding no error in its proceedings or decisions. View "USA v. King" on Justia Law

The United States Court of Appeals for the Fifth Circuit affirmed the district court’s decision to order Marty Johnson, the owner of a mental health rehabilitation clinic, and Keesha Dinkins, an employee of the clinic, to pay $3.5 million in restitution. Johnson and Dinkins had pleaded guilty to charges related to a fraudulent billing scheme targeting Medicaid that lasted from 2014 to 2018. On the day before their jury trial was set to begin, both defendants pled guilty to their respective charges and agreed in their plea deals to recommend $3.5 million in restitution. However, after their pleas were accepted, both defendants objected to the restitution order, arguing that it was erroneous. Johnson challenged the loss and restitution calculation while Dinkins argued that the entire loss should not have been attributed to her. The court held that the defendants were bound by the plea agreements they had made and affirmed the district court’s order for each defendant to pay $3.5 million in restitution. The court found that there was sufficient evidence to support the pleas, the restitution amount did not exceed the actual loss, and the district court appropriately used the total loss amount when calculating Dinkins’s sentence. View "USA v. Dinkins" on Justia Law

In the United States Court of Appeals for the Fifth Circuit, the case involved Marty Johnson, the owner of a mental health rehabilitation clinic, and Keesha Dinkins, an employee of the same clinic. Both defendants fraudulently billed Medicaid for illegitimate services between 2014 and January 2018. On the day their jury trial was scheduled to begin, Johnson pled guilty to conspiracy to commit healthcare and wire fraud, and Dinkins pled guilty to misprision of a felony. Each of their plea agreements stipulated a loss of $3.5 million and recommended that the judge order $3.5 million in restitution to the government. The district court accepted the defendants' recommendations and ordered each to pay $3.5 million in restitution. After receiving the benefit of their plea bargain, both defendants argued that the $3.5 million order was erroneous. Dinkins also contended that under the sentencing guidelines, the entire loss should not have been attributed to her. The court held the defendants to the plea bargain they had made and affirmed the district court's decision. The Court of Appeals determined that the district court's restitution order was valid under the Mandatory Victims Restitution Act (MVRA). View "USA v. Johnson" on Justia Law

In the case of Wages and White Lion Investments, L.L.C., doing business as Triton Distribution; Vapetasia, L.L.C., versus the Food & Drug Administration, the court found that the FDA acted arbitrarily and capriciously in its denial of Premarket Tobacco Product Applications (PMTAs) for flavored e-cigarette products.The petitioners, Triton Distribution and Vapetasia, are manufacturers of flavored e-cigarette liquids. They filed PMTAs for their products, as required by the Family Smoking Prevention and Tobacco Control Act, which prohibits the sale of any “new tobacco product” without authorization from the FDA. The FDA, after issuing detailed guidance on the information it required for approval of e-cigarette products, subsequently denied all flavored e-cigarette applications, including those of the petitioners, on the grounds that they failed to predict new testing requirements imposed by the FDA without notice.The court found that the FDA had failed to provide the manufacturers with fair notice of the rules, had not acknowledged or explained its change in position, and had ignored the reasonable and serious reliance interests that manufacturers had in the pre-denial guidance. Furthermore, the FDA attempted to cover up its mistakes with post hoc justifications at oral argument.As a result, the court granted the petitions for review, set aside the FDA's marketing denial orders, and remanded the matters to the FDA. The court rejected FDA's argument that even if it arbitrarily and capriciously denied petitioners’ applications, that error was harmless, stating that the harmless error doctrine is narrow and does not apply to discretionary administrative decisions. The court also rejected FDA's contention that it gave manufacturers fair notice of their obligations to perform long-term scientific studies in its pre-denial guidance documents. View "Wages and White Lion Invest v. FDA" on Justia Law

In a case involving the State of Texas, the American Association of Pro-Life Obstetricians & Gynecologists, and the Christian Medical & Dental Associations as plaintiffs, and the United States Department of Health and Human Services (HHS), its Secretary Xavier Becerra, the Centers for Medicare and Medicaid Services (CMS), and other officials as defendants, the United States Court of Appeals for the Fifth Circuit affirmed the district court's decision. The plaintiffs challenged HHS's guidance on the Emergency Medical Treatment and Active Labor Act (EMTALA), which they alleged mandated providers to perform elective abortions beyond HHS's authority and contrary to state law. The plaintiffs sought to enjoin the enforcement of this guidance. The district court granted the injunction within Texas or against any member of a plaintiff organization, and HHS appealed.The Court of Appeals held that the HHS guidance constituted a final agency action as it binds HHS to a particular legal position and has clear legal consequences should a physician or hospital violate it. The court found that HHS's guidance exceeds the statutory language of EMTALA, which does not mandate any specific type of medical treatment, let alone abortion care. The court also held that HHS was required to subject the guidance to notice and comment as it "establishes or changes a substantive legal standard." The court affirmed the injunction, finding it not overbroad, but rather tailored based on the parties, issues, and evidence before it. View "Texas v. Becerra" on Justia Law

A group of Doctors sued the FDA and the Department of Health and Human Services (together, the “Agencies”), claiming an FDA ad intended to deter people from off-label use of ivermectin to treat COVID-19. Each Doctor says that FDA’s messaging interfered with their own individual medical practice.The Doctors argue that FDA’s ad and similar public statements violated FDA’s enabling act (“Act”) and the Administrative Procedure Act (“APA”). The district court held that sovereign immunity protects the Agencies and the Officials, and it dismissed the suit. The Fifth Circuit reversed.The Fifth Circuit held that the Doctors can use the APA to bypass sovereign immunity and assert their ultra vires claims against the Agencies and the Officials. The ad was plausibly agency action, because it publicly announced the general principle that consumers should not use ivermectin to treat the coronavirus, and the Doctors fall within the Act’s zone of interests.The Doctors’ pure APA claim cannot go forward because the ad does not determine legal rights and thus lacks the finality. However, the Fifth Circuit held that the Doctors’ first theory was enough to allow this suit to proceed. View "Apter v. Dept of Health & Human Svc" on Justia Law

The United States Food and Drug Administration approved mifepristone for use in 2000 under the brand name Mifeprex. FDA approved a generic version in 2019, and in 2021, FDA announced that it would not enforce an agency regulation requiring mifepristone to be prescribed and dispensed in person. The agency moved that requirement from mifepristone’s conditions for use. The subject of this appeal is those four actions: the 2000 Approval, the 2016 Amendments, the 2019 Generic Approval, and the 2021 Non-Enforcement Decision. Plaintiffs, Medical Organizations and Doctors contend that FDA overlooked important safety risks in approving mifepristone and amending its restrictions. The Medical Organizations and Doctors moved for preliminary injunctive relief. The district court granted the motion but stayed the effective date of each of the challenged actions under 5 U.S.C. Section 705. FDA appealed, as did Intervenor Danco Laboratories, LLC.     The Fifth Circuit vacated in part and affirmed in part. The court vacated in part and concluded that the Medical Organizations and Doctors’ claim as to the 2000 Approval is likely barred by the statute of limitations. Thus, until final judgment, Mifeprex will remain available to the public under the conditions for use that existed in 2016. The court also vacated the portion of the order relating to the 2019 Generic Approval because Plaintiffs have not shown that they are injured by that particular action. The generic version of mifepristone will also be available under the same conditions as Mifeprex. The court affirmed the components of the stay order that concern the 2016 Amendments and the 2021 Non-Enforcement Decision. View "Alliance Hippocratic Medicine v. FDA" on Justia Law

A company providing crane services, TNT Crane & Rigging, Inc., petitioned the Fifth Circuit to overturn the final orders of the Occupational Safety and Health Review Commission. Those orders reversed decisions by an administrative law judge that were favorable to the company. The principal dispute is whether regulations applicable to the disassembly of a crane apply to the tragic accident that occurred here.   The Fifth Circuit denied the petition. The court held that substantial e supports the Commission’s determination that TNT did not have a work rule designed to prevent violations of Section 1926.1407(b)(3). Second, substantial evidence supports the Commission’s determination that TNT did not adequately monitor employee compliance with its power line safety rules. Finally, substantial evidence supports the Commission’s determination that TNT did not prove it effectively enforced its power line safety rules when it discovered violations. View "TNT Crane & Rigging v. OSHC" on Justia Law

President Biden issued Executive Order 14043, which generally required all federal employees to be vaccinated. Employees who didn’t comply would face termination. He also issued Executive Order 14042, imposing the same requirements and punishments for federal contractors. Plaintiffs, Feds for Medical Freedom, raised several constitutional and statutory claims. First, they asserted constitutional objections. They claimed both mandates were arbitrary, capricious, and otherwise not in accordance with law under the Administrative Procedure Act (“APA”). And the contractor mandate violated the APA because it was not in accordance with law. Finally, they sought relief under the Declaratory Judgment Act (“DJA”). Plaintiffs sought preliminary injunctions against both mandates. The district court declined to enjoin the contractor mandate because it was already the subject of a nationwide injunction. But it enjoined the employee mandate on January 21, 2022. On an expedited appeal, the Fifth Circuit majority held that the Civil Service Reform Act of 1978 (“CSRA”) precluded the district court’s jurisdiction. The Government timely appealed that injunction. The Government’s contention is that the CSRA implicitly repeals Section1331 jurisdiction over Plaintiffs’ claims.   The Fifth Circuit affirmed the district court’s decision and held that it has jurisdiction over pre-enforcement challenges to President Biden’s vaccine mandate for federal employees. The court explained that the text and structure of the CSRA create a decades-old, well-established, bright-line rule: Federal employees must bring challenges to CSRA-covered personnel actions through the CSRA, but they remain free to bring other, non-CSRA challenges under the district courts’ general Section 1331 jurisdiction. View "Feds for Medical Freedom v. Biden" on Justia Law

The Food and Drug Administration denied Petitioner R.J. Reynolds Vapor Company’s (“RJRV”) application to market menthol-flavored e-cigarettes. Petitioners so ughta stay pending review of the denial order on the merits. RJRV petitioned the FDA for a stay, which was denied. RJRV and three other companies then petitioned the Fifth Circuit for review and moved to stay the Denial Order.   The Fifth Circuit entered a full stay pending resolution of RJRV’s petition on the merits. The court explained that the FDA’s disregard for the principles of fair notice and consideration of reliance interests is exacerbated by its failure to consider alternatives to denial. When an agency changes course, as the FDA did here, it must take into account “alternatives that are within the ambit of the existing policy.” Here, the court wrote, the FDA gave RJRV no such opportunity for its menthol PMTA. Further, the court explained that the FDA did not adequately address RJRV’s evidence that substantial health benefits would accrue to adult and youth cigarette smokers alike who switched to menthol Vuse, while popularity among youth would remain low overall. Moreover, the court found that RJRV has adduced evidence that the FDA has effectively banned all non-tobacco-flavored e-cigarettes, pursuant to its new and secret heightened evidentiary standard, without affording affected persons any notice or the opportunity for public comment. The court also held that given RJRV’s uncontested allegations and legal arguments, RJRV has met its burden of showing irreparable harm if denied a stay pending appeal. View "R.J. Reynolds v. FDA" on Justia Law