Justia Health Law Opinion Summaries

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

Griffith Foods International and Sterigenics U.S. operated a medical supply sterilization plant in Willowbrook, Illinois, emitting ethylene oxide (EtO) over a 35-year period. In 2018, a report revealed high cancer rates in Willowbrook, allegedly due to these emissions. Griffith and Sterigenics faced over 800 lawsuits from residents claiming bodily injuries, including cancer, caused by the emissions. Griffith had obtained permits from the Illinois Environmental Protection Agency (IEPA) for the plant's operation, which included EtO emissions.The United States District Court for the Northern District of Illinois reviewed the case. Griffith and Sterigenics sought declarations that National Union Fire Insurance Company had a duty to defend them under their commercial general liability (CGL) policies. The district court ruled in favor of Griffith and Sterigenics, determining that the pollution exclusion in the CGL policies did not apply because the emissions were authorized by IEPA permits. The court relied on the Illinois appellate decision in Erie Insurance Exchange v. Imperial Marble Corp., which found ambiguity in the pollution exclusion when emissions were permitted by regulatory authorities.The United States Court of Appeals for the Seventh Circuit reviewed the case. The court acknowledged the importance of the pollution exclusion in CGL policies and the precedent set by the Illinois Supreme Court in American States Insurance Co. v. Koloms. The Seventh Circuit noted the conflicting interpretations between Koloms and Imperial Marble regarding the scope of the pollution exclusion. Given the significant implications for Illinois law and the insurance industry, the Seventh Circuit decided to certify the question to the Illinois Supreme Court to determine the relevance of regulatory permits in applying the pollution exclusion in CGL policies. View "Griffith Foods International Inc. v National Union Fire Insurance Company of Pittsburg" on Justia Law

In March 2023, the State charged Christopher Allman with multiple counts of domestic violence, felonious restraint, and terrorizing, alleging he assaulted his wife and their live-in girlfriend, locked them in a room, and refused to let them leave. The parties agreed Allman would undergo a mental health examination to determine his criminal responsibility. The examination was delayed due to issues with obtaining Allman’s records from the Veterans Administration. The evaluation, completed in August 2024, concluded Allman did not suffer from a mental condition precluding criminal liability. A jury trial in August 2024 resulted in guilty verdicts on all counts, and Allman was sentenced to consecutive five-year terms of imprisonment, with credit for time served on one count.The District Court of McKenzie County, Northwest Judicial District, oversaw the initial proceedings. Allman appealed, arguing errors related to the criminal responsibility evaluation, his fitness to stand trial, his right to a speedy trial, and the legality of his sentence. He claimed his constitutional rights were violated by the evaluation order, asserting it was against his will and violated his right against self-incrimination. He also argued the court should have ordered a fitness evaluation and that his right to a speedy trial was denied due to the delays in obtaining his mental health records.The Supreme Court of North Dakota reviewed the case. It held that the district court did not err in ordering the criminal responsibility evaluation because the parties had stipulated to it. The court found no grounds to doubt Allman’s fitness to stand trial and noted he did not request a fitness evaluation. The court also determined that Allman’s right to a speedy trial was not violated, as the delays were not due to the State’s conduct, and Allman did not properly assert his right. Finally, the court affirmed the legality of Allman’s sentence, rejecting his argument about credit for time served. The Supreme Court of North Dakota affirmed the district court’s judgment. View "State v. Allman" on Justia Law

Two elderly individuals, Ms. Penelope Lamle and Ms. Maxine Houston, applied for Medicaid but faced delays and additional questions from the Oklahoma Department of Human Services, allegedly directed by attorney Susan Eads. They refused to answer these questions and subsequently sued, seeking an expedited decision, payment of Medicaid benefits, and damages. Both applicants died during the litigation, and their estates were substituted as parties in the appeal.The United States District Court for the Western District of Oklahoma dismissed the action with prejudice, citing the plaintiffs' failure to state a valid claim. However, the court was unaware that the applicants had died while the action was pending.The United States Court of Appeals for the Tenth Circuit reviewed the case. The court found that the claims for an injunction became moot when the agency denied benefits and the applicants died. The court noted that the requested relief would no longer benefit the estates, as the Oklahoma Department of Human Services had already denied the applications. The court also held that the Eleventh Amendment barred the requested retrospective relief. Consequently, the court remanded the case to the district court with instructions to vacate the judgment on the claim for a prospective injunction and dismiss it without prejudice.Regarding the claim against Ms. Eads in her individual capacity, the Tenth Circuit held that she was entitled to qualified immunity. The court found that the plaintiffs did not allege facts showing the violation of a clearly established right. As a result, the court affirmed the dismissal with prejudice of the claim for damages against Ms. Eads. View "Lamle v. Eads" on Justia Law

Scott Breimeister and four codefendants were tried for allegedly defrauding public and private healthcare programs of over $140 million through a scheme involving false claims for prescription drugs. During the trial, the Government made late disclosures of evidence favorable to the defense, affecting a significant portion of the testimony. The district court, concerned about the fairness of the trial, declared a mistrial sua sponte after determining that curative measures would not suffice to ensure a fair verdict.The United States District Court for the Southern District of Texas denied Breimeister's subsequent motion to bar retrial, finding that the Double Jeopardy Clause did not preclude a second trial because the mistrial was a "manifest necessity." Breimeister appealed this decision.The United States Court of Appeals for the Fifth Circuit reviewed the case and affirmed the district court's decision. The appellate court held that Breimeister had impliedly consented to the mistrial by failing to object contemporaneously, and thus, the Double Jeopardy Clause did not bar retrial. Additionally, the court found that the district court did not abuse its discretion in declaring a mistrial due to manifest necessity, given the extensive impact of the Government's late disclosures on the trial's fairness. The appellate court concluded that the district court had carefully considered alternatives and acted within its discretion in declaring a mistrial. View "United States v. Breimeister" on Justia Law

California collects a fee from in-state hospitals and uses the revenue, along with federal Medicaid funds, to provide subsidies to California hospitals serving Medicaid beneficiaries. Out-of-state hospitals near the California border, which sometimes serve California Medicaid beneficiaries but do not pay the fee, sought access to these subsidies. They argued that their exclusion violated the dormant Commerce Clause, the Equal Protection Clause, and federal Medicaid regulations.The United States District Court for the District of Columbia rejected the out-of-state hospitals' arguments and granted summary judgment in favor of the Centers for Medicare and Medicaid Services (CMS). The hospitals appealed the decision.The United States Court of Appeals for the District of Columbia Circuit reviewed the case de novo and affirmed the district court's decision. The court held that the QAF program does not discriminate against interstate commerce because it does not tax out-of-state hospitals, and the supplemental payments are based on in-state provision of medical care. The court also found that the program does not violate the Equal Protection Clause, as California could rationally decide to target subsidies to in-state hospitals serving a disproportionate share of Medi-Cal beneficiaries. Lastly, the court concluded that the QAF program does not violate federal Medicaid regulations, as the regulation in question pertains to base payments for specific services rendered to beneficiaries, not supplemental subsidies like the QAF payments. View "Asante v. Kennedy" on Justia Law

Jeffrey Campbell, the owner and lead doctor at Physicians Primary Care (PPC), and Mark Dyer, a nurse practitioner at PPC, were indicted in 2020 on multiple counts related to overprescribing opioids and engaging in a scheme to seek fraudulent reimbursements from health insurance providers. The indictment included charges of unlawfully distributing controlled substances, conspiracy to unlawfully distribute controlled substances, health-care fraud, conspiracy to commit health-care fraud, and money laundering.The case proceeded to trial in the United States District Court for the Western District of Kentucky. The jury found Campbell guilty on several counts, including conspiracy to unlawfully distribute controlled substances, health-care fraud, conspiracy to commit health-care fraud, and money laundering. Dyer was also found guilty on similar counts. The district court sentenced Campbell to 105 months of imprisonment and Dyer to 60 months, followed by three years of supervised release for both. The district court also ordered restitution payments from both defendants.The United States Court of Appeals for the Sixth Circuit reviewed the case. The defendants challenged the jury instructions, sufficiency of the evidence, and the district court’s evidentiary rulings. The appellate court found that the jury instructions, although not fully compliant with the Supreme Court's decision in Ruan v. United States, were adequate under the court's precedents. The court also found sufficient evidence to support the convictions for conspiracy to unlawfully distribute controlled substances, health-care fraud, and money laundering. The court held that the district court did not abuse its discretion in admitting the testimony of government experts and other evidence.The appellate court affirmed the convictions and sentences, concluding that any potential errors in the district court’s intended-loss calculation for sentencing were harmless, as the sentences imposed were well below the applicable Guidelines range. The court also noted that the defendants failed to properly appeal the restitution order, making it outside the scope of the current appeal. View "United States v. Campbell" on Justia Law

The case involves the Food and Drug Administration (FDA) denying authorization for respondents to market certain flavored e-cigarette products. The FDA's decision was based on the lack of sufficient scientific evidence demonstrating that these products would be appropriate for the protection of public health. The FDA emphasized the need for evidence from randomized controlled trials or longitudinal cohort studies, which the respondents did not provide. Instead, respondents submitted literature reviews and cross-sectional surveys, which the FDA found inadequate.The United States Court of Appeals for the Fifth Circuit, sitting en banc, reviewed the FDA's denial orders. The court found that the FDA acted arbitrarily and capriciously by applying different standards than those articulated in its predecisional guidance. The court was particularly concerned with the FDA's failure to review marketing plans, which it had previously deemed critical. The Fifth Circuit rejected the FDA's argument that any errors were harmless and remanded the case to the FDA.The Supreme Court of the United States reviewed the case and vacated the Fifth Circuit's decision. The Court held that the FDA's denial orders were consistent with its predecisional guidance regarding scientific evidence, comparative efficacy, and device type, and thus did not violate the change-in-position doctrine. However, the Court agreed with the FDA that the Fifth Circuit's interpretation of harmless error was overly broad. The Supreme Court remanded the case to the Fifth Circuit to reconsider the harmless-error question without relying on its expansive reading of Calcutt v. FDIC. View "FDA v. Wages and White Lion Investments, LLC" on Justia Law