Justia Health Law Opinion Summaries

Roy Lee Jones, Jr. was involved in a methamphetamine-trafficking organization in North-Central Louisiana. He received large shipments of methamphetamine from his California-based supplier, DeLewis Johnson IV, and redistributed them to Willie Todd Harris, who then sold them to street-level dealers. After a ten-month investigation, federal law enforcement initiated grand jury proceedings, resulting in a five-count indictment. Jones was charged under 21 U.S.C. §§ 841(a)(1) and 846 for conspiracy to distribute and possess with intent to distribute methamphetamine.Jones and Johnson were tried as co-defendants and convicted by a jury. The initial presentence report (PSR) calculated Jones' offense level as 37, recommending a Guidelines range of 210-262 months. The district court sentenced Jones to 210 months' imprisonment. Jones appealed his conviction and sentence, which were affirmed by the United States Court of Appeals for the Fifth Circuit. The Supreme Court denied Jones' petition for a writ of certiorari.Jones filed a motion for a sentence reduction under Amendments 821 and 825 of the United States Sentencing Guidelines. The district court denied the motion, finding that Jones was ineligible for a reduction under USSG § 4C1.1(a)(10) because he had received an aggravating role enhancement under § 3B1.1 and had engaged in a continuing criminal enterprise as defined in 21 U.S.C. § 848.The United States Court of Appeals for the Fifth Circuit reviewed the district court's decision for abuse of discretion, its interpretation of the Guidelines de novo, and its findings of fact for clear error. The court held that either receiving a § 3B1.1 adjustment or engaging in a continuing criminal enterprise is sufficient to disqualify a defendant from a sentence reduction under § 4C1.1(a)(10). Since Jones received an aggravating role enhancement, he was ineligible for a reduction. The court affirmed the district court's decision. View "United States v. Jones" on Justia Law

Dr. Timothy Baxter, while working for Indivior, a pharmaceutical company, distributed misleading information to Massachusetts’s Medicaid program about the safety of new opioid drugs. This led to his conviction for misdemeanor drug misbranding. Following his conviction, the Secretary of Health and Human Services banned him from participating in federal healthcare programs for five years. Baxter challenged this exclusion, arguing that his crime did not categorically relate to the delivery of an item or service under a state healthcare program.The United States District Court for the Eastern District of Virginia granted summary judgment in favor of the Secretary, rejecting Baxter’s claims. Baxter then appealed to the United States Court of Appeals for the Fourth Circuit.The Fourth Circuit reviewed the case and held that the exclusion statute, 42 U.S.C. § 1320a-7(a), does not require a categorical approach. Instead, it employs a circumstance-specific approach, meaning it looks at the actual conduct of the individual rather than the elements of the statute of conviction. The court found that Baxter’s conduct—misbranding drugs to influence MassHealth’s coverage decisions—was related to the delivery of an item under a state healthcare program. Therefore, his exclusion was mandatory under the statute.The Fourth Circuit affirmed the district court’s decision, upholding Baxter’s exclusion from federal healthcare programs. View "Baxter v. Kennedy" on Justia Law

A group of over 200 hospitals claimed that the Department of Health and Human Services (HHS) miscalculated their Disproportionate Share Hospital (DSH) adjustments, which provide additional funding to hospitals treating a high percentage of low-income patients. The dispute centered on the interpretation of the phrase "entitled to supplementary security income (SSI) benefits" under subchapter XVI. The hospitals argued that this phrase should include all patients enrolled in the SSI system at the time of hospitalization, even if they were not entitled to an SSI payment during that month. HHS, however, interpreted it to mean patients who were eligible to receive an SSI payment during the month of hospitalization.The Provider Reimbursement Review Board denied the hospitals' request for additional reimbursement on procedural grounds, and the Centers for Medicare & Medicaid Services denied relief on the merits. The District Court rejected the hospitals' claims and granted summary judgment to HHS. The D.C. Circuit affirmed, concluding that SSI benefits are about cash payments for needy individuals and that it makes little sense to say individuals are entitled to the benefit in months when they are not eligible for a payment.The Supreme Court of the United States held that an individual is "entitled to [SSI] benefits" for purposes of the Medicare fraction when she is eligible to receive an SSI cash payment during the month of her hospitalization. The Court reasoned that SSI benefits are cash benefits determined on a monthly basis, and eligibility for such benefits is also determined monthly. The Court affirmed the judgment of the D.C. Circuit, respecting the specific formula that Congress prescribed for calculating the Medicare fraction. View "Advocate Christ Medical Center v. Kennedy" on Justia Law

Mark Eugene Ricks, a Texas state prisoner, filed a pro se lawsuit under 42 U.S.C. § 1983 against employees of the University of Texas Medical Branch (UTMB), alleging violations of his Eighth Amendment rights. Ricks claimed that he was denied treatment for chronic hepatitis C virus (HCV) based on nonmedical reasons and that the TDCJ HCV Policy was the driving force behind this unconstitutional denial of treatment. He sought injunctive and declaratory relief, as well as damages.The United States District Court for the Southern District of Texas granted the defendants' motion to dismiss Ricks's complaint for failure to state a claim, concluding that his allegations did not support a claim for deliberate indifference. The district court also denied Ricks's motion for appointment of counsel. Ricks filed a timely appeal, and the district court denied him leave to proceed in forma pauperis (IFP) on appeal, certifying that any appeal would not be taken in good faith.The United States Court of Appeals for the Fifth Circuit reviewed the case de novo and found that the district court erred in dismissing Ricks's complaint without allowing him an opportunity to amend his pleadings. The appellate court held that Ricks's allegations, when liberally construed, could potentially raise a viable claim of deliberate indifference. The court also found that the district court abused its discretion in denying Ricks's motion for appointment of counsel without considering the relevant factors set out in Ulmer v. Chancellor.The Fifth Circuit vacated the district court's orders granting the motion to dismiss and denying the appointment of counsel. The case was remanded with instructions for the district court to allow Ricks to amend his pleadings and to appoint counsel to represent him. View "Ricks v. Khan" on Justia Law

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