Justia U.S. 4th Circuit Court of Appeals Opinion Summaries
Articles Posted in Health Law
United States v. Williams
A father, Scott Williams, and his son, Taeyan Williams, were convicted by a federal jury of various drug-related offenses, including conspiracy to distribute and possess with intent to distribute marijuana and cocaine. The case stemmed from an investigation into the disappearance of a drug dealer, Noah Smothers, who supplied drugs to Scott and Taeyan. A search of Scott's home revealed large quantities of drugs, firearms, and cash. Both Scott and Taeyan were found guilty of conspiracy and possession with intent to distribute, while Scott was also convicted of additional charges related to methamphetamine and evidence destruction.The United States District Court for the District of Maryland denied Scott's motion to suppress evidence obtained from the search, despite his claim that law enforcement failed to knock and announce before entering. The court held that suppression was not the appropriate remedy. Scott and Taeyan were sentenced to 276 months and 150 months in prison, respectively, followed by five years of supervised release. Both appealed their convictions and sentences.The United States Court of Appeals for the Fourth Circuit reviewed the case. The court affirmed Taeyan's conviction, finding sufficient evidence to support his possession with intent to distribute charges, based on his connection to the drugs found in Scott's home. The court also upheld the district court's denial of Scott's motion to suppress, citing exigent circumstances that justified the no-knock entry. Additionally, the court rejected Scott's request for a sentence reduction under the newly promulgated U.S.S.G. § 4C1.1, advising him to seek relief through a motion under 18 U.S.C. § 3582. Finally, the court found no improper delegation of judicial authority in the conditions of Scott's supervised release, affirming the district court's judgments in their entirety. View "United States v. Williams" on Justia Law
Lucas v. VHC Health
Nia Lucas, an African American woman with military service-related disabilities, including PTSD, depression, anxiety, panic attacks, and a traumatic brain injury, sought care at VHC for her pregnancy. Despite her complaints of pre-term contractions and pain, the Labor and Delivery Unit staff did not treat her as prescribed by her doctor. Lucas alleged that she was told her pain was not real and was only in her head. After complaining to VHC staff about racial and disability discrimination, she received a letter terminating her care, and she was subsequently dismissed from a scheduled appointment. Lucas gave birth prematurely and experienced ongoing physical and mental suffering.The United States District Court for the Eastern District of Virginia dismissed Lucas' claims of racial discrimination, disability discrimination, and retaliation under the Affordable Care Act (ACA). The court found that Lucas did not plausibly plead that she was denied treatment because of her disabilities and that her racial discrimination claim was based on a single, isolated statement. The court also concluded that the ACA did not support an independent cause of action for retaliation.The United States Court of Appeals for the Fourth Circuit reviewed the case. The court affirmed the dismissal of Lucas' disability discrimination claim, finding that she did not allege facts connecting her disabilities to the denial of treatment or her termination. However, the court reversed the dismissal of her racial discrimination claim, holding that Lucas plausibly alleged that VHC acted with deliberate indifference to her complaints of racial discrimination. The court also held that the ACA permits retaliation claims, and Lucas plausibly pled a retaliation claim based on the temporal proximity between her complaints and her termination. The case was remanded for further proceedings consistent with this opinion. View "Lucas v. VHC Health" on Justia Law
Posted in:
Civil Rights, Health Law
United States ex rel. Wheeler v. Acadia Healthcare Company, Inc.
Lisa Wheeler, a physician assistant and former Assistant Medical Director at Acadia Healthcare Company’s Asheville, North Carolina clinic, filed a complaint alleging that Acadia falsified medical records to claim payments from government healthcare programs. Wheeler claimed that Acadia, which provided methadone-assisted treatment for opioid use disorder, failed to provide required therapy and counseling services, instead fabricating therapy notes to submit fraudulent claims to Medicare, Medicaid, and other government programs.The United States District Court for the Western District of North Carolina dismissed Wheeler’s amended complaint, concluding that she failed to adequately plead that Acadia’s false claims were material or submitted to the government. The court found that Wheeler did not sufficiently allege that Acadia’s failure to provide therapy was material to the government’s payment decisions or that false claims were actually submitted to the government.The United States Court of Appeals for the Fourth Circuit reviewed the case and reversed the district court’s decision. The Fourth Circuit held that Wheeler adequately pled her claims of presentment, false statement, false certification, and fraudulent inducement under the False Claims Act. The court found that Wheeler’s allegations of falsified therapy notes and non-compliance with federal opioid treatment standards were material to the government’s payment decisions. The court also concluded that Wheeler sufficiently alleged that Acadia submitted false claims to government healthcare programs and that the fraudulent conduct was central to the government’s decision to pay.Additionally, the Fourth Circuit held that Wheeler adequately pled her reverse false claim, finding that the stipulated penalties in Acadia’s Corporate Integrity Agreement with the government constituted an obligation under the False Claims Act. The court remanded the case for further proceedings consistent with its opinion. View "United States ex rel. Wheeler v. Acadia Healthcare Company, Inc." on Justia Law
Posted in:
Government & Administrative Law, Health Law
Pharmaceutical Coalition for Patient Access v. United States
The Pharmaceutical Coalition for Patient Access (the Coalition), a charitable organization involving drug manufacturers, challenged an unfavorable advisory opinion issued by the Office of the Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS). The dispute centered on the Coalition’s proposed patient assistance program for Medicare beneficiaries, which aimed to subsidize co-pays for oncology drugs. The OIG determined that the program would violate the Anti-Kickback Statute if the required mens rea were present, as it would offer remuneration to induce the purchase of specific drugs.The United States District Court for the Eastern District of Virginia granted summary judgment in favor of the defendants, the United States, HHS, and related officials, and dismissed the Coalition’s claims. The court found that the OIG’s advisory opinion was not arbitrary or capricious and that the Coalition’s program would indeed fall within the Anti-Kickback Statute’s prohibitions.The United States Court of Appeals for the Fourth Circuit reviewed the case de novo. The court affirmed the district court’s decision, agreeing that the word “induce” in the Anti-Kickback Statute should be construed under its ordinary meaning, not its specialized criminal law meaning. The court also concluded that “remuneration” in the statute includes any payment or compensation, not just corrupt payments that distort medical decision-making. The court found that the Coalition’s program involved a quid pro quo, as it offered subsidies for the purchase of specific drugs.The Fourth Circuit also upheld the district court’s dismissal of the Coalition’s disparate treatment claim for lack of subject matter jurisdiction, ruling that the OIG’s enforcement discretion is not subject to judicial review. The court concluded that the OIG had consistently applied the Anti-Kickback Statute to similar proposals and that the Coalition’s challenge was directed against the OIG’s enforcement discretion, which is unreviewable under the Administrative Procedure Act. View "Pharmaceutical Coalition for Patient Access v. United States" on Justia Law
Posted in:
Government & Administrative Law, Health Law
United States v. Jackson
Dr. Anita Jackson, an otolaryngologist, was convicted of various offenses related to her private medical practice in North Carolina. She was the leading Medicare biller for balloon sinuplasty surgery, a procedure treating chronic sinusitis. Jackson reused single-use medical devices, specifically the Entellus XprESS Multi-Sinus Dilation Tool, on multiple patients without proper sterilization, leading to potential contamination. She also incentivized employees to recruit Medicare patients for the procedure, often bypassing proper medical assessments. Additionally, Jackson falsified documents and patient signatures in response to Medicare audits.The United States District Court for the Eastern District of North Carolina convicted Jackson on all counts, including violating the Food, Drug, and Cosmetics Act (FDCA) by holding for resale adulterated medical devices, violating the federal anti-kickback statute, making materially false statements, committing aggravated identity theft, mail fraud, and conspiracy. Jackson was sentenced to twenty-five years in prison and ordered to pay over $5.7 million in restitution. She moved for a judgment of acquittal and a new trial, which the district court denied.The United States Court of Appeals for the Fourth Circuit reviewed the case. Jackson argued that the devices were not "held for sale" under the FDCA, that her actions were protected under 21 U.S.C. § 396, and that the Government relied on a defective theory of per se adulteration. She also challenged the exclusion of certain evidence and jury instructions. The Fourth Circuit found no reversible error in the district court's rulings, holding that the devices were indeed "held for sale," that § 396 did not protect her conduct, and that the Government's theory was valid. The court also upheld the exclusion of evidence and the jury instructions. Consequently, the Fourth Circuit affirmed all of Jackson's convictions. View "United States v. Jackson" on Justia Law
Island Creek Coal Co. v. Blankenship
Jerry L. Blankenship applied for living miner benefits under the Black Lung Benefits Act, claiming he suffered from coal dust-induced pneumoconiosis and was totally disabled. An Administrative Law Judge (ALJ) found Blankenship entitled to a rebuttable presumption of total disability due to pneumoconiosis under 30 U.S.C. § 921(c)(4) and determined that his former employer, Island Creek Coal Company, failed to rebut this presumption. Consequently, Blankenship was awarded benefits. The Benefits Review Board affirmed the ALJ’s decision.Island Creek petitioned for review, arguing that the ALJ improperly conflated the presence of pneumoconiosis and disability causation with the separate total disability analysis. Additionally, Island Creek contended that the ALJ failed to adequately explain his decision to credit the opinions of Blankenship’s medical experts over those of Island Creek’s experts.The United States Court of Appeals for the Fourth Circuit reviewed the case and agreed with Island Creek. The court found that the ALJ improperly relied on the presence of pneumoconiosis and the causation of Blankenship’s impairment in concluding that he was totally disabled. The court also determined that the ALJ failed to provide a sufficient explanation for crediting the medical opinions of Drs. Nader and Green over those of Drs. McSharry and Sargent, violating the duty of explanation under the Administrative Procedure Act.The Fourth Circuit granted Island Creek’s petition for review, vacated the decision of the Benefits Review Board, and remanded the case with instructions for the Board to return Blankenship’s case to the ALJ for reconsideration consistent with the court’s opinion. View "Island Creek Coal Co. v. Blankenship" on Justia Law
United States v. Henderson
The case involves Jamie Christopher Henderson, who was convicted and sentenced following a jury trial for conspiracy to distribute cocaine and cocaine base, possession with intent to distribute cocaine base, and possession of firearms in furtherance of his drug trafficking crimes. Henderson appealed his convictions and sentence, arguing that the evidence was insufficient to support these convictions, and that his sentence is procedurally and substantively unreasonable.The case originated from an incident on April 30, 2019, when law enforcement officers executed a search warrant at Henderson’s residence. They witnessed Henderson toss items underneath a vehicle, including a gun. The officers recovered a loaded handgun, a plastic bag with cocaine and crack cocaine, a cigarette lighter, and a glass crack pipe from underneath the vehicle. Henderson was arrested. Inside the trailer, police found a loaded rifle, a loaded handgun, cocaine powder and crack cocaine in a toilet tank, and a second loaded handgun in a kitchen trash can. They also seized three digital scales and a digital video recorder containing footage from security cameras showing Henderson and other men, armed with multiple handguns and a rifle, standing in the front yard of the residence as cars and people would approach it.Henderson was charged with conspiracy to distribute cocaine and cocaine base, possession of a firearm in furtherance of the drug-distribution conspiracy, possession with intent to distribute cocaine and cocaine base, possession of a firearm in furtherance of the possession-with-intent offense, and possession of a firearm as a felon. He pleaded not guilty. At trial, the Government presented the testimony of the law enforcement officers, Henderson’s videotaped confession, the security footage from the trailer, and a letter Henderson had written to his brother. Henderson presented the testimony of his mother and daughter who claimed that Henderson was a drug user, thief, and liar—but not a drug dealer. The jury convicted Henderson on all counts.The United States Court of Appeals for the Fourth Circuit affirmed the convictions and sentence. The court found that there was substantial evidence to support the conviction and that the sentence was not procedurally or substantively unreasonable. The court noted that Henderson faced a heavy burden in challenging the sufficiency of the evidence and that the court's role was limited to considering whether there was substantial evidence to support the conviction. The court found that there was abundant independent evidence that Henderson was engaged in a large-scale drug trade, which supported the trustworthiness of his confessions. The court also found that the district court did not err in calculating the quantity of drugs attributable to Henderson for sentencing purposes. The court concluded that Henderson's sentence was substantively reasonable and that he failed to overcome the presumption of reasonableness that applies to a below-Guidelines sentence. View "United States v. Henderson" on Justia Law
United Therapeutics Corporation v. Commissioner of Internal Revenue
The case involves United Therapeutics Corporation (UTC), a biotechnology company, and the Commissioner of Internal Revenue. The dispute centers on the interpretation of a tax provision that coordinates two tax credits: the research credit and the orphan drug credit. The Commissioner claimed that UTC disregarded one of the provision’s two commands, improperly reducing its tax liability by over a million dollars. UTC argued that the relevant half of the coordination provision lost effect in 1989 and has been moribund since.The United States Tax Court disagreed with UTC's argument. The court interpreted the statute’s terms by reference to their ordinary meaning, giving effect to the full coordination provision. The court rejected UTC's argument that changes to the tax law since its enactment rendered part of the coordination provision ineffective. The court also disagreed with UTC's interpretation of two regulations it relied on for support.The United States Court of Appeals for the Fourth Circuit affirmed the tax court's decision. The appellate court agreed with the tax court's interpretation of the coordination provision according to its ordinary meaning. The court also found that the tax court correctly rejected UTC's arguments based on the interpretation of predecessor statutes and regulations. The court concluded that the tax court correctly resolved the case in favor of the Commissioner. View "United Therapeutics Corporation v. Commissioner of Internal Revenue" on Justia Law
United States v. Davis
Antonio Davis, who was serving a 210-month prison sentence for conspiracy to possess with intent to distribute heroin, petitioned the district court for compassionate release due to his elevated risk of severe COVID-19 and a change in the law regarding his career offender status. The district court denied his request, concluding that Davis was not due compassionate release based on his susceptibility to COVID-19 and did not fully consider each of Davis’s arguments.Davis was indicted on charges of conspiracy to distribute and conspiracy to possess with intent to distribute heroin in January 2013. He pled guilty to conspiracy to possess with intent to distribute heroin in June of that year. Davis received a career offender enhancement because he had previously been convicted of certain other offenses and because the offense at issue here was a “controlled substance offense” at the time of conviction. In February 2021, Davis filed a pro se motion for compassionate release under 18 U.S.C. § 3582(c)(1)(A), arguing that he was uniquely susceptible to the potential spread of COVID-19 due to his type-2 diabetes and hypertension. He also argued that a recent court decision invalidated his career offender Guidelines designation.The United States Court of Appeals for the Fourth Circuit affirmed in part, vacated and remanded in part the district court's decision. The court concluded that the district court did not abuse its discretion in finding that Davis failed to show extraordinary and compelling reasons for release based on the pandemic. However, the court found that the district court did not properly address Davis’s arguments regarding intervening changes in law and rehabilitation. Therefore, the court vacated the district court’s denial of compassionate relief and remanded for further proceedings. View "United States v. Davis" on Justia Law
Posted in:
Criminal Law, Health Law
Vanda Pharmaceuticals, Inc. v. Centers for Medicare & Medicaid Services
The case involves Vanda Pharmaceuticals, a drug manufacturer, and the Centers for Medicare & Medicaid Services (CMS). Vanda challenged a 2020 regulation by CMS that expanded the definition of a "line extension" drug under the Medicaid Drug Rebate Program. This program requires drug manufacturers to reimburse Medicaid if they increase their prices faster than inflation. A "line extension" drug, which is a new formulation of an existing drug, can also be liable for price increases of the original drug. Vanda argued that the regulation expanded the definition of a line extension beyond what the Medicaid statute permitted.Previously, the district court granted summary judgment to CMS, disagreeing with Vanda's argument. The court held that the agency's regulation was within the bounds of the Medicaid statute.The United States Court of Appeals for the Fourth Circuit affirmed the district court's decision. The court found that the agency's definitions of "line extension" and "new formulation" were within the Medicaid statute's ambit. It also held that the agency's interpretation of the oral-solid-dosage-form requirement was not contrary to law. The court rejected Vanda's argument that the agency's rulemaking process was arbitrary and capricious, finding that the agency had reasonably considered the relevant issues and explained its decision. View "Vanda Pharmaceuticals, Inc. v. Centers for Medicare & Medicaid Services" on Justia Law