Justia Health Law Opinion Summaries

Three plaintiffs alleged they suffered injuries after receiving the Gardasil vaccine, which is designed to prevent certain strains of human papillomavirus. Each plaintiff experienced adverse symptoms following their Gardasil injections, but the onset of these symptoms occurred more than three years before they filed petitions for compensation under the National Vaccine Injury Compensation Program. The plaintiffs acknowledged to the special master that their petitions were untimely and sought equitable tolling of the Vaccine Act’s limitations period.The special master in the United States Court of Federal Claims found the petitions untimely and denied equitable tolling, resulting in dismissal of the claims. The plaintiffs then filed suit against Merck & Co. and Merck Sharp & Dohme LLC in the United States District Court for the Western District of North Carolina, which was handling multi-district litigation related to Gardasil. Merck moved to dismiss, arguing that the plaintiffs had failed to timely pursue their remedies under the Vaccine Act. The district court dismissed the complaints, holding that the proper forum for challenging the special master’s timeliness rulings was the Court of Federal Claims and the Federal Circuit, not the district court. The court also rejected a constitutional challenge to the process by which Gardasil was added to the Vaccine Injury Table.On appeal, the United States Court of Appeals for the Fourth Circuit affirmed the district court’s rulings. The Fourth Circuit held that the addition of Gardasil to the Vaccine Injury Table did not violate the Constitution. It further held that timely participation in the Vaccine Act compensation program is a prerequisite to bringing a tort suit, and that courts hearing vaccine-related tort suits may not reconsider the timeliness of a Vaccine Act petition once the special master has made a finding. The court affirmed the dismissal of the plaintiffs’ complaints. View "Needham v. Merck & Company Inc." on Justia Law

Donald Booker owned and operated United Youth Care Services, which billed North Carolina’s Medicaid program for millions of dollars’ worth of medically unnecessary drug tests. Booker was involved in a scheme where his company, along with United Diagnostic Laboratories, recruited individuals to submit to drug testing, which was then billed to Medicaid. The company used several medical providers to certify the testing as medically necessary, even though these providers often did not meet with the beneficiaries. Booker directed the testing protocols, which included testing all participants twice per week regardless of medical need. He also arranged kickback schemes with other entities to recruit Medicaid beneficiaries for the drug tests.The United States District Court for the Western District of North Carolina convicted Booker on ten counts, including conspiracy to defraud the United States, commit health care fraud, pay illegal kickbacks, and money laundering. Booker represented himself at trial, and the jury found him guilty on all counts. The district court denied his motion for judgment of acquittal and sentenced him to 200 months in prison, considering a loss amount exceeding $9.5 million.The United States Court of Appeals for the Fourth Circuit reviewed the case and affirmed the district court’s judgment. The appellate court found that there was substantial evidence to support Booker’s convictions, including testimony from co-conspirators and evidence of kickback payments. The court also rejected Booker’s arguments regarding the nondelegation doctrine, the sufficiency of the evidence for his money-laundering convictions, and the alleged Confrontation Clause violations. The court upheld the district court’s loss-amount calculation and found Booker’s sentence to be substantively reasonable, noting that his co-defendants were not similarly situated and had cooperated with the government. View "United States v. Booker" on Justia Law

Dr. Ron Elfenbein, who runs an urgent-care clinic in Maryland, was charged with healthcare fraud for allegedly overbilling insurers by using high-level codes for simple COVID-19 tests and submitting false medical records. The clinic, which shifted to primarily COVID-19 testing during the pandemic, billed five patient visits at level four, which is typically reserved for more complex medical decision-making.In the United States District Court for the District of Maryland, a jury found Elfenbein guilty on all charges after an 11-day trial. However, the district court acquitted him, reasoning that the evidence was insufficient to support the jury's verdict. The court also conditionally granted a new trial, citing the close nature of the case and the significant evidence that came from Elfenbein's own witnesses.The United States Court of Appeals for the Fourth Circuit reviewed the case. The court found that the jury had enough evidence to convict Elfenbein, as the government presented sufficient testimony and documentation to support the charges of overbilling and submitting false records. The court noted that the jury could reasonably conclude that the level-four codes were inappropriate for the simple COVID-19 tests and that the medical records were materially false.However, the Fourth Circuit also affirmed the district court's decision to grant a new trial. The appellate court acknowledged that the district court did not abuse its discretion in ordering a new trial, given the weaknesses in the government's case-in-chief and the significant evidence that came from the defense. The case was remanded for a new trial. View "United States v. Elfenbein" on Justia Law

GenBioPro, Inc., a manufacturer of generic mifepristone, filed a complaint against West Virginia officials, arguing that the state's law prohibiting most abortions was preempted by federal law. The company claimed that the FDA Amendments Act of 2007 (FDAAA), which regulates the distribution of high-risk drugs like mifepristone, preempted the state law. GenBioPro contended that the FDAAA established a comprehensive scheme for regulating REMS drugs with safe-use elements, leaving no room for state regulation.The U.S. District Court for the Southern District of West Virginia dismissed GenBioPro's complaint, finding no preemption. The court held that abortion regulation is a matter of health and safety traditionally occupied by the states. It determined that Congress had not expressed an intent to occupy the field of drugs subject to a REMS in a manner that would preempt West Virginia's abortion restrictions. The court also found that the FDAAA's requirement to consider patient access was a limitation on the FDA's own restrictions, not a command to ensure access for all patients.The United States Court of Appeals for the Fourth Circuit affirmed the district court's decision. The Fourth Circuit held that the FDAAA did not preempt West Virginia's abortion law. The court emphasized the presumption against preemption in areas of traditional state regulation, such as health and safety. It found that the FDAAA did not demonstrate a clear intention to displace the state's historic and sovereign right to regulate abortion. The court concluded that the FDAAA's focus on drug safety did not create a right to access specific high-risk drugs, and the statute did not preempt state laws regulating the incidence of abortion. View "GenBioPro, Inc. v. Raynes" on Justia Law

West Virginia filed a complaint in state court against CaremarkPCS Health, LLC, a pharmacy benefit manager (PBM), alleging that Caremark unlawfully drove up the cost of insulin, causing financial harm to the state. The complaint included state law claims of civil conspiracy, unjust enrichment, fraud, and breach of contract. Caremark removed the case to federal court under the federal officer removal statute, 28 U.S.C. § 1442(a)(1), arguing that its conduct in negotiating rebates, which is central to the complaint, was performed under the direction of the federal government as part of its work for federal health plans.The United States District Court for the Northern District of West Virginia found that removal was unwarranted and remanded the case to state court. The district court concluded that Caremark failed to meet the requirements for federal officer removal and noted that West Virginia had disclaimed any federal claims in its complaint.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 Caremark was entitled to remove the case to federal court under § 1442(a)(1). The court found that Caremark acted under a federal officer because it administered health benefits for federal employees under contracts with FEHBA carriers, which are supervised by the Office of Personnel Management (OPM). The court also determined that Caremark had a colorable federal defense, specifically that federal law preempted West Virginia's claims. Finally, the court concluded that the charged conduct was related to Caremark's federal work, as the rebate negotiations for federal and non-federal clients were indivisible. Thus, the Fourth Circuit reversed the district court's remand decision and returned the case to the district court for further proceedings. View "West Virginia ex rel. Hunt v. CaremarkPCS Health, L.L.C." on Justia Law

T.M. has a medical condition that causes psychosis when she ingests gluten. After an episode in 2023, she was involuntarily committed to Baltimore Washington Medical Center. Despite her and her father's request for voluntary admission, an administrative hearing led to her involuntary commitment. A clinical review panel approved forcibly injecting T.M. with antipsychotic medication, a decision affirmed by a Maryland administrative law judge. T.M. and the medical center later reached an oral agreement for her release, which was formalized in a consent order by a state court. The consent order required T.M. to follow certain conditions, including taking prescribed medications and dismissing other lawsuits.The United States District Court for the District of Maryland dismissed T.M.'s claims, citing the Rooker-Feldman doctrine, which prevents federal courts from reviewing state court judgments. The court found it lacked subject matter jurisdiction over T.M.'s claims and dismissed the parents' claims for failure to state a claim. T.M.'s claims were dismissed with prejudice, while the parents' claims were dismissed without prejudice.The United States Court of Appeals for the Fourth Circuit affirmed the district court's dismissal of T.M.'s claims for lack of subject matter jurisdiction under the Rooker-Feldman doctrine. The court held that T.M. was a state court loser seeking to overturn a state court judgment, which is barred by the doctrine. The court vacated the dismissal with prejudice and remanded with instructions to modify the judgment to dismiss T.M.'s claims without prejudice. The court also affirmed the dismissal of the parents' claims for failure to state a claim, noting that the complaint did not allege a violation of their First Amendment rights. View "T.M. v. University of Maryland Medical System Corporation" 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 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

Real Time Medical Systems, LLC provides analytics services to skilled nursing facilities by accessing health records from PointClickCare Technologies, Inc., which operates a system hosting patients’ electronic health records. Real Time uses automated bots to access these records. PointClickCare, citing security and performance concerns, blocked users suspected of using bots. Real Time sued to stop PointClickCare from restricting its access, and the district court granted a preliminary injunction in favor of Real Time.The United States District Court for the District of Maryland granted Real Time a preliminary injunction, finding that PointClickCare’s actions likely constituted information blocking under the 21st Century Cures Act. The court concluded that Real Time was likely to succeed on the merits of its claims for unfair competition and tortious interference with contracts. The court also found that Real Time would suffer irreparable harm without the injunction, that the balance of equities favored Real Time, and that the public interest supported granting the injunction.The United States Court of Appeals for the Fourth Circuit reviewed the case and affirmed the district court’s decision. The Fourth Circuit agreed that Real Time was likely to succeed on the merits of its unfair competition claim, as PointClickCare’s actions likely violated the Cures Act’s prohibition on information blocking. The court found that PointClickCare failed to demonstrate that any exceptions to the information-blocking provision applied. The court also agreed that Real Time would suffer irreparable harm without the injunction, that the balance of equities favored Real Time, and that the public interest supported the injunction. The court concluded that the district court did not abuse its discretion in granting the preliminary injunction. View "Real Time Medical Systems, Inc. v. PointClickCare Technologies, Inc." on Justia Law

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