Justia Health Law Opinion Summaries

Acorda Therapeutics, Inc. developed Ampyra®, a drug for multiple sclerosis, and had a licensing agreement with Alkermes PLC, which owned a patent for Ampyra’s active ingredient. The patent expired in July 2018, but Acorda continued to make royalty payments to Alkermes until July 2020, when it began making payments under protest. Acorda initiated arbitration in July 2020, seeking a declaration that the royalty provisions were unenforceable post-patent expiration and a refund of royalties paid since July 2018.The arbitration tribunal agreed that the royalty provisions were unenforceable but ruled that Acorda could only recoup payments made under formal protest. Acorda then petitioned the United States District Court for the Southern District of New York to confirm the tribunal’s rulings except for the denial of recoupment of unprotested payments. The district court rejected Acorda’s arguments, which were based on the tribunal’s alleged “manifest disregard” of federal patent law and a non-patent-law principle, and confirmed the award in full.Acorda appealed to the United States Court of Appeals for the Federal Circuit, seeking to reverse the district court’s denial of the 2018–2020 recoupment. The Federal Circuit concluded that it lacked jurisdiction over the appeal because Acorda’s petition did not necessarily raise a federal patent law issue. The court determined that the petition’s request for confirmation did not require a determination of federal patent law, and the request for modification presented alternative grounds, one of which did not involve patent law. Consequently, the Federal Circuit transferred the case to the United States Court of Appeals for the Second Circuit. View "Acorda Therapeutics, Inc. v. Alkermes PLC" 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

Keith Huck, an elected member of the Perry County Common Council, was covered under the county's group health insurance plan. In 2023, the Perry County Board of Commissioners voted to exclude part-time employees from health insurance coverage, classifying elected officials, including Huck, as part-time employees. As a result, Huck and his spouse lost their health insurance coverage on January 1, 2024. Huck sought declaratory and injunctive relief, arguing that as an elected official, he should be considered a full-time employee and thus eligible for health insurance coverage.The Perry Circuit Court granted Huck's request for a preliminary injunction, ordering the county to reinstate his insurance coverage. The County appealed, and the Indiana Court of Appeals determined that the county had the authority to classify elected officials as part-time employees and exclude them from health insurance coverage. Huck then sought transfer to the Indiana Supreme Court, which vacated the appellate opinion and reviewed the case.The Indiana Supreme Court held that the county was within its rights to classify Huck as a part-time employee and exclude him from group health insurance coverage. The court found that Indiana law allows local governmental units to exclude part-time employees from group health insurance and that the county's classification of Huck as a part-time employee was permissible. The court reversed the trial court's ruling, vacated the preliminary injunction, and remanded the case for further proceedings consistent with its opinion. View "Perry County v. Huck" on Justia Law

A healthcare provider, Neurological Surgery Practice of Long Island, PLLC, provides out-of-network medical services governed by the No Surprises Act. This Act requires out-of-network providers to seek compensation from the patient’s healthcare plan rather than billing patients directly. If a provider and a healthcare plan cannot agree on a compensation amount, an independent dispute resolution (IDR) process is used. Neurological Surgery alleges that a backlog of disputes has resulted in unpaid or delayed reimbursements due to the Departments of Health and Human Services, Treasury, and Labor failing to implement the Act properly, violating the Administrative Procedure Act (APA) and the Due Process Clause of the Fifth Amendment.The United States District Court for the Eastern District of New York dismissed Neurological Surgery’s claims. The court concluded that the claims were moot due to the reopening of the IDR portal, Neurological Surgery lacked standing to compel the Departments to enforce the Act’s deadlines on third parties, and the claims regarding the Departments’ failure to certify a sufficient number of arbitrators and provide guidance on New York’s surprise billing law were foreclosed by the APA.The United States Court of Appeals for the Second Circuit reviewed the case. The court affirmed the district court’s judgment, agreeing that the challenge to the pause of the IDR portal was moot since the portal was operational. The court also held that Neurological Surgery lacked standing to compel the Departments to enforce deadlines on healthcare plans and IDR entities, as the injury was caused by third parties, not the Departments. Additionally, the court found that the challenge to the Departments’ failure to certify a sufficient number of IDR entities was foreclosed by the APA, as the Act did not specify discrete actions required by the Departments. Lastly, the court held that the challenge to the Departments’ failure to issue guidance on New York’s surprise billing law failed to state a claim under the APA. View "Neurological Surgery v. Department of Health & Human Services" on Justia Law

Frederick Brewer was convicted by a jury of distributing fentanyl, possessing with intent to distribute fentanyl, and participating in a conspiracy to distribute fentanyl. The jury, however, found that the government did not prove beyond a reasonable doubt that Brewer's conspiracy and possession convictions involved at least 40 grams of fentanyl. Brewer moved for acquittal twice, arguing insufficient evidence, but the district court denied both motions. Brewer appealed, contending that the evidence was insufficient to support his convictions and that the district court erred in calculating the drug quantity for sentencing.The United States District Court for the Eastern District of Wisconsin initially denied Brewer's motions for acquittal. The court found sufficient evidence to establish that Brewer and his co-defendant, Don James, Jr., were engaged in a conspiracy to distribute fentanyl, rather than a simple buyer-seller relationship. The court also rejected Brewer's argument that the jury's finding regarding the drug quantity undermined the guilty verdicts. At sentencing, the district court attributed 1.2 to 4 kilograms of fentanyl to Brewer, resulting in a higher base offense level and a sentence of 144 months in prison followed by 120 months of supervised release.The United States Court of Appeals for the Seventh Circuit reviewed the case and affirmed the district court's decisions. The appellate court held that the evidence was sufficient to support Brewer's convictions for conspiracy, possession, and distribution of fentanyl. The court also upheld the district court's drug quantity determination for sentencing purposes, noting that the sentencing court could consider conduct underlying acquitted charges if proven by a preponderance of the evidence. Brewer's conviction and sentence were affirmed. View "United States v. Brewer" on Justia Law

Laguerre Payen, a federal inmate, was convicted in 2010 of multiple terrorism-related charges and sentenced to 25 years imprisonment. During his incarceration, Payen exhibited disruptive and dangerous behavior, including numerous assaults, threats, and other violations. He was diagnosed with schizophrenia and mild intellectual disability and was committed twice under 18 U.S.C. § 4245 for mental health treatment. Despite some improvement, Payen's behavior remained inconsistent, and he refused medication after his commitments ended.The United States District Court for the Western District of Missouri committed Payen under 18 U.S.C. § 4246, finding by clear and convincing evidence that his release would pose a substantial risk of bodily injury or serious property damage due to his mental illness. Payen appealed, arguing that the district court relied on erroneous facts and that the government failed to prove his dangerousness by clear and convincing evidence.The United States Court of Appeals for the Eighth Circuit reviewed the district court's finding of dangerousness for clear error. The court noted that the district court had relied on the unanimous opinions of experts, including an independent evaluator, who diagnosed Payen with schizophrenia and intellectual disability and concluded that his release would pose a substantial risk. The court also considered Payen's extensive history of violent and disruptive behavior, his refusal to take medication voluntarily, and the lack of a suitable release plan.The Eighth Circuit affirmed the district court's decision, finding no clear error in the determination that Payen's release would create a substantial risk of harm to others or their property. The court emphasized that the district court had properly focused on the expert reports and Payen's history of dangerous behavior in making its decision. View "United States v. Payen" on Justia Law

The plaintiffs, Cynthia Wilson, Erin Angelo, and Nicholas Angelo, filed a class action lawsuit against Centene Management Company, L.L.C., Celtic Insurance Company, Superior HealthPlan, Inc., and Centene Company of Texas, L.P. They alleged that the defendants provided materially inaccurate provider lists for their health insurance plans, causing the plaintiffs and proposed class members to pay inflated premiums. Specifically, the plaintiffs claimed that the inaccuracies in the provider directories led to overcharges for access to healthcare providers who were not actually available.The United States District Court for the Western District of Texas denied class certification, concluding that the plaintiffs lacked standing because they failed to establish an injury-in-fact. The court found that the plaintiffs did not adequately demonstrate that they had reasonable expectations regarding the size of the provider network and that the premiums they paid were inflated due to discrepancies between the promised and actual network sizes. The court also questioned the plaintiffs' expert report, which attempted to show a correlation between network size and premium prices, stating that it only showed correlation, not causation.The United States Court of Appeals for the Fifth Circuit reviewed the case and determined that the district court erred by not considering the appropriate test for determining standing at the class-certification stage. The Fifth Circuit adopted the class-certification approach, which requires only that the named plaintiffs demonstrate individual standing before addressing class certification under Rule 23. The appellate court found that the district court improperly engaged in a merits-based evaluation of the plaintiffs' expert testimony when determining standing. The Fifth Circuit vacated the district court's order denying class certification and remanded the case for further proceedings consistent with its opinion. View "Wilson v. Centene Management" 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

Plaintiffs, limited liability companies, filed class action lawsuits in the United States District Court for the District of Maryland seeking relief under the Medicare Secondary Payer (MSP) provisions. These provisions make Medicare a secondary payer when a beneficiary has other insurance coverage. Plaintiffs obtained assignments from Medicare Advantage Organizations and other secondary payers to seek reimbursement from primary payers like the defendants, Government Employees Insurance Company and its affiliates (GEICO). Plaintiffs had no preexisting interest in the claims and were compensated on a contingency basis.The United States District Court for the District of Maryland denied GEICO's motion to dismiss the case, which argued that the assignments were void as against Maryland public policy based on the doctrines of maintenance, champerty, and barratry. The court found no clear statement of Maryland law on this issue and certified questions to the Supreme Court of Maryland.The Supreme Court of Maryland held that Plaintiffs did not violate Maryland’s barratry statute, which prohibits soliciting another person to sue for personal gain without an existing relationship or interest. Plaintiffs did not solicit secondary payers to file lawsuits but obtained the right to sue in their own names through assignments. The court also held that the common law doctrines of maintenance, champerty, and barratry, to the extent they still apply, do not invalidate Plaintiffs’ assignments. The court concluded that the assignments are not void as against public policy and did not address the enforceability of choice-of-law provisions in the agreements. View "GEICO v. MAO-MSO Recovery II" on Justia Law