Justia Health Law Opinion Summaries

A former employee of a pharmaceutical manufacturer brought a qui tam lawsuit under the False Claims Act, alleging that the company improperly calculated and reported its “Best Price” for certain drugs to the Centers for Medicare and Medicaid Services (CMS), as required under the Medicaid Rebate Statute. The plaintiff claimed that, during a period from 2005 to 2014, the company failed to aggregate multiple rebates and discounts given to different entities on the same drug, resulting in inflated “Best Price” reports and underpayment of rebates owed to Medicaid. The complaint asserted that the company was subjectively aware that CMS interpreted the statute to require aggregation of all such discounts, especially after the company’s communications with CMS during a 2006–2007 rulemaking process and the company’s subsequent internal audit.After the government and several states declined to intervene, the United States District Court for the District of Maryland dismissed the amended complaint, finding that, even under the subjective scienter standard established in United States ex rel. Schutte v. SuperValu Inc., the plaintiff had not plausibly alleged that the company acted with actual knowledge, deliberate ignorance, or reckless disregard as to the truth or falsity of its reports. The district court also suggested that ambiguity in the statute precluded a finding of falsity.On appeal, the United States Court of Appeals for the Fourth Circuit reviewed the dismissal de novo. The Fourth Circuit held that the plaintiff’s allegations—including the company’s awareness of CMS’s interpretation of the rule, its targeted audit and compliance efforts, and its continued use of non-aggregated reporting—plausibly alleged the requisite subjective scienter under the False Claims Act. The court clarified that statutory ambiguity does not, at the pleading stage, negate scienter or falsity, and remanded for the district court to address other elements, including falsity, in the first instance. The Fourth Circuit reversed the dismissal and remanded for further proceedings. View "United States ex rel. Sheldon v. Allergan Sales, LLC" on Justia Law

Kaiser Foundation Health Plan, Inc. operated a health plan primarily using its own facilities, but its members sometimes sought emergency medical care at non-Kaiser hospitals, including Pomona Valley Hospital Medical Center. From 2004 until late 2017, Kaiser reimbursed Pomona Valley Hospital for emergency services at contractual rates under a written agreement. After Kaiser terminated this contract in 2017, it began paying Pomona Valley Hospital at a lower, unilaterally determined rate. Dissatisfied with these payments for services rendered from October 2017 through March 2020, Pomona Valley Hospital sued Kaiser in quantum meruit, seeking the asserted reasonable value of its emergency services, which it claimed was approximately $66 million more than what Kaiser had paid.The Superior Court of Los Angeles County held a jury trial in which Pomona Valley Hospital prevailed, and the jury awarded the full amount sought. Kaiser moved for a new trial, arguing, among other things, that the trial court erred by admitting the parties’ prior contract into evidence. The trial court agreed that admitting the contract was legal error but found the error only affected damages, not liability, and conditionally granted a new trial unless Pomona Valley Hospital accepted a remittitur, reducing the award by about $8 million. Pomona Valley Hospital accepted the remittitur, and judgment was entered. Kaiser appealed, and Pomona Valley Hospital cross-appealed, claiming the new trial should not have been granted.The California Court of Appeal, Second Appellate District, Division Two, held that the trial court erred in granting Kaiser’s new trial motion. The appellate court concluded the contract was properly admitted because its exclusionary clause only applied to regulatory valuations, not to common law quantum meruit actions like this one. The court also rejected Kaiser’s other arguments except for the prejudgment interest rate, holding that interest should be awarded at 7 percent, not 10 percent. The appellate court reversed the new trial order, vacated the amended judgment, and remanded for entry of judgment on the jury’s original verdict, subject to the corrected interest rate. View "Pomona Valley Hospital v. Kaiser Foundation Health etc." on Justia Law

A woman with a history of serious mental illness was civilly committed after being found incompetent to stand trial for a criminal vehicular homicide. She was diagnosed with schizoaffective disorder, bipolar type, and persistent psychosis, and resided in a secure state hospital. After multiple unsuccessful attempts with medication and therapy, her treating psychiatrist petitioned the district court for authorization to administer electroconvulsive therapy (ECT), asserting it was necessary due to her refractory symptoms and inability to consent.The District Court for Dakota County appointed two examiners, both of whom agreed that ECT was medically necessary and reasonable under the Price v. Sheppard balancing test, which weighs the patient’s need for treatment against the intrusiveness of the prescribed treatment. After considering the examiners’ reports and testimony, the district court authorized ECT, finding clear and convincing evidence that the treatment was necessary and reasonable. The patient appealed, arguing that the district court erred by not separately analyzing whether ECT was “necessary to preserve [her] life or health” as required by Minn. Stat. § 253B.03, subd. 6(b). The Minnesota Court of Appeals affirmed, holding that the Price/Jarvis balancing test subsumed the statutory requirement.The Minnesota Supreme Court reviewed whether the Price/Jarvis balancing test adequately addresses the statutory language requiring that treatment be “necessary to preserve the life or health” of a committed patient. The court held that the balancing test does address this requirement, as it requires a court to determine that treatment is both necessary and reasonable. Therefore, the Supreme Court affirmed the decision of the court of appeals, upholding the district court’s authorization of ECT. View "In the Matter of the Civil Commitment of: Graeber" on Justia Law

Several individuals who participate in West Virginia’s Medicaid program and have been diagnosed with gender dysphoria sought surgical treatments that are excluded from coverage under West Virginia’s Medicaid plan. The state plan expressly excludes coverage for “sex change” or “transsexual” surgeries, though it covers these procedures for other medical indications, such as cancer or congenital abnormalities. The plaintiffs, representing a class of similarly situated individuals, alleged that this exclusion discriminates against them in violation of the Equal Protection Clause, Section 1557 of the Affordable Care Act, and certain provisions of the Medicaid Act.In proceedings before the United States District Court for the Southern District of West Virginia, the court granted summary judgment to the plaintiffs on all claims. The court found that the exclusion was unlawful under the Equal Protection Clause, the Affordable Care Act’s anti-discrimination provision, and the Medicaid Act’s comparability and availability requirements. The district court issued a declaratory judgment and enjoined enforcement of the exclusion. On appeal, the United States Court of Appeals for the Fourth Circuit sitting en banc affirmed the district court’s judgment. The state defendants then sought review by the Supreme Court, which granted certiorari, vacated the Fourth Circuit’s en banc decision, and remanded for reconsideration in light of two recent Supreme Court cases: United States v. Skrmetti and Medina v. Planned Parenthood South Atlantic.Upon reconsideration, the United States Court of Appeals for the Fourth Circuit reversed the district court. The court held that, under Skrmetti, West Virginia’s exclusion does not violate the Equal Protection Clause or the Affordable Care Act, because the exclusion is based on medical diagnosis rather than sex or transgender status and is supported by rational, non-discriminatory reasons. Applying Medina, the court further held that the Medicaid Act’s comparability and availability requirements do not provide a private right of action, and thus plaintiffs could not sue under those provisions. The Fourth Circuit reversed and remanded the case with instructions to enter summary judgment for the defendants. View "Anderson v. Crouch" on Justia Law

Three Medicaid beneficiaries in Indiana challenged the federal agency’s approval of a ten-year extension to Indiana’s Medicaid program, known as HIP 2.0, asserting that the program did not comply with the requirements of the federal Medicaid Act. The plaintiffs argued that the agency’s 2020 approval, as well as a 2023 letter maintaining the program despite concerns about coverage reductions, were arbitrary and capricious under the Administrative Procedure Act. Indiana, seeking to defend HIP 2.0, intervened in the case.The United States District Court for the District of Columbia granted summary judgment to the beneficiaries, holding that the agency’s approval was not based on reasoned decision-making and failed to consider all relevant factors, particularly whether the program would help furnish medical assistance. The court vacated the 2020 approval and remanded the matter to the agency for further proceedings but stayed the vacatur order, allowing most of HIP 2.0 to remain in effect except for specific premium requirements. Indiana appealed, seeking review of the district court’s remand order, while the beneficiaries and the federal agency argued that the order was not a final, appealable decision.The United States Court of Appeals for the District of Columbia Circuit reviewed whether it had jurisdiction over Indiana’s appeal. The court held that the district court’s remand order was not a final decision under 28 U.S.C. § 1291 because it did not end the litigation on the merits and substantive proceedings before the agency remained. The appellate court also found that none of the exceptions to the final judgment rule applied, including the collateral-order doctrine or Rule 54(b) certification. Accordingly, the D.C. Circuit dismissed Indiana’s appeal for lack of jurisdiction. View "Rose v. Kennedy" on Justia Law

A resident of Puerto Rico suffered work-related injuries in 1994, resulting in permanent total disability. His employer and its insurance carrier were ordered to provide medical care under Section 7 of the Longshore and Harbor Workers’ Compensation Act, as extended by the Defense Base Act. In 2019, a Puerto Rico-licensed physician recommended medical cannabis-infused edibles to treat the petitioner’s chronic pain. The petitioner sought reimbursement for these products from the employer’s insurance carrier, which denied the request.The petitioner then asked the United States Department of Labor’s Office of Administrative Law Judges to order reimbursement, arguing that medical cannabis was a reasonable and necessary treatment. The Administrative Law Judge denied the request, finding that marijuana’s classification as a Schedule I substance under the Controlled Substances Act (CSA) meant it could not have an accepted medical use under federal law. On appeal, the Department of Labor Benefits Review Board affirmed this decision by a 2-1 vote, agreeing that reimbursement was barred by the CSA and rejecting arguments that recent federal appropriations riders or executive actions altered the federal legal status of marijuana.On further appeal, the United States Court of Appeals for the Second Circuit reviewed the case. The court held that because marijuana remains a Schedule I substance under the CSA, it cannot be considered a reasonable and necessary medical expense for purposes of reimbursement under the Longshore and Harbor Workers’ Compensation Act. The court found that neither appropriations riders nor recent executive or legislative actions had changed marijuana’s federal classification or its legal status under the Act. Therefore, the court denied the petition for review. View "Garcia v. Department of Labor" on Justia Law

A man was convicted by a Michigan state jury for delivering oxycodone to a friend, resulting in her death from a drug overdose. The evidence showed that the man and the deceased had a longstanding relationship, and after her release from jail, he purchased 40 Percocet pills—containing oxycodone and acetaminophen—and spent time with her at a hotel where she died. Medical experts found oxycodone in her blood and acetaminophen in her urine, both components of Percocet, and testified that oxycodone was a substantial factor in causing her death.After his conviction, the defendant sought a new trial in the Michigan courts, arguing that his trial counsel was ineffective for two reasons: failing to investigate an “acetaminophen-based” defense (that the absence of acetaminophen in the blood meant the deceased had not consumed Percocet), and failing to call an expert witness to challenge the prosecution’s case on causation. The trial court held a hearing and ultimately rejected these claims. The Michigan Court of Appeals affirmed, and the Michigan Supreme Court denied further review.The United States District Court for the Eastern District of Michigan then denied the defendant’s petition for habeas corpus, and the case was appealed to the United States Court of Appeals for the Sixth Circuit. The Sixth Circuit held that, under the highly deferential standards of the Antiterrorism and Effective Death Penalty Act (AEDPA), the state courts did not unreasonably apply clearly established Supreme Court law or make unreasonable determinations of fact in rejecting the ineffective assistance claims. The court further held that counsel’s strategic decisions were not objectively unreasonable and that the alleged failures did not prejudice the outcome of the trial. The Sixth Circuit affirmed the denial of habeas relief. View "DeBruyn v. Douglas" on Justia Law

A patient was hospitalized after contracting COVID-19 and, as his condition worsened, was transferred between several hospitals in Kentucky and Indiana. During his treatment, he was intubated, placed on a ventilator, and medically immobilized. While under this care, he developed a severe bed sore that progressed to necrotizing fasciitis. Despite ongoing treatment, he ultimately died, with his death certificate listing multiple causes including cardiopulmonary arrest and sepsis. His estate claimed that negligence in the treatment of the bed sore caused his death and filed a proposed medical malpractice complaint against more than eighty healthcare providers.The case began when the estate filed its complaint with the Indiana Department of Insurance, while a medical-review panel was being requested. Before the panel was constituted, the providers moved for summary judgment in Vanderburgh Superior Court, arguing they were immune from liability under Indiana’s Healthcare Immunity Act, Premises Immunity Act, and the federal PREP Act. The trial court granted summary judgment for the providers, finding that statutory immunity applied and that the court, not the medical-review panel, could decide the immunity issue. The estate appealed, and the Indiana Court of Appeals reversed, holding that the question of immunity required expert input from the medical-review panel, especially regarding causation.The Indiana Supreme Court granted transfer, vacating the Court of Appeals’ decision. It held that the trial court could make a preliminary determination on statutory immunity without waiting for a medical-review panel’s opinion, since the facts relating to the connection between the patient’s COVID-19 treatment and his injury were undisputed for summary judgment purposes. The court further held that the providers were immune from civil liability under both state and federal law, as the patient’s injuries arose from treatment provided in response to the COVID-19 emergency. The court affirmed summary judgment for the providers. View "Estate of Waggoner v. Anonymous Health System, Inc." on Justia Law

The City of Boston, along with its Public Health Commission and Housing Authority, brought suit against two pharmacy benefit managers (PBMs), OptumRx and Express Scripts, alleging that the PBMs had worked with opioid manufacturers to misrepresent the risks of opioid drugs. The City claimed that this conduct violated Massachusetts public nuisance law and resulted in harm to the City. The PBMs removed the case to federal court and argued that the suit was untimely because it was brought after the three-year statute of limitations had expired. The City responded by asserting that its complaint sufficiently alleged a continuing nuisance and that the statute of limitations should be tolled due to the PBMs’ fraudulent concealment of their wrongdoing.The United States District Court for the District of Massachusetts granted the PBMs’ motion to dismiss, finding that the City either knew or should have known of its injuries and of the PBMs’ alleged role before 2021, based on public records and prior litigation, and thus failed to file suit within the statutory period. The district court further ruled that the City had not adequately pled a continuing nuisance, as it did not allege any specific, recent unlawful acts within the limitations period, and rejected the City’s claim of fraudulent concealment, determining that the City had the means to discover the facts needed for its claim. The district court also denied a motion by the PBMs to disqualify the City's law firm, Motley Rice.On appeal, the United States Court of Appeals for the First Circuit affirmed both the dismissal of the City’s state law claim and the denial of the motion to disqualify Motley Rice. The court held that the action was time-barred and that the City had not met the requirements for tolling the statute of limitations or for pleading a continuing nuisance under Massachusetts law. View "The City of Boston v. OptumRx, Inc." on Justia Law

The case centers on a dispute involving a pharmaceutical company founded by the plaintiff, who also served as its CEO. The plaintiff obtained investment from a Canadian entity controlled by one of the defendants, who later became a director. The company entered into a profitable licensing agreement for a drug, and the plaintiff claims he was personally entitled to 30% of the profits based on an oral agreement. The investor and his affiliates, however, allege that the plaintiff wrongfully diverted corporate assets by taking this share. After disagreements arose, the investor replaced himself and another director on the board with officers from his own affiliates, who began investigating the alleged diversion. In response, the plaintiff initiated litigation, asserting that the investigation was a breach of fiduciary duty and that the investor and his affiliates acted in bad faith for their own benefit.Previously, the Court of Chancery of the State of Delaware was asked to consider several claims, including breach of fiduciary duty, civil conspiracy, and tortious interference against the investor, his affiliates, and the two new directors. The investor’s affiliate moved to dismiss for lack of personal jurisdiction, and the court found it had no jurisdiction over the affiliate. The court also examined whether it had jurisdiction over the investor for claims other than those related to his service as a director, finding it did not because the complaint failed to state a viable claim against him in that capacity.In the present decision, the Court of Chancery held that it lacked personal jurisdiction over the investor’s affiliate and over the investor in his non-director capacities, dismissing those claims without prejudice. The court further dismissed with prejudice the breach of fiduciary duty and conspiracy claims against the directors and the investor in his director capacity, finding no viable claims were stated. However, the court allowed the plaintiff’s claim for a declaratory judgment regarding his right to the profits from the drug to proceed against the company, provided an amended complaint is filed naming the company as a proper defendant. View "MacLaughlan v. Einheiber" on Justia Law