Justia Health Law Opinion Summaries

A nurse practitioner was accused of orchestrating a large-scale Medicare fraud scheme beginning in 2018. The evidence showed that she signed prescriptions for durable medical equipment and genetic testing that were medically unnecessary, often without examining patients or verifying their needs. She worked with telemarketers who cold-called Medicare beneficiaries, fabricated records, and sold prescriptions to medical providers who then billed Medicare. The practitioner received significant kickbacks for her participation and later recruited others to help. When government investigations targeted similar schemes, she attempted to cover her tracks but continued fraudulent conduct by billing for nonexistent telemedicine appointments, at times claiming over twenty-four hours of appointments in a single day. Ultimately, she received more than $1.66 million from these activities, and law enforcement discovered a written confession during a search of her residence.A grand jury indicted her on conspiracy, health care fraud, and false statement charges. Pretrial, the United States District Court for the Southern District of Florida denied her motion to exclude her written statement, finding the attorney-client privilege was waived. During jury selection, her request to strike a potentially biased juror for cause was denied, forcing her to use a peremptory challenge. At trial, disputes arose over the introduction of her inculpatory statement, and the court allocated more time for the government’s closing argument than for her defense. The jury found her guilty, and she was sentenced based on intended loss, not just actual billed amounts, despite her objections.The United States Court of Appeals for the Eleventh Circuit reviewed her claims, including the unequal allocation of closing argument time, a misstatement in oral jury instructions, jury selection issues, the handling of her statement, and sentencing calculations. The court held that although the district court abused its discretion by giving the government more closing argument time based solely on its burden of proof, this error was harmless due to overwhelming evidence of guilt. The court found no reversible error on the other grounds and affirmed her conviction. View "USA v. Hernandez" on Justia Law

The defendant, a physician specializing in obstetrics and gynecology in Illinois, owned and operated a medical practice where she engaged in fraudulent billing to health care benefit programs, including Medicaid and Tricare, from February 2018 to April 2022. She submitted claims for procedures and services that were either not provided or not medically necessary, including telemedicine visits, office visits, and tests. Some of these fraudulent claims were for endometrial ablations, a procedure with significant consequences for patients’ reproductive health.Facing a thirteen-count indictment for health care fraud, the defendant pleaded guilty to two counts pursuant to a plea agreement. These counts specifically alleged the submission of fraudulent claims to Tricare for a telemedicine visit and lab testing. The United States District Court for the Northern District of Illinois, Eastern Division, held a sentencing hearing, during which it considered testimony from patients, expert witnesses, and victim impact statements. The court found that the defendant performed medically unnecessary procedures without informed consent, and that her statements during the plea hearing and subsequent professional regulation proceedings indicated a failure to accept responsibility.On appeal, the United States Court of Appeals for the Seventh Circuit reviewed three main issues: the district court’s denial of a reduction for acceptance of responsibility, application of a sentencing enhancement for reckless risk of serious bodily injury, and the substantive reasonableness of the 120-month sentence. The Seventh Circuit held that the district court did not clearly err in its factual findings, properly applied the sentence enhancement, and did not abuse its discretion in weighing aggravating and mitigating factors. The court affirmed the judgment of the district court, upholding the defendant’s sentence. View "USA v Ghosh" on Justia Law

After the death of their fourteen-year-old daughter Taylor Rose Sookra in December 2021, four months after she received Pfizer’s COVID-19 vaccine, Arthur Sookra and April Burch-Sookra filed a lawsuit. They alleged willful misconduct under the Public Readiness and Emergency Preparedness Act (PREP Act) against Pfizer, federal officials, the physician who administered the vaccine, and the pediatric practice. Their claims included both federal law claims and state-law tort claims.Initially, the case was filed in the United States District Court for the Eastern District of New York. When the Sookras added a PREP Act willful-misconduct claim, they requested and obtained a transfer to the United States District Court for the District of Columbia, as required by the statute. The defendants moved to dismiss, and the motions were referred to a magistrate judge who recommended dismissal of the claims against the federal government on sovereign immunity grounds and against Pfizer for failure to exhaust administrative remedies. The magistrate also recommended dismissal of Pfizer’s state-law claims based on immunity and advised that the court decline supplemental jurisdiction over the remaining state-law claims. The district court adopted these recommendations, dismissed the case, and denied as moot the plaintiffs’ later request for a three-judge court.On appeal, the United States Court of Appeals for the District of Columbia Circuit held that the district court erred by dismissing the complaint without first convening a three-judge court, as required by 42 U.S.C. § 247d-6d(e)(5) for willful-misconduct claims under the PREP Act. The appellate court vacated the district court’s judgment and remanded with instructions to initiate procedures for convening a three-judge court. The court did not address the other arguments raised by the parties. View "Sookra v. Pfizer Inc." on Justia Law

The dispute centers on allegations by a Minnesota-based health insurer that several related pharmaceutical companies carried out an unlawful scheme involving the distribution and sale of repackaged and adulterated oncology drugs. The scheme allegedly involved breaking sterile seals on medication vials, pooling overfill amounts—which were not intended for patient use—and creating pre-filled syringes that were then sold to healthcare providers. These syringes were ultimately administered to cancer patients, including many insured under programs operated by the plaintiff. The defendants did not themselves submit claims for reimbursement, but the plaintiff asserts it paid for treatments using these adulterated drugs, unaware of their compromised quality.Prior to this lawsuit, the scheme was the subject of other civil actions and federal investigations, including qui tam actions and a federal criminal prosecution. The defendants disclosed these investigations in annual reports filed with the Securities and Exchange Commission and the events received media attention beginning in 2012. In 2017, a related company pleaded guilty to federal charges, admitting to the repackaging scheme, and paid significant fines and settlements. The plaintiff filed suit in 2023, asserting claims for common-law fraud, unjust enrichment, and violations of several Minnesota consumer protection statutes. The United States District Court for the District of Minnesota dismissed the complaint, finding the claims were barred by the applicable six-year statute of limitations, and that the plaintiff had failed to sufficiently plead fraudulent concealment to toll the limitations period.The United States Court of Appeals for the Eighth Circuit reviewed the district court’s dismissal de novo. It concluded that publicly available disclosures and the plaintiff’s own allegations established that the plaintiff should have discovered its causes of action no later than 2016. Because the plaintiff did not file suit until 2023, its claims were untimely. The court affirmed the district court’s judgment, holding that all claims were barred by the statute of limitations. View "United HealthCare Services, Inc. v. AmerisourceBergen Corporation" on Justia Law

In 2024, Iowa enacted legislation (HF 2677) prohibiting the manufacture and sale of electronic nicotine delivery systems (ENDS) that had not received marketing authorization from the United States Food and Drug Administration (FDA). The law required manufacturers to certify their compliance with federal premarket approval requirements or demonstrate that their products were pending FDA review. Several manufacturers, retailers, and consumers challenged the law, contending it was preempted by federal law, specifically the Family Smoking Prevention and Tobacco Control Act, and that it violated constitutional equal protection guarantees.The United States District Court for the Southern District of Iowa granted a preliminary injunction, halting enforcement of the law. The district court found that at least one plaintiff had standing, was likely to succeed on the merits of the preemption claim, and was not required to post a security bond. It dismissed claims against the Iowa Department of Revenue based on Eleventh Amendment immunity but allowed the case to proceed against the Director in her official capacity. The Department voluntarily stayed enforcement while the litigation continued.The United States Court of Appeals for the Eighth Circuit reviewed the district court’s order. The Eighth Circuit held that at least one retailer plaintiff had Article III standing, as they plausibly alleged injury from the credible threat of enforcement. However, the appellate court concluded the plaintiffs were not likely to succeed on the merits of their preemption claim. The court determined that HF 2677 was not preempted by federal law, as it fell within the scope of the Tobacco Control Act’s savings clause, which permits state requirements relating to the sale and distribution of tobacco products. The Eighth Circuit vacated the preliminary injunction and remanded the case for further proceedings. View "Iowans for Alternatives v. Mosiman" on Justia Law

Buyers of over-the-counter nasal decongestants containing oral phenylephrine brought numerous class actions against drug manufacturers and retailers, alleging that for years these companies sold and advertised decongestant products they knew to be ineffective. The plaintiffs claimed that scientific studies, particularly since 2016, had shown oral phenylephrine to be no better than a placebo at relieving congestion, yet the companies continued to market their products as effective decongestants and complied with Food and Drug Administration (FDA) labeling requirements. The FDA, despite mounting evidence, did not remove oral phenylephrine’s designation as an effective decongestant under its regulations.The Judicial Panel on Multidistrict Litigation consolidated nearly one hundred class actions and transferred them to the United States District Court for the Eastern District of New York. Plaintiffs filed a complaint asserting New York statutory and common-law claims as well as a federal RICO claim. The district court granted the defendants’ motion to dismiss, holding that the Federal Food, Drug, and Cosmetic Act (FDCA) expressly preempted the state law claims because the drugs’ labels complied with FDA requirements, and that the plaintiffs lacked standing to bring the RICO claim. The court also dismissed a Lanham Act claim brought by one pharmacy plaintiff.On appeal, the United States Court of Appeals for the Second Circuit held that the FDCA expressly preempts most of the state law claims because the federal regime requires manufacturers to follow the FDA-approved labeling, but it vacated the dismissal for claims regarding “Maximum Strength” labeling and brand-name drugs approved via the New Drug Application process, remanding those for further proceedings. The court affirmed dismissal of the RICO claim, adopting the indirect purchaser rule, and upheld denial of the pharmacy’s motion for reconsideration regarding its Lanham Act claim. View "Yousefzadeh v. Johnson & Johnson Consumer Inc." on Justia Law

A hospice provider participated in the Medicare program and sought reimbursement for hospice services provided to several patients. Medicare, through its contractor, conducted a review and determined that a substantial number of the provider's claims did not meet the required coverage criteria, resulting in a demand for repayment of nearly $1 million. The contractor’s decision was partially reversed at the next level of administrative review for some claims, but a significant number were still denied. The provider pursued further administrative appeals, including a hearing before an administrative law judge (ALJ), where testimony and medical records were considered. The ALJ ultimately found that some additional claims were covered but upheld the denial of coverage for others, concluding that the provider was financially responsible for those denied claims and could not benefit from the statutory safe harbor.After the Medicare Appeals Council failed to resolve the provider’s appeal within the prescribed time, the provider sought judicial review in the United States District Court for the Northern District of Ohio. The district court affirmed the ALJ’s decision, agreeing with the denial of coverage for the disputed claims and with the determination that the provider was not entitled to the safe harbor protection.On appeal, the United States Court of Appeals for the Sixth Circuit reviewed two issues: whether substantial evidence supported the ALJ’s denial of Medicare coverage for the claims, and whether the ALJ properly applied the Medicare statute’s safe harbor provision. The appellate court held that substantial evidence did support the denial of coverage. However, it determined that the ALJ had applied the wrong legal standard to the safe harbor inquiry. The Sixth Circuit clarified that the correct standard requires assessment of whether the provider reasonably interpreted the relevant Medicare guidance as covering the disputed claims. The court vacated the district court’s judgment as to the safe harbor issue and remanded with instructions to return the case to the ALJ for application of the correct safe harbor standard to each disputed claim. View "In Home Health, LLC v. Kennedy" on Justia Law

The plaintiff participated in a clinical trial for an experimental COVID-19 vaccine manufactured by AstraZeneca in November 2020. Before receiving the vaccine, she signed an informed-consent form stating that AstraZeneca would compensate her for injuries caused by the vaccine, including providing medical care and reimbursement, and that the company had an insurance policy to cover such costs. The form also disclosed that federal law may limit her right to sue for vaccine-related injuries, referencing the Public Readiness and Emergency Preparedness Act (PREP Act), which provides broad immunity to vaccine manufacturers during a public health emergency.After suffering debilitating medical injuries from the vaccine, the plaintiff requested compensation and care from AstraZeneca, which was denied. She then filed suit in the United States District Court for the District of Utah, alleging breach of contract and breach of the contractual duty of good faith and fair dealing. AstraZeneca moved to dismiss the complaint, arguing that the PREP Act immunized it from liability. The district court denied the motion, holding that the PREP Act’s immunity provision applies only to tort claims, not to contract-based claims. The court further reserved judgment on whether AstraZeneca had waived its statutory immunity in the informed-consent form.The United States Court of Appeals for the Tenth Circuit reviewed the case and reversed the district court’s ruling. The appellate court held that the PREP Act’s immunity provision applies to “all claims for loss,” including those arising from breach of contract, provided they bear a causal relationship to the administration or use of a covered countermeasure like a vaccine. The court remanded the case for the district court to consider whether AstraZeneca waived immunity in the informed-consent form. View "Dressen v. AstraZeneca AB" on Justia Law

The plaintiff, an advocacy organization representing nurse anesthetists, filed suit against the Secretary and Department of Health and Human Services (HHS) after several private insurers reduced reimbursement rates for nurse anesthetists practicing independently, compared to physician anesthesiologists. The plaintiff alleged these lower rates violated a nondiscrimination provision in the Affordable Care Act (ACA), which prohibits insurers from discriminating against healthcare providers acting within the scope of their license. The ACA assigns primary enforcement of this provision to the states, but allows HHS to intervene if a state fails to enforce it. The plaintiff sought a writ of mandamus compelling HHS to enforce the provision and also asserted a claim under the Administrative Procedure Act for agency action unlawfully withheld or unreasonably delayed.The United States District Court for the Northern District of Ohio granted HHS’s motion to dismiss, concluding that the plaintiff lacked standing. The court found the plaintiff had not adequately established that its members had suffered a cognizable injury or that any alleged injury was traceable to HHS’s conduct.On appeal, the United States Court of Appeals for the Sixth Circuit reviewed the district court’s dismissal de novo. The Sixth Circuit determined that even if the plaintiff’s members had experienced monetary harm, they failed to show that the harm was caused by HHS’s alleged nonenforcement, as it was the insurers—not HHS—that set the reimbursement rates. The court found the causal link between government inaction and insurers’ decisions too speculative. Additionally, the court held that any relief ordered by the court would not likely redress the alleged injuries, given the discretionary nature of enforcement and uncertainty about how insurers would respond. Therefore, the Sixth Circuit affirmed the district court’s dismissal for lack of standing. View "Am. Ass'n of Nurse Anesthesiology v. Kennedy" on Justia Law

Several third-party payors who covered prescriptions for Avandia, a diabetes medication manufactured by GlaxoSmithKline LLC, brought a putative class action alleging that the company misrepresented Avandia’s cardiovascular risks and benefits. They claimed these misrepresentations led health care providers to prescribe Avandia more frequently than less expensive alternatives, causing the payors to reimburse for prescriptions that otherwise would not have been issued. The plaintiffs sought class certification on behalf of entities that paid for Avandia prescriptions during a specified period.The United States District Court for the Eastern District of Pennsylvania previously reviewed this case. It denied GlaxoSmithKline’s motion to dismiss the plaintiffs’ Racketeer Influenced and Corrupt Organizations Act (RICO) claim, and the Third Circuit affirmed that denial. Later, the District Court granted summary judgment to GlaxoSmithKline on certain claims, but the Third Circuit reversed in part and remanded for further proceedings. Most recently, the District Court granted class certification, finding the class ascertainable and concluding that common issues would predominate regarding causation. It relied on evidence of a common scheme to deceive and statistical analyses showing marketing campaigns increased prescriptions.The United States Court of Appeals for the Third Circuit reviewed the District Court’s class certification. The Third Circuit held that while the class is ascertainable, the record does not yet demonstrate that common questions predominate on causation. The court clarified that plaintiffs in pharmaceutical fraud RICO class actions may use statistical evidence to prove causation, but such evidence must establish causation, not merely correlation. Because the plaintiffs’ statistical evidence failed to satisfy this standard, the Third Circuit vacated the District Court’s class certification and remanded for further fact-finding on predominance under the clarified standard. View "In re Avandia Marketing" on Justia Law