Justia Health Law Opinion Summaries

A biotechnology company developed a gene therapy for two hereditary blood disorders, which may negatively affect patients’ fertility. To address potential deterrence due to fertility concerns, the company created a program offering up to $70,000 for fertility services to patients receiving the therapy. The program was initially limited to privately insured patients, as the company was concerned it might violate federal healthcare statutes if extended to federally insured patients. To clarify the legality, the company requested an advisory opinion from the Department of Health and Human Services (HHS), arguing that the program did not violate relevant statutes and, alternatively, qualified for statutory exceptions.After significant delays and exchanges, HHS issued an unfavorable advisory opinion, concluding the program violated both the Anti-Kickback Statute (AKS) and the Beneficiary Inducement Statute (BIS), and denied immunity from enforcement. The company sued HHS and its officials in the United States District Court for the District of Columbia, challenging both the advisory opinion and the regulations governing timing for advisory opinions. The district court granted summary judgment to HHS, finding that the program violated the AKS and deferring to HHS’s reasoning regarding the BIS exception, while dismissing the challenge to the timing regulations as moot after the opinion was issued.On appeal, the United States Court of Appeals for the District of Columbia Circuit reviewed the district court’s decision de novo. The court affirmed summary judgment for HHS regarding the AKS, holding that the program constituted prohibited remuneration intended to induce patients to purchase the therapy. However, it reversed as to the BIS, finding HHS’s determination arbitrary and capricious due to its failure to explain why the statutory exception did not apply. The court also held that the company had standing to challenge HHS’s timing regulations and that those regulations unlawfully evaded the statutory deadline. The judgment was affirmed in part, reversed in part, and remanded. View "Vertex Pharmaceuticals Inc. v. HHS" on Justia Law

A woman brought her nearly two-year-old son to a hospital in Lincoln, Nebraska, where he was found with multiple injuries, including bruises, swelling, and a fractured leg. Subsequent medical examinations revealed further injuries, such as broken ribs, a lung contusion, brain swelling, and ultimately, the child died from his injuries. The mother, who had left the child in the care of her boyfriend and others, admitted to noticing symptoms and injuries over a period of weeks but did not seek medical care, citing reasons such as believing the injury was minor and fear of involvement with Child Protective Services. Evidence at trial included interviews, witness testimony, text messages, and internet searches indicating the mother was aware of the child’s worsening condition.The District Court for Lancaster County reviewed the case and presided over a jury trial. The jury found the mother guilty of intentional child abuse resulting in death, intentional child abuse resulting in serious bodily injury, and possession with intent to deliver or delivery of a controlled substance near a school. The court denied pretrial motions to exclude certain photographic evidence and sentenced her to consecutive prison terms totaling 70 years to life for the most serious charges, and additional years for the drug offense.The Nebraska Supreme Court examined claims of insufficient evidence, improper admission of photographs, ineffective assistance of counsel, and excessive sentencing. Applying the appropriate standards of review, the court held that there was sufficient evidence for the convictions, the photographs were relevant and not unduly prejudicial, and the sentences were within statutory limits and not an abuse of discretion. Claims of ineffective assistance were rejected as either unsupported or not prejudicial. The court affirmed the judgment of the district court. View "State v. Cook" on Justia Law

A healthcare administrator at a Mississippi correctional facility, who had served in that role for many years, was employed by a new contractor after it obtained the healthcare services contract for the facility. The administrator became concerned that a prison physician was providing inadequate care and might be impaired by drugs, reporting these concerns to her employer and recommending the physician’s termination. Despite those reports, the physician remained employed after a brief administrative leave. Later, the administrator was notified her employment would be terminated because the employer required all administrators to be registered nurses, and she did not meet that requirement.After her termination, the administrator filed suit in the Sunflower County Circuit Court, alleging wrongful termination and tortious interference. She argued her firing was due to her refusal to participate in denying adequate medical care and her repeated reports about the physician’s performance and possible drug use. The employer denied these allegations, and moved for summary judgment, asserting that she was an at-will employee and had not reported conduct subject to criminal penalties as required under the public-policy exceptions recognized in McArn v. Allied Bruce-Terminix Co., Inc. The circuit court granted summary judgment for the employer, finding that her claims did not implicate criminal conduct and thus did not fall within McArn’s exceptions.The Supreme Court of Mississippi reviewed the case de novo. It held that the administrator failed to show a genuine issue of material fact that she was discharged for refusal to participate in or for reporting criminal conduct, as required under McArn. The Court further clarified that Swindol v. Aurora Flight Sciences Corp. did not expand McArn beyond criminal conduct. Accordingly, the Supreme Court of Mississippi affirmed the circuit court’s grant of summary judgment in favor of the employer. View "Knighten v. VitalCore Health Strategies, LLC" on Justia Law

Jessica Stuart was convicted of health care fraud and using false identification after she falsely claimed to be a Board-Certified Behavioral Analyst, rendering services to children with autism and causing significant financial losses to her employer and Medicaid. Her criminal history included multiple instances of fraud and larceny, such as issuing bad checks, stealing from individuals with whom she resided, and manipulating payments for personal gain. After serving her sentence, Stuart’s supervised release was marked by additional violations, including failing to make restitution payments, moving without approval, committing new frauds involving food stamps and unemployment benefits, and failing to report police contact.The United States District Court for the District of Connecticut initially sentenced Stuart to incarceration and supervised release. When she violated conditions of her supervised release, the court, now presided over by Judge Nagala, imposed a new special condition authorizing the Probation Office to notify third parties—including employers, potential employers, and others to whom Stuart might pose a risk—of her criminal history and past conduct. Stuart objected, arguing the condition improperly delegated judicial authority to the Probation Office by granting it sole discretion to determine who qualifies as a third party at risk.The United States Court of Appeals for the Second Circuit reviewed the challenge. Applying an abuse of discretion standard and reviewing legal questions de novo, the court held that the district court had sufficiently limited the Probation Office’s discretion. The condition was found permissible because it was rooted in Stuart’s varied and opportunistic risk profile, and the court had provided enough guidance to constrain arbitrary use of delegated authority. The Probation Office’s role was determined to be execution, not imposition, of the condition. Accordingly, the Second Circuit affirmed the judgment of the district court. View "United States v. Stuart" on Justia Law

A physician brought a lawsuit on behalf of the United States under the False Claims Act (FCA), alleging that her employer and associated healthcare entities knowingly submitted false diagnosis codes to Medicare in order to obtain inflated payments. The case proceeded for several years. In February 2024, the defendants sought judgment on the pleadings or dismissal, arguing that the FCA’s qui tam provisions—which allow private individuals (relators) to sue on behalf of the government—violated the Constitution’s Appointments Clause, Take Care Clause, and Vesting Clause.The United States District Court for the Middle District of Florida granted the defendants’ motion, concluding that the qui tam provisions violated the Appointments Clause. The district court reasoned that relators are “officers of the United States” because they exercise significant federal authority and occupy a continuing position established by law, but are not appointed by the President as required by Article II. The court dismissed the case, finding the relator lacked authority to proceed on behalf of the United States, and did not address the other constitutional arguments.On appeal, the United States Court of Appeals for the Eleventh Circuit reviewed the district court’s constitutional analysis de novo. The Eleventh Circuit disagreed with the lower court’s conclusion, holding that relators under the FCA are not officers of the United States because they do not occupy a continuing position established by law. The court explained that relators’ roles are temporary, personal, and lack a continuing emolument or transferable duties. Therefore, the FCA’s qui tam provisions do not violate the Appointments Clause. The Eleventh Circuit vacated the district court’s dismissal and remanded the case for consideration of the remaining constitutional arguments. View "Zafirov v. Florida Medical Associates, LLC" on Justia Law

Several plaintiffs challenged a New Jersey law requiring any doctor who wishes to provide telemedicine services to a patient located in New Jersey to first obtain a license from the state’s Board of Medical Examiners. The plaintiffs included two physicians licensed outside New Jersey and three New Jersey residents who wanted to receive virtual medical consultations from those doctors. The doctors argued that New Jersey’s licensing requirement placed an undue burden on their ability to provide telemedicine services, especially since they were already licensed in their home states. The patients and a parent also raised claims based on their rights to receive medical advice and direct their child’s care.The United States District Court for the District of New Jersey dismissed all the plaintiffs’ claims for failure to state a claim. The court held that the licensing requirement did not violate the First Amendment, the dormant Commerce Clause, the Privileges and Immunities Clause, or substantive due process. The plaintiffs appealed, maintaining that the law, as applied, unconstitutionally restricted their right to free speech and imposed excessive burdens on interstate medical practice.The United States Court of Appeals for the Third Circuit affirmed the District Court’s dismissal of all claims, with one modification. The Third Circuit held that requiring a medical license to provide telemedicine services is a content-based restriction on speech, but such regulations have a long tradition and thus do not warrant strict scrutiny. Instead, the law survives intermediate scrutiny because the burdens imposed are not substantial compared to New Jersey’s interest in ensuring competent medical care. The court further held that the law does not violate the dormant Commerce Clause or the Privileges and Immunities Clause, as it applies equally to all doctors regardless of their state of residence. The court also found that the plaintiff asserting a substantive due process right lacked standing, and that claim was ordered dismissed without prejudice for lack of jurisdiction. View "MacDonald v. President NJ State Board of Medical Examiners" on Justia Law

Exelixis, Inc. developed Cabometyx®, a cancer treatment containing cabozantinib (L)-malate. After identifying and characterizing crystalline and amorphous forms of this compound, Exelixis obtained several related patents. MSN Laboratories Private Limited and MSN Pharmaceuticals, Inc. sought FDA approval for a generic version using a specific polymorph of cabozantinib (L)-malate and received their own patent for that form. Exelixis sued MSN in the United States District Court for the District of Delaware, alleging infringement of patents covering crystalline cabozantinib (L)-malate salts (the “Malate Salt Patents”) and a patent directed to pharmaceutical compositions with low levels of a genotoxic impurity (the ’349 patent).The District Court held a bench trial. MSN conceded infringement of the Malate Salt Patents but argued they were invalid for lack of written description under 35 U.S.C. § 112(a). For the ’349 patent, MSN contested both infringement and validity. The District Court found the Malate Salt Patents were not invalid, holding the written description requirement was met because the patents disclosed the chemical structure, formula, and crystalline nature of the claimed salts. The court analogized its analysis to GlaxoSmithKline LLC v. Banner Pharmacaps, Inc. For the ’349 patent, the court found no infringement and no invalidity, concluding that the evidence failed to show the prior art inherently disclosed the “essentially free” impurity limitation.The United States Court of Appeals for the Federal Circuit reviewed the case. It affirmed the District Court’s finding that the asserted claims of the ’439, ’440, and ’015 patents had adequate written description support. Regarding claim 3 of the ’349 patent, the Federal Circuit dismissed MSN’s appeal as moot after Exelixis dropped its cross-appeal and vacated the District Court’s judgment of nonobviousness of that claim. The main holdings were affirmance of written description support for the asserted Malate Salt Patents and dismissal and vacatur regarding claim 3 of the ’349 patent. View "EXELIXIS, INC. v. MSN LABORATORIES PRIVATE LTD. " on Justia Law

A ten-year-old child, considered an Indian child under the Indian Child Welfare Act, was taken into emergency state custody due to neglect and self-harm concerns. The Office of Children’s Services (OCS) placed the child in foster care and later admitted him to a residential psychiatric facility for mental health treatment. The Native Village of Hooper Bay, the child’s tribe, intervened in the child in need of aid (CINA) proceeding and sought access to the child’s unredacted psychotherapy records, arguing they were necessary to secure appropriate services for the child. The child’s attorney objected to the release of these records, citing confidentiality concerns, while the court-appointed guardian ad litem (GAL) waived the psychotherapist-patient privilege.The Superior Court for the State of Alaska, Fourth Judicial District, Hooper Bay, ruled that the GAL held the authority to waive the child’s psychotherapist-patient privilege under CINA Rule 9(b)(3)(F)(ii) because the child was under twelve. The court ordered the release of the records to all parties, finding that the child’s attorney’s objection did not nullify the GAL’s waiver. The child’s motions for reconsideration and for an in camera review were denied, and the records were disclosed.The Supreme Court of the State of Alaska reviewed whether a child between ten and twelve can, through an attorney’s objection, override a GAL’s waiver of the psychotherapist-patient privilege in CINA proceedings. The court held that a child’s objection does not nullify the GAL’s waiver of the privilege. However, following an objection, the child bears the burden of showing that confidentiality should be maintained under the multi-factor framework of CINA Rule 9(b)(3)(D). The Supreme Court found that the superior court adequately applied the relevant factors and affirmed the decision to disclose the child’s records. View "Tanuk S. v. State of Alaska" on Justia Law

Two individuals, who were patients of a regional healthcare provider, filed a class action lawsuit alleging that the provider’s website used tracking software to intercept and share users’ personally identifiable health information with a third-party technology company. This software, known as Meta Pixel, collected data such as IP addresses, device identifiers, and details about users’ interactions with the website, transmitting this information to the technology company, which then used it for commercial purposes, including targeted advertising. The healthcare provider also received data analysis from the technology company and was paid for allowing access to this information. The plaintiffs claimed they did not consent to this sharing of their health information.After the claims against the technology company were transferred to another district, the U.S. District Court for the Eastern District of Pennsylvania reviewed several amended complaints against the healthcare provider. The District Court dismissed the plaintiffs’ second amended complaint with prejudice, concluding that the allegations did not sufficiently specify what personal health information was actually shared and that further amendment would be futile. When the plaintiffs sought reconsideration and submitted a proposed third amended complaint, the District Court denied the motion, citing undue delay because the plaintiffs could have included the new details earlier and had been clearly informed of the deficiencies.The United States Court of Appeals for the Third Circuit reviewed the case and affirmed both orders of the District Court. The Third Circuit held that, although plaintiffs had Article III standing, the District Court did not abuse its discretion in dismissing the second amended complaint with prejudice or in denying the motion for reconsideration. The appellate court concluded that plaintiffs had sufficient notice of the complaint’s deficiencies after oral argument and did not act promptly to address them, justifying denial of further amendment. View "Santoro v. Tower Health" on Justia Law

The plaintiff, a former Senior Reimbursement Manager at a national pharmacy provider, alleged that her employer engaged in a scheme to overcharge government healthcare programs such as Medicare and Medicaid. She claimed the company exploited billing system discrepancies and other tactics to cause overpayments, including billing for deceased patients and miscoding pharmacy types for higher reimbursements. The company allegedly concealed these overpayments in its internal accounting and, after a period, transferred the unreturned funds into its own revenues. The plaintiff reported these practices to management and internal audit, but the issues persisted.After filing a complaint in the United States District Court for the Eastern District of New York, the plaintiff amended her allegations. The District Court dismissed all federal claims with prejudice, finding that the plaintiff did not meet the heightened pleading standards for fraud required under Federal Rule of Civil Procedure 9(b) for “direct” False Claims Act (FCA) claims (those based on submitting fraudulent invoices or statements to the government). The court also denied leave to further amend the complaint, and denied reconsideration.On appeal, the United States Court of Appeals for the Second Circuit reviewed the case de novo. The Second Circuit affirmed the District Court’s dismissal of the plaintiff’s direct FCA claims, holding that she did not identify any specific fraudulent submissions to the government, nor adequately allege that such information was solely within the defendants’ control. However, the Second Circuit vacated the dismissal of the “reverse” FCA claim, which is based on knowingly retaining government overpayments. The court found the plaintiff sufficiently alleged that the company had an obligation to return identified overpayments and knowingly concealed or improperly avoided that obligation. The case was remanded for further proceedings on the reverse FCA claim. View "United States v. Amerisource Bergen Corp." on Justia Law