Justia Health Law Opinion Summaries

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Several pharmaceutical manufacturers and a trade association challenged a Louisiana statute, Act 358, which restricts drug manufacturers from interfering with the delivery of federally discounted drugs through contract pharmacies. The statute was passed in response to manufacturers’ efforts to limit the distribution of discounted drugs under the federal 340B Program, particularly through arrangements with contract pharmacies serving vulnerable populations. The plaintiffs argued that the Louisiana law was preempted by federal law and violated several constitutional provisions, including the Takings Clause, the Contracts Clause, and the Due Process Clause’s prohibition on vagueness.The United States District Court for the Western District of Louisiana considered three related cases together. It denied the manufacturers’ motions for summary judgment and instead granted summary judgment for the State of Louisiana and the Louisiana Primary Care Association (LPCA) on all claims. The district court also allowed LPCA to intervene in each case, over the objection of one plaintiff.On appeal, the United States Court of Appeals for the Fifth Circuit reviewed the case de novo. The court held that Act 358 is not preempted by federal law. It found that the federal 340B statute does not occupy the field of pharmacy regulation and does not conflict with or frustrate federal objectives, as it is silent on the use of contract pharmacies and leaves room for state regulation. The court also concluded that Act 358 does not effect a physical or regulatory taking, does not substantially impair contract rights under the Contracts Clause, and is not unconstitutionally vague. However, the Fifth Circuit reversed the district court’s order permitting LPCA to intervene in AbbVie’s case, finding that LPCA’s interests were adequately represented by the State and it did not show it would present a distinct defense. The court affirmed summary judgment for Louisiana on all claims. View "AstraZeneca v. Murrill" on Justia Law

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A Texas nonprofit health center, CentroMed, experienced a data breach in 2024 that exposed the personal information of its patients. Arturo Gonzalez, representing himself and others affected, filed a class action in Bexar County, Texas, alleging that CentroMed failed to adequately protect their private information. CentroMed, which receives federal funding and has occasionally been deemed a Public Health Service (PHS) employee under federal law, sought to remove the case to federal court, claiming removal was proper under 42 U.S.C. § 233 and 28 U.S.C. § 1442.After CentroMed was served, it notified the Department of Health and Human Services (HHS) and the United States Attorney, seeking confirmation that the data breach claims fell within the scope of PHS employee immunity. The United States Attorney appeared in state court within the required 15 days, ultimately informing the court that CentroMed was not deemed a PHS employee for the acts at issue because the claims did not arise from medical or related functions. Despite this, CentroMed removed the case to the United States District Court for the Western District of Texas 37 days after service. The district court granted Gonzalez’s motion to remand, concluding that removal was improper under both statutes: the Attorney General had timely appeared, precluding removal under § 233, and removal under § 1442 was untimely.On appeal, the United States Court of Appeals for the Fifth Circuit affirmed the district court’s remand. The Fifth Circuit held that CentroMed could not remove under § 233 because the Attorney General had timely appeared and made a case-specific negative determination. The court further held that removal under § 1442 was untimely, as CentroMed did not remove within 30 days of receiving the initial pleading. Thus, the remand to state court was affirmed. View "Gonzalez v. El Centro Del Barrio" on Justia Law

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Lewis Vanalen Borek was arrested for felony driving under the influence following a car accident in Star, Idaho. Officers at the scene administered a breathalyzer test, which returned a reading of .000, but Borek showed signs of impairment during field sobriety tests and admitted to taking anti-depressant medication. Subsequent blood tests revealed the presence of prescription drugs for mental health conditions. The State obtained records from the Idaho Prescription Monitoring Program (PMP), Ada County Jail, and Star Pharmacy, which included information about Borek’s prescriptions, medical history, and treatment.Borek initially moved to suppress all evidence from his arrest, arguing that officers lacked probable cause for a felony DUI, citing Idaho constitutional protections. The District Court denied his motion, but Borek appealed. The Idaho Court of Appeals reversed, agreeing that there was no probable cause for a felony DUI, and suppressed both the blood test results and statements made by Borek to medical staff. On remand, after further motions, the District Court allowed the State to obtain medical and prescription records from various sources. Borek filed a motion in limine to exclude these records, arguing they were privileged under Idaho Rule of Evidence 503. The District Court granted Borek’s motion, finding the records to be confidential communications protected by the psychotherapist-patient privilege.The Supreme Court of the State of Idaho reviewed the District Court’s order on permissive appeal. It held that the PMP and Star Pharmacy records did not constitute confidential communications under Rule 503(b)(2) and that Borek failed to meet his burden to prove that the Ada County Jail medical questionnaire was privileged. However, the State waived its challenge to exclusion of other jail records. The Supreme Court reversed the District Court’s order granting Borek’s motion in limine and remanded for further proceedings. View "State v. Borek" on Justia Law

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Jackson County Heart ASC, LLC submitted an application to the Mississippi State Department of Health (MSDH) seeking a certificate of need (CON) to establish a joint venture cardiac ambulatory surgical facility (JV-CASF) in Gautier, Mississippi. The proposed facility would provide outpatient cardiac catheterization services and was to be jointly owned by an acute care hospital and licensed cardiologists, as defined by the Mississippi State Health Plan. The application included supporting affidavits from cardiologists and financial projections, indicating that this would be the only freestanding outpatient JV-CASF in the Gulf Coast service area.MSDH staff recommended approval of the application, finding substantial compliance with relevant criteria. Following Singing River Health System’s request for a hearing, a hearing officer considered testimony and evidence from both sides, including expert witnesses and financial analyses. Although one supporting physician withdrew his endorsement at the hearing, the hearing officer ultimately recommended approval based on the entirety of the evidence. MSDH’s state health officer adopted these findings and issued a final order approving the CON. Singing River appealed to the Hinds County Chancery Court, which affirmed the approval after oral argument. Singing River then appealed to the Supreme Court of Mississippi.On appeal, the Supreme Court of Mississippi reviewed arguments regarding the adequacy of the application, economic viability, and potential adverse impacts on Singing River’s services and charitable care. Applying a highly deferential standard, the Court found substantial evidence supporting MSDH’s decision. The Court held that the application met the requirements of the State Health Plan and CON Review Manual, satisfied economic viability, and would not have a significant adverse impact on Singing River or its ability to provide charitable care. The Supreme Court affirmed MSDH’s approval of the CON. View "Singing River Health System v. Mississippi State Department of Health" on Justia Law

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A parent enrolled his teenage son, who had a history of serious behavioral and mental health issues, in a residential treatment center after other interventions failed. The family’s health insurer initially approved and paid for the first 21 days of residential treatment, then denied further coverage, asserting that the treatment was no longer medically necessary. The parent appealed this decision through the insurer’s internal process, submitting medical records and opinions from the child’s treating clinicians that supported the need for continued residential care. The insurer upheld its denial after cursory reviews that did not address the treating clinicians’ recommendations or key evidence of the child’s ongoing difficulties.The parent filed suit in the United States District Court for the Western District of Kentucky, alleging that the insurer’s denial was arbitrary and capricious under the Employee Retirement Income Security Act (ERISA) and violated the Mental Health Parity and Addiction Equity Act. The district court granted summary judgment to the insurer on both claims, finding that the decision to deny coverage was not arbitrary and capricious and that there was no evidence of a parity violation.On appeal, the United States Court of Appeals for the Sixth Circuit found that the insurer’s coverage decision was procedurally arbitrary and capricious, as it failed to consider the treating clinicians’ opinions, selectively reviewed the medical record, and did not adequately explain its change from initially approving coverage to denying it. The appellate court vacated the district court’s judgment on the ERISA claim and remanded with instructions to send the matter back to the insurer for a full and fair review. However, it affirmed the district court’s judgment on the Parity Act claim, holding that the parent failed to produce evidence showing that the insurer’s limitations on mental health treatment were more restrictive than those applied to medical or surgical benefits. View "T. E. v. Anthem Blue Cross Blue Shield" on Justia Law

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A telehealth company developed software that enables individuals to determine their refractive eye error using a computer or smartphone without an in-person visit to an optometrist or ophthalmologist. This technology, approved by the FDA and available in many states, was offered in South Carolina until the enactment of the Eye Care Consumer Protection Law in 2016. The law prohibits eye doctors from prescribing spectacles or contact lenses based solely on information from automated equipment, including kiosks or online applications, and requires a valid prescription from a provider following an in-person examination.After the law was enacted, the company ceased providing its service in South Carolina, as local eye doctors were no longer willing to issue prescriptions based solely on remote test results. The company challenged the constitutionality of the law, arguing it violated equal protection and due process guarantees under the South Carolina Constitution. The Circuit Court for Richland County initially granted summary judgment for the defendants, finding the law’s purpose was to protect public health and that its provisions were reasonably related to maintaining the standard of care for medical professionals.Upon direct appeal, the Supreme Court of South Carolina reviewed the case. The Court applied the rational basis test and held that the legislature’s decision to require in-person examinations before prescribing corrective lenses was rationally related to the legitimate government interest of protecting public health. The Court found the classification created by the Act was reasonable and did not violate equal protection, as it treated similarly situated eye doctors alike and addressed unique risks in eye care. The Supreme Court of South Carolina affirmed the circuit court’s grant of summary judgment, upholding the constitutionality of the law. View "Opternative v. South Carolina Optometric Physicians Association" on Justia Law

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The appellant was previously convicted of multiple serious offenses, including attempted murder, grand larceny of a vehicle, and three counts of first-degree murder, for which he received a death sentence and additional prison terms. Decades later, federal habeas relief was granted on the basis of ineffective assistance of counsel regarding his insanity defense, resulting in the vacatur of his conviction and sentence. Upon the State’s attempt to retry him, a competency evaluation found him incompetent to stand trial. The criminal complaint was dismissed without prejudice, and the State sought his civil commitment based on evidence that he has a mental disorder and poses a danger to himself and others.Following a hearing, the Eleventh Judicial District Court of Pershing County found clear and convincing evidence supporting civil commitment and ordered the appellant to a forensic mental health facility, to remain until he either qualifies for conditional release or reaches the statutory maximum duration for such commitment. The appellant argued that he should be credited for the time he spent in prison under the vacated conviction, citing NRS 176.055, and also contended that the civil commitment should not exceed ten years. The district court rejected these arguments, determining that credit for time served under NRS 176.055 does not apply to civil commitments, as such credit is limited to sentences imposed for criminal convictions.The Supreme Court of Nevada affirmed the district court’s order. The court held that Nevada’s statutory scheme does not allow credit for time served in prison under a vacated criminal judgment to be applied against the duration of civil commitment, as civil commitment is a preventive and treatment-oriented measure rather than punitive. The court further held that NRS 178.463 does not provide credit in this context, as it applies only to time spent on conditional release, which the appellant has not received. View "Rogers v. State of Nevada" on Justia Law

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G.H. was a child with serious, complex medical issues requiring extensive treatment. In 2011, his older sister died from a mitochondrial disorder. Afterward, G.H. began showing symptoms believed to be similar, and his mother, J.S.H., sought care for him at Boston Children's Hospital. Dr. Alice Newton, head of the hospital’s child protection team and a mandated reporter, filed a report with the Massachusetts Department of Children and Families (DCF) alleging medical child abuse by J.S.H., based on perceived inconsistencies in reported symptoms. The report was unsubstantiated, and subsequent similar reports from other sources were also unsubstantiated. In 2013, Dr. Newton moved to Massachusetts General Hospital (MGH). In 2018, after learning J.S.H. was identified as a witness in an unrelated trial, Dr. Newton reviewed G.H.’s medical records at MGH and again raised concerns of medical child abuse, documenting her findings and filing another report with DCF, which was also deemed unsubstantiated.J.S.H. filed suit in the United States District Court for the District of Massachusetts against Dr. Newton and MGH, asserting state-law emotional distress claims and a federal disability discrimination claim under Section 504 of the Rehabilitation Act. The district court granted summary judgment in favor of the defendants, finding insufficient evidence to proceed to trial. The court declined to consider an affidavit submitted by J.S.H. on the grounds of untimeliness.The United States Court of Appeals for the First Circuit reviewed the district court’s summary judgment de novo. The appellate court held that expert testimony was required to establish negligence for the emotional distress claims but was not provided. The court further found no evidence that Dr. Newton’s actions constituted extreme and outrageous conduct or caused harm to G.H., nor evidence that MGH denied or limited services to G.H. based on disability. The First Circuit affirmed the district court’s grant of summary judgment to both defendants. View "J.S.H. v. Newton" on Justia Law

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The Missouri General Assembly enacted two statutes effective August 28, 2023: the SAFE Act, which generally prohibits health care providers from performing gender transition surgeries or prescribing cross-sex hormones and puberty-blocking drugs for minors, and the Medicaid ban, which precludes MO HealthNet payments for such treatments when used for gender transition. The statutes include specific exemptions, such as for treatment of certain medical conditions and for minors already receiving such care prior to enactment. E.N., on behalf of her minor child and joined by medical professionals and organizations, challenged both laws, alleging violations of equal protection, due process, and the gains of industry clause under the Missouri Constitution.The Circuit Court of Cole County conducted a two-week bench trial and entered judgment in favor of the State, upholding the constitutionality of both statutes. The court found the challengers had raised only facial challenges and determined that neither statute violated the constitutional provisions cited. The challengers appealed, raising multiple points of error regarding the constitutional analysis and factual findings at trial.The Supreme Court of Missouri reviewed the circuit court’s determination de novo, applying a presumption of constitutionality. Relying on recent decisions from the United States Supreme Court and the United States Court of Appeals for the Eighth Circuit, the court held that both statutes classify based only on age and medical use, not on sex or transgender status. Thus, rational-basis review applied. The court found that the statutes are rationally related to legitimate state interests, such as safeguarding minors and managing public resources, and do not infringe fundamental rights. The court affirmed the circuit court’s judgment, concluding that the challengers failed to demonstrate any constitutional violation. View "E.N. v. Kehoe" on Justia Law

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Amanda Ann Soron, who was unhoused, gave birth outdoors in freezing temperatures behind a retail store. Police discovered her with her newborn, who was still attached by the umbilical cord and subsequently pronounced dead at the hospital. Greenwood Village Police Officer Moreno accompanied Soron in the ambulance and remained present during her treatment, recording procedures and statements with a body-worn camera and documenting evidence during her hospital stay. Four months after the incident, Soron was arrested and charged with child abuse resulting in death. The prosecution sought and obtained a court order for production of all medical records related to Soron and her child’s hospital stay.In the Arapahoe County District Court, Soron moved to prevent the prosecution from accessing her medical records, arguing they were protected by the physician-patient privilege and that the request for records was misleading. After a period during which Soron was found incompetent and later restored to competency, the trial court ruled in her favor. The court found that the child abuse exception to the physician-patient privilege only applied to testimony, not to documents, and that the medical records—including those captured on Officer Moreno’s body-worn camera—were privileged. The court ordered the medical records and camera footage to be sealed and preserved, and denied Soron’s request for a veracity hearing as moot.The Supreme Court of Colorado reviewed the suppression order on interlocutory appeal. It affirmed the trial court’s decision that Soron’s medical records are protected by the physician-patient privilege and that the child abuse exception does not extend to documentary evidence. However, the Supreme Court reversed the portion of the order sealing the body-worn camera footage and related notes, remanding for further factual findings to determine whether that material is privileged or subject to other policy considerations. View "People v. Soron" on Justia Law