Justia Health Law Opinion Summaries

In 1984, the Department of Health and Human Services (HHS) created the U.S. Preventive Services Task Force to make evidence-based recommendations on preventive healthcare services. The Affordable Care Act of 2010 required most health insurers to cover services rated "A" or "B" by the Task Force without cost sharing. Plaintiffs, including Braidwood Management, objected to these requirements and argued that Task Force members are principal officers who must be appointed by the President with Senate consent, not by the Secretary of HHS.The U.S. District Court for the Northern District of Texas agreed with the plaintiffs, ruling that Task Force members are principal officers because they have no superior who supervises and directs them. The court enjoined the government from enforcing the insurance coverage mandates based on Task Force recommendations issued after 2010. The U.S. Court of Appeals for the Fifth Circuit affirmed, holding that Task Force members are principal officers because they cannot be independent and free from political pressure while being supervised by a political appointee.The Supreme Court of the United States reversed the Fifth Circuit's decision, holding that Task Force members are inferior officers. The Court reasoned that the Secretary of HHS has the authority to remove Task Force members at will and to review and block their recommendations before they take effect. This supervision and direction by the Secretary, a principal officer, means that Task Force members are inferior officers. Therefore, their appointment by the Secretary of HHS is consistent with the Appointments Clause of the Constitution. The case was remanded for further proceedings consistent with this opinion. View "Kennedy v. Braidwood Management, Inc." on Justia Law

Thomas Keller, a physician specializing in pain management, was convicted of prescribing controlled substances outside the scope of professional practice. Keller was known for prescribing large quantities of opioids, which led to a federal investigation. During the investigation, agents seized a journal from Keller's residence, which contained patient information and medical notes. Keller was subsequently indicted on federal charges, including unlawfully dispensing controlled substances and health care fraud. He was convicted on four counts of distributing controlled substances outside the scope of professional practice.The United States District Court for the Northern District of California denied Keller's motion to suppress the journal, finding it fell within the scope of the search warrant and was supported by probable cause. The court also declined to hold an evidentiary hearing on the suppression motion, ruling that Keller's allegations did not establish contested issues of fact. Additionally, the court rejected Keller's argument that the charges violated the nondelegation doctrine, holding that the Attorney General's regulations were within the scope of authority delegated by Congress. Keller was sentenced to 30 months in prison and 3 years of supervised release.The United States Court of Appeals for the Ninth Circuit affirmed Keller's conviction and sentence. The court held that the district court did not err in denying the motion to suppress the journal, as it was properly seized under the search warrant. The court also found no abuse of discretion in the district court's decision not to hold an evidentiary hearing. The court upheld the constitutionality of the nondelegation doctrine as applied to Keller's charges. Finally, the court ruled that the district court correctly calculated Keller's sentencing range using the drug conversion ratio found in the Sentencing Guidelines commentary, as it was properly incorporated into the Guidelines. View "United States v. Keller" on Justia Law

Jazz Pharmaceuticals, Inc. (Jazz) challenged the FDA's approval of Avadel CNS Pharmaceuticals Inc.'s (Avadel) drug Lumryz, which contains the same active ingredient, oxybate, as Jazz's drug Xywav. Jazz argued that the FDA's approval violated its seven-year marketing exclusivity under the Orphan Drug Act (ODA). The key issue was whether Lumryz and Xywav are considered the "same drug" under the ODA, which would bar the FDA from approving Lumryz during Xywav's exclusivity period.The United States District Court for the District of Columbia granted summary judgment in favor of the FDA and Avadel, concluding that the FDA's approval of Lumryz did not violate the ODA. The court reasoned that the statutory text, history, and purpose indicated that Congress intended to incorporate the FDA's regulatory definition of "same drug," which includes a clinical superiority requirement. The court found that Lumryz, being clinically superior to Xywav due to its once-nightly dosing regimen, was not the "same drug" as Xywav.The United States Court of Appeals for the District of Columbia Circuit affirmed the district court's decision. The appellate court held that the FDA did not act beyond its statutory authority in approving Lumryz. The court concluded that Congress, by amending the ODA in 2017, intended to incorporate the FDA's longstanding regulatory definition of "same drug," which includes the concept of clinical superiority. Since Lumryz was found to be clinically superior to Xywav, it was not considered the "same drug," and thus, the FDA's approval of Lumryz during Xywav's exclusivity period was lawful. View "Jazz Pharmaceuticals, Inc. v. Kennedy" on Justia Law

In 2018, South Carolina excluded Planned Parenthood from its Medicaid program, citing state law prohibiting public funds for abortion. Planned Parenthood and patient Julie Edwards sued, claiming the exclusion violated the Medicaid any-qualified-provider provision, which allows Medicaid beneficiaries to obtain services from any qualified provider. Edwards preferred Planned Parenthood for gynecological care but needed Medicaid coverage. They filed a class action under 42 U.S.C. §1983 to enforce rights under the federal Medicaid statutes.The district court granted summary judgment for the plaintiffs and enjoined the exclusion. The Fourth Circuit affirmed. The Supreme Court granted certiorari, vacated, and remanded the case in light of Health and Hospital Corporation of Marion Cty. v. Talevski, which addressed whether another spending-power statute created §1983-enforceable rights. On remand, the Fourth Circuit reaffirmed its decision.The Supreme Court of the United States held that Section 1396a(a)(23)(A) does not clearly and unambiguously confer individual rights enforceable under §1983. The Court emphasized that spending-power statutes rarely create enforceable rights and that the any-qualified-provider provision lacks the clear rights-creating language necessary to support a §1983 action. The Court reversed the Fourth Circuit's decision and remanded the case for further proceedings consistent with this opinion. View "Medina v. Planned Parenthood South Atlantic" on Justia Law

Alicia Rae Pufahl applied for disability insurance benefits from the Social Security Administration in August 2012, citing limitations due to Wegener’s granulomatosis, depression, pulmonary disease, back injury, bipolar disorder, and excessive fatigue. She needed to establish disability between August 8, 2011, and December 31, 2016. Her application was initially denied in November 2012, followed by several unfavorable decisions from Administrative Law Judges (ALJs), appeals, and remands. The most recent ALJ decision concluded that she was not disabled during the relevant period, and the district court affirmed this decision.The United States District Court for the Eastern District of Wisconsin affirmed the ALJ’s decision, finding that substantial evidence supported the agency’s determination. The Appeals Council denied further review, making the ALJ’s decision the final decision of the Commissioner of Social Security.The United States Court of Appeals for the Seventh Circuit reviewed the case and affirmed the district court’s judgment. The court held that the ALJ properly weighed the medical opinion evidence, including the opinions of Ms. Pufahl’s neurologist, primary care provider, and psychiatrist, and found substantial evidence supporting the ALJ’s decision to not give controlling weight to these opinions. The ALJ’s evaluation of Ms. Pufahl’s subjective complaints was not patently wrong, as it was supported by specific reasons and evidence. Additionally, the hypothetical question posed to the vocational expert (VE) sufficiently accounted for Ms. Pufahl’s mental limitations, including her ability to maintain attention and concentration for two-hour segments. The court concluded that the ALJ’s decision was supported by substantial evidence and affirmed the district court’s judgment. View "Pufahl v Bisignano" on Justia Law

Randy Wiertella died in the Lake County Adult Detention Facility on December 10, 2018. Dennis Wiertella, as the Administrator of Randy's estate, filed a lawsuit claiming that Randy's constitutional rights under the Eighth and Fourteenth Amendments were violated by Jail staff Diane Snow, RN, and Christina Watson, LPN. Randy had been booked into the Jail without his essential medications for heart disease, diabetes, high blood pressure, and a psychiatric disorder. Despite multiple requests, he did not receive all necessary medications, leading to his death from hypertensive cardiovascular disease.The United States District Court for the Northern District of Ohio denied Snow and Watson's motion for summary judgment, which sought dismissal based on qualified immunity. The court found that there were genuine disputes of material fact regarding whether Snow and Watson were aware of the substantial risk to Randy's health and whether they failed to respond reasonably.The United States Court of Appeals for the Sixth Circuit reviewed the case. The court held that Snow and Watson were not entitled to qualified immunity. The court found that both nurses were aware of Randy's serious medical conditions and the need for continuous medication. Despite this knowledge, they failed to ensure that Randy received his essential medications in a timely manner. The court concluded that their actions were unreasonable and violated Randy's constitutional rights. The court affirmed the district court's decision and remanded the case for further proceedings on the Estate's § 1983 claim. View "Wiertella v. Lake County" on Justia Law

Dr. Brian Carpenter was involved in a scheme to defraud TRICARE, the Department of Defense’s health insurance program. The scheme was orchestrated by Britt and Matt Hawrylak, who hired sub-reps to obtain medical information about TRICARE beneficiaries and identify doctors willing to write unnecessary prescriptions for compounded medications. These prescriptions were filled by Rxpress Pharmacy, which billed TRICARE at high rates. Carpenter, a podiatrist, was recruited by his co-defendant Jerry Hawrylak to write these prescriptions. Carpenter initially refused but later agreed to write prescriptions without receiving payment, claiming it was to help veterans. However, evidence showed that Carpenter's prescriptions were highly profitable for the Hawrylak brothers and Jerry, who made millions from the scheme.In September 2019, Carpenter and Jerry were indicted on six counts of healthcare fraud and one count of conspiracy to commit healthcare fraud. They were convicted on all counts in April 2023 by the United States District Court for the Northern District of Texas. Carpenter appealed, raising several issues, including the district court’s decision to excuse a juror mid-trial.The United States Court of Appeals for the Fifth Circuit reviewed the case. The court found that the district court abused its discretion by excusing a juror after the first day of trial without a legally relevant reason or factual basis. The juror was excused based on an email from her principal stating that her absence would cause hardship for her school, but there was no indication that the juror was unable to perform her duties. The appellate court held that this error was prejudicial and required vacating Carpenter’s convictions. The court remanded the case for a new trial. View "United States v. Carpenter" on Justia Law

Michael Cannata served as a firefighter for the town of Mashpee for over a decade before leaving in 2004 as a "deferred retiree." During his employment, he was enrolled in the town's group health insurance plan, but his enrollment ended upon his departure. In 2021, after turning fifty-five and beginning to collect retirement benefits, Cannata sought to re-enroll in the town's health insurance plan as a retiree. The town denied his request, citing various reasons, including his lack of "time in-service" and the town's practice of denying coverage to retirees not enrolled in the plan at the time of retirement.Cannata filed an action in the Superior Court, seeking a judgment declaring that the town's denial of benefits violated G. L. c. 32B, § 9. The Superior Court judge granted the town's motion to dismiss for failure to state a claim, concluding that Cannata was required to apply for continued coverage and pay the full premium cost during his deferral period in order to later enroll in the town's group health insurance plan upon retirement. Cannata appealed the decision.The Supreme Judicial Court of Massachusetts reviewed the case. The court held that G. L. c. 32B, § 9, neither requires nor prohibits a municipality from enrolling individuals like Cannata in its group health insurance plan upon retirement. The court concluded that the third paragraph of the statute, which the lower court relied on, did not govern Cannata's case. The court determined that municipalities may, but are not obligated to, allow such individuals to enroll in group health insurance upon retirement. The court affirmed the judgment of dismissal on the alternative ground that Cannata's complaint failed to plausibly allege entitlement to relief beyond a speculative level. The case was remanded with instructions to dismiss the complaint without prejudice, allowing Cannata an opportunity to amend his request for declaratory relief. View "Cannata v. Town of Mashpee" on Justia Law

In 2023, Tennessee enacted Senate Bill 1 (SB1), which prohibits healthcare providers from prescribing, administering, or dispensing puberty blockers or hormones to minors for the purpose of enabling them to identify with a gender different from their biological sex or to treat discomfort from such discordance. However, SB1 allows these treatments for minors with congenital defects, precocious puberty, disease, or physical injury. Three transgender minors, their parents, and a doctor challenged SB1 under the Equal Protection Clause of the Fourteenth Amendment.The District Court partially enjoined SB1, finding that transgender individuals constitute a quasi-suspect class, that SB1 discriminates based on sex and transgender status, and that it was unlikely to survive intermediate scrutiny. The Sixth Circuit reversed, holding that SB1 did not trigger heightened scrutiny and satisfied rational basis review. The court found that SB1 did not classify based on sex or transgender status and that Tennessee had provided considerable evidence regarding the risks associated with the banned treatments.The Supreme Court of the United States reviewed the case and held that SB1 is not subject to heightened scrutiny under the Equal Protection Clause and satisfies rational basis review. The Court determined that SB1 does not classify on any bases that warrant heightened review, such as sex or transgender status. Instead, it classifies based on age and medical use, which are subject to rational basis review. The Court found that Tennessee had a rational basis for enacting SB1, citing concerns about the risks and unknown long-term effects of the treatments, the maturity of minors, and the availability of less invasive approaches. The judgment of the Sixth Circuit was affirmed. View "United States v. Skrmetti" on Justia Law

New York City is legally required to provide health insurance coverage for its retired employees. For over 50 years, the City offered a choice of health insurance plans, including Medicare supplemental plans and Medicare Advantage plans (MAPs). In 2021, to reduce costs, the City decided to discontinue most options, including the popular Senior Care plan, and enroll all retirees in a custom-designed MAP managed by Aetna Life Insurance Company. Petitioners, consisting of nine retirees and one organization, initiated this proceeding to prevent the City from eliminating their existing health insurance plans.The Supreme Court ruled in favor of the petitioners on their promissory estoppel cause of action and their claim under Administrative Code of the City of New York § 12-126 (b) (1). The Appellate Division affirmed the decision, concluding that the City had made a clear and unambiguous promise to provide Medicare supplemental coverage for life and that petitioners reasonably relied on this promise.The Court of Appeals of New York reviewed the case and determined that the petitioners were not entitled to judgment on their promissory estoppel cause of action. The court found that the Summary Program Descriptions (SPDs) provided by the City did not constitute a clear and unambiguous promise of lifetime Medicare supplemental insurance coverage. The court also rejected the petitioners' alternative grounds for relief, including their claim under Administrative Code § 12-126 (b) (1) and the Moratorium Law. Consequently, the Court of Appeals reversed the order of the Appellate Division and remitted the matter to the Supreme Court for further proceedings. View "Matter of Bentkowski v City of New York" on Justia Law