Justia Health Law Opinion Summaries

Aletha Porcaro was admitted to The Heights of Summerlin, a skilled nursing facility, for rehabilitation after surgery. Upon her discharge, she contracted COVID-19 and died eight days later. Her daughter, Rachelle Crupi, filed a lawsuit against The Heights and its parent companies, alleging that they failed to implement effective COVID-19 safety protocols. The claims included negligence, wrongful death, and other related causes of action.The Heights removed the case to federal court, which remanded it back to state court. In state court, The Heights moved to dismiss the case, arguing that the federal Public Readiness and Emergency Preparedness Act (PREP Act) and Nevada’s Emergency Directive 011 granted them immunity from Crupi’s claims. The district court dismissed the professional negligence claim but allowed the other claims to proceed.The Heights then petitioned the Supreme Court of Nevada for a writ of mandamus, seeking to dismiss the remaining claims based on the same immunity arguments. The Supreme Court of Nevada reviewed the petition and concluded that the PREP Act does not apply to a lack of action or failure to implement COVID-19 policies. The court also determined that Directive 011 does not grant immunity to health care facilities, as it applies to individual medical professionals, not facilities.The Supreme Court of Nevada denied the petition for a writ of mandamus, holding that neither the PREP Act nor Directive 011 provided immunity to The Heights for the claims brought by Crupi. The court affirmed the district court’s decision to allow the remaining claims to proceed. View "The Heights of Summerlin, LLC v. District Court" on Justia Law

Plaintiffs M.S. and L.S. sought insurance coverage for mental health treatments for their child, C.S., under a health benefits plan provided by M.S.'s employer, Microsoft Corporation. The plan, administered by Premera Blue Cross, is subject to ERISA and the Parity Act. Premera denied the claim, stating the treatment was not medically necessary. Plaintiffs pursued internal and external appeals, which upheld the denial. Plaintiffs then sued in federal district court, alleging improper denial of benefits under ERISA, failure to produce documents in violation of ERISA’s disclosure requirements, and a Parity Act violation for applying disparate treatment limitations to mental health claims.The United States District Court for the District of Utah granted summary judgment to Defendants on the denial-of-benefits claim but ruled in favor of Plaintiffs on the Parity Act and ERISA disclosure claims. The court found that Defendants violated the Parity Act by using additional criteria for mental health claims and failed to disclose certain documents required under ERISA. The court awarded statutory penalties and attorneys’ fees to Plaintiffs.The United States Court of Appeals for the Tenth Circuit reviewed the case. The court vacated the district court’s grant of summary judgment on the Parity Act claim, finding that Plaintiffs lacked standing to bring the claim. The court reversed the district court’s ruling that Defendants violated ERISA by not disclosing the Skilled Nursing InterQual Criteria but affirmed the ruling regarding the failure to disclose the Administrative Services Agreement (ASA). The court upheld the statutory penalty for the ASA disclosure violation and affirmed the award of attorneys’ fees and costs to Plaintiffs. View "M.S. v. Premera Blue Cross" on Justia Law

The case involves Sam Sarkis Solakyan, who owned multiple medical-imaging companies. Solakyan conspired with physicians and medical schedulers to route unsuspecting patients to his companies for unnecessary MRI scans and other medical services, generating $263 million in claims. The scheme involved bribery and kickbacks to physicians who referred patients to Solakyan’s companies, violating California’s anti-kickback statutes.The United States District Court for the Southern District of California presided over the initial trial. Solakyan was charged with conspiracy to commit honest-services mail fraud and health-care fraud, as well as substantive counts of honest-services mail fraud and aiding and abetting. After a seven-day trial, the jury found Solakyan guilty on all counts. The district court sentenced him to 60 months in prison and ordered him to pay $27,937,175 in restitution to the affected insurers.The United States Court of Appeals for the Ninth Circuit reviewed the case. The court affirmed Solakyan’s conviction, holding that honest-services mail fraud under 18 U.S.C. §§ 1341 and 1346 includes bribery and kickback schemes that deprive patients of their right to honest services from their physicians. The court also held that actual or intended tangible harm is not an element of honest-services fraud. The indictment was found sufficient in alleging willful misconduct for health-care fraud. The court did not find any abuse of discretion in the jury instructions regarding the mens rea for the conspiracy charges or the use of mails in the fraud scheme. However, the court vacated the restitution order, remanding the case for further proceedings to determine if the restitution amount should be reduced by the cost of medically necessary MRIs that insurers would have paid for absent the fraud. View "USA V. SOLAKYAN" on Justia Law

The case involves doctors who create and administer a stem cell mixture called stromal vascular fraction (SVF) by removing fat tissue from patients, processing it to concentrate stem cells, and then re-administering it to the same patients. The FDA inspected the clinics and found that the doctors were manufacturing and administering unapproved drug products, leading to a lawsuit alleging violations of the Food, Drug, and Cosmetic Act (FDCA).The United States District Court for the Central District of California held a bench trial and ruled in favor of the defendants. The court concluded that the SVF was not a "drug" under the FDCA and that the same-day SVF treatment fell under the "same surgical procedure" (SSP) exception, which exempts certain procedures from FDA regulation. The district court found that the cells in the same-day SVF were not altered chemically or biologically and that the procedure did not introduce any foreign material into the body.The United States Court of Appeals for the Ninth Circuit reviewed the case and reversed the district court's judgment. The appellate court held that the SVF constitutes a "drug" under the FDCA based on the plain text of the statute, which defines drugs as articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body. The court also rejected the defendants' argument that their same-day SVF treatment was exempt from FDA regulation under the SSP exception. The court concluded that the SSP exception applies only if the removed and implanted human cells, tissues, and cellular and tissue-based products (HCT/Ps) are the same, and in this case, the removed fat tissue and the implanted SVF are not the same.The Ninth Circuit reversed the district court's judgment and remanded the case for further proceedings. View "USA V. CALIFORNIA STEM CELL TREATMENT CENTER, INC." on Justia Law

The case involves John Holland, William Moore, and Ed Cota, who were accused of participating in an illegal healthcare kickback scheme. The government alleged that Holland and Moore, hospital executives for Tenet Healthcare, paid the Cotas to refer Medicaid or Medicare-covered pregnant women to Tenet hospitals. The payments were purportedly disguised as contracts for translation services. Tracey Cota, Ed Cota's wife, pleaded guilty to violating the Anti-Kickback Statute (AKS) by participating in this scheme. However, the other defendants argued that their business relationship did not violate the AKS because they lacked the requisite mental state or mens rea.The United States District Court for the Northern District of Georgia held a pretrial "paper" hearing to determine the admissibility of out-of-court statements made by the defendants' alleged coconspirators. The district court concluded that the government needed to prove by a preponderance of the evidence that the defendants' conduct was illegal to admit the statements under Rule 801(d)(2)(E). The court found that the government failed to prove the defendants' knowledge of illegality and thus excluded the coconspirator statements.The United States Court of Appeals for the Eleventh Circuit reviewed the district court's decision. The appellate court held that the district court erred in requiring proof of an illegal conspiracy to admit coconspirator statements. The court clarified that under Rule 801(d)(2)(E), it is sufficient to show that the statements were made during and in furtherance of a joint venture, regardless of the venture's legality. The Eleventh Circuit reversed the district court's decision and remanded the case for further proceedings consistent with this opinion. View "United States v. Holland" on Justia Law

The case involves a dispute over the taxability of personal property used by a hospital at an outpatient rehabilitation facility. The plaintiff, a hospital owned by a health system, operates a rehabilitation facility in a leased suite. The plaintiff claimed that the personal property used at this facility was exempt from taxation under Connecticut General Statutes § 12-81 (7) or (16), which provide tax exemptions for charitable and hospital property, respectively. The town's assessor denied the tax exemption, and the town's board of assessment appeals upheld this denial.The trial court reviewed the case and sided with the plaintiff, granting its motion for summary judgment. The court reasoned that although the plaintiff is part of a health system, the personal property was located at a leased facility, not owned by the health system, and therefore did not fall under the purview of General Statutes § 12-66a. The court concluded that the personal property was exempt from taxation under § 12-81 (7) and (16).The Connecticut Supreme Court reviewed the case and reversed the trial court's decision. The Supreme Court held that the personal property used at the rehabilitation facility is taxable under § 12-66a, even if it would otherwise be exempt under § 12-81 (7) or (16). The Court determined that the term "acquired" in § 12-66a includes leased property, not just purchased property. The Court emphasized that the statute aims to protect municipalities from losing tax revenue due to health systems acquiring tax-exempt status for properties they use, whether owned or leased. The Court also clarified that the plaintiff, as part of a health system, falls under the statute's provisions, making the personal property taxable.The Supreme Court reversed the trial court's judgment and remanded the case with directions to deny the plaintiff's motion for summary judgment and for further proceedings. View "William W. Backus Hospital v. Stonington" on Justia Law

Roy Lee Williams, a death-row inmate with a history of mental illness, was held in solitary confinement for twenty-six years. Williams filed a lawsuit claiming that his prolonged solitary confinement without penological justification violated the Eighth Amendment's prohibition against cruel and unusual punishment and the Americans with Disabilities Act (ADA). The District Court granted summary judgment in favor of the defendants, ruling that the former Secretary of the Pennsylvania Department of Corrections (DOC) was entitled to qualified immunity on the Eighth Amendment claim and that Williams could not prove deliberate indifference under the ADA.Before the summary judgment, the District Court dismissed Williams' Fourteenth Amendment claim for failure to state a claim. Williams appealed both the summary judgment and the dismissal of his Fourteenth Amendment claim.The United States Court of Appeals for the Third Circuit reviewed the case. The court concluded that the Secretary had "fair and clear warning" that keeping Williams in solitary confinement without penological justification was unconstitutional, thus rejecting the qualified immunity defense. The court held that it was clearly established that someone with a known preexisting serious mental illness has a constitutional right not to be held in prolonged solitary confinement without penological justification.Regarding the ADA claim, the court found that the District Court erred in concluding that a trier of fact could not find the DOC deliberately indifferent to the risk of harm caused by placing and keeping Williams in solitary confinement despite his mental illness. The court vacated the District Court's grant of summary judgment on both the Eighth Amendment and ADA claims and remanded for further proceedings. However, the court affirmed the dismissal of Williams' Fourteenth Amendment claim. View "Williams v. Secretary Pennsylvania Department of Corrections" on Justia Law

The case involves an encounter between the Hawai'i Police Department (HPD) and Steven Hyer, which resulted in Hyer's death. On June 22, 2018, HPD officers responded to calls about Hyer's erratic behavior. Hyer, who had a history of mental illness, barricaded himself in his apartment. After several hours of failed negotiations and attempts to subdue him, including the use of a Taser and chemical munitions, HPD officers deployed a police dog. When Hyer allegedly threatened the officers with a compound bow, Corporal Torres shot and killed him.The United States District Court for the District of Hawaii granted summary judgment in favor of the defendants, the City and County of Honolulu, and several HPD officers. The court excluded the plaintiffs' expert reports, finding them speculative, unreliable, and containing legal conclusions. The court ruled that the use of force was objectively reasonable and that the officers were entitled to qualified immunity. The court also dismissed the plaintiffs' claims under the Americans with Disabilities Act (ADA) and various state law claims.The United States Court of Appeals for the Ninth Circuit reviewed the case. The court held that the district court erred in excluding the entirety of the plaintiffs' expert reports, as the reports were based on sufficient facts and data. The Ninth Circuit found that the exclusion of these reports was prejudicial because they created genuine disputes of material fact regarding the reasonableness of the use of deadly force and chemical munitions, as well as potential ADA violations. The court reversed the district court's summary judgment on these claims but affirmed the grant of qualified immunity regarding the use of the police dog, as the law was not clearly established. The case was remanded for further proceedings. View "HYER V. CITY AND COUNTY OF HONOLULU" on Justia Law

The case involves the National Infusion Center Association (NICA) and other plaintiffs challenging the constitutionality of the Drug Price Negotiation Program established by the Inflation Reduction Act. This program requires the Department of Health and Human Services (HHS) to negotiate drug prices with manufacturers, setting a "maximum fair price" between 40% and 75% of the market price. Manufacturers who do not comply face significant fines or must withdraw from Medicare coverage entirely.The United States District Court for the Western District of Texas dismissed NICA's lawsuit for lack of subject-matter jurisdiction. The district court reasoned that NICA's claims had to be "channeled" through HHS as required by 42 U.S.C. § 405, which mandates that claims arising under the Medicare Act be decided by the relevant agency before being brought to federal court. The district court also dismissed the remaining plaintiffs due to improper venue without NICA.The United States Court of Appeals for the Fifth Circuit reviewed the case and found that NICA had standing based on both economic and procedural injuries. The court determined that NICA's claims did not arise under the Medicare Act but rather under the Inflation Reduction Act, and thus did not require channeling through HHS. The court held that the district court had subject-matter jurisdiction over NICA's claims and reversed the lower court's dismissal, remanding the case for further proceedings. View "Natl Infusion Center v. Becerra" on Justia Law

The case involves hundreds of plaintiffs who allege that they were injured by the drug Fosamax, manufactured by Merck Sharp & Dohme Corp. (Merck), due to inadequate warnings about the risk of atypical femoral fractures. The plaintiffs claim that they would not have taken the drug if they had been properly warned. Merck contends that it proposed a label change to the Food and Drug Administration (FDA) to address this risk, but the FDA rejected the proposed change due to insufficient scientific support.The United States District Court for the District of New Jersey granted summary judgment in favor of Merck, concluding that the plaintiffs' state law claims were preempted by federal law. The court found that Merck had fully informed the FDA of the justifications for the proposed warning and that the FDA had rejected the proposed label change, thus preempting the state law claims. The court relied on the FDA's Complete Response Letter and other communications to determine that the FDA's rejection was based on a lack of sufficient scientific evidence linking Fosamax to atypical femoral fractures.The United States Court of Appeals for the Third Circuit reviewed the case and vacated the District Court's judgment. The Third Circuit concluded that the District Court erred in its preemption analysis by giving too little weight to the presumption against preemption. The appellate court found that the FDA's Complete Response Letter was ambiguous and that the District Court placed too much reliance on informal FDA communications and an amicus brief to interpret the letter. The Third Circuit emphasized that the presumption against preemption is strong and that Merck did not meet the demanding standard of showing that federal law prohibited it from adding any and all warnings that would satisfy state law. The case was remanded for further proceedings. View "In re: Fosamax" on Justia Law