Justia Health Law Opinion Summaries

The case involves Lucas Sirois and Alisa Sirois, who were indicted for conspiracy to distribute and possess with intent to distribute marijuana under the Controlled Substances Act (CSA). They sought to enjoin the Department of Justice (DOJ) from prosecuting them, arguing that their conduct was in substantial compliance with the Maine Medical Use of Cannabis Act, which allows for the use, distribution, possession, and cultivation of medical marijuana under state law. The defendants claimed that the DOJ's prosecution violated the Rohrabacher-Farr Amendment, which prohibits the DOJ from using funds to prevent states from implementing their medical marijuana laws.The United States District Court for the District of Maine denied the defendants' request for injunctive relief. The court held a hearing where the government presented evidence that the defendants' operations, particularly a grow operation known as the "Shoe Shop," violated Maine's medical marijuana laws by operating as a collective and engaging in black-market sales. The court found that the government had met its burden of production, showing a substantial evidentiary basis for the prosecution. However, the defendants failed to meet their burden of persuasion to demonstrate that the prosecution lacked a substantial evidentiary basis or was arbitrary or irrational.The United States Court of Appeals for the First Circuit reviewed the case and affirmed the District Court's decision. The appellate court held that the defendants did not show by a preponderance of the evidence that they were in substantial compliance with Maine's medical marijuana laws. The court noted significant evidence that the Shoe Shop operated as a collective and that Lucas Sirois engaged in black-market sales. The court concluded that the defendants failed to demonstrate that the DOJ's prosecution would prevent Maine from giving practical effect to its medical marijuana laws, as required under the Rohrabacher-Farr Amendment. Therefore, the denial of the motion to enjoin the prosecution was affirmed. View "United States v. Sirois" on Justia Law

K.M., an adult with multiple disabilities, including autism and a seizure disorder, has been receiving Medicaid-funded developmental disabilities services for over twenty years. These services, provided by Washington County Mental Health Services (WCMHS), were supposed to include more than thirty hours of community support each week. However, since March 2020, K.M. has only received two to five hours of support weekly, leading to negative health effects.K.M. petitioned the Human Services Board to order the Department of Disabilities, Aging, and Independent Living (DAIL) to provide the full services he is entitled to. The Board dismissed his petition, stating it failed to specify the action required for compliance and that an order to provide services without available staff was too vague. The Board also interpreted K.M.'s request as seeking a broader policy change, which it deemed outside its authority, citing Husrefovich v. Department of Aging & Independent Living.The Vermont Supreme Court reviewed the case and reversed the Board's dismissal. The Court held that the Board has the statutory authority to order DAIL to provide the services K.M. is entitled to under federal and state law. The Court clarified that while the Board cannot issue broad policy injunctions, it can provide specific relief to individuals. The Court found K.M.'s request for services clear and specific enough to inform DAIL of the required action. The case was remanded to the Board for further proceedings consistent with this opinion. View "In re Appeal of K.M." on Justia Law

The case involves a challenge to two Montana laws, HB 544 and HB 862, and a rule adopted by the Montana Department of Public Health and Human Services (DPHHS) regarding Medicaid funding for abortions. The plaintiffs, including Planned Parenthood of Montana and other healthcare providers, argue that these provisions infringe on the constitutional rights of their patients by imposing restrictions on Medicaid coverage for abortions. Specifically, the laws and rule bar Medicaid from covering abortions provided by non-physicians, require prior authorization for abortion services, and limit Medicaid coverage to abortions deemed "medically necessary" under a restrictive definition.The First Judicial District Court of Lewis and Clark County issued a preliminary injunction to halt the enforcement of HB 544, HB 862, and the DPHHS rule. The court found that the plaintiffs were likely to succeed on the merits of their claims, which included violations of the right to privacy and equal protection under the Montana Constitution. The court applied strict scrutiny, determining that the laws and rule were not narrowly tailored to serve a compelling state interest. The court also found that the plaintiffs would suffer irreparable harm without the injunction and that the balance of equities and public interest favored granting the injunction.The Montana Supreme Court reviewed the case and affirmed the District Court's decision to grant the preliminary injunction. The Supreme Court agreed that the plaintiffs were likely to succeed on the merits, as the challenged provisions infringed on the fundamental right to privacy and equal protection. The court held that the state failed to demonstrate that the laws and rule were narrowly tailored to address a medically acknowledged, bona fide health risk. The Supreme Court also found that the plaintiffs would suffer irreparable harm without the injunction and that the balance of equities and public interest supported maintaining the injunction. View "Planned Parenthood v. State" on Justia Law

The case involves a challenge to Montana House Bill 702 (HB 702), which prohibits discrimination based on vaccination status. Plaintiffs, including health care providers and individuals with compromised immune systems, argued that HB 702 is preempted by the Americans with Disabilities Act (ADA) and the Occupational Health and Safety Act (OSH Act) and violates the Equal Protection Clause of the Fourteenth Amendment. They sought to invalidate HB 702 in all health care settings, claiming it prevents employers from knowing employees' vaccination status, thus hindering ADA-required accommodations and OSH Act compliance.The United States District Court for the District of Montana ruled in favor of the plaintiffs, holding that HB 702 is preempted by the ADA and the OSH Act and violates the Equal Protection Clause. The court issued a permanent injunction against the enforcement of HB 702 in health care settings, reasoning that the law conflicts with federal requirements for reasonable accommodations and workplace safety.The United States Court of Appeals for the Ninth Circuit reversed the district court's decision and vacated the injunction. The Ninth Circuit held that neither the ADA nor the OSH Act facially preempts HB 702 in health care settings. The court found that the plaintiffs did not demonstrate a genuine conflict between HB 702 and the ADA or OSH Act in any specific case, much less in all health care settings. The court also held that HB 702 does not violate the Equal Protection Clause, as the classification and differential treatment of facilities could rationally reflect Montana's interest in balancing personal privacy and public health.The Ninth Circuit reserved judgment on whether the ADA and the OSH Act could preempt HB 702 on a narrower, as-applied basis in future cases. The court deemed moot the portion of the district court's order related to interim CMS regulations, as those regulations have been rescinded. The court concluded that HB 702 is not facially invalid under the ADA, OSH Act, or Equal Protection Clause and vacated the district court's injunction in full. View "MONTANA MEDICAL ASSOCIATION V. KNUDSEN" on Justia Law

Theresa Johnson, individually and as executor of her deceased husband Nathaniel Johnson's estate, filed a wrongful-death action against Jackson Hospital & Clinic, Inc. Nathaniel, suffering from COVID-19, was admitted to Jackson Hospital on November 26, 2020. He was placed on a BiPAP device for breathing assistance. On December 6, 2020, he was to be moved to another floor. During the transfer, the BiPAP device was removed, and an oxygen mask was allegedly placed on him. However, Nathaniel experienced distress and died shortly after.The Montgomery Circuit Court initially granted Jackson Hospital's motion for summary judgment, but later set it aside to allow further discovery. Johnson argued that Jackson Hospital's actions were wanton and did not comply with public health guidance. The trial court ultimately denied Jackson Hospital's renewed motion for summary judgment, holding that Johnson's action could proceed under an exception in the Alabama Covid Immunity Act (ACIA).The Supreme Court of Alabama reviewed the case. It found that Jackson Hospital was immune from Johnson's negligence claims under the ACIA and the May 8 proclamation issued by Governor Ivey, which provided liability protections for health-care providers during the COVID-19 pandemic. The court also determined that Johnson did not present clear and convincing evidence of wanton conduct by Jackson Hospital's staff. Consequently, the Supreme Court of Alabama granted Jackson Hospital's petition for a writ of mandamus, directing the trial court to enter a summary judgment in favor of Jackson Hospital on all claims. View "Ex parte Jackson Hospital & Clinic, Inc." on Justia Law

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