Justia Health Law Opinion Summaries

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moot the portion of the district court's order related to interim CMS regulations, as those regulations have been rescinded.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

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 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

Artak Ovsepian participated in a healthcare fraud scheme at Manor Medical Imaging, Inc., a sham clinic in Glendale, California. The clinic generated prescriptions for unnecessary medications, which were billed to Medicare and Medi-Cal. Manor employees used the identifying information of Medicare and Medi-Cal beneficiaries, often without their knowledge, to fill these prescriptions. Ovsepian joined the conspiracy in 2010, managing drivers who transported beneficiaries to pharmacies to fill fraudulent prescriptions.The government charged Ovsepian with conspiracy to commit healthcare fraud and aggravated identity theft under 18 U.S.C. § 1028A(a)(1). At trial, the government narrowed the aggravated identity theft charge to the possession of one victim’s identifying information. The jury found Ovsepian guilty on all counts, and he was sentenced to 180 months, including a mandatory 24-month sentence for aggravated identity theft. Ovsepian’s direct appeals were unsuccessful, and the Supreme Court denied his petition for a writ of certiorari.Ovsepian filed a 28 U.S.C. § 2255 motion to vacate his aggravated identity theft conviction, arguing actual innocence. The district court denied the motion, and the Ninth Circuit initially denied a certificate of appealability. However, the Supreme Court remanded the case for reconsideration in light of Dubin v. United States, which clarified the interpretation of the aggravated identity theft statute.The Ninth Circuit reversed the district court’s denial of Ovsepian’s § 2255 motion. The court held that a petitioner convicted under a divisible statute must demonstrate actual innocence only for the prong under which they were convicted. The court found that the jury instructions were erroneous because they did not convey that possession of another’s identifying information must be central to the healthcare fraud to sustain a conviction. Consequently, the Ninth Circuit vacated Ovsepian’s conviction and sentence for aggravated identity theft. View "USA V. OVSEPIAN" on Justia Law

The case involves a coalition of states led by Washington suing the FDA over its 2023 REMS, which eliminated in-person dispensing requirements for the abortion drug mifepristone. Washington argues that the FDA should have further reduced restrictions on the drug, claiming that the remaining requirements impose unnecessary hurdles. Idaho, leading another coalition of states, sought to intervene, arguing that the elimination of the in-person dispensing requirement would harm its interests by making the drug easier to obtain and harder to police, potentially increasing Medicaid costs and endangering maternal health and fetal life.The United States District Court for the Eastern District of Washington denied Idaho's motion to intervene. The court found that Idaho did not have a significantly protectable interest that would be impaired by the litigation, as its complaint concerned different aspects of the 2023 REMS. The court also denied permissive intervention, concluding that Idaho's claims did not share common questions of law or fact with Washington's claims.The United States Court of Appeals for the Ninth Circuit reviewed the case and affirmed the district court's denial of Idaho's motion to intervene as of right. The Ninth Circuit held that Idaho must independently satisfy the requirements of Article III standing because it sought different relief from Washington. The court concluded that Idaho's complaint did not establish a cognizable injury-in-fact that was fairly traceable to the FDA's revised safe-use restrictions. Idaho's alleged economic injuries, law enforcement burdens, and quasi-sovereign interests were deemed too speculative or indirect to confer standing. The court dismissed for lack of jurisdiction the portion of the appeal concerning the denial of permissive intervention. View "STATE OF WASHINGTON V. FDA" on Justia Law

The case involves three sets of plaintiffs who filed class-action lawsuits against their healthcare provider, Cedars-Sinai Health System and Cedars-Sinai Medical Center. The plaintiffs alleged that Cedars-Sinai unlawfully disclosed their private medical information to third parties through tracking software on its website. Cedars-Sinai removed the suits to federal court, arguing that it developed its website while acting under a federal officer and at the direction of the federal government.The district court disagreed with Cedars-Sinai's argument. It held that Cedars-Sinai developed its website in compliance with a generally applicable and comprehensive regulatory scheme and that there is therefore no federal jurisdiction under § 1442(a)(1). The court found that although Cedars-Sinai’s website furthers the government’s broad goal of promoting access to digital health records, Cedars-Sinai’s relationship with the federal government does not establish that it acted pursuant to congressionally delegated authority to help accomplish a basic governmental task.The United States Court of Appeals for the Ninth Circuit affirmed the district court’s orders remanding the removed actions to state court. The court agreed with the district court that Cedars-Sinai developed its website in compliance with a generally applicable and comprehensive regulatory scheme under the Health Information Technology for Economic and Clinical Health Act, and that there was therefore no federal jurisdiction under § 1442(a)(1). The court concluded that Cedars-Sinai did not meet § 1442(a)(1)’s “causal nexus” requirement. View "Doe v. Cedars-Sinai Health System" on Justia Law

The case involves a group of plaintiffs, including the Health Freedom Defense Fund, Inc. and California Educators for Medical Freedom, who challenged the COVID-19 vaccination policy of the Los Angeles Unified School District (LAUSD). The policy, which was in effect for over two years, required employees to get the COVID-19 vaccination or lose their jobs. The plaintiffs argued that the policy interfered with their fundamental right to refuse medical treatment.The case was initially dismissed by the United States District Court for the Central District of California, which applied a rational basis review under Jacobson v. Massachusetts, concluding that the policy served a legitimate government purpose. The court held that even if the vaccine did not prevent transmission or contraction of COVID-19, it furthered the purpose of protecting LAUSD students and employees from COVID-19.The plaintiffs appealed to the United States Court of Appeals for the Ninth Circuit. During the appeal, LAUSD rescinded its vaccination policy. LAUSD then asked the court to dismiss the appeal, arguing that the case was now moot. The plaintiffs objected, arguing that LAUSD withdrew the policy because they feared an adverse ruling.The Ninth Circuit held that the case was not moot, applying the voluntary cessation exception to mootness. The court found that LAUSD's pattern of withdrawing and then reinstating its vaccination policies, particularly in response to litigation risk, was enough to keep the case alive.On the merits, the Ninth Circuit held that the district court misapplied the Supreme Court’s decision in Jacobson v. Massachusetts. The court found that Jacobson did not apply because the plaintiffs had plausibly alleged that the COVID-19 vaccine does not effectively prevent the spread of COVID-19. The court vacated the district court’s order and remanded the case for further proceedings under the correct legal standard. View "HEALTH FREEDOM DEFENSE FUND, INC. V. ALBERTO CARVALHO" on Justia Law

A class of individuals and businesses in Northern California, who paid health insurance premiums to certain health plans, sued Sutter Health, a healthcare system operator in the region. They alleged that Sutter abused its market power to charge supracompetitive rates to these health plans, which were then passed on to the class in the form of higher premiums. The case went to trial on claims under California’s Cartwright Act for tying and unreasonable course of conduct. The jury returned a verdict in favor of Sutter.The plaintiffs appealed, arguing that the district court erred by failing to instruct the jury to consider Sutter’s anticompetitive purpose and by excluding evidence of Sutter’s conduct before 2006. The United States Court of Appeals for the Ninth Circuit agreed with the plaintiffs. It held that the district court contravened California law by removing “purpose” from the jury instructions, and that the legal error was not harmless. The court also held that the district court abused its discretion under Federal Rule of Evidence 403 in excluding as minimally relevant all evidence of Sutter’s conduct before 2006. The court concluded that these errors were prejudicial and reversed the district court’s judgment, remanding the case for a new trial. View "SIDIBE V. SUTTER HEALTH" on Justia Law

The case involves Bristol SL Holdings, Inc., the successor-in-interest to Sure Haven, Inc., a defunct drug rehabilitation and mental health treatment center, and Cigna Health and Life Insurance Company and Cigna Behavioral Health, Inc. Bristol alleged that Sure Haven's calls to Cigna verifying out-of-network coverage and seeking authorization to provide health services created independent contractual obligations. Cigna, however, denied payment based on fee-forgiving, a practice prohibited by the health plans. Bristol brought state law claims for breach of contract and promissory estoppel against Cigna.The district court initially dismissed Bristol’s claims, but the Ninth Circuit Court of Appeals reversed the dismissal, holding that Bristol had derivative standing to sue for unpaid benefits as Sure Haven’s successor-in-interest. On remand, the district court granted Cigna’s motion for summary judgment, ruling that the Employee Retirement Income Security Act of 1974 (ERISA) preempted Bristol’s state law claims.On appeal, the Ninth Circuit Court of Appeals affirmed the district court's decision. The court held that Bristol’s state law claims were preempted by ERISA because they had both a “reference to” and an “impermissible connection with” the ERISA plans that Cigna administered. The court reasoned that Bristol’s claims were not independent of an ERISA plan because they concerned the denial of reimbursement to patients who were covered under such plans. The court also held that allowing liability on Bristol’s state law claims would interfere with nationally uniform plan administration, a central matter of plan administration. View "Bristol SL Holdings, Inc. v. Cigna Health and Life Insurance Co." on Justia Law