Justia Health Law Opinion Summaries

A registered nurse was convicted by a jury of misdemeanor elder or dependent adult abuse for her role in the care of a 62-year-old dependent adult, Michael H., at an unlicensed boarding house in Riverside, California. The facility, Secure Hands, was not authorized to provide medical care and was intended for residents who could manage their own daily activities. However, Michael, who had recently suffered a stroke and had significant physical and mental limitations, was admitted to the facility under the nurse’s assessment and supervision. The nurse determined his care needs, recommended equipment, and was responsible for ensuring that appropriate caregivers were available. Despite knowing the facility was not equipped for dependent adults, she admitted Michael and did not report or address ongoing concerns about his care, including poor hygiene and lack of basic necessities, which were repeatedly brought to her attention.The Superior Court of Riverside County initially charged the nurse with four counts of felony elder or dependent adult abuse, but one count was dismissed before trial. The jury deadlocked on two counts, resulting in a mistrial for those, but found her guilty of the lesser included misdemeanor offense regarding Michael. She was sentenced to four months in county jail and fined $1,000.On appeal, the nurse argued that the definition of “care or custody” from the Elder Abuse and Dependent Adult Civil Protection Act should apply to her criminal prosecution, and that there was insufficient evidence she had such responsibility. The California Court of Appeal, Fourth Appellate District, Division Two, rejected this argument, holding that “care or custody” in Penal Code section 368(c) should be interpreted according to its plain and ordinary meaning, not the more restrictive civil definition. The court found substantial evidence supported the jury’s verdict and affirmed the conviction. View "P. v Molina" on Justia Law

Plaintiffs, which are self-insured health and welfare trust funds, challenged a statutory requirement under the Patient Protection and Affordable Care Act (ACA) that obligated them to pay contributions to the Transitional Reinsurance Program (TRP) for the 2014, 2015, and 2016 benefit years. They argued that these mandatory payments constituted a taking of their property under the Fifth Amendment, claiming a protected property interest in the specific funds held in their trust accounts, which are maintained solely for providing health and welfare benefits to covered individuals.The United States Court of Federal Claims reviewed the case and granted the Government’s motion for partial summary judgment on the Fifth Amendment takings claim. The Claims Court found that the plaintiffs did not possess a cognizable property interest in the TRP payments, as the obligation was merely to pay money, not to surrender specifically identifiable funds. The court rejected the argument that the trust agreements created a property interest in the sums paid, and also dismissed the alternative claim that the trust accounts themselves were the specific funds at issue. The Claims Court further held that a taking would only occur if the government appropriated the entire fund, which did not happen here. Plaintiffs’ motion for reconsideration was denied.On appeal, the United States Court of Appeals for the Federal Circuit reviewed the grant of summary judgment de novo. The Federal Circuit affirmed the Claims Court’s decision, holding that the statutory obligation to pay TRP contributions did not constitute a taking under the Fifth Amendment because it was an obligation to pay money, not an appropriation of a specific, identifiable fund. The court clarified that a mere requirement to pay money, even from a trust account, does not give rise to a takings claim. The Federal Circuit also found harmless error in the Claims Court’s alternative reasoning regarding appropriation of funds in toto. The judgment was affirmed. View "ELECTRICAL WELFARE TRUST FUND v. US " on Justia Law

Jill Esche, who was seven months pregnant, was admitted to Renown Regional Medical Center in Nevada with severe hypertension and erratic behavior. Hospital staff, believing she was mentally ill and a danger to herself and her fetus, petitioned for her involuntary commitment under Nevada law. While the petition was pending, Esche was kept in the hospital, given psychiatric and medical treatment against her will, restricted from visitors and phone use, and not informed that a public defender had been appointed for her. After giving birth by C-section, the hospital decided to withdraw the commitment petition but allowed Esche to leave while she was still in fragile condition. She died outside near the hospital that night. Her estate and survivors sued the hospital and several staff members, alleging violations of her constitutional rights under 42 U.S.C. § 1983 and Nevada law.The United States District Court for the District of Nevada granted summary judgment to the defendants on some claims, including unreasonable seizure and procedural due process claims, but denied summary judgment on others, such as substantive due process, conspiracy, and failure-to-train-or-supervise claims. The court also denied the defendants’ assertion of a good-faith defense to § 1983 liability, finding that the defense did not apply because the hospital was not required by law or directed by a public official to hold Esche involuntarily. Both sides appealed: the defendants challenged the denial of the good-faith defense, and the plaintiffs cross-appealed the dismissal of other constitutional claims.The United States Court of Appeals for the Ninth Circuit reviewed the case and held that the district court’s denial of the good-faith defense was not immediately appealable under the collateral order doctrine, as the defense is a defense to liability, not an immunity from suit. The court dismissed both the defendants’ appeals and the plaintiffs’ cross-appeal for lack of jurisdiction. View "Estate of Esche v. Bunuel-Jordana" on Justia Law

Natalya Shvets was convicted by a jury in 2014 for healthcare fraud and conspiracy to commit healthcare fraud, stemming from her role as a nurse at Home Care Hospice, Inc. (HCH). Evidence showed she and other employees created false records for high-priced “continuous care” services, resulting in fraudulent bills submitted to Medicare. Shvets was ordered to pay $253,196 in restitution, jointly and severally with eight other defendants, for her involvement in 52 false bills. The broader scheme allegedly caused $16.2 million in losses to Medicare, with seventeen individuals ordered to pay varying restitution amounts.After sentencing in the United States District Court for the Eastern District of Pennsylvania, Shvets moved for an accounting and to declare her restitution judgment satisfied, arguing that payments by herself and her jointly liable co-defendants had collectively exceeded $253,196. The District Court, relying on United States v. Sheets, held that Shvets’s judgment would not be satisfied until she personally paid the full amount or until all defendants collectively paid $16.2 million. The Clerk of Court, using a complex allocation method, also reported Shvets’s balance as outstanding, but the District Court did not resolve whether the Clerk’s method was correct.On appeal, the United States Court of Appeals for the Third Circuit affirmed in part, vacated in part, and remanded. The Court held that sentencing judges may issue “hybrid” restitution orders under the Mandatory Victim Restitution Act, combining joint and several liability with apportioned liability. The Court found the District Court erred by applying the Sheets rule, which conflicted with the language of Shvets’s judgment. The Third Circuit directed the District Court to determine whether the Clerk’s accounting method is fair and appropriate, and to decide if Shvets’s restitution judgment has been satisfied. View "United States v. Shvets" on Justia Law

A patient with a long history of severe depression and multiple suicide attempts underwent 95 electroconvulsive therapy (ECT) treatments at a Nebraska hospital between 2014 and 2016. The ECT was administered using a device manufactured by Somatics, LLC. After the treatments, the patient experienced significant memory loss and was diagnosed with a neurocognitive disorder. In 2020, he filed suit against Somatics in the United States District Court for the Middle District of Florida, alleging negligence, strict product liability, breach of warranties, violation of Nebraska’s Consumer Protection Act, and fraudulent misrepresentation, primarily claiming that Somatics failed to adequately warn of the risks associated with ECT.The district court dismissed the claims under Nebraska’s Consumer Protection Act and for fraudulent misrepresentation, merged the strict liability and breach of implied warranty claims, and granted summary judgment to Somatics on the design defect, manufacturing defect, and breach of express warranty claims. The remaining claims for negligence and strict liability, both based on failure to warn, were merged for trial. The jury found that while Somatics failed to provide adequate warnings, this failure was not the proximate cause of the plaintiff’s injuries, and awarded no damages. The district court denied the plaintiff’s post-trial motions, including for a new trial.On appeal, the United States Court of Appeals for the Eleventh Circuit reviewed the district court’s decisions de novo for summary judgment and for abuse of discretion on evidentiary and procedural rulings. The Eleventh Circuit held that the district court properly granted summary judgment on the design defect claim, correctly merged the negligence and strict liability claims, gave an appropriate jury instruction on proximate cause, and did not abuse its discretion in excluding certain evidence and expert testimony. The judgment of the district court was affirmed. View "Thelen v. Somatics, LLC" on Justia Law

An attorney based in Oklahoma developed a business model to help out-of-state clients enter the state’s medical marijuana industry, which is governed by strict residency and disclosure requirements. He created a two-entity structure: one company, with nominal Oklahoma-resident owners, obtained the necessary state licenses, while a second company, owned and operated by out-of-state clients, ran the actual marijuana operations. The attorney did not disclose the true ownership structure to state authorities, and in some cases, marijuana was grown before the required state registrations were obtained. State authorities began investigating after noticing irregularities, such as multiple licenses listing the same address and repeated use of the same Oklahoma residents as owners, many of whom had little or no involvement in the businesses.Oklahoma state prosecutors charged the attorney with multiple felonies related to his business practices, including conspiracy and submitting false documents. While those charges were pending, a federal grand jury indicted him for drug conspiracy and maintaining drug-involved premises, based on the same conduct. In the United States District Court for the Western District of Oklahoma, the attorney moved to enjoin his federal prosecution, arguing that a congressional appropriations rider barred the Department of Justice from spending funds to prosecute individuals complying with state medical marijuana laws. The district court held an evidentiary hearing and denied the motion, finding that the attorney had not substantially complied with Oklahoma law, particularly due to nondisclosure of ownership interests and failure to obtain required registrations.On appeal, the United States Court of Appeals for the Tenth Circuit affirmed. The court held that the appropriations rider does bar the Department of Justice from spending funds to prosecute private individuals who comply with state medical marijuana laws. However, the court found that the attorney failed to substantially comply with Oklahoma’s requirements, so the rider did not protect him. The court concluded that the district court did not abuse its discretion in denying the injunction. View "United States v. Stacy" on Justia Law

Novartis Pharmaceuticals Corporation manufactures Entresto, a drug used to treat chronic heart failure. MSN Pharmaceuticals, Inc. sought approval from the Food and Drug Administration (FDA) to market a generic version of Entresto by submitting an abbreviated new drug application (ANDA). MSN’s application excluded certain methods of use protected by Novartis’s patents and claimed that the generic drug contained the same active ingredients as Entresto. The FDA approved MSN’s application, prompting Novartis to challenge the approval, arguing that the generic’s labeling and composition were unlawfully different from Entresto.The United States District Court for the District of Columbia reviewed Novartis’s claims under the Administrative Procedure Act. Novartis argued that the FDA’s approval of MSN’s ANDA and denial of Novartis’s citizen petitions were arbitrary and capricious, particularly regarding the omission of patented dosing regimens and indications from the generic’s label, and the determination that the generic contained the same active ingredients as Entresto. The district court granted summary judgment in favor of the FDA, finding that the agency’s actions were reasonable and consistent with statutory and regulatory requirements. Novartis appealed this decision.The United States Court of Appeals for the District of Columbia Circuit affirmed the district court’s judgment. The appellate court held that the FDA reasonably concluded the generic drug’s labeling changes were permissible to avoid patent infringement and did not render the generic less safe or effective for non-patented uses. The court also found that the FDA’s determination that the generic and Entresto shared the same active ingredients was supported by scientific evidence and regulatory guidance. The court applied de novo review to legal questions and deferred to the FDA’s scientific expertise, ultimately upholding the agency’s approval of MSN’s ANDA. View "Novartis Pharmaceuticals Corp. v. Kennedy" on Justia Law

An employee at a hospital operated by the University of California, Los Angeles (UCLA Health) photographed confidential patient information and posted it to his personal Instagram account, despite having received training and signing agreements to protect patient privacy. Although the employee redacted some information, personal details of ten patients remained visible. The hospital responded by placing the employee on administrative leave, ultimately terminating him, notifying affected patients, and reiterating privacy policies to staff. No patients reported adverse consequences from the disclosure.The California Department of Public Health investigated and imposed a $75,000 penalty on the hospital, finding a violation of Health and Safety Code section 1280.15, which requires health facilities to prevent unauthorized disclosure of patient medical information. An administrative law judge (ALJ) upheld the Department’s finding and penalty, interpreting section 1280.15 as imposing strict liability for any unauthorized disclosure, regardless of whether the hospital had implemented appropriate safeguards. The ALJ noted that the Department did not find a violation of section 1280.18, which requires reasonable safeguards, but still held the hospital responsible. The Department adopted the ALJ’s decision.The Regents of the University of California challenged the decision in the Superior Court of Sacramento County, seeking a writ of administrative mandate and declaratory relief. The trial court ruled in favor of the hospital, holding that a violation of section 1280.15 cannot occur without a concurrent violation of section 1280.18, thus importing a reasonableness standard into section 1280.15. The court ordered the Department to vacate its decision and remanded the matter.On appeal, the California Court of Appeal, Third Appellate District, affirmed the trial court’s judgment. The court held that section 1280.15 is not a strict liability statute; liability requires a failure to implement reasonable safeguards as mandated by section 1280.18. The hospital was not liable absent proof of such a failure. View "Regents of the Univ. of Cal. v. State Dept. of Public Health" on Justia Law

A licensed veterinarian developed and manufactured undetectable performance enhancing drugs (PEDs) for use in professional horse racing, selling them to trainers who administered them to horses to gain a competitive edge. His salesperson assisted in these activities, operating a company that distributed the drugs without prescriptions or FDA approval. The drugs were misbranded or adulterated, and the operation involved deceptive practices such as misleading labeling and falsified customs forms. The PEDs were credited by trainers for their horses’ successes, and evidence showed the drugs could be harmful if misused.The United States District Court for the Southern District of New York presided over two separate trials, resulting in convictions for both the veterinarian and his salesperson for conspiracy to manufacture and distribute misbranded or adulterated drugs with intent to defraud or mislead, in violation of the Food, Drug, and Cosmetic Act. The district court denied motions to dismiss the indictment, admitted evidence from a prior state investigation, and imposed sentences including imprisonment, restitution, and forfeiture. The court calculated loss for sentencing based on the veterinarian’s gains and ordered restitution to racetracks based on winnings by a coconspirator’s doped horses.On appeal, the United States Court of Appeals for the Second Circuit held that the statute’s “intent to defraud or mislead” element is not limited to particular categories of victims; it is sufficient if the intent relates to the underlying violation. The court found no error in the admission of evidence from the 2011 investigation or in the use of gain as a proxy for loss in sentencing. However, it vacated the restitution order to racetracks, finding no evidence they suffered pecuniary loss, and vacated the forfeiture order, holding that the relevant statute is not a civil forfeiture statute subject to criminal forfeiture procedures. The convictions and sentence were otherwise affirmed. View "United States v. Fishman" on Justia Law

After the Washington Medical Commission adopted a policy to discipline physicians for spreading COVID-19 “misinformation,” several plaintiffs—including physicians who had been charged with unprofessional conduct, physicians who had not been charged, and advocacy organizations—filed suit. The Commission’s actions included investigating and charging doctors for public statements and writings about COVID-19 treatments and vaccines. Some plaintiffs, such as Dr. Eggleston and Dr. Siler, were actively facing disciplinary proceedings, while others, like Dr. Moynihan, had not been charged but claimed their speech was chilled. Additional plaintiffs included a non-profit organization and a public figure who alleged their right to receive information was affected.The United States District Court for the Eastern District of Washington dismissed the plaintiffs’ First Amended Complaint. The court found that the claims were constitutionally and prudentially unripe, and that the doctrine of Younger abstention required federal courts to refrain from interfering with ongoing state disciplinary proceedings. The district court also addressed the merits, concluding that the plaintiffs failed to state a plausible First Amendment or due process claim, but the primary basis for dismissal was abstention and ripeness.On appeal, the United States Court of Appeals for the Ninth Circuit affirmed the district court’s dismissal. The Ninth Circuit held that Younger abstention barred claims challenging ongoing state disciplinary proceedings (including as-applied and facial constitutional challenges, and due process claims) for all plaintiffs subject to such proceedings. The court also held that Younger abstention did not apply to claims for prospective relief by plaintiffs not currently subject to proceedings, but those claims were constitutionally and prudentially unripe because no concrete injury had occurred and further factual development was needed. The Ninth Circuit thus affirmed the dismissal of all claims. View "STOCKTON V. BROWN" on Justia Law