Justia Health Law Opinion Summaries

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

A group of drug manufacturers that participate in the federal Section 340B program challenged a Mississippi law, H.B. 728, which prohibits manufacturers from interfering with healthcare providers’ use of contract pharmacies to distribute discounted drugs to low-income and uninsured patients. The manufacturers argued that the law compels them to transfer drugs at a discount to private, for-profit pharmacies and expands their obligations under federal law, potentially enabling improper resale of discounted drugs. They sought a preliminary injunction to prevent the law from taking effect, claiming it constituted an unconstitutional taking and was preempted by federal law.The United States District Court for the Southern District of Mississippi denied the manufacturers’ motion for a preliminary injunction. The court found that the manufacturers had not demonstrated a substantial likelihood of success on the merits of their takings or preemption claims, and thus were not entitled to preliminary injunctive relief. The manufacturers appealed this decision.The United States Court of Appeals for the Fifth Circuit reviewed the district court’s denial of a preliminary injunction for abuse of discretion, applying clear error review to factual findings and de novo review to legal conclusions. The Fifth Circuit affirmed the district court’s decision, holding that the manufacturers had not shown a substantial likelihood of success on their claims. The court concluded that H.B. 728 did not effectuate a physical or regulatory taking, nor was it preempted by federal law under either field or conflict preemption theories. The court emphasized that, on the record presented, the manufacturers had not met their burden to justify the extraordinary remedy of a preliminary injunction. The district court’s denial of injunctive relief was therefore affirmed. View "AbbVie v. Fitch" on Justia Law

A group of plaintiffs, including a medical practice, individual physicians, a medical society, and two patients, brought various claims against a health insurer, alleging that the insurer interfered with doctor-patient relationships, denied or delayed coverage for medical services, and caused significant harm to patients. The claims included tortious interference with contractual rights, unfair competition, RICO violations, and emotional distress, with specific factual allegations that the insurer’s actions led to worsened medical outcomes for the patients involved.The Circuit Court of the Third Circuit reviewed the insurer’s motion to compel arbitration based on arbitration clauses in provider agreements and member handbooks. Instead of determining whether the claims were subject to arbitration, the circuit court focused on the alleged unconscionability of the contracts as a whole, finding them to be contracts of adhesion and unconscionable, and denied the motion to compel arbitration. The court also denied summary judgment as to one patient’s claims and did not stay the medical society’s claims pending arbitration.The Supreme Court of the State of Hawaiʻi reviewed the case and held that the circuit court erred by not following the required analytical framework for arbitrability. The Supreme Court vacated the lower court’s order in part, holding that claims arising under the Participating Physician Agreement must be referred to arbitration because the agreement delegated the question of arbitrability to the arbitrator. Claims under the Medicare and QUEST Agreements were also subject to arbitration, as the arbitration clauses were not shown to be substantively unconscionable. However, the Court held that the claims of one patient and the physician as a patient were not subject to mandatory arbitration, and another patient’s claims were not subject to a grievance and appeals clause. The case was remanded for further proceedings consistent with these holdings. View "Frederick A. Nitta, M.D., Inc. v. Hawaii Medical Service Association." on Justia Law

Central Vermont Medical Center (CVMC) submitted its proposed budget for fiscal year 2025, seeking an 11.9% increase in net patient service revenue (NPR) and a 5.5% increase in commercial rates, both of which exceeded the benchmarks set by the Green Mountain Care Board. The Board’s benchmarks, established in its annual guidance, were 3.5% for NPR growth and 3.4% for commercial rate growth. The Board required hospitals exceeding these benchmarks to provide credible justification, such as evidence of improved access or quality of care. CVMC’s submission was reviewed through hearings and public comment, during which the Board found that CVMC’s justifications were insufficient, particularly regarding efficiency, productivity, and cost containment.The Green Mountain Care Board, after considering the evidence and statutory obligations, modified CVMC’s budget, allowing a 6% NPR growth and a 3.4% commercial rate increase. The Board found that CVMC could achieve financial sustainability through cost reductions and improved productivity rather than higher price increases. The Board imposed specific terms and conditions on the budget, emphasizing the need for efficient operations and balancing financial needs with statewide health care affordability and access.On appeal, the Vermont Supreme Court reviewed the Board’s decision under a deferential standard, presuming the Board’s actions valid unless shown otherwise by clear and convincing evidence. The Court rejected CVMC’s arguments that the Board acted with unfettered discretion, violated procedural due process, or was required to regulate on a per-capita basis. The Court found that the Board’s process was guided by statutory standards, rules, and annual guidance, and that CVMC had adequate notice and opportunity to participate. The Supreme Court of Vermont affirmed the Board’s decision. View "In re Central Vermont Medical Center Fiscal Year 2025" on Justia Law

A pharmaceutical company challenged provisions of the Inflation Reduction Act of 2022, which established a program requiring the Department of Health and Human Services, through the Centers for Medicare and Medicaid Services (CMS), to negotiate maximum fair prices for certain high-cost prescription drugs covered by Medicare. The company’s drug was selected for the program, and it signed the required agreements to participate. The program imposes significant penalties and an excise tax on manufacturers who do not comply, but allows manufacturers to exit Medicare and Medicaid programs to avoid the tax, a process the company argued was not a realistic option.After its drug was selected, the company filed suit in the United States District Court for the District of New Jersey, alleging that the program violated the Eighth Amendment’s Excessive Fines Clause, the Fifth Amendment’s Takings Clause, and the First Amendment’s Free Speech Clause. The District Court granted summary judgment for the government, holding that participation in the program is voluntary and that the program primarily regulates conduct, not speech. The court also found it lacked jurisdiction over the Eighth Amendment claim due to the Tax Anti-Injunction Act and the Declaratory Judgment Act.On appeal, the United States Court of Appeals for the Third Circuit affirmed. The court held that the company’s Eighth Amendment claim was barred by the Tax Anti-Injunction Act and the Declaratory Judgment Act, as the relief sought would restrain the assessment or collection of a federal tax. The court further held that the program does not violate the Takings Clause or the First Amendment, relying on its recent precedent. The judgment of the District Court was affirmed. View "Novartis Pharmaceuticals Corp v. Secretary Department of Health" on Justia Law