Justia Health Law Opinion Summaries

In 2018, the plaintiff was placed on an involuntary 72-hour psychiatric hold, resulting in the creation of a confidential record by the Orange County Sheriff’s Department. In 2021, during a legal dispute over their father’s estate, the plaintiff discovered that his sister’s attorney had obtained this confidential record and used it to threaten him in an attempt to force dismissal of his elder abuse lawsuit against his sister. The record had been released by an office specialist at the Sheriff’s Department, who admitted knowing the sister was not entitled to the record but disclosed it anyway, believing she was concerned for the plaintiff’s well-being.A jury in the Superior Court of Orange County found that the office specialist willfully and knowingly disclosed the confidential record, awarding the plaintiff $29,000 in economic damages and $40,000 in noneconomic damages. The jury also found the plaintiff’s sister and her attorney responsible for 25 percent of the damages. However, the trial court granted a motion for partial judgment notwithstanding the verdict, concluding there was insufficient evidence of willfulness, declined to treble the damages, and apportioned both economic and noneconomic damages, entering judgment for 75 percent of the total damages against the office specialist and the County.The California Court of Appeal, Fourth Appellate District, Division Three, reversed the trial court’s order. The appellate court held that “willfully and knowingly” under Welfare and Institutions Code section 5330 means intentionally releasing confidential records to someone known to be unauthorized, regardless of intent to harm. The court found substantial evidence supported the jury’s finding of willfulness, requiring trebling of damages. The court also held that while noneconomic damages could be apportioned to other tortfeasors, economic damages could not. The case was remanded with instructions to enter judgment for $177,000 against the County and the office specialist, jointly and severally. View "Doe v. County of Orange" on Justia Law

Mathew James, a former nurse and owner of a medical billing business, was convicted after a jury trial for health care fraud, conspiracy to commit health care fraud, wire fraud, and aggravated identity theft. The charges arose from a scheme in which James and his employees falsified insurance claims by “upcoding” and “unbundling” medical procedures, directed patients to emergency rooms for pre-planned surgeries, and impersonated patients in communications with insurance companies. The fraudulent activity spanned several years, involved nearly 150 physicians, and resulted in tens of thousands of claims. While some of James’s business was legitimate, the government’s evidence focused on the fraudulent aspects of his operations.The United States District Court for the Eastern District of New York (Judge Seybert) presided over the trial and sentencing. The jury convicted James on most counts but acquitted him of money laundering conspiracy. During trial, jurors were inadvertently given access to transcripts of two recorded calls not admitted into evidence, but the district court declined to conduct an inquiry into the exposure, instead instructing the jury to disregard any material not in evidence. At sentencing, the court imposed a 144-month prison term, a forfeiture order of over $63 million, and restitution of nearly $337 million. The court applied sentencing enhancements for James’s leadership role and abuse of trust, and increased the sentence after considering James’s potential eligibility for earned time credits and rehabilitation programs.The United States Court of Appeals for the Second Circuit affirmed James’s conviction, finding any jury exposure to extra-record material harmless. However, the court vacated the sentence, including the forfeiture and restitution orders, holding that the district court erred by enhancing the sentence based on potential earned time credits and rehabilitation program eligibility, misapplied sentencing enhancements without adequate findings, and failed to properly calculate forfeiture and restitution by including legitimate business revenue. The case was remanded for resentencing. View "United States v. James" on Justia Law

Cordell Sanders, an inmate at Pontiac Correctional Center, suffered from serious mental health issues and spent over eight years in segregation housing due to multiple disciplinary infractions. He received mental health services from various providers employed by Wexford Health Sources, the prison’s contracted healthcare provider. Sanders alleged that these providers were deliberately indifferent to his mental health needs, offering inadequate treatment and failing to advocate for him during disciplinary proceedings. He also claimed that Wexford maintained a widespread practice of denying mental health care until inmates were in crisis and failed to implement policies guiding provider participation in disciplinary hearings.The United States District Court for the Central District of Illinois granted summary judgment in favor of all defendants. The court found that Sanders had not presented sufficient evidence to support his claims of deliberate indifference or to establish a Monell claim against Wexford. Sanders appealed this decision, arguing that the providers’ treatment was ineffective and that Wexford’s practices and lack of policy amounted to constitutional violations.The United States Court of Appeals for the Seventh Circuit reviewed the district court’s summary judgment order de novo. The appellate court held that Sanders failed to provide evidence from which a reasonable jury could find that the providers’ conduct constituted deliberate indifference under the Eighth Amendment. The court emphasized the lack of expert testimony regarding the effectiveness of Sanders’s treatment and found no substantial departure from professional standards. Regarding Wexford, the court concluded that Sanders did not demonstrate a widespread practice of denying care or that the absence of a more detailed policy caused constitutional harm. The Seventh Circuit affirmed the district court’s grant of summary judgment for all defendants. View "Sanders v. Moss" on Justia Law

Lauren Richwine, through her business Death Done Differently, provides services as a “death doula,” assisting clients and their families with end-of-life planning, emotional support, and guidance on funeral arrangements. Richwine is not a licensed funeral director, and her website notes that her services are performed under the supervision of a licensed funeral director. In 2021, a complaint was filed with the Indiana Public Licensing Agency alleging that Richwine was practicing funeral services without a license. Following an investigation, the Indiana Attorney General sought a cease-and-desist order from the State Board of Funeral and Cemetery Service, which was approved. The order prohibited Richwine and her company from advertising or providing certain services related to funeral planning, community death care, and support with funeral homes.After the cease-and-desist order was issued, Richwine and Death Done Differently filed suit in the United States District Court for the Northern District of Indiana, Fort Wayne Division, arguing that enforcement of the Indiana statute against them would violate their First Amendment rights. The district court granted a preliminary injunction, enjoining enforcement of the statute against the plaintiffs. The defendants appealed, arguing that the plaintiffs had waived their rights by signing the cease-and-desist agreement and that federal abstention doctrine barred the suit. The district court rejected these arguments, finding no clear and unmistakable waiver of federal rights and no ongoing state proceeding that would justify abstention.The United States Court of Appeals for the Seventh Circuit reviewed the district court’s decision. The Seventh Circuit held that the Indiana statute, as applied to Richwine and Death Done Differently, burdens substantially more speech than necessary to further the state’s interests in public health, safety, and consumer protection. The court found that the statute’s restrictions on the plaintiffs’ speech and advertising likely violate the First Amendment. The Seventh Circuit affirmed the district court’s preliminary injunction and remanded for further proceedings. View "Richwine v. Matuszak" on Justia Law

The petitioner received a flu vaccine on November 1, 2017. Over a month later, he developed upper respiratory symptoms and, after several days, experienced sudden generalized weakness. He was diagnosed with Guillain-Barré Syndrome (GBS) and also found to have a bacterial infection (H. influenzae pneumonia). During his hospitalization, multiple treating physicians associated his GBS with his respiratory infection, and none suggested a link to the flu vaccine. Upon discharge, his diagnoses included both GBS and H. influenzae pneumonia.The petitioner filed a claim for compensation under the National Childhood Vaccine Injury Act in the United States Court of Federal Claims, alleging that the flu vaccine caused his GBS. The case was assigned to a special master, who found that although the petitioner established a prima facie case for vaccine causation, the government had shown by a preponderance of the evidence that the unrelated H. influenzae infection was the sole substantial factor causing the GBS. The special master explicitly excluded the vaccine as a causal factor. The petitioner sought review in the Court of Federal Claims, arguing that the special master erred in applying the burden of proof and in making certain factual findings. The Court of Federal Claims rejected these arguments and upheld the special master’s decision.On appeal, the United States Court of Appeals for the Federal Circuit reviewed the Claims Court’s decision de novo, applying the same standards of review. The Federal Circuit held that, in a Table case under the Vaccine Act, the government must prove by a preponderance of the evidence that a factor unrelated to the vaccine was the sole substantial cause of the injury, but need not disprove vaccine causation as if it had been affirmatively established. The court found that the special master’s findings were not arbitrary or capricious and that the correct legal standards were applied. The Federal Circuit affirmed the Claims Court’s decision denying compensation. View "WHITE v. HHS " on Justia Law

Oregon enacted a law requiring prescription drug manufacturers to report detailed information about certain drugs, including pricing, costs, and factors contributing to price increases, to the state’s Department of Consumer and Business Services. The law also directs the agency to post most of this information online, but prohibits public disclosure of information designated as a trade secret unless the agency determines that disclosure is in the public interest. Since the law’s enactment, manufacturers have claimed thousands of trade secrets, but the agency has not publicly disclosed any such information.A trade association representing pharmaceutical manufacturers sued the director of the Oregon agency in the United States District Court for the District of Oregon, raising several facial constitutional challenges. The district court granted summary judgment for the association on two claims: that the reporting requirement violated the First Amendment by compelling speech, and that any use of the public-interest exception to disclose trade secrets would constitute an uncompensated taking under the Fifth Amendment. The court declared the entire reporting requirement unconstitutional and held that any disclosure of trade secrets under the public-interest exception would violate the Takings Clause unless just compensation was provided.The United States Court of Appeals for the Ninth Circuit reviewed the case. It reversed the district court’s summary judgment for the association on both the First and Fifth Amendment claims. The Ninth Circuit held that the reporting requirement compels commercial speech and survives intermediate scrutiny under the First Amendment, as it directly advances substantial state interests in transparency and market efficiency and is not more extensive than necessary. On the takings claim, the court found the association’s challenge justiciable but concluded that, under the Penn Central regulatory takings framework, none of the factors supported a facial claim that every disclosure under the public-interest exception would constitute a taking. The court remanded with instructions to enter summary judgment for the state on these claims. View "Pharmaceutical Research and Manufacturers of America v. Stolfi" on Justia Law

A certified nurse midwife in Nebraska sought to provide home birth services but was prevented from doing so by state law. The Nebraska Certified Nurse Midwifery Practice Act requires midwives to work under a supervising physician through a practice agreement and prohibits them from attending home births outside authorized medical facilities. The midwife alleged that these restrictions forced her to turn away women seeking home births and sued state officials, claiming the law violated her constitutional rights and the rights of her prospective patients.The United States District Court for the District of Nebraska dismissed the midwife’s claims. The court found that she failed to state a claim for violation of her own rights under the Due Process Clause and lacked standing to assert claims on behalf of her prospective patients. The district court concluded that the statutory requirements were rationally related to legitimate state interests in health and safety and that the midwife did not have a sufficiently close relationship with prospective patients nor could she show that those patients were hindered from bringing their own suits.On appeal, the United States Court of Appeals for the Eighth Circuit reviewed the district court’s dismissal de novo. The appellate court held that the Nebraska law regulating midwifery is subject to rational basis review and that the legislature could rationally believe the restrictions serve legitimate interests in public health and safety. The court also held that the midwife lacked third-party standing to assert the rights of prospective patients because she did not have a close relationship with them and they were not hindered from bringing their own claims. The Eighth Circuit affirmed the district court’s judgment, upholding the dismissal of all claims. View "Swanson v. Hilgers" on Justia Law

A group of hospitals challenged the calculation of their Medicare fractions for fiscal year 2007, which is a key component in determining eligibility and payment amounts under the Medicare disproportionate share hospital (DSH) adjustment. The DSH adjustment provides increased reimbursement to hospitals serving a high number of low-income patients. The hospitals disputed the inclusion of Medicare Part C beneficiaries in the Medicare fraction, arguing that this reduced their payments. After the Centers for Medicare and Medicaid Services (CMS) published the Medicare fractions, the hospitals appealed to the Provider Reimbursement Review Board, seeking review of the calculation before the final DSH adjustment was determined.The Provider Reimbursement Review Board dismissed the hospitals’ appeal for lack of jurisdiction, reasoning that a challenge could only be brought after the final determination of the DSH adjustment was made and reflected in the Notice of Program Reimbursement (NPR). The Board concluded that publication of the Medicare fraction alone did not constitute a “final determination” as required by statute. The hospitals then sought review in the United States District Court for the District of Columbia, which disagreed with the Board and held that the hospitals’ challenge could proceed, interpreting precedent to allow appeals at the stage of Medicare fraction publication.The United States Court of Appeals for the District of Columbia Circuit reviewed the case and reversed the district court’s judgment. The court held that the Board lacked jurisdiction to hear the hospitals’ challenge prior to the issuance of the NPR, because only the NPR constitutes the Secretary’s “final determination as to the amount of the payment” under the relevant statutory provision. The court clarified that while some prospective payment system components may be appealed before the NPR, retrospective adjustments like the DSH adjustment require final settlement before an appeal is ripe. View "Battle Creek Health System v. Kennedy" on Justia Law

A physician who worked at several cancer centers in Kentucky brought a lawsuit under the False Claims Act, alleging that his former employers fraudulently billed Medicare and other federal programs. He claimed that the centers submitted claims falsely representing that radiation and chemotherapy services were either supervised or performed by qualified physicians, when in fact, they were not. The allegations included both radiation services and chemotherapy services, with the core assertion being that the centers either lacked proper physician supervision or used unqualified personnel, and that this resulted in improper billing to federal programs.The United States District Court for the Eastern District of Kentucky initially dismissed some of the physician’s claims and, after discovery, granted summary judgment to the defendants on the remaining claims. The court found that the plaintiff failed to show that Medicare required the specific type of physician supervision he alleged for radiation services, and that he did not provide sufficient evidence of any specific fraudulent chemotherapy claims. The court also determined that the plaintiff’s analysis of schedules and staffing was unreliable and speculative, and that he could not identify a single false claim actually submitted to the government. The court dismissed the radiation-services claims for failure to state a claim and granted summary judgment on the chemotherapy claims due to lack of evidence.On appeal, the United States Court of Appeals for the Sixth Circuit reviewed the district court’s decisions de novo. The appellate court held that the plaintiff failed to establish that the alleged physician supervision requirements were material preconditions for Medicare payment, and that he did not present evidence of any specific false claims for chemotherapy services. The court also found that the conspiracy claim failed because there was no underlying FCA violation. Accordingly, the Sixth Circuit affirmed the district court’s dismissal and grant of summary judgment in favor of the defendants. View "United States ex rel. O'Laughlin v. Radiation Therapy Services" on Justia Law

A pharmaceutical company developed a sublingual opioid painkiller, DSUVIA, which could only be administered in medically supervised settings due to safety concerns and was subject to a strict FDA Risk Evaluation and Mitigation Strategy (REMS). The company marketed DSUVIA with the slogan “Tongue and Done” at investor conferences, accompanied by additional disclosures about the drug’s limitations and REMS requirements. After the FDA issued a warning letter objecting to the slogan as potentially misleading under the Federal Food, Drug, and Cosmetic Act, several shareholders filed suit, alleging that the slogan misled investors about the complexity of administering DSUVIA and the drug’s limited market potential.The United States District Court for the Northern District of California dismissed the shareholders’ complaint, finding that the plaintiffs failed to adequately plead facts supporting a strong inference of scienter, but did not rule on whether the statements were false or misleading. The plaintiffs were given two opportunities to amend their complaint, but the court ultimately dismissed the case with prejudice.On appeal, the United States Court of Appeals for the Ninth Circuit reviewed the dismissal de novo. The Ninth Circuit held that the plaintiffs failed to adequately plead falsity because a reasonable investor would not interpret the “Tongue and Done” slogan in isolation, but would consider the context provided by accompanying disclosures and other available information. The court also held that the FDA’s warning letter did not establish falsity under securities law, as the standards and intended audiences differ. Additionally, the court found that the plaintiffs did not plead a strong inference of scienter, as the facts suggested the company’s officers acted in good faith. The Ninth Circuit affirmed the district court’s dismissal. View "Sneed v. Talphera, Inc." on Justia Law