Justia Health Law Opinion Summaries

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

Russell Johnson, a resident of a continuing care retirement community operated by Stoneridge Creek, filed a class action lawsuit alleging that Stoneridge Creek unlawfully increased residents’ monthly care fees to cover its anticipated legal defense costs in ongoing litigation. Johnson claimed these increases violated several statutes, including the Health and Safety Code, the Unfair Competition Law, the Consumer Legal Remedies Act (CLRA), and the Elder Abuse Act, and breached the Residence and Care Agreement (RCA) between residents and Stoneridge Creek. The RCA allowed Stoneridge Creek to adjust monthly fees based on projected costs, prior year per capita costs, and economic indicators. In recent years, Stoneridge Creek’s budgets for legal fees rose sharply, with $500,000 allocated for 2023 and 2024, compared to much lower amounts in prior years.The Alameda County Superior Court previously denied Stoneridge Creek’s motion to compel arbitration, finding the RCA’s arbitration provision unconscionable. Johnson then moved for a preliminary injunction to prevent Stoneridge Creek from including its litigation defense costs in monthly fee increases. The trial court granted the injunction, finding a likelihood of success on Johnson’s claims under the CLRA and UCL, and determined that the fee increases were retaliatory and unlawfully shifted defense costs to residents. The court also ordered Johnson to post a $1,000 bond.The California Court of Appeal, First Appellate District, Division Four, reviewed the case and reversed the trial court’s order. The appellate court held that the fee increases did not violate the CLRA’s fee-recovery provision or other litigation fee-shifting statutes, as these statutes govern judicial awards of fees, not how a defendant funds its own legal expenses. The court further concluded that Health and Safety Code section 1788(a)(22)(B) permits Stoneridge Creek to include reasonable projections of litigation expenses in monthly fees. However, the court remanded the case for the trial court to reconsider whether the fee increases were retaliatory or excessive, and to reassess the balance of harms and the appropriate bond amount. View "Johnson v. Stoneridge Creek Pleasanton CCRC" on Justia Law

Two hospitals incorporated and operating in Mexico provided emergency medical care to individuals insured under Medicare Advantage plans issued by a Maine-based health insurance company. The patients, while in Mexico, signed contracts with the hospitals agreeing to pay for all services rendered and provided their insurance information. The hospitals, through a third-party administrator, contacted the insurer and received representations that the patients had “full medical insurance benefits” for the proposed out-of-country emergency services. Relying on these representations, the hospitals provided extensive treatment. After the patients were discharged, the insurer refused to reimburse the hospitals beyond a $25,000 cap, citing the terms of the Medicare Advantage plans.The hospitals filed separate lawsuits in the United States District Court for the District of Maine, asserting Maine common-law claims for promissory estoppel and negligent misrepresentation. They argued that the insurer’s representations induced them to provide care for which they were not fully reimbursed. The insurer moved to dismiss, contending that the claims were, in substance, claims for Medicare benefits and thus subject to the Medicare Act’s administrative exhaustion requirements. The district court agreed, finding that the claims arose under the Medicare Act and that the hospitals had not exhausted administrative remedies. The court dismissed both actions for lack of subject-matter jurisdiction and later denied the hospitals’ motions to alter the judgments, rejecting the argument that foreign hospitals are exempt from the exhaustion requirement.On appeal, the United States Court of Appeals for the First Circuit affirmed. The court held that the hospitals’ claims, though styled as common-law torts, were “inextricably intertwined” with determinations of Medicare benefits and thus arose under the Medicare Act. Because the hospitals had not exhausted administrative remedies, the district court properly dismissed the actions for lack of subject-matter jurisdiction. The court also found no basis to excuse exhaustion for foreign hospitals. View "Hospital Amerimed Cancun S A DE C V v. Martin's Point Health Care, Inc." on Justia Law

After suffering spinal fractures in a car accident, the plaintiff received surgical treatment and post-operative care from a neurosurgeon and a surgical nurse. The plaintiff was insured at the time, and the medical provider received his insurance information but did not bill the insurer. Instead, the provider filed a medical lien for over $180,000 against any potential recovery the plaintiff might obtain from a third-party tortfeasor, pursuant to Idaho Code section 45-704B. The plaintiff’s attorney objected, arguing that the Idaho Patient Act (IPA) required the provider to bill the patient’s insurance before filing such a lien. The provider maintained the lien was proper under the medical lien statute and did not comply with the IPA.The District Court of the Fourth Judicial District, Ada County, reviewed cross-motions for partial summary judgment. The court determined that the medical lien was not subject to the IPA because it did not constitute an “extraordinary collection action” as defined by the Act. The court also found a factual dispute regarding whether the charges were reasonable, ultimately concluding after a bench trial that the physician’s charges were reasonable but the nurse’s charges should be excluded. The court dismissed the plaintiff’s claims with prejudice, and the plaintiff appealed.The Supreme Court of the State of Idaho reversed the district court’s decision, holding that the medical lien did constitute an “extraordinary collection action” under the IPA because it was a lien placed on the patient’s property in connection with a debt. The Supreme Court further held that, because the provider failed to bill the patient’s insurance before filing the lien, as required by the IPA, the lien was invalid. The judgment was vacated, and the case was remanded with instructions to enter judgment for the plaintiff and declare the lien invalid. The Supreme Court also awarded attorney fees on appeal to the plaintiff. View "DeKlotz v. NS Support, LLC" on Justia Law

Two brothers with developmental disabilities, Gaven and Jared, live with their parents, who are certified to provide in-home care. Both brothers qualified for Maine’s “Single Member Services,” which would allow each to receive one-on-one care from a designated provider. The family requested that each parent be reimbursed for providing care to one brother. However, the Maine Department of Health and Human Services determined that, because the brothers lived together, they were only eligible for “Two Member Services,” meaning a single provider would be reimbursed to care for both, at half the total rate. The parents continued to provide one-on-one care to both brothers, but were only reimbursed for one provider, resulting in a significant financial shortfall.The family challenged this determination in Maine Superior Court, which ruled in their favor, finding that the Department’s interpretation of its rules was arbitrary and inconsistent with its policies. Following this decision, the Department began reimbursing both parents for providing one-on-one care. The family then filed a federal lawsuit seeking damages for the period before the state court’s ruling, alleging discrimination under Title II of the Americans with Disabilities Act (ADA). The United States District Court for the District of Maine dismissed the case, holding that the Department was protected by Eleventh Amendment sovereign immunity.On appeal, the United States Court of Appeals for the First Circuit reversed the district court’s dismissal. The First Circuit held that the Department was not entitled to sovereign immunity because Congress validly abrogated such immunity under Title II of the ADA in this context. The court found that the Department’s policy violated the brothers’ equal protection rights, as there was no rational basis for providing reduced services solely because the brothers lived together. The case was remanded for further proceedings. View "McKenna v. Maine Department of Health and Human Services" on Justia Law