Justia Health Law Opinion Summaries

Lucas Warner, a young man with a history of seizures and cerebrovascular disease, died after taking a single dose of Aimovig, a biologic drug manufactured by Amgen and approved by the FDA to prevent migraines. His mother, acting as representative of his estate, argued that the drug’s label was inadequate because it failed to disclose that the clinical trials excluded people with histories of seizures and neurological disorders, and did not warn of specific risks for such patients. She contended that this omission was especially relevant to Lucas’s medical circumstances.After Warner filed a wrongful death claim in Massachusetts state court, Amgen removed the case to the United States District Court for the District of Massachusetts. Amgen moved to dismiss the complaint, arguing federal law preempted Warner’s state law claims because Amgen was required to use the FDA-approved label and Warner had not shown Amgen could have unilaterally changed it. At the hearing, Warner sought leave to amend her complaint, alleging newly available studies could have permitted Amgen to update the label using FDA’s Changes Being Effected (CBE) procedure. The district court dismissed the complaint as preempted and denied leave to amend, finding the studies insufficient and the amendment futile.The United States Court of Appeals for the First Circuit reviewed the case. It affirmed the dismissal of Warner’s original complaint, holding that federal law preempted the claim because Amgen could not unilaterally alter the label during FDA approval, and the FDA would have rejected Warner’s proposed label changes. However, it reversed the denial of leave to amend, holding Warner plausibly alleged that certain studies constituted newly acquired information under the CBE process. The case was remanded for further proceedings limited to Warner’s claims based on this post-approval labeling theory. View "Warner v. Amgen Inc." on Justia Law

A former Michigan Department of Corrections prisoner with asthma and an alleged allergy to dogs experienced allergic reactions while incarcerated at multiple facilities that housed dogs for training purposes. He reported symptoms such as asthma attacks and respiratory infections to prison officials, who provided prescribed treatments but did not confirm a specific dog allergy. After pursuing the prison’s grievance process, he was moved within the facility but still encountered dogs during required programming. Subsequently, he requested an ADA accommodation to be housed away from dogs, but this was denied due to lack of medical documentation. He later filed suit, alleging violations of the Eighth Amendment, the ADA, the Rehabilitation Act, and state laws.The United States District Court for the Western District of Michigan granted summary judgment in favor of the defendants. The court found that prison officials were not deliberately indifferent to his medical needs under the Eighth Amendment, as they consulted medical staff who did not recommend a transfer based on his condition. For the ADA and Rehabilitation Act claims, the court determined that inadequate medical treatment was not actionable under those statutes and that the plaintiff had not demonstrated denial of prison services or programs due to his disability. The court also declined to exercise supplemental jurisdiction over the state-law claims.The United States Court of Appeals for the Sixth Circuit reviewed the district court’s decision de novo. The appellate court affirmed the grant of summary judgment, holding that the prison counselor was entitled to qualified immunity because no clearly established law required the transfer of prisoners with asthma to facilities without dog programs. The court also found that the plaintiff failed to provide sufficient medical documentation to support the necessity of the requested accommodation under the ADA and Rehabilitation Act and did not establish discriminatory animus. The district court’s refusal to exercise supplemental jurisdiction over state-law claims was also affirmed. View "Miles-El v. Michigan" on Justia Law

Two individuals who were enrolled in a health insurance plan administered by a company alleged that their sensitive health information was disclosed without their authorization. In August 2023, the company sent each of them a letter explaining that an associate had mistakenly emailed a spreadsheet containing their private health information—including names, provider details, dates of service, and amounts billed or paid—to one or more other plan members. The plaintiffs asserted that they had entrusted this information to the company based on explicit and implicit promises of confidentiality and that the company’s privacy policy reinforced those expectations. They claimed the company’s unauthorized disclosure deprived them of the benefit of their bargain and diminished the value of the contracted services.Reviewing the case, the United States District Court for the District of Idaho dismissed the plaintiffs’ class action lawsuit on the grounds that they had not suffered an “injury in fact” necessary for Article III standing. The district court reasoned that disclosure of private information, without more, did not constitute a concrete injury and that the plaintiffs had not shown a substantial likelihood of future harm.On appeal, the United States Court of Appeals for the Ninth Circuit reviewed the dismissal de novo. The court held that the plaintiffs’ alleged harm—the unauthorized disclosure of sensitive health information entrusted on the basis of confidentiality—was analogous to the common law actions for breach of confidence and breach of contract, both of which were historically recognized as sufficient to support lawsuits. The court further noted that congressional judgment, as reflected in federal statutes like HIPAA, underscored the sensitivity of such information. Accordingly, the Ninth Circuit concluded that the plaintiffs had adequately alleged an injury sufficient for Article III standing, reversed the district court’s dismissal, and remanded the case for further proceedings. View "BLACK V. IEC GROUP, INC." on Justia Law

Needy children in Texas receive orthodontic care through Medicaid, which is administered by the Texas Health and Human Services Commission (HHSC). HHSC contracted with Conduent State Healthcare, LLC (formerly known as Xerox Corporation and ACS State Healthcare, LLC) to review and approve prior-authorization requests for these services. After Conduent allegedly approved requests without adequately assessing medical necessity, legal disputes arose. The State of Texas pursued civil penalties against Conduent for violating Medicaid policy, resulting in a settlement. Separately, dentists, including Diana Malone, DDS; Scott Malone, DDS; and M&M Orthodontics, PA, settled Medicaid-fraud claims by paying $2 million. Subsequently, these dentists sued Conduent and the State, alleging tortious conduct by Conduent in approving requests without proper review.In Travis County District Court, the State’s plea to the jurisdiction based on sovereign immunity was granted, dismissing it from the case. Conduent’s plea to the jurisdiction, which invoked derivative sovereign immunity and the election-of-remedies provision in the Texas Tort Claims Act, was denied. Conduent appealed this interlocutory order. The Court of Appeals for the Third District of Texas affirmed the district court’s denial of Conduent’s plea, addressing Conduent’s immunity arguments on the merits. A dissenting justice argued that the appeal should have been dismissed for lack of appellate jurisdiction.The Supreme Court of Texas reviewed whether the court of appeals had jurisdiction to hear Conduent’s interlocutory appeal. It held that Conduent, as a private contractor, is not a “governmental unit” under the relevant statutory definitions, and thus cannot utilize Section 51.014(a)(8) or Section 51.014(a)(5) to appeal the denial of its jurisdictional plea. The Supreme Court vacated the court of appeals’ opinion and judgment and remanded the case to the district court. View "CONDUENT STATE HEALTHCARE, LLC v. M&M ORTHODONTICS, PA" on Justia Law

Federal law enforcement officers executed a search warrant at a residence in Dayton, Ohio, after learning that Nathan Goddard was storing large quantities of fentanyl and cocaine in the basement. Goddard, his associate Cahke Cortner, and others were present when officers entered. Goddard, using a pistol acquired and equipped with a laser sight with Cortner's help, fired at Officer Jorge Del Rio, fatally wounding him. Cortner, armed, retreated to a back room. Both men surrendered after the incident. Evidence showed Goddard’s long history of drug trafficking and that Cortner had participated in drug-related communications and activities.The United States District Court for the Southern District of Ohio reviewed pretrial motions, including Goddard’s motion to suppress evidence from the search, which it denied, and granted the government’s motion to exclude evidence concerning the DEA’s operational plan. Combs, a co-defendant, pled guilty; Goddard and Cortner proceeded to trial. The jury convicted both on all counts, including conspiracy to possess and distribute drugs, possession with intent to distribute, and, for Goddard, murder of a federal officer and intentional killing during a drug-trafficking offense. Cortner was convicted of intentional killing under Pinkerton liability. Both received life sentences.The United States Court of Appeals for the Sixth Circuit affirmed the convictions and sentences. It held that probable cause supported the search warrant, the exclusion of operational-plan evidence was not an abuse of discretion, and sufficient evidence supported all convictions. The court found Pinkerton liability applicable to Cortner’s intentional killing charge and rejected arguments about procedural and substantive unreasonableness in sentencing. The court’s main holdings were to affirm the convictions and sentences for both defendants, upholding the district court’s rulings and jury findings. View "United States v. Goddard" on Justia Law

A.R., after her divorce in 2023, returned to her hometown of West Yellowstone and has struggled with mental health issues since 2019, including intermittent treatment and prescribed antipsychotic medications, which she sometimes refused to take. In March 2024, her mental health appeared to worsen, leading to an incident where she drove her car toward her parents, almost colliding with them and their house. Following this episode and a subsequent psychiatric evaluation diagnosing her with an unspecified schizophrenia spectrum and other psychotic disorder, the State filed a petition for her involuntary commitment.The Eighteenth Judicial District Court, Gallatin County, found probable cause to detain A.R., ordered a mental health evaluation, and held a hearing where a professional testified based on various sources, including A.R.’s own statements. At the hearing, A.R.’s counsel objected to testimony recounting her parents’ account of the driveway incident as hearsay, but the District Court overruled the objection. The District Court relied primarily on A.R.’s own admissions and statements during her evaluation to find she suffered from a mental disorder, posed a risk to herself and others, and was unable to provide for her own safety, resulting in a 90-day commitment order.The Supreme Court of the State of Montana reviewed the District Court’s evidentiary rulings for abuse of discretion and the sufficiency of evidence in a light most favorable to the prevailing party. The Supreme Court held that the District Court did not err in relying on A.R.’s own statements to the professional person, which were admissible as party-opponent admissions under Montana Rule of Evidence 801(d)(2), and were sufficient to support the statutory grounds for commitment. The Court affirmed the District Court’s April 2, 2024 Order of Commitment. View "In re A.R." on Justia Law

In August 2021, a city implemented a COVID-19 vaccination policy for its employees, requiring them to either receive the vaccine or request a medical or religious exemption. Employees granted an exemption were required to undergo weekly COVID-19 testing and wear masks in shared spaces. One employee, a forensic specialist, requested and received a religious exemption but objected to the testing and masking requirements, claiming they revealed his unvaccinated status and created a hostile work environment. He was placed on unpaid leave for refusing to comply but eventually agreed to the requirements and returned to work. He continued to challenge the policy until it was rescinded in March 2022.The employee filed suit in the United States District Court for the Central District of California, asserting federal and state claims against the city and several employees related to the testing and masking requirements. The district court found that the Public Readiness and Emergency Preparedness (PREP) Act applied but initially did not grant immunity to all individual defendants for each claim. Ultimately, the court dismissed the complaints, denied the employee’s motion for reconsideration, and entered judgment for the defendants.The United States Court of Appeals for the Ninth Circuit reviewed the case. The court held that both the city and individual defendants were “covered persons” under the PREP Act, and that COVID-19 tests and masks constituted “covered countermeasures” authorized for emergency use. The court clarified that the causation requirement for PREP Act immunity is satisfied if the injury alleged arises from the administration or use of a covered countermeasure, regardless of the legal theory. Because the employee’s alleged harms were directly linked to the city’s COVID-19 safety policy, the court affirmed the district court’s dismissal and denial of reconsideration, holding that PREP Act immunity barred all claims. View "SCHMIDT V. CITY OF PASADENA" on Justia Law

Several skilled nursing facilities providing long-term care to Medicaid recipients challenged the Pennsylvania Department of Human Services’ methodology for calculating Medical Assistance reimbursement rates. The dispute centered on the “Inflation Factor” used in the annual rate-setting process, specifically whether the Department should adjust costs from the end-point of each cost report year to the mid-point of the rate year (the Department’s method), or from the mid-point of the cost report year to the mid-point of the rate year (as the providers argued, based on federal Medicare principles).After the Department issued rate notices using its chosen methodology, the providers requested hearings before the Bureau of Hearings and Appeals (BHA). An Administrative Law Judge found the Department’s interpretation reasonable and consistent with its regulations, noting the Department had used this method since the inception of the case-mix payment system. The BHA adopted these findings, and the Commonwealth Court affirmed, applying agency deference and holding the regulation was ambiguous and the Department’s interpretation was not clearly erroneous or inconsistent with the regulation.The Supreme Court of Pennsylvania, Middle District, reviewed whether Pennsylvania courts should follow the “genuinely ambiguous” standard for agency deference articulated in Kisor v. Wilkie and whether the Department’s methodology was correct. The Court declined to adopt Kisor’s framework, instead clarifying that Pennsylvania courts must use the Statutory Construction Act to interpret ambiguous regulations, considering agency interpretations as one factor among many. The Court held that, although the relevant regulation was ambiguous regarding the starting point for inflation, the Department’s longstanding end-point to mid-point methodology was correct based on the factors in the Statutory Construction Act. Accordingly, the Court affirmed the Commonwealth Court’s decision. View "Lutheran Home v. DHS" on Justia Law

While detained in jail after allegedly assaulting his father, the plaintiff experienced a severe mental-health crisis. Medical staff from Hennepin Healthcare System evaluated him, but he was uncooperative and refused treatment. Over several weeks, his condition deteriorated, exhibiting erratic behavior, withdrawal, and ultimately refusing to eat or communicate. Dr. Sloan, a psychiatrist, initially assessed him as not an immediate danger and attributed his symptoms to substance withdrawal, opting for continued monitoring rather than immediate psychiatric hospitalization. When the plaintiff’s health worsened, Dr. Sloan transferred him to an acute psychiatric ward, where his condition improved with medication. After discharge, delays in transferring him to the Minnesota Security Hospital for long-term care, controlled by the Minnesota Department of Human Services, left him in jail for more than a year. During this time, Dr. Sloan continued to treat him, including obtaining a court order for forced medication when he again refused treatment.The United States District Court for the District of Minnesota denied Dr. Sloan’s motion to dismiss, holding that the plaintiff’s complaint plausibly alleged deliberate indifference to his serious medical needs and thus denying qualified immunity at the motion-to-dismiss stage.The United States Court of Appeals for the Eighth Circuit reviewed the denial of qualified immunity de novo. The court concluded that the plaintiff’s complaint did not plausibly allege deliberate indifference by Dr. Sloan, finding that her actions constituted medical judgment and, at most, medical negligence—not deliberate disregard for the plaintiff’s medical needs. The court also noted that delays in transferring the plaintiff were not attributable to Dr. Sloan, and that she continued to treat him during those periods. The Eighth Circuit reversed the district court’s denial of qualified immunity and remanded for entry of judgment in favor of Dr. Sloan on the deliberate-indifference claim. View "Doe v. Hennepin Healthcare System, Inc." on Justia Law

A psychiatrist in Massachusetts operated his own private practice and, between 2015 and 2018, submitted fraudulent bills to a range of private and public health insurers, including Medicare and several major insurance companies. The fraudulent conduct included billing for over a thousand sessions at times when either he or the purported patient was out of the country. When insurers began to scrutinize his claims and requested additional billing records, he delayed responses and provided falsified records to support his claims. Eventually, at least one insurer halted payments pending his compliance, and another made payments contingent on preauthorization. Following federal investigation, the psychiatrist was indicted and, in October 2023, convicted by a jury on fourteen out of fifteen counts related to the fraud.In the United States District Court for the District of Massachusetts, the sentencing judge calculated his guidelines range based on a loss amount equating to the total billed—about $19 million—which resulted in a twenty-level sentencing enhancement. He was sentenced to ninety-nine months on the main counts, with additional concurrent sentences, and was ordered to pay approximately $6.5 million in restitution and a similar amount in criminal forfeiture. The defendant challenged both the intended loss calculation used for sentencing and the restitution amount.The United States Court of Appeals for the First Circuit reviewed the appeal. The court applied a burden-shifting framework, allowing the billed amount as prima facie evidence of intended loss, and found that the defendant did not provide sufficient evidence to show he intended to obtain less than he billed, even considering his status as an in-network provider. The appellate court also rejected his argument that restitution should be offset by claims for legitimate, unpaid services, holding that such offsets are not appropriate in the context of criminal restitution. The First Circuit affirmed the district court’s decisions in all respects. View "US v. Kinrys" on Justia Law