Justia Health Law Opinion Summaries

The case involves Vanda Pharmaceuticals, a drug manufacturer, and the Centers for Medicare & Medicaid Services (CMS). Vanda challenged a 2020 regulation by CMS that expanded the definition of a "line extension" drug under the Medicaid Drug Rebate Program. This program requires drug manufacturers to reimburse Medicaid if they increase their prices faster than inflation. A "line extension" drug, which is a new formulation of an existing drug, can also be liable for price increases of the original drug. Vanda argued that the regulation expanded the definition of a line extension beyond what the Medicaid statute permitted.Previously, the district court granted summary judgment to CMS, disagreeing with Vanda's argument. The court held that the agency's regulation was within the bounds of the Medicaid statute.The United States Court of Appeals for the Fourth Circuit affirmed the district court's decision. The court found that the agency's definitions of "line extension" and "new formulation" were within the Medicaid statute's ambit. It also held that the agency's interpretation of the oral-solid-dosage-form requirement was not contrary to law. The court rejected Vanda's argument that the agency's rulemaking process was arbitrary and capricious, finding that the agency had reasonably considered the relevant issues and explained its decision. View "Vanda Pharmaceuticals, Inc. v. Centers for Medicare & Medicaid Services" on Justia Law

The case involves Adree Edmo, a transgender woman incarcerated in Idaho, who sued the State of Idaho, private prison company Corizon, and individual prison officials for failing to provide her with adequate medical care, including gender-confirmation surgery. Edmo alleged violations of the Eighth Amendment, the Fourteenth Amendment’s Equal Protection Clause, the Affordable Care Act, the Americans with Disabilities Act, and negligence under Idaho law. The district court granted an injunction on Edmo’s Eighth Amendment claim and ordered the defendants to provide her with adequate medical care, including gender-confirmation surgery. The court denied preliminary injunctive relief on Edmo’s Fourteenth Amendment and ACA claims because the record had not been sufficiently developed.The district court's decision was appealed, and the injunction was stayed. The Ninth Circuit Court of Appeals affirmed the district court’s decision except as it applied to five defendants in their individual capacities. After the Supreme Court denied a writ of certiorari, the parties engaged in settlement negotiations that led to Edmo voluntarily dismissing the remainder of her claims. The district court awarded Edmo $2,586,048.80 for attorneys’ fees incurred up until the injunction became permanent and all appeals were resolved.The Ninth Circuit Court of Appeals reversed in part, affirmed in part, and vacated in part the district court’s award of attorneys’ fees to Edmo. The court held that Edmo was entitled to fees incurred litigating her successful Eighth Amendment claim. However, the court found that the district court erred in calculating the lodestar amount to include fees incurred litigating unsuccessful claims advanced in the complaint, even if those claims were premised on the same facts that supported Edmo’s Eighth Amendment claim. The court also held that the district court did not err by applying an enhancement to the lodestar amount given that Edmo’s counsel operated under extraordinary time pressure and that the customary fee for counsel’s services is well above the PLRA cap. The case was remanded for recalculation of the lodestar amount to include only fees incurred litigating Edmo’s successful claim against the defendants who remained in the case. View "Edmo v. Corizon, Inc." on Justia Law

In 2019, MO CANN Do, Inc. (MCD) applied for a medical marijuana cultivation license in Missouri. However, the Department of Health and Senior Services (DHSS) rejected MCD's application as it failed to include a certificate of good standing demonstrating its authorization to operate as a business in Missouri. An administrative hearing commission upheld DHSS's decision, and MCD appealed to the circuit court, which also affirmed the decision.The Supreme Court of Missouri found that MCD's application did not meet the minimum standards for licensure, as it failed to provide a certificate of good standing from the Secretary of State, as required by DHSS's regulations. MCD argued that its certificate of incorporation satisfied the standard requiring proof of authorization to operate as a business in Missouri, but the Court disagreed, stating that the regulatory language was unambiguous and the certificate of good standing was a specific requirement.MCD further argued that DHSS waived the certificate of good standing requirement by failing to specify it in the deficiency letter sent to MCD. The Court rejected this argument, stating that DHSS never affirmatively waived the deficiencies in MCD's application.Lastly, MCD claimed that DHSS should be estopped from denying its application based on the missing certificate of good standing due to its failure to notify MCD of this specific deficiency. The Court denied this claim, stating that it is generally inappropriate to estop governmental agencies tasked with administrating licensure in highly regulated industries, which include the marijuana industry. In conclusion, the Supreme Court of Missouri affirmed the circuit court’s judgment. View "MO CANN Do, Inc. vs. Missouri Department of Health and Senior Services" on Justia Law

The Florida Supreme Court was asked to review a proposed amendment to the state constitution legalizing the recreational use of marijuana. The court evaluated the amendment for adherence to the constitution’s single-subject requirement, the clarity of the ballot summary, and whether the amendment was facially invalid under the federal constitution. The amendment, titled "Adult Personal Use of Marijuana," aimed to modify the Florida Constitution to legalize the personal use of marijuana by adults and allow licensed centers to sell and distribute marijuana for personal use.The court ruled that the amendment adhered to the single-subject requirement as it focused on a single dominant plan or scheme, which is the legalization of marijuana for personal use. The court disagreed with the argument that the amendment violated the single-subject requirement by both decriminalizing and commercializing recreational marijuana, stating that the sale and possession are logically and naturally related as part of a dominant plan or scheme.The court also ruled that the ballot summary met the statutory standard for clarity. The court disagreed with the opposition that the ballot summary was misleading because it implied that there were already other state-licensed entities ready to engage in the sale of recreational marijuana.Lastly, the court ruled that the amendment is not facially invalid under the U.S. Constitution. The court rejected the argument that the proposed amendment is preempted by the federal Controlled Substances Act and thus invalid under the Supremacy Clause.In conclusion, the court approved the proposed amendment for placement on the ballot, finding it complies with the requirements imposed by the Florida Constitution and Florida Statutes. View "Advisory Opinion to the Attorney General Re: Adult Personal Use of Marijuana" on Justia Law

This case before the Supreme Court of Florida concerned a constitutional challenge to an amended Florida statute that prohibits abortions if the gestational age of the fetus is more than 15 weeks, with certain exceptions. The petitioners, a group of abortion clinics and a medical doctor collectively known as Planned Parenthood, alleged that the statute violated the Privacy Clause of the Florida Constitution, which guarantees the right to be let alone and free from government intrusion into private life.While acknowledging the moral, ethical, and policy issues implicated in the subject matter of abortion, the court focused on the Privacy Clause’s text, its context, and the historical evidence surrounding its adoption. The court concluded that there was no basis under the Privacy Clause to invalidate the statute. In reaching this conclusion, the court receded from prior decisions in which it held that the Privacy Clause guaranteed the right to receive an abortion through the end of the second trimester.As such, the court found that the petitioners were not entitled to the temporary injunction granted by the trial court. The court approved the outcome reached by the First District Court of Appeal, which had reversed the temporary injunction on the basis that Planned Parenthood could not establish irreparable harm. Therefore, the Florida statute prohibiting abortions after 15 weeks of gestational age, subject to certain exceptions, was upheld. View "Planned Parenthood of Southwest and Central Florida v. State of Florida" on Justia Law

The case involves Haitham Yousef Alhindi, the defendant-appellant, who was charged with five counts of cyberstalking. Alhindi's counsel requested a competency evaluation, which was conducted by the Bureau of Prisons (Bureau), albeit late. Based on limited information and caution, the Bureau's report deemed Alhindi incompetent. The court ordered Alhindi to be hospitalized for treatment under 18 U.S.C. § 4241(d)(1). However, before Alhindi was hospitalized, the Bureau reported that he was not exhibiting any signs of mental illness and recommended a second competency evaluation, which the court ordered over Alhindi's objection. The second evaluation also concluded that Alhindi was incompetent. Alhindi appealed, arguing that the district court lacked authority to order a second competency evaluation and commitment for hospitalization.The U.S. Court of Appeals for the Eleventh Circuit disagreed, holding that 18 U.S.C. § 4241 authorizes district courts to order multiple competency evaluations and commitments for hospitalization when appropriate under the statute's terms. The court also found that the four-month limit in § 4241(d)(1) applies to the period of hospitalization, not the entire commitment period. The court emphasized the importance of district courts’ continued close supervision of competency proceedings. The court affirmed the district court's entry of the commitment order. View "USA v. Haitham Alhindi" on Justia Law

The United States Court of Appeals for the Fourth Circuit ruled on a case involving a plaintiff, Joann Ford, and a healthcare provider, Sandhills Medical Foundation, Inc. Ford, a former patient of Sandhills, alleged negligence, breach of implied contract, invasion of privacy, and breach of confidentiality against Sandhills for failure to protect her personally identifying information (PII). Her PII was stolen from Sandhills' third-party computer system in a cyberattack after she had ceased being a patient.The district court had previously granted Sandhills immunity from the suit, concluding that the theft of Ford's PII arose out of Sandhills' performance of “medical, surgical, dental, or related functions,” as per 42 U.S.C. § 233(a), thus substituting the United States as the defendant. However, the Fourth Circuit Court disagreed with the lower court's interpretation of § 233(a).The appellate court determined that data security does not fall under a “related function” within the meaning of the statute. The court emphasized that § 233(a) immunity applies when alleged damages arise from the provision of healthcare, which was not the case here. Ford’s injury did not arise from Sandhills’ provision of healthcare, but from a data security breach that occurred at least a year after she ceased being a patient at Sandhills.Therefore, the court concluded that Sandhills was not immune from the suit under § 233(a) and that the United States could not be substituted as the defendant. The case was vacated and remanded for further proceedings. View "Ford v. Sandhills Medical Foundation, Inc." on Justia Law

The Supreme Court of Mississippi was asked to decide whether the Mississippi State Department of Health (MSDH) was required to admit evidence of a concurrent Certificate of Need (CON) application during the CON hearing for another healthcare facility. The MSDH had simultaneously considered two CON applications, one from Encompass Health Rehabilitation Hospital and one from Baptist Memorial Rehabilitation Hospital, for the same category of services. The MSDH did not admit the Baptist application or certificate, and the chancery court reversed the decision solely on this issue.The Supreme Court of Mississippi ruled that the chancery court was in error, and that the MSDH's decision on relevance or its decision not to reopen a closed hearing was not reversible error. The Supreme Court found that the MSDH did not abuse its discretion or violate due process in determining that the Baptist CON application was not relevant to the Encompass' CON application proceedings.The Supreme Court vacated the chancery court’s decision and remanded the case to the chancery court for a decision on the merits of Methodist’s appeal. The chancery court had failed to address the substance of Methodist’s appeal regarding the granting of a CON to Encompass, and the issue was not squarely before the Supreme Court. View "Encompass Health Rehabilitation Hospital of Flowood, LLC v. Mississippi Methodist Hospital and Rehabilitation Center, Inc." on Justia Law

The Supreme Court of California considered whether a health care agent, who had signed two contracts with a skilled nursing facility on behalf of a principal, had the authority to sign an optional, separate arbitration agreement. The first contract ensured the principal’s admission to the facility, while the second made arbitration the exclusive method for resolving disputes with the facility. The court concluded that the execution of the arbitration contract was not a "health care decision" within the authority of the health care agent. Therefore, the facility’s owners and operators could not rely on the agent’s execution of the arbitration agreement to compel arbitration of claims arising from the principal’s alleged maltreatment. The court affirmed the judgment of the Court of Appeal and remanded the case for further proceedings. View "Harrod v. Country Oaks Partners, LLC" on Justia Law

This case deals with the importation of two transcatheter heart valve systems by Meril Life Sciences Pvt. Ltd. and Meril, Inc. (collectively, "Meril") into the United States for a medical conference in San Francisco. The plaintiff, Edwards Lifesciences Corporation and Edwards Lifesciences LLC (collectively, "Edwards"), a competitor medical device company, alleged that this act constituted patent infringement. Meril argued that the importation was covered by the "safe harbor" provision of 35 U.S.C. § 271(e)(1), which exempts certain activities from being considered patent infringement if they are reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs.The district court granted summary judgment in favor of Meril, and Edwards appealed to the United States Court of Appeals for the Federal Circuit. The Court of Appeals affirmed the decision of the district court, noting that the undisputed evidence showed that the importation of the valve systems was reasonably related to submitting information to the United States Food and Drug Administration. The court rejected Edwards' arguments that the district court had disregarded contemporaneous evidence, applied the safe harbor with an objective standard, and relied improperly on declarations from Meril employees. The court affirmed the district court's conclusion that there was no genuine dispute of material fact and that Meril was entitled to judgment as a matter of law. View "EDWARDS LIFESCIENCES CORPORATION v. MERIL LIFE SCIENCES PVT. LTD. " on Justia Law