Justia Health Law Opinion Summaries

The case involves four plaintiffs who took docetaxel, a chemotherapy drug, as part of their treatment for early-stage breast cancer and subsequently suffered permanent chemotherapy-induced alopecia (PCIA). The plaintiffs allege that the manufacturers of the drug, Hospira, Inc., Hospira Worldwide, LLC, and Accord Healthcare, Inc., violated state law by failing to warn them that docetaxel could cause PCIA.The case was initially heard in the United States District Court for the Eastern District of Louisiana, where the defendants moved for summary judgment on the basis that the plaintiffs' state law failure-to-warn claims were preempted by federal law. The district court denied the motion, and the defendants appealed.The United States Court of Appeals for the Fifth Circuit was tasked with determining whether federal law preempts the plaintiffs' state law failure-to-warn claims against the defendant drug manufacturers. The court found that the district court had erred in its interpretation of what constitutes "newly acquired information" under the changes-being-effected (CBE) regulation, which allows manufacturers to file a supplemental application with the FDA and simultaneously implement a labeling change before obtaining FDA approval. The court held that the district court failed to enforce the requirement that newly acquired information must "reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA."The court vacated the district court's judgment on the plaintiffs' failure-to-warn claims and remanded the case for further consideration of one outstanding issue: whether the Bertrand Abstract, a scientific study, constituted "newly acquired information" that revealed a greater risk of PCIA than previously known. If the Bertrand Abstract does not meet this standard, the court held that the defendants would not be liable to the plaintiffs on their state law failure-to-warn claims. View "Hickey v. Hospira" on Justia Law

Seth Lookhart, a dentist, was convicted of numerous crimes related to a fraudulent scheme that endangered his patients' health and safety. The scheme involved unnecessary sedation of patients to fraudulently bill Alaska’s Medicaid program, overcharging it by more than $1.6 million. Lookhart also stole $412,500 from a business partner. His reckless sedation practices nearly resulted in the loss of two patients' lives. He was arrested in April 2017 and convicted on 46 charges in January 2020, leading to a sentence of 20 years in prison with eight years suspended.Following Lookhart's convictions, the Division of Corporations, Business and Professional Licensing sought to revoke his dental license. Lookhart agreed to the facts of the accusation but argued that revocation was not an appropriate sanction. The administrative law judge (ALJ) disagreed, stating that Lookhart's misconduct was more severe than any prior case and that revocation was the clear and obvious sanction. The Board of Dental Examiners adopted the ALJ's decision.Lookhart appealed to the superior court, arguing that the Board's decision was inconsistent with its prior decisions. The court disagreed, stating that the Board had wide discretion to determine appropriate sanctions and that no prior case was comparable to Lookhart's. The court affirmed the Board's decision. Lookhart then appealed to the Supreme Court of the State of Alaska.The Supreme Court affirmed the lower court's decision. It held that the Board of Dental Examiners did not abuse its discretion by revoking Lookhart's license. The court found that none of the Board's prior licensing cases involved misconduct of the scope and severity in this case, so there was no applicable precedent to limit the Board's exercise of its discretion. View "Lookhart v. State of Alaska, Board of Dental Examiners" on Justia Law

A teacher, who was involved in a car accident caused by a third party, sustained serious injuries. The teacher was covered under his employer’s self-insured healthcare plan, which stipulates that the employer has a right of reimbursement for medical expenses if a covered person receives a separate settlement. The employer paid for the teacher’s medical expenses and the teacher also received $500,000 in settlements from two separate insurers. The teacher requested that the employer waive its right to reimbursement twice, but the employer never agreed. Two years after the teacher notified the employer of his insurance settlements, the employer requested reimbursement and later sued him for breach of contract.The Superior Court of the State of Alaska granted summary judgment to the employer on the issue of whether the teacher breached the contract to reimburse the employer. The employer then moved for summary judgment on the amount of damages, providing an affidavit from its Plan Administrator and a claims ledger. The teacher opposed the motion, providing his own affidavit and a self-created spreadsheet in support of his argument that some of the medical costs paid by the employer were not associated with the accident. The court granted the employer’s motion for summary judgment on contract damages.The Supreme Court of the State of Alaska affirmed the lower court’s summary judgment order regarding breach of contract, but held that the teacher raised a genuine dispute of material fact regarding damages. Therefore, the Supreme Court reversed and remanded the lower court’s summary judgment order regarding contract damages. View "Fischer v. Kenai Peninsula Borough School District" on Justia Law

Michele Rawlins, a former school principal and member of the Teachers' Retirement System of the City of New York (TRS), was diagnosed with post-traumatic stress disorder (PTSD) following a series of incidents involving a disgruntled food-service worker. The worker's behavior left Rawlins feeling threatened and harassed, leading to her inability to perform her job responsibilities. The final incident occurred in April 2019, when the worker, who had been transferred to another location, entered the school and demanded to speak with Rawlins, insisting she had his "belt and wallet." Rawlins interpreted the worker's remarks as having "sexual overtones" and felt she was being stalked. She left the school building and never returned to work following the incident.Rawlins applied for accidental disability retirement benefits (ADR) from the TRS, but her application was denied. The TRS Medical Board determined that she did not sustain an accident in the work setting and that "purposeful conduct by coworkers giving rise to a disabling injury is not an accident within the meaning of the pension statute." Rawlins reapplied for ADR, but the Board maintained its previous determination. Rawlins then commenced a CPLR article 78 proceeding to annul the Board's determination. The Supreme Court denied the petition and dismissed the proceeding, stating that the Board's determination had a rational basis. The Appellate Division affirmed the Supreme Court's decision, and Rawlins was granted leave to appeal.The Court of Appeals affirmed the lower courts' decisions. The court held that substantial evidence supported the Board's determination that Rawlins' injury was not caused by an "accident" within the meaning of the statutory scheme. The court declined to adopt a rule that "purposeful conduct by coworkers" can never be the basis for an award of ADR. Instead, the court stated that when a member's disability is alleged to have resulted from the intentional acts of any third party, the relevant question continues to be whether the injury-causing event was sudden, unexpected, and outside the risks inherent in the work performed. View "Matter of Rawlins v Teachers' Retirement Sys. of the City of N.Y." on Justia Law

An inmate, Timothy Finley, who suffers from severe psychiatric disorders, was placed in a heavily restrictive cell in administrative segregation for approximately three months by prison officials. Finley brought a case against the deputy wardens, Erica Huss and Sarah Schroeder, alleging violations of the Eighth Amendment and his right to procedural due process, as well as disability-discrimination claims under the Americans with Disabilities Act and the Rehabilitation Act.The district court granted summary judgment to Huss and Schroeder on all claims. On appeal, the United States Court of Appeals for the Sixth Circuit affirmed the lower court's decision on Finley’s procedural due process and statutory discrimination claims. However, the court reversed the lower court's decision on Finley’s Eighth Amendment claim, finding that he presented sufficient evidence to find that the deputy wardens violated his clearly established rights. The court remanded the case for further proceedings on the Eighth Amendment claim. View "Finley v. Huss" on Justia Law

The case involves the West Virginia Department of Health, Office of the Chief Medical Examiner, and Dr. Allen R. Mock (collectively "Petitioners") and Dr. Patsy Cipoletti, Jr., administrator of the estate of his deceased wife, June Cipoletti ("Respondent"). The Respondent filed a complaint against the Petitioners, alleging that they violated the West Virginia Medical Professional Liability Act (MPLA) by negligently determining Mrs. Cipoletti’s cause of death. The Petitioners filed a motion to dismiss, arguing that the Respondent had not asserted a proper cause of action under the MPLA. The circuit court denied the motion to dismiss, determining that the MPLA applied and that Petitioners were not entitled to qualified immunity.The Circuit Court of Kanawha County denied the Petitioners' motion to dismiss. The court determined that the MPLA applied and that Petitioners were not entitled to qualified immunity. The court found that Dr. Mock’s conduct fell under and was governed by the MPLA, thus depriving Petitioners of qualified immunity.The Supreme Court of Appeals of West Virginia reversed the circuit court's decision. The court found that the Petitioners' actions were discretionary and not in violation of any "clearly established statutory or constitutional rights or laws" and were not "otherwise fraudulent, malicious, or oppressive." Therefore, the court concluded that the Petitioners were entitled to qualified immunity from the lawsuit. The court also found that the Respondent had failed to plead a viable MPLA cause of action against the Petitioners. The court remanded the case to the circuit court with directions to grant the Petitioners' motion to dismiss. View "West Virginia Department of Health v. Cipoletti" on Justia Law

The case involves Novartis Pharmaceuticals Corporation and United Therapeutics Corporation, both drug manufacturers, and the Health Resources and Service Administration (HRSA). The dispute centers around Section 340B of the Public Health Service Act, which mandates drug manufacturers to sell certain drugs at discounted prices to select healthcare providers. These providers often contract with outside pharmacies for distribution. The manufacturers argued that these partnerships have left the Section 340B program vulnerable to abuse, leading them to impose their own contractual terms on providers, such as limits on the number of pharmacies to which they will make shipments. The government contended that these restrictions violate the statute.The case was initially heard in the United States District Court for the District of Columbia. The district court ruled that Section 340B does not prohibit manufacturers from limiting the distribution of discounted drugs by contract.The case was then reviewed by the United States Court of Appeals for the District of Columbia Circuit. The court agreed with the district court's ruling, stating that Section 340B does not categorically prohibit manufacturers from imposing conditions on the distribution of covered drugs to covered entities. The court further held that the conditions at issue in this case do not violate Section 340B on their face. The court did not rule out the possibility that other, more onerous conditions might violate the statute or that these conditions may violate Section 340B as applied in particular circumstances. The court affirmed the district court's decision to set aside the enforcement letters under review, while reserving the possibility of future enforcement under theories of liability narrower than the one pressed here. View "Novartis Pharmaceuticals Corporation v. Johnson" on Justia Law

The case involves the Roman Catholic Diocese of Albany and other entities, who provide medical insurance plans to their employees. They challenged a regulation by the Department of Financial Services, which requires New York employer health insurance policies that provide hospital, surgical, or medical expense coverage to include coverage for medically necessary abortion services. The plaintiffs argued that the exemption for "religious employers" was too narrow, violating the First Amendment rights of certain types of religiously affiliated employers who do not meet the terms of the exemption.The case began in 2016, raising a federal Free Exercise Claim that was similar to a previous case, Catholic Charities of Diocese of Albany v Serio. The lower courts dismissed the plaintiffs' complaints based on the principle of stare decisis, and the Appellate Division affirmed on the same ground. The plaintiffs appealed to the Supreme Court of the United States, which remanded the case to the Appellate Division to reconsider in light of a recent decision, Fulton v Philadelphia.On remand, the Appellate Division held that Serio was still good law and affirmed its previous decision that neither the medically necessary abortion regulation nor the "religious employer" exemption as defined violated the Free Exercise Clause. The Court of Appeals agreed, stating that under Fulton, both the regulation itself and the criteria delineating a "religious employer" for the purposes of the exemption are generally applicable and do not violate the Free Exercise Clause. The court concluded that the "religious employer" exemption survives the general applicability tests delineated in Fulton, and therefore, the Appellate Division order should be affirmed. View "Roman Catholic Diocese of Albany v Vullo" on Justia Law

Carlos Esteras and Raphael Frias were convicted of fentanyl trafficking charges and appealed their sentences, arguing that the district court erred in calculating their respective Guidelines ranges. Esteras contended that the district court wrongly calculated his base offense level by applying a two-level increase for maintaining a premises for narcotics trafficking and declining to apply a two-level reduction for being a minor participant in the trafficking scheme. He also argued that the district court wrongly applied a two-point increase to his criminal history score after finding that he was on parole at the time of the offense. Frias argued that the district court erred in applying the two-level premises enhancement and a four-level increase for being an organizer or leader of the scheme, and failed to adequately consider his mitigating evidence in declining to vary downwards.The United States District Court for the Northern District of New York had sentenced Esteras to 84 months' imprisonment and Frias to 135 months' imprisonment. The court had applied several sentencing enhancements, including a two-level enhancement for maintaining a premises for narcotics trafficking and a four-level enhancement for being an organizer or leader of the scheme.The United States Court of Appeals for the Second Circuit affirmed each of the district court’s sentencing decisions except its application of the organizer or leader enhancement to Frias. The court affirmed Esteras’s sentence and vacated and remanded Frias’s sentence for further proceedings consistent with its opinion. The court found that Esteras's home qualified for the stash-house enhancement and that he was not a minor participant in the conspiracy. The court also found that Esteras was on parole when he committed his offenses, warranting a two-point increase to his criminal history score. However, the court found that Frias did not qualify as an organizer or leader under the Guidelines, warranting a remand for further proceedings. View "United States v. Frias" on Justia Law

The case revolves around an employment discrimination suit filed by Dr. Tara Loux against her former employers, BayCare Medical Group and St. Joseph’s Hospital. Dr. Loux sought to discover BayCare’s internal documents about the performance of other doctors who were not fired despite also committing errors. BayCare objected to disclosing certain documents, such as its “quality files” and “referral logs,” arguing that they were privileged under the Patient Safety and Quality Improvement Act of 2005. The Act creates a statutory privilege for work product prepared for or reported to patient safety organizations.The district court ordered BayCare to produce the disputed documents, concluding that the Act does not privilege documents if they have a “dual purpose,” only one of which relates to making reports to a patient safety organization. The court held that these documents were not privileged because BayCare used information in the documents for other purposes, such as internal safety analysis and peer review.The United States Court of Appeals for the Eleventh Circuit disagreed with the district court's interpretation of the Act. The appellate court found that the district court had applied an incorrect "sole purpose" standard to assess whether BayCare’s quality files and referral logs fell under the privilege. The court held that the Act does not require that privileged information be kept solely for provision to a Patient Safety Organization. The court granted BayCare's petition for a writ of mandamus, directing the district court to vacate its orders compelling the disclosure of the privileged documents and reconsider BayCare’s assertion of privilege consistent with the appellate court's opinion. View "In re: Baycare Medical Group, Inc." on Justia Law