This research presents a comprehensive review of the regulatory framework for pharmaceutical patents in Japan by analyzing the foundational legal structures governing the pharmaceutical sector, with a focus on the marketing authorization and reimbursement pricing mechanism. Through an in-depth assessment of patent legislation and its pharmaceutical applications, the paper also highlights ongoing challenges within existing legislative and enforcement mechanisms, referencing key judicial decisions and prevailing industry practices. Furthermore, the study offers practical suggestions to address such challenges with reference to other countries' experiences and practices, aiming to enhance the protection of stakeholders' rights and promote the advancement of the healthcare sector, which ultimately contributes to innovation development and improved medical access in Japan.

This study aimed to characterize litigation involving urethroplasties to identify common medical and legal trends. We queried the Westlaw and Bloomberg Law databases using the term “urethroplasty.” Cases from January 1979 to June 2023 were reviewed. We included both medical malpractice and nonmalpractice lawsuits. We excluded cases that did not mention the urologist, preoperative care, postoperative care, or complications. Cases were categorized based on the reason for litigation and the related complications, involved parties, and if they resulted in settlement. We identified 17 cases that met inclusion criteria. Seven of the cases were medical malpractice lawsuits, with four directly implicating urologists. Two malpractice cases resulted in verdicts awarding financially to plaintiffs, $810,000 and $1,006,000. Most malpractice cases alleged postoperative care negligence (n = 4, 57.1%), with the most common complications being physical pain (n = 3, 42.9%) and penile deformity (n = 3, 42.9%). Most nonmalpractice cases alleged delays in treatment (n = 5, 50%) with physical pain cited in 70% (n = 7) of these cases. In conclusion, most urethroplasty-related litigation were nonmalpractice lawsuits. Half of the malpractice cases resulted in verdicts favoring the plaintiff, while all verdicts for nonmalpractice cases favored the defendant. Awareness of litigation trends may help urologists improve patient care and counseling.

Recently, healthcare providers adopted telemedicine as a means to remotely grant access to patients seeking treatment for attention-deficit/hyperactivity disorder (ADHD). Two significant changes occurred during COVID-19 that facilitated the growth of telemedicine and the emergence of direct-to-consumer telemedicine-only corporations treating mental health conditions. First, the Drug Enforcement Administration issued a temporary rule suspending the requirement that providers conduct an in-person exam of patients before prescribing controlled substances. Second, states began to modify their licensing requirements, allowing providers to treat patients residing in other states. This article provides an overview of laws governing telemedicine, including prescribing requirements, licensing, and variations in prescription drug monitoring programs. Telehealth-only corporations raise new considerations for how to ensure quality and safety, guard against stimulant misuse, and prevent diversion. This article also explains two potential legal consequences for improper or excessive prescribing, including administrative sanctions by state medical boards and two recent cases of criminal liability.

Hip fractures are highly prevalent and associated with significant morbidity and mortality. This study aims to provide a comprehensive analysis of malpractice claims related to hip fractures. The Westlaw legal database was queried for all malpractice cases involving hip fractures from 1978 to 2020. Demographic data, monetary payouts, reasons for litigation, and case outcomes were analyzed. In total, 80 cases were included with a mean plaintiff age of 58 years and 60% female. Fifty-five cases (69%) resulted in a defendant verdict, while 25 cases (31%) resulted in a plaintiff verdict/settlement. The most common reasons for litigation were procedural/intraoperative errors (52, 65%), need for additional surgery (40, 50%), functional limitation (27, 34%), and continued/worsened pain (24, 30%). Multivariable logistic regression modeling showed that only diagnostic error was significantly associated with a plaintiff verdict (OR 12.57). Inflation-adjusted indemnity payments for cases resulting in plaintiff verdict/settlement ranged from $83,404 to $10,424,587. In conclusion, diagnostic error was associated with a plaintiff verdict, reinforcing the importance of timely and accurate diagnosis. Monetary awards to plaintiffs ranged from $86,000 to over $10 million; however, more than two-thirds of cases resulted in a verdict in favor of the defendant.

Asthma is the most common chronic lung disease in children and disproportionately impacts children from marginalized populations. Pediatric asthma health disparities are persistent, and multi-level solutions are needed to achieve health equity. Health policy, when equitably and successfully implemented, has the capacity to address these disparities and improve health outcomes. A stock inhaler policy is a simple policy solution to the lack of rescue inhaler access in the school setting, with a necessity for deescalating asthma symptoms, which are common. Despite this being a commonsense policy, implementation of stock inhaler programming after passage of Public Act 100-0726 in 2018 has been slow. One reason for this has been the reluctance of prescribers and school administrations due to liability concerns. Two recent studies corroborated that this was a heightened concern. To assess the legitimacy of potential liability concerns raised, a legal analysis of Public Act 100-0726 was conducted. This article details our collaborative legal analysis conducted with key partners in public health, medical, and legal fields. The results of the legal analysis suggest that risk of liability is low and concerns are overestimated. Therefore, efforts to mitigate perceptions of liability and to link schools to universal prescribers may facilitate stock inhaler policies in Illinois and beyond.