Healthcare Litigation Research Articles

Profile of judicialization in access to antineoplastic drugs and their costs: a cross-sectional, descriptive study based on a set of all lawsuits filed between 2016 and 2018 in a state in the Northeast Region of Brazil.

BackgroundThe judicialization of the acquisition of medication for healthcare is not restricted to Brazil but can also be found in other Latin American countries, despite the existence of a universal health system in the case of Brazil, the Unified Health System (known as the SUS). Right-to-medicines litigation has existed ever since the emergence of a high demand for treatment of Acquired Immuno-deficiency Syndrome (AIDS) but the current focus is on cancer. Pharmaceutical Assistance (PA) is the area within the SUS that is responsible for ensuring access to medication and the aim of this article is thus to draw up a profile of litigation related to PA in one economically significant state in the Northeast Region of Brazil, in terms of the following characteristics of lawsuits: the plaintiff filing the lawsuit; medical and health information; the cost of acquiring the requested medications; and the proportion accounted for by spending on antineoplastic drugs.MethodsA cross-sectional, descriptive study was conducted of lawsuits filed between 2016 and 2018 at the Litigation Center of the State of Pernambuco Department of Health.ResultsA total of 2,947 lawsuits containing at least one requested medication were analyzed. The majority of the plaintiffs were male (51.7%); 49.8% of the requests originated in the Unified Health System (SUS), and plaintiffs were primarily patients in the Metropolitan region of the State capital, Recife. The most frequent cancers involved were those classified by the ICD as C61, C71 and C50. The median general expense on medications for the actions was U$1,734.94. Considering antineoplastic drugs alone, the cost exceeded U$7,500 per lawsuit over the three years, given that the median unit price for antineoplastic drugs is approximately US$65 compared to US$4 for non-antineoplastic drugs.ConclusionThe present study is of relevance to the field of public health and examines how a profile of such healthcare litigation can be used as a tool for managing and improving decision-making in times of economic austerity.Supplementary InformationThe online version contains supplementary material available at 10.1186/s12889-022-14199-1.

Sanctions against health system demonstrate that it's time to get serious about audit trail discovery.

In the world of health care litigation it has become clear that medical malpractice cases now contain two claims-one on the medicine and one on the electronic health record (EHR). Two years of contentious discovery motions over the production of a complete copy of the EHR and audit trail in a case involving the delivery of a baby recently resulted in a nightmare scenario for a large health care system: sanctions in the form of an order entering judgment of liability in favor of the patient. The order was entered before depositions on the medicine were ever held. The decision in Prieto v. Rush University Medical Center (RUMC), etal. is the premiere example why patients' lawyers are focused on the audit trail. In this case, they were able to secure a legal victory without even litigating the underlying facts of the case.

Reimagining Doctrinal Orientations of English Health Care Law Scholarship Since 1980

Defining a legal field has functional importance and a legitimising usefulness for the field. There is no doubt that health care law (HCL) has emerged as a field of law and a discrete academic discipline in England and Wales with indicators that gradually became identifiable post-1980. Increasingly, patients aggrieved by their clinical experiences have sought redress in the courts. Doctors have also resorted to the courts for declarations as to the legality of proposed procedures that are ethically sensitive. The burgeoning litigation in healthcare has not only generated an avalanche of case law for academic study, but has also exposed the inadequacy of the common law in resolving the specific bioethical and legal challenges raised by healthcare. Specific legislation was enacted for the first time to address issues raised by medical advances. Concomitant with the evolution of this field of law was the emergence of its academic discipline. It entered the curriculum of legal education as many universities began to teach HCL. This eventually triggered a proliferation of textbooks and journals. The proliferation of literature was accompanied by the creation of academic research centres. Active scholarship in this field has manifested itself in four different doctrinal orientations, namely medical ethics, human rights, and multidisciplinary and socio-legal approaches.

Characteristics of trauma patients that leave against medical advice: An eight-year survey analysis using the National Hospital Ambulatory Medical Care Survey, 2009–2016

BackgroundLeaving against medical advice (AMA) is associated with increased readmission rates, fragmented patient care, and healthcare litigation. Understanding the factors associated with trauma patients leaving AMA from acute care settings will help guide better communication with trauma patients and improve patient satisfaction. This study aims to assess the sociodemographic and in-hospital care characteristics of trauma patients that leave AMA from acute care centers across the U.S. MethodsWe pooled and analyzed eight years of data (2009–2016) from the National Hospital Ambulatory Medical Care Survey. The outcome variable was whether the patient left AMA or not. The main predictors were the triage class, weekend presentation, health insurance status, the presence of chronic diseases, and the receipt of therapeutic and diagnostic procedures. The sociodemographic characteristics -age, sex, and race/ethnicity, were measured as potential confounders in the developed model. We performed logistic regression and reported the unadjusted and adjusted odds of leaving AMA as well as the 95% confidence intervals. ResultsThe weighted percent of the trauma patient population that left AMA was 1.8%. The odds of leaving AMA decreased with advancing age, and increased among non-Hispanic Blacks, compared with non-Hispanic Whites. After adjusting for age, race, and gender, the odds of leaving AMA increased among patients that lacked health insurance (AOR: 1.86; 95% CI: 1.51–2.31), and had diagnostic procedures (AOR: 2.79; 95% CI: 2.32–3.36). The odds of leaving AMA reduced among trauma patients who were classified as emergent (AOR: 0.70; 95% CI: 0.50–0.98) and had therapeutic procedures (AOR: 0.39; 95% CI: 0.32–0.47). ConclusionPredicting trauma patients with increased odds of leaving AMA will inform intentional communication that may reduce leaving AMA rates and improve care.

The Emerging Hazard of AI-Related Health Care Discrimination.

Artificial intelligence holds great promise for improved health-care outcomes. But it also poses substantial new hazards, including algorithmic discrimination. For example, an algorithm used to identify candidates for beneficial "high risk care management" programs routinely failed to select racial minorities. Furthermore, some algorithms deliberately adjust for race in ways that divert resources away from minority patients. To illustrate, algorithms have underestimated African Americans' risks of kidney stones and death from heart failure. Algorithmic discrimination can violate Title VI of the Civil Rights Act and Section 1557 of the Affordable Care Act when it unjustifiably disadvantages underserved populations. This article urges that both legal and technical tools be deployed to promote AI fairness. Plaintiffs should be able to assert disparate impact claims in health-care litigation, and Congress should enact an Algorithmic Accountability Act. In addition, fairness should be a key element in designing, implementing, validating, and employing AI.

Litigation for Health Technology Accessibility: A Tool for Inequality? Reflections Based on Case Study Analysis

INTRODUCTION The objective of this work is to analyze the characteristics of litigation for access to health’s goods and services in the Social Health Insurance (SHI) of Buenos Aires, Argentina. METHOD Descriptive study with analytical stage, performed in SHI, analyzing litigation done by beneficiaries along 15-years period to obtain goods or service from health managers. Variables explored were: Reason for litigation, delay time in case resolution, final result of judicial sentence, judges, lawyers and intervening professionals, income level of beneficiaries who started the litigation. RESULT 825 cases were analyzed during the study period according the method described. Demands increased 29.2 ±% per year. Medicines were the goods that most requested legal protection resources (32.5%). 51.9% of these litigations were due to medicines that have less than 24 months of registration by the National Regulatory Agency. The average delay for the final resolution of the procedure was 3.7 months. Judge's sentence was favorable to the beneficiaries in 97.4%. Although there are 27 judicial departments and many courts in each one; cases were concentrated in 47.4% only 2 very few courts. Litigation cases promoted by 112 out of the 15000 doctors that provides services to the SHI. In 73.7% of the cases, beneficiaries that litigated had a salary that exceed 4 times the minimum wage, and only 3.2% of them had low income. CONCLUSION We show how legal appeals might be working as an inverse strategy to the one desired, transferring collective resources belonging to the entire population, towards an specific demand from the most economically wealthy sector of society. As long as access to health care litigation maintains its current individualistic pattern, it will hardly be able to develop its full potential to guarantee effective respect for the collective right to access to goods that beneficiary the whole community.

Litigation to Access Health Services: Ally or Enemy of Global Public Health?

Background:Some scholars and global health advocates argue that litigation is a strategy to advance public health care, especially in those countries that do not have specific legislation to guarantee access to basic health care services. However, strategic litigation has another side, known as judicialization of the right to health, particularly present in the Latin American region where most countries incorporate the right to health into their constitutions, but their citizens still struggle with health disparities.Objectives:Considering these two perspectives on litigation in health care, this paper examines the phenomenon of litigation in health care and its impact on public health in Brazil, where there is an ambiguous process of litigation in health care.Methods:Comparing the literature of both the use of strategic litigation for advancing public health and the judicialization of the right to health, this paper develops an ethical analysis of the impacts of strategic litigation for individuals and societies, using Brazil’s public health care system and its policies as case-study of the impact of court decisions on the management of the system.Findings:Supporters of strategic litigation present experiences in African countries using this strategy to access a specific medical service led to enforce the creation of health-related policies by authorities and policymakers. However, in Brazil, a country with the right to health guaranteed by its Constitution, strategic litigation creates access to health care for some individuals, but also results in complex sociomedical challenges with significant impact for public administration and distributive justice.Conclusions:Strategic litigation can lead to ambiguous results, which will depend on the local context and the existence or not of public health services and health-related policies. When this strategy is considered, ethical analysis helps to understand how litigation can both benefit and damage individuals’ health and the public health system in the complex context and diverse reality of Brazil. As a result, strategic litigation must be considered from an ethical perspective of prudence and discernment in a close interaction with the local reality, its particular circumstances, culture, policies, and laws.

Medical Futility in Concept, Culture, and Practice

This article elucidates the premises and limited meaning of medical futility in order to formulate an ethically meaningful definition of the term, that is, a medical intervention’s inability to deliver the benefit for which it is designed. It uses this definition to show the two ways an intervention could become medically futile, to recommend an even more limited usage of medical futility, and to explain why an intervention need not be futile in order to be withdrawn over patient-based objections. If an intervention retains some benefit, then patients or surrogates might legitimately consider that benefit in their case and request the intervention. Physicians might still be justified in declining it on the grounds that the burdens greatly outweigh the benefits, but not on the grounds of futility. Finally, the article uses bioethics research and healthcare litigation to clarify the meaning of futility in practice and recommends alternative language when possible.

Judicialization of the Right to Health and Institutional Changes in Brazil

The judicialization of the right to health in Brazil may be generating institutional innovations in the system. This judicialization has had unexpected effects, such as disrupting budgetary allocations of public healthcare resources. To deal with such effects, many public authorities directly or indirectly involved with the Brazilian Public Health Care System have created a series of institutional innovations. These innovations aim at i) minimizing the budgetary effects of judicialization and/or ii) decreasing litigation involving the public healthcare system. This chapter highlights two demonstrative cases: the healthcare settlement chambers [Câmaras de Conciliacao de Litigios de Saude] and the centers for technical advisement of judges (Nucleo de AssistenciaTecnica - NAT). This article provides a description of the centers for technical advisement of judges and show the still preliminary attempts to institutionalize extrajudicial forms of settling healthcare litigation.

Counting the public healthcare litigation bill

In addition to the cost in grief and trauma to families and the shattered confidence of under-resourced, under-supervised and over-worked doctors, South Africa (SA)'s nine provincial health departments face a ZAR24 billion patient litigation bill (2010 - 2014, with ZAR500 million paid).

Answering Subpoenas Poses Legal, Privacy Risks

Answering Subpoenas Poses Legal, Privacy Risks

Medical Malpractices and the Complexity of Healthcare Litigation: Is There a Case for No-Fault Compensation Regime in England and Wales?

Although health care law (HCL) has attained the status of a discrete field of law during the past four decades, yet malpractice litigation is heavily based upon the traditional requirements of tort law which is largely entangled with its complexities in establishing medical liability. This conundrum is exacerbated by the perceived excessive deference to medical paternalism in English and Welsh courts. Whether or not medical malpractice litigation should be exempted from strictures of the traditional paradigm of the common law in establishing liability for negligence remains contested. In this paper, I argue that due to the practical difficulties entailed in pursuing healthcare malpractice grievances via the courts system particularly the uphill task of proving clinical negligence, lawmakers should revisit the possibility of adopting a no-fault compensation scheme for all cases that can properly be categorized as medical malpractice.

Let's do no harm: Medication errors in nursing: Part 1

In the current climate of global economic chaos and increasing healthcare litigation, it is perhaps simultaneously unsurprising and yet perplexing that patients continue to fall foul of healthcare systems worldwide. Major incidents in patient care such as serious misdiagnoses, medication errors, the proliferation of superbugs and malpractice persist leading to injury or death of patients, emotional trauma to their families and, understandably, a reduction in the public's confidence in the healthcare system not to mention the financial consequences. Many, if not most or indeed all, of these incidents are preventable and should not happen. Yet the systems in place within healthcare permit their occurrence, with worrying regularity, it would appear. The area that this paper will focus on specifically is that of medication errors. The worrying trends with regard to medication errors will be presented. Potential contributing factors will be examined. The specific aim of this paper is to illuminate the extent and severity of the problem of medication errors in practice and to explore elements within the practice setting that can compound the problem. The multi-faceted nature of the problem will also be considered.

Addressing Equity in Health Care at the Public-Private Intersection: The Role of Health Rights Enforcement in Hungary

This paper examines the role of the rights-based review in addressing inequities in access to health care. Focusing on the case of Hungary, the analysis intends to contribute to the debate about factors that bring about/sustain inequalities in health and health care at the public-private intersection and the role of law and rights-based litigation in addressing these inequalities. Towards this end, the paper presents first an overview of the Hungarian health care system. It then analyzes the scope and content of the right to health by discussing the constitutional protection of health rights and the right to health care guaranteed within the public health system. Further to that, the paper reviews the main mechanisms of rights enforcement in health care. It describes the health care litigation that has taken place in Hungary with focus on equity issues at the public-private intersection. The analysis is concluded by a discussion of the role of health rights enforcement in promoting equity in access to health care. The paper is a chapter of a book titled ''The Right to Health at the Public/Private Divide: A Global Comparative Study'', edited by Prof. Aeyal Gross and Prof. Colleen Flood, forthcoming by Cambridge University Press.

Courts as Healthcare Policy-Makers: The Problem, the Responses to the Problem and Problems in the Responses

This article starts by analysing healthcare litigation in Brazil by means of a literature review of articles that contribute with empirical findings on this phenomenon. Based on this review, I argue that health care litigation in Brazil makes the public health system less fair and rational. In the second part of this article, I discuss the three most overarching responses to control the level of litigation and its impact on the public health system: (i) the public hearing held by the Supreme Federal Court and the criteria the court established thereafter; (ii) the recommendations by the National Council of Justice aimed at building courts’ institutional capacity; and (iii) the enactment of the Federal Law 12.401/11, which created a new health technology assessment system. I argue that latter is the best response because it keeps the substantive decisions on the allocation of healthcare resources in the institution that is in the best position to make them. Moreover, this legislation will make the decisions about provision of health treatments more explicit, making easier for courts to control the procedure and the reasons for these decisions.

Quality and Outcomes in Anaesthesia

Summary Healthcare litigation in the UK continues to grow at an alarming rate, with claims against anaesthetists and critical care physicians increasing each year. This has led to a huge financial burden for the taxpayer and a sharp increase in professional indemnity fees for individual doctors. Although such litigation should provide valuable information to educate practitioners and reduce future similar claims, there appear to be significant barriers preventing important lessons from being learned. Detailed learning opportunities are available only to the healthcare providers being sued or the expert witnesses employed to analyse the claims. Most practitioners have to rely on indemnifiers' case reports, closed-claim analyses, and ad hoc publications for information. In this review, we suggest ways in which important lessons from litigation could be brought to the attention of all clinicians. Currently, most clinicians are unable to determine whether key components of their practice such as consent, clinical decision-making, and documentation are of an acceptable standard for legal scrutiny. By reporting outcomes of Coroners' inquests, clinical and criminal negligence cases, and referrals to the General Medical Council, it would be hoped that more explicit standards of performance could be derived. Ultimately, this may not only improve patient safety, but protect practitioners from unjustifiable claims. Finally, given the critical importance of experts in the above process, we believe that a system for professional registration and regulation should be explored to ensure that they offer accurate, representative, and unbiased opinions and have the appropriate expertise in the subject matter to be analysed.

Competing Stories: A Case Study of the Role of Narrative Reasoning in Judicial Decisions

Part I of this article briefly reviews some of the foundational principles of narrative theory that are useful in studying the healthcare litigation. Part II sets the stage for the study by describing generally the broad reach of the litigation across the country. Part III takes a look at the trial briefs filed by the parties to the litigation to determine what story they attempted to tell. Although study focuses on the trial court briefs and decisions (because they are a larger data set), the article will occasionally refer to some of the Court of Appeals decisions that have come down as of this writing. I will not attempt to predict the outcome of the pending Supreme Court appeal, since my purpose here is only to examine how narrative may have influenced the trial court judges who had to decide different iterations of essentially the same case.Part IV then examines the opinions in the major cases and describes how the cases were decided. Finally, Part V considers the possible role that the different narrative choices might have played in reaching different outcomes.

Complaints and litigation in health care: issues and recommendations

Complaints and litigation in health care: issues and recommendations

Who's Responsible for Impaired Doctors?

Who's Responsible for Impaired Doctors?

Facility Litigation: View From Expert Witnesses

DALLAS — For years, the approach to improving quality of care in nursing facilities has been through regulation, not litigation. In the 1990s, several landmark cases in California, Texas, Arkansas, and Florida signaled a change. “[Nursing facility cases have] now become one of the fastest growing areas of health care litigation, with the majority of cases initiated by children of the resident,” said Dr. Randall Huss, C.M.D., in a presentation on nursing facility litigation and liability. The most common allegations are the ones we expect on pressure ulcers, dehydration, emotional distress, and falls, said copresenter Dr. David A. Smith, C.M.D., FAAFP. The presenters, who spoke at the annual symposium of the American Medical Directors Association, said they were aware of only one major case (Hayward v. Valley Vista Care Corp.) where a physician was named as defendant in his role as medical director. That medical director also served as the resident's attending physician. In April 2005, the Idaho Supreme Court's written opinion contained language supportive of medical directors. The opinion said that the medical director is not responsible for each and every act of the attending physician. “You don't have to look at every order and make sure those orders are okay,” said Dr. Smith, professor of family medicine at Texas A & M University Medical College at College Station. But, he cautioned, if you were called upon by the facility, and this was not your patient, and you did not act appropriately, you legitimately could be included in a lawsuit. With the enactment by the Centers for Medicaid and Medicare Services of the Revised Medical Director F-Tag 501, many have questioned how it affects their liability. The regulation does not add new roles, but it clarifies the medical director's existing roles and responsibilities to surveyors. The F-Tag 501 must be cited in combination with some other type of quality-of-care citation, such as pressure ulcers. If a facility is cited for the F-Tag 501, and surveyors find that the policies were not in place to prevent a quality-of-care concern, that situation could create a road map of accountability and potential civil liability for the medical director in cases of negligence, abuse, or neglect by the facility. The presenters also reported an increase in cases where federal and state regulations are serving as the basis for a cause of action. While regulations may form the basis of state surveys, they are not the standard of care, said Dr. Huss, president of St. John's Clinic in Rolla, Mo. Nevertheless, until we can stop these types of cases from occurring, “any action taken to address deficiencies cited by surveyors should be well documented by the defendant.” So, if you are involved in nursing facility litigation, you should avoid these pitfalls: altering the medical record, a lack of documentation of care, end-of-shift rote charting, a failure to follow established policies and protocols, care plans not updated to reflect current status of and appropriate goals for resident, failure to follow the care plan, failure to communicate care plan elements to weekend and temporary staff, failure to recognize or respond appropriately to change in resident status, failure to notify a physician of significant problems or change in resident status, and a care plan that promises more than can be reasonably delivered. The presenters also offered steps to protect the facility and providers from liability: ▸ Complete reports and follow-up with investigation of potentially litigious events. ▸ Allegations of or claims of witnessing abuse require immediate reporting to the director of nursing/administrator. ▸ Be sure to have adequate staffing, supervision, regular in-service training, and background checks, where appropriate. ▸ You must have accurate, complete, and timely documentation. Any event important enough to fax or call a physician about should trigger a note in the record reflecting the concern, the response received, and the actions undertaken. ▸ Properly complete the minimal data set and establish the appropriate care plan. ▸ Document all conversations with the family and responsible party. ▸ Require initials and dates for all orders. If errors are made, correct with a single strike through with initials. ▸ Regularly update care plans to reflect the resident's current status and goals of care, especially regarding end-of-life care. “Good documentation, communication, and care planning process are the key in risk reduction, Dr. Huss said.