Evidentiary Standards Research Articles

Soft Law – The Intermediate Stage Between Freedom and Control

Abstract The soft law is placed on a scale between freedom and control, autonomy, and hard law. At first sight, it falls short of building elements known in the legal principles of law, like transparency, certainty, and predictability, but on the other hand, it is needed to address areas where complexity reigns, where flexibility is needed, where hard law is too hard, invasive, and inappropriate to achieve more distant goals. As soft law can have not only practical but also legal effects, this paper analyses the basic elements of soft law, its practice in the US, France, and the EU and gives pro et contra arguments to be able to recognise it as such and to apply it on a more objective manner. This can be done with the help of the manifest error standard of the judiciary, its structure, and the help of participatory collective wisdom. A first step could be the use of the evidentiary standard of manifest error as a possible solution for the most effective soft law (a la “Turing style”), after which the structure and collective wisdom follow. When the principle of loyal cooperation among institutions is established, the soft law hardens more and more into clay and/or hard law. It thus matters who, when, how, and why to enact the soft law.

Classification of a Claim as the Way of Abuse

The article is dedicated to the visibility of the issue of classification of a claim as the way of abuse, in particular, another result of court protection in case of changing the cause of action when the complaints have the equal nature. The author agrees that the choice of classification of a claim must be the prerogative of the injured, but based on specific examples from different spheres (corporate law, insolvency law, contract law, tort law, unjust enrichment) demonstrates the possibility of taking advantage because of such choice. It is proved that different result of court protection can’t be achieved by manipulation of classification of a claim, that allows current regulatory environment. It is emphasized that the final step to prevent such abusive behavior (when the choice of classifications gives the opportunity to prolong procedural deadlines, lowering of evidentiary standards, simplification for producing a desired) must be court, with the authority to change the classification that is offered by the party of a dispute.

The Prescription Drug User Fee Act: Much More Than User Fees.

The Prescription Drug User Fee Act (PDUFA) is due for reauthorization in 2022. Beyond creating the user fee program which now generates a majority of the Food and Drug Administration (FDA) Human Drugs Program budget, PDUFA has made numerous additional changes to FDA policy during its 29-year history. FDA's budgetary dependence on user fees may advantage the industry in negotiating favorable policy changes through PDUFA. The full texts of all prior PDUFA reauthorization bills and all submitted public comments and meeting minutes for the 2022 reauthorization were reviewed. Provisions affecting FDA regulatory authority and processes were identified. PDUFA legislation has instituted a broad range of changes to FDA policy, including evidentiary standards for drug approval, accelerated pathways for approval, industry involvement in FDA decision-making, rules regarding industry information dissemination to providers, and market entry of generic drugs. Negotiations over the 2022 reauthorization suggest that industry priorities include increased application of real-world evidence, regulatory certainty, and increased communication between FDA and industry during the drug application process. The need for PDUFA reauthorization every 5 years has created a recurring legislative vehicle through which far-ranging changes to FDA have been enacted, reshaping the agency's interactions and relationship with the regulated industry. The majority of policy changes enacted through PDUFA legislation have favored industry through decreasing regulatory standards, shortening approval times, and increasing industry involvement in FDA decision-making. FDA's budgetary dependence on the industry, the urgency of each PDUFA reauthorization's passage to maintain uninterrupted funding, and the industry's required participation in PDUFA negotiations may advantage the industry.

Measure of Value: FDA in the Age of COVID

The US Food and Drug Administration (FDA) is the institutional regulatory gateway through which healthcare business sectors gain access to commercial markets in pharmaceuticals, biologicals, vaccines, medical devices, diagnostic test kits and persona protective equipment. The unfolding of events for the COVID-19 pandemic serve as a case study for understanding, in real time, how FDA has contributed value to the healthcare sector. Federal regulatory agencies, such as FDA, require strong processes to provide fair and consistent outcomes to retain the trust of the stakeholder community. These processes include statutes and regulations, internal manual of standard operating procedures and policies, guidance documents, external advisory committees and the Office of Inspector General. These processes cover the following activities: product development conditions, regulatory pathways, types of approvals, manufacturing quality, and post marketing safety. Together, the institutional experiences that led to and shaped these processes prepared FDA for the challenges associated with COVID-19. The sum of twelve decades of experience comes down to the following goals that provide value to the degree with which each is successful: 1) The manufacturing process must meet standards of quality and be secured. 2) Medical products must be shown, through scientific evidence and based on evidentiary standards, to be safe and effective for human use. 3) Identified risks must be mitigated, by labeling at a minimum, with additional strategies as necessary. 4) Provisions must exist for extraordinary circumstances of limited unmet medical needs and of threats to public health and national security. https://doi.org/10.21423/jrs-v10i1beninger

Quality of Evidence and Legal Decision-Making

Abstract We analyze a setting where the court has to impose liability with imperfect evidence on the defendant’s actions, and where the court is concerned about both deterrence and judicial errors. We provide a formal definition of the quality of evidence that allows us to compare evidence from very different sources and of a very different nature in terms of informativeness. When imposing liability, the court’s optimal policy is to set an evidentiary standard. The main result of the article is that with a higher quality of evidence, more lenient evidentiary standards generate greater welfare. We also find that when the agent can influence the informativeness of the evidence the interests of court and agent are not aligned. The optimal court policy may involve penalizing (even forbidding) actions leading to less informative evidence.

Stakeholder Perspectives on Navigating Evidentiary and Decision Uncertainty in Precision Oncology.

(1) Background: Precision oncology has the potential to improve patient health and wellbeing through targeted prevention and treatment. Owing to uncertain clinical and economic outcomes, reimbursement has been limited. The objective of this pan-Canadian qualitative study was to investigate barriers to precision oncology implementation from the perspectives of health system stakeholders. (2) Methods: We conducted 32 semi-structured interviews with health technology decision makers (n = 14) and clinicians (n = 18) experienced with precision oncology. Participants were recruited using a purposive sampling technique. Interviews were analyzed using thematic analysis. Recruitment continued until two qualitative analysts reached agreement that thematic saturation was reached. (3) Results: While cautiously optimistic about the potential for enhanced therapeutic alignment, participants identified multiple decisional challenges under conditions of evidentiary uncertainty. Decision makers voiced concern over resource requirements alongside small benefitting patient populations and limited evidence supporting patient and health system impacts. Clinicians were comparatively tolerant of evidentiary uncertainty guiding clinical decision-making practices. Clinicians applied a broader definition of patient benefit, focusing on the ability to assist patients making informed clinical decisions. (4) Conclusions: Sustainable precision oncology must balance demand with evidence demonstrating benefit. We show that clinicians and decision makers vary in their tolerance for evolving knowledge, suggesting a need to establish evidentiary standards supporting precision oncology reimbursement decisions.

BUSCA PESSOAL NO POLICAMENTO PREVENTIVO E REPRESSIVO. FUNDAMENTO CONSTITUCIONAL E STANDARDS PROBATÓRIOS AUTORIZADORES

The personal serch is used as a preventive and repressive policing measure. Decisions of the Superior Court of Justice limited its legitimacy to the envidentiary purpose and restricted the hypotheses characterizing the well-founded suspicion capable of motivating the Search. Through the use of deductive methodology, bibliographic and jurisprudential research, the reserach intends to investigate whether the personal search as a preventive police measure it is constitutional; if there is consistency in the judgments of the Superior Court of Justice and if it is possible to suggest objective elements that fulfill the evidentiary standard of well-founded suspicion required by the Code of Criminal Procedure. Objectives: 1. To analyze the constitutionality of the personal search as a preventive police measure. 2. Identify the main judgments of the Superior Courts on the personal search. 3. Suggest objective elements that fulfill the evidentiary standard of well-founded suspicion required by the Criminal Procedure Code. The conclusion is that the personal search is na importante tool for the realization of the fundamental right to public security and finds constitutional support to be used in the preventive and repressive scope. The situational factors of suspicious attitude, criminal rates and characteristics of the environment fulfill the evidentiary standard required by the Criminal Procedure Code.

Retos de la jurisprudencia de la Corte Interamericana de Derechos Humanos en la categorización de conductas como crímenes internacionalesChallenges of the Inter-American Court of Human Rights’ jurisprudence in the categorization of conducts as international crimes

Abstract The Inter-American Court of Human Rights has been carrying out a harmonious application of various regimes of International Law, in particular International Human Rights Law and International Criminal Law. One of the results of this harmonious application is the use of the figure of international crimes in its jurisprudence. This text explores the requirements of provenance that have been developed by the jurisprudence of the Inter-American Court for the application of the figure of international crimes in the contentious cases of the Court, as well as the challenges that derive from this application. Some of these challenges are: (i) different legal qualifications of the same facts due to the differences between the evidentiary standards of human rights and international criminal law; (ii) possible effects on the judicial independence of national judges; and (iii) possible effects on the criminal guarantees of those allegedly responsible for the crimes.

Adoption of Ultrahypofractionated Radiation Therapy in Patients With Breast Cancer

IntroductionThe first high-quality clinical trial to support ultrahypofractionated whole-breast irradiation (ultra-HF-WBI) for invasive early-stage breast cancer (ESBC) was published in April 2020, coinciding with the beginning of the COVID-19 pandemic. We analyzed adoption of ultra-HF-WBI for ductal carcinoma in situ (DCIS) and ESBC at our institution after primary trial publication. Methods and MaterialsWe evaluated radiation fractionation prescriptions for all patients with DCIS or ESBC treated with WBI from March 2020 to May 2021 at our main campus and regional campuses. Demographic and clinical characteristics were extracted from the electronic medical record. Treating physician characteristics were collected from licensure data. Hierarchical logistic regression models identified factors correlated with adoption of ultra-HF-WBI (26 Gy in 5 daily factions [UK-FAST-FORWARD] or 28.5 Gy in 5 weekly fractions [UK-FAST]). ResultsOf 665 included patients, the median age was 61.5 years, and 478 patients (71.9%) had invasive, hormone-receptor-positive breast cancer. Twenty-one physicians treated the included patients. In total, 249 patients (37.4%) received ultra-HF-WBI, increasing from 4.3% (2 of 46) in March-April 2020 to a high of 45.5% (45 of 99) in July-August 2020 (P < .001). Patient factors associated with increased use of ultra-HF-WBI included older age (≥50 years old), low-grade WBI without inclusion of the low axilla, no radiation boost, and farther travel distance (P < .03). Physician variation accounted for 21.7% of variance in the outcome, with rate of use of ultra-HF-WBI by the treating physicians ranging from 0% to 75.6%. No measured physician characteristics were associated with use of ultra-HF-WBI. ConclusionsAdoption of ultra-HF-WBI at our institution increased substantially after the publication of randomized evidence supporting its use. Ultra-HF-WBI was preferentially used in patients with lower risk disease, suggesting careful selection for this new approach while long-term data are maturing. Substantial physician-level variation may reflect a lack of consensus on the evidentiary standards required to change practice.

Annals for Educators - November 2021.

Annals for Educators - November 2021.

Somebody’s – Or Nothing: Visual Evidence, Blackness and the Limits of Legal Seeing

Why does visual evidence, when in defence of Black people, always fail to meet the proper evidentiary standards? This article suggests that one part of an answer to this question might be found in early legal debates about how to deal with ‘evidence’ that photography allegedly proffers to the trier of fact. These debates revealed how the introduction of visual culture in the courtroom challenged a legal culture that hinged on the spoken and written word. Likewise, it also marked the beginning of an unstable legal discourse on visual evidence that continues to shape our present-day understanding of evidence and how we have come to see and interpret visual evidence. The argument advanced here, then, is that this legal seeing—refracted by and through whiteness and foundationally anti-Black—is the ideological filter through which the public have been conditioned to make sense of visual evidence of anti-Black violence and death. Finally, the article turns to the work of Carrie Mae Weems to claim that Black people, through a multitude of practices, continue to construct alternative forms of visual evidence that challenge law’s stronghold on what counts as evidentiary.

U.S. Food and Drug Administration Reasoning in Approval Decisions When Efficacy Evidence Is Borderline, 2013-2018.

The U.S. Food and Drug Administration (FDA) has substantial flexibility in its approval criteria in the context of life-threatening disease and unmet therapeutic need. To understand the FDA's evidentiary standards when flexible criteria are employed. Case series. Applications submitted between 2013 and 2018 that went through multiple review cycles because the evidence for clinical efficacy was initially deemed insufficient. Information was obtained from the approval package (available on Drugs@FDA), including advisory committee minutes, FDA reviews, and complete response letters. Of 912 applications reviewed, 117 went through multiple review cycles; only 22 of these faced additional review primarily because of issues related to clinical efficacy. Concerns about the end point, the clinical meaningfulness of the observed effect, and inconsistent results were common bases for initial rejection. In 7 of the 22 cases, the approval did not require new evidence but rather new interpretations of the original evidence. No FDA decisions cited reasoning used in previous decisions. The conclusions rely on the authors' interpretation of the FDA statements and on a series of "close calls." The FDA has no mechanism to find or tradition to cite similar cases when weighing evidence for approvals, resulting in standalone, bespoke decisions. These decisions show highly variable criteria for "substantial evidence" when flexible evidential criteria are used, highlighted by the recent approval of aducanumab. A precedential tradition and suitable information system are required for the FDA to improve institutional memory and build upon past decisions. These would increase the FDA's decisional transparency, consistency, and predictability, which are critical to preserving the FDA's most valuable asset, the public's trust. U.S. Food and Drug Administration.

La necesidad de establecer el estándar Daubert como criterio de admisibilidad para las decisiones sobre el decreto y práctica de la prueba pericial de parte en Colombia

El presente artículo tiene como objetivo general analizar la necesidad de establecer estándares probatorios extra para los criterios de admisibilidad expuestos en el Código General del Proceso (CGP) sobre la prueba pericial. Con ese objetivo, el aporte fundamental desarrollado en la investigación es indicar que los criterios establecidos en el caso Daubert son los necesarios para incluir dentro del proceso judicial colombiano. La pregunta problema giró en torno a definir si es necesario establecer criterios adicionales de admisibilidad al estándar probatorio Daubert para la decisión de decreto y práctica de la prueba pericial en el proceso colombiano. Así se pudo concluir que, además de estos estándares obligatorios a tener en cuenta por el juez, se requieren tres que versan sobre aspectos técnicos del dictamen

Some Evidentiary Problems in the Fight Against Money Laundering: International Legal Framework and Its Projection on the Spanish System

The fight against money laundering represents significant difficulties for the States, among which are the difficulties related to the proof of this crime. The complexity of its typical configuration, its link to a previous criminal activity and the need to prove the intentional elements characterizing these offenses makes it necessary to resort to the use of circumstantial evidence. This form of proving money laundering is generally accepted in international treaties and conventions in this area. This article shall analyze the evidentiary standards used by the Spanish Supreme Court to convict for money laundering.

Comparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized Reliance

The principles of comparability assessments have been accepted globally as offering sensitive and reliable tools with which to evaluate potential changes to biologics that may arise either through processing changes or through the creation of a copy (biosimilar) by a different sponsor. The comparability approach has evolved through systematic advances in four areas: clear and convergent guidelines for evaluation of potential changes to biologics; risk-based systems of weighting analytical data; progressive improvements in analytical methods; and advanced understanding of post-translational modifications. Routine regulatory expectations for clinical equivalence data are being reevaluated, as they seldom contribute to the assessment of similarity. Similarly, we show that requirements to compare biosimilars and locally sourced versions of their reference products are of questionable scientific value and represent a double standard by comparison with the invariable acceptance of the clinical profiles of novel biologics without reference to their sources. The consistent application of evidentiary standards for comparability to all biologics offers an opportunity for regulators to curtail their own assessments of new biosimilars and instead to recognize comparability assessments made in another jurisdiction (reliance), thereby gaining important efficiencies in the regulatory review of biosimilars and improving the competitiveness of the biosimilars market. Such consistency can also enhance the confidence of all stakeholders, especially patients and their providers, in all biologics.

LB0001 MAVRILIMUMAB IMPROVES OUTCOMES IN PHASE 2 TRIAL IN NON-MECHANICALLY-VENTILATED PATIENTS WITH SEVERE COVID-19 PNEUMONIA AND SYSTEMIC HYPERINFLAMMATION

Background:Granulocyte/macrophage-colony stimulating factor (GM-CSF) is a cytokine both vital to lung homeostasis and important in regulating inflammation and autoimmunity1,2,3 that has been implicated in the pathogenesis of respiratory failure and death in patients with severe COVID-19 pneumonia and systemic hyperinflammation.4-6 Mavrilimumab is a human anti GM-CSF receptor α monoclonal antibody capable of blocking GM-CSF signaling and downregulating the inflammatory process.Objectives:To evaluate the effect of mavrilimumab on clinical outcomes in patients hospitalized with severe COVID-19 pneumonia and systemic hyperinflammation.Methods:This on-going, global, randomized, double-blind, placebo-controlled seamless transition Phase 2/3 trial was designed to evaluate the efficacy and safety of mavrilimumab in adults hospitalized with severe COVID-19 pneumonia and hyperinflammation. The Phase 2 portion comprised two groups: Cohort 1 patients requiring supplemental oxygen therapy without mechanical ventilation (to maintain SpO2 ≥92%) and Cohort 2 patients requiring mechanical ventilation, initiated ≤48 hours before randomization. Here, we report results for Phase 2, Cohort 1: 116 patients with severe COVID- 19 pneumonia and hyperinflammation from USA, Brazil, Chile, Peru, and South Africa; randomized 1:1:1 to receive a single intravenous administration of mavrilimumab (10 or 6 mg/kg) or placebo. The primary efficacy endpoint was proportion of patients alive and free of mechanical ventilation at Day 29. Secondary endpoints included [1] time to 2-point clinical improvement (National Institute of Allergy and Infectious Diseases COVID-19 ordinal scale), [2] time to return to room air, and [3] mortality, all measured through Day 29. The prespecified evidentiary standard was a 2-sided α of 0.2 (not adjusted for multiplicity).Results:Baseline demographics were balanced among the intervention groups; patients were racially diverse (43% non-white), had a mean age of 57 years, and 49% were obese (BMI ≥ 30). All patients received the local standard of care: 96% received corticosteroids (including dexamethasone) and 29% received remdesivir. No differences in outcomes were observed between the 10 mg/kg and 6 mg/kg mavrilimumab arms. Results for these groups are presented together. Mavrilimumab recipients had a reduced requirement for mechanical ventilation and improved survival: at day 29, the proportion of patients alive and free of mechanical ventilation was 12.3 percentage points higher with mavrilimumab (86.7% of patients) than placebo (74.4% of patients) (Primary endpoint; p=0.1224). Mavrilimumab recipients experienced a 65% reduction in the risk of mechanical ventilation or death through Day 29 (Hazard Ratio (HR) = 0.35; p=0.0175). Day 29 mortality was 12.5 percentage points lower in mavrilimumab recipients (8%) compared to placebo (20.5%) (p=0.0718). Mavrilimumab recipients had a 61% reduction in the risk of death through Day 29 (HR= 0.39; p=0.0726). Adverse events occurred less frequently in mavrilimumab recipients compared to placebo, including secondary infections and thrombotic events (known complications of COVID-19). Thrombotic events occurred only in the placebo arm (5/40 [12.5%]).Conclusion:In a global, diverse population of patients with severe COVID-19 pneumonia and hyperinflammation receiving supplemental oxygen therapy, corticosteroids, and remdesivir, a single infusion of mavrilimumab reduced progression to mechanical ventilation and improved survival. Results indicate mavrilimumab, a potent inhibitor of GM-CSF signaling, may have added clinical benefit on top of the current standard therapy for COVID-19. Of potential importance is that this treatment strategy is mechanistically independent of the specific virus or viral variant.

FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs.

The FDA conducts independent reviews of scientific data obtained with investigational drug products to ensure that they are safe and effective. As a result of this process, FDA-approved product labeling is generated that is considered one of the most trusted sources of information for use of an approved drug. But FDA approval is only the beginning of the life cycle of a new drug; the first oncology drugs now have more than 7 decades of clinical experience in the postmarketing setting. Due, in part, to lack of incentives, some companies may not seek inclusion of new data, other than new safety information, in FDA-approved product labeling. Ensuring that product labeling provides adequate directions for use is important for all drugs, including older therapies that may form the backbone of many standard combination regimens for pediatric and adult cancers. Project Renewal is an FDA Oncology Center of Excellence pilot program that leverages expertise from the clinical and scientific oncology communities to review published literature and generate a drug-specific product report summarizing data that may support updates to FDA-approved product labeling. This article provides a broad overview of Project Renewal's collaborative pilot process for identifying and assessing literature supporting potential labeling updates, while engaging the oncology community to increase awareness of FDA's evidentiary standards and deliberative processes used when considering the addition of new indications and dosing regimens to product labeling.

Delusions, Moral Incapacity, and the Case for Moral Wrongfulness

Responsibility is a legal—not medical—construct. However, science can be useful in exposing faulty assumptions underlying current doctrine or practice, illuminating changes in practice or evidentiary standards to better effectuate the law’s animating purpose, and even suggesting updates to legal standards to account for modern understandings of functionalities of concern. This Article uses the science of delusions to assess the law regarding, and practice of establishing, criminal irresponsibility for defendants with psychosis. Over the last two decades, researchers from the cognitive sciences have compiled strong evidence that a host of cognitive and emotional impairments contribute to the origin and maintenance of delusions by impairing decision-making. This Article uses insights from those literatures to make three contributions. First, it analyzes current insanity standards and demonstrates their intimate relationship with rationality. It then argues that courts should consider evidence of any significant reasoning impairment, whether cognitive or emotional, as probative to sanity. Second, and more controversially, the Article explains how the reasoning impairments associated with delusions could bear upon a defendant’s incapacity to know, or her ignorance of, the wrongfulness of her criminal act. In assessing the latter, the Article argues that scientific research exposes as misguided the narrow test of actual knowledge currently employed in nine jurisdictions across the United States. Courts in these jurisdictions hold that a delusional defendant lacked knowledge of her act’s wrongfulness only if her delusion, had it been true, would have justified or excused her act. Instead, the science of persecutory delusions exposes the legal wrongfulness standard as inappropriate for populations with delusions and suggests that courts should consider excusing defendants whose delusions fall within the broad contours of a legal defense. A copy of the current draft is available upon request.

Fire Alarm Fatigue: How Politicians Evade Accountability

Independent and objective oversight bodies, congressional committees and the news media, are widely expected to help hold politicians accountable. We develop a model in which an informed oversight body may warn citizens about misconduct by an incumbent. Matching conventional logic about the benefits of caution, high evidentiary standards are necessary for warnings to be persuasive. However, the straightforward connection between caution and efficacy breaks down if we allow for uncertainty about the quality of oversight. With even a small chance of fake news, caution can backfire, as incumbents strategically manipulate the reputation of the oversight body to destroy effective oversight.

Šta čini sistem krivičnopravne zaštite integriteta tržišta kapitala u Sjedinjenim Američkim Državama efikasnim - blanketna krivična dela protiv integriteta tržišta kapitala i sistem krivičnog gonjenja

The article explores the key factors that make the securities criminal law of the United States (US), as one of the integral building blocks of the capital markets and securities regulatory system, efficient. This includes the role and characteristics of sectoral (blanket) all-embracing securities crimes enshrined into the federal securities statutes, their nexus with general crimes, the close cooperation of the Securities Exchange Commission (SEC) and prosecutorial offices, the applicable evidentiary standards, and the fundamental policies undergirding these laws. The rich repository of US experiences should be instructive not only to the Member States of the European Union (EU) striving to forge deeper capital markets but also to those endeavoring to accede the EU (e.g., Serbia), or to create deep capital markets for which efficient prosecution of securities crimes is inevitable.