DNA as patentable subject matter and a narrow framework for addressing the perceived problems caused by gene patents

Concerns about the alleged harmful effects of gene patents--including hindered research and innovation and impeded patient access to high-quality genetic diagnostic tests--have resulted in overreactions from the public and throughout the legal profession. These overreactions are exemplified by Association for Molecular Pathology v. U.S. Patent and Trademark Office, a 2010 case in the Southern District of New York that held that isolated DNA is unpatentable subject matter under 35 U.S.C. § 101. The problem with these responses is that they fail to adequately consider the role that gene patents and patents on similar biomolecules play in facilitating investment in the costly and risky developmental processes required to transform the underlying inventions into marketable products. Accordingly, a more precisely refined solution is advisable. This Note proposes a narrowly tailored set of solutions to address the concerns about gene patents without destroying the incentives for companies to create and commercialize inventions derived from these and similar patents.     

Stressful events as a trigger of sudden death: a study of 43 medico-legal autopsy cases

The reports relating emotional stress to sudden death are largely anecdotal. In addition to experimental and electrophysiological studies, an opportunity for a better understanding of possible stress-related sudden death (SSD) may be provided by medico-legal autopsies. The goal of our autopsy study was to analyze cardiovascular pathologic findings in cases of SSD and if possible identify mechanisms by which the stressful event (SE) could be the cause. Forty three cases were studied (29 males and 14 females). In all cases, the SE and the death were witnessed. The age range was 22 to 90 years in males (mean, 52) and 30 to 92 years in females (mean, 64). Death occurred in all cases without premonitory symptoms. In 20 cases, death occurred during the SE and in the other 23 cases occurred within 2 h of the event. SE included fear, 15 cases; altercation, 21 cases; sexual activity, 3 cases; police questioning or arrest, 4 cases. According to police reports, in 40 cases (90%), the victims had no previous clinical history of cardiovascular disease. At autopsy, the heart weight in males ranged from 255 to 1000 g with a mean of 517 g and in females the range was 250–700 g with a mean of 417 g. In only 3 cases, gross and microscopic examination of the heart was normal. In 2 of the remaining 40 cases the subjects died of subarachnoid hemorrhage. In 38 cases, a cardiac cause of death was found as follows: coronary heart disease, 27 cases; cardiomyopathy, 6 cases; aortic valvular stenosis, 2 cases and right ventricular dysplasia, 3 cases. A coronary artery thrombosis was found in 8 cases of sudden coronary death. Post myocardial infarction fibrosis was present in 25 cases (92%) of sudden coronary death. In conclusion, it appears from our autopsy study that SSD occurs primarily in those individuals with severe heart disease, especially coronary heart disease.     

Non-diagnosed pheochromocytoma as a cause of sudden death in a 49-year-old man: a case report with medico-legal implications

Pheochromocytomas are known to be rare causes of sudden death. A 49-year-old man with a medical history of arterial hypertension and diabetes mellitus complained about nausea and malaise in the morning. During the day his condition deteriorated. He went to the emergency department, where he was given intravenous drugs against nausea and was sent home. On the way back, his condition deteriorated dramatically so that his wife drove back to the emergency room, where he collapsed and sustained cardiac arrest; resuscitation efforts were unsuccessful. Autopsy revealed a large tumour of the left adrenal gland. The strong suspicion of pheochromocytoma was confirmed by histology, immunohistochemistry and biochemical investigations. An acute hypertensive crisis, caused by the hitherto unknown pheochromocytoma was ascertained as the cause of death. The morphological findings are presented, the difficulty to diagnose pheochromocytoma and the medico-legal implications are discussed.     

Transnational law as a framework for law clinics

Jindal Global Law Review - As the law becomes increasingly globalised and online education is increasingly emphasised, clinical legal education presents new opportunities for transnational...     

Pressing need for national governmental recognition of forensic anthropology in South Africa as illustrated in a medico-legal case

Forensic anthropology in South Africa is well developed in the higher education sector, with advanced training and research programmes. Despite this and decades of academic involvement in casework, forensic anthropology still lacks a defined framework and mandate at a governmental level. Therefore, the involvement of forensic anthropologists’ expertise varies markedly between cases, provinces, and among various stakeholders within the country, to the detriment of dispensation of social and criminal justice. The lack of clearly defined guidelines for the rendering of the service was exemplified and demonstrated through a recent forensic case. Here, contextual information was absent, and the remains posed a challenge to analyse, ostensibly due to missing information. Numerous questions were raised during the analysis of the remains, and broader concerns about the investigative involvement of a forensic anthropologist within South African casework were brought to the fore. Through the analysis of this case, we describe the deductive processes that led to the formation of an opinion that the skeletal linear defects were the result of taphonomic changes. In addition, we highlight how these efforts where constrained and each step in the process unnecessarily hindered. Finally, we demonstrate the capacity and willingness of forensic anthropology practitioners to be involved, and how, without governmental support, it is a great potential lamentably untapped.     

Virological analysis in the diagnosis of sudden children death: a medico-legal approach

Infections are considered to be an important cause of unexpected death in children. It has also been assumed that respiratory viruses are involved in the genesis of sudden infant death syndrome (SIDS). The Spanish National Institute of Toxicology and Forensic Sciences act as the forensic reference centre for Spain. We analyse the experience of this centre in the virological study of 64 cases of sudden children death where viral serology, virological cultures, herpesviruses polymerase chain reaction (PCR) and electron microscopy were performed. According to pathological findings, death could only be attributed to an adenovirus infection in one amygdalitis with upper airways stenosis and asphyxia. Human herpes virus 6 (HHV-6) was detected by PCR in one case with pathological findings characteristic of SIDS. Recent infection by respiratory syncytial virus (RSV), Epstein-Barr virus (EBV) and cytomegalovirus (CMV) were also detected. Meanwhile, 85.9% of the cases yielded negative viral results. Twenty-eight infants were finally categorised as SIDS. Pathological findings of infection were detected in 12 patients despite the negativity of viral analyses. Although viral infection is an uncommon cause of sudden children death, a complete microbiological investigation will help to solve the puzzle of SIDS. Definitive guidelines for microbiological analyses need to be updated whilst new pathogens are discovered or new techniques are implemented in order to clarify unsolved cases.     

Diagnostic value of the placenta in medico-legal practice

In three suspected cases of infanticide, histological examinations of the placentas were effective in clarifying the circumstances. We have estimated the 5th month of pregnancy from pieces of the placenta in one case and diagnosed the causes of perinatal abnormalities in two cases, those being acute chorioamnionitis and possible premature separation of normally implanted placenta.     

The value of the medico-legal examination in sexual offences

A review is presented of medico-legal examinations performed on two series of rape and attempted rape in 1975 and 1980 with a total of 74 victims. Judicial outcome was known in 93% of the cases and is compared with the results of the medico-legal examinations. Between the two series, public discussions and pressure from feminist movements concerning the procedure in rape cases together with modifications of civil penal code resulted in alterations of police practice. Eighteen percent of known offenders in 1975 and 42% in 1980 were charged, 50% and 90%, respectively, of these were convicted. A correlation between the judicial outcome and the results of the medico-legal examination was not found in all cases. The importance of psychological guidance to the victim at the medico-legal examination is stressed.     

Protection motivation theory as a theoretical framework for understanding the use of protective measures

The use of defensive measures can be a double-edged sword: it can provide the means to protect people and property from potential criminal victimization, but can also be a costly and possibly unnecessary endeavor. However, research examining the factors contributing to the decision whether or not to engage in protective measures is often limited in both quantity and scope. In this article, we propose a theoretical framework for understanding the use of protective measures in response to criminal victimization threats based on Ronald Rogers’ protection motivation theory. Our discussion details Rogers’ theory, suggests variables and measures appropriate for the context of criminal victimization and protective responses, and provides guidance on testing and model adaptation issues. We hope that this will encourage further model development and testing to improve the understanding of individual protective behavior in response to crime or the threat of crime.     

"Legal highs"-Toxicity in the clinical and medico-legal aspect as exemplified by suicide with bk-MBDB administration

The easily available "legal highs", which are products containing psychoactive substances, such as cathinones, piperazines and synthetic cannabinoids, are abused by adolescents in Poland and in the world as alternatives to classic drugs, such as amphetamines or marijuana. The majority of these potentially dangerous substances are still legal and they are associated with a risk of severe poisoning or even death, and provide new challenges in clinical and forensic toxicological practice. Investigations in the field of "designer drugs" may be well illustrated by the case of a suicide of a 21-year old male who ingested a specified dose of a preparation called "Amphi-bi-a" that contains bk-MBDB, chemically 2-methylamino-1-(3,4-methylenedioxyphenyl) butan-1-one, which belongs to the cathinone group, as a synthetic euphoric empathogen and psychoactive stimulant that is chemically similar to MDMA. It is one of more common components of "legal highs" examined in Poland and other countries. The documentation of the case includes a clinical assessment of the patient's health status performed during his almost 4-h hospitalization before death, autopsy and histological examinations supported by toxicological findings revealing bk-MBDB at extremely high concentrations (at 20mg/l in the blood and 33mg/kg in the liver); hence, this body of evidence contributes to knowledge in the field of "designer drugs". Inventions of designers of new psychoactive xenobiotics, which are much in demand, especially in view of the dynamic Internet marketing, which drums up narcobusiness, must be balanced by a national strategy developed by medical, legal and educational circles in the modern civilized world in order to prevent the spreading of the phenomenon.     

Correction to: Transnational law as a framework for law clinics

Jindal Global Law Review - A correction to this paper has been published: https://doi.org/10.1007/s41020-021-00137-6     

Is zinc a reliable biochemical marker of chronic alcoholism in the overall context of a medico-legal autopsy?

The purpose of our investigation is to appreciate the usefulness of zinc determination in the human body with regard to the tracing of chronic alcoholism at forensic autopsies. The analysis of zinc was performed in vitreous humour and in skeletal muscle. Our results tend to prove that, in post-mortem material, zinc is not a suitable marker of chronic alcoholism. Furthermore one has to take into account the frequent contamination during collection and storage of the samples and also the post-mortem increase of zinc in the vitreous humour due to autolysis.     

Preserving human potential as freedom: a framework for regulating epigenetic harms

Epigenetics is a rapidly evolving scientific field of inquiry examining how a wide range of environmental, social, and nutritional exposures can dramatically control how genes are expressed without changing the underlying DNA. Research has demonstrated that epigenetics plays a large role in human development and in disease causation. In a sense, epigenetics blurs the distinction between "nature" and "nurture" as experiences (nurture) become a part of intrinsic biology (nature). Remarkably, some epigenetic modifications are durable across generations, meaning that exposures from our grandparents' generation might affect our health now, even if we have not experienced the same exposures. In the same vein, current exposures could affect the health of not only individuals currently living but also future generations. Given the relative novelty of epigenetics research and the multifactorial nature of human development and disease causation, it is unlikely that conclusive proof can be established showing that particular exposures lead to epigenetic risks that manifest into specific conditions. Using the Capabilities Approach ("CA") developed by Amartya Sen and Martha Nussbaum, this article argues that epigenetic risk is not merely a medical issue, but that it more generally implicates the underlying fairness and justice of our social contract. For instance, how we develop mentally or physically has a tremendous impact upon our inherent capabilities and our set of life options. The CA prompts us to ask questions such as: (1) what impact do particular epigenetic risks have on our ability to exercise free choices; (2) are these risks avoidable; and (3) how are these risks distributed across society? Due to the complex nature of epigenetic risk, tort law is predictably incapable of addressing this harm. Further, while regulatory agencies possess the statutory authority to begin addressing epigenetic harms, currently these agencies are not attuned to measure or to respond to this type of harm. This article argues that it is imperative to initiate a regulatory framework to address epigenetic risk from specific substances even if conclusive proof of disease causation cannot be established. Shifting the burden of generating epigenetic risk data to producers of suspected harmful substances serves as a start. As information concerning epigenetic risks accrues, the regulatory response should evolve concurrently. As part of a dynamic policy-making approach our goals need to encompass the following: (i) promotion of knowledge in the scientific, legal, and public domains; (ii) assessment and modification of current regulations to address preventable risk; and (iii) an overarching commitment to protect human capabilities in an equitable manner.     

Forensic investigation framework for the document store NoSQL DBMS: MongoDB as a case study

The NoSQL DBMS provides an efficient means of storing and accessing big data because its servers are more easily horizontally scalable and replicable than relational DBMSs. Its data model lacks a fixed schema, so that users can easily dynamically change the data model of applications. These characteristics of the NoSQL DBMS mean that it is increasingly used in real-time analysis, web services such as SNS, mobile apps and the storage of machine generated data such as logs and IoT (Internet of Things) data. Although the increased usage of the NoSQL DBMS increases the possibility of it becoming a target of crime, there are few papers about forensic investigation of NoSQL DBMS.In this paper, we propose a forensic investigation framework for the document store NoSQL DBMS. It is difficult to cover all of the NoSQL DBMS, as 'NoSQL' includes several distinct architectures; our forensic investigation framework, however, is focused on the document store NoSQL DBMS. In order to conduct an evaluative case study, we need to apply it to MongoDB, which is, a widely used document store NoSQL DBMS. For this case study, a crime scenario is created in an experimental environment, and then we propose in detail a forensic procedure and technical methods for MongoDB. We suggested many substantial technical investigation methods for MongoDB, including identifying real servers storing evidences in a distributed environment and transaction reconstruction method, using log analysis and recovering deleted data from the MongoDB data file structure.