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.     

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...     

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.     

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     

"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.     

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.     

Parliaments as changing institutions and as agents of regime change: Evolving perspectives and a new research framework

In this review, the scholarly literature dealing with the role and dynamics of parliaments as institutions that undergo change within themselves and that support and enhance change in the larger regime is considered. One central theory of scholarship dealing with parliamentary change, that of legislative institutionalisation, is examined and found wanting as an explanation of change in mature parliamentary institutions. In discussion of analyses of five instances of parliamentary change, it is shown that parliaments can change in a wide variety of contexts and conditions ‐ including such well‐established legislatures as the United States Congress after over 200 years of evolution. There is no ‘end of history’ in parliamentary change, only the possibility of sometimes startling change from what has gone before. The examination of five instances of parliamentary change also supports the thesis that parliamentary institutional change, and regime change enhanced by parliamentary change, are inexorably linked. Finally, a tentative research framework is evolved from the above analyses and proposed as a means for considering the role of parliaments as changing institutions and as institutions enhancing systemic change.     

Quality of health care and the role of relationships: bridging the medico-legal divide

This Article focuses on an often overlooked barrier to efforts to enhance the quality of health care: the relationship crisis that currently exists between physicians and patients. This state of affairs has resulted from the divide between the medical and legal worlds. The medical arena has understandably tended to view the doctor-patient relationship as a purely medical issue, ignoring the law's impact in generating and sustaining problematic relationship patterns. The legal world has yet to fully recognize this state of affairs, and the law's role in its evolution and persistence. We offer a relational approach to health-care law as a means of bridging the divide between the two disciplines. In the malpractice context, this would entail adopting a no-fault compensation scheme, which is committed to strengthening collaborative doctor-patient relations, enhancing patient safety and systemic learning, while providing adequate compensation.     

Reduced punishment in Israel in the case of murder: bridging the medico-legal gap

The psychiatrist's assessment of criminal responsibility of an accused in court for an act of crime has always been a matter of great difficulty. In 1997, clause 300a was incorporated into the Penal Code of Israel, thereby permitting a more lenient punishment for murder than mandatory life imprisonment. The clause includes the definition of what is meant by "severe mental disorder" and "significantly restricted capacity" by the defendant to understand the criminal nature of his or her act and to refrain from committing it. Usage of the concepts "disorder" and "significantly restricted capacity" in addressing the issue of diminished responsibility of the mentally ill is new to the Israeli legal code. The emergence and evolvement of the above concepts are presented through a historical review of the Israeli encoded law concerning mental illness, analyzed from a psychiatric perspective.     

Fibromuscular dysplasia of the basilar artery: an unusual case with medico-legal implications

A 28-year-old male car driver was reported to suddenly loose the control over his vehicle, to hit the right and middle crash barrier, and to be unconscious as the car came to a halt in a position at right angles to the road. The car was hit in its left side by an automobile with high velocity, and the 28-year-old driver died. Examination of the brain revealed a massive isolated basal subarachnoid hemorrhage and a complete tearing of the basilar artery. A macroscopically detectable aneurysm was not found. However, histological examination of the large arteries at the base of the brain showed (i) fibromuscular dysplasia (FMD) mostly involving the basilar artery (ii) with a ruptured micro-aneurysm in its upper third part. The observations of the eye witnesses that the driver initially lost control over his car were judged in favour of the accused to be due to that rupture of the micro-aneurysm, while complete transverse tearing of the basilar artery occurred during the car crash due to hyperextension and rotation of his neck. Intracranial FMD is a rare cause in the differential diagnosis of isolated basal subarachnoid hemorrhage. The medico-legal implications of this entity are described in the presented case.     

The importance of medico-legal autopsies. An analysis of the complex problems regarding damages

One hundred forty-four medico-legal autopsies were performed at the University Institute of Forensic Medicine in Copenhagen during the period 1973-77, all requested by the National Office of Social Security in order to estimate whether the cause of death could be related to the work of the deceased. The total number of medico-legal autopsies in the same period was 4050. The material included only four women. One hundred seventeen men died during work, 26 cases were accepted. Clear cases of accidents were always accepted and damages were paid. In cases where the deceased died on his way to or from work damages were rejected. Nineteen men (13%) had died after returning to their homes. Two cases among these were accepted (fall from scaffolding during working hours, arsenic poisoning where death occurred later in hospital). The mean age of the group was about 50 years, which is less than in an average medico-legal population. In all cases but two the autopsy revealed the cause of death, i.e. that unknown causes of death totalled 1.4%. The manner of death was elucidated in all cases. The most frequent cause of death in men turned out to be coronary sclerosis and coronary thrombosis. All such cases were rejected as being due to working conditions, because in no case was extraordinary working stress found to be evident. The two cases of death which occurred at home showed the importance of being aware of injuries due to working conditions, even if death could not be directly related to an industrial accident.     

The Haddon matrix: applying an epidemiologic research tool as a framework for death investigation

The Haddon matrix is a research tool used by injury epidemiologists. Although this matrix has typically been used only in epidemiologic studies, it may serve as a framework to investigate the circumstances of traumatic deaths. This matrix consists of three rows representing time phases (before the injury incident, during the incident, and after the incident) and four columns representing the energy agent, characteristics of the deceased person, the environment, and the vehicle or vector resulting in the abnormal energy exchange, which are considered in the context of the three time phases. The authors present four cases illustrating how this epidemiologic tool can be useful during death investigations. Although the objectives for epidemiologic studies and medicolegal death investigations differ, this approach can be used to describe the circumstances surrounding an injury-related death.     

两地区医疗纠纷法医学尸检鉴定质量的比较研究

目的研究影响涉及医疗纠纷法医学尸检鉴定质量差异的原因。方法两个具有代表性的法医学尸检鉴定机构所涉及医疗纠纷的相关案例,进行字2检验、t检验等统计学研究。结果通过字2检验发现,在设定的10个指标中,有7个指标存在显著性差异,提示两鉴定单位在“涉及医疗纠纷的法医学尸检鉴定”中检验手段和标准、规范性等均存在极大的差异。结论通过研究,提示法医学鉴定人素质、尸检的标准化和规范化、尸检检材的提取标准化、死因或疾病的诊断标准、会诊制度及法医学鉴定书的书写规范化等是法医学尸检鉴定质量控制和管理的重要环节。