Controversies and Challenges of Mass Vaccination against SARS-CoV-2 in Italy: Medico-Legal Perspectives and Considerations.

The worldwide spread of SARS-CoV-2 and the pandemic has resulted in a serious global crisis in the health, social and economic spheres. After an initial period of enthusiasm related to the efficacy of vaccines, in many European countries, a growing distrust in the population has matured, due to the reporting of severe adverse effects. Throughout the world, some cases of adverse events after the administration of the vaccine have been reported. In this communication, we want to discuss all the medico-legal aspects related to the global vaccination companion in terms of medical professional responsibility, informed consent and vaccination obligation, with particular attention to the Italian situation. Health professionals are tasked with promoting confidence in vaccination for the general population. Complete and detailed information and reliance on scientific research is essential to understand the great importance of the vaccination campaign. From a criminal point of view, we must avoid blaming health professionals in the case of side effects. At the same time, we must protect the population, ensuring compliance with the indications, guidelines, and an adequate method of administration. On the other hand, from a civil law perspective, it is correct to ensure full protection of those rare cases in which the administration of the vaccine is related to adverse events. Without a broad and global vaccination campaign, it will be impossible to overcome COVID-19.

COVID-19-related deaths in residential care homes for elderly: The situation in Italy.

The whole population is susceptible to infection but elderly people with previous diseases are at greater risk. All these epidemiological data show that older age represents an important risk factor for infection and especially for mortality. In recent weeks an increase in mortality among the elderly has been observed in many Italian residential care homes. In these accommodations a worrying spread of COVID-19 cases has been ascertained. According to the ISS report, 7.4% of the total deaths in care homes for elderly involved patients with SARS-CoV-2 infection and 33.8% involved patients with flu-like symptoms. Herein, we discuss the dangerous spread of COVID-19 in residential care homes for elderly. In addition, we present a case of an elderly person admitted to a residential care home, whose COVID-19 diagnosis was performed only after death.

Elder abuse in Europe's "most elderly" city: an update of the phenomenon based on the cases reported to the Penal Court of Genoa from 2015 to 2019 and literature review.

BACKGROUND: Elder abuse is currently a worldwide problem. The literature reports that one elderly person out of six is a potential victim. AIMS: To analyse cases reported to the judicial authorities in the territory of Genoa in the period 2010-2019, to investigate the features of elder abuse, to assess the trend of this phenomenon and to propose preventive strategies. METHODS: We analysed the data on reports of abuse passed by the Court of Genoa in the period 2015-2019 concerning physical and mental maltreatment, abandonment and financial exploitation of elderly subjects. These data were compared with those recorded in the previous 5-year period and in the literature. RESULTS: In the period 2015-2019, 156 cases of elder abuse were identified (versus 63 in the previous period): 18 cases of domestic violence, 5 cases of abuse of the means of correction, 18 cases of caregiver neglect, 76 cases of physical injury and 39 cases of financial exploitation. DISCUSSION: Abuse was seen to be perpetrated most frequently in the domestic setting and by the victims' relatives. The main risk factors were female gender and the victim's dependence on others, the maltreating subject's mental illness and substance abuse. CONCLUSIONS: We documented a progressive increase in the number of abuses reported to the judicial authority; this reflects greater awareness of the problem. However, our figures remained well below the incidence estimated in the literature. It is necessary to train healthcare personnel to identify and manage cases of suspected abuse, and to provide adequate support in situations at risk.

Medico-legal assessment of personal damage in older people: report from a multidisciplinary consensus conference.

Ageing of the global population represents a challenge for national healthcare systems and healthcare professionals, including medico-legal experts, who assess personal damage in an increasing number of older people. Personal damage evaluation in older people is complex, and the scarcity of evidence is hindering the development of formal guidelines on the subject. The main objectives of the first multidisciplinary Consensus Conference on Medico-Legal Assessment of Personal Damage in Older People were to increase knowledge on the subject and establish standard procedures in this field. The conference, organized according to the guidelines issued by the Italian National Institute of Health (ISS), was held in Bologna (Italy) on June 8, 2019 with the support of national scientific societies, professional organizations, and stakeholders. The Scientific Technical Committee prepared 16 questions on 4 thematic areas: (1) differences in injury outcomes in older people compared to younger people and their relevance in personal damage assessment; (2) pre-existing status reconstruction and evaluation; (3) medico-legal examination procedures; (4) multidimensional assessment and scales. The Scientific Secretariat reviewed relevant literature and documents, rated their quality, and summarized evidence. During conference plenary public sessions, 4 pairs of experts reported on each thematic area. After the last session, a multidisciplinary Jury Panel (15 members) drafted the consensus statements. The present report describes Conference methods and results, including a summary of evidence supporting each statement, and areas requiring further investigation. The methodological recommendations issued during the Conference may be useful in several contexts of damage assessment, or to other medico-legal evaluation fields.

Elder abuse: a retrospective analysis of autopsy cases from the department of legal medicine in Genoa from 2006 to 2017.

Elder abuse is a form of violence that is often misunderstood and still underestimated. This kind of abuse is classified in physical abuse, psychological abuse, financial abuse, sexual abuse, neglect and self-neglect. In this study, 784 cases of dead people over 65 years of age were retrospectively analyzed: in all cases, the cause of death was determined by the autopsy. Ten cases have been classified as victims of elder abuse: 7 females and 3 males aged between 67 and 91 (average age of 78.9 years). The types of abuse were as follows: neglect: 8 cases; physical abuse: 2 cases; psychological abuse: 2 cases; financial abuse: 2 cases; self neglect: 2 cases. In three cases, the victims had been subjected to two or more types of abuse. In 5 cases the victims had a neuro-psychic decay. In cases of neglect the cause of death was due to sepsis or dehydration. In a case of physical abuse, death was traumatic and related to physical violence. In cases of self neglect, death occurred due to cardiac causes. In cases of domestic abuse, the perpetrator was in most cases the elder's son and in one case the paid caregiver. In three cases, however, the abuses were committed against elderly guests in Nursing Homes. In three cases the perpetrator was affected by psychiatric disorders. Recognizing the elder abuse is often difficult and the understanding of the phenomenon in the case of death requires an integrated analysis of the autopsy data and the anamnesis of the victim.

How Italy has moved from anatomical studies in the sixteenth century to body donation in the twenty-first century.

INTRODUCTION: The anatomical dissection plays a fundamental role in the students' formation as well as in the specialists' updating. In contrast to what happened in the sixteenth century, when medical students and professors from all over the Europe were used to come in Italy, today Italian surgeons have to go abroad to attend training courses, with inevitable economic costs and personal inconveniences. The reason for this circumstance lies in the existence of obsolete and even ethically unacceptable legal rules. The recent unanimous approval by the Italian Senate of the bill on postmortem body donation opens important perspectives. MATERALS AND METHODS: The authors, after having reviewed the main historical stages in anatomical dissection, examine the above mentioned recent bill n. 733 (XVIII Legislature) concerning the disposition of one's body and post-mortem tissues for the purposes of study, training and scientific research, taking into consideration also the international context. DISCUSSION: The bill aims to fill the serious legislative gap, not only offering the possibility of satisfying the noble needs of human solidarity, but also giving to future doctors a contact with death capable of promoting human and ethical values such as the respect for life. CONCLUSIONS: The Italian legal system presents - right now - serious operational gaps which make body donation practically unapplied. While waiting for the bill to finally see light, it is necessary to engage in educational activities that can promote the culture of this "gift" and, at the same time, that of respect for the body of the deceased person. KEY WORDS: Anatomical dissection, Body donation, Study and research.

Review on post-mortem diagnosis in suspected SUDEP: Currently still a difficult task for Forensic Pathologists.

Sudden and unexpected death in epilepsy (SUDEP) represents the predominant cause of premature deaths in young adults with epilepsy and is more common with patients with poorly controlled and generalized convulsive seizures. It is reported that there are 1,16 cases for every 1000 subjects affected with epilepsy. This review takes stock of the current problems and issues in the autopsy of cases of sudden death with epileptic people. For this purpose, all the possible findings of post-mortem examinations reported in the literature were analyzed and summarized, which can currently be considered useful for autopsy diagnoses as well as in the comprehension of the physiopathology of SUDEP. The enormous limitation of forensic pathology studies is the complete lack of a specific SUDEP diagnostic marker. Only in a few cases was it possible to find pathological signs of the brain that would clarify epilepsy-related deaths. Genetic research has tracked down variants of neurocardiac genes of ion channels in a restricted percentage of suspected SUDEP cases. The actual pathogenicity test requires an in-depth statistical analysis in order to prove there is a real excess of variants and evidence that the mutation alters the function. Despite scientific efforts, it is often difficult to distinguish SUDEP from other causes of sudden death. For these reasons, it will be necessary to create an international standard SUDEP death scene investigation and postmortem examination protocols. Further future studies of immunohistochemistry or genetics may help and may facilitate post-mortem diagnosis in cases of presumed SUDEP.

Spastic quadriplegia following intradermal use of hydrogen peroxide in the tardive curettage procedure for the treatment of a giant congenital nevus.

The possible transformation of a giant congenital melanocytic nevi (GCMN) in malignant melanoma estimated from 0.05% to 40% depend on the size of the lesions. Many are the surgical procedures proposed, including: full or partial-thickness excisions, dermabrasion, curettage in the first weeks of life and laser treatment. The curettage technique has been proposed in the literature for the treatment of GCMN in the first few weeks of life and defined as a relatively atraumatic surgery procedure without general complications. The authors report the first case in the literature of embolization due to use of subcutaneous peroxide infiltration before a tardive curettage procedure in a newborn case of GCMN resulting in spastic quadriplegia with dystonic reaction. Consequently, a lawsuit, due to this medical malpractice, has been opened.

Medico-legal considerations on "Lotus Birth" in the Italian legislative framework.

The term "Lotus Birth" identifies the practice of not cutting the umbilical cord and of leaving the placenta attached to the newborn after its expulsion until it detaches spontaneously, which generally occurs 3-10 days after birth. The first reported cases of Lotus Birth date back to 2004 in Australia.Supporters of such a procedure claim that the newborn is better perfused, endowed with a more robust immune system and "less stressed".However, it should be pointed out that histopathological study of the placenta is increasingly being requested in order to investigate problems of an infective nature or dysmaturity affecting the foetus, and situations of risk affecting the mother. Moreover, from the legal standpoint, there is no uniform position on the question of whether the placenta belongs to the mother or to the newborn. Lastly, a proper conservation of the embryonic adnexa is very difficult and includes problems of a hygiene/health, infectivological and medico-legal nature.The authors analyzed all these aspect in the Italian legislative framework, reaching the conclusion that Lotus Birth is inadvisable from both the scientific and logical/rational points of view.

Sudden, Unexpected Death Due to Pseudo-Meigs Syndrome: A Case Report and Review of the Literature.

Meigs syndrome is the triad of ascites, hydrothorax, and benign ovarian tumor (mostly fibroids). It is a diagnosis of exclusion, and the characteristic symptoms disappear after resection of the tumor. Instead, in Pseudo-Meigs syndrome, the triad includes a nonfibroma ovarian tumor. The latter may consist of benign tumors (ie, of fallopian tube or uterus, struma ovarii, and ovarian leiomyomas) but can also comprise ovarian or metastatic gastrointestinal malignancies.The authors describe a case of sudden death in a 43-year-old woman, with no noteworthy reported history of present illness or medical history and in apparently good health before death.The autopsy showed a picture of bilateral hydrothorax with lung collapse, ascites, and a large left-sided ovarian mass, approximately 15 cm in diameter. Histopathological examinations revealed an ovarian epithelial malignancy (cystadenocarcinoma). There was also lung atelectasis with accompanying thrombosis of small and medium blood vessels. The combination of autopsy and histological findings allowed us to establish the diagnosis of Pseudo-Meigs syndrome, undiagnosed antemortem, resulting in death due to pulmonary and thrombotic complications. Our subsequent review of the literature found no case reports of undiagnosed Pseudo-Meigs syndrome presenting as sudden death, highlighting the uniqueness of the case presented herein.

An Unusual Murder: Vasovagal Death From Atypical Stabbing to the Neck.

Fatalities due to stabbings are usually caused by large blood vessels or organs injuries resulting in hemorrhagic shock. Vagal inhibition from a stab to the neck is an undeniably exceptional event, infrequently described in the literature. In our case report, we describe one such fatality.The body of a deceased 38-year-old man was found near a public garden. According to a bystander, the victim had been assaulted by 2 individuals, sustaining a stab wound to the neck with a broken glass bottle. At the autopsy, there was a large, inverted L-shaped cut wound in the left cervical region, measuring approximately 4.5 × 3 cm. The carotid artery and the jugular vein, as well as their main branches, were uninjured. The trachea and bronchi contained no exudate or blood. There was a hematoma near the trunk of the vagus nerve and its branches.The cause of death was attributed to the deep stab wound to the neck via vasovagal inhibition and parasympathetic nervous system stimulation.

Medico-legal aspects of deaths related to neglect and abandonment in the elderly.

As life expectancy increases, the phenomenon of the neglect of elderly persons is becoming increasingly relevant in the fields of both medicine and social care. This work analyses the cases of two subjects whose deaths initially seemed to have been attributable to natural causes. The autopsy findings and the analysis of clinical data, however, were able to establish that neglect had played a determining role in their deaths. These cases highlight the need for healthcare workers to be more alert to the clinical signs of neglect. Finally, in cases of death, the forensic pathologist must conduct a meticulous post-mortem examination to detect the physical signs of neglect and to establish if abuse has been responsible for the death.

Elder abuse in Europe's "most elderly" city: an assessment of the phenomenon and an analysis of the data from the Penal Court of Genoa from 2010 to 2015.

INTRODUCTION: In Italy, 5% of the elderly are estimated to have suffered abuse. While the Penal Code refers to generic types of abuse, such as physical and psychological maltreatment, abandonment and financial fraud, it does not specifically protect the elderly as a category. AIMS: To assess the frequency and modalities of elder abuse in Genoa and its Province, and to compare these data with those reported in the literature, in order to provide a picture of the current situation that can be used by the authorities to combat this phenomenon. METHODS: We analysed the first-degree verdicts issued by the Court of Genoa regarding accusations of physical, psychological and moral abuse and maltreatment of elderly subjects (over 65 years) in the period 2010-2015. RESULTS: Only 85 of the 4028 court verdicts analysed involved elderly persons: 19 cases of domestic maltreatment, 3 of abuse of the means of correction or discipline, 18 of personal injury, 5 of abandonment and 40 of circumvention (deceiving someone, especially an elderly or mentally impaired person, to obtain a profit). DISCUSSION AND CONCLUSIONS: A gap was observed between the number of crimes reported to the judicial authorities (tip of the iceberg) and the estimated prevalence of the phenomenon in the literature. There is a need both to create a network of protection for the elderly involving medical and judicial specialists and to train healthcare professionals to better recognise and report cases of maltreatment.

A fatal case of iatrogenic aortic arch rupture occurred during a tracheostomy.

The authors illustrate a rare case of aortic arch rupture in a 60-year-old woman, occurred during a tracheostomy performed using the Griggs method. The autopsy examination showed an aortic arch rupture in an intermediate position situated in the area between the brachiocephalic artery ostium and the left common carotid artery ostium, associated to a hemorrhage filling of the adjacent connective and muscular tissue. The death was therefore determined by cardiac arrest secondary to massive hemorrhagic hypovolemic shock caused by the aortic arch rupture. The lethal iatrogenic lesion was determined by the aortic arch traction caused by the dilatation. The surgeon's incautious use of the Howard-Kelly forceps introduced in the mediastinum was therefore hypothesized.

Health management and patients who lack capacity: forms of guardianship in European health policy.

The focus of healthcare debate has in recent years shifted from doctors and healthcare professionals in general to patients and the principle of patient self-determination. Patient competence therefore plays an increasingly central role in the legal framework of many Europeans countries. Consequently, healthcare policy has to address the possible repercussions of a non-systematic approach to cases of patient incapacity. The diverse nature of the experiences of the mentally or physically disadvantaged clearly raises problems for the healthcare professional. In this setting, we examine Italy's Law no. 6/2004 from a comparative perspective, in particular analysing legislation in the same area from Spain, France, Great Britain and the Netherlands.

Results and unsolved problems following the amendment to the Italian Law on assisted reproduction brought about by the Constitutional Court.

Since the approval of Law N° 40/2004, Italian specialists have been applying assisted reproductive techniques in compliance with a number of restrictions. Several attempts were made to find a solution to the practical and ethical issues brought about by this restrictive legislation. Finally, in May 2009, the Italian Constitutional Court banned most of the limitations. In the last year the authors worked together to study the impact of the Italian Constitutional Court modifications on assisted reproduction from both a gynecological and medico-legal point of view. Despite the clinically positive impact of the ruling, a lot of technical and legal unsolved issues still exist. Analyzing these problems, the authors stress the importance of a multidisciplinary approach to achieve adequate legislation in order to improve patients' outcome and avoid "reproductive migration" from Italy to other European Countries. New regulation could also be important for practitioners by keeping the risk of legal troubles to the minimum.

Loss of chance: a new kind of damage to ophthalmologic patients from Europe to Italy.

This work was inspired by a recent juridical development in Italy, whose purpose is to prevent rejection of damage claims whenever it is not possible to prove a causal link between iatrogenic illicit behavior and damage to the patient, despite the fact that the patient has clearly suffered physical or mental injury. In view of this, some European countries-e.g., France and Germany-have recently come up with a new damage interpretation called loss of chance, i.e., the missed opportunity to get a more favorable outcome through different or more timely and efficient therapies. Although the problem has been thoroughly discussed on several levels, no countries have conformed their legislation accordingly, leaving it up to the courts to settle issues of damage claims where loss of chance can be applied and to resolve doubts about the limits of applicability of this new type of damage interpretation. The concept of loss of chance seems to be applicable to many cases in ophthalmologic practice. For example, glaucoma and macular degeneration are common, serious, and potentially blinding diseases in which delayed diagnosis and therapy reduce the chances not only to limit injuries, but also to stop future progress of the disease. Hence, the authors emphasize that a good practice is the only way for ophthalmologists to avoid malpractice claims related to the new developments in tort law in Italy and in other European countries following the creation of new definitions of damage.

Old age as an "alternative" to illness: gerontological and medico-legal aspects.

The current trend toward an ever increasing aging population forces society to face the problem of how to care for elderly people who are exposed to the risk of so-called "elder abuse," a phenomenon becoming increasingly widespread in Italy, as legislation does not provide a precise juridical definition of "elderly" nor does it provide for their specific protection. From a geriatric and medico-legal point of view, it is difficult to assess the cognitive performance of elderly individuals due to a number of factors, including the lack of evaluation tools with well-defined reference parameters for assessing decision-making capacities. Nonetheless, according to Italian penal code, abandoning a person incapable of self-support due to old age is considered a violation of the obligation of family assistance. Just as in the USA, which has instituted the Adult Protective Services, the Authors propose that the local health authorities provide help desks for the victims of elder abuse in Italy.

Instrumental misdiagnosis and colon perforation: an autopsy case.

The authors report the case of a 75 year old man with bilateral inguinal hernia who suddenly died a few hours after hospitalization. Autopsy revealed death was related to a stercoral peritonitis ensuing from a perforation of the colon. The clinical picture during hospitalisation showed no typical signs of this. Court proceedings identified failure by the radiologist to identify the radiological signs of an intestinal perforation. The case report reviews the matter of the cause-effect relationship between death and radiological misdiagnosis and on the possible judicial consequences in Italy for the doctor, responsible for the failure to diagnose.