Umberto Genovese

Central venous catheters: legal issues.

In dialysis patients, both central venous catheter (CVC) insertion and CVC use during the dialysis procedure pose important legal issues, because of potentially severe, even fatal, complications. The first issue is the decision of the kind of vascular access that should be proposed to patients: an arteriovenous (AV) fistula, a graft, or a CVC. The second issue, when choosing the CVC option, is the choice of CVC: nontunneled versus tunneled. Leaving a temporary nontunneled CVC for a prolonged time increases the risk of complications and could raise a liability issue. Even when choosing a long-term tunneled CVC, nephrologists should systematically explain its potential harms, presenting them as “unsafe for long-term use” unless there is a clear contraindication to an AV native or prosthetic access. Another critical issue is the preparation of a complete, informative, and easy-to-understand consent form. The CVC insertion procedure has many aspects of legal interest, including the choice of CVC, the use of ECG monitoring, the use of ultrasound guidance for cannulation, and the use of fluoroscopy for checking the position of the metal guidewire during the procedure as well as the CVC tip before the end of the procedure. Use of insertion devices and techniques that can prevent complications should obviously be encouraged. Complications of CVC use are mainly thrombosis and infection. These are theoretically expected as pure complications (and not as malpractice effects), but legal issues might relate to inappropriate catheter care (in both the inpatient and outpatient settings) rather than to the event per se. Thus, in the individual case it is indeed very difficult to establish malpractice and liability with a catheter-related infection or thrombosis. In conclusion, we cannot avoid complications completely when using CVCs, but reducing them to a minimum and adopting safe approaches to their insertion and use will reduce legal liability.

Asbestos Lung Burden in Necroscopic Samples from the General Population of Milan, Italy

The present study analysed the asbestos lung burden in necroscopic samples from 55 subjects free from asbestos-related diseases, collected between 2009 and 2011 in Milan, Italy. Multiple lung samples were analysed by light microscopy (asbestos bodies, AB) and EDXA-scanning electron microscopy (asbestos fibres and other inorganic fibres). Asbestos fibres were detected in 35 (63.6%) subjects, with a higher frequency for amphiboles than for chrysotile. Commercial (CA) and non-commercial amphiboles (NCA) were found in roughly similar frequencies. The estimated median value was 0.11 million fibres per gram of dry lung tissue (mf g(-1)) for all asbestos, 0.09 mf g(-1) for amphiboles. In 44 (80.0%) subjects no chrysotile fibres were detected. A negative relationship between asbestos mass-weighted fibre count and year of birth (and a corresponding positive increase with age) was observed for amphiboles [-4.15%, 95% confidence interval (CI) = -5.89 to -2.37], talc (-2.12%, 95% CI = -3.94 to -0.28), and Ti-rich fibres (-3.10%, 95% CI = -5.54 to -0.60), but not for chrysotile (-2.84%, 95% CI = -7.69 to 2.27). Residential district, birthplace, and smoking habit did not affect the lung burden of asbestos or inorganic fibres. Females showed higher burden only for amphiboles (0.12 versus 0.03 mf g(-1) in males, P = 0.07) and talc fibres (0.14 versus 0 mf g(-1) in males, P = 0.03). Chrysotile fibres were shorter and thinner than amphibole fibres and NCA fibres were thicker than CA ones. The AB prevalence was 16.4% (nine subjects) with concentrations ranging from 10 to 110 AB g(-1) dry, well below the 1000 AB g(-1) threshold for establishing occupational exposure. No AB were found in subjects younger than 30 years. Our study demonstrated detectable levels of asbestos fibres in a sample taken from the general population. The significant increase with age confirmed that amphibole fibres are the most representative of cumulative exposure.

Lethal pulmonary thromboembolism: An autopsy-based study on a rare but legally relevant event

Context: Pulmonary thromboembolism (PTE) is the severe end stage of many different diseases producing prolonged patient immobilization or a hypercoagulative state. Lethal PTE is also one of the most frequent topics for suspected medical malpractice, especially when dealing with patients originally affected by non-critical illnesses and suddenly killed by a non-prevented embolic event. The crucial forensic question about a lethal PTE is the following one: was this lethal PTE an unpreventable complication or was it a consequence of real medical malpractice? Materials and methods: The authors analyzed the 1999–2009 autopsy archive of the Institute of Forensic Medicine of Milan University and selected all the cases where PTE was the cause of death. For every selected case, the authors also collected all the available demographic and clinical data. Statistical analysis was performed using SPSS V.16.00. Results: In the period 1999–2009, 129 (1.25%) cases out of a total of 10,288 autopsies were diagnosed as having suffered lethal PTE. The male to female ratio was 1:2 (34.1% versus 65.9%). The mean age at death was 67 ± 18 years. In 41% of cases the death occurred outside of the hospital and in the absence of any medical support; in 36.5% of cases it occurred during the territorial paramedical support or during the very first evaluation in the emergency; and in the remaining 22.5% of cases it occurred during a period of hospitalization. In 33.4% of the selected cases, a typical preliminary event was positively identified: a pure major trauma (18.6%); a trauma followed by a major surgery (7%); a major non post-traumatic surgery (7%); and a non-surgical delivery. Symptoms suggesting PTE were detected in 46 cases (35.7%). Nine cases underwent a judicial autopsy in the same original hypothesis of a medical malpractice for incorrect prophylaxis in acutely bed-restricted patients. Conclusions: Post-surgical PTE cannot be automatically labeled a consequence of medical malpractice. The combination of correct prophylaxis, careful diagnostic monitoring of the high-risk patient and the correct therapy surely reduces the occurrence of lethal PTE, but it does not completely erase such an insidious pathology. In the hypothesis of a causative medical malpractice, only careful analysis by an experienced forensic pathologist can make a reliable distinction between an unpreventable complication and real medical malpractice.

The medical malpractice in Milan-Italy. A retrospective survey on 14 years of judicial autopsies

The medical malpractice is a rising and central topic for the forensic pathologist and forensic autopsies are a mandatory step in the judicial evaluation of the suspected medical malpractice. Reliable national and international registers about the medical malpractice are still missing and nowadays the necroscopic archives are therefore one of the best sources of data about such a complex phenomenon. We analyzed the archive of the Institute of Forensic Medicine of the Milan University from 1996 to 2009 and selected 317 lethal cases of suspected medical malpractice. The mean age of our cases was 60±18 years for males and 58±19 years for the females. In 70% of such cases the patient death occurred in a hospital setting. The first 24h of hospitalization turned out to be the hottest period for deaths followed by malpractice claims. The surgical branches were obviously the most involved, with abdominal surgery, orthopedics, neurosurgery and gynecology as the main contributors. Just 12% of the total amount of cases came from all the internistic branches put together. Non-hospital malpractice was typically caused by misdiagnosed myocardial infarctions and aortic ruptures. A full forensic report was present in 71 cases (all belonging to the 2007-2009 period): in 69% of cases the judicial autopsy revealed as a sufficient tool for diagnosing the cause of death; medical malpractice was confirmed in only 17% of the whole cases and a causal link between the ascertained malpractice and the patient death was recognized in only 12.7% cases.

Informed Consent, Medico-Legal Implications, Public and Private Insurance Issues and Quantification of Disability in Hand Transplantation

The first hand transplant meant — apart from the extraordinary surgical procedure and due to the particular therapeutic purpose — an opportunity for a multidisciplinary (medical, juridical, ethical) consideration to support or contradict such a therapeutic procedure’s legitimacy, which could be considered “the most hazardous and dangerous and greatest adventure on which man has ever embarked”.

Alleged malpractice in orthopaedics. Analysis of a series of medmal insurance claims

BackgroundMedical malpractice is an important topic worldwide, and orthopedics is a clinical branch that is considered to be at a high risk for claims. The analysis of a series of medmal insurance claims allows forensic pathologists, clinicians, and insurance companies to probe the risk of a specific clinical branch for medical malpractice claims and highlights areas where care may be improved. We investigated the main features of a major Italian insurance broker’s archive in order to identify recurrent pitfalls in this field.Materials and methodsA retrospective study was carried out on orthopedics claims. The archive covered claims from 2002 to 2013 that targeted 1980 orthopedists.Results635 claims were found and analyzed with a focus on the clinical activity invocked in the claim, the presence of alleged team malpractice, the clinical outcome of the case, and the final forensic decision regarding the claim. 299 orthopedists had at least one malpractice claim made against them during the available period; 146 orthopedists were subject to more than one malpractice claim. Most of the claims regarded perioperative and operative cases, usually originating from civil litigation. The anatomical sites most commonly involved were the hip or knees, and sciatic nerve lesions were the main contributor.ConclusionsOrthopedics is a medical specialty with a high risk for malpractice claims. In our study, medical malpractice was observed in nearly 50% of the cases—typically in surgery-linked cases resulting in permanent impairment of the patient. Death from orthopedics malpractice seemed to be rare.Level of EvidenceIV.

Responsible Precision Medicine in Pediatric Acute Respiratory Distress Syndrome: The Challenge of Searching for Biomarker-Driven Earlier Diagnosis, Effective Treatment, and Stratified Outcomes*

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A new paradigm on health care accountability to improve the quality of the system: Four parameters to achieve individual and collective accountability

So, the growing demand among patients for increasingly high quality treatments, the obligation to reduce adverse events in health care, the need for transparency in health care systems, and the current economic situation compound the difficulties in improving health care delivery. The debate on these issues now transcends national borders and single organisational, political and jurisprudential systems. Also, the problem of escalation of litigation in health care is applicable to all physicians regardless of age, geographical origin, and specialisation and it should be solved.

Medical decision making and risky choices: psychological and medicolegal consequences of HIV and HCV contamination of blood products

Aims The overall goal of this article is to make a scientific comment about the psycho-social consequences of hemophilia patients affected by human immunodeficiency virus (HIV) and/or hepatitis C virus (HCV) and to point out the related medicolegal issues. Methods This commentary takes into account some published evidences about the current scenario of hemophilia patients infected by HIV and/or HCV who received contaminated blood products in the late 1970s through 1985. Results Several psychological and medicolegal consequences are related with HIV and HCV contamination of blood products. A multidisciplinary approach is needed to treat all the difficulties experienced by these patients and to ensure good clinical decisions in medical practice. Conclusion The literature on the psychosocial functioning of hemophilia patients with human HIV and HCV infection offers a number of implications, including medicolegal issues, that can be discussed for guaranteeing a good level of care and safeguard of this group of patients.

The Damages from Unwanted Birth in the Italian Legal System: Between Law and Social Consciousness

In Europe, the modern legal systems, as a rule, provide for the right of citizens to a free and informed choice in matter of family planning and procreation, and therefore the right of women to resort to abortion in case of medical and social indications, or even in case of the mother’s request to terminate an unwanted pregnancy. However, being abortion not only a legal issue, but also a social and moral one, different legal systems adopt a wide range of normative models, which take into account, among other things, the existing cultural traditions and the influence of Church on society. Many states recognize the mother and other relatives’ right to compensation arising from the birth of an unwanted child. Much more controversial is the recognition of the rights of a child with a congenital pathology to indemnity from unwanted birth as a result of medical error. In the present article it is examined the experience of Italy, a country where family traditionally represents a considerable cultural and symbolic value. The paper reviews the main normative acts governing the performance of abortion. The research investigates the issues concerning the legal regulation of the compensation for damages arising in connection with the birth of an unwanted child. The present study examines the trend, emerging in the judicial practice, towards the recognition of the physically challenged child’s rights to compensation for the damage deriving from the birth as a result of medical errors.