Gianluca Montanari Vergallo

Is age the limit for human-assisted reproduction techniques? ‘Yes’, said an Italian judge

Although use of assisted reproduction techniques was examined by an ad hoc act in 2004 in Italy, there are many opposing views about ethical and economic implications of the technologies dealing with infertility and sterility problems. In this paper, the authors examine a recent judges decision that ordered the removal and subsequent adoption of a 1-year-old child because her parents were considered too old to be parents. The couple had had recourse to heterologous artificial insemination abroad and decided to give birth in Italy. The judgement deals with and discusses the complex issue of the right to procreate in order to balance the opportunities offered by scientific progress with the unborn childs condition.

Smart drugs and synthetic androgens for cognitive and physical enhancement: revolving doors of cosmetic neurology.

Cognitive enhancement can be defined as the use of drugs and/or other means with the aim to improve the cognitive functions of healthy subjects in particular memory, attention, creativity and intelligence in the absence of any medical indication. Currently, it represents one of the most debated topics in the neuroscience community. Human beings always wanted to use substances to improve their cognitive functions, from the use of hallucinogens in ancient civilizations in an attempt to allow them to better communicate with their gods, to the widespread use of caffeine under various forms (energy drinks, tablets, etc.), to the more recent development of drugs such as stimulants and glutamate activators. In the last ten years, increasing attention has been given to the use of cognitive enhancers, but up to now there is still only a limited amount of information concerning the use, effect and functioning of cognitive enhancement in daily life on healthy subjects. The first aim of this paper was to review current trends in the misuse of smart drugs (also known as Nootropics) presently available on the market focusing in detail on methylphenidate, trying to evaluate the potential risk in healthy individuals, especially teenagers and young adults. Moreover, the authors have explored the issue of cognitive enhancement compared to the use of Anabolic Androgenic Steroids (AAS) in sports. Finally, a brief overview of the ethical considerations surrounding human enhancement has been examined.

Stem cell therapy: from evidence-based medicine to emotion-based medicine? The long Italian way for a scientific regulation

On 23 May 2013, the Italian health minister decided to endorse a law regarding controversial stem cell-based therapies in 32 young terminally ill patients, shocking many scientists. According to the international scientific community, these therapies could be dangerous because they were not rigorously tested in humans. This decision was made after many days of media and judiciary pressure. Several lawsuits regarding stem cell-based therapies were brought before the judiciary districts of different Italian regions. We analyzed the Italian legal context regarding the field of pharmaceutical and medical devices, including the European Union trend. A national database - commonly used to manage legal materials for professional or educational purposes or both - was used to find relevant legal cases involving stem cell-based therapies. Stem cell-based therapies endorsed by the new Italian law have been the subject of an important discussion not only in the scientific community but also in various courts. We found several legal actions filed by parents in order to make stem cells available to their young children, who had serious neurodegenerative diseases. The majority of the analyzed legal disputes were settled in favor of the applicants, whereas only two decisions (Courts of Justice of Rome and Florence) rejected the complaint because of the absence of sufficient scientific data regarding stem cell-based therapies. The present Italian situation is influencing the destiny of future young patients and strongly impacting public and institutional opinion. It is a practical example of the complexity of the decision of not providing unapproved scientific stem cell-based therapies when medicine does not have any other alternative therapies.

Ethical and Legal Implications of Elective Ventilation and Organ Transplantation: “Medicalization” of Dying versus Medical Mission

A critical controversy surrounds the type of allowable interventions to be carried out in patients who are potential organ donors, in an attempt to improve organ perfusion and successful transplantation. The main goal is to transplant an organ in conditions as close as possible to its physiological live state. “Elective ventilation” (EV), that is, the use of ventilation for the sole purpose of retrieving the organs of patients close to death, is an option which offsets the shortage of organ donation. We have analyzed the legal context of the dying process of the organ donor and the feasibility of EV in the Italian context. There is no legal framework regulating the practice of EV, neither is any real information given to the general public. A public debate has yet to be initiated. In the Italian cultural and legislative scenario, we believe that, under some circumstances (i.e., the expressed wishes of the patient, even in the form of advance directives), the use of EV does not violate the principle of beneficence. We believe that the crux of the matter lies in the need to explore the real determination and will of the patient and his/her orientation towards the specific aim of organ donation.

Not Only a Clinical Nightmare: Amniotic Fluid Embolism in Court

Amniotic fluid embolism (AFE) is an uncommon obstetric condition involving usually women in labour or in the early post-partum period. Clinical consequences of this unpredictable and unpreventable pathology may be extremely serious with high morbidity and mortality rates. Data obtained from the US Amniotic Fluid Embolism Registry show that the process is more similar to anaphylaxis than to embolism, and the term anaphylactoid syndrome of pregnancy has been suggested because foetal tissue or amniotic fluid components are not universally found in women who present signs and symptoms related to AFE. The first aim of this paper has been to focus on the medico-legal aspects concerning the misdiagnosis and the treatment of the AFE and the Authors, with this purpose in mind, reviewed the main national law cases on medical malpractice claims involving both physicians and hospitals. The second aim has been to highlight the need to introduce a National register as a useful tool to raise the awareness of this disease among physicians and to improve the quality of care, which can be achieved through a proper identification and reporting of AFE cases. The application of a national register may limit the number of medico-legal litigations, which according to the national and foreign Jurisprudence are not currently based in favour of the predictability of AFE, but they focus their discussion on the importance of a prompt medical assistance when the effects of this disorder occur.

Can the intrapartum ultrasonography reduce the legal liability in distocic labor and delivery

Abstract The authors emphasize the importance of performing an intrapartum ultrasonography in order to prevent maternal and neonatal complications but also physician legal liability. The main advantages of using this technique are: improvement of fetal head’s malposition diagnosis; prevention of maternal and fetal complications of childbirth due to the use of forceps or vacuum extractor (VE); a more accurate planning of cesarean section; a proof of professional correctness.

The issue of delivery room infections in the Italian law. A brief comparative study with English and French jurisprudence

Abstract Delivery room infections are frequent, and many of them could be avoided through higher standards of care. The authors examine this issue by comparing it to English and French reality. Unlike England, in Italy and France the relationship established between health facility, physician and patient is outlined in a contract. In England, the judges’ decisions converge toward a better and higher protection of the patient–the actor–and facilitate the probative task. In case of infections, including those occurring in the delivery room, three issues are evaluated: the hospital’s negligent conduct, damages if any and causal nexus. Therefore, the hospital must demonstrate to have taken the appropriate asepsis measures according to current scientific knowledge concerning not only treatment, but also diagnosis, previous activities, surgery and post-surgery. In order to avoid a negative sentence, both physicians and hospital have to demonstrate their correct behavior and that the infection was caused by an unforeseeable event. The authors examine the most significant rulings by the Courts and the Supreme Court. They show that hospitals can avoid being accused of negligence and recklessness only if they can demonstrate to have implemented all the preventive measures provided for in the guidelines or protocols.

Surrogate motherhood: Where Italy is now and where Europe is going. Can the genetic mother be considered the legal mother?

This paper explores a recent case, which has reawakened the debate in Italy over the opportunities offered by technological progress in the field of Assisted Reproduction. On 17 January 2013, the Juvenile Court of Brescia ordered the removal and adoption of a newborn baby whose parents had turned to surrogate motherhood and heterologous insemination in Ukraine, thus expressly violating the Italian and Ukrainian laws. The authors provide a critical analysis of the legal reasoning given by the Court in order to balance the best interests of the unborn child and the needs of certain parents suffering from sterility/infertility problems. In establishing the legal status of parent, the guiding principle must be the childs right not to be objectified or exploited by the adult. Therefore, it is necessary to provide appropriate tools to balance, on the one hand, the defence of the desire to become parents, if legitimate, and on the other the preservation of the legal and harmonious development of the child. Thus, the professionals have the burden of adapting the legal rules to a variety of individual cases, always taking into account the need to comply with the principles of both Constitutional and European Union law.

Mario Monicelli's Grande Guerra: the right of living and the choice of dying

Monicellis suicide has reawakened a political and legal dispute about the medical role in end-of-life decisions, allowing us to discuss medical, ethical, legal, religious and political debate in various paradigmatic conscious and unconscious cases of end-of-life decision. We analyse the uncertainty about the ‘a priori’ choice between different specific legislative systems, highlighting the need for a unifying model, dictated by the existing trust in the critical relationship between patient and doctor, whose primary mission should be not only ‘to cure’ but also ‘to care’.

Kristeller maneuvers or fundal pressure and maternal/neonatal morbidity: obstetric and judicial literature review

Abstract Aim: A significant amount of data concerning maternal-fetal damage arising from the exertion of Kristeller maneuvers (KMs) or fundal pressure (FP) go unreleased due to medicolegal implications. Materials and methods: For this reason, the paper gathers information as to the real magnitude of litigation related to FP-induced damages and injuries. The authors have undertaken a research in order to include general search engines (PubMed-Medline, Cochrane, Embase, Google, GyneWeb) and legal databases (De Jure, Italian database of jurisprudence daily update; Westlaw, Thomson Reuters, American ruling database and Bailii, UK Court Ruling Database). Results: Results confirm said phenomenon to be more wide ranging than it appears through official channels. Several courts of law, both in the United States of America (USA) and in European Union (EU) Member States as well, have ruled against the use of the maneuver itself, assuming a stance conducive to a presumption of guilt against those doctors and healthcare providers who resorted to KMs or FP during deliveries. Given how rife FP is in mainstream obstetric practice, it is as if there were a wide gap between obstetric real-life and what official jurisprudence and healthcare institutions-sanctioned official practices are. Conclusion: The authors think that it would be desirable to draft specifically targeted guidelines or recommendations on maneuvers during vaginal delivery, in which to point out exactly what kinds of maneuvering techniques are to be absolutely banned and what maneuvers are to be allowed, and under what conditions their application can be considered appropriate.