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The topic of informed consent has become increasingly important in recent decades, both in the ethical-deontological field and as a duty of law. The review covered all sentences issued by the 13th section of the Civil Court of Rome during the period January 2016–December 2020. During this period, 156 judgments were found in which a breach of consent was required; in 24 of these, specific liability was proven, and the corresponding compensation liquidated. Moreover, 80% of the cases concerned the lack of information provided. The most involved branches were those related to surgical areas: general surgery, plastic surgery and aesthetic medicine and orthopaedics. The total amount of compensation paid was EUR 287,144.59. The research carried out has highlighted how, in a broad jurisprudential context, the damage caused by the violation of the right related to informed consent is considered, and how it impacts on the economic compensation of damages. Additionally, it showed that the areas most affected by the information deficit are those related to the performance of surgical activities, which are characterized by greater invasiveness and a higher risk of adverse events. The data reported underline the exigency to consider informed consent not as a mere documentary allegation but as an essential moment in the construction of a valid therapeutic alliance, which is also useful for avoiding unnecessary litigation that is becoming increasingly burdensome for healthcare systems all over the world.
Keywords: informed consent, malpractice, medical errors, liability, legal, physician–patient relations, communication
The informed consent doctrine, with particular reference to the field of healthcare, relies on professional ethics-related aspects rather than on purely medical procedures. It is only in the second half of the last century that the informed consent doctrine became part of various legal systems, having its conceptual origins in the United States at the beginning of the twentieth century. Previously, patient clinical information was mostly left unspoken of, in accordance with the Hippocratic oath stating that physicians have to reveal nothing to their patients about their future or present clinical condition [1]. This attitude relied on a paternalistic doctor–patient relationship until a few decades ago. Over time, along with the evolution of medical science, a step forward was made in approaching the physician–patient relationship, leading to the consideration of patients as real decision-makers about their own healthcare and treatments.
One of the first legal cases concerning the acknowledgment of the patient’s right to be informed and to self-determination about his/her health dealt with the American case Shloendorff v. New York Hospital in 1914. The landmark judgment about the aforementioned judicial matter stated that “… Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent, commits an assault, for which he is liable in damages …” [2].
The first time “informed consent” appeared in a medical-related judgment was on October 22, 1957 in a malpractice judgment from California Court of Appeals—Salgo v. Leland Stanford Jr. University Board of Trustess. In this case, the court concluded that: “A physician violates his duty to his patient and subjects himself to liability if he withholds any facts which are necessary to form the basis of an intelligent consent by the patient to the proposed treatment … in discussing the element of risk a certain amount of discretion must be employed consistent with the full disclosure of facts necessary to an informed consent …” [3].
At the international level, the transposition of this principle can be related to what emerged from the famous Doctors’ Trial held in Nuremberg in 1947 against Nazi doctors, which stated the mandatory consent by the concerned party to undergo health treatments and scientific research protocols [4]. In Europe, the recognition of the above-mentioned principles may also be found in various documents, most notably the Charter of Fundamental Rights of the European Union providing that: “in the medical field and biology, the following requirements are needed: the free and informed consent by the person concerned, in the manner laid down by law”.
Respect for everyone’s right to self-determination in health care decisions has also involved some specific aspects such as the ability to make choices, the right to obtain a free, prior and informed consent of the party concerned, and the possibility to donate one’s body to medical science after death, a choice that is currently protected by specific laws in much of the world [5].
At a global level, as a result of this conceptual progress, various countries have made efforts to promote, through specific regulations, compliance both with autonomy and, consequently, with informed consent in the health field.
Looking at the Italian scenario, before the introduction of a specific law, the Italian Constitutional Court approached the informed consent issue in judgment no. 438 of 23.12.2008, providing an informed consent intended as the expression of conscious compliance with any medical treatment proposed by healthcare professionals and as a real individual’s right according to the rules stated in Art. 2 of the Constitution, protecting and promoting their fundamental rights, and in Articles no. 13 and 32 of the Italian Constitution.
Following the aforementioned judgment, Law No. 219/2017 entitled “Provisions for informed consent and advance treatment directives” was introduced in Italy, published in the Italian Official Gazette in January 2018. With this regulatory action, particular attention has been given to the doctor–patient relationship and the resulting care relationship as prerequisites to informed consent which, in turn, brings into focus both patient and doctor autonomy in clinical decision making as well as the physician’s ensuing liability [6,7]. This law also introduced into the Italian legislative framework for the first time the opportunity for each citizen, in the event of his or her future inability to self-determine, to define in advance to which treatments he or she will be subjected [8].
Therefore, it is evident that in the healthcare field, informed consent has long become an act both of legal and ethical-deontological relevance. In recent literature, the topic of the legal aspects related to informed consent has been addressed by considering not only its reflections in daily practice, but in relation to specific situations of current relevance such as the practice of telemedicine [9] and the digitization of health systems [10], biomedical research [11], and palliative and end-of-life care [12].
Regarding the duty to inform, it should be noted that information standards vary according to the legal system. For instance, two distinct models called ‘reasonable medical practitioner’ and ‘reasonable patient standard’ have been proposed in recent years. According to the first model, the amount of information should conform to what a reasonable doctor in that situation would provide, whereas in the case of the second model, the level of information should concern what a standard patient would want to know about his or her specific situation [13].
Therefore, with regard to the legal implications, the omission or lack of prior information to be provided to the patient and the obtaining of valid informed consent can be considered elements of liability for healthcare professionals and may lead to compensation for damage with the risk of being charged with damages resulting both from harm and the breach of the right to self-determination. Law no. 219/2017, Art. 1 paragraph 1 states that “… no health treatment can be started or continued without the free and informed consent of the person concerned, except in cases expressly provided for by law…” [14], and Art. 1 paragraph 4 refers to the ways by which consent must be acquired (“documented in writing or through video recordings or, for the disabled person, through devices that allow them to communicate…”), ruling the terms and procedures guidelines on informed consent. In addition, the aforementioned Law states that “the time of communication between doctors and patients constitutes healthcare time”, thus emphasizing the importance of promoting and enhancing a trusty physician–patient relationship. Moreover, according to the intention of the Italian legislator, the time spent communicating with the patient is an integral part of the health treatment path as it is always in the best interest of the patient in order to protect him/her from harm [15].
The aim of our research is to present the data relating to the phenomenon of medical malpractice resulting from non-compliance with the informed consent regulations through the analysis of the judgments from the Civil Court of Rome.
The retrospective review covered all judgments issued by the Judges of the Civil Court of Rome, XIII Section, published between January 2016 and December 2020. Only first instance judgements were taken into consideration, excluding both second instances, as well as those issued by the Supreme Court of Cassation. The XIII Section of the Civil Court of Rome deals with professional liability trials, including the medical field. The University of Rome “Tor Vergata” and the Civil Court of Rome signed an agreement, for which the court provided the judgments for analysis. The research was initially performed using the keywords “medical liability” and “medical professional”. The documents were saved in PDF format and anonymized to preserve the litigants’ personal identities and remove any connection between the tort in question and specific individuals or institutions. At the end of the anonymization phase, out of 1190 total documents (of which 23 duplicates were deleted), only 1167 underwent a preliminary analysis, performed by three different auditors skilled in medical professional liability, which led to a further exclusion of 50 documents not referable to medical negligence issues, but rather concerning, more specifically, veterinary and car accident liability.
The second step involved the analysis of 1117 documents exclusively relating to medical malpractice cases. For the analysis, a work grid was used to process the data, using the EXCEL program (Office 365) to systematize the data mining.
The grid was also set up with some locked fields, to minimize the inter-individual variability between the three auditors. The items present in the columns of the excel grid were: judgment no., occurrence year, publication year of the judgment, medical specialty involved, type of negligence/liability sued and recognized, type of damage (injury/death), type of parties involved (public/private facility or single healthcare worker), outcome of the trial, and compensation paid. At the end of this step, 156 judgments concerning informed consent omission or violation were investigated ( Figure 1 ).