L'ACCERTAMENTO DELLA RESPONSABILITÀ CIVILE DEL MEDICO TRAMITE L'UTILIZZO DELLE LINEE-GUIDA E DEGLI ALTRI DOCUMENTI SCIENTIFICI

PHD DISSERTATION - ABSTRACT - THE ASCERTAINMENT OF MEDICAL MALPRACTICE THROUGH CLINICAL PRACTICE GUIDELINES AND OTHER SCIENTIFIC DOCUMENTS. This PhD dissertation aims to analyze a specific aspect of Medical Malpractice Law: the use of scientific documents – known as practice parameters, practice patterns, written policies, protocols, standards or clinical practice guidelines – by rule makers (legislators and Courts) in order to identify the standard of care for health care practitioners.
In the first chapter, after a short introduction on fundamental notions of medical epistemology, guidelines’ content and their production, some interactions between Science and Law are described, picking the European Union Law, Council of Europe Law and finally Italian Law.
Research on guidelines and Medical Malpractice calls for taking the advantage of Comparative Legal Studies. In particular, the legal system of the United States of America has been chosen. This because American scholars have first proposed in the ‘80s to use guidelines in Medical Malpractice trials. The second chapter offers thus a detailed picture of the sources of the law, including the role of state and federal Courts in making American Law. Focusing then on Medical Malpractice, it has to be said that the majority of the States adopted medical custom as the standard of care, which is a matter of fact, to be proven in front of the jury. According to this, in Medical Malpractice trials expert witness testimony about medical custom became very relevant, but no Court in the U.S. appoints experts. This, and the fact that the plaintiff retains the burden of proof of the breach of duty, makes partisan expert testimony mandatory for the claim of the patient to be heard by the jury. Therefore, Courts and scholars in the United States put guidelines in the Evidence Law frame, looking at how they interact – or sometimes clash – with expert testimonies. So, the chapter ends with an analysis of the Law of Evidence, with a focus on the so called “Daubert test” on expert witnesses, and one on the admissibility of documents.
The third chapter demonstrates that the use of clinical practice guidelines in Medical Malpractice trials is way more frequent than American scholars think. Furthermore, it shows that the above-mentioned rules of Evidence are still the most relevant source of the law governing admissibility and relevance of these documents. Evidence Law indeed is far more relevant than the small number of state and federal statutes on Medical Malpractice that mention guidelines as a judicial tool for assessing liability. But these statutes seem to have inspired the Italian legislator seems adopting the so called “decreto Balduzzi” (see art. 3, comma 1 d.l. n. 158 of 2012 – l. n. 189 of 2012).
The fourth chapter goes back to the Italian legal system, describing the path that brought Medical Malpractice from Tort Law to Contract Law through the so called “contatto sociale” doctrine. Furthermore, the case law caused some distortions of the rules that are now similar to strict liability.
The fifth chapter describes a legal transplant from American Tort Law to the very different Italian legal environment: the idea of giving a defense to doctors who complied with clinical practice guidelines. Anyhow, some American state statutes, not the prevailing traditional Evidence Law pattern, have influenced the Italian legislator.
Moreover, the conceptual framing of clinical practice guidelines under Italian Law is very different from the original. In Italy, Medical Malpractice is a branch of Contract Law, according to which the clinician is bound to perform treatments with the due technical expertise (“perizia”). Scientific documents can help Courts to define doct