Corte Assise of Florence, 18/10/1990 (the so-called Massimo case)
Informed consent is specific and binding
The primary hospital surgeon who, in subjecting an elderly patient to surgery, instead of carrying out the planned transanal removal of a villous adenoma, has without prior consent and in the absence of need and therapeutic urgency proceeded to the total abdominal removal -perineal of the rectum, causing the death of the woman two months later as a consequence of the extremely traumatic and bloody surgery.
Cass. Civ., Section III, 8/07/1994, n. 6464
The doctor is liable for damages resulting from the negligence of the duty of complete information
The provision of art. 2236 of the Italian Civil Code, which in cases of services that involve the solution of particularly difficult technical problems, limits the liability of the professional to only cases of willful misconduct or gross negligence, does not apply to damages related to negligence or imprudence , of which the professional, consequently, is liable even for slight negligence. Therefore, the doctor is liable for damages resulting from the violation, through negligence, of the patient's duty to inform the patient about the possible outcomes of the surgery, to which he is required in any case, and especially in that of voluntary interruption of the pregnancy, in which the patient's right to information is expressly sanctioned by art. 14 of the law n. 194/1978 (the hospital doctor had not informed the patient, subjected to abortion surgery, of the possible negative outcome of the operation and the consequent need for a histological check to ascertain this outcome, resulting in the patient's disinterest that only when the abortion operation could not be repeated did she realize the failure and found herself in the need to carry the unwanted pregnancy to term).
Cass. civ., section III, 15/01/1997, n.364
The doctor cannot act without informed consent which must be extended to every single phase, to the various alternatives and to the risks
In the context of surgical interventions conducted as a "team", the doctor cannot intervene without the informed consent of the patient, and, if the individual phases assume management autonomy and present various alternative solutions, each of which entails different risks, his duty to inform also extends to the individual phases and the respective risks.
Cass. civ., section III, 24/09/1997, n.9374
In the hospital, in case of lack of consent, the body is liable
In the hospital, in case of lack of consent, the body is liable
In the event that the execution, even if prudent, diligent and technically correct, of a surgical intervention or an invasive diagnostic assessment, results in damage or even death of the patient, not informed by doctors, (in this case employees of a hospital company) serious risks to life or physical safety that could be encountered, in order to give the necessary consent to proceed, there is the responsibility of the body, even if the doctor who was responsible for this obligation has not been identified.
Civil Cassation Section III sentence 9705 of 6 October 1997
for a valid informed consent it is necessary that the professional inform the patient of the benefits, the modalities of the intervention, of the possible choice between different surgical techniques and, finally, of the foreseeable risks during the operation, but this does not mean that he must go into details of the chosen technique and, therefore, inform the patient of changes in the operative plan of the surgical program, without prejudice to the agreed technique.
Pret. Lecce, 04/02/1998
The principles on which the therapeutic freedom of doctor and patient is based
The exercise of the therapeutic freedom of the doctor and the patient must be based on the following assumptions. 1 - therapeutic need due to the particular severity of the disease; 2 - ineffectiveness of traditional consolidated therapy; 3 - reasonableness of the alternative - innovative therapeutic attempt; 4 - direct and responsible prescription from the trusted doctor; 5 - informed consent of the patient: 6 - non-harmfulness of the prescribed drugs, assumptions that are consistent with the precepts of the code of medical ethics, as approved by the National Committee for Bioethics, and with the social function of law.
Court of Milan, section VII, 14/05/1998, n. 5510
Informed consent is personal and if the patient is capable of understanding and willing the relative cannot make decisions on his behalf
(...) a family member of the patient, even though he is closer to the patient than the doctor, cannot rise to the figure of nun-cius of his will, if he is capable of understanding and willing, not being able to take decisions in place of the person concerned. (...) the Court does not justify the fact that it considered the provision of consent by a relative to be sufficient, who had no power to replace the person entitled to consent to interventions on his own body.
Treviso District Court, 29/04/1999
The right to refuse treatment
The subject has the right to use as well as refuse the treatments that the doctor offers him; that is, there is a right not to be treated even if such conduct exposes the subject to the risk of life. (...). In the present case, the patient had clearly expressed his disagreement with hospitalization and further treatment. (...) From an examination of the documents it appears that sufficient information was provided to M. regarding the dangers deriving from his decision (...) it emerges that correct information was provided on the risks associated with the lack of treatment and hospitalization, that M. was aware of the consequences of the lack of treatment (...) it is also useful to underline that the inability must be recognized or recognizable by the doctor, with all the consequences in the event of an excusable error (... ) in the case in question the M. (..) appeared in a state of ability to understand and will at the moment of the fact (...)
Cass. civ., section III, 16/05/2000, n.6318
The doctor's duty to also inform about the hospital situation, the omission of which constitutes serious negligence
The responsibility and duties of the doctor do not concern only his own activity and any "team" that responds to him, but extends to the state of efficiency and the level of equipment of the healthcare facility in which he works, and translates in a further duty to inform the patient. Informed consent - personal of the patient or of a family member - in view of surgery or other specialized therapy or invasive diagnostic assessment, does not only concern the objective and technical risks in relation to the subjective situation and the state of the art of the discipline , but also concern the concrete, perhaps temporarily lacking hospital situation, in relation to the facilities and equipment, and their regular functioning, so that the patient can not only decide whether or not to undergo the operation, but also whether to do it in that structure or ask to move to another. Failure to provide information on this point can constitute serious negligence, for which the doctor will be liable in conjunction with the hospital in terms of civil liability, therefore of compensation for damage, and possibly also on a professional, ethical - disciplinary level.
Court of Milan, section I civ., 13/07/2000
Incorrect behavior of the doctor in acquiring consent
The surgeon acted incorrectly, for having obtained the patient's consent when he was not in the full capacity to understand and will, being still under the effect of the anesthetic used to carry out the angioplasty examination.
In addition, the surgeon's behavior appeared to be extremely censurable, as he never met the patient and never visited him before.
Furthermore, the operator, before proceeding with a new intervention, after the result of the angioplasty, should have consulted the patient's doctor.
Court of Milan, 21/07/2000
The responsibility of the crime of injury in the absence of consent to therapy, even more so if for experimental therapy
He is responsible for the crime of injury referred to in art. 582 of the Criminal Code the doctor who, by prescribing the systematic administration of insulin for anti-abortion purposes, causes the patient to hypoglycemic crises characterized by a state of malaise, suffering and neurological disorders, such as to result in the absolute inability to attend to ordinary occupations for a period of 13 days during hospitalization, on the basis of a therapy applied outside of any protocol accepted by the scientific community and, in any case, in the absence of explicit consent to the therapy by the patient both in terms of experimental therapy and informed consent to therapy already in use. On the other hand, the aforementioned doctor cannot be held responsible for the serious injuries with permanent sequelae that occurred to the patient, consisting in neurological damage resulting from cerebral haemorrhage, since, not being known in the world scientific literature a haemorrhage as a consequence of hypoglycemia, there is no evidence of the existence of the causal link between the hypoglycemic crises, a consequence of the prescribed experimental therapy, and the brain damage itself.
Court of Monza, 07/12/2000
Informed consent in the case of a medical patient - Insufficient information cannot be complained of
In the event that the patient is also a medical profession and therefore certainly more than a "quisque de populo" able to understand the techniques of the operation and to assess the risks and consequences, insufficient information on the consequences of the type of surgery, all the more so if the so-called "informed consent".
Cass. pen., section IV, 27/03/2001, n.731
The surgeon cannot act in case of express dissent
If we must take into account the therapeutic purpose of the doctor's conduct (who does not want to cause a disease of the body or mind, but to overcome it) so that the lawfulness of this activity cannot be justified only in consent (within or beyond the category referred to in 50 of the Italian Criminal Code, but in accordance with the principle enunciated by it), there is no doubt that the surgeon's action on the patient's person against the patient's will, without prejudice to the imminent danger of death or irreparable damage close to it. , which cannot otherwise be overcome, results in an unlawful conduct capable of configuring several types of crime, such as private violence (Article 610 of the Penal Code, violence being inherent in the violation of the contrary will), intentional personal injury (Article 582 of the Penal Code) and, in case of death, manslaughter (art. 584 of the criminal code). In these cases, it is not already the scope and extent of consent to tamper with one's own body in the presence of a therapeutic purpose which is in itself discriminatory (typified or not), but rather the violation of the prohibition of tampering with the human body and, therefore, the conscious violation of the person's right to preserve his or her physical integrity in actuality - as it is now - to no avail in such a situation the importance that this can possibly be improved, and the respect for his determination regarding his to be. It follows the rule according to which the surgeon can not tamper with the physical integrity of the patient, except in danger of life or other irreparable damage otherwise not obvious, when the latter has expressed dissent.
Cass. civ., section III, 23/05/2001, n. 7027
The doctor, apart from some exceptional cases, cannot intervene without the express consent
It should be premised, in general, that medical activity finds its foundation and justification, in the legal system, not so much in the consent of the entitled person (Article 51 of the Criminal Code), as was believed in the past, since this opinion would conflict with the art. 5 of the Italian Civil Code, regarding the prohibition of disposition of one's body, but as it is legitimate itself, aimed at protecting a constitutionally guaranteed good, such as that of health. From the self-legitimacy of medical activity, (...), however, one cannot be convinced that the doctor can, out of certain exceptional cases (...), intervene without the consent, or, a fortiori, despite the dissent of the patient. The need for consent can be seen, in general, from art. 13 of the Constitution which establishes the inviolability of personal freedom, which includes the freedom to safeguard one's health and physical integrity (...). But above all, art. 32 of the Constitution, for which “No one can be subjected to a specific health treatment except by law (which) cannot in any case violate the limits imposed by respect for the human person. In particular, since consent to be “informed” presupposes specific and detailed information, there can be no doubt as to who is required to provide it: “it can only come from the healthcare professional who must perform his professional activity. This consent implies full knowledge of the nature of the medical and / or surgical intervention, its scope and extent, its risks, achievable results and possible negative consequences ".
Cass. pen., section IV, 11/07/2001, n.1572
Without informed consent, medical-surgical treatment is arbitrary with criminal relevance
The lack of consent (appropriately "informed") of the patient or his invalidity for other reasons determines the arbitrariness of the medical-surgical treatment and its criminal relevance, as it is carried out in violation of the personal sphere of the subject and his right to decide whether to allow foreign interventions on your body. (In motivation, the Court specified that the rule of the necessary consent of the person who must undergo medical treatment, the hypotheses of mandatory treatments "ex lege", ie those in which the patient is not in a position to give his consent, are exempt or refuse to lend it and the medical intervention is urgent and cannot be delayed).
Court of Palermo, 25/07/2001
The patient's right to self-determination - willful crime when the doctor intervenes arbitrarily
In conditions that do not require urgency, everyone has the right to self-determine by accessing the choices that they deem best suited to their needs, being able to even decide not to undergo treatment, and in this case the health care professional cannot act. without previously obtaining valid informed consent and must answer for an intentional crime, when it occurs arbitrarily. Consequently, the healthcare professional who operates without the patient having issued an informed consent is responsible for the crime of private violence at least, without prejudice to further liability also pursuant to art. 586 of the Italian Criminal Code, where the intervention has an unfortunate or otherwise harmful outcome for the patient.
Court of Naples, 12/10/2001
The burden of proof of non-consent lies with the patient
The burden of proof of the doctor's failure to fulfill his duty to provide information (informed consent) rests on the patient, who takes legal action to obtain the surgeon's assertion of responsibility.
Cass. pen., section I, 29/05/2002, n.528
The absence of consent and the responsibility of the doctor
Despite the absence of an informed consent of the patient - and provided that there is no express disagreement of the same to the proposed therapeutic treatment - it must be excluded that the doctor is criminally responsible for the injuries to the life or physical and mental intangibility of the patient on whom he has operated in compliance with the leges artis, since the therapeutic activity, being instrumental to the guarantee of the right to health provided for by art. 32 Cast, is authorized and disanimated by the legal system and is therefore parted by an ontologically intrinsic "state of necessity", without it being necessary to refer to the codified causes of justification.
Cass., Section IV, 5/11/2002, n. 1240
In the absence of information, the consent is flawed
In the event that, due to negligence or recklessness, the surgeon fails to adequately inform the patient about the risks he is facing, the consent is vitiated (i.e. invalid as the patient has not been adequately informed).
Court of Brescia, section III, 27/11/2003
Without consent or in the case of vitiated consent, medical-surgical treatment is arbitrary with criminal relevance and civil implications
The lack of the patient's consent or his invalidity renders illegal the behavior of the doctor who is liable both criminally and civilly for all the damages suffered by the patient. In conditions not needed by the urgency, everyone has the right to self-determine by accessing the choices that they deem most suited to their needs, even being able to choose not to undergo treatment, and in this case the healthcare professional cannot act without obtaining a preventive valid informed consent and must answer for an intentional crime when it occurs arbitrarily. Consequently, the healthcare professional who operates without the patient has issued an informed consent is liable - at least - for the crime of private violence, without prejudice to further liability also pursuant to art. 586 of the Criminal Code where the intervention has an unfortunate or otherwise harmful outcome for the patient. (In this case, the consent was given only to the amniocentesis and not to the different "villocentesis" from which the death of the fetus was derived).
Court of Brescia, section III, 31/12/2003
Once the diagnostic phase has been completed, the surgeon's duty arises to inform about any therapeutic treatment and the omitted information entails a contractual liability
If the professional activity of the doctor requires two phases, one, preliminary, diagnostic, aimed at collecting symptomatological data., The other, consequent, therapeutic (and it is in this context that the surgical indication is inserted) is evident that the correct information of the patient is functional to allow him to consciously self-determine himself in the decision-making process of adhering to the proposed therapeutic treatment. It follows that only once the diagnostic phase has been completed does the surgeon have the duty to inform the patient about the nature and possible dangers of the therapeutic (and, where appropriate, operative) intervention. It is therefore understood that the duty to provide information already pertains to the execution phase of the contract, falling within the overall performance due; therefore the responsibility for omitted information, in such cases, is contractual, according to the professional performance, and not pre-contractual. The consequences of this classification are not insignificant because if the information obligation is brought back to the pre-contractual liability, the consequent damage is commensurate with the so-called interest. negative (consisting of both unnecessary expenses incurred in view of the conclusion of the contract and the loss of advantageous opportunities or the possibility of stipulating equally or more advantageous contracts) while if it is configured as contractual liability, the damage extends to the so-called interest. positive and therefore also include the cd. biological damage, such as damage from injury to health. Property whose preservation must be guaranteed by the doctor who, having not acquired the necessary informed consent, fully assumes the risk of failure and complications, predictable or not, subject to the limits set out in art. 1218 cc.
Cass. pen. section VI, 15/04/2004, n. 606
Informed consent and abusiveness
The so-called "informed consent" given by the patient to a complex medical-surgical intervention (in this case, dental implant surgery) cannot be considered valid, if the same has been misled about the quality of the operator, not authorized to exercise the medical profession, regardless of his actual or presumed professional skills. (The Court annulled the appeal sentence by postponement in the part which excluded, as it did not exist, the offense referred to in art.590 of the criminal code and redetermining the penalty for the offense of abusive exercise of a profession, pursuant to art.348 cp).
Court of Venice, section III Civil, 24/06/2004
How to collect consent
The consent must be the result of an interpersonal relationship between the healthcare professionals and the patient, developed on the basis of information that is consistent with the state, including the emotional one, and the level of knowledge of the latter. The compliance of the conduct of the health workers with the obligation to provide adequate information must be assessed not so much on the technical-operative level, but on the nature of the intervention, on the existence of practicable alternatives, even of a non-bloody type, on the risks correlates and on the possible complications of the different types of treatment such as to compromise the overall picture of the patient, marking the transition from the phase of assent to that of consent, that is, the convergence of wills towards a common plan of intent.
Court (Decr.) Modena, 28/06/2004
The informed consent of the support administrator in the event of patient dissent may be authorized by the judge
The support administrator can be authorized by the judge to express informed consent to a necessary and unpostponable surgical intervention on the person of the beneficiary, who refuses it by citing delusional beliefs and motivations, if such intervention is necessary to avoid permanent damage, and the person concerned is unable - due to his pathology (chronic psychosis with acute exacerbation) - to express an autonomous and conscious critical evaluation of the disease and the consequences of refusing to undergo therapeutic treatment.
Court of Reggio Emilia, 20/07/2004
Importance of information in consent
From the peculiar nature of the voluntary health treatment, in order to obtain a valid manifestation of consent on the part of the patient, the need arises for the professional to inform him of the benefits, the methods of intervention, the possible choice between different operating techniques and, finally, of foreseeable post-operative risks. The violation of the duty to inform, in other words, qualifies as damage to physical integrity the results, even if inevitable, of the surgery to which someone has voluntarily undergone without, however, having been informed of the results. And since the patient asserts the contractual responsibility of the doctor, the latter bears the burden of proving that he has fulfilled the obligations arising from the work contract, including the obligation to inform that, deriving from a norm of constitutional significance to protect the primary right of the person, it is autonomous and not ancillary or instrumental.
Cass. civ., section III, 30/07/2004, n.14638
For the acquisition of consent, the duty to inform the efficiency and equipment of the health facility
In the contract for the performance of intellectual work between the surgeon and the patient, the professional, even when the object of his performance is only of means, and not of result, has the duty to inform the patient about the nature of the intervention, about the scope and extent of its results and the possibilities and probabilities of achievable results, both because it would violate, failing that, the duty to behave in good faith in the conduct of negotiations and in the formation of the contract (Article 1337 of the Civil Code), and because this information is indispensable condition for the validity of the consent, which must be aware, to the therapeutic and surgical treatment, without which the intervention would be prevented by the surgeon as much by art. 32 of the Constitution, second paragraph, (according to which no one can be obliged to perform a specific health treatment except by law), as per art. 13 of the Constitution, (which guarantees the inviolability of personal freedom with reference also to the freedom to safeguard one's health and physical integrity), and by art. 33 of the law of 23 December 1978, n. 833 (which excludes the possibility of investigations and medical treatments against the will of the patient, if the patient is able to provide it and the conditions of the state of necessity do not exist; pursuant to art. 54 of the criminal code). The obligation to provide information, which extends to the state of efficiency and the level of equipment of the healthcare facility where the doctor works, concerns only the foreseeable risks and not anomalous outcomes, and extends to various phases of the themselves who assume their own management autonomy, and, in particular, to anesthetic treatments. In any case, in order for the non-fulfillment of the information obligation to give rise to compensation, there must be a causal relationship between the surgical intervention and the worsening of the patient's condition or the onset of new pathologies. (In the present case, the Court of Cassation confirmed the decision on the merits which had rejected the claim of the plaintiff who assumed damages suffered for an inadequate intubation maneuver during a hip arthroplasty surgery, asserting the responsibility of the surgeon due to lack of informed consent in relation to the anesthetic treatment, from which the phonetic damage would have resulted; on this occasion, the Court of Cassation deemed the appeal sentence correct which, confirming the first degree decision, had excluded the existence of causal link between the orotracheal intubation treatment and the dysphonia that had affected the applicant).
Court of Venice section III, 04/10/2004
The information must be complete and detailed
It affects the patient's right to self-determination with regard to his own health, and is consequently required to compensate the existential damage pursuant to art. 2059 of the Italian Civil Code, the health facility which, despite having the inpatient sign the form for informed consent, does not provide adequate information on the risks and any complications related to the surgery, also in relation to the nature of the operation and the level cultural and emotional patient. The burden of proof relating to the contractual fulfillment of the information obligation is incumbent on art. 1218 and 1176 of the Civil Code on the health facility, also in consideration of the fact that, at the time of the facts, the latter was required to keep the patient's personal data pursuant to law 675 of 1996.
App. Naples, 01/02/2005, n. 242
Liability for lack of consent even if the intervention was performed correctly
The health care professional is responsible for the damages deriving from the intervention carried out in the absence of informed consent even if the intervention itself has been carried out correctly.
Court of Milan, 25/02/2005, n. 2331
Importance of accurate information in acquiring consent
In the presence of a declaration signed by the patient, containing all the relevant information and therefore certifying that the information received is adequate, complete, clear and perfectly intelligible by the patient, the burden of proof on the doctor must be considered fulfilled.
Certainly there are no legal limits for the abstract admissibility of the textual evidence aimed at contrasting the circumstances resulting from the form. However, it is up to the judge to judge the relevance of the witness evidence, or its suitability to prove circumstances other than those contained in the document signed by the patient (apart from any subsequent further assessment of the reliability of the witness itself). Well, this Judge [...] believes that the completeness and intelligibility of the statements contained in the form, freely signed by the patient, prove in themselves the fulfillment of the doctor's obligation to provide information. In the specific case, exactly the event foreseen in the declaration of informed consent occurred: [...] decreased sensitivity or alteration of the sensitivity of the mucous membrane of the lips "[...]
According to the judge, signing the form therefore implies that the plaintiff has effectively “understood the information” received and the “appropriate explanations” of the case, confirming his acceptance of the clinical program proposed to him; moreover, this declaration immediately precedes the subscription.
In this case, the Court found that the patient's right to self-determination was not violated on the basis of the form he signed only.
Court of Milan, 29/03/2005, n. 3520
The pre-printed forms in the informed consent
The form, as formulated, is in no way suitable for considering the information burden on the part of doctors to be fulfilled. In fact it is concise, not detailed, and only generically indicates that the patient will be subjected to surgery. It does not indicate at all which intervention it is and, although mention is made of the "benefits, risks, additional or different procedures" that may be necessary in the opinion of the doctor, it is not specified which are the specific risks, or the different possible procedures, therefore, it cannot be considered that the patient, even by simply reading this form, could have effectively understood the procedures and risks associated with the intervention, in order to consciously exercise his right to self-determination in view of the same .
The judge then admitted the test by witnesses and the doctor's hearing; however, given the time that had passed, no one remembered the story exactly, so the Court decided only on the basis of the aforementioned form; since the latter was unsuitable, the Court concluded by declaring the responsibility of the doctor and the hospital company for violation of the patient's right to self-determination.
Court of Milan, 29/03/2005
Lack of consent and intervention carried out correctly
The consolidated principle in jurisprudence according to which the doctor can no longer intervene on the patient without having first received his consent does not have as its object a purely formal and bureaucratic act, but is the essential condition for transforming an illicit act (the violation of psycho- physical) in a lawful act. From this it follows that the failure to request effective informed consent must be considered as an independent source of responsibility for doctors for infringement of the constitutionally protected right of self-determination, whose injury gives rise to non-pecuniary damage. However, in the hypothesis in which the outcome of the intervention has not been given the patient's informed consent (or in which such consent has been given for an intervention performed in a manner other than those envisaged), in the absence of medical fault, does not result in any harm to the patient's health, but rather an improvement in his psycho-physical conditions, the infringement of the right to self-determination does indeed produce non-pecuniary damage, albeit ontologically negligible or in any case of no appreciable economic entity.
Court of Monza, 29/08/2005, n. 2244
Acquisition of consent from the doctor who performs the service
The formation of (informed) consent presupposes specific information on what is the subject of it, which can only come from the same healthcare professional who is required to perform the professional service and, to be valid and effective, must be expressed before the healthcare service is carried out; indeed, in the context of surgical interventions, the duty of information concerns the scope of the intervention, the inevitable difficulties, the achievable effects and the possible risks, so as to put the patient in a position to decide on whether to proceed or to omit it ; therefore, there is the responsibility of the healthcare professional for violation of the obligation to inform and the same is liable for the harmful consequences that arise for the patient.
Court of Appeal Rome, 12/01/2006
Complete and detailed information for the acquisition of consent even if the patient is a doctor
The need for the professional to inform the patient correctly and completely, especially with regard to the benefits, possible drawbacks and risks of the intervention, does not disappear simply because, in the case in question, the patient is also surgeon, since the existence of effective and correct information must be concretely verified, with reference to the specific nature of the intervention and the extent of the achievable results, without being able to detect, for these purposes, the (generic) professional title obtained from the patient, provided that it does not appear that to that title also correspond a specialization and an effective professional experience in the field object of the intervention (in this case, it appears instead that P. is a specialist in child neuropsychiatry).
Court of Genoa section II, 12/05/2006
Information for consent with forms
With regard to therapeutic services, it is believed that informed consent should not be confused with documented consent and if the signing of the relative form does not constitute proof of informed consent, even the absence of the signed pre-printed does not mean that the health service was lacking by the visual angle of the right to information. In the case under examination, for the type of intervention, no particular forms were required to confirm the transmission from the doctors to the patient of the necessary and sufficient information to allow her to choose the therapeutic act with a minimum knowledge of the facts: so that the relative demonstration can be also provided through oral tests.
Civil Court, section III, 14/03/2006, n. 5444
Each healthcare professional must acquire consent and its absence is a punishable offense regardless of the correct execution of the treatment
The obligation of informed consent is the responsibility of the healthcare professional who, once requested by the patient to carry out a specific treatment, decides in full autonomy according to the lex artis to accept the request and to proceed with it, noting that the request of the patient comes from a prescription from another healthcare provider.
Failure to obtain informed consent is an obligation whose violation constitutes in itself a cause of responsibility for the doctor and it is completely indifferent whether the treatment has been performed correctly or not.
In fact, the correctness or otherwise of the processing does not assume any importance for the purposes of the existence of the offense due to the violation of informed consent, as it is completely indifferent to the configuration of the harmful omissive conduct and the injustice of the fact, which exists for the simple reason that the patient, due to the lack of information, has not been put in a position to consent to medical treatment with a willingness aware of its implications, with the consequence that, therefore, such treatment cannot be said to have taken place after providing valid consent .
Court of Appeal Rome, section II, 22/06/2006
Liability for lack of informed consent
In terms of medical liability, for the purposes of the existence of the offense due to violation of informed consent, or for violation of the obligation to inform the patient about everything concerning the intervention to be performed, including the risks associated with the possible complications of the next phase to the operation (in this case it was a surgical operation aimed at eliminating the stenosis of the left carotid, followed by various complications, including considerable dysphonia), is irrelevant, where there is a causal link between the operation and the production of 'harmful event, the existence of profiles of inexperience, imprudence or negligence. The hypothesis (such as the one that is recognized in the case in question) of surgery performed in the absence of such consent involves a violation both of the Constitution, in Articles 32, paragraph 2, regarding freedom in subjecting to medical treatment, and 13, where the inviolability of personal freedom is guaranteed with reference to the freedom to safeguard one's health and physical integrity, as per art. 22 of Law no. 833/1978, which excludes the possibility of performing health interventions against the will of the patient if he is able to provide it.
Civil Cassation, Section III, 19/10/2006, n. 22390
For the diagnostic-therapeutic treatment, consent is required after adequate and detailed information
The conduct of correct information on health treatment, especially when it is at high risk, [...] does not belong to a prodromal moment external to the contract, but is conducted within the medical-health contact and is a structural element internal to the legal relationship which determines the consent to health treatment. When the intervention was carried out (6 September 1988), Law no. 30 July 1998 was not in force. 281, which, in compliance with European directives, recognizes the patient, as a user of the health service, the fundamental and inalienable right to adequate information on health services, and therefore to informed consent. But this rule is not innovative with respect to the law existing at the time regarding health guarantees, operating in this sense the guarantee of the right to health, pursuant to art. 32 of the Constitution, as a parameter of conformation of the contractual relationships between doctor and patient or between patient and health facility.
It means that if the consent to a service or surgical act must be given, the content of the consent must necessarily be enriched by the prior correct information on the quality and safety of the health service and on the adequate prior information on the operator and post-operative risks, also in relation the efficiency of the host healthcare facility.
Court of Monza, Section I, 25/01/2007
Responsibility for lack of informed consent regardless of the success of the treatment
The responsibility of the healthcare professional and, consequently, of the structure for which he acts, for violation of the obligation of informed consent derives from the conduct of an omission of the fulfillment of the obligation to inform about the foreseeable consequences of the treatment to which the patient is subjected and from the subsequent verification, as a consequence of the treatment itself, of an aggravation of the patient's health conditions.
For the purposes of configuring this responsibility, which is considered to have a contractual nature (for all Cass. 29.3.1978 n. 11321), it appears completely indifferent whether the treatment has been carried out correctly or not, according to the orientation of the SC, lastly reaffirmed with sentence 14.3.2006 n. 5444.
This orientation appears to be fully acceptable. Medical responsibility, in the hypothesis of incorrect execution, operates on a different level, compared to the responsibility in the hypothesis of absence of informed consent. In the present case, the actor was suffering from an inguinal hernia which does not necessarily have to be treated surgically. If the patient had been informed of the foreseeable risks of the surgery, such as residual painful symptoms, caused by trivial movements and which can last for several hours after the appearance, he could also decide not to undergo the surgery.
Court of Appeal Genoa, 07/02/2007
Value of informed consent to accept or not the doctor's decision
The verification of the existence of informed consent only detects whether the intervention involves risks that the patient may decide to face or not, but when it comes to choosing how to set up an intervention and which type to perform, evaluating the risks connected to one or to the other situation, the doctor is the only one required to decide.
Court of Monza, 07/03/2007
Compensation for lack of consent
The violation of the obligation to inform the patient about the nature and extent of the intervention, the risks it could entail, the achievable results, the potential negative consequences, the various procedures and any alternative therapies, is not compensable ipso iure, but only if there is a causal link between surgery and worsening of the patient's condition.
Civil Cassation Section III, 23/02/2007, n. 4211
Refusal of medical treatment. If the patient is unconscious, the duty of care prevails
Dissent, like consent, must be unequivocal, current, effective and aware; consequently, in the light of these elements and of a dissent expressed before the state of unconsciousness resulting from the anesthesia, it is legitimate for health professionals to ask themselves - later - whether the patient wants to be transfused or not, if the health conditions of the same worsen making it life threatening.
In the various situations that can be configured in the current debate on the dramatic theme of death, situations to be kept very distinct in order to avoid misleading overlaps, the issue in question concerns precisely the refusal to treatment, but not in the sense of ruling on the legitimacy of the right to refuse in the case of Jehovah's Witnesses blood transfusions even if this determines death but, more limitedly, to ascertain the legitimacy of the behavior of the doctors who practiced the transfusion in the reasonable belief that the patient's original refusal was no longer valid and operative.
Court of Appeal Rome, section III, 27/03/2007
Importance of signing the consent form
For informed consent, particular importance must be attributed to the form signed by the patient.
The information of the type of intervention by the surgeon (even if correctly modified at the time of execution), resulting from the information and consent form, freely signed by the patient, implied, in the specific case, the non-opposability witness evidence against said writing.
Civil Court Paola, 17/04/2007, n. 462
If informed consent is lacking, the patient must be compensated
Compensation for damage can be recognized solely for the non-fulfillment of the obligation of exact information that the healthcare professional is required to fulfill. This non-fulfillment gives rise to the right to compensation for damage resulting from this specific cause which must be distinguished from compensation for damage related to the type of intervention carried out. The patient is therefore entitled to compensation for the damage for the simple fact that an operation was carried out without making her aware of the possible negative consequences.
Court of Novara, 05/06/2007
Violation of informed consent for different or additional surgical therapies
The responsibility of the health workers operating in the hospital [PO] for violation of the obligation of informed consent is realized by the very fact of the lack of information about the foreseeable consequences of the treatment to which the patient is subjected, and therefore, even more so for the execution of surgical treatments other than or additional to those for which the information has been provided and the consent given: whenever, in causal connection with the unauthorized treatment, an aggravation of the initial health conditions of the patient.
This implies that, for the purposes of ascertaining responsibility for non-fulfillment of the information obligation, it is completely indifferent whether the treatment not subject to consent has been technically carried out correctly.
Court of Forlì, section dist. Cesena, 21/06/2007, no.209
A pre-printed, generic form is no indication of informed consent
Even if the surgery has been performed correctly, there is the (contractual) responsibility of the health workers in the absence of informed consent, as medical treatment given without consent violates Articles. 32 and 13 of the Constitution.
Without prejudice to the fact that the burden of proof of having provided valid informed consent lies with the respondents, the Court clarifies that the signing of a pre-printed and generic form, without specific references to the specific case, does not even constitute an indication in this regard; the sentence is also interesting from the point of view of the damage: in line with the prevailing doctrinal thought and constant jurisprudence, it is stated that, in the absence of valid informed consent, the entire damage suffered by the patient and not only the damage deriving from the violation of the right to self-determination.
Cass. Civ., Section III, 06/08/2007, n. 17157
The importance of signing informed consent
The exclusion of the doctor's responsibility can be based, as in the present case, on the signature affixed by the patient to the medical record, in which he formally declared to accept the anesthesia, rather than on the testimonial results and the technical advice of the office. intervention and prescribed therapy.
Court of Monza section I, 09/10/2007
Importance in the consent of detailed information
Where it was believed that the patient's thesis was credited, that she had not been adequately informed about all the risks and complications of the intervention, the pathology from which she was affected was of such gravity that it could not lead to not undergoing the planned intervention. The risks associated with the treatment were, however, much lower than the presumably fatal outcome in case of non-intervention. Moreover, the patient had signed the informed consent form which described the intervention to which she would be subjected: radical hysterectomy, ie removal of the uterus. The nature of the intervention is immediately understood by any woman, even as regards the consequences. In the present case, it must be considered that the lady was fully aware of the nature of the intervention, of the risks and complications, also due to her qualification as a professional nurse, who works in a hospital, as an operating theater operator, which entails medical knowledge such as to allow her to evaluate, even better, the meaning of the intervention.
Criminal Court of Rome, 17/10/2007, n. 2049
When removing the respirator is not a crime
A doctor who, with the patient's consent, interrupts the assisted ventilation therapy, while administering sedative therapy, is not punishable.
The judge observed that the conduct carried out by the doctor falls within the case of the murder of the consenting person provided for by article 579 of the Criminal Code, but that the accused is not punishable since the continuation of the ventilation was refused by the patient who had thus exercised the right of self-determination with respect to health treatments enshrined in Article 32 of the Constitution.
The motivation of the sentence carefully examines the question of the validity of the desire expressed by the patient not to suffer further the continuation of the therapy in progress and it is emphasized that the patient's dissent had all the requisites prescribed as it was manifested with a "personal, authentic, informed, real and current ". In the presence of a decided and contrary will of the patient, it is therefore not permissible to continue with the administration of a medical therapy, including life support, such as assisted ventilation.
Cass. Civ., Section III, 28/11/2007, n. 24742
Liability for lack of consent - Liability of the nursing home
The surgeon is liable for the damage suffered by the patient if he has not informed him of the risks even when the intervention is absolutely necessary.
Furthermore, the nursing home is responsible in the event that the surgeon only relied on the private company for the intervention even if the reality was the patient's trusted doctor.
In fact, the relationship that is established between the patient and the nursing home (or hospital institution) has its source in an atypical contract for compensatory services with protective effects towards the third party, from which, in the face of the obligation to pay the fee (which may well be fulfilled by the patient, by the insurer, by the national health service or by another body), the nursing home (or body), alongside those of the "lato sensu" type of hotels, are subject to provision of auxiliary medical staff, paramedical staff and the provision of all necessary equipment, also in view of any complications or emergencies. It follows that the responsibility of the nursing home (or institution) towards the patient has a contractual nature and can result, pursuant to art. 1218 of the civil code, the non-fulfillment of the obligations directly against him, as well as, pursuant to art. 1228 of the civil code, the non-fulfillment of the medical-professional service carried out directly by the healthcare professional, as his necessary auxiliary even in the absence of an employment relationship, in any case there is a connection between the service performed by him and his company organization, not detecting on the contrary, in this regard, the circumstance that the healthcare professional is also “trusted” by the same patient or in any case chosen by the same patient (Cass. n. 13066/2004, Cass. n. 1698/2006 and Cass. 13953/2007).
Cassation 2007, number 21748
Right to self-determination and right to life: assets that can be protected in a situation of vegetative coma
The examination of the specific case makes it possible to easily identify which rights are involved, of primary constitutional importance. A young woman who has been in a permanent vegetative state for over fifteen years and is kept alive by means of a nasogastric tube that provides her hydration and nutrition, having no ability to relate to the outside world or any physical or psychological autonomy. His condition is not comparable on a scientific and legal level to brain death due to the preservation of cardiac, circulatory and ventilation activity but his maintenance in life is guaranteed exclusively by hydration and artificial nutrition, in the absence of which death would occur in very few days. The father, who became a guardian after the declaration of interdiction of the injured person, requests an order to stop forced feeding, believing that he fully expresses the will of his daughter who would not have chosen, if she had had the possibility, to continue to survive in the present condition without any awareness of the continuation of existence.
The Court identifies in the - right to self-determination - and in the - right to life - the two subjective situations in potential conflict and establishes some key principles of the final decision that should be remembered. The selection of the interests at stake has led to establish that in the event that a patient is in an irreversible coma condition, he cannot in any way relate to the outside world and is fed and hydrated by means of a nasogastric tube, the judge, at the request of the guardian and in contradiction with the special curator, can authorize the deactivation of the health facility only when the vegetative state is, on the basis of a rigorous clinical evaluation, irreversible and there is no possibility of recovery or even minimal recovery of perception of the outside world according to internationally recognized scientific standards and only if this request is really expressive, based on clear, univocal and convincing evidence of the patient's idea of the dignity of life and its minimum livability level, to be inferred from his previous statements or from the personality, from the reference values, from the overall style d i life adopted until the loss of capacity.
According to Vincenzo Carbone, president of the Supreme Court, "informed consent has as its correlation the faculty not only to choose between the different possibilities of medical treatment, but also to possibly refuse therapy and to consciously decide to interrupt it, at all stages of life, even in the terminal one. In allowing medical treatment or in disagreeing with the continuation of the same on the incapable person, the representation of the guardian is subject to a double order of constraints: he must, first of all, act in the exclusive interest of the incapable, in the search for the best interest- must decide not in the place of the incapable nor for the incapable, but with the incapable: therefore reconstructing the presumed will of the unconscious patient, already an adult, before falling into this state, taking into account the wishes expressed by him before the loss of conscience, or by inferring that will from his personality, his lifestyle, his inclinations, his reference values and his ethical, religious, cultural and philosophical convictions ".
Court of Milan, civil section V, 4/03/2008 no. 2847
The criteria for calculating compensation for damage, following lack of informed consent
The compensation request must be rejected in the event that only the proof of the infringement of one's right to self-determination has been provided, in the absence of allegation or demonstration of the damage-compensable consequence, nor in relation to subjective moral damage, understood as a worry of mind interior, nor in relation to the so-called existential damage, understood as an external compromise of one's life habits.
Furthermore, since such damages are never in re ipsa, and, in the present case, are not accompanied by the damage to the good health, but, on the contrary, an improvement in the patient's health conditions is even proven, neither is a any evidence for presumptions.
The burden of attaching specific sufferings or worsening of their daily living conditions immediately after noticing the execution of the unauthorized therapeutic treatment falls on the applicant
Court of Benevento, 10/03/2008
The signed consent can be classified as a private agreement that gives full proof of the origin and content
The contestation of non-exhaustiveness of the signed informed consent cannot be considered founded even in the event that the health facility has subsequently replaced the form with a more detailed one, this when the patient has been made orally informed of particular events that could have occurred following the 'intervention.
In any case, it appeared from the signed consent form - which can be classified as a private agreement that makes full proof of the origin and content - that the event that actually took place could occur.
N ° 11335 Cassation of 14 March 2008
Pre-printed and generic informed consent and doctor's professional responsibility
The informed consent given by the patient on pre-printed and generic forms does not save the doctor from his responsibilities. However, if the patient dies from a wrong intervention, the health care provider risks a conviction for manslaughter, but not for manslaughter.
In fact, from the relief attributed to the patient's consent, the consequence cannot be derived that from the intervention carried out in the absence of consent or with consent given in an invalid way it is always possible to profile the responsibility by way of intentional homicide, in the event of a lethal outcome, or by way of willful injury.
This in relation to the subjective element of these crimes, which is normally not configurable with respect to the doctor's activity.
In other words, in relation to the specific case, although it is admitted that the consent has been given in a coarse and unsatisfactory manner, with forms that are beyond generic and not able to demonstrate the awareness of the consenting recipient, it does not appear to be shared, online in principle, the assumption that would like to frame the facts in the context of the crimes of intentional injury and manslaughter: consent that may be invalid because it was not knowingly given cannot in itself lead to the charge for willful misconduct.
Criminal Cassation, 20/03/2008, n. 12387
The limits of blood sampling without consent
For the purposes of evidential usability of the results of a blood sample, the examination must have been performed as part of an emergency medical protocol. In fact, it has been specified that, to ascertain the offense of driving under the influence of alcohol, the results of the blood sampling that has been carried out can be used - according to the criteria and ordinary first aid health protocols, during hospitalization at a public hospital structure following a road accident, being, in this case, evidence acquired through medical documentation, with consequent irrelevance, for these purposes, of the lack of consent.
Court of Modena, 13/05/2008
The refusal of invasive therapies, even life-saving, can be expressed by the support administrator who supports the patient
On the basis of art. 2, 13 and 33 of the Constitution, in favor of the right to self-determination of a person to respect the natural biological path towards the death event, the tutelary judge of Modena authorized the support administrator to deny the health professionals the necessary consent to practicing forced ventilation on the patient, while asking the doctors themselves for the most effective palliative care to eliminate any suffering to the person.
Cassation section IV, 01/08/2008, n. 32423
The contents of the communication for the acquisition of informed consent in medicine and cosmetic surgery for a better evaluation of the cost-benefit ratio of the treatment
Informed consent obviously cannot be limited to the communication of the name of the product that will be administered or generic information, but must invest, especially in the case of treatments that are not aimed at combating a pathology, but for exclusively aesthetic purposes that are therefore exhausted. in unnecessary, if not superfluous, treatments of any negative effects of the administration so that the patient is allowed to adequately evaluate the cost-benefit ratio of the treatment and to take into account the existence and severity of the hypothetical consequences.
Civil Cassation section III, 15/09/2008, n. 23676
Refusal of medical treatment only if expressed and current
In the event of serious and immediate danger to the patient's life, the patient's dissent must be the subject of an express, equivocal, current and informed manifestation.
However, this does not mean that, in all cases in which the patient with strong ethical-religious convictions (e.g. Jehovah's Witnesses) is in a state of unconsciousness, he must therefore undergo therapeutic treatment contrary to his faith. But it is undeniable, in this case, the need that, to express the dissent to the treatment (in this case transfusion) it is the patient himself who brings with him an articulated, punctual, express declaration from which it emerges equivocally at will to prevent the treatment (specifically the transfusion) even in the event of life threatening, or a different subject indicated by himself as the ad acta representative who, having demonstrated the existence of his representative power in part here, confirms this dissent to the outcome of the received information from the health professionals
Criminal Cassation section IV, 30/09/2008, n. 37077
Value of informed consent and the physician's criminal liability
Even if the medical-surgical activity to be legitimate requires the informed consent of the patient, it is to be excluded that from the intervention carried out without consent or with a consent
lent in an invalid way can lead to the responsibility of the doctor by way of voluntary injury or, in the event of death, of manslaughter. This is because the healthcare professional who, except for anomalous and distorted situations (in which the configurability of such crimes could be admitted: for example, in cases where death results from a mutilation procured in the absence of any need or impairment inflicted, with mortal, for exclusively scientific purposes), is found to act, perhaps erroneously, but still with a curative purpose, which is conceptually incompatible with the willfulness of injuries.
In fact, it is not possible to hypothesize the lack of informed consent as an element of fault because the obligation to acquire informed consent does not integrate a precautionary rule whose non-compliance affects guilt.
Criminal Cassation section V, 08/10/2008, n. 38345
Demolition intervention in the absence of consent validly given by the patient, informed only of the laparoscopy
Since the resolution of the question whether or not it has criminal relevance is preliminary, and, in the case of an affirmative answer, what criminal hypothesis constitutes the conduct of the healthcare professional who, in the absence of the patient's informed consent, subjects the patient to a specific surgical treatment in the respect for the rules of the art and with auspicious outcome, recognizing a non-unanimous internal orientation and different positions in the doctrine, summarizing the different profiles at stake in an excellent synthesis, referred the cause to the United Sections in order to resolve the conflict: if the intervention is a correct and obligatory choice, the question is whether or not it has criminal relevance, and, if so, what criminal hypothesis constitutes, the conduct of the healthcare professional who, in the absence of informed consent, subjects the patient to a specific surgical treatment in the respect for the rules of art and with an auspicious outcome.
Cass. pen., section V, 28/10/2008, no. 40252
The absence of informed consent is not sufficient to determine the doctor's sentence
The doctor should not be sentenced automatically for voluntary injuries for an operation carried out without the patient's consent.
In fact, it should be borne in mind that there are no criminal provisions that expressly sanction the conduct of the doctor who has not observed the obligation to acquire informed consent, provided for by extensive legislation as well as by the medical code of ethics.
In particular, the lack of consent cannot lead to the identification of intentional malice in the conduct of the doctor, not taking into account, in this perspective, the therapeutic purpose or the correct execution of the intervention. In fact, it should be borne in mind that therapeutic conduct, even if harmful and without consent, is not typical and in any case it is not malicious.
Cassation United Civil Sections 11/11/2008 n.26973
Informed consent configured as a structural element of protection contracts
The basis of Informed Consent is configured as a structural element of protection contracts, such as those that are concluded in the medical sector.
4.1. The constitutionally oriented interpretation of article 2059 of the Italian Civil Code now makes it possible to affirm that compensation for non-pecuniary damage is also given in the matter of contractual liability.
From the principle of the necessary recognition, for the inviolable rights of the person, of the minimum protection constituted by compensation, it follows that the infringement of the inviolable rights of the person who caused a non-pecuniary damage entails the obligation to compensate such damage, whatever the source of liability, contractual or extra-contractual.
If the non-fulfillment of the obligation determines, in addition to the violation of the obligations of economic significance assumed with the contract, also the infringement of an inviolable right of the person of the creditor, the protection of the non-pecuniary damage can be paid in the contractual liability action , without resorting to the expedient of the accumulation of shares.
4.3. First of all, the cd. protection contracts, such as those that are concluded in the health sector. In these, the interests to be realized pertain to the sphere of health in the broad sense, so that the debtor's default is likely to damage the person's inviolable rights, causing non-pecuniary prejudices.
In this sense, a conspicuous jurisprudence of this Court is expressed, which has been able to place the responsibility of the doctor and the health facility within the scope of contractual liability (sentence no. 589/1999 and subsequent compliant, which, as regards the structure, have applied the principle of responsibility from qualified social contact), and to recognize protection, in addition to the patient, to third parties, to whom the protective effects of the contract extend, and therefore, in addition to the pregnant woman, to the unborn child, subject to birth (sent . no. 11503/1003; no. 588 1/2000); and to the father, in the case of failure to diagnose fetal malformations and consequent unwanted birth (sentence no. 6735/2002; no. 14488/2004; no. 20320/2005).
The aforementioned subjects, according to the cases, had suffered the violation of the inviolable right to health (article 32 of the Constitution, paragraph 1), in terms of both physical and psychological biological damage (sentence no. 1511/2007); of the inviolable right to self-determination (article 32, paragraph 2 and article 13 of the Constitution), as in the case of the pregnant woman who, due to a diagnostic error, was not placed in a position to decide whether to terminate the pregnancy (sentence no. 6735/2002 and compliant cited), and in cases of violation of the obligation of informed consent (sentence no. 544/2006); of the rights of the family (articles 2, 29 and 30 of the Constitution), as in the case referred to in sentences no. 6735/2002 and compliant cited.
Criminal Cassation United Sections, 18/12/2008 - 21/01/2009, n. 2437
The absence of consent, in the absence of explicit refusal, when the intervention has produced a benefit for the patient's health does not incur criminal liability for the doctor
Where the doctor subjects the patient to a surgical treatment other than that in relation to which informed consent was given, and this intervention, performed in compliance with the protocols and the legis artis, is concluded with a favorable outcome, in the sense that the intervention itself an appreciable improvement in health conditions has resulted, also with reference to any appreciable alternatives, and without there being any contrary indications from the patient himself, this conduct is devoid of criminal relevance, both from the point of view of personal injury and of private violence.
That of the doctor is a profession of "public necessity" and it is for this reason that this activity does not need, to legitimize itself, a standardized discrimination such as the patient's consent to treatment that excludes the unlawfulness of conduct instrumental to medical treatment, even if implemented according to the rules.
Lombardy Tar sect. III sentence n. 214/09
Assistance also due to those who want to stop treatment
The Administration's assertions that the National Health Service is not obliged to take care of a patient who a priori refuses the care necessary to keep him alive and that the medical staff could not give effect to the will to refuse treatment, under penalty of violation of their service obligations, do not appear to comply with the principles governing the matter. The constitutional right to refuse treatment, as described by the Supreme Court, is a right of absolute freedom, the duty of respect for which is imposed erga omnes, towards anyone who maintains the care relationship with the patient, no matter if inside a public or private health facility. The manifestation of this conscious refusal therefore makes it necessary to suspend therapeutic means whose use does not give any hope of leaving the vegetative state in which the patient finds herself and does not correspond with the method of values and the vision of dignified life that is proper to the subject. . If the patient decides to refuse treatment (if unable, through a legal representative duly authorized by the Tutelary Judge), this last manifestation of refusal would immediately invalidate the legal title of legitimacy of the medical treatment (or informed consent), an essential prerequisite the lawfulness of the medical treatment itself, resulting in the legal obligation (even before professional or ethical) of the doctor to interrupt the administration of unwanted therapeutic materials. As the Supreme Court has specified, this legal obligation exists even in the case of life-sustaining treatment whose refusal leads to death, since this hypothesis does not constitute, according to our legal system, a form of euthanasia (by which only the behavior must be understood etiologically intended to shorten life and positively cause death) but rather the unquestionable choice of the patient to have the disease follow its natural course until the inexorable exitus. Refusing hospitalization, due in principle by the NHS to anyone suffering from medical diseases, only for the fact that the patient has announced his intention to avail himself of the right to interrupt treatment, means in fact unduly limiting this right. . In fact, admission to the public health facility cannot be conditioned on the patient's renunciation of exercising a fundamental right. Nor can the refusal opposed by the Administration to the request be justified on the basis of reasons relating to conscientious objection.
Court of Milan section V, 09/02/2009
Unjust modification of the agreed intervention
The Court of Milan affirmed the responsibility of the doctor who had submitted a patient to a necessary but not urgent intervention without having clear knowledge of the situation; it was ascertained, in the course of the case, that the (presumed) prospect of the intervention actually performed as an alternative to the one for which the patient signed informed consent, was in reality evaluated only during the treatment, when the woman was already anesthetized.
It was believed that the doctor had changed - unjustifiably - an agreed choice, carrying out surgical actions much more invasive in terms of execution and consequences without the authorization of the interested party.
According to the Court this would constitute an undeniable and autonomous title of non-fulfillment with consequent infringement of the right of self-determination of the productive patient, in the specific case, of consequences on the psychophysical integrity for which the author must answer.
Cass. pen., section IV, 25/09/2009, n.37875
The lack of informed consent does not determine the automatic responsibility of the doctor
The obligation to acquire the patient's informed consent is not only not required to take place strictly in writing, but it does not even constitute a precautionary rule and therefore its non-compliance by the doctor cannot constitute, if the intervention has caused of the injuries, an element to automatically affirm the responsibility for fault of the latter, unless the failure to solicit consent prevented him from acquiring the necessary knowledge of the patient's condition and acquiring a complete medical history.
Civil Cassation - Section III, sent. n. 20806 of 29.09.2009
Informed consent is a contractual obligation of the doctor
Informed consent, an expression of the very personal right, of constitutional relevance, to therapeutic self-determination, is a contractual obligation of the doctor because it is functional to the correct fulfillment of the professional service, while being autonomous from it.
In the case, the judges of the first instance ascertained that the doctor had guaranteed the patient the positive outcome of the cataract surgery - so much so that the judges themselves had held that the obligation assumed had been a result - not only because of routine but also because the patient was in good health, he was sixty-six and his eyes were healthy.
Criminal Cassation - Section IV, Sent. n. 48322 of 17.12.2009
Dentistry and the absence of informed consent
A dentist was sent for trial to answer for the crime referred to in Articles 590, 51 and 55 of the Criminal Code for causing serious injuries consisting in the demolition of the four upper incisors, with consequent permanent weakening of the chewing function.
More precisely - according to the prosecution - a therapeutic and aesthetic intervention was performed demolishing, rather than conservative and this in the absence of an express consent and therefore negligently exceeding in the exercise of his right of activity as a dentist.
The Court of Cassation, confirming the acquittal, stated that the conduct of the doctor who subjects the patient to a surgical treatment other than that in relation to which consent was given does not integrate the crime of personal injury or that of private violence informed, in the event that the intervention, carried out in compliance with the protocols and the leges artis, has concluded with an auspicious outcome, since it has resulted in an appreciable improvement in health conditions, also with reference to any conceivable alternatives and without were indications to the contrary by the same.
Civil Cassation Section III 30/1/2010, n. 2468
No HIV test without informed consent
The law. 5 June 1990, n. 135, art. 5, paragraph 3, according to which no one can be subjected to the anti-HIV test without his consent, except for reasons of clinical necessity, in his interest must be interpreted in the light of art. 32 of the Constitution, paragraph 2, in the sense that, even in cases of clinical necessity, the patient must be informed of the treatment to which he wishes to undergo, and has the right to give or deny his consent, in all cases in which is able to decide freely and consciously.
Consent could be disregarded only in cases of objective and undelayable urgency of medical treatment, or for specific needs of public interest (risks of contagion for third parties, or other).
The principle was affirmed by the Supreme Court in a trial undertaken by a patient to obtain compensation for damages in the amount of one billion, as, following a hospitalization for a severe fever attack with a diagnosis of leukopenia, he had been subjected to anti -HIV without having been asked for consent.
The subject of the judgment was also the management of medical records and sensitive data.
Civil Cassation Section III 02/02/2010, n.2354
The obligation to inform the patient is not subject to discretionary assessments
The obligation to fully inform the patient, prescribed by the code of medical ethics, albeit with due caution, is not subject to any discretionary evaluation and therefore includes all the diagnostic and prognostic aspects of the patient's state of health and therefore also the lesser risks. probable, provided they are not completely anomalous, in order to allow him to understand not only his current state, but also any diseases that may develop, the percentages of auspicious and inauspicious outcome of the same, as well as the diagnostic program to follow the evolution of conditions of the patient and the indication of the specialized structures where to carry it out, or of expert specialists to formulate it, even if for this purpose the patient must leave the place where he is being treated.
The obligation has legal significance because it integrates the content of the contract and qualifies the professional's diligence in carrying out the service. The violation of it can lead to the violation of fundamental and inviolable rights (such as the right to express one's personality, personal freedom, health - articles 2, 13 and 32 of the Constitution - the right to life, to respect for private life and family, to the formation of the family: articles 2, 8 and 12 European Convention on Human Rights).
Civil Cassation Section III 09/02/2010, n.2847
Proof of consent must be given by the doctor
In the judgment of liability, it was stated in defense of the doctor, that the patient's consent would be inherent to a phase that precedes the contract for the professional work and would be in the hypothesis of pre-contractual liability governed by the rule (more favorable to the health care professional) according to which the proof of the illicit fact (failure to obtain consent) must be given by the patient.
On the contrary, the Court of Cassation highlighted, rejecting the exception, that the intervention of the doctor, even if only for a diagnostic function, however, gives rise to the establishment of a contractual relationship.
It follows that, once the diagnosis has been made in execution of the contract, the illustration to the patient of the consequences (certain or uncertain, as long as they are not completely anomalous) of the therapy or intervention that the doctor considers necessary or appropriate in order to obtain the necessary consent to the execution of the therapeutic service, constitutes an obligation whose fulfillment must be proven by the party that the other claims to be in default, and therefore by the doctor in the face of the complaint formulated by the patient.
Civil Cassation Section III 11/02/2010, n.3075
Professional performance in favor of a minor without the consent of the custodial parent can be sanctioned
A psychologist judicially challenged the resolution of the Council of the Order of Psychologists with which the sanction of the warning for violation of art. 31 of the code of ethics having submitted to psychological observation a minor of about five years, natural daughter recognized by the parents, on behalf of the father of which he was Technical Consultant of the Party [CTP] in the dispute before the Juvenile Court with the mother and without the consent of her, custodian of the same.
The Court of Cassation rejected the appeal, confirming the previous judgment and emphasizing the principle - referred to in the aforementioned Article 31 of the code of ethics - whereby professional services to minors or disabled persons are generally subject to the consent of those who exercise the same parental responsibility or guardianship.
Court of Auditors Sicily of 26 April 2010 n. 828
Medical act - Without consent damage to the tax authorities
A doctor cannot intervene on the patient without having received informed consent as an unavoidable prerequisite for a correct exercise of medical activity.
Without informed consent, the doctor neglects those precautions that constitute the minimum standard of diligence required by adopting a conduct characterized by gross negligence and, as such, punishable by the accounting judiciary.
In the specific case, lack of information about the nature, extent and consequences of the surgery he had undergone was given by the doctor who had compiled the medical record, while the surgeon who then proceeded with the surgery had not proceeded to make sure that the patient had revealed valid informed consent.
Criminal Cassation Section IV filed on June 8, 2010 n. 21799
Without consent, if the outcome is bad there is malice
In the absence of informed consent, in the event of an unfortunate intervention, liability could be discussed for voluntary injury or, in the event of death, for intentional homicide in the presence of absolutely anomalous and distorted behavior of the doctor and in any case dissonant with respect to the curative purpose that must characterize their own therapeutic approach.
United Sections Cassation sentence 2437 of 18 December 2008: the conduct of the doctor who subjects the patient to a surgical treatment other than that in relation to which informed consent was given does not integrate the crime of personal injury or that of private violence, in the case in which the intervention, carried out in compliance with the protocols and the leges artis, ended with an auspicious outcome.
But in the case of the aforementioned sentence, it was an intervention with an outcome that was harmful to the patient's health.
Cassation Section III of 2 July 2010 n. 15698
The doctor fails to give his consent unless he gives complete and exhaustive information
The doctor fails to comply with his obligation to provide informed consent if he does not provide the patient, in an exhaustive and complete way, with all the scientifically possible information regarding the therapies he intends to practice and the surgery he intends to perform, with the relative modalities. Therefore, the healthcare professional who does not inform the patient of changes in the operating program on a surgical intervention must be sentenced to compensation for damage, even where the previously agreed technique remains unchanged.
Cassation Civil Section III sentence 9705 of 6 October 1997: for a valid informed consent it is necessary that the professional inform the patient of the benefits, the modalities of the intervention, of the possible choices between different operating techniques and, finally, of the foreseeable risks during the operation, but this does not mean that he should go into the details of the chosen technique and, therefore, inform the patient of changes in the operative plan of the surgical program, without prejudice to the agreed technique.
Court of Cassation section 3 civil of 17 February 2011 n. 3847
Lack of information on any shortcomings and organizational limits of the structure
The doctor who works in a private clinic, whether or not he is an employee, always has the duty to inform the patient of any organizational or structural deficiencies or limitations of the clinic itself (such as, in this case, the lack of an adequate neonatal resuscitation); if he does not do this, he is jointly and severally liable with the clinic for the damage suffered by the patient as a result of that organizational or structural "deficit", where it can be assumed that the patient, if properly informed, would have made use of another health facility
Civil Cassation section III of 30 March 2011 n. 7237
Informed consent and patient self-determination right
Civil Cassation - the existence of the etiological link between failure to obtain informed consent and the injury suffered (in this specific case, gastric resection) should not be investigated only in relation to the consequential relationship between therapeutic intervention and health damage, but must be verified in relation to the relationship between the omissive activity of the healthcare professional for not having informed the patient and execution of the intervention. In other words, the question does not so much concern the lawfulness of the doctor's intervention, but arises from the violation of that fundamental right to self-determination of the patient, by the healthcare professional, who is called to respond, if he has not adequately or not at all informed to acquire the preventive, conscious consent.
Civil Cassation section III of 28 July 2011 n. 16543
The right to informed consent, as an untraceable right of the person, must always be respected by the healthcare professional, unless there are cases of urgency
According to the Supreme Court, the right to informed consent, as an untraceable right of the person, must always be respected by the doctor, unless there are cases of urgency, found, following an agreed and scheduled intervention and for which it has been requested and is consent has been obtained, which endanger the life of the person, an asset that receives and is accompanied by primary protection in the scale of legal values at the basis of the legal order and civil value, or it is a compulsory medical treatment.
This consent is so mandatory that it does not assume any relevance to exclude that the intervention was carried out in a technically correct way, for the simple reason that due to the total lack of information the patient is not placed in a position to consent to the treatment, so against him, however, there is a lesion of that dignity that connotes his existence in crucial moments - physical and / or mental suffering.
Court of Salerno n. 1689 of 12 August 2011
The informed consent of the patient is not required in case of mandatory health treatment
A patient sued the Health Authority to obtain compensation for the damage suffered, exposing that he had been subjected to mandatory health treatment with continuous administration of medicines that had led to the loss of personal cognition and the external environment, without the urgency " life-saving "and without his consent, with omission of information and with violation of the right of self-determination and that the therapy administered coercively had determined the onset of the pathology called" induratio penis Plastica ". The hypothesis of compulsory treatment consists of the case of the patient who, due to mental illness, is unable to voluntarily undergo the necessary treatments, so that the assessment of this need is left to the health professionals and to the mayor as well as to the subsequent validation of the judicial authority .
In the actual case, the Court observed, it is precisely the hypothesis of compulsory health treatment and therefore the therapy provided was independent of the patient's consent by law. Furthermore, when the TSO ended, the man had continued his hospitalization voluntarily, signing the declaration included in the medical record. With regard to the question of the need and adequacy of the drug therapy carried out during hospitalization, based on the results of the arranged technical consultation, it was ascertained that the procedures for hospitalization and therapeutic treatment were consistent with the conditions of the subject at the time of the facts and in compliance with the protocols doctors. The Court rejected the patient's request for compensation, sentencing him to pay court costs.
App. Milan I Section Civ. n. 2359 of 19 August 2011
Forced blood transfusion, condemned doctors
The Court of Appeal of Milan 1st civil section with sentence 2359 of 19 August 2011 affirmed the right to self-determination of the patient to treatment and, in particular, to any refusal: the good of life as an entity external to man, cannot impose itself against and in spite of the will of man (as long as current with a conscious person and capable of understanding with manifest and conscious "dissent" to medical treatment). Great attention must be paid to the hierarchy of sources of law: Article 32 of the Constitution provides that no medical treatment may be imposed if it is not provided for by law, in which case, however, it must not violate the limits imposed by respect for the human person, while the Article 40 of the Criminal Code provides that not preventing an event, which there is a legal obligation to prevent, is equivalent to causing it.
Cassation section III civil no. 20984 of November 27, 2012
Even if the patient is a doctor, he always needs informed consent
The doctor, for each diagnostic and therapeutic act, is required to ensure the right to self-determination of the patient, who will be free to accept or refuse the health service. It is therefore evident that the quality of the patient (in this case a radiologist) is irrelevant in order to exclude the duty to acquire it, while it may affect the modalities of the information, with the adoption of a language that takes into account his particular subjective state and which, in the case of patient-doctor, can be parameterized to his scientific knowledge on the subject. It should also be borne in mind that without informed consent, the doctor's event is certainly illegal, outside of cases of medical treatment required by law or in which a state of necessity occurs, even when it is in the patient's interest. The following principles were therefore specified in the sentence: 1) there can be no tacit consent per facta conclusentia; 2) the personal quality of the subject to be informed (in this case, a doctor) does not negate the obligation to inform; 3) the burden of proof with regard to the illustration of the possible harmful consequences of the therapy rests with the doctor, once the relative non-fulfillment has been deduced from the patient.
Court of Appeal of L'Aquila Civile of 23 January 2013 n. 36
Liability for failure to correct information
The professional responsibility of the doctor, even if the latter is limited to the diagnosis and illustration to the patient of the consequences of the therapy or intervention that he deems necessary to carry out, in order to obtain the necessary and necessary informed consent, is of a contractual nature. In this sense, it is emphasized that the patient's right to informed consent is an untraceable right of the person and, as such, must always and in any case be respected by the doctor, unless there are urgent cases or it is a matter of a mandatory health intervention. However, where the patient claims the non-fulfillment of this obligation to provide information, it is the doctor who is obliged to prove that he has fulfilled this obligation. That said, the responsibility of the healthcare professional can be affirmed if it is ascertained, on the one hand, that where the patient, if correctly informed of the possible worsening of the pathology and of the therapeutic urgency, would certainly have given consent to immediate hospitalization and the necessary intervention surgery and, on the other hand, that timely intervention would, with a high probability, have avoided the harmful event that subsequently occurred. And in fact, in terms of civil liability, in order to ascertain the causal link between the unlawful conduct and the harmful event, the demonstration of a necessary consequential relationship between the first and the second is not necessary, indeed, the existence of a relationship of mere scientific probability. In light of these considerations, in this case, in acceptance of the appeal filed, the responsibility of the health authority and of the appellant doctor was affirmed, having been ascertained, based on the preliminary findings, that the failure to detect the clinical urgency '' omitted correct information about the need for hospitalization by the doctor, had certainly contributed to the aggravation of the patient's pathology who, instead, if treated promptly and adequately, would not have reached, with high probability, the fatal epilogue then happened (necrosis of the testicle and its removal). Consequently, in the face of the ascertained suitability of the negligent conduct of the healthcare professional for the production of the harmful event, since neither the healthcare company nor the doctor has provided positive proof of the non-attributable cause, or of a sufficiently certain fact that, unequivocally, could exclude the etiological link at the root, the responsibility of both the Health Authority and the professional for the damaging event occurred to the son of the appellants was affirmed.
Court of Cassation section III civil sentence no. 2253 of January 31, 2013
Surgery without consent: harm to the dignity of the person
The patient's right to informed consent is an untraceable right of the person and that, in order to exclude it, the fact that the intervention has been carried out in a technically correct way is of no importance, for the simple reason that, due to the total deficit of information, the patient was not placed in a position to consent to the treatment, so that, in any case, a violation of that dignity that characterizes human existence in the crucial moments of physical and / or mental suffering was consumed.
Civil Cassation Section III of May 16, 2013 n. 11950
Violation of the doctor's obligation to inform related to damage to health and self-determination
The violation, by the doctor, of the duty to inform the patient, can cause two different types of damage: damage to health, existing when it is reasonable to believe that the patient, who bears the related burden of proof, if correctly informed, would have avoided undergoing the surgery and suffering the disabling consequences; as well as damage from injury to the right to self-determination in itself, which exists when, due to the information deficit, the patient has suffered a prejudice, patrimonial or non-pecuniary (and, in the latter case, of appreciable gravity), different from the violation of the right to health.
Civil Cassation Section III 04/06/2013, n.14024
Modification of the intervention and informed consent
The Supreme Court confirmed the negative jurisprudential approach to the dilation of informed consent: the manifestation of the consent given by the patient cannot be extended to a different intervention and with different possible consequences compared to the one initially envisaged and accepted.
Therefore, without prejudice to situations of obvious urgency that pose a serious risk to the patient's safety, the execution of more incisive surgical maneuvers in the face of complications detected during the agreed and planned intervention cannot ignore the renewal of informed consent.
Informed consent is -specific-, that is, it must refer only to the performance that is proposed. Conduct other than that for which consent was given is not legitimate, except in cases in which a state of necessity can be configured.
Responsibility or obligation of informed consent
The violation of the obligation of informed consent, understood as an expression of conscious adherence to the medical treatment proposed by the doctor and, therefore, as a real right of the person, based on the principles expressed in the articles 2, 13 and 32 of the Constitution, determines, for the healthcare professional, and consequently for the structure for which he acts, a responsibility that derives from the omissive conduct held in relation to the fulfillment of the obligation to provide information regarding the foreseeable consequences of the treatment which the patient is subjected to and from the occurrence, as a consequence of the execution of the treatment itself, of an aggravation of the patient's health conditions. On the other hand, it does not assume any influence, for the purposes of the existence of the offense for violation of informed consent, the correct or not execution of the treatment. Respect for the patient's self-determination, which is what is to be protected, with the consequent compensation for damage due to lack of consent, must in any case be assessed in practice, having regard to the real possibilities of choice of the patient if adequately informed. The causal relevance of the lack of consent exists, therefore, only when such misinformation has led to a therapeutic choice that, otherwise, would have been, with high probability, rejected or modified by the patient. The significant non-fulfillment in the context of the liability action for damages, in the so-called behavioral obligations, is not any non-fulfillment, but only the one that constitutes an efficient cause (or contributing cause) of the damage, which entails, on the one hand , the need, for the instant party, to attach a qualified non-fulfillment, i.e. abstractly efficient to the production of the damage and, on the other hand, that the existence of the etiological link must be investigated not only in relation to the consequential relationship between the intervention or therapy adopted and injury to health, but also in relation to the relationship between the doctor's omissive activity, for not having informed the patient, and the execution of the intervention or the adoption of a specific therapy.
Civil Cassation Section III 31/07/2013, n.18334
Informed consent cannot be generic and the patient must be aware of the risks of any surgery
The doctor is obliged to provide all possible information to the patient regarding the medical treatment or surgery to be performed, so much so that he submits to the patient, for signing it, a non-generic form, from which it is possible to deduce with certainty the patient's obtaining exhaustively of said information: it follows that the surgeon fails to fulfill his obligation in order to obtain the so-called -informed consent- if he does not provide the patient, in a complete and exhaustive manner , all the scientifically possible information on the surgery he intends to perform and especially on the risk / benefit balance of the intervention.
Civil Cassation Section III 20/08/2013, n.19220
The signature on the form is not enough
In a personal relationship with the patient in the process of diagnostic-therapeutic measures, the patient has the right to receive information on the advantages and risks or alternatives of the proposed measure in language that must take into account the cultural level of the person assisted (clear language that takes into account the particular subjective state and degree of specific knowledge).
In the specific case, "the responsibility of the healthcare professional for violation of the obligation of informed consent derives from:
- a) by the omissive conduct held in relation to the fulfillment of the obligation to inform regarding the foreseeable consequences of the treatment to which the patient is subjected;
- b) from the occurrence, as a consequence of the execution of the treatment itself, and, therefore, by virtue of a causal link with it, of an aggravation of the patient's health conditions.
On the other hand, the fact that the processing has been carried out correctly or not does not assume any influence for the purposes of the existence of the offense for violation of informed consent. From this point of view, in fact, what is relevant is that the patient, due to the lack of information (he was made to sign by a secretary, in the dim light of a waiting room, a pre-printed sheet without anything having been communicated to him in relation the possibility of a negative outcome of the intervention, with consequent limitation of sight) has not been put in a position to consent to the medical treatment with a will aware of its implications, consuming, towards him, a damage to that dignity that connotes the existence in crucial moments of physical and mental suffering (see Cass. July 28, 2011, n. 16543 and Cass. November 27, 2012, n. 20984).
Civil Cassation Section III 11/12/2013, n.27751
The correct performance does not justify the shortcomings of the Informed Consent
The doctor has the duty and obligation to inform the patient that he is about to be operated on, especially in cases where the intervention is elective (ie not urgent), also of the risks associated with "extraordinary events" that occur rarely. In particular, the obligation to inform about the consequences of a treatment by the doctor always exists, even in cases in which it has been performed correctly: an intervention even if performed correctly does not justify the shortcomings of informed consent.
Criminal Cassation section IV 20/01/2014, n. 2347
The lack of consent determines in itself the arbitrariness of the treatment and its criminal relevance regardless of a harmful conduct on the part of the doctor towards the patient
Given that the "consent" of the patient constitutes a prerequisite for the lawfulness of the treatment and that the "consent", to legitimize the therapeutic treatment, must be "informed", that is, expressed following a complete information, by the doctor, of the possible negative effects of therapy or surgery, with possible contraindications and an indication of the severity of the effects of the treatment, the Informed Consent has as its concrete content the faculty of the patient's free choice of therapeutic diagnostic treatment in compliance with the individual's right to health, protected by article 32 of the Constitution: the criterion governing the doctor-patient relationship is that of the free availability of the good health by the patient in possession of the intellectual and volitional abilities, according to a total autonomy of choices that may involve sacrifice of the very good of life and which must always be respected by the healthcare professional.
It follows that the lack of consent or a vitiated consent of nullity determines in itself the arbitrariness of the treatment and its criminal relevance regardless of a harmful conduct by the doctor towards the patient.
Thus, the judgment on the existence of guilt does not present any differences depending on whether or not there was the patient's informed consent. In fact, it is not possible to base blame on the lack of consent because the obligation to acquire informed consent does not integrate a precautionary rule whose non-observance affects guilt, since the acquisition of consent is preordained to avoid not already foreseeable (and avoidable) harmful facts. , but to protect the right to health and, above all, the right to conscious choice in relation to any damage that may arise from the therapeutic choice in implementation of the aforementioned art. 32 of the Constitution, paragraph 2.
Therefore, informed consent does not integrate a justification of medical activity since, expressed by the patient following complete information on the effects and possible contraindications of a surgical intervention, it represents only a real assumption of lawfulness of the activity of the doctor who administers the treatment, who does not have a general right to treat regardless of the patient's wishes.
This is all the more so in the specific case, since it is cosmetic surgery which by its nature is not characterized by urgency but aimed at improving the patient's physical appearance according to his relationship life.
Court of Florence 22/01/2014 n. 170
Inadequate informed consent violates the right to self-determination
Failure or vitiated informed consent violates the right to self-determination and constitutes compensable damage, even if the patient, even if correctly informed, would not have escaped the intervention and if the intervention was performed without errors.
Who is subjected to invasive interventions must be aware of the nature of the operation, of its typical characteristics (duration, hospitalization, subsequent rehabilitations, permanent lesions, scars, etc.) and of the risks for foreseeable complications for the specific intervention.
In particular, not only in the case in which a denial can be presumed in the case of specific information, but also in cases in which it can be considered that the patient, even if adequately informed, would not have escaped the intervention, the lack of or incomplete information , even in the absence of damage to health, it determines a violation and damages the right to self-determination, hence the right to compensation.
Civil Court of Campobasso of 4 February 2014 n. 98
Correctness or otherwise of the processing and unlawful due to vitiated informed consent
The violation of the cd. informed consent and the consequent damage must be evaluated preliminarily and independently with respect to that linked to the negligence of the healthcare practitioner, as it does not depend on the outcome of the healthcare service. The responsibility of the healthcare professional for violation of the obligation of informed consent derives from the conduct of the omission of fulfillment of the obligation to inform about the foreseeable consequences of the treatment to which the patient is subjected and from the subsequent verification, as a consequence of the execution of the treatment itself, and, therefore, by virtue of a causal link with it, an aggravation of the patient's health conditions. For the purposes of configuring this responsibility, it is completely indifferent whether the processing has been carried out correctly or not, as the correctness of the execution is emphasized for the purposes of configuring a responsibility under a different profile, or attributable, even if within the framework of the unit. relationship by virtue of which the treatment took place, directly to the part of the healthcare service that resulted in the performance of the treatment execution activity. The correctness or otherwise of the processing, therefore, does not assume any significance for the purposes of the existence of the offense due to the violation of informed consent, since it is completely indifferent to the configuration of the harmful omissive conduct and the injustice of the fact, which exists for the simple reason that the patient, due to the lack of information, has not been put in a position to consent to medical treatment with a willingness aware of its implications and that, therefore, such treatment cannot be said to have taken place after providing valid consent and appears performed in violation of art. 32, paragraph 2, of the Constitution, as per art. 13 of the Constitution and art. 33 of L. n. 833 of 1973, which excludes the possibility of investigations and medical treatments against the will of the patient, if the patient is able to provide it and the conditions of the state of necessity do not exist. The omission of the necessary information constitutes a form of contractual responsibility, since the information to the patient and the obtaining of an effective consent issued in the knowledge of what is about to be implemented, constitutes part of the wider relationship, qualified as a contractual type , which is established between patient and doctor. This injury affects a primary and constitutionally protected asset which entails the right to compensation for non-pecuniary damage. It is the patient's responsibility to attach the breach of contract, while the doctor must provide proof of the non-imputability of this breach, without presuming the release of informed consent on the basis of the patient's personal qualities, as they can only affect the modalities information, which must be substantiated in detailed explanations appropriate to the patient's cultural level, with the adoption of a language that takes into account his particular subjective state and the degree of specific knowledge he has. In this sense, it is not sufficient to sign a generic form from which it is not possible to infer that the patient has obtained all the necessary information. (All this being stated, in this case, where the plaintiff complained that the defendant doctors had failed to provide correct and exhaustive information in order to allow her to express valid informed consent about the surgical treatment she was subjected to and, in particular, with with reference to the possible negative outcomes of the same, the absence of proof of the fulfillment of the aforementioned duty by the defendants was noted.
Criminal Cassation Section IV 28/04/2014 n.17801
Refusal of treatment must be aware
In case of refusal of medical treatment, even when they can cause death, dissent, to be valid and exempt the doctor from the power-duty to intervene, must be expressed, unequivocal and current.
In particular, a generic manifestation of dissent formulated ex ante and at a time when the patient was not in danger of life is not sufficient, since the dissent must be expressed ex post, i.e. after the patient has been fully informed about the severity of their situation and, above all, on the risks deriving from refusing treatment.
In fact, the refusal of medical treatment must consist in the patient's conscious and voluntary behavior, who must express in an express form, without the possibility of misunderstanding, the will to escape medical treatment. Therefore, in order to make an informed choice, it is necessary that the patient is aware of his actual health conditions, especially in terms of their severity.
Civil Cassation Section III 06/06/2014 n.12830
Cosmetic surgery: attention to informed consent
When cosmetic surgery results in a more serious imperfection than that which was aimed at eliminating or mitigating, the ascertainment that the patient had not been fully and scrupulously informed of this possible outcome ordinarily follows the responsibility of the doctor for the damage caused. , even if the intervention has been correctly performed. The particularity of the result pursued by the patient and its normal non-declinability in terms of health protection make it possible to presume that consent would not have been given if the information had been offered and therefore make the assessment superfluous, instead necessary when the intervention is aimed at protecting health and the same is compromised by an intervention, even if necessary and correctly performed, on the determinations that the patient would have reached if he had been informed of the possible risks.
"This duty to inform is particularly meaningful in cosmetic surgery, because the doctor is required to offer the patient the possibility of achieving an effective improvement in physical appearance, which also has a favorable impact on professional life and in relationships".
"The particularity of the result pursued by the patient and its normal non-declinability in terms of health protection allow us to presume, referring to the categories of rationality and normality, that consent would not have been given if the information had been offered".
"In the field of unnecessary interventions (according to the medical science of the time), an intervention carried out without valid consent loses any source of legitimacy (in this case the intervention becomes illegitimate and exposes the person who performs it to all the consequences of his conduct".
Civil Cassation Section III 27/08/2014 n.18304
It is the doctor's duty to also inform about the reality of the structure
The conduct of a doctor who subjects a patient to surgery at an inadequate health facility without giving notice of this situation and failing to refer him to another suitable facility is contrary to good faith.
In fact, it is the duty of the doctor to give complete and exhaustive information to the patient also of the structural and organizational deficiencies of the hospital or nursing home.
The violation of these obligations entails responsibility profiles for any false expectations, even if only negligently generated, in the patient.
In the case of activities in a nursing home, please note that the absence of an employee relationship is irrelevant for compensation claims to the structure: the appropriation of the activity of others also involves the assumption of the risk for the damage that may derive from it.
N ° 19731 Civil Cassation section III of 19 September 2014
Informed consent is a fundamental element of patient protection
The basis of informed consent is configured as a structural element of protection contracts, such as those that are concluded in the health sector. In these, the interests to be realized pertain to the sphere of health in a broad sense. Consequently, the debtor's non-fulfillment of the guarantee is capable of damaging the inviolable rights of the person, also causing non-pecuniary damage.
Exact information on the conditions and foreseeable risks of a surgery or health treatment for preventive or preparatory investigations, if it constitutes in itself an obligation or duty that relates to good faith in the formation of the contract and is an indispensable element for the validity of the consent that must be aware of the therapeutic and surgical treatment is also a constitutive element of the protection of the patient with constitutional significance.
Civil Cassation Section III - sentence no. 12205/2015
Intervention performed without consent: the benefits do not compensate for the loss of the right to choose less demolishing treatments
The possibility of choosing not to undergo the intervention is an eventuality that is preserved by the right to informed consent. This last right consists in the faculty not only to choose between the different possibilities of medical treatment, but also to refuse the therapy and to consciously decide to interrupt it at all stages of life including the terminal one. Therefore, the circumstance that the medical intervention not preceded by the acquisition of consent was, in hypothesis, resolutive of the pathology that the patient presents, is not suitable in itself to eliminate the consequent damages. In fact, the benefit derived from the execution of the intervention in these hypotheses does not "compensate" for the loss of the possibility of carrying out a less demolishing one and not even one that, if performed by others, would have caused less suffering.
Court of Florence, civil section II, sentence 452 of 11 February 2015
Plastic Surgery - informed consent is essential
It is the surgeon's responsibility, before proceeding with an operation, in order to obtain a valid consent of the patient, especially in the case of cosmetic surgery, to inform them of the actual scope of the intervention, of the achievable effects, of the inevitable difficulties, of any complications, foreseeable risks involving the probability of a bad outcome. When a blemish that is more serious than that which was aimed at eliminating or mitigating results, the ascertainment that the patient had not been fully and scrupulously informed of this possible outcome ordinarily follows the responsibility of the doctor for the damage resulting from it, even if the intervention has been correctly carried out. And the quality of this information in the present case was not guaranteed, since the possibility - even statistically very probable - that a pre-prosthetic capsular contracture such as to determine the migration of the prostheses could occur as a consequence of the intervention upwards so as to leave the underlying part of the breast flabby and asymmetries between the two breasts could occur which would have led to the possibility that the nipples would have turned downwards.
N ° 2854 Civil Cassation section III of 13 February 2015
Compensation for damage due to lack of informed consent
The acquisition of informed consent constitutes, also in terms of compensation liability, a different and different service compared to that of the intervention.
There are two distinct and fundamental rights to which reference is made: that is, the right to express and conscious adherence to treatment and the different right to health.
The obligation of informed consent, which the doctor must obtain from the patient as legitimacy and foundation of health treatment, pertains to the person's fundamental right to the expression of conscious and free self-determination; while the treatment requested of the doctor concerns the protection of the different, but fundamental right to health
Criminal Cassation section IV Sentence no. 8527/2015
Child death - Ayurvedic medicine instead of antibiotic therapy - refusal of treatment
The doctor, even if he is a freelancer, who treats a minor assumes a position of guarantee. It fails in its duty when it does not prevent the lethal event determined by the administration of an ineffective alternative therapy, consequently, in the specific case, it is responsible for manslaughter for the death of the child.
The sentence addresses two important issues: the limit of informed consent when a minor is present and the correct behavior that the doctor must adopt in the event that parents refuse treatment, especially when it is replaced by non-conventional therapies.
The healthcare professional, the judges affirm: "is responsible for the interruption of traditional therapies, despite the conscious choice of the parents, and in any case it is up to the treating physician, not only the task of suggesting the certain unsuitability of Ayurvedic therapy (in itself insufficient to guarantee therapeutic solutions that are truly alternative to the traditional one) and therefore the real consequences to which abandonment of the traditional therapeutic path would have led, but the duty - in the face of a parental choice oriented in terms so clearly and seriously risky for the health of the minor child - to involve in the decision-making process the institutional subjects responsible for the public protection of the minor (the general practitioner; the tutelary judge; etc.) in order to solicit a juridically correct and substantially more profitable dialogue for identifying the "best interest" of minor; dialogue that is all the more essential (and legally obligatory) where the adoption of treatments is envisaged which (due to the prevalent purpose of guaranteeing an acceptable quality standard of life in a context of ascertained incurability) are worth proposing as merely palliative or compassionate therapeutic forms: extreme solution that parents must consider themselves not entitled to assume, in the absence of an adequate comparison with the subjects institutionally responsible for the control and protection of the minor ".
In this case, the health care professional was accused of violating the traditional parameters of generic guilt, as well as the deontological rules and the rules of medical science, for having subjected a five-year-old child, suffering from cystic fibrosis from birth, to Ayurvedic treatments. The child died following a bilateral necrotizing pulmonary exacerbation in a cystic fibrosis picture. A situation that would have required, according to the judges, a decisive response (immediate hospitalization; antibiogram; massive and targeted administration of intravenous antibiotics) that the doctor "sensationally omitted".
Thesis contested by the doctor, according to which the parents had already interrupted traditional treatments before turning to him and had already interrupted the relationship with the pediatrician. The child who was already in critical condition and had limited himself to supporting the child with alternative medicine, in perfect agreement with the parents who were aware of the limitations of that medical practice.
N ° 21537 Criminal Cassation section IV of 24 March 2015
Criminal relevance for failure or invalidity of informed consent
As a rule, it is not possible to found guilt on the lack of consent, because the obligation to acquire informed consent does not integrate a precautionary rule whose non-observance affects the guilt.
Only in a single case could the failure to obtain consent be relevant as an element of guilt and, precisely, when the failure to solicit informed consent has ended up determining, in the meantime, the impossibility for the doctor to know the real conditions of the patient. and to acquire a complete medical history.
No. 6439 Civil Cassation Section III published on March 31, 2015
Verification of informed consent in a routine and outpatient operation
The Supreme Court affirmed that the verification of consent in a routine and outpatient operation is usually done through an oral interview, moreover with a patient already known and treated, in a previous period. The oral test was tested both through the production of the synthetic informed consent form and through qualified testimonies such as that of prof. R. regarding the practice of forming the consent itself.
Civil Cassation section III sentence n. 9331 of 08 May 2015
When the damage is caused by a necessary act without consent
In the presence of a necessary and correctly performed therapeutic action, from which however harmful consequences for health have arisen, if the patient has not been adequately informed about the possible unforeseeable harmful effects, the doctor can be called to compensate the damage to health. only if the patient demonstrates, even through presumptions, that, if fully informed, he would probably have refused the event, not being otherwise able to lead to the non-fulfillment of the obligation to inform any causal relevance to the damage to health.
N ° 19212 Civil Cassation Section III published on 29 September 2015
Informed consent in writing
In the sentence n.19212 of the Cassation third civil section filed on 29 September 2015 the verbal form of acquisition of consent is objected.
Evidence that informed consent was actually and explicitly given may be presumptive, but the doctor must prove it.
And in the case that is the subject of the dispute, why, having received written consent from the patient for the operation on the right knee, the surgeon induced himself to operate (also) the left one, on the basis of a consent allegedly acquired verbally by the patient, who did not did he even know Italian?
The problem of the form of acquisition of consent therefore arises: no request for information and acquisition purposes for the written form, however the signature would be a certain and only not presumed proof.
We recall the new Code of Ethics:
Informed consent and dissent
The acquisition of consent or dissent is an act of specific and exclusive competence of the doctor, which cannot be delegated.
The doctor does not undertake or continue in diagnostic procedures and / or therapeutic interventions without the preliminary acquisition of informed consent or in the presence of informed dissent.
The doctor acquires, in written and signed form or with other methods of equal documental efficacy, the consent or dissent of the patient, in the cases provided for by the law and by the Code and in those foreseenly burdened by a high risk of mortality or by outcomes that affect relevant to psycho-physical integrity.
The doctor takes into due consideration the opinions expressed by the minor in all decision-making processes concerning him.
N ° 4540 Civil Cassation section III of 3 December 2015 published on 8 March 2016
Hospital facilities - Duty to inform
In the absence of adequate equipment, the structure has the duty to inform the user about the possibility of resorting to more specialized centers, but beware the organizational deficit reproachful to the body also requires the doctor, especially when the technical equipment is not adequate for the purpose, to give information to the patient, also indicating where he can turn to meet his needs.
When a patient goes to a health facility for diagnostic tests, the facility has an obligation to provide trained health personnel and suitable and efficient equipment.
“The healthcare facility is obliged, precisely on the basis of the aforementioned hospitalization contract, to make available not only the healthcare personnel, but also the necessary suitable and efficient equipment. The non-fulfillment (by the health facility) of the obligation most recently indicated generates the aforementioned additional information obligation, which is intended to protect the patient and which affects not only the health facility, but, this time, also the operating doctor, who, even if free from professional fault in the executive phase of his intervention, is in any case obliged to warn the patient of the inadequacy of the diagnostic tools, so as not to determine in him the onset of an innocent reliance on the sure goodness of the instrumental examination.
And it is precisely in this perspective that this Court has stated that it is necessary to recognize the fault of the doctor who fails to take action for the transfer of a patient to a more suitable hospital where he cannot be adequately treated in that of hospitalization (Cass., 22 October 2014 , no. 22338).
Therefore, the protective information obligation arises in one with the failure by the health facility of the obligation of organizational adequacy in relation to the assumption of hospitalization services in favor of the patient despite the organizational deficit. Therefore, the principle enunciated by the decision of 2011 does not always and in any case require the health facility and the structured doctor (who has correctly operated on the basis of the diagnostic tools at his disposal) to refer the patient to a more highly specialized ultrasound center, but only where the technical equipment is not adequate for the purpose; that is - in this case - they were not such as to provide a correct and complete answer regarding the morphological diagnosis of the fetus differently from other ultrasound instruments present in different health facilities ".
Information - It must include a description of the method and the therapeutic alternatives, the chances of success, the risks, the side effects.
- the obligation to provide information also extends to the specific risks determined by alternative choices to allow the patient to orientate himself towards one of the possible choices by consciously evaluating the risks and advantages;
- the obligation to provide information extends to foreseeable risks and not to anomalous outcomes to the limit of fortuitous, since the need for information has to be reconciled with the need to prevent the patient from avoiding a trivial intervention;
- the information must also extend to the state, the facilities and equipment of the health facility and their efficiency.
Civil Court Section III, 07.12.2016, n. 24072
If the principle of allegation is missing, compensation is not due
With reference to the damage from self-determination, it is necessary that whoever invokes the infringement of the right to self-determination (from violation of the right to express valid consent on a surgical intervention then undergone), attaches in a specific way (thus providing the judge with precise facts known from which to derive, presumptively, the unknown facts that one intends to prove) which, due to the omitted or incomplete information, has lost (cumulatively or alternatively) the possibility of self-determination by choosing, in a thoughtful way, the place where to perform the surgery then carried out, the doctors to be operated on, the timing of the surgery as well as the possibility of elaborating the need for the aforementioned intervention (thus getting used to the idea of being forced to undergo surgery). Precluding these possibilities of choice, integrates the consequence because it is concretized in the deprivation of the patient's freedom to self-determine about
N ° 10414 Civil Cassation section III of 18 December 2015 published on 20 May 2016
Damage due to lack of informed consent
The acquisition of the informed consent of the patient, by the healthcare professional, constitutes a different and different service compared to that concerning the therapeutic intervention, so that the incorrect execution of the latter gives rise to damage susceptible to further and autonomous compensation with respect to that due for the violation of the obligation to provide information, also due to the diversity of rights, respectively, for the self-determination of therapeutic choices and psychophysical integrity - affected in the two different hypotheses.
Civil Cassation Judgment n. 8035/16
Patient's right to informed consent
The doctor has the duty to inform the patient about the nature of the intervention, the extent of the possible and probable results and the verifiable implications. The acquisition by the doctor of the informed consent constitutes a different and different service from that of the medical intervention requested, assuming autonomous relevance for the purposes of any compensation liability in the event of failure by the patient. In this regard, it should be further emphasized that the doctor is in fact breaching the obligation to provide a valid and exhaustive informed consent to the patient, not only when he completely fails to tell him about the nature of the treatment he will have to undergo, the related risks and the possibilities success, but also when it acquires the consent from the patient in improper ways.
Court of Caltanissetta 21 November 2016
Right to information
The information must be appropriate to the patient's cultural level and knowledge and must concern the purpose and nature of the intervention, as well as its consequences and risks.
It must allow the patient to choose whether to remain in the conditions that according to the doctor would require the intervention.
Since the information has the function of allowing the patient to self-determine, the responsibility does not cease even in the case in which the intervention has had an auspicious and fully resolving outcome of the complained pathology.
Trib. Court of Appeal of Naples 30.01.2017, n.393
Informed Consent in Aesthetic Surgery
If a more serious imperfection results from a cosmetic surgery than the one you wanted to eliminate or alleviate and the patient was not informed, the doctor will be responsible even if the operation has been well performed
N ° 4362 Tivoli Tribunal GIP order of 11 February 2017
Lack of consent and negative consent
The Gip underlines the difference between absent consent and refusal of consent: the medical treatment performed in the absence of the prescribed consent does not integrate the crime referred to in art. 610 of the Criminal Code, since it cannot be affirmed that the surgeon, by carrying out a specific surgical act on the unconscious patient (or, in the case in question, by performing a blood transfusion) not previously permitted, commits violence against him in the sense defined by art. 610 cp This conclusion, however, is valid only in the case in which the medical treatment has been practiced in the "absence" of the prescribed consent (United Cassation Sections judgment 2437 of 18.12.2008).
On the contrary, however, in the event of an express disagreement with the blood transfusion expressed by the patient still in a state of lucidity, and then confirmed in writing by the support administrator (negative consent to the blood transfusion, relieving doctors and hospital from any responsibility) on the same day in to which the doctor consulted him to communicate the imminent danger of life of the and the need for transfusion.
Court of Rome section XIII sentence no. 802/2017
Informed consent cannot be limited to a list of possible complications
Informed consent must not be limited to a list of possible complications, but on the one hand it must explain their meaning and on the other hand it must indicate whether they are more or less probable in relation to the actual physical conditions of the patient.
In fact, it is not a question of providing information that could be taken from a page of any text, but of explaining to the patient, in relation to his concrete conditions and the characteristics of his pathology, the type of intervention, the possible positive and negative effects. , the possible risks determined not only on the basis of the generic statistical recurrence but adapted to his concrete physical conditions, all explained in clear terms that allow the patient to understand, and in the event that a written form is drawn up, which allow the judge to reconstruct if what was proposed was actually when it should be said and if what was said corresponded to the best medical science of the moment.
Court of Naples section VIII sentence n. 4071/2017
The signing of the informed consent forms does not exclude liability
The profiles relating to the signing of the so-called forms cannot be of any relevance. "informed consent"; as emerged from the report of the Technical Consultancy of the Office, it was not just a matter of mere complications resulting from a correctly performed surgery, but rather of damaging results deriving from a hypothesis of negligence and, therefore, of inadequately performed medical-surgical service . According to the Court of Cassation, in fact, although there is conscious consent, responsibility for damage to health can well be configured if the therapeutic service is nevertheless inadequately performed; the consent given by the patient is irrelevant, since the injury to health is causally linked to the negligent conduct of the doctor in carrying out the therapeutic service, which was incorrectly fulfilled after the diagnosis. (Avv. Ennio Grassini - in Health Law)
Civil Cassation Judgment n. 16503/2017
Lack of informed consent and compensation for damage
The physician has the duty to inform the patient about the nature of the intervention, the extent of the possible and probable results and the verifiable implications; therefore the acquisition by the doctor of the informed consent constitutes a different and different service from that of the medical intervention requested, assuming autonomous relevance for the purposes of any compensation liability in the event of failure by the patient.
Civil Cassation section I Judgment number 14158/2017
Support administrator and advance directives for care
The early designation allowed by art. 408 c. 1 not only has the function of indicating to the judge the person to be appointed as support administrator for the relationship of trust that binds them, but the designator can well indicate his intentions on the interventions that may be necessary in case of future incapacity, will the which must then be expressed by the designated person.
Civil Cassation section VI Judgment number 4989/2016
The requirements to define the medical record incomplete
The incompleteness of the medical record can, under certain conditions, constitute evidence to the detriment of the doctor, and not to his favor. The jurisprudence, however, has not established a rigid automatism between the incompleteness of the same and the responsibility of the healthcare professional, but has identified the principle according to which the shortcomings of the document, meanwhile, can lead to the presumption of the existence of a causal link between the conduct of the health and damage, when two conditions concur with them:
(a) the conduct of the physician was abstractly capable of causing the event;
(b) the impossibility of ascertaining the existence of the causal link between the doctor's conduct and the damage event depends solely on the incompleteness of the medical record.
Council of State section III sentence number 3058/2017
There is a right to refuse ongoing therapeutic treatment, including artificial life support
Although an obligation has sometimes been proposed for the individual to take action for the benefit of his own health or a prohibition to refuse treatment or to omit behavior deemed advantageous or even necessary for the maintenance or re-establishment of it, the Board believes that the health of the individual cannot be subject to authoritative-coercive taxation. Faced with the refusal of treatment by the person concerned, there is space - in the framework of the "therapeutic alliance" that holds the patient and the doctor together in the search, together, of what is good while respecting the cultural paths of each one - for a strategy of persuasion, because the task of the legal system is also to offer the support of maximum concrete solidarity in situations of weakness and suffering; and, even before, there is the duty to verify that that refusal is informed, authentic and current. But when the refusal has such connotations there is no possibility of ignoring it in the name of a duty to take care of oneself as a principle of public order.
Milan Court section 1, 24/07/2017, n.8243
Limits to the plastic surgeon's liability and informed consent
The ruling addresses several issues relating to medical liability, in particular by placing limits on the liability of the plastic surgeon.
The Judge, with particular reference to cosmetic surgery, noted that "regardless of the qualification of the obligation in question as a means or result (see on the point of Cass. 10014/1994 which favors the qualification as an obligation of result and . 12253/1997 which qualifies the obligation of the aesthetic surgeon as an obligation of means), there is no doubt that those who turn to a plastic surgeon do so for often exclusively aesthetic purposes and, therefore, to remove a defect, and to achieve a certain result , and not to cure a disease. It follows that the result represented by the aesthetic improvement of the patient's appearance is not only a reason, but becomes part of the causal nucleus of the contract, and determines its nature ”.
In the specific case, he then shared the findings received by the CTU, which excludes the doctor's responsibility on the circumstance that the intervention was performed in a workmanlike manner and on the lack of objective documentation proving the causal link between the conduct of the surgeon and the symptoms complained of by the patient.
The doctor's liability is also excluded in relation to the alleged infringement of the right to informed consent, since the plaintiff has not discharged the burden on the same and the defendant, on the other hand, has proved the fulfillment of the obligation to fully inform the patient of the risks and complications related to the surgery performed.
The judge concludes by specifying: "the burden of proving is on the patient:
i) the existence of the causal link between the damage to his right to self-determination and the injury to health deriving from a foreseeable consequence of a surgery correctly performed but not correctly consented by the patient (the patient having to prove, also by means of presumptions, that where adequately informed would have refused the intervention);
ii) the existence of the damage deriving from the lack of information, which can be declined both in terms of damage to the right to health (due to the disabling consequences deriving from the intervention) and in terms of damage to the right to self-determination (provided that an assets of an appreciable entity) ".
Cass. pen. section IV, 19/10/2017, no. 50078
Medical liability - Inexperience and liability
In the new law on the responsibility of the doctor establishes the operating health profession as the "cause of" non "punishment of the practitioner, in accordance with the conditions provided for by the legislative provision (compliance with the guidelines or, failing that, good clinical-assistance practices, adequate to specificity of the case) only in the case of inexperience, regardless of the degree of guilt, compliance with the guidelines and good practices being compatible with the imperative conduct of their application (second paragraph of article 590-sexies of the Italian penal code. introduced by law no. 8 of 2017 March 24, the so-called Gelli-Bianco law) ".
Cass. civ. section III, 14/11/2017, no. 26827
Informed consent and pre-printed forms
A pre-printed document, as it is undated and does not contain the patient's name, is not sufficient to prove that the hospital has fulfilled its obligation to acquire valid informed consent.
"The signing of a completely generic" informed consent "form by the patient is not suitable to presume that the doctor obliged to do so has communicated orally to the patient all the necessary information that he was contractually obliged to provide for this purpose"
Cass. civ. section III 22/12/2017 n. 7516
Omitted information to the patient does not detect if aware
The patient as the holder of the right to health cannot make any conscious choice if he does not know what consequences he is exposed to by adopting one therapy rather than another. "But if he knows perfectly what the nature, consequences, risks and alternatives are of an intervention, any non-fulfillment by the doctor of the obligation to provide information becomes legally irrelevant as the causal link between the non-fulfillment and the harmful consequences of the "vulnus" to the freedom of self-determination is missing.
In fact, any disadvantageous consequences must be traced back to the patient's conscious choices, rather than a lack of information from the doctor.
Furthermore, although the patient's consent can never be presumed, the same can nevertheless be proved by the doctor presumptively.
Cass. civ. section III 9/01/2018 n. 7250
Omitted or defective keeping of the medical record
This Court, called to deal with cases in which the reconstruction of the modalities and timing of the doctor's conduct could not take advantage of the annotations contained in the medical record, due to the omitted or incomplete drafting of the same, has constantly attributed the effects to the professional , either by attributing to the omissions in the compilation of the file the value of presumed etiological link, or by recognizing a symptomatic figure of inexact fulfillment, being the doctor's obligation - and explanation of the particular diligence required in the execution of the obligations inherent to the exercise of a professional activity ex art. 1176 cc - check the completeness and accuracy of medical records and attached reports. In this regard, it was specified that the faulty record keeping not only does not exclude the existence of the etiological link between the negligent conduct of doctors and an ascertained pathology, but allows recourse to presumptions, as occurs in any case in which the evidence cannot be given for conduct attributable to the same party against which the fact to be proved could have been invoked, within the framework of the principles regarding the distribution of the burden of proof and the relevance assumed for this purpose by the aforementioned criterion of proximity to proof , that is, the effective possibility for one or the other party to offer it. Therefore, the hypothesis of incompleteness of the medical record must be considered a factual circumstance that the trial judge can use to deem the existence of a valid causal link between the doctor's work and the damage suffered by the patient, by operating the following necessary double check so that that incompleteness is relevant for the purposes of deciding or, on the one hand, that the existence of the causal link between the doctor's conduct and the patient's damage cannot be ascertained precisely because of the incompleteness of the file; on the other hand, that the doctor has in any case put in place a conduct that is abstractly suitable for causing the damage, impending on the
health facility and on the doctor to demonstrate that no non-fulfillment is attributable to them or that it was not the cause of the damage, with the risk of lack of proof hanging over them.
Cass. pen. section IV 12/01/2018 n. 15178
Fragmentation of specialist medicine
In the game of the three "m" (patient - doctor - medicine) the patient is at the center of the doctor's respect and attention in the vortex of medicine, an expression of care for good health.
But in the exasperated concept of the rationing of resources, today more than the man to be treated, we look at a budget to be respected, even if in health the good health is not marketable, it is not a shoe or a kilo of potatoes, it is a supreme good.
Exasperated by the "hyperspecialism", the patient is fragmented, not seen and treated as a whole, but broken into many pieces: the heart, the lung, the right knee rather than the left and so on and the doctor in the vortex of fast treatment and anatomical part seems to forget the sick individual as a whole.
Recently the Supreme Court has censored the behavior of a doctor: the specialist must not limit himself to treating a patient according to his specialization; in fact: if this does not result in obvious damage to the patient's state of health, he must continue the investigations demonstrating flexibility that leads him to consider pathologies not in his own field and must subject the patient to further and different tests.
Cass. civ. section III 10/01/2018 n. 9180
Injury damage from informed consent
Regarding the doctor's responsibility, in the presence of a necessary and correctly performed therapeutic act according to the rules of the art, from which, however, harmful consequences for health have arisen, where such intervention has not been preceded by adequate information of the patient about the possible prejudicial effects that are not unpredictable, the doctor can be called to compensate the damage if the patient proves, also through presumptions, that, if fully informed, he would probably have refused the intervention. And the lack of consent can be relevant for compensatory purposes when prejudicial consequences deriving from the violation of the fundamental right to self-determination in itself considered are configurable, completely regardless of the innocent injury to the patient's health.
Cass. civ. section III 24/01/2018 n. 7260
If the diagnosis is late, the patient must be compensated
The violation of the right to freely determine oneself in the choice of one's own existential paths in a life condition affected by pathologies with an unfortunate outcome, does not coincide with the loss of chances connected to the carrying out of individual specific life choices that could not be made, but in the injury of an asset that is in itself autonomously appreciable on a substantial level, such as not to require, once the guilty diagnostic delay of a pathological condition with an unfortunate outcome (by the respondents) has been certified, the fulfillment of any further burden of argumentative allegation or evidential, being able to justify a sentence to pay compensation for the damage thus inflicted on the basis of an equitable settlement.
Cass. civ. section III 31/01/2018 n. 2369
With specific reference to the division of the burden of proof weighing on the parties, it is necessary to reiterate: on the one hand, that the patient's consent to the medical act can never be presumed or tacit, but must be expressly provided, after having received adequate information, also explicit; presumptive, on the other hand, can be proof that informed consent has been effectively and explicitly given, and the relative burden falls on the doctor; on the other hand, that, in the presence of a therapeutic act which is necessary and correctly performed according to the rules of the art, from which, however, harmful consequences for health have arisen, where such intervention has not been preceded by adequate information to the patient about the possible prejudicial effects that are not unpredictable, the doctor can be called to compensate the damage to health only if the patient demonstrates, also through presumptions, that, if fully informed, he would probably have refused the intervention, not being otherwise able to lead back to the non-fulfillment of the 'obligation to inform any causal relevance to the damage to health.
edited by Marcello Fontana - Legislative Office FNOMCeO
Cass. civ. section III 31/01/2018 n. 2369
Absent information, as well as incomplete information, undermines the patient's right to self-determination.
A hospital was sentenced to pay damages to the family members of a woman who died of breast cancer after several tests were carried out showing the disease but without the doctors having duly informed the patient of the seriousness of her state of health.
Court of Modena section II civil - 18/01/2018 n. 136/2008
Consent must be clear
The Court of Modena (decree 18 January 2018), also on the basis of the law on bioassay (219/2017), bearing in mind that
“It is well known how it is possible to disregard the patient's informed consent in medical-health matters in the presence of an urgent situation, that is, of a state of need and in the face of a person's unconsciousness. In this case, by virtue of the code of medical ethics (art. 36: "the doctor ensures essential assistance, in urgent and emergency conditions, in compliance with the expressed wishes, keeping the advance declarations of treatment if manifested") the operation carried out by health personnel is sanctioned pursuant to art. 54 of the criminal code and pursuant to art. 2045 cc Similarly, the art. 1, paragraph 7, of the law of 22 December 2017, n. 219, (published in the Official Gazette no. 12 of 16 January 2018 "Rules on informed consent and advance treatment provisions" which states: "In emergency or urgent situations, the doctor and the members of the health team ensure the necessary care , in compliance with the will of the patient where his clinical condition and circumstances allow it to be incorporated ")"
"In this case (patient with unclear wishes previously expressed, in a state of unconsciousness, for which the support administrator to whom he was entrusted had asked the Court for authorization for a tracheotomy), a state of necessity seems to exist, it being essential to carry out a "life-saving" intervention for the benefit of the patient, lacking any therapeutic alternatives ".
And so what
"It is the responsibility of the medical-health personnel to ensure the patient the care necessary for his survival in a state of necessity, without the informed consent of the person being able to be replaced and surrogated by the support administrator (arg. Ex art. 3, paragraph 4, law no. 219/2017) ".
1. in the event of a life-saving intervention and in conditions of contradictory expression of the patient's will, it is in any case the medical team to decide;
2. the contradictory will of the patient at the moment in which this could be expressed removes the doubt about the medical intervention to be performed which in this case must privilege life, even in the presence of any contrary will of the support administrator (who in this case case this negative will was not there).
Civil Court Section II of Bari - 19/02/2018 n. 753
Informed consent in cosmetic surgery
Regardless of the qualification of the obligation in question as a means or a result, there is no doubt that those who turn to a plastic surgeon do so for often exclusively aesthetic purposes and, therefore, to remove a defect, and to achieve a certain result, and not to cure a disease.
It follows that the result represented by the aesthetic improvement of the patient's appearance is not only a reason, but becomes part of the causal nucleus of the contract, and determines its nature (see ref. Milan Court judgment no. 8243/2017)
Therefore, when cosmetic surgery leads to a more serious imperfection than that which was aimed at eliminating or mitigating, ascertaining that the patient had not been fully and scrupulously informed of this possible outcome ordinarily follows the responsibility of the doctor for the damage. derived from it, even if the intervention has been correctly performed.
Furthermore, in the event of incomplete consent, considering that the purpose of cosmetic surgery is beyond the protection of the patient's health and is aimed at the aesthetic improvement of the person, it can be assumed that the patient would not have given his consent to the intervention if duly informed that all the intervention could have achieved a more serious imperfection than that which was aimed at eliminating or mitigating.
Cass. civ. section III 19/03/2018 n. 6688
The written report does not exhaust the doctor's duty as it falls within the obligations of each doctor, as stated in the code of ethics, to provide the patient with all the necessary explanations on his state of health, also taking into account ... also the interlocutor's ability to understand , for which for the radiologist "his communication work cannot and must not be exhausted only through that report", "communication tool in technical language". "Therefore, in the case in which a doctor carries out a diagnostic test by coming into direct contact with the patient - as in the hypothesis, for example, of an ultrasound or an X-ray -, drawing up a report in scientific terms on his result is not it is the fulfillment of the obligation to provide information, but fulfillment, in the final part, of the obligation to carry out the examination. Certainly not being able to believe that, for what has already been pointed out, the obligation to provide information • should exclusively involve the subjecting to therapeutic treatments, as it also includes the diagnostic results, logically including the related consequences of these, • information in non-specific terms professionally cryptic but adequate to the knowledge and subjective state of the patient of the meaning of the report as well as of the consequences that should be drawn from it - identified, logically, even on a temporal level - in further diagnostic and / or therapeutic terms constitutes the prerequisite for the exercise of the right of self-determination of the subject examined, id est the presupposition of his subsequent choices. Incomplete information, just like absent information, therefore undermines this right of the patient; and incomplete information cannot be other than information that does not explain the characteristics of severity or risk of severity of what has been found, and that does not signal the presence of any urgency in a specific and clearly perceptible way, also in consideration of its scientific knowledge , by the patient. In conclusion, the territorial court "atrophied" the professional obligations of doctor C. in the performance of the service - in the sense of exact diagnosis and exact identification of what would consequently have occurred -, not taking into account the obligation to inform his result to the patient, an obligation that is not fulfilled by means of a technical and atemporal illustration, but must consist in a translation of the diagnosis to the patient's level of scientific knowledge both under the aspect of intrinsic meaning, and under the consequent aspect of the time limits carry out further diagnostic or therapeutic initiatives, or further choices by the patient ".
edited by Marcello Fontana - Legislative Office Fnomceo
Cass. civ. section III 23/03/2018 n. 7248
Damage from violation of the duty of correct informed consent
Informed consent must be based on detailed information, suitable for providing full knowledge of the nature, scope and extent of the medical-surgical intervention, its risks, achievable results and possible negative consequences.
In particular, correct and complete information follows:
1. the right for the patient to choose between different medical treatment options;
2. the right to acquire, if necessary, further opinions from other health professionals;
3. the right to choose to turn to another healthcare provider and other facility, which offer greater and better guarantees (in percentage terms) of the desired result, possibly also in relation to the post-operative consequences;
4. the right to refuse the intervention or therapy - and / or to consciously decide to stop it;
5. the faculty to prepare oneself to consciously face the consequences of the intervention, where these are particularly burdensome and harbinger of foreseeable (for the doctor) and unexpected (for the patient) suffering due to the post-operative and rehabilitative omitted information ".
Furthermore, informed consent must be based on detailed information, suitable to provide full knowledge of the nature, scope and extent of the medical-surgical intervention, its risks, achievable results and possible negative consequences, while it is not possible to obtain consent. by signing a completely generic form; the obligation to provide suitable information to the patient is not fulfilled by the doctor when the consent is acquired in an improper manner, so that the consent expressed orally by the patient cannot be considered validly given.
Cass. civ. section III 20/03/2018 n.10608
Informed consent - Violation by the doctor of the duty to inform the patient with damage to health and with damage from injury to the right to self-determination
The violation, by the doctor, of the duty to inform the patient, can cause two different types of damage: damage to health, existing when it is reasonable to believe that the patient, who bears the related burden of proof, if correctly informed, would have avoided undergoing the surgery and suffering the disabling consequences; damage from injury to the right to self-determination, predictable if, due to the information deficit, the patient has suffered a pecuniary or non-pecuniary injury other than the damage to the right to health; this is to be said from the perspective of legitimate claim, for the patient, to know with the necessary and reasonable precision the probable consequences (not even the absolutely exceptional and highly improbable ones) of the medical intervention, in order to prepare to face them with greater and better awareness, given that our Constitution establishes respect for the human person at any moment of his life and in the entirety of his psychophysical essence, in consideration of the bundle of moral, religious, cultural and philosophical convictions that guide his volitional determinations.
edited by Marcello Fontana - Legislative Office Fnomceo
Court of Termini Imerese 06/04/2018 n.465
Informed consent - Refusal to transfusion
Doctor convicted in criminal proceedings for having blood transfusion of one of Jehovah's Witnesses who had refused the transfusion.
"The conduct held by the accused, as well as constituting a criminal offense, also constitutes a civil offense against the subject with the interest protected by the penal law, since the infringement of the interest protected by the criminal law constitutes unjust damage pursuant to art. 2043 cc The accused must therefore be sentenced to pay compensation for the damages suffered by the civil party as a result of the unlawful conduct ... referring, in the absence of suitable quantification documents, to the competent civil judge for their complete liquidation ".
Cass. pen. section IV 18/04/2018 n.31628
Medical liability: urgency excludes consent
The doctor's position of guarantee derives from the obligation to proceed with the necessary care for the patient whenever there is a situation of danger for his physical integrity
The patient's omitted consent does not necessarily imply the health care provider's criminal responsibility for personal injury or private violence (Article 610 of the Italian Criminal Code: when "anyone, with violence or threat, forces others to do, tolerate or omit something").
In fact, if the intervention was performed in compliance with the protocols and the leges artis, it led to an appreciable improvement in the patient's health conditions and therefore ended with an auspicious outcome, the doctor cannot be called to criminally answer for his work. .
This is a principle that has long been enshrined in the United Sections in judgment number 2437/2008.
Civil Court Section III 10/11/2017 dep. 20/04/2018 n.9806
Is the drawing sufficient in informed consent?
The doctor has several ways to adequately inform the patient. However, it is always essential that the explanations are detailed and appropriate to his cultural level.
With sentence number 9806/2018, the Court of Cassation considered valid the information about a surgical intervention for the removal of a tattoo made also by drawing the cut that would have been made directly on the patient's body and thus concretely envisaging the scarring results that would have resulted from the operation.
It is of fundamental importance that "the explanations are detailed and appropriate to the patient's cultural level, with the adoption of a language that takes into account his particular subjective state and the degree of specific knowledge he has".
Cass. civ. section III 15/05/2018 n.11749
Lack of informed consent and damage to self-determination
If a surgery is not successful and the patient complains of a lack of informed consent, it is he who must demonstrate that, if he had done it correctly, he would not have been operated on. But it is also true that he is still entitled to the non-pecuniary damage from failure to request and, therefore, the impossibility of self-determination.
Cass. civ. section III 08/06/2018 n.26728
Omitted informed consent
In terms of informed medical consent regarding the execution of an operation, if it appears, as in the present case, that it was performed by a healthcare professional as head of the medical-surgical team, but that other healthcare professional who participated in the operation as an assistant surgeon, was the one who advised the patient to carry out the surgery, erroneously the judgment on the merits, having ascertained the lack of informed consent, refers the responsibility to the head of the medical team only, even if he has performed the surgery, and not even to the assistant-surgeon, since he, in performing his own service by recommending the surgery, must also consider himself responsible for not having provided the due information.
Cass. civ. section III 27/06/2018 n.24189
Medical liability: anyone in a vegetative state must be treated
Whoever is in a permanent vegetative state is a person in the full sense and his fundamental rights must be respected and protected. In fact he is a "person in the full sense", with the consequence that his "non-life" can never be considered a "good of life".
Cass. civ. section III 22/08/2018 n.20885
Omitted informed consent - The distinction of the Cassation
The cases in which the patient complains of damage to health from those in which he complains of the infringement of the right to self-determination must be kept apart.
For the judges, two hypotheses must be distinguished:
- the one in which the violation of the right to informed consent has determined, even in an innocent way, the harmful consequences for the patient's health, for which the latter therefore requests compensation for damage to health,
- that in which the patient, following the omitted consent, only invokes the infringement of his right to self-determination, which in any case derives from the violation of the relative obligation by the doctor and the health facility.
Harm to health
In the case of damage to health deriving from the omitted informed consent, the patient can be compensated only to the extent that he attaches and proves that if he had been fully informed he would have refused to undergo the therapy that was practiced.
Injury to the right to self-determination
If, on the other hand, the patient complains that his right to conscious self-determination is being violated, proof of refusal of treatment is not necessary in the event of complete information.
However, this does not mean, for the judges, that such damage is unconditionally compensable.
In fact, the threshold of the seriousness of the offense must be exceeded, to be determined according to the parameter of social conscience at a given historical moment.
Furthermore, the existence of prejudices that can be traced back to the treatment and which, for the Court, can also consist in the inconvenience and suffering resulting from the methods and times of execution of the treatment itself must be proved.
Civil Court Section III 13/09/2018 n.30852
Even the "minimal" risks to a patient must clearly be part of informed consent.
According to the Supreme Court, the Court of Appeal was wrong in not recognizing the loss of the patient's right to be informed of the real risks, and not vague and generic, printed on a form and accepted the reason for the appeal of a patient's heir deceased related to the violation of his right to informed consent.
Cases the sentence and sends it back to the Court of Appeal in a different composition to decide on the amount to be paid.
Civil Court Section III 05/10/2018 n.31234
Medical fault - Proof of harm in the event of failure to inform consent
In the event of a life-saving medical intervention correctly performed, but which the patient would have refused if, unlike what happened, he had been adequately informed, compensation for the damage is not due regardless. In order to be compensated for the unforeseeable consequences of the therapeutic act performed according to the leges artis, it is in fact necessary to demonstrate that, in the event of correct information, the intervention would have been refused.
In judging such situations, the judge of the merit, according to the Court of Cassation, must ascertain whether the correct fulfillment of the information duties by the health professionals would have produced the effect of the non-execution of the intervention from which it then derived, without fault, the pathological state or whether it would have allowed the patient to prepare and prepare to face the post-operative period with the "full and necessary awareness of its unfolding over time".
Civil Court Section III 03/04/2018 dep. 17/01/2019 n.1043
The clinic pays even if the doctor is not an employee
The structure is liable for the failure to obtain consent even if this constitutes a different service from that which is the subject of the intervention. In fact, the structure is contractually liable for the damages suffered by the patient, for their own reasons, both when these have depended on his inadequacy, and when they have depended on the fault of the health professionals he uses, even if they are not his employees. Furthermore, it does not find an obstacle in the circumstance, although considered true and confirmed, that the acquisition of informed consent constitutes a service by the healthcare professional other and different from that which concerns the therapeutic intervention.
Cassation section III civil sentence no. 6449 dep. 06/03/2019
There is no informed consent, the doctors compensate the patient
If informed consent is lacking, healthcare professionals are required to compensate the patient for the harmful consequences deriving from an intervention even if this has been correctly performed and this correctness has been ascertained in court.
Civil Cassation Judgment n. 8756 dep. 29/03/19
Omitted informed consent
It is necessary here to reiterate that the correctness or otherwise of the processing does not assume any importance for the purposes of the existence of the offense for violation of informed consent, as it is completely indifferent to the configuration of the harmful omissive conduct and the injustice of the fact, which it exists for the simple reason that the patient, due to the information deficit, has not been able to consent to medical treatment with a willingness aware of its implications. Indeed, the processing, carried out without prior provision of valid consent, occurs in violation: both of the art. 32, 2nd co., Of the Constitution (according to which no one can be obliged to a specific medical treatment except by law); both of art. 13 of the Constitution (which guarantees the inviolability of personal freedom with reference also to the freedom to safeguard one's health and physical integrity); both of art. 33 of I. n. 833/1978 (which excludes the possibility of investigations and medical treatments against the will of the patient, if the patient is able to provide it and the conditions of a state of necessity do not exist; pursuant to art. 54 of the Italian penal code).
Civil Cassation Judgment n. 10423/19 dep. 15/04/2019
Omitted informed consent
The Court of Cassation affirmed that in the presence of a necessary and correctly performed therapeutic act according to the rules of the art, from which, however, harmful consequences for health have arisen, where such intervention has not been preceded by adequate patient information about the possible prejudicial effects that are not unpredictable, the doctor can be called to compensate the damage to health only if the patient demonstrates, also through presumptions, that, if fully informed, he would probably have refused the intervention, not being able otherwise to lead back to the non-fulfillment of the obligation to inform no causal relevance to the damage to health.
Civil Cassation section 1 Ordinance n. 12998 dep. 15/05/19
End of life administrator - the patient can appoint a person to avoid treatment
The seriously ill can appoint a support administrator by private writing to refuse treatment in case of impossibility to give dissent.
In the sentence, the possibility of early designation when one is still in the fullness of one's cognitive and volitional faculties of a support administrator with the latter's right to be able to issue directives of refusal to care when the situation of impossibility of the designant arises.
Civil Cassation Judgment n. 15867 dep. 13/06/2019
Transfusions - Medical Liability
The Court of Merit gave account of the very serious condition of the patient and the valid indication for the administration of transfusions assuming, as regards the profile of informed consent, that even if they had been informed of the possible risks of transfusions, the parents would certainly have given their consent. The ruling was intended to give continuity to the jurisprudence of this Court according to which, in order to configure the infringement of the right to be informed, it is necessary to obtain proof, also through presumptions that, if fully informed, the patient would probably have refused the intervention, not any causal relevance to the damage to health could otherwise be traced back to the non-fulfillment of the obligation to provide information.
Civil Cassation Section III - 25/09/2018 dep. 25/06/2019 n. 16892
The omitted informed consent is an autonomous damage
The omitted informed consent is an autonomous damage and must be compensated further and autonomously with respect to the damage from incorrect medical treatment.
In judgments of medical responsibility, it must always be considered that the failure to obtain consent and the error in medical intervention constitute two very distinct services, which cannot be considered as a whole.
This distinction, in practical terms, implies that the compensation due to the patient who has not given his consent to an intervention which, then, has not even been performed correctly is double: one for the incorrect execution of the health care service and another , further and autonomous, for the omitted informed consent.
In fact, "informed consent pertains to the person's fundamental right to express conscious adherence to the medical treatment proposed by the doctor ... and, therefore, to the patient's free and conscious self-determination".
As far as therapeutic medical treatment is concerned, it "has vice versa with regard to the protection of the (different) fundamental right to health".
If the injury is double, then the compensation is also double.
Civil Cassation Section III - 07/11/2018 dep. 19/09/2019 n. 23328
Informed consent on pre-printed form
Informed consent does not apply when the patient signs a pre-printed form. We need detailed explanations and not generic formats on the risks of the operation.
Furthermore, it is not the patient who must prove that he would not have undergone the remedial intervention if adequately informed.
... informed consent must be based on detailed information, suitable for providing full knowledge of the nature, scope and extent of the medical-surgical intervention, its risks, achievable results and possible negative consequences, the subscription being not suitable for this purpose on the part of the patient, of a completely generic form, nor noting, for the purposes of the completeness and effectiveness of the consent, the quality of the patient, which affects only the modalities of the information, to be adapted to his cultural level through a language to him understandable, according to his subjective state and the degree of specific knowledge he has (Section 3, Sentence no. 2177 of 04/02/2016, Rv. 639069 - 01).
... in consideration of the restorative nature of the surgical interventions subsequent to the first one and which were part of an injury that has already occurred, the profile relating to prior information could not fail to assume a particularly meaningful character, having to be translated into detailed and specific communications in order to allow the patient to know the exact terms of the pathology determined by previous interventions and the concrete prospects for overcoming those critical issues. Therefore, the particular characteristics of the information obligation are completely incompatible with the generic indications provided by the health professionals before the first intervention as ascertained by the judges of merit.
... ultimately, from the "remedial" nature of the interventions subsequent to the first one and from the non-definitive outcome of the same, it follows that the burden of proving that, if adequately informed, the patient would probably have refused the intervention does not fall on the latter . This principle, in fact, operates in the hypothesis, not recurring in the present case, of intervention correctly carried out (Civil Cassation Section 3 ", Sent., 9-2-2010, no. 2847).
In particular (Anna Macchione - Fnomceo Legislative Office), it is also underlined that the violation by the doctor of the duty to inform the patient can cause two different types of damage: damage to health, existing when it is reasonable to believe that the patient, who bears the related burden of proof, if properly informed, would have avoided undergoing the operation and suffering the disabling consequences; as well as damage from injury to the right to self-determination in itself, which exists when, due to the information deficit, the patient has suffered a prejudice, patrimonial or non-patrimonial (and, in the latter case, of appreciable gravity), different from the violation of the right to health.
Cassation Civil Section VI - 13/06/2019 dep. 18/11/2019 Ord. n. 29827
In cosmetic surgery I also agree with the result that can be obtained
In cosmetic surgery, informed consent for surgery is not sufficient; it is also necessary that the result obtained as a private choice and reserved for those who undergo the intervention.
... in cosmetic surgery the consent must be formed not only in relation to the risks of the intervention and the chosen techniques, but also in relation to the aesthetic result that will arise from it, since the choice on the aesthetically preferable option cannot be left to the healthcare professional in any case, which is an extremely private choice and reserved for the patient ...
Civil Cassation Section III - 02/07/2019 sentence 28985
Lack of information
The violation of the duty to inform the patient can cause two different types of harm: damage to health and damage to the right to self-determination.
Civil Cassation Section III - 02/07/2019 dep. 10/12/2019 sentence 32124
Importance of handwritten additions to the informed consent form
The consent form signed on the same day of the intervention does not invalidate the conclusion of the correct fulfillment of the relative obligation of the treating doctors, if the written document appears as the end of a path followed in previous meetings and discussions concerning the evaluation of pathologies pre-existing patient, the need to proceed with the surgery, the risks associated with it and its possible complications and possible infections.
The handwritten additions referring to the patient's situation make further findings on the content of the form irrelevant for the purpose of judging the adequacy of consent.
(lawyer Ennio Grassini)
Very interesting are some clarifications in the sentence:
- The acquisition by the doctor of the informed consent constitutes a different and different service from that of the medical intervention provided, with two distinct rights:
- informed consent pertains to the fundamental right of the person as an expression of the conscious adherence to the health treatment proposed by the doctor and therefore to the free and conscious self-determination of the patient, since no one can be obliged to a specific health treatment except by law;
- on the other hand, therapeutic medical treatment has regard to the protection of the (different) fundamental right to health.
- In the absence of informed consent, the intervention of the doctor is (apart from cases of compulsory medical treatment or in which a state of necessity occurs) certainly illegal, even when it is in the patient's interest.
- The obligation of informed consent constitutes the legitimacy and foundation of health treatment with information about the foreseeable consequences of the treatment to which the patient is subjected in order to put him in conditions of knowingly consenting to it (execution, risks, "unalteration" that is null and void outcome and its uselessness).
- The duty of the facility and the doctor is to inform the patient in order
- the nature of the intervention,
- at its risks,
- the possible and probable achievable results,
- the verifiable implications
- a language he understands,
- also taking into account the subjective state and the degree of specific knowledge available.
- Informed consent must always be acquired
- both in the case of low probability (fortuitous case)
- both in the case of high probability (almost certain case)
for an accurate risk assessment by the patient as the holder of the right and therefore the health facility and the professional cannot fail to provide all the necessary information.
- Consent must not only be informed but also free. It can never be presumed or tacit, but must always be expressly provided, after adequate, explicit information that allows the patient to choose between the different possibilities or to refuse or interrupt.
- It is the responsibility of the structure and the doctor to prove the fulfillment of the obligation to have provided complete and effective information on the treatment and its consequences and in this regard pay attention to any improper procedures and among these the submission by the patient of a form completely generic.
In this regard the importance:
- various notes on the pre-printed form;
- documentation and testimonies of previous doctor-patient meetings regarding the pathology, the intervention and possible complications.
It is also clear from the above that both the structure and the doctor are responsible in the face of a flawed consent: the structure for not having supervised, the doctor for having collected a flawed consent.
Criminal Cassation Section IV - 02/12/2019 sentence no. 50619
Senior delegating physician
The "delegating" top doctor does not completely free himself from his original position of guarantee, maintaining a position of supervision, direction and control over the work of the delegates: there would in fact be a power-duty on the part of the senior medical manager to dictate directives general and specific, to supervise and verify the autonomous and delegated activity of the doctors assigned to the structure, and finally the residual power to take over the management of individual patients.
Civil Cassation Section III - 15/01/2020 dep. 26/05/2020 Ord. 9887
Flawed informed consent - The patient must demonstrate that if properly informed he would not have been operated on
The Court of Cassation underlines first of all that in the medical field, the manifestation of the patient's consent to surgery is an expression of the right to self-determination, which has its foundation as sanctioned by Articles 2, 13 and 32, paragraph 2, of the Fundamental Charter of Rights. However, he specifies that, when the patient takes legal action because he believes that his right to self-determination has been violated, it is his responsibility to prove that due to incomplete or incorrect information from the healthcare professional, he would have made a different choice, such as postponing the operation, choose another specialist or do not undergo surgery at all.
Civil Cassation Section III - 04/02/2020 dep. 19/08/2020
Omitted informed consent: the possibility of a refusal is not enough
Compensation for failure to inform consent cannot be based on the possibility of a refusal of the intervention.
The right to compensation for damage in the event of omitted informed consent can also be triggered when the patient, following the operation, has suffered damage to health but has not been able to demonstrate the responsibility of the doctor.
In this case, in fact, the right to self-determination has been violated and that is enough to determine a hypothesis of medical responsibility.
However, the right to self-determination is not always compensable, but only when the patient is able to demonstrate that, if he had been in possession of the information that was not provided, he would have refused the intervention and, possibly, would have addressed to another facility.