In the past, everything concerning the medical act fell within the discretionary power of health professionals.
The patient had no right to be informed about his state of health and had no say in the care provided. Considered as a simple ethical duty, the disclosure of medical information was subject only to the sole will of the doctor.
The patient's right to be informed about his state of health and its corollary, the doctor's obligation to inform his patient, is the result of a long development in case law enshrined in the Kouchner law known as “on the rights of patients” of 4 March 2002.
The patient, now involved in the decision-making of care concerning him, must have all the information relating to his state of health, because, it is up to him and, except in emergencies, to him alone, that will rest with the final decision. 'accept, or refuse, a treatment or an operation.
The recognition of this principle of autonomy of the patient's will has reinforced the obligation to inform the doctor who will be held responsible for the slightest breach.
The foundations of the information obligation
An ethical duty
The code of medical ethics specifies in article 35 that " The doctor owes the person he examines, treats or advises, loyal, clear and appropriate information on his condition, the investigations and the care he offers. ».
Any breach of this principle will result in disciplinary proceedings.
A jurisprudential principle
It was in the Mercier judgment of May 20, 1936, that the Court of Cassation recognized for the first time the existence of a care contract binding any patient to his doctor and, on whom now weighs, the obligation to provide "conscientious, dedicated, attentive care in accordance with the data acquired from science"
The Teyssier judgment rendered on January 28, 1942 by the appeals chamber of the Court of Cassation, will specify the extent of the obligation to inform the doctor which must be delivered with clarity and humanity: “ the duty of conscience, with regard to respect for the human person order clear information from his patient and the collection of his informed consent for the care envisaged and provided ».
To be specified: The duty to inform weighs independently on each healthcare professional, whether it is a doctor, anesthesiologist, surgeon, etc. No one involved in the care pathway can consider himself freed from his duty to inform on the pretext that one of his colleagues had informed the patient.
A legal obligation
Both nationally and internationally, legal sources referring directly or indirectly to the obligation to inform have multiplied in recent years.
The duty to inform the patient is imposed by:
- Articles L.1111-2, R. 4127-35 and R. 4127-36 of the public health code.
- Article 16-3 paragraph 2 of the Civil Code “The consent of the person concerned must be obtained beforehand except in the case where his condition necessitates a therapeutic intervention to which he is not able to consent”.
- Article 3 of the Charter of Fundamental Rights of the European Union, which imposes, in addition to the "right [of everyone] to their physical and mental integrity", that "in the context of medicine and biology, must in particular to be respected […] the free and informed consent of the person concerned, in accordance with the procedures defined by law ”.
- The Charter of Fundamental Rights of the European Union adopted in Nice on September 7, 2000.
- The convention on human rights and biomedicine signed in Oviedo on April 4, 1997.
The content of the information obligation
The criteria for the content of the information are specified in article 35 of the code of medical ethics and often taken up by case law: " Information must be clear, fair and appropriate ».
The information is transmitted during an individual interview and must be understood by the patient. The doctor must adapt as much to the personality as to the level of intellectual and psychological understanding of his patient.
Because providing information is not everything, there is also the art and the manner of announcing it. Which requires a minimum of attention and humanity.
Any information delivered in a brutal and/or incomplete manner will be deemed faulty and a source of moral prejudice.
A patient had to undergo a partial ablation of the colon, but following a cerebral accident which occurred during the operation, the doctors operated on the total ablation of the colon. There was no therapeutic alternative and the total ablation responded to a vital emergency.
However, the judges sanctioned the conditions of delivery of the information which was done in a brutal way in the middle of medical students, without the patient understanding the meaning, until she consult his medical file (Administrative Court of Appeal of April 7, 2005).
Information must also come at the right time. The legislator has provided that the patient must be informed both before, during and after the medical act.
Information prior to the medical act
The doctor is required to inform the patient about:
- His state of health: Specify the pathology from which the patient is suffering and its possibilities of evolution.
- The envisaged medical act: This covers all the treatments and examinations that can be carried out with an explanation of the results obtained; the treatments and preventive actions that can be considered with regard to the advantages and disadvantages; their usefulness, the urgency of practicing them ...
- Consequences: these are frequent or foreseeable risks, from the most trivial to the most serious; the therapeutic alternative solutions and the risks incurred in the event of refusal of the proposed procedures.
Note: Civil and administrative case law was more severe since it made the doctor responsible for informing the patient of all “serious risks, even exceptional ones”. (1st civ. October 7, 1998 – CE January 5, 2000). While the Kouchner law only considers “frequent or serious risks that are normally foreseeable”. A serious risk is one whose consequences are fatal or disabling.
The particular case of cosmetic surgery
The case law included in article 6322-2 of the public health code considers that a medical act devoid of therapeutic necessity places a heightened obligation on the doctor to provide information. The information covers all the risks and complications incurred, the prices charged and a statutory cooling-off period of 7 days.
Information after the medical procedure
The doctor's obligation to provide information does not end with the operation.
Once performed, the doctor is required to inform the patient about how the medical procedure took place. If the operation did not go as planned, the patient has the right to full information on the causes and consequences that the harmful act may entail.
- Article 1111-2 of the Public Health Code extends the obligation to postoperative risks, to all the precautions to be taken and to the treatment performed.
- Article 1142-4 of the public health code imposes, in the event of damage occurring after the medical act, monitoring of the patient with interviews to be carried out all 15 days.
- In this case, article 1111-7 of the public health code allows "any person direct access to all information concerning their health, held by health professionals and personnel". In all cases, the patient must have access to his medical file.
Details: The information relates only to the risks known to the doctor. Knowledge evaluated with regard to the data acquired from science.
Beneficiaries of the right to information
Minors have the right to be informed and to participate in decision-making. It is up to the holders of parental authority to inform it. However, the law of March 4, 2002, allows minors to oppose their parents 'medical confidentiality on their state of health and allows doctors to perform acts without the parents' consent.
According to Article L. 1111-5 of the Public Health Code, amended by Law No. 2016-41 of January 26, 2016, “ By way of derogation from article 371-1 of the Civil Code, the doctor or midwife may dispense with obtaining the consent of the holder (s) of parental authority on the medical decisions to be taken when the preventive action, screening, diagnosis, treatment or intervention is necessary to safeguard the health of a minor, in the event that the latter expressly opposes the consultation of the holder (s) of parental authority in order to keep the secret of his state of health. However, the doctor or midwife must first try to obtain the minor's consent to this consultation. If the minor maintains his opposition, the doctor or midwife can implement the preventive action, screening, diagnosis, treatment or intervention. In this case, the minor is accompanied by an adult of his choice."
"When a minor, whose family ties are broken, benefits personally from the reimbursement of benefits in kind from health and maternity insurance and from the additional cover set up by law 99 641 of 27 July 1999 on creation of universal health coverage, his sole consent is required. »
Article 1111-2 of the CSP provides that the doctor must adapt to the discernment capacities of the adult under tutorship in order to obtain his consent in the same way as that of the tutor.
Informing relatives and family
The principle is that the information is due to the patient and not to third parties, such as relatives or family. The court of cassation recalled that if the patient had understood the information and consented to the operation (following which he died), the doctor was not bound by the obligation of information towards the widow or the patient's children.
This supposes, on the contrary, that the exception to this rule of confidentiality is admitted when the patient is not in a state to consent to the medical intervention (Cass, civ. 1st December 6, 2007, no. 03-19.365).
Except in the event of express opposition from the patient, article 1110-4 of the public health code provides that in the event of a serious prognosis, medical confidentiality does not apply to relatives, people of trust and the family. of the patient (determined by the patient himself as permitted by article 1111-6 of the Public Health Code) in order to provide him with support.
Clarification: If the attending physician refers the patient to a specialized physician, it is the latter's responsibility to inform the attending physician of the results, conclusions and suggestions for appropriate treatment following the examination carried out. In a judgment, the Court of Cassation held the responsibility of a radiologist who, by not transmitting the results of a mammogram to his colleague, caused a delay in the diagnosis of the patient's breast cancer. (Cass, civ. 1st November 29, 2005, n°04-13.805).
Proof of information
Previously, it was up to the patient to prove that he had not received sufficient information. Which ultimately was impossible to prove! Jurisprudence will therefore lay down the principle of the burden of proof by a Hédreul judgment (Cass, civ. 1ère of February 25, 1997 n°94-19. 685) which places on the doctor the proof that he has fulfilled his obligation of information.
"Anyone who is legally bound by a particular obligation to inform must provide proof of the fulfillment of the obligation... The doctor is bound by an obligation to inform his patient and it is his responsibility to to prove that he has fulfilled this obligation. »
The so-called Guyomar case law (Cass, civ, October 14, 1997 n ° 95-19.609), will relax the system of proof weighing on the doctor by allowing him to demonstrate that he has fulfilled his obligation to provide information "by all means" . This principle is now codified in article 1111-2 of the public health code.
Evaluated in the light of serious and concordant precise presumptions, case law has thus taken into account:
- The long interviews with the patient who had expressed hesitation and anxieties before deciding to have the operation.
- A correspondence between colleagues providing for additional analyzes which appeared in the medical file.
- Letters sent by the surgeon to the attending physician stating that he had informed the patient of the disorders resulting from the treatment.
Conversely, the refusal of an act by the patient is not enough to demonstrate that he was sufficiently informed of the consequences incurred following the refusal.
Clarification: As we have seen, information must be provided during individual interviews. In the event of prosecution, there will therefore be a problem of proof. Health professionals then took care to protect themselves with a written document in order to pre-constitute proof. This could be information forms containing the care protocol… which will necessarily be signed by the patient.
However, these documents constitute only one mode of proof among many others. They do not bind the patient who can validly question them.
From a legal point of view, the obligation to inform is not understood as an inventory at the Prévert listing on 30 pages all the undesirable effects and all the risks involved, nor a summary of the Vidal for Dummies. It is an exchange during which the "knowing", the doctor, shares his knowledge with a "layman", the patient, by putting himself at his level, in order to allow him to understand what is wrong with his body and explain to him how it will be possible to cure him.
Similarly, you should know that some of these documents may include exonerating or limiting liability clauses: they have no value!
Nothing can exempt the doctor from his obligation to provide information. If not… to provide clear, fair and appropriate information during an individual interview. Unless the doctor, debtor of the information obligation, asserts a legal exception.
The limits of the information obligation
Three limits moderate this right to information.
Article 1111-2 of the public health code, amended by the law of January 26, 2016, recognizes only two cases allowing the doctor to limit the information due to the patient: urgency and the impossibility of informing. While article 1111-4 of the public health code grants the patient the right not to be informed.
The patient's refusal to be informed
The right to know necessarily has as a corollary the refusal to know. As a result, the patient may decide not to be informed about his state of health. Unless there is a risk of disease transmission to third parties.
However, the doctor should not be satisfied with a simple refusal. He must inform him of the risks and consequences of his refusal. The patient can also refuse the proposed care. Article 1111-4 of the public health code provides for the obligation for the doctor to respect the wishes of the patient who can refuse or interrupt any treatment, even if this puts his or her life in danger.
However, the doctor is not released from his obligation to inform, he must then specify to the patient all the risks that this refusal entails and do everything possible to convince the patient to reconsider his decision. The doctor will only be exonerated from his liability if the patient has been sufficiently informed (Cass, civ 1ère November 15, 2005).
The doctor's inability to inform his patient
This concerns two distinct hypotheses:
Articles L.1111-4 and R. 4127-9 of the public health code require the doctor to act even without the patient's consent if there is a danger to his life.
This covers the case of an unconscious person admitted urgently to a care establishment. If the person is accompanied by their family or a loved one, the doctor has the option and not the obligation to seek their opinion.
The impossibility of informing
The doctor may act without the patient's consent if he is unable to transmit the information to the patient or if he is faced with a therapeutic exception.
The problem of understanding
The term impossibility covers several notions, whether it is an impossibility of material understanding (with a foreign patient) or psychological (decrease in intellectual faculties). Case law regularly admits that the information given to the patient is limited in psychiatry (Cass, civ. 1st May 23, 2000, n ° 98-18.513).
This impossibility of informing also covers cases of legitimate conscience of the doctor faced with a serious diagnosis or prognosis: this is the “therapeutic exception”.
The therapeutic exception
Provided for in the old article 35 of the medical code of ethics, and now codified in article R.2147-35 of the public health code, the doctor can decide in all conscience to delay, to minimize, or even not to inform the patient on his actual state of health.
This provision allows doctors, faced with a risk of imminent death or a serious prognosis, to adapt their speeches to psychologically weakened patients to whom the announcement of an imminent or irremediable death would cause a psychological shock.
This power to limit or withhold information is not easy to implement. Especially since this legitimate choice of the doctor has very murky contours. Thus, case law does not accept this right to silence on the sole ground that the operation was inevitable (Cass, civ. 1st July 18, 2000 n°99-10.886). This choice, even made in conscience, should only be considered from the point of view of the patient's interest.
Apart from these exceptions, the patient has a right to information which should enable him to participate in all decision-making concerning his state of health. In the event of a breach of his obligation to inform, the doctor will have committed a fault liable to engage his civil liability.