[DOCTOR'S DUTY TO INFORM - EXCEPTIONAL SERIOUS RISK]

[MEDICAL AND PARAMEDICAL PROFESSIONS - DOCTOR - MEDICAL LIABILITY - DUTY TO INFORM - DIGNITY - EXCEPTIONAL RISK - LEGAL CERTAINTY]

🚨The doctor's duty to inform is likely to affect the validity of the patient's informed consent to a medical act or treatment.

⚖️ In a French Cour de Cassation case law of 9 October 2001, a doctor had monitored a patient's pregnancy. The delivery took place on the patient's bed at home on a basin. The doctor and a midwife each held one of the woman's legs. Because of the breech presentation, the baby's arms were raised. During the obstetric manoeuvres, the child's shoulders became dystociated, resulting in bilateral paralysis of the right brachial plexus, and his partial permanent disability after consolidation was estimated at 25%. An expert report submitted to the court stated that the manoeuvres performed on the basin to treat the dystocia "were certainly not made any easier" (Cour de Cassation, 1st Civil Division, 9 October 2001, 00-14.564).

After coming of age, the child brought an action against the doctor and the clinic. The first argument concerned a fault made during the delivery. The second argument concerned a failure to inform the mother of the risks inherent in a breech presentation when vaginal delivery was preferred to a caesarean section.

In its decision, the Lyon Court of Appeal held that the a failure to provide information about the risks could not be established since the "doctor was not contractually obliged in 1974 to provide full information about the complications associated with the investigations and care proposed, especially as the risk in this case was exceptional".

The Cour de cassation did not agree with this interpretation and ruled that a doctor cannot be exempted from his duty to inform his patient, even if the serious risk involved was exceptional. This obligation is incumbent on all doctors, whether self-employed or hospital-based.

The Cour de cassation also enshrined the principle that "no one can claim an acquired right to a case law frozen in time".

⚠ The principle of informed consent by the patient is an essential principle in healthcare.

According to established case law, "the consent of the person being examined or treated must be sought in all cases. (...) If the patient is incapable of expressing his wishes, the doctor may not intervene unless the dersignated person of trust, or failing that, the family or a close relative, has been informed and notified, except if it would be urgent or impossible to do so". (Article 36 of the Code of Medical Ethics; Article R.4127-36 of the Public Health Code); Law no. 2002-303 of 4 March 2002). "Every person makes decisions concerning his/her own health, together with the healthcare professional and in the light of the information and recommendations provided to him/her. Every person has the right to refuse or not to receive treatment. The doctor is obliged to respect the person's wishes after informing him/her of the consequences of his/her choices and the seriousness of those consequences. (...) No medical procedure or treatment may be carried out without the free and informed consent of the person concerned, and this consent may be withdrawn at any time." (Article L. 1111- 4 of the French Public Health Code).

However, there is a limited exception: "When the person is incapable of expressing his or her wishes, no intervention or investigation may be carried out, unless it is urgent or impossible (...)" (Article L1111- 4 of the French Public Health Code). "Any doctor who is in the presence of a sick or injured person in danger, or who is informed that a sick or injured person is in danger, must provide assistance or ensure that he or she receives the necessary care" (Article R. 4127-9 of the French Public Health Code).

The Cour de cassation points out that the doctor's duty "to provide the patient with care that is attentive, conscientious and in line with the latest scientific knowledge includes the duty to obtain precise information about the patient's state of health, in order to assess the risks involved and enable the patient to give informed consent". Article L111-2 of the French Public Health Code states that "everyone has the right to be informed about their state of health". This information must be fair, clear and appropriate (Article 35 of the Code of Medical Ethics; Article R.4127-35 of the Public Health Code), which would not be the case when "the indication given regarding side effects is vague and does not make it possible to know the risks actually mentioned, the only one expressly cited being the well-known one" in view of the information and documents presented to the patient as a whole (Cour de Cassation, 1st civ., 9 September 2020, 19-10.404).

Even when no fault can be attributed to the doctor in the performance of a technical therapeutic act, his responsibility relating to his information obligation cannot be set aside, subject to certain restrictively applicable limits. Indeed, a doctor cannot be exempted from his duty to inform his patient, which is based on the requirement to respect the constitutional principle of safeguarding human dignity. This obligation applies even if the serious risk in question occurs only exceptionally (Cour de Cassation, 1ère civ., 9 October 2001, 00-14.564). In this respect, the Conseil d'Etat has accepted that: "when the medical act envisaged, even if performed in accordance with the rules of the art, involves known risks of death or invalidity, the patient must be informed under conditions that enable him or her to give informed consent; while this information is not required in cases of urgency, impossibility or refusal by the patient to be informed, the mere fact that the risks are only realised exceptionally does not relieve practitioners of their obligation" (Conseil d'Etat, 5 January 2000, rulings n°198530 and n°181899). In this context, the Agence nationale d'accréditation et d'évaluation en santé (‘ANAES’) drew up recommendations in this regard in its publication entitled ‘Information des patients. Recommendations for doctors’ (March 2000).

It is the doctor's responsibility to prove that he has informed the patient of the risks of the treatment or investigation he is proposing (Castagnet, Civ.1ère, 7 October 1998, no. 97-12185 ).

Medical liability may be sought in the event of a breach.

In principle, the patient would be entitled to compensation for the loss of the opportunity to avoid the damage through appropriate and complete information. However, experience in the courts shows that the quantum of damages awarded is often proportional or equivalent to that which the patient would have obtained to compensate for the final loss constituted by the disability itself.