Tres claves del consentimiento informado

responsabilidad sanitaria

El consentimiento informado no tiene que referirse a la totalidad de los riesgos posibles que pudieran derivarse de la actuación médica.

This was understood by the Supreme Court in its judgment of 24 November 2016, en la que se absuelve al demandado del pago de 787.000 € por considerar que se informó suficientemente al paciente sobre los riesgos de la operación.

The factual background were the following:

D. Norberto, which it had been operated on for cancer and treated with radiation therapy to the neck and jaw to 03/1997, he went to the clinic in Tuñón SL 07/2008 mobility problems dentures in both jaws. indicó que había sufrido cáncer y sido tratado con radio, I was smoking a pack of cigarettes a day, and not taking any medication or had medical problems except "poor circulation".

The 30/07/2008, informed consent after signing day 28/07/2008, you were placed five lower jaw implants prior panoramic radiograph. Such implants caused him pain, so D. Norbert was treated with tetracyclines washings and placing human collagen. The treatment had no effect, and after some consultation, clinical tests and admission to hospital, Day 20/10/2008 ONJ was detected, confirmed the 29/10/2008. A result of the operation of implant, D. Norberto was badly damaged in the face and neck, scars and unable to speak, open your mouth and eat naturally.

So things, D. Norberto filed suit against the clinic Tuñón SL, D. Gabino, it was the owner, y WR. Berkley España SL, D insurer: Gabino, en reclamación de 787.000 € for material and moral damages resulting from the failed implantation of the implants and the lack of information of informed consent.
Dicha demanda fue estimada íntegramente por la sentencia de 25/04/2013, the Court of First Instance No. 03 Oviedo, to understand that in the phase of "preoperative" D. Gabino and clinical Tuñón SL did not act with due diligence, to the extent that, considering the medical history of D. Norberto (cancer surgery, with poor circulation), they did enough evidence to prove the potential risks of the operation of the five implants, so that these were made in haste and taking serious risks which he never reported to D. Norberto, without the informed consent document explained nothing about the risks that the wounds will not heal, stitches or that the bone is damaged by pretreatment with radiation to break loose.

Against that judgment, los demandados interpusieron appeal, which it was estimated by the Provincial Court of Oviedo in Case 11/11/2013, concluding that D. Norberto had not suffered osteonecrosis, but a osteorradionecrosis, so that the causal link between the conduct of the defendants and the damage suffered by D. Norberto was broken, to the extent that they had been caused by a pathology not apparent nor predictable, and without being able to appreciate professional negligence by D. Gabino and medical. A lo anterior añadía la sentencia de segunda instancia que el documento de consentimiento informado sí contenía suficiente información sobre los riesgos de la intervención.

La parte demandante interpuso appeal contra dicha sentencia, basing it on the breach of Article 10.1 b), c) and d) law 41/2002, of 14 November, Basic regulating patient autonomy and rights and obligations regarding clinical information and documentation.
In relation to the first ground, the appellant contended that informed consent warned not D. Norberto of the risks, as patient treated with radium, He presented in relation to the operation of five implants. According to the appellant, that lack of consent, He combined with improvisation and speed with which the operation was performed, considering the complexity plus a patient as D. Norberto involved, means that the clinical and D. Gabino acted negligently.

In relation to this plea, the Supreme Court recalls that the following are the fundamental characteristics of informed consent:

– It is essential budget and the lex artis and is part of any action assistance, constituting an ethical and legally enforceable requirement for members of the medical profession(SSTS 29 May; 23 July 2003; 21 December 2005; 15 November 2006; 13 and 27 May 2011; 23 October 2015).

– It includes diagnosis, prognostic and therapeutic alternatives, with its risks and benefits.

– In cases of curative medicine, It does not include the obligation to provide detailed information on the risks that do not have a typical character, provided that they are not exceptional or extraordinary gravity (SSTS 28 December 1998, 17 April 2007, rec. 1773/2000, and 30 April 2007, rec. 1018/2000).

In that sense, the Supreme Court recalls that the information D. Norberto facilitates the medical clinic, He is stating that it was not subject to any medication, it provoked treat him as an ordinary patient without additional risks. Ello, joined the determining vascular pathology of the damage was not patent, and in the informed consent document related risks punishment and sedation is indicated, determines that the defendants have performed proper compliance with the obligation to provide information to the patient of the risks involved in the intervention, without requiring them fit to report on each and every one of the possible risks and potential (STS 30 April 2007).

Por lo anterior, the Supreme Court rejected the appeal and confirmed the judgment on appeal, in the sense acquit the defendants of the obligation to indemnify D. Norbert in the amount of 787.000 €.

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