Case 247/2010

Jose Pablo underwent surgery to correct his atlantoaxial luxation, a disorder that impairs rotation of the neck. He and his family believed that he was undergoing a simple and routine procedure, although this turned out not to be the case. Jose Pablo suffered quadriplegia as a result of the surgery, due to the misplacement of the medullary canal of the iliac crest graft that was installed during the surgery, and died shortly thereafter. Jose Pablo and his family had not known that quadriplegia was a risk, and denied that they were informed of such a danger. The appellants, the Regional Government of Castilla-La Mancha and the insurer Zurich, countered that the patient signed a contract detailing the risks of the procedure, and that the aforementioned document specifically listed quadriplegia as a potential risk.

The plaintiffs brought suit in the Administrative Litigation Court n. 2 of Toledo. The Administrative Litigation Court, holding that the Public Health Administration did not fulfil its informational obligation to Jose Pablo, awarded plaintiffs 102,655.04 Euros, plus legal interest.

Appellants appealed to the Superior Court of Justice of Castilla-La Mancha

The Court held that the health care providers did not meet their burden of obtaining informed consent from the patient and dismissed the appeal.

The Court pointed to Law 41/102, which concerned regulation of health information and documentation, as evidence that the health care providers in this instance failed to meet the burden of obtaining informed consent. Article 3 of the law stated that “the free, voluntary and conscious approval of the patient, being of sound and disposing mind and memory, after receiving all pertinent information in order to undergo medical action.” The Court also cited Article 4.2, which required that the patient receive the information “in a comprehensible and adequate way.”

The Court then laid out the standard that health care providers must meet: (1) they must inform the patient of certain consequences of the procedure, (2) they must disclose probable risks, personally and professionally, for the patient if she undergoes the procedure, and (3) they must let the patient know of likely risks under normal circumstances in accordance with the current state of the science on the matter.

The Court also stressed that the lack of informed consent causes “moral damage” and undercut patient autonomy. Such damage justified pecuniary compensation.

Finally, the Court looked at the text of the contract that appellants pointed to as evidence of informed consent and found that the document did not go into enough detail nor provide enough information about the relevant risk to qualify as informed consent.

“Article 3 points out that informed consent is “the free, voluntary and conscious approval of the patient, being of sound and disposing mind and memory, after receiving all pertinent information in order to undergo medical action”; this right does not only include receiving true information, but also “in a comprehensible and adequate way”, helping him to take the right decision according to his own will (art. 4.2). Therefore, the doctor will have to provide the patient the following information: pertinent or important consequences that the surgery will definitely have, probable risks that personal or professional circumstances of the patient might lead to, likely risks under normal circumstances with accordance to the experience and state of science or directly related to the type of surgery” [Second section]

“The absence of informed consent led to serious moral damage, which consists on the injury to the patient’s right of autonomy, different of the physical damage that, might have been caused by the surgery. This gives rise to a pecuniary compensation by the health administration and has to be considered without taking into account if there was malpractice or not (Supreme Court Ruling 3, Section 6, dated 9 March 2005, appeal n. 2562/2001).” [Second section]