General characteristics
The general characteristics of the cases involved in this study are presented in
Table 1. Among 13 patients, seven (54%) were male. The sex of six patients (46%) was not identified. The number of patients aged below 60 was three (23%), and above 60 was four (31%). The age of the other six patients (46%) was not identified. Regarding the type of defendant institution, six cases (46%) were from general hospitals and seven cases (54%) were from tertiary hospitals. According to the diagnoses, six patients (46%) had angina pectoris.
Among the patients with angina pectoris, three (23%) had stable angina, two (15%) had unstable angina, and one (8%) had unclassifiable angina. Seven patients had MI (54%). Among the patients with MI, two (15%) had NSTEMI, three (23%) had STEMI, and two had unclassifiable MI.
The most common complication that caused the disputes was coronary artery injury with six cases (46%), including three cases (23%) of coronary perforation, two cases (15%) of coronary dissection, and one case (8%) of iatrogenic atheroma rupture. In relation to device failure, there was one case (8%) of stent thrombosis and one case (8%) of residual stent balloon after deflation failure. Disease-related complications included atrioventricular (AV) block, myocardial rupture, and suspected ventricular fibrillation or spasm, with one case each.
The complications resulted in the death of 11 patients (85%), one patient had hypoxic brain damage, and another patient had to undergo follow-up out-patient department care due to ischemic heart failure. A detailed summary of all the cases is listed in
Table 2.
Violation of duty of care
Four cases were ruled in favor of the plaintiff (from 13 total cases that claimed violation of duty of care) (
Table 4). Of them, three were ruled as performance error and one as diagnostic error around the course of PCI.
As can be seen in
Table 2, the cases were titled according to their date. In case no. 1, there was a no-reflow phenomenon after stent deposition, and repetitive balloon dilatation was performed on the lesion of the coronary artery. Thereafter, coronary perforation occurred. Negligence was recognized because of perforation from repeated balloon dilatation without identification of the cause of the no-reflow phenomenon, despite no high-risk lesions, such as calcified or tortuous lesions, having been observed.
In case no. 3, revascularization, such as thrombolysis or PCI, was delayed for seven hours because of a misdiagnosis of acute MI based on the presence of Q wave on the electrocardiogram (ECG), leading to a diagnosis of recent MI. The court recognized the misdiagnosis based on the existence of ST-segment elevation on the ECG and the cardiac marker, with initial normal range, becoming elevated in a matter of hours. Therefore, the court determined that there had been negligence by the physician because there was a causal relationship between misdiagnosis, delays in revascularization, and death.
In case no. 6, negligence of inappropriate device manipulation was identified because of acute thrombotic occlusion caused by iatrogenic atheroma rupture with a device such as a guidewire or intravascular ultrasound (IVUS) catheter. Delayed revascularization by two episodes of guidewire distortions and guidewire also repeatedly stimulated myocardium and induced ventricular fibrillation.
In case no. 11, Adams-Stokes syndrome (characterized by a decrease in cardiac output and loss of consciousness due to a transient arrhythmia such as AV block or tachy-brady syndrome [
9]) occurred from decreased cerebral blood flow after AV block-induced bradycardia, resulting in cerebral infarction. The court ruled that although death itself is highly likely due to MI and cardiogenic shock, there was a causal relationship between cerebral infarction, the fact that a temporary pacemaker should have been inserted, and, possibly, death. In the end, physician negligence was determined.
On the other contrary, nine cases with a total of 28 issues related to violation of duty of care were dismissed (
Table 5). Errors in management after complications and procedural skills were alleged by the plaintiffs in most of the dismissed cases.
The court pointed out that the plaintiff must prove the physician’s fault, such as by exhibiting a substandard level of medical knowledge or skill or any violation of fiduciary duty. Thus, evidence should be presented to prove the physicians’ fault, but in most dismissed cases,
Table 3. Details of awarded amounts there was insufficient or no evidence of malpractice. For example, in a case in which the patient presented with sudden death three days after PCI, and aortic dissection rupture was confirmed after an autopsy, the plaintiff alleged the following: (1) aortic dissection may be misdiagnosed as unstable angina based on chest pain prior to the procedure and (2) aortic injury had occurred during the procedure based on the patient’s severe back pain after PCI. The court judged that the diagnosis of unstable angina was not a deviation from standard care, based on the stenosis of vessels on the CAG and the improved symptoms after PCI. There were no findings indicating aortic dissection, such as mediastinal widening around the procedure. In addition, the court recognized that severe back pain, not a specific symptom for suspecting aortic dissection, may occur due to supine position on bed required to prevent bleeding after the procedure. Therefore, the possibility of aortic dissection around the PCI was not proven due to lack of evidence.
Claims based on nonspecific symptoms alone or other diseases showing lack of probability were dismissed. In a case with stent thrombosis, the plaintiff claimed that there was delayed recognition of the complication despite the complaint of nonspecific chest discomfort. However, the court dismissed the claim because non-specific chest discomfort frequently occurs after a PCI. In addition, as there were no signs of MI on the ECG, it was judged that a CAG was not urgent. In a case with hemothorax confirmed after cardiopulmonary resuscitation (CPR), the plaintiff claimed that the hemothorax was a procedure-related complication. However, the judge denied that there was a causal relationship, as hemothorax is not a common complication, and hypovolemic shock should have occurred immediately if the aorta had been injured during the procedure. Furthermore, the patient had no complaints until the next morning. In addition, the court commented that a proximate causal relationship between the physician’s negligence and the consequences, when there is a lack of probability, is not acceptable.
The court did not accept negligence only based on the fact that an adverse outcome had occurred. If complications occurred despite the physician’s practice of medicine with a high standard of care, the court judged whether the given complication was outside of the generally accepted range based on the contents of the medical practice and procedures, the site and degree of the complication, the standard level of medical care at that time, and the proficiency of the physician in charge. In contrast to a previous case of coronary perforation in which the plaintiff was partially awarded, the court dismissed the plaintiff’s claim that perforation occurred due to procedural error ruling that negligence is not recognized by that fact alone in two other cases of coronary perforation. In one of the two case, the court dismissed the plaintiff’s claim that the unreasonably expanded balloon led to the coronary artery perforation because contrast leakage was detected at the end of procedure, not immediately after the balloon dilatation. In the other case, the court recognized that there was no definitive evidence (such as the size, length, or pressure of the balloon, or inflation time, etc.) that the physician had violated the standard of care. In a case of stent thrombosis, the plaintiff claimed that it originated from the possibility of stent underexpansion. However, the court recognized that stent thrombosis is an unavoidable complication (with less than a 1% probability), and there is no way to expand the stent completely to contact the entire vessel area in the current level of medical care. The reasons provided were the size discrepancy of the proximal and distal reference vessels and the possibility of coronary dissection occurring when the balloon is inflated using higher pressure. Finally, the judge did not accept the allegation that disputed complications are beyond the range of general acceptance. In a case of deflation failure and residue of balloon in the vessel, the court dismissed the claim ruling that defects in the balloon itself could not be ruled out, and that there was no proof of the physician’s malpractice. Additionally, in both dismissed cases of coronary dissection, negligence was not determined based on lack of evidence during the physicians’ procedures.
Violation of duty of explanation
In nine of 13 cases, the plaintiffs insisted that the physicians had breached their duty of explanation. Two of those cases were admitted. In both cases, violations were recognized for the following reasons (
Table 6).
In case no. 5, there was a manual description that emphasized the necessity of the procedure, but no information on the possibility of adverse outcomes. In case no. 9, a specified description about coronary dissection was not given, and only the unspecified vascular complications were mentioned. Additionally, the fact that it was a non-emergency situation was pointed out to support the infringement of right to self-determination through lack of explanation. For reference, the consent form being signed on the day before the procedure was highlighted to support the violation of duty of explanation in the first instance but not commented on in appeal.
The judgments noted that there was no additional explanation regarding details other than those printed in both cases. In general, to determine whether the situation was explained in detail, the court considered the presence of additional drawings such as circular marking or underlines on the printed contents, at least, as explanation.
In contrast, the other seven cases were dismissed for the following reasons. In four cases, from the evidence submitted, it was identified that sufficient informed consent was taken. In two cases, the plaintiffs claimed that the physician who explained the procedure was not the one who performed it. However, in both cases, the court ruled that the physician's performance itself was not negligent.
Lack of detailed explanations about unexpected critical consequences was claimed in one case, but it was dismissed because the scope of duty of explanation does not include explanations that are irrelevant to the procedure. As an example in case no. 2, the court recognized that the hemothorax that occurred after CPR was an irrelevant complication of the procedure considering the circumstances surrounding medical practice.
Regarding the signing of the agreement, in one case, the plaintiff claimed that the wife had signed on the agreement, not the patient himself, and that was a breach of duty. However, the court dismissed this claim recognizing the circumstances wherein explanation was given to both the patient and his wife.
In another case, the plaintiff claimed that there was no explanation regarding the capacity of the healthcare provider and the entire system to cope with an emergency if it did occur. The court ruled that an emergency could occur in any procedure, and in that case, the patient could be transported to a tertiary hospital, as a simple matter of common sense. In a situation wherein the plaintiff did not request further explanations about emergency handling, the court ruled that the extent of a physician’s explanation does not include a guarantee for the choice of selecting other hospitals by preemptive self-notification.