Ethical Issues Around the Withdrawal of Dialysis Treatment in Japan

Abstract

In Japan, terminating life-sustaining treatment (LST) in non-terminal patients is legally and ethically problematic given the lack of legal regulations regarding the termination of LST, including dialysis treatment. This article describes an ethically problematic case that happened at a hospital in Tokyo in March 2019, in which a patient died after a physician withdrew kidney dialysis upon the patient’s request. Most national newspapers in Japan reported the case extensively and raised the question of ethical and legal permissibility of withdrawing dialysis treatment from non-terminal patients. In this article, we first examine the case within the current policy framework in Japan and then discuss how Japan can improve its end-of-life practice, focusing specifically on the patient’s right to self-determination and treatment refusal. We recommend that policymakers consider legalizing the termination of LST and the patient’s right to refuse treatment based on the principle of respect for autonomy.

Introduction

The number of dialysis patients in Japan was roughly 330,000 in 2017 but has been increasing every year (Nitta et al. 2018). Dialysis is an effective treatment that allows patients with end-stage renal disease (ESRD) to maintain and live a relatively normal life. Increasingly more ESRD patients have come to rely on dialysis as life-sustaining treatment (LST) for long periods of time, primarily because patients undergoing dialysis treatment tend to be elderly (mean age of patients who initiated dialysis treatment in 2017 was 69.68 years; Watanabe et al. 2015) but also because the number of living and cadaver kidney transplants remains low (approximately 1700 in 2017; the Japan Society for Transplantation 2019). The number of chronic dialysis patients who die from forgoing dialysis treatment each year is unknown. According to statistical data from the Japanese Society for Dialysis Therapy (JSDT), among the causes of death in chronic dialysis patients, the rate of suicide and refusing dialysis treatment was 0.6% (196 persons) in 2017. However, details of each case (e.g., non-terminal or terminal) have not been published. In Japan, terminating LST in non-terminal patients is ethically and legally problematic given the lack of legal regulations regarding the termination of any LST, including dialysis treatment.

Case report

On March 7, 2019, the Mainichi (a leading daily newspaper in Japan) reported a case of dialysis treatment termination as a headline article. According to the Mainichi and other sources, a 44-year-old chronic kidney disease (CKD) patient died a week after terminating dialysis treatment in a public hospital in Tokyo in August 2018.

The patient’s attending physician suggested several treatment options, including kidney transplantation and hemodialysis. According to the independent enquiry conducted by the JSDT, the patient’s medical condition was not considered terminal, since she likely could have lived at least another 6 months had the dialysis been continued. The patient indicated she understood the physician’s explanation that she would die within 2 weeks if dialysis was terminated. Nonetheless, after several discussions with the medical team and her husband, the patient signed a consent form to authorize the termination of dialysis, which was stopped shortly afterwards.

According to the hospital’s report and the investigation conducted by local government officials, the patient experienced pain and panic the day after the dialysis treatment was stopped and rescinded her will to terminate treatment due to respiratory distress. Nurses calmed her down with breathing exercises, and the attending physician administered a sedative. The patient indicated only a wish to treat the respiratory discomfort and did not insist on resuming dialysis. In response, the physician offered pain relief without reinitiating dialysis. The patient died shortly afterwards.

The JSDT guidelines allow withholding and withdrawing hemodialysis only if a patient’s general medical condition is extremely poor. The Tokyo Metropolitan Government (TMG) and the JSDT investigated the case, questioning whether the patient’s status was terminal and whether the medical team properly confirmed her will to terminate dialysis (The Asahi Shimbun 2019). The TMG did not judge whether the hospital adequately informed the patient about the consequences of withdrawing dialysis. Rather, the TMG only investigated whether the hospital properly managed medical records based on the Medical Care Act.

More recently, the husband and one of the patient’s sons sued the hospital, noting that withdrawal of dialysis treatment was illegal even with the patient’s consent because the patient was not in the terminal stage, and the hospital failed to resume dialysis treatment after the patient clearly withdrew her original consent to terminate dialysis (The Mainichi 2019).

In this article, we discuss how medical professionals in Asian countries should respond to cases such as that described above. Several Asian countries, such as Singapore, South Korea, Taiwan and Thailand, have laws that address the termination of medical treatments. However, withdrawal of dialysis treatment in non-terminal cases may be ethically and legally problematic even in these Asian countries. What are the practices currently considered ethically and legally acceptable, and what should be the ideal practice?

Commentary

We have described an ethically problematic case of withdrawal of dialysis treatment. We now examine the case within the current policy framework in Japan and finally discuss how Japan can improve its end-of-life practices, focusing particularly on the patient’s right to self-determination and treatment refusal.

1. The current policy framework in Japan concerning treatment options for ESRD patients

Relevant regulations and court cases

First, we will consider the case in question based on the current policy framework in Japan. Given that the patient was not considered to be terminally ill (i.e., the doctors thought she would survive for another 3 or 4 years with dialysis treatment), it is unclear whether termination of dialysis treatment in a patient such as this one would be legal in Japan. No Japanese law addresses forgoing LSTs from non-terminal patients. Several court decisions, including the Tokai University Hospital Case (The Yokohama District Court 1995) (Table 1) and the Kawasaki Kyodo Hospital Case (The Yokohama District Court 2005; The Tokyo High Court 2007; The Supreme Court 2009) (Table 2), and the Guideline for Medical Decision-Making Process in End-of-Life (Terminal) Care (so-called Process Guidelines) set forth by the Ministry of Health, Labour and Welfare (MHLW) (The MHLW 2018) only address forgoing treatments for terminally ill patients.

Table 1.

Admissibility requirements for forgoing treatment established by the Yokohama District Court in the Tokai Case [1995]

■ Three admissibility requirements for forgoing LSTs
1	The patient has no hope of recovery and death is imminent
2	It is desirable that the patient has declared his or her wishes when forgoing treatment is considered an option. It is permissible to presume the family’s will to be the patient’s will, provided that the patient’s family makes a deliberate decision that takes into consideration the patient’s perspective
3	Treatments that can be forgone include all treatments considered to be curative measures, supportive measures, or LSTs, e.g., drug administration, chemotherapy, artificial dialysis, artificial ventilator, blood transfusion and artificial nutrition and hydration (ANH)
Case overview: The attending physician withdrew treatment from a patient suffering from end-stage multiple myeloma at Tokai University Hospital. The physician then administered sedative drugs to stop the patient from stertorous breathing, followed by potassium chloride, which causes heart failure if injected undiluted. The patient subsequently died from cardiac arrest, and the attending physician was prosecuted for homicide. In March 1995, the Yokohama District Court found the attending physician guilty of murder and sentenced him to 2 years in prison with 2 years of suspension. In the ruling, the Court not only set forth admissibility requirements for active euthanasia but also provided admissibility criteria for forgoing LSTs in the obiter dictum.

Table 2.

The Kawasaki Kyodo Hospital Case

Case overview: The attending physician removed the endotracheal tube from a patient upon request from the patient’s family. The patient was unconscious due to hypoxic brain injury accompanied by status asthmaticus. When the physician could not alleviate the patient’s heavy breathing, she ordered an assistant nurse to inject a muscle relaxant, and the patient eventually died. The doctor was later charged with homicide. In early 2007, the Tokyo High Court sentenced the physician to 1 year in prison with 3 years of suspension. In 2009, the Supreme Court ruled to uphold the High Court ruling.

Specifically, a series of high-profile cases in which attending physician’s decisions and acts during end-of-life care were held legally problematic led the MHLW to publish the Process Guidelines in 2007. The Process Guidelines place significant emphasis on consensus building among those involved in the patient’s end-of-life care. The MHLW revised the Process Guidelines in 2018, focusing on advance care planning (ACP) (Table 3).

Table 3.

Main points of the revised Process Guidelines

1	Self-determination	Respecting patient autonomy based on informed consent
2	Consultation	Setting up an advisory committee (including holding meetings with health-care providers other than attending physicians and nurses)
3	ACP	Discussing treatment options with the patient, the family and the health-care team repeatedly
4	Home-care	Covering not only hospital care but also home care

The Process Guidelines are widely understood to express the official position of the MHLW concerning end-of-life care. However, it has no legal basis and lacks penal or administrative sanctions. Moreover, the national survey conducted by the MHLW suggested that physicians in charge of one or more deceased patients per month were unlikely to have utilized the Process Guidelines correctly because roughly 20% of them claimed that they had no knowledge of any guidelines (The MHLW 2018).

The Process Guidelines stipulate the following two requirements: (1) the patient condition is judged to be terminal, and (2) the patient indicates his/her will (includes the will as presumed by the patient’s family). Although the Process Guidelines do not define which conditions are considered “terminal,” it does not apply to non-terminal cases such as the case in question.

The same applies to the Recommendations of the JSDT, which allow withholding and withdrawing hemodialysis under the following two situations: (1) when it is challenging to perform hemodialysis safely and it is highly likely that hemodialysis itself would be life-threatening, and (2) when the patient’s overall condition is extremely poor and either the patient’s preference regarding the forgoing of hemodialysis has been expressed or the family can clearly presume the patient’s will (Watanabe et al. 2015) (Table 4). The JSDT judged after the investigation of the present case that the case fell outside the scope of the Recommendations since the patient was not considered to be terminal.

Table 4.

Situations for considering when to forego hemodialysis according to JSDT recommendations (Watanabe et al. 2015)

1	It is challenging to perform hemodialysis safely, and it is highly likely that hemodialysis itself would be life-threatening	• Hemodialysis can further endanger the patient’s life due to the presence of multi-organ failure with complications of cardiovascular/respiratory problems and profound continuous hypotension
		• Maintaining vascular access and extracorporeal circulation during the dialysis session with safety is not feasible, unless the patient is restrained by instruments or sedation with narcoleptics during every dialysis session
2	The patient’s overall condition is extremely poor, and either the patient’s preference regarding the forgoing of hemodialysis has been expressed or the family can clearly presume the patient’s will	• The patient has difficulty understanding necessary information regarding hemodialysis and long-term self-care because of severe brain dysfunction caused by various factors, such as cerebrovascular diseases and head injury
		• The patient has complications of incurable malignant disease, with imminent and inevitable death
		• The patient cannot eat or drink anymore and cannot survive for long without artificial hydration and nutrition

Quoted from the Recommendations of the JSDT, and partly modified to facilitate understanding, the official English title for the JSDT’s guidelines is “Proposal for the Shared Decision-Making Process Regarding Initiation and Continuation of Maintenance Hemodialysis”. However, the term “Recommendations” is used throughout this article, as this term seemed more appropriate to describe the contents of the JSDT’s guidelines

Moral dilemma

Cases like this present a moral dilemma under the current regulations in Japan. On the one hand, if the physician terminates dialysis treatment at the patient’s request, the former may run the risk of being prosecuted for homicide or homicide with consent. On the other hand, if treatment is continued, then the physician may be acting against the ethical principle of patient autonomy.

Specifically, with regard to patient autonomy, there are several ethical problems regarding the present case: (1) whether the patient’s refusal of dialysis treatment was assessed correctly and (2) whether the physician responded adequately to the patient’s apparent withdrawal of the consent. Regarding the first point, it is unclear if the physician correctly assessed the patient’s competence both at the time of terminating dialysis treatment and at the time of her request to withdraw her previous consent. According to the statements of the JSDT (JSDT 2019), it is also unclear if the physician correctly explained to the patient the outcomes of each treatment option and her care plan, including palliative care. With regard to the second point, it is unclear whether the physician discussed the matter sufficiently enough with the medical team before choosing to reject the patient’s request. When facing a complicated case such as this, physicians should seek advice from a clinical ethics committee.

2. Focusing on the patient’s right to self-determination and treatment refusal

Thinking beyond Japan’s current regulatory framework, we believe patients should have the right to self-determination that includes the informed refusal of treatment. Regarding informed consent, health-care providers in Japan tend to emphasize the dimension of “consent to treatments.” However, patients should have the right to refuse as well as consent to suggested treatments. Some Western countries guarantee such rights by legislation or court decisions. For instance, the Patient Self-Determination Act (PSDA, a federal law) (American Bar Association 2013) in the USA requires health-care institutions to inform patients of their rights in writing. Rights pertaining to health-care decisions include the following items: consent for or refusal of LSTs and other specific medical procedures, a will regarding organ donation and preferences regarding pain control and comfort care. In England, an adult patient who has the capacity to do so may decide to refuse treatment even if refusal may result in harm to themselves or their death (General Medical Council 2010; Airedale NHS Trust v Bland 1993; Re 1998, 2001).

As we described above, a physician in Japan could be prosecuted if he or she terminates treatments because the patient’s right to refuse treatment has no legal basis. Regardless of whether the patient is at a terminal stage or not, no law explicitly allows or prohibits the termination of treatment, so the situation is legally ambiguous. Indeed, the JSDT guidelines explicitly state that the physician who terminated treatment may not be protected from legal liability even if the physician respected the patient’s advance directive and observed the MHLW’s process guidelines.

Conclusions

This case was ethically and legally problematic in Japan mainly because no law or guideline exists in Japan to cover the termination of LSTs from non-terminal patients. We recommend that policymakers consider legalizing the termination of LSTs and the patient’s right to refuse treatment based on the principle of respect for autonomy. A patient’s decision to refuse treatment should be respected if the patient has received an adequate explanation from the physician and has correctly understood the consequences of treatment termination.

Funding information

This research was supported by the Fund for the Promotion of Joint International Research (Fostering Joint International Research (B)) of JSPS KAKENHI, the Uehiro Foundation on Ethics and Education and the Fondation Brocher.