Litigation & Dispute Resolution

Medical Incidents and Malpractice Claims in Japan

When something goes wrong in the course of treatment at a hospital or clinic in Japan, several things begin at once. The facts have to be established, the patient or the family has to be given an explanation, an internal investigation may have to be carried out, and the question of legal responsibility arises. These do not happen one after the other, and the way the first days are handled affects each of them.

Japan also has features that an overseas reader will not find at home. A statutory investigation system operates separately from any question of liability, and reports go to a national body — the Medical Accident Investigation and Support Center — rather than to the parties. Malpractice claims are heard, in the larger courts, by divisions that deal only with medical cases and that use their own methods for handling clinical evidence. Administrative and criminal processes can run alongside the civil claim, on their own timetables and to their own standards.

This page is written for those responsible for a medical institution in Japan — the operating corporation and its management, and the physicians concerned. It sets out what the first response involves, how the statutory investigation system works, how explanations to the patient and family are handled alongside the question of compensation, and what a malpractice claim looks like in the Japanese courts.

Our attorneys include a former judge who presided over cases in a court division specializing in medical malpractice litigation.

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What to check first

The following are the points to establish at the outset. They are worked on in parallel as the case requires; nothing here suggests that treatment, an explanation or a report should wait until every check has been completed or a lawyer has been consulted.

Preserve the clinical record — the medical record, imaging and test data, nursing, operating theatre and anaesthesia records, and device logs. Where a correction or an addition has to be made, it is made so that the original entry, the person making the change, the time and the content all remain identifiable.
Record the sequence and what has been said — when the event occurred, when it was recognised and what was done, who was involved, and what has already been explained to the patient or the family. Facts that have been confirmed are recorded separately from inference and evaluation.
Confirm the internal reporting and who is responsible for what — whether the administrator and the patient safety function have been informed, and who is handling the investigation, the explanation to the patient and family, and communications with anyone outside the institution.
Establish what the patient and family have been told — to whom, what was said, and what questions or requests have been raised, together with what can be explained now, what is not yet established and what will happen next.
Consider the statutory investigation system — the administrator decides whether the case falls within it. What supports that decision is the clinical course and the explanations and records made beforehand, and the reasons for the decision are themselves recorded.
Check other reports and any deadline — separately from the statutory investigation system, whether a report or notification to an administrative body or to the police is required. Where an enquiry or a court document has been received, its content and any time limit are confirmed immediately.
Contact the insurer and any lawyer already involved — the notification and settlement procedures under the applicable liability insurance and how costs are handled, together with the division of roles with anyone already advising, including through a medical association.
Where an overseas parent or investor is involved — who within the group is to be informed, and on what basis, so that reporting upwards does not cut across the clinical record, the explanation to the family or the position on privilege and confidentiality in Japan.

Where a matter is already under way, we start from where it stands rather than from the beginning.

Contents

Four processes, running at the same time
The first response and the internal investigation
The statutory medical accident investigation system
Explaining to the patient and family, and the question of compensation
Malpractice litigation in the Japanese courts
Administrative and criminal processes
Prevention, standing arrangements and how we help
Frequently Asked Questions

Four processes, running at the same time

They do not resolve in sequence

An incident produces several obligations at once: establishing what happened, explaining it to the patient or the family, investigating internally and preventing a recurrence, and assessing legal responsibility. It is tempting to treat these as stages, dealing with the facts first and the rest later. In practice they overlap from the first day, and a step taken for one purpose — a note added to a record, a sentence in an explanation, a report sent upwards — is read afterwards in all of them.

What each process is actually asking

It also helps to keep the processes apart, because they ask different questions, apply different standards and are decided by different people. The statutory investigation exists to examine the circumstances and the possible causes of a case that falls within it; it is not a mechanism for allocating blame, and its conclusion does not settle civil liability. A civil claim asks whether the standard of care was met and whether the outcome would have been different. Administrative and criminal processes are separate again. Confusing them tends to produce both an over-cautious explanation to the family and an investigation report that serves neither purpose well.

Process	Who decides	What it asks	Relationship to the others
Statutory investigation	The administrator of the institution determines whether the case meets the statutory criteria. The institution reports the case and carries out an internal investigation, with support where needed; the Center may investigate separately if asked.	The circumstances and the possible causes of a qualifying death or stillbirth, and what may help prevent a recurrence.	Not a process for determining legal responsibility. Its findings do not establish negligence, although a report may be produced in later proceedings.
Civil claim	The patient or another eligible claimant decides whether to bring a claim; the court determines liability where it is disputed.	Whether the care given met the standard at the time, whether the outcome would have been avoided, whether the risks were explained, and the amount of loss.	Independent of the investigation. Runs on its own timetable, often long afterwards.
Administrative	The public health authorities and, for a physician, the national process under the medical practitioners legislation.	Whether the institution or the practitioner has complied with the requirements applying to them.	Separate purpose and separate standard. Inspections and enquiries can arrive at any point.
Criminal	The police investigate, the public prosecutor decides whether to prosecute, and the court determines criminal liability.	Whether the conduct amounts to an offence.	Independent again. The existence of an investigation does not depend on the civil or administrative position.

Which of these arise depends on the case. The table sets out how they differ, not a sequence that every incident follows.

Where an overseas group is involved

Where the institution sits within a group that reports outside Japan, one further question arises early: what is reported upwards, to whom, and in what form. Internal reporting is legitimate and often necessary, but a summary written for a board in another country can later be read as the institution’s own account of the incident. It is worth settling who prepares such material, on what basis, and how it is kept consistent with the clinical record and with what the family has been told. The related questions that arise when a hospital or clinic changes hands are dealt with in “M&A and Investment in Hospitals and Clinics in Japan”.

The first response and the internal investigation

Preserving the record

The clinical record is the foundation of everything that follows, and its integrity matters more than its tidiness. Medical records, imaging and test data, nursing, operating theatre and anaesthesia records, device logs and, where relevant, communications between staff are all preserved. Where an entry has to be corrected or added to after the event, it is done in a way that leaves the original entry, the identity of the person making the change, the time and the content all visible. A record that has been amended transparently is usually easier to explain than one that appears to have been tidied.

Establishing the sequence, and interviewing staff

The next task is to set out what happened and when: the time of the event, when it was recognised, what was done in response, who was involved, and what has already been said to the patient or the family. What has been confirmed is recorded separately from what is inferred or evaluated, and the two are not merged into a single narrative. Interviews with the staff involved are conducted with that distinction in mind, and with an awareness that the notes taken will exist afterwards.

An incident is also unsettling for the people who were present. An investigation conducted as a search for the individual at fault tends to produce a poorer account of what happened than one directed at the sequence and the conditions that allowed it, and it makes the second, preventive purpose of the exercise harder to achieve.

Who does what

The institution decides who leads the investigation, who explains matters to the patient and family, and who handles contact with anyone outside — the insurer, an administrative body, the press. Keeping those roles distinct avoids the situation in which the person conducting the investigation is also negotiating, and it makes the record of each easier to follow. Where the physicians involved may have interests of their own, that is identified at the outset rather than after positions have been taken.

The statutory medical accident investigation system

What the system is, and what it is not

Japan operates a statutory investigation system under the Medical Care Act. It does not cover every adverse event: it applies to certain deaths and stillbirths that are caused, or suspected to have been caused, by medical care and that were not anticipated by the administrator of the institution. Its purpose is to contribute to medical safety by examining the circumstances and the possible causes of such a case, and identifying what may help prevent a recurrence. It is not a procedure for determining the legal responsibility of an institution or of an individual. Neither the institution’s own investigation nor any separate investigation carried out by the Medical Accident Investigation and Support Center determines civil liability; a report may be produced in later proceedings, but its relevance and the weight to be given to it are matters for the court.

That does not mean the report is without consequence. It may later be produced in evidence in civil proceedings. The right response to that is not to write the report with an eye to litigation, selecting facts according to whether they help. It is to distinguish clearly between what has been established, what the medical assessment is, and what remains unexplained, and to make the basis for each of them visible. A report constructed that way is both more useful for prevention and easier to stand behind afterwards.

Deciding whether a case falls within the system

The administrator determines whether the case meets the statutory criteria — whether the death or stillbirth is suspected to have been caused by medical care, and whether it was anticipated — having considered the clinical records, what was explained to the patient beforehand and the views of the staff involved. Where the case is one that falls within the system, the institution reports it to the Medical Accident Investigation and Support Center and carries out an internal investigation, obtaining support from an appropriate organisation where that is needed. Once the case has been reported, the Center may carry out a separate investigation if the institution or the bereaved family asks it to. The reasoning behind the administrator’s decision, and the course by which it was reached, are themselves recorded: a decision that can be explained later, whichever way it went, is worth more than one reached quickly.

The report, and the material behind it

The investigation looks beyond the actions of individuals to the arrangements around them: how work was organised, how information passed between staff, how equipment was managed. The formal report and the material underlying it — interview notes and internal working documents — are distinguished for the purposes of retention, access and disclosure. Neither is automatically privileged or immune from disclosure, and what applies has to be considered in context. The institution makes the reports and explanations the system requires, and separately settles how the underlying material is retained, shared and disclosed, taking account of the privacy of those involved and of what the law requires.

Explaining to the patient and family, and the question of compensation

Explaining the facts

Explanations to the patient or the family do not wait, as a matter of course, until the investigation is complete. What is set out is what has been established so far, what is not yet known, and what will happen next, with those three kept distinct. Neither error serves the institution: stating an evaluation as settled when it is not, and blurring a fact that has been established. Questions and observations from the family are recorded, and what they raise is added to the list of things to be checked.

Keeping the explanation separate from the negotiation

Explaining what happened and discussing legal responsibility and money are different conversations, and are better handled as such. Where compensation is in issue, the notification and settlement procedures under the institution’s liability insurance apply, and the insurer will need to be involved. Where a lawyer is already acting through a medical association or an insurer, the division of roles is settled before matters proceed rather than in the middle of them.

Settlement, mediation and medical ADR

Where the assessment of negligence and causation makes a negotiated resolution appropriate, the terms and the content of the settlement agreement are worked out. Court-annexed civil mediation and medical alternative dispute resolution are also available. Whichever route is used, the resolution is built on the facts that have been established and on the medical assessment, not on an estimate of how much pressure each side can bring.

Malpractice litigation in the Japanese courts

What has to be shown

A malpractice claim turns on whether the care provided fell short and whether that made the difference. Negligence is assessed against the standard of care reasonably to be expected at the time, taking account of the nature and the role of the institution and the circumstances in which the care was given — the examination, the treatment, the monitoring or the decision to refer. It is not a question of whether the best available care was given, judged with hindsight.

Causation requires the claimant to establish, to the applicable standard of proof, a legally sufficient connection between the breach alleged and the harm; the usual enquiry is whether the outcome would have been materially different had appropriate care been given. Where that connection cannot be established to the required standard, a claim may still be advanced on a narrower footing, and the Japanese courts have recognised the loss of a substantial possibility of a better outcome as a distinct head.

Separately from the treatment itself, a claim may be based on the duty to explain: whether the patient was given, in a manner appropriate to the circumstances, enough information about the nature and the purpose of the treatment proposed, its material risks and the alternatives available, to make an informed decision. Where liability is established, the recoverable loss is quantified in its own right, and may include the additional medical and care expenses attributable to the injury, loss of earnings and non-pecuniary damages, depending on the circumstances.

The specialised divisions and how they work

Malpractice claims are treated in Japan as specialist litigation. In the courts that have specialised medical divisions or panels, a claim may be managed using methods developed for complex clinical evidence. These may include a chronological table of the clinical course, setting symptoms and findings, investigations, diagnosis and treatment side by side in time, and, where the case calls for it, the involvement of expert commissioners to supply medical background or of court-appointed experts, including conference-style examination in which more than one expert is heard together. Which of these is used depends on the case; none of them applies as a matter of course.

What follows for a party is that the strength of a case usually depends substantially on how well the clinical argument is supported by the contemporaneous records, the medical literature and any expert evidence. Establishing the facts precisely from the records, placing the literature and any supporting opinion where it belongs, and identifying which of negligence, causation and the duty to explain is actually in issue, matter more than the general force of the submissions.

How we approach it

Our lawyers include a former judge who sat in a court division specialising in medical litigation. That experience informs how we work on these cases: examining the records closely to establish the clinical course, identifying where the medical assessment sits in relation to the legal test, and organising the evidence and the argument around the issues the court will actually have to decide.

Administrative and criminal processes

They run on their own terms

An incident may become the subject of processes outside the civil claim. A public health authority may make enquiries or carry out an inspection; a physician may face a process under the legislation governing medical practitioners; the police may investigate. Each of these proceeds independently, with its own purpose and its own standard, and none of them is determined by the statutory investigation or by the civil position.

What that means in practice is that the institution may be responding to several bodies at once, about the same events, on different timetables. Consistency across those responses matters, and so does keeping track of what has been said to whom. We advise on the character of each process and on how the responses are handled.

Prevention, standing arrangements and how we help

From the causes to the arrangements

What the investigation establishes feeds into the clinical procedures, the way staff work together, the way records are made and the management of equipment. Locating the cause in an individual’s conduct alone rarely prevents a recurrence; treating it as a question about the arrangements and how they operate usually does more.

What can be settled in advance

The first response is steadier where the groundwork has been done: the threshold and the route for internal reporting, who explains matters to patients and families and how those explanations are recorded, how clinical records are managed, and the steps to be followed under the statutory investigation system. Reviewing the internal rules and the training that supports them is work that can be done at any time, and it is considerably easier than doing it during an incident.

How we work with you

First response and internal investigation — the scope of what should be preserved, how interviews are conducted and recorded, how the internal response is organised, and the decision under the statutory investigation system and the report that follows.
Explanation, negotiation and litigation — how explanations to the patient and family are handled, coordination with insurers, settlement, mediation and medical ADR, and the conduct of malpractice litigation.
Administrative and criminal processes — enquiries and inspections by administrative bodies, processes affecting a physician, and the response where the police are involved.
Prevention and standing arrangements — internal rules, reporting routes, record management and training, reviewed against what the incident revealed.

Where the matter forms part of a wider dispute, or where the institution faces litigation of other kinds, the general framework is set out in “Litigation and Dispute Resolution”.

Frequently Asked Questions

Can we consult you before we know whether anything went wrong?

Yes, and it is usually the better time. The steps that matter most — preserving the record, setting out the sequence, deciding what to say to the family and recording the basis for the decision under the statutory investigation system — all arise before anyone knows whether the care fell short. Waiting until the position is clear tends to mean that those steps have already been taken, one way or another.

What do we tell the family while the investigation is still running?

What has been established, what is not yet known, and what will happen next, kept distinct from one another. An evaluation that is not settled is not presented as though it were, and a fact that has been established is not left vague. Questions and observations from the family are recorded and added to what still has to be checked. Explaining the facts and discussing legal responsibility or money are treated as separate conversations.

Does a report under the statutory investigation system mean we have admitted liability?

No. The system is intended to contribute to medical safety by examining the circumstances and the possible causes of a case that falls within it, and identifying what may help prevent a recurrence; it is not a procedure for determining legal responsibility, and its findings do not of themselves establish negligence. A report may nevertheless be produced in later proceedings, and its relevance and the weight to be given to it are matters for the court. That is a reason to write it carefully — distinguishing what is established, what the medical assessment is and what remains unexplained — rather than a reason to write it defensively.

A lawyer is already involved through our medical association or insurer. Can we still consult you?

Yes. We would confirm what you are seeking advice on, what support is already in place and whether any conflict arises, and then identify what we can properly do. The insurance procedures and the treatment of costs are checked, and the division of roles with the lawyer already acting is settled before we proceed.

If the institution instructs you, does that cover the individual physician as well?

Not automatically. The institution and the physician may have interests that diverge, and whether one lawyer can act for both is a question to be resolved at the outset rather than when a difference emerges. We identify the position early and, where separate representation is appropriate, say so.

We have received a request for disclosure, a court notice or order relating to the preservation of evidence, or a complaint. What should we check?

Establish precisely what has been received, when and how it was served, and any date for a response or a hearing. Where preservation of evidence ordered by a court is involved, take legal advice at once and keep the paper and electronic records concerned exactly as they are: they are not to be altered, supplemented, reorganised or deleted. Alongside that, identify the scope and the location of the records, who within the institution holds them, and the practical arrangements the court procedure will require. Because this can arrive with little warning, knowing where the records are and who holds them is better established in advance than worked out on the day.

This page sets out general legal issues arising when a medical incident occurs in Japan and is not legal advice on any particular matter. The applicable legislation, subordinate regulations, notices, guidelines and administrative practice are subject to change. In any matter, the law and the practice applying at the time must be confirmed for the institution and the circumstances concerned.

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This article is provided for general informational purposes only and does not constitute legal advice on any specific matter. Please consult us regarding your specific situation. The content is based on the laws and regulations in effect as of the date of the last update.