What is clinical negligence?

What does clinical negligence mean?

Clinical negligence is the area of civil law concerned with harm caused by negligent healthcare. It can involve treatment, diagnosis, monitoring, referral, prescribing, surgery, maternity care, consent and many other aspects of healthcare.

The expression medical negligence is also widely used. In ordinary conversation the two expressions are often used to mean the same thing. “Clinical negligence” is the broader term because healthcare is provided by many different professionals and organisations, not only doctors.

A clinical negligence claim is not simply an investigation into whether care could have been better. To establish legal liability, the claimant normally has to prove the relevant legal elements of negligence.

What normally has to be proved?

A clinical negligence claim will usually involve four connected questions:

• Was the patient owed a duty of care?
• Did the healthcare provided fall below the legally required standard — a breach of duty?
• Did that breach cause the injury or loss complained of?
• What injury, financial loss or other legally recoverable damage resulted?

These questions are separate. Showing that one part of the care was negligent does not automatically establish that the negligence caused the outcome for which compensation is sought.

What is a duty of care?

A duty of care is the legal obligation to take reasonable care for another person in circumstances where the law recognises that obligation.

In ordinary treatment relationships, the existence of a duty between a healthcare provider and patient is often straightforward. The more difficult questions in clinical negligence cases are commonly whether the required standard was breached and, if so, what difference that breach made to the patient’s outcome.

What is breach of duty?

A breach of duty means that the care fell below the standard required by law.

For questions involving diagnosis and treatment, the courts have traditionally considered whether the clinician acted in accordance with a practice accepted as proper by a responsible body of appropriately skilled professional opinion. This principle is commonly associated with Bolam.

The later decision in Bolitho made clear that the existence of supportive professional opinion is not automatically conclusive. The court must be satisfied that the body of opinion relied upon is responsible and capable of withstanding logical analysis.

What is causation?

Causation asks what difference the breach of duty made.

Even where negligent care is proved or admitted, the claimant must still establish the necessary connection between that negligence and the injury for which the claim is being made.

For example, treatment may have been delayed or an investigation may have been missed, but a legal claim still requires consideration of what would probably have happened if appropriate care had been provided. In some cases the eventual medical outcome would have been the same despite the breach. In others, the breach may have caused additional injury or made an existing condition materially worse.

Causation can be one of the most technically difficult parts of a clinical negligence case and often requires independent medical expert evidence.

Does a bad medical outcome mean there was negligence?

No. Healthcare can involve uncertainty, unavoidable risks and conditions that worsen despite appropriate treatment.

A poor outcome does not automatically establish negligence merely because:

• treatment did not work;
• a recognised complication occurred;
• a condition became worse;
• another clinician would have chosen a different reasonable treatment;
• a diagnosis was difficult to make;
• the patient experienced an adverse event; or
• the patient is dissatisfied with the care.

Equally, the fact that a complication is recognised does not automatically mean that no negligence occurred. The circumstances still need to be considered: what care was required, what was actually done and whether any failure caused additional harm.

Can clinical negligence involve failure to diagnose or delay?

Yes. Clinical negligence is not limited to something actively done during treatment. It can also concern an omission or delay.

Examples of issues that may require investigation include:

• failure to investigate symptoms appropriately;
• delayed diagnosis;
• failure to act on an abnormal test result;
• failure to refer to another service or specialist;
• delayed treatment;
• inadequate monitoring;
• failure to recognise deterioration; or
• failure to follow up a patient or test result.

The existence of a delay is not enough by itself. The investigation must still consider whether the delay amounted to a breach of duty and whether earlier appropriate care would probably have changed the outcome.

Can lack of informed consent be clinical negligence?

It can be.

Consent is not limited to obtaining a signature on a form. In Montgomery v Lanarkshire Health Board, the Supreme Court held that a doctor must take reasonable care to ensure that a patient is aware of material risks involved in recommended treatment and of reasonable alternative or variant treatments.

Whether a risk is material is patient-focused. It includes risks that a reasonable person in the patient’s position would be likely to consider significant, as well as risks the clinician knows or should know that the particular patient would be likely to consider significant.

The detailed law on treatment options, reasonable alternatives and informed consent is considered separately in the breach-of-duty guide.

Who can clinical negligence involve?

Clinical negligence is not limited to hospital doctors.

Depending on the care involved, a clinical dispute can concern:

• hospitals and NHS trusts or health boards;
• GPs and GP practices;
• dentists;
• nurses;
• midwives;
• pharmacists;
• physiotherapists;
• paramedics and ambulance services;
• other registered healthcare professionals;
• private hospitals and clinics; or
• other healthcare providers.

The Civil Procedure Rules’ Clinical Disputes Protocol applies broadly to claims against hospitals, GPs, dentists and other healthcare providers and covers both NHS and private healthcare.

What is the difference between an NHS complaint and a clinical negligence claim?

A complaint and a clinical negligence claim are different processes.

A complaint may seek an explanation, apology, investigation, service improvement or answers about what happened. A clinical negligence claim asks whether there is a civil legal liability for injury or loss.

Information produced during a complaint or patient-safety investigation can sometimes be relevant to a later legal investigation, but the outcome of one process does not automatically decide the other.

Do I need to prove that someone deliberately did something wrong?

No. Clinical negligence is not based on proving that a clinician intended to cause harm.

The central question is whether the care met the standard required by law and, if it did not, whether the failure caused relevant injury or loss.

How is clinical negligence usually investigated?

Clinical negligence cases are evidence-based. The investigation commonly begins with understanding the medical history and obtaining the relevant records.

Depending on the case, independent healthcare experts may then be asked to consider whether the care met the required standard and whether any identified breach caused the injury or altered the outcome.

Where a legal claim is pursued, the Pre-Action Protocol for the Resolution of Clinical Disputes sets out the normal steps before court proceedings. These include obtaining relevant health records, investigating the allegations, exchanging information through a Letter of Claim and Letter of Response, considering expert evidence and exploring whether the dispute can be resolved without litigation.

Is there a time limit for clinical negligence claims?

Yes.

In England and Wales, the usual limitation period for a personal injury claim is three years from the date the cause of action accrued or, if later, the claimant’s date of knowledge.

That is only the general rule. Different provisions can affect claims involving children, people who lack the relevant mental capacity, deaths and cases where the court is asked to exercise its discretion to allow a claim to proceed after the ordinary period.

Does clinical negligence always result in court proceedings?

No. The pre-action process is intended to allow the parties to understand the dispute, investigate it and consider whether it can be resolved without litigation.

A case may end because the evidence does not support a claim, because liability or part of it is admitted, because the parties reach an agreement, or because proceedings become necessary to resolve issues that remain disputed.

The Clinical Disputes Protocol specifically encourages discussion, negotiation and other forms of alternative dispute resolution where appropriate.

What information can be useful if something may have gone wrong?

A person does not need to decide for themselves whether the care was negligent before gathering information about what happened.

Useful information can include:

• the dates and places where care was provided;
• the names of services or clinicians involved, where known;
• appointment and discharge letters;
• test and scan results;
• prescriptions and medication information;
• correspondence with the healthcare provider;
• complaint or investigation responses;
• a simple chronology of what happened; and
• the relevant medical records.

Medical records are often central to understanding the sequence of events, but records alone do not necessarily answer whether the care was negligent. Their significance may need to be assessed alongside independent expert evidence and the other circumstances of the case.