How Failure to Obtain Consent Can Lead to Clinical Negligence

Consent in medical treatment is a fundamental legal and ethical requirement in healthcare across England and Wales. Patients must be given enough information to make an informed decision about whether to undergo any form of treatment or procedure. When proper informed consent is not obtained and a patient is harmed as a result, this can give rise to a clinical negligence claim. This article explains the legal framework governing consent, how failure to obtain valid consent can lead to claims, the court tests involved, typical scenarios, how the legal process works, relevant time limits, and practical guidance for those considering a claim.

What Is Informed Consent in Healthcare?

Informed consent means that before a doctor, surgeon or other healthcare professional carries out a treatment, the patient must understand the nature of the intervention, the material risks, potential benefits, and reasonable alternatives - including the option of receiving no treatment at all. Consent must be given voluntarily and with sufficient understanding for the patient to make a meaningful choice. Simply signing a form does not automatically mean that proper consent was obtained - the discussion and understanding of risks are central to the consent process.

In certain urgent or life‑saving emergency situations, consent may be implied to avoid harm if a patient cannot provide it. However, outside of those limited circumstances, explicit informed consent is legally required before treatment begins.

Legal Framework for Consent and Clinical Negligence

The Duty to Inform

In England and Wales, healthcare professionals owe a legal duty to their patients to take reasonable care in providing treatment and advice. This duty includes ensuring patients receive enough information to make an informed decision about their care. In clinical negligence law, failure to obtain informed consent can itself be a breach of that duty if the lack of proper consent causes harm.

Key Legal Cases

The leading authority on informed consent in the UK is Montgomery v Lanarkshire Health Board [2015] UKSC 11. In this Supreme Court case, the court held that doctors must take reasonable care to ensure patients are aware of material risks of proposed treatments and reasonable alternatives. The test for materiality focuses on what a reasonable person in the patient's position would attach significance to, and what this specific patient would likely consider significant.

Prior to Montgomery, decisions such as Sidaway v Board of Governors of the Bethlem Royal Hospital [1985] UKHL 1 applied a more deferential medical opinion‑based test (relying on what a responsible body of medical opinion would disclose). Montgomery displaced this approach in favour of a patient‑centred standard.

Another notable case, Chester v Afshar [2004] UKHL 41, established that failure to inform patients of risks may itself be actionable without needing to show that the lack of information caused the specific harm.

What Constitutes a Failure to Obtain Informed Consent?

A failure to obtain consent may occur when:

• A patient was not given sufficient information about the nature of the procedure, including risks, benefits and reasonable alternatives.
• Information was not tailored to the patient's personal circumstances or concerns - for example, specific health factors that would make certain risks particularly relevant.
• The procedure carried out was different to what the patient agreed to.
• A patient was coerced, unduly pressured, or unable to understand the information provided due to lack of capacity.
• Consent was obtained in a way that did not allow for meaningful understanding - for example, overly technical explanations or absence of clarity about serious risks.

Consent must be specific to the treatment; a general consent form for some procedures cannot be assumed to cover subsequent, unrelated interventions.

How Does Failure to Obtain Consent Lead to a Clinical Negligence Claim?

To bring a successful clinical negligence claim based on failure to obtain consent, a claimant must generally show:

1. Duty of Care - that the healthcare provider owed a legal duty of care (automatic once treatment is proposed).
2. Breach of Duty - that the provider failed to ensure the patient was properly informed before treatment.
3. Causation - that, but for the failure to obtain valid informed consent, the patient would not have agreed to the treatment or would have chosen a different option.
4. Harm or Loss - that the patient suffered injury, harm or loss as a direct result of undergoing treatment they would not otherwise have chosen.

It is not enough to show a procedural failure in consent; there must be a real connection between the lack of informed consent and the decision to proceed that led to harm.

Typical Scenarios Where Lack of Consent Arises

Examples of situations that frequently lead to consent‑related claims include:

• A patient suffering a serious complication that was not disclosed as a material risk.
• A patient consenting to one type of procedure but undergoing something more invasive without clear updated consent.
• A patient not told about alternative treatments that might have been appropriate.
• A patient with specific health concerns not given information relevant to those concerns.

In each of these situations, the claim would focus not on that the healthcare was necessarily performed poorly, but that the patient did not make an informed decision before treatment.

The Clinical Negligence Claims Process

Initial Assessment

A clinical negligence solicitor experienced in informed consent claims will first review medical records and details of the consent process to assess whether there are reasonable grounds for a claim. Evidence of consent discussions, written records, and how risks were communicated will be critical.

Gathering Evidence

Medical records are obtained, and independent expert medical opinions are commissioned. These experts assess whether the consent process met legal standards and if a reasonable person in the patient's position would have made a different decision with full information.

Letter of Claim

If there is a plausible case, a formal letter of claim is sent to the healthcare provider (such as an NHS Trust or private hospital) outlining how consent was deficient and the harm that resulted.

Response and Negotiation

The defendant may admit or deny liability. Many consent‑related claims are resolved by negotiation before trial, often involving detailed exchanges of evidence.

Court Proceedings

If settlement cannot be reached, claims proceed to court where a judge will determine liability and assess compensation. Consent cases can be technically complex and typically require specialist legal representation.

Time Limits for Consent‑Related Claims

Under the Limitation Act 1980, most clinical negligence claims, including those for lack of consent, must be started within three years:

• From the date of injury, or
• From the date of knowledge - when the claimant realised that the harm was due to substandard care.

For claims on behalf of minors, a parent or guardian can bring a claim on the child's behalf up to the child's 18th birthday, after which the child may have until their 21st birthday to start a claim.

Compensation in Lack of Consent Claims

Compensation may include:

• General damages for pain, suffering and loss of amenity.
• Special damages for financial losses such as treatment costs, care needs and lost earnings resulting from the harm.
• Future care costs where harm leads to long‑term disability.

The amount awarded depends on the severity of harm and the impact on the claimant's life.

Practical Considerations

Signed Consent Forms Are Not Definitive

A signed consent form is evidence that a discussion took place, but not proof that the patient fully understood material risks and alternatives. Courts look at the content and quality of the consent discussion.

Specialist Legal Advice

Claims based on failure to obtain informed consent are highly fact‑specific and often technically challenging. Specialist clinical negligence solicitors and medical expert reports are usually necessary.

Complaints and Redress

Before or during a claim, patients may use NHS complaints procedures or alternative dispute resolution schemes such as those under the NHS Redress Act 2006 which allow for certain clinical negligence complaints without full court proceedings (though these schemes have limitations and are not suitable for all cases).

Common Questions from our Readers

Is informed consent required for every procedure?
Informed consent is required before most non‑emergency medical treatments. For emergencies where a patient cannot consent, providers may proceed to prevent serious harm.

Can I claim if I signed a consent form but was not told about serious risks?
Yes. Signing a form does not guarantee informed consent; what matters is whether the patient was adequately informed of material risks and alternatives.

What if I misunderstood the risks?
If a patient can show they were not given sufficient understandable information about material risks and that this lack of information affected their decision, there may be grounds for a claim.

Final Thoughts

Failure to obtain valid informed consent can form the basis of a clinical negligence claim in England and Wales when it results in harm that a patient would have avoided had they been fully informed. The law, particularly following Montgomery v Lanarkshire Health Board, prioritises patient autonomy and requires healthcare professionals to disclose material risks and alternatives relevant to the individual. Understanding the legal duties, how to demonstrate a breach, the claims process, and applicable time limits can help those affected consider their options. Seeking specialist legal advice early is vital for navigating evidence requirements and ensuring claims are handled effectively.