Clinical negligence: insights on surgical planning, informed consent and complication occurrence

The recent High Court decision in HQA v Newcastle-upon-Tyne Hospitals NHS Foundation Trust [2025] EWHC 2121 (KB)provides detailed guidance on the legal standards that govern high-risk surgical practice.

The judgment explores where the line is drawn between an unavoidable complication and a negligent failure in preparation and communication. While not binding in Scotland, the decision of the English & Welsh courts provides guidance on three areas that are central to many clinical negligence claims:

• pre-operative planning and risk management;
• the scope of informed consent; and
• the limits of liability where complications arise from recognised risks despite the exercise of reasonable skill and care.

Factual background

The claimant had complex congenital heart disease and had undergone several major procedures in childhood. By 2022, at the age of 25, her condition had deteriorated, and she required further surgery. She was to undergo pulmonary valve replacement and a PEARS procedure, with possible aortic valve intervention. This would be her third “redo” sternotomy - a procedure known to carry higher risks.

Two issues arose before surgery:

• The consent process: A registrar first quoted a 20% mortality risk, but the consultant later revised this to 5-10%. The main discussion with the consultant happened only on the day of the operation.
• No steps were taken to expose and prepare the femoral vessels before sternotomy, despite scans showing the aorta was only 3mm from the sternum.

On 3 May 2022, during the sternotomy, the oscillating saw transected the aorta. Severe bleeding followed, and establishing bypass was delayed because femoral access had not been prepared. The claimant suffered hypoxia, resulting in severe brain injury.

The claim was brought on three main grounds:

1. That the consent process was inadequate and took place too late.
2. That pre-operative planning was negligent, particularly in failing to prepare femoral vessels.
3. That the intraoperative use of the saw was negligent.

The court’s findings

1. Pre-operative planning

The court found a clear breach of duty in how the operation was planned. Both experts agreed that the claimant’s anatomy created a medium to high risk of aortic injury. The judge held that preparing the femoral vessels was the minimum standard of care in such circumstances.

It was concluded that this failure caused delay in establishing bypass and materially contributed to the brain injury, estimating that around 13 minutes of hypoxia could have been avoided.

2. Intraoperative skill

The claimant alleged negligence in how the saw was handled. Here, the court took a different view. Expert evidence confirmed that aortic injury is a recognised complication of redo sternotomies, even where the surgeon exercises reasonable skill and care. The judge agreed stating that: “Such a misjudgement…falls squarely within the category of a risk of error which cannot be eliminated entirely…” No breach of duty was therefore established in relation to the saw injury itself.

3. Informed consent

The Court was critical of both the timing and content of the consent process.

• Timing: The claimant first met her consultant surgeon on the morning of surgery.
• Content: The claimant was not informed about the option of exposing the femoral vessels, nor about the risks created by her specific anatomy.

The judge stated that it is not for the surgeon to determine for the claimant, what the claimant’s risk appetite should be and that it was a breach of the duty of care owed by the surgeon not to explain to the claimant that another option was available. During evidence it was heard that the claimant would have chosen the variant procedure involving femoral preparation, although she would not have delayed surgery.

Wider commentary

The court reiterated the principle from Montgomery v Lanarkshire Health Board [2015] UKSC 11 that it is for the courts, not the medical profession, to define the scope of a patient’s rights. The court emphasised that while doctors exercise professional judgment when deciding on treatment options, they cannot unilaterally determine what risks to disclose to the patient. Instead, patients must be given the information necessary to make their own decisions about the risks they are willing to accept.

The judgment also highlights that determining whether a risk is “material” is fact-specific and patient-specific, considering not just statistical likelihood but also the potential impact on the patient’s life, the importance of the benefits sought, and the risks associated with alternative treatments. This approach reinforces the Montgomeryprinciple that consent is not a routine process, and it is a patient-centred discussion that must reflect the individual’s perspective and circumstances.

The court further criticised governance and documentation in this case. The operation note was not completed until 16 days after surgery, and no Datix or Serious Incident investigation was carried out. The absence of contemporaneous records made it more difficult for the Trust to defend its position and illustrates the importance of proper documentation in supporting compliance with both clinical and legal standards.

Key takeaways

This case provides helpful commentary on the Court’s application of the Supreme Court decision in Montgomery. Key takeaways from the judgement are:

• Pre-operative planning: Foreseeable catastrophic risks must be actively managed. Failure to take obvious steps, such as preparing femoral access, will be treated as a breach.
• Informed consent: Montgomery remains central. Surgeons must explain not just material risks, but also reasonable alternative techniques that may reduce those risks.
• Recognised risks: A poor outcome is not proof of negligence. If a complication arises that is well-recognised and the surgeon acted with reasonable care, no breach will be found.
• Documentation: Late or inadequate records undermine both patient safety and the ability to defend a claim.