Factual and Procedural Background
This opinion concerns a trial of the Plaintiff’s claim for damages for clinical negligence against the Defendant, relating to a laparoscopic low anterior resection of rectal cancer performed using a trans-anal total mesorectal excision (TaTME) technique. The Plaintiff alleges failure to obtain fully informed consent and negligent intra-operative care. The Defendant admits inadequate consent but denies causation and denies negligent intra-operative care. The Plaintiff claims that, if properly consented, he would have chosen a conventional total mesorectal excision (TME) rather than TaTME and would not have suffered severe injuries including permanent impotence, urinary and fecal incontinence, exacerbation of Low Anterior Resection Syndrome (LARS), and psychological disorders.
The Plaintiff was a 56-year-old engineer and NHS patient at the time of surgery, treated at the Defendant’s hospital. The surgery took place on 8 December 2015, lasting approximately 8½ to 9 hours. The Defendant’s surgical team included two surgeons early in their TaTME learning curve. The Plaintiff experienced significant post-operative complications including total impotence, urinary and fecal incontinence, and psychological injury.
The procedural history includes admission of a witness statement from a lay witness unable to attend trial, extensive medical and trial bundles, and expert witness reports from both parties. The Defendant admitted breach of duty in failing to properly consent the Plaintiff but disputed causation and negligent care during surgery. The trial examined clinical governance, training, supervision, patient selection, consenting process, operative records, and the application of NICE guidance concerning TaTME.
Legal Issues Presented
- Whether the Defendant breached its duty of care by failing to obtain fully informed consent from the Plaintiff before performing the TaTME procedure.
- Whether the Defendant was negligent in the intra-operative care during the TaTME surgery.
- Whether the Plaintiff’s injuries were causally linked to the Defendant’s breaches, including the failure to properly consent and alleged intra-operative negligence.
- The applicability and adherence to NICE guidance and clinical governance standards in the introduction and performance of TaTME at the Defendant’s hospital.
- The extent and impact of the Defendant’s failure to provide appropriate training, mentoring, supervision, and documentation in the surgical procedure and patient management.
Arguments of the Parties
Plaintiff's Arguments
- The Defendant failed to adequately inform the Plaintiff of the risks associated with TaTME, including the limited evidence on its safety and efficacy, the higher risks during the surgeons’ learning curve, and alternative surgical options such as conventional TME.
- The Plaintiff would have declined TaTME if properly informed and would have chosen a laparoscopic TME, avoiding the severe injuries suffered.
- The Defendant failed to implement special arrangements for clinical governance, consent, audit, and research as required by NICE guidance.
- The Defendant’s surgeons lacked appropriate mentoring and supervision during the Plaintiff’s surgery, contributing to wrong-plane dissection and nerve injuries.
- The Defendant’s documentation, including operation notes, MDT records, and consent forms, were inadequate and failed to comply with professional and regulatory standards.
- The Plaintiff’s injuries, including total impotence, urinary and fecal incontinence, and psychological harm, were caused by negligent surgical technique and failure to follow proper clinical governance.
- The Plaintiff claims general damages for pain, suffering and loss of amenities, as well as past and future financial losses related to care, treatment, and lifestyle impacts.
Defendant's Arguments
- The Defendant admits breach of duty in failing to obtain fully informed consent but denies that this caused the Plaintiff’s injuries.
- The Defendant denies negligent intra-operative care, asserting that the surgery was performed competently and that complications are recognized risks of pelvic surgery.
- The Defendant contends that even if fully informed, the Plaintiff would have consented to TaTME due to urgency and the risk of colostomy with other procedures.
- The Defendant disputes that the surgeons’ early learning curve or lack of mentoring caused the injuries, asserting equivalence of risks between TaTME and conventional TME.
- The Defendant claims that documentation failures represent routine form-filling issues rather than substantive breaches of governance.
- The Defendant challenges the Plaintiff’s evidence regarding consultations, patient selection, and the telephone advice to cancel appointments.
- The Defendant disputes claims for certain financial losses, including loss of earnings and costs related to the Plaintiff’s business.
Table of Precedents Cited
| Precedent |
Rule or Principle Cited For |
Application by the Court |
| Price v Cwm Taf University Health Board [2019] PIQR P14 |
Departure from NICE guidelines is not prima facie evidence of negligence, but requires explanation. |
The Court applied this principle to assess the Defendant’s failure to follow NICE guidance on TaTME and found the Defendant’s explanation inadequate. |
| Tahir v Haringey Health Authority [1998] Lloyds Rep (Med) 104 |
Claimant must prove that delay caused actual injury, not just increased risk. |
Referenced regarding timing of surgery and causation of injury, emphasizing the need to prove measurable damage. |
| Sadler v Filipiak [2011] EWCA Civ 1728 |
Assessment of general damages requires consideration of combined effect of injuries to avoid double counting or undervaluation. |
The Court applied this approach to assess the aggregate general damages for the Plaintiff’s injuries. |
| C v North Cumbria University Hospitals NHS Trust [2014] EWHC 61 |
Criteria for weighing expert opinions based on experience, consistency, and logic. |
The Court evaluated expert witness credibility by applying these criteria and preferred certain expert evidence accordingly. |
Court's Reasoning and Analysis
The Court conducted a detailed analysis of the factual and expert evidence, focusing on the Defendant’s breach of duty in failing to obtain fully informed consent and the alleged intra-operative negligence during the TaTME procedure. The Court examined the introduction and governance of TaTME at the Defendant’s hospital, finding no credible evidence of special arrangements for clinical governance, consent, audit, or research as required by NICE guidance. The Defendant’s failure to provide mentoring and supervision to the surgeons early in their learning curve was found to be negligent.
The Court accepted the Plaintiff’s evidence and expert opinions that the surgeons were inexperienced in TaTME, lacked supervision, and likely performed wrong-plane surgery, causing extensive bilateral pelvic autonomic nerve injury. This was supported by the excessive duration of the operation, inadequate operation notes, and the nature and severity of the Plaintiff’s injuries.
The Court rejected the Defendant’s argument that the Plaintiff would have consented to TaTME regardless of full disclosure, finding that the Plaintiff proved on the balance of probabilities that he would have chosen a conventional laparoscopic TME if properly informed.
The Court found the Plaintiff’s tumour was mid-rectal, suitable for conventional TME, and rejected the Defendant’s contention that the Plaintiff was not a candidate for TME or that conversion to abdomino-perineal excision (APER) was likely.
Regarding causation, the Court accepted expert evidence that the Plaintiff’s total impotence, loss of ejaculatory function, urinary urgency, and incontinence were caused by nerve damage during the TaTME, likely due to wrong-plane surgery by inexperienced surgeons. The Court found that these injuries would probably have been avoided with a conventional laparoscopic TME.
The Court acknowledged that the Plaintiff would have suffered major Low Anterior Resection Syndrome (LARS) regardless of the procedure due to tumour height and neoadjuvant radiotherapy, but found no sufficient evidence that TaTME caused a measurable exacerbation of LARS.
The Court found that injury to the internal anal sphincter was caused by the prolonged use of transanal surgical instruments during TaTME and that this injury contributed materially to the Plaintiff’s faecal incontinence, which was more severe than would have been expected after conventional TME.
The Court assessed damages comprehensively, applying the Judicial College Guidelines and considering overlap of injuries. It awarded general damages for pain, suffering, and loss of amenities for impotence, urinary and faecal incontinence, and psychiatric injury, as well as past and future losses for care, treatment, and related expenses. Certain claims, including loss of earnings and costs attributable to LARS, were disallowed.
Holding and Implications
Judgment was given in favour of the Plaintiff, finding the Defendant liable for clinical negligence in failing to obtain fully informed consent and for negligent intra-operative care during the TaTME procedure.
The Court held that the Plaintiff proved on the balance of probabilities that the Defendant’s breaches caused the Plaintiff’s severe injuries, including total impotence, urinary and faecal incontinence, and psychological harm. The Defendant’s failures in clinical governance, training, supervision, consenting, and documentation were integral to the negligence.
The Plaintiff was awarded general damages of £180,000 for pain, suffering and loss of amenities, interest on damages, and past and future financial losses totaling approximately £298,617. Specific awards were made for care, treatment costs, and related expenses, with appropriate apportionments to exclude losses attributable to LARS where compensation was not awarded.
No new legal precedent was established; the decision primarily reinforces the importance of adherence to clinical governance, proper consenting processes, surgeon training and supervision, and the application of NICE guidance in introducing novel surgical techniques.