Deborah Biggadike v Kamilia El Farra & Anor

In medical negligence claims, NICE guidance does not have the force of law. Departure from a strong recommendation may nevertheless require adequate explanation and justification in the circumstances of the individual case. A responsible body of clinicians may adopt a different approach where the departure is reasoned and clinically defensible.

The Montgomery duty requires disclosure of material risks and reasonable alternative treatments. The duty is fact-sensitive and depends on the patient’s circumstances. A procedure lacking clinical justification cannot be validly consented to without disclosure of that fact and its implications.

The claimant brought negligence claims arising from pelvic surgery performed by two consultant urogynaecologists. The first defendant implanted TVT-A tape and performed prolapse surgery in January 2017. The claimant alleged failures to offer pelvic floor exercises, arrange pre-operative urodynamic studies and obtain informed consent.

The second defendant later excised mesh and performed a colposuspension. The claimant alleged that mesh excision was unjustified and that the colposuspension lacked clinical justification and informed consent. The central issues were whether the defendants had breached the professional practice test, whether the claimant was properly informed, and what loss was caused by any breach.

1. Claim against the first defendant dismissed. The court found that supervised pelvic floor exercises had been offered, together with other conservative options, and that the claimant chose surgery. The first defendant had also explained the proposed procedures, material risks and benefits, provided relevant EIDO leaflets, explained the difference between TVT and TVT-A tape, and discussed conservative treatment. The Montgomery duty was therefore discharged.
2. The failure to arrange urodynamic studies was not a breach of duty. Applying Bolam, as qualified by Bolitho and confirmed in McCulloch, the court found responsible bodies of clinicians on both sides of the issue. Although the NICE recommendation to perform testing in cases involving stress incontinence and anterior prolapse was strong, it was not mandatory. The first defendant had positively decided that testing would add no value, relying on the clinical history and her assessment that the claimant wanted surgery. That departure was sufficiently explained and justified. The court preferred the opinion of Mr Toozs-Hobson.
3. Mesh excision by the second defendant in March 2018 was within the range of reasonable treatment options. The claimant had localised pain over the mesh, dyspareunia and a strong wish for removal. The court held that causation would also have failed because she would probably have pursued mesh removal shortly afterwards even if a less invasive procedure had first been attempted.
4. The colposuspension was not clinically justified. The claimant had no symptoms of recurrent stress incontinence, the urodynamic testing was normal, and neither an open bladder neck nor an intra-operative abdominal pressure test justified the procedure. The second defendant’s handwritten annotation was found to be contrived and false.
5. The failure to disclose the normal urodynamic results vitiated consent to the colposuspension. Had the claimant been told that the procedure was not clinically indicated, she would not have agreed to it. Judgment was entered for the claimant against the second defendant for £195,887.66, with interest to be calculated.