<!-- wp:paragraph --> <p>Donna Ockenden’s investigation into Nottingham University Hospitals NHS Trust has begun, with the aim of making sure <em>‘the performance at the trust’s maternity service improves as quickly as possible, and in a way that means those improvements are sustained.’ </em>The report will assess <em>‘whether cases of concern were adequately investigated by the Trust at the time, if the lessons for learning were appropriate ones, and whether the lessons were indeed learned and acted upon.’</em></p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>In 2021 it was identified that dozens of grieving families at Nottingham’s City Hospital and Queen’s Medical Centre, had been told that catastrophic maternity care failings leading to death and significant injuries were ‘one offs’.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>Investigations by <em>The Independent</em> and Channel 4 suggested a pattern of poor care, inquiries that were delayed and that minimised concerns, and a failure to make changes that could have kept mothers and their newborns safe. <em>The Independent </em>has reported that in some cases notes were missing or never made, and in other cases they were inaccurate.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>It is suggested that the Trust has known for some time that the standard of care was not acceptable within the hospitals.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>In 2018, the Trust’s board was sent a letter from doctors and midwives working across its two sites, saying that a lack of staff in its maternity units was endangering patient safety.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>In 2020 the Care Quality Commission identified <em>‘several serious concerns’ </em>including poor risk management which they said threatened the safety of mothers and babies. Maternity care was rated as inadequate.&nbsp;</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>Figures obtained by the BBC found that between 2005-6 and 2020-21 there were 207 claims against the Trust’s maternity services, including 36 for cerebral palsy, 26 for stillbirths and 24 for brain damage. In excess of £110m in damages was awarded over that period.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>In April 2022 a thematic report was published, commissioned by the local Clinical Commissioning Group (CQC) and NHS England. It was roundly criticised as being too narrow and not independent enough.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>In May 2022 CQC inspectors returned to find some improvements, although stated that further improvements were needed to ensure that the Trust comprehensively manages risks to all people’s safety. Concerns were raised about triage services and an increase in stillbirths.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>Donna Ockenden, who has previously led the investigations at Shrewsbury and Telford NHS Trust was appointed in May 2022 to lead the Nottingham investigation. By November 2022 over 700 families and 250 staff members had got in touch.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>The Trust has now recognised that more than 1,000 families may have a relevant case for review. Those families have been contacted by the Trust, and others who may have a relevant case are urged to come forward. These are cited as cases from the last 5 years in the following 5 categories:</p> <!-- /wp:paragraph --> <!-- wp:list {"ordered":true,"type":"1"} --> <ol type="1"><li>Still births;</li><li>Neonatal deaths from 24 weeks gestation that occur up to 28 days of life. The review will also consider neonatal serious incident reports and neonatal never events;</li><li>Babies diagnosed with Hypoxic Ischemic Encephalopathy (Grades 2 and 3) and other significant hypoxic injuries;</li><li>Maternal death up to 42 days postpartum; and</li><li>Severe maternal harm, to include all unexpected admissions to ITU requiring ventilation, major obstetric haemorrhage, peri-partum hysterectomy and other major surgical procedures arising from the maternity episode, eclampsia and clinically significant cases of pulmonary embolus requiring further treatment. </li></ol> <!-- /wp:list --> <!-- wp:paragraph --> <p>For some of these families, it is claimed that the letters from the Trust were the first time they had been notified that they may have received poor care.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>The Trust has stated that it is committed to making necessary and sustainable changes to ensure the safety of women and babies going forward. It is hoped that the report will sit alongside the already published reports from other Trusts and contribute further evidence and recommendations to ensure safety within maternity services nationwide.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>The Healthcare Safety Investigation Branch stated that 760 investigations took place in the year to March 2021 involving incidents at 125 NHS Trusts. Their findings highlighted concerns in respect of communication, poor clinical record keeping, a failure to ensure consultant oversight of care in high-risk cases and a vast quantity of guidance produced at a national and local level for midwives that was at times unclear and conflicting.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>It is clear now that maternity services across the nation are under intensive scrutiny. Whether Nottingham is the last to undergo independent investigation remains to be seen. What is clear is that the guidance that will come out of the reports will be extremely important in ensuring future care for pregnant women and their babies is safe and consistent.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>So, what does this mean for us as lawyers? Whilst the outcome of the enquiry is yet to be determined, it will make for essential reading for representatives for both claimant and defendant. It is hoped that this report will chime with those already published (Shrewsbury, Morcambe) and clearly articulate what the standard of care <em>should </em>have been and give examples of where care fell short. For claimant practitioners this will be invaluable. The analysis of guidance available for midwives and obstetric staff, particularly where this has been contradictory may give rise to further lines of enquiry when making a claim. For defendants this may be crucial to assist in assessing risk and identifying those cases in which early settlement may be appropriate.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p><em>The Ockenden report into maternity services in Nottingham University Hospitals NHS Trust is expected to be published in March 2024.</em></p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p><em>To contact the review team, email </em><a href="mailto:nottsreview@donnaockenden.com"><em>nottsreview@donnaockenden.com</em></a><em> or telephone 01243 786 993.</em></p> <!-- /wp:paragraph -->

<!-- wp:paragraph --> <p>This article will consider two recent cases that consider the impact of clinical guidelines on the test for breach of duty.</p> <!-- /wp:paragraph --> <!-- wp:paragraph {"style":{"typography":{"fontSize":"25px"}}} --> <p style="font-size:25px"><strong>O’Brien (administratrix of the estate of John Berry (deceased) v Guy’s and St.Thomas’ NHS Trust, [2022] EWHC 2735 (KB)</strong></p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p><strong>The background</strong></p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>B died in 2019. There is no suggestion that his death was as a result of any negligent treatment.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>B’s sister brought the claim, asserting that B’s treatment in March 2017 had been negligent. B was prescribed 400mg of the antibiotic gentamicin, which she claimed was a&nbsp; negligently excessive dose due to B’s lack of effective renal function.&nbsp;</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>It was agreed that the gentamicin dose had caused B’s ‘ototoxicity’ side effects, leading to balance problems which had required care from the claimant. It was disputed that the drug had also caused B’s hearing loss.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>Subject to liability, damages were agreed at £45,000.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p><strong>The decision</strong></p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>The decision centred around whether the decision to prescribe 400mg of gentamicin had been <em>Bolam</em> negligent.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>The claim was dismissed because the prescription of gentamicin (and it’s administration some hours later when the infection had become worse) had not been negligent despite causing B ototoxicity with balance problems and hearing loss.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>The Court did not accept the argument that Dr M had simply ‘applied’ the ICU guidelines, nor that he had ‘overlooked B’s condition or extremely limited renal function.’</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>The Court noted that even if Dr M <em>had</em> applied the ICU guideline without adaptation, the specific circumstances were sufficiently nuanced for him to have done so.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>Indeed, the Court concluded that even if the circumstances had been insufficiently nuanced, there were cogent reasons for taking a ‘one size fits all’ approach in ICU.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>The Court noted that there were good, logical and indeed cogent reasons for ICU guidelines or practice to depart from national guidelines which turn on creatinine clearance rate/glomerular filtration rate levels.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>Dr M departing from the NICE/BNF guideline for B had been justified by good, logical and cogent reasons. His decision to prescribe 400mg of gentamicin to B, despite his improvement in clinical presentation, and the planned step down to Stephen Ward if he had tolerated faster dialysis had been logical, reasonable and in accordance with a responsible body of clinical opinion.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>The fact that Dr M had used a flawed guideline did not prove that his decision had been negligent. In adapting the guidelines which were poorly worded (as opposed to blindly applying them) Dr M had made a ‘<em>Bolitho­</em>-logical’, <em>Bolam</em>-compliant clinical judgment in accordance with a sound body of practice confirmed by Dr D.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>Causation was therefore not proven.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p><strong>The law</strong></p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>A review of the authorities raised the following points for practitioners:</p> <!-- /wp:paragraph --> <!-- wp:list {"ordered":true,"type":"1"} --> <ol type="1"><li>Even ‘national’ clinical guidelines were not a substitute for clinical judgment in an individual case.</li><li>It followed that even ‘national’ clinical guidelines were not a substitute for expert evidence about that impugned clinical judgment. However, they might inform expert evidence, e.g. as additional evidence of a <em>Bolam </em>compliant body of practice at a particular time, even if the guideline came later.</li><li>Departure from a national guideline was not necessarily prima facie evidence of negligence, but would be likely to require some explanation, with the nature and detail required being dependant upon the circumstances, including the ‘strength’ of the guideline’s steer. An incomplete or contradictory guideline may require less explanation.</li><li>Compliance with a national guideline might be prima facie inconsistent with negligence if the guideline constituted a <em>Bolam </em>compliant body of opinion. Even if the national guidelines were incomplete or unsatisfactory, compliance with them may still ‘militate against negligence’ depending upon the circumstances. However, the same cannot be said of in house guidelines as a defendant could not set their own <em>Bolam </em>standard of care.</li><li>What ultimately matters are whether the conduct fell within a <em>Bolam</em> compliant practice in the usual way. Clinical guidelines are relevant, and should be considered, but were no substitute (or shortcut) for clinical judgment and expert evidence.</li></ol> <!-- /wp:list --> <!-- wp:paragraph {"style":{"typography":{"fontSize":"25px"}}} --> <p style="font-size:25px"><strong>Thorley (by his litigation friend) v Sandwell and West Birmingham NHS Trust [2021] EWHC 2604 (QB)</strong></p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p><strong>The background</strong></p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>In February 2002 Graham Thorley was diagnosed with atrial fibrillation and prescribed a daily 3.5mg dose of warfarin.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>In March 2005 Mr Thorley suffered chest pain and a coronary angiogram was arranged. On advice, Mr Thorley stopped his daily dose of warfarin for a 6 day period (4 days prior to, and one day post procedure).</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>The angiogram was uneventful and Mr Thorley was discharged home. He asked about the warfarin dose and it was agreed that he would not restart it until he attended the follow up clinic post procedure. At the clinic, Mr Thorley was advised to restart the drug on a reduced dose of 3mg.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>3 days after the angiogram, Mr Thorley suffered an ischaemic stroke resulting in permanent and severe physical and cognitive disability.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>Mr Thorley asserted that the Trust was in negligent breach of duty in that the cessation of warfarin should have been limited to the three days prior to the angiogram, and should have been restarted the same day as the procedure at the usual dose of 3.5mg, as set out in the 2004 guidance (Anticoagulation and Surgery (Sandwell)). These breaches caused or materially contributed to the occurrence of the stroke.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>The Trust denied the breach, save as to admit that warfarin should have been restarted by no later than the day after the angiogram at the usual dose of 3.5mg. As to causation, the Trust asserted that Mr Thorley would have suffered the stroke in any event.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p><strong>The decision</strong></p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>The Court rejected the case that those treating the claimant should have applied the provisions within the 2004 document. The existence of the 2004 guidance did not mean that it had been ‘illogical’ to have applied an alternative and responsible practice of a body of competent practitioners. The expert evidence provided no basis to conclude that a three day period of omission of warfarin would have constituted ‘better’ practice when compared to four or five days.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>In respect of the decision to wait until the day after the procedure to restart the warfarin, there was a body of competent and responsible practitioners, including Dr C who gave expert evidence on behalf of the Trust, who would have deferred the restart of warfarin until the day after the practice.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>In light of these findings, the ‘but for’ case on causation was academic.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p><strong>The law</strong></p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>It was reiterated that the principle test remained that a doctor was not negligent if he had acted in accordance with a practice accepted as proper by a reasonable body of medical men skilled in that particular art (as per <em>Bolam</em>).&nbsp; Further, the Court had to be satisfied that the exponents of the body of opinion relied upon could demonstrate that such an opinion had a logical base (<em>Bolitho</em>).</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>The Court affirmed that any Judge determining such a case would need to be satisfied that the experts had directed their minds to the comparative risks and benefits, and had reached a defensible conclusion.&nbsp;</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p><strong>Points to take away from both cases</strong></p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>The headline point is clear – the law as set out in <em>Bolam </em>and <em>Bolitho </em>stands.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>Whilst clinical guidelines are important and may provide evidence of ‘a reasonable body of medical men’ to satisfy the <em>Bolam </em>test, they are not necessarily determinative. A failure to follow guidelines does not automatically mean that a practitioner has been negligent provided that they are able to evidence that they have relied upon or considered alternative reputable expert advice. In any case, the individual circumstances need to be considered and the risks and benefits carefully weighed up.</p> <!-- /wp:paragraph --> <!-- wp:paragraph --> <p>In short – following guidelines may amount to a defence (provided that they are considered and not simply applied without any consideration). Not following guidelines will likely require explanation but does not automatically equate to negligence.</p> <!-- /wp:paragraph -->