Graham Leslie Thorley (by his litigation friend, Susan Thorley) v Sandwell & West Birmingham Hospitals NHS Trust
| Jurisdiction | England & Wales |
| Judge | Mr Justice Soole |
| Judgment Date | 01 October 2021 |
| Neutral Citation | [2021] EWHC 2604 (QB) |
| Court | Queen's Bench Division |
| Docket Number | Case No: QB-2018-001283 |
[2021] EWHC 2604 (QB)
IN THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION
Royal Courts of Justice
Strand, London, WC2A 2LL
Mr Justice Soole
Case No: QB-2018-001283
Susan Rodway QC (instructed by Moore Blatch Resolve LLP) for the Claimant
Andrew Post QC (instructed by Bevan Brittan LLP) for the Defendant
Hearing dates: 11–14 May 2021
Approved Judgment
I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
This is the trial of the issues of breach of duty and causation in this claim of clinical negligence by Mr Graham Thorley (dob 13.4.53) against the Defendant Trust. In February 2002 he was diagnosed with atrial fibrillation (AF), a condition that carries an increased risk of blood clots and consequent thromboembolic events including stroke. Accordingly his treatment for this condition included a daily 3.5mg dose of warfarin, an anticoagulant. In March 2005 Mr Thorley suffered chest pain. A review at the Trust's Sandwell Hospital concluded that investigation by coronary angiogram was necessary. This was arranged to take place on 27 April 2005. In accordance with the advice given to him because of the bleeding risk in any such procedure, Mr Thorley stopped his daily dose of warfarin for the 6-day period 23–28 April (inclusive) and restarted on 29 April at a reduced dose of 3mg. The angiogram on 27 April was uneventful and he was discharged home that day. However on 30 April he suffered an ischaemic stroke which has resulted in permanent and severe physical and cognitive disability.
Mr Thorley alleges that the Trust was in negligent breach of duty in that the cessation of warfarin should have been limited to the 3-day period 24–26 April (inclusive) and restarted at the usual 3.5mg, not 3mg. These breaches caused or materially contributed to the occurrence of the stroke.
The Trust denies breach of duty, save to admit that warfarin should have been restarted by no later than the day after the angiogram (i.e. 28 April) and at the previous dose of 3.5mg. As to causation, and whatever the conclusion on breach of duty, it contends that Mr Thorley would have suffered the stroke in any event.
The issues in this trial depend on the Court's assessment of the rival expert evidence, together with certain issues of law. Mr Thorley's wife and litigation friend gave uncontested evidence in a witness statement. The Trust called no evidence of fact. As to breach of duty, I heard from the cardiologists Professor Roger Hall and Dr T.R. Cripps; as to causation, from the haematologists Dr Trevor Baglin and Professor K. John Pasi. Contrary to various matters put to them in the course of cross-examination and then advanced in argument, I am quite satisfied that each at all stages carried out his task and gave his evidence impartially and in full accordance with his duties to the Court.
Before turning to the narrative of events, I should set out various matters which are uncontroversial as between the experts.
AF is a cardiac arrhythmia in which heart rate and rhythm are abnormal. In consequence of unsynchronised atrial contraction there is a pooling of blood in the atria with a risk of formation of blood clots (thrombi). These thrombi can then break off and pass into the circulation (embolise) causing obstruction of a blood vessel elsewhere in the body (thromboembolism). When a blood vessel in the brain is blocked this causes an ischaemic stroke, also known as a cerebrovascular accident (CVA). Accordingly AF carries an increased risk of thromboembolic events including stroke.
An objective measurement of thrombosis risk in patients with AF is provided by the CHADS 2 score. This scores the risk of stroke on the basis of AF in addition to other risk factors (e.g. cardiac failure, hypertension, age over 65, diabetes or previous stroke). On this measure and with a history of hypertension Mr Thorley had a (low) score of 1. Such a score has an adjusted stroke risk of 2.8% p.a. A score of 0 (AF with no additional risk factors) has an adjusted stroke risk of 1.9% p.a.
Warfarin is prescribed for AF patients to reduce the risk of the formation of clots and thereby the risk of thromboembolism including stroke. However, warfarin does not dissolve thrombus which has formed, nor therefore affect the consequent risk of thromboembolism.
The effect of stable warfarin treatment is measured by way of INR (International Normalised Ratio) which indicates the time taken for the blood to clot. The target INR for prevention of thromboembolism associated with AF is 2.5 (typical range 2.0 to 3.0); and the average dose required to achieve that target is between 3 and 5 mg. Mr Thorley's target INR was 2.5 and his regular dose was established at 3.5mg. In this case it will be of particular importance to consider what is meant by stable warfarin treatment.
Because of its anticoagulant effect, the major complication of treatment with warfarin is an increased risk of bleeding, including excessive or spontaneous bleeding after surgery and other invasive procedures. There is no dispute that this required Mr Thorley's warfarin to be stopped in the perioperative period of the angiogram; the issue on breach of duty is for how long, having regard to the balance of risk between bleeding and thromboembolic events including stroke.
Narrative
The essential narrative of events is largely uncontroversial. In February 2002 Mr Thorley, then aged 48, was diagnosed with AF and was prescribed long-term warfarin, taken each evening at about 6 p.m. He attended regular outpatient appointments at the anticoagulation clinic at Sandwell Hospital where his INR was checked and his dose of warfarin adjusted accordingly. By 2004/5 his INR and dose were fairly stable. Thus:
| Clinic date | Target INR | Actual INR | Warfarin dose (per day) |
| 22.10.04 | 2.5 | 2.4 | 3.5mg |
| 25.2.05 | 2.5 | 2.3 | 3.5mg |
| 31.3.05 | 2.5 | 2.6 | 3.5mg |
On 17.3.05 he was admitted to Sandwell Hospital with a history of two days of chest pain and some breathlessness. He was diagnosed with troponin negative acute coronary syndrome. He was started on 75mg aspirin daily; and discharged on 18.3.05 with arrangements for an outpatient coronary angiogram. The medical notes include the observation ‘needs to be off warfarin for four days’. The risk assessment included the observation that he was obese; with weight of 143Kg, height 1.84m and thus a body mass index of approximately 42.
The angiogram was arranged to take place on 27.4.05. On 19.4.05 at a pre-assessment clinic Mr Thorley was advised to stop taking warfarin prior to the angiogram because of the risk of bleeding at the time of cardiac catheterisation. In accordance with the advice received he took his last pre-angiogram dose on 22.4.05, i.e. so that he was off warfarin for 4 days prior to the day of the angiogram.
The consent form signed by Mr Thorley for the procedure included the statement ‘Serious and frequently occurring risks “See patient information 1/1000 risk of a serious complication which includes heart attack, stroke, bleeding or damage to blood vessels which in very rare cases can be fatal”’.
On attendance for the angiogram on 27.4.05 his INR was measured at 1.3; thus reflecting the 4 days without warfarin. The angiogram proceeded uneventfully and he was discharged at 4.30 pm. Mrs Thorley collected him from the ward. Her unchallenged evidence is that he told her that he had asked about whether he should restart his warfarin but the staff did not know. She then asked the junior doctor who said that he would go and find out. On his return the doctor asked Mr Thorley for the date of his next anticoagulant clinic appointment. On being told that it was in two days' time, i.e. Friday 29.4.05, the doctor told him to hold off restarting warfarin until then. The discharge notes record ‘patient to restart Warfarin after appointment on Friday’.
Mr Thorley duly attended the clinic on 29.4.05. His INR was recorded as 1.5. Since he had taken no warfarin since the reading of 1.3 on 27.4.05, the experts agree that this record of 1.5 must be an error. Mr Thorley was restarted on warfarin that day at about 6 p.m, but at a dose of 3mg rather than 3.5mg.
On 30.4.05 Mr Thorley suffered an ischaemic stroke. He was admitted to hospital as an emergency. His INR was recorded at 1.2. In consequence of the stroke that he suffers severe physical and cognitive disability.
Breach of duty
The duty and standard of care are of course determined by the principles established in Bolam v Friern Hospital Committee [1957] 1 WLR 582, as clarified by the House of Lords in Bolitho v City and Hackney Health Authority [1998] AC 232. Familiar as they are, they deserve repetition in this case. Thus the principal test in Bolam that a doctor ‘…is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a reasonable body of medical men skilled in that particular art… Putting it the other way round, a doctor is not negligent, if he is acting in accordance with such a practice, merely because there is a body of opinion that takes a contrary view’ (p.587); and the clarification in Bolitho that ‘…the court has to be satisfied that the exponents of the body of opinion relied upon can demonstrate that such opinion has a logical basis. In particular in cases involving, as they so often do, the weighing of risks against benefits, the judge before accepting a body of opinion as being responsible, reasonable or respectable, will need to be satisfied that, in forming their views, the experts have directed...
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